...because, um, it's actually not.

http://www.commondreams.org/newswire/2008/11/11-2

FOR IMMEDIATE RELEASE November 11, 2008 12:40 PM

CONTACT: Environmental Working Group (EWG) EWG Public Affairs, (202) 667-6982

WASHINGTON - November 11 - As the clock runs out on the Bush administration, officials at EPA handed industry another victory last month: it relied on a chemical industry-funded consulting firm to justify its decision not to set safety standards for the toxic rocket fuel component perchlorate in drinking water - a move that would have cost defense and aerospace contractors hundreds of millions of dollars in cleanup costs.

Instead of using real-world data, EPA officials contracted the perchlorate assessment out to the Chemical Industry Institute of Toxicology <http://www.thehamner.org/institutes/ciit/> (CIIT), which its website says was created in 1974 by "chemical industry leaders."

The consulting firm devised a computer model for the assessment that suggested that perchlorate-contaminated water and food presented relatively minor risks to humans. EPA officials used the CIIT data as a basis for refusing to crack down on water pollution caused by perchlorate.

A CDC national survey found perchlorate in the urine of every person tested and found that children between 6 and 11 had perchlorate levels 1.6 times higher than adults. Even more alarming, CDC researchers found that exposure to perchlorate at levels that are considered safe by EPA resulted in significant changes in thyroid hormone levels in the one third of U.S. women tested whose iodine levels are on the low side. These findings of high levels of human exposure have aroused great concern because tests show that the chemical disrupts production of thyroid hormones at these levels, and inadequate levels of thyroid hormones interfere with normal brain development and growth in infants and children.

 "It's simply mind-boggling that the EPA would base its actions on any advice from the chemical industry, which has millions of dollars at stake in EPA's position on perchlorate," said EWG senior scientist Anila Jacob, a medical doctor. "Worse yet, this particular industry consultant is notorious for cooking its results to please the industry. Its computer model is voodoo science, plain and simple."

"If President Bush moves forward with this giveaway to industry, we will ask the incoming Obama administration to reverse course immediately and implement stringent safety standards to protect future generations from exposure to this toxin," added Jacob.

CIIT is no stranger to controversy. Its 2004 risk assessment for formaldehyde claimed the chemical was 2,500 to 10,000 times less dangerous than EPA had previously asserted. Since 1981, the U.S. federal government has listed formaldehyde as a "probable human carcinogen." (Formaldehyde-treated plywood and other components were found to have sickened Hurricane Katrina survivors living in trailers provided by the Federal Emergency Management Agency.) 

The U.S. Appeals Court for the District of Columbia overturned EPA's formaldehyde loophole in 2007. Even so, EPA has continued to use CIIT assessments instead of making its own calculations or turning to risk assessment experts independent of the chemical industry. In a September 18 report, the U.S. Government Accountability Office (GAO) <http://www.gao.gov/products/GAO-08-1168T>  raised questions about CIIT's insistence that people are at low risk from formaldehyde emissions. CIIT researchers, GAO said, did not take into account 2003 and 2004 studies by the National Cancer Institute and the National Institute for Occupational Safety and Health that found a "relationship between formaldehyde and certain cancers, including leukemia."

EPA issued its preliminary decision not to regulate perchlorate on Oct. 10.  At that time, the agency set a deadline of 30 days, to Nov. 10 for public comments. EWG and other environmental groups pressed for a 60-day extension, to Jan. 9, 2009, to allow more time for discussion. Yesterday [Nov. 10], EPA granted an 18-day extension, to Nov. 28. EWG responded by renewing its request for an extension to Jan. 9. The letter from EWG to the EPA is attached to this release.  

###

Please click over to Age of Autism to read Kent Heckenlively's informative post on this topic. Here are a couple of paragraphs to give you a taste:

"It’s been part of the autistic canon for so long that it often gets overlooked in our discussions of autism.

That is the observation that prior to the development of autism, many of our children had multiple ear infections, which were then treated with antibiotics.  Many parents believe the antibiotic treatment in some way set the stage for their child’s autism.  I know that my own daughter had several ear infections in her first year of life which were treated with antibiotics."

well, you know. I guess this is the easiest thing to do when you've given up being able to control the amount of crap put into our food by the Chinese (or hell, even American or European) companies. Just say the crap isn't crap! Just like thimerosal, tobacco, perchlorate (oops, no, that's the EPA), and BPA (oh, wait, they're not sure about that one, are they?).

It's pretty clear that the US government doesn't want to tick off the folks at Nestle or Bristol-Myers Squibb. What I'd like to see here is a strong statement from the Surgeon General contradicting these findings and asking why more American mothers aren't breast-feeding their children instead of feeding them a combination of powder and poison. It's practically free--even if you pump, you only have to buy the pump once--and it's better for your baby in every possible way.

http://www.bloomberg.com/apps/news?pid=20601124&sid=akqGpCNTbElU&refer=home

Small Melamine Amounts in Formula Are Safe, FDA Says (Update2)

By Catherine Larkin

Nov. 28 (Bloomberg) -- The industrial chemical melamine is safe in baby formula in small amounts, U.S. regulators said, revising their earlier recommendations.

The Food and Drug Administration’s discovery of melamine and a byproduct of the chemical in two U.S.-made formulas doesn’t pose health risks, said Stephen Sundlof, director of the agency’s Center for Food Safety and Applied Nutrition, on a conference call today with reporters. The FDA had said before finding the contamination that melamine may be harmful in infant formula in any amount.

The FDA began blocking Chinese milk products from entering U.S. ports this month after melamine-tainted milk sickened more than 50,000 children in China since September. Members of Congress and consumer groups criticized the agency earlier this week for not publicly disclosing that a formula made in the U.S. had also tested positive for “trace” amounts of the chemical.

“The domestic supply of infant formula is safe,” Sundlof told reporters today. Switching infants from these or other formulas may mean the babies receive inadequate nutrition, he said.

Melamine, a chemical used in plastics and fertilizer, also has been found in Chinese eggs and feed for farmed fish. Ingesting the chemical can lead to kidney damage or even death.

In China, officials said melamine was added to milk illegally to artificially boost protein readings. The FDA said that wasn’t the case with the U.S. samples. Melamine is approved for use in some food containers and may leach from packaging, Sundlof said.

“I don’t know the reason it is appearing in some products and not others,” he told reporters. “I really don’t want to speculate on why it is in some and not in others because the real answer is that we don’t know at this point.”

74 Products Tested

The FDA began testing infant formula in September and has so far analyzed 74 of the 87 products it has collected. None of the samples contained both melamine and a related compound, cyanuric acid. After reviewing the samples and animal studies, the agency decided that either melamine or cyanuric acid alone is safe in formula at 1 part per million or less.

Nestle SA’s liquid Good Start Supreme Infant Formula with Iron tested positive for melamine in as much as 0.14 parts per million, and cyanuric acid was found in Bristol-Myers Squibb Co.’s powder Enfamil Lipil with Iron, in as much as 0.249 parts per million, Sundlof said.

No Safety Determination

The FDA still doesn’t know what level is safe if both compounds are present in formula because the combination has been linked to more buildup in the kidneys. For other foods, that level is 2.5 parts per million.

“FDA and formula companies both owe parents a promise to move quickly to limit avoidable sources of these compounds in infant formula, and provide data to prove that low-level exposures will not cause harm,” said Sonya Lunder, a senior scientist with the Environmental Working Group in Washington, in an e-mail today.

“Mead Johnson remains confident in the safety of our products, and so should parents and health-care professionals,” said the Mead Johnson unit of Bristol-Myers in an e-mailed statement. “We maintain stringent standards at all our manufacturing sites to ensure high quality, safe products.”

David Mortazavi, a spokesman for Nestle Infant Nutrition, didn’t return a voice mail and e-mail.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net. Last Updated: November 28, 2008 18:34 EST

...but at least you can sue them.

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/11/26/BA7G14C3N5.DTL

This is the problem (well, one of many) with the Republican party. True conservatism would include preserving the environment, particularly working to curb pollution and toxic emissions. Bush is letting us down (again).

http://features.csmonitor.com/environment/2008/11/25/democrats-brace-for-%E2%80%98midnight-rules%E2%80%99-from-bush/

Democrats brace for ‘midnight rules’ from Bush

White House hastens to put new regs in place – and out of Obama’s reach, watchdogs say.

By Mark Clayton| Staff writer of The Christian Science Monitor/ November 25, 2008 edition

Will last-gasp “refinements” to the Clean Air Act let power plants locate near national parks next year? Will a new federal rule allow coal-mining debris to be dumped closer to streams? Will factory farms soon get a pass on reporting hazardous chemical releases?

So goes the worry list of environmentalists awaiting what they suspect may be an avalanche of last-minute “midnight rules” by the Bush administration that favor industrial polluters by relaxing or undermining environmental standards.

It has become a rite of outgoing presidents to push through, in their final weeks, federal regulations they favor to extend their policies beyond their administrations. Once such a rule is formally enacted by being printed in the Federal Register, the law usually requires another 30 to 60 days to pass before the rules take effect. After that, a rule can be very difficult to reverse.

But while a rule is not yet in effect, it is vulnerable. A raft of last-minute rules that President Clinton did not publish quickly enough were put on hold the day after President Bush took office in 2001. By contrast, Mr. Clinton’s “Roadless Rule,” which restricts road building on federal land, was published and in effect in time. It has been impossible for the Bush White House to undo. Apparently mindful of this, White House Office of Management and Budget (OMB) chief Joshua Bolten, in a memo this spring, had told federal agencies to have rules to his office for vetting no later than Nov. 1 so they could be in effect by Jan. 20, 2009 – Inauguration Day.

But there is rising hope among environmentalists and Democratic lawmakers that any last-minute onslaught will be blunted this time, if not turned back entirely. They look to a little-known and little-used law called the Congressional Review Act of 1996.

The CRA gives Congress fast-track authority to hold filibuster-free votes on regulations if they were enacted within a certain time frame – 60 legislative days – after Congress had adjourned. Given Congress’s frequent ad­­journ­­ments this year, the law may allow the new Congress to vote on regulations enacted by the Bush administration as far back as June, regulatory experts say.

“Usually these rules are very difficult to reverse, except this year might be different,” says Veronique de Rugy, a senior fellow at the Mercatus Center at George Mason University in Fairfax, Va., and an expert on midnight regulations. “Congress could use the CRA, and that would create an expedited process to repeal any rule by simple majority vote. I suspect this time we’re going to see a lot of that happening.”

One key reason the CRA is not often used is that it requires a rare alignment of stars in the political sky: President and Congress must be of the same party. That’s because CRA legislation can be used only at the beginning of a new presidential term, and all CRA bills go to the new president – who can veto them. Presidential vetoes are unlikely this time, since the incoming Obama administration is on the same wavelength as the incoming Democratic-majority Congress.

Ironically, the 1996 law was passed by the Republican-dominated House, led by Newt Gingrich, to try to thwart the first-term Clinton White House from pushing through its own midnight rulings.

Congressional aides say Demo­crats are already fine-tuning CRA-based legislation to turn back some expected rules if the Obama administration is unable to do so through executive action. One expected Bush rule, for example, would undermine the Endangered Species Act – critics say – by relaxing requirements for federal agencies to consult about the effects of their actions on endangered species and critical habitat.

“We are drafting legislation as we speak to block the rule that would harm the Endangered Spe­­cies Act,” says Eben Burnham-Snyder, an aide to Rep. Ed Markey (D) of Massachusetts. Mr. Markey chairs the House Select Committee on En­­ergy  Inde­pen­dence. “It would be something you’d see very quick action on – and that’s why we’re making sure to have legislative language action-ready,” Mr. Burnham-Snyder says.

That sort of ramping-up on Cap­­­­­itol Hill cheers environmentalists.

“Obviously the Bush administration has made a conscientious effort to get these rules done in a way that’s more difficult to overturn,” says Josh Dorner, a spokesman for the Sierra Club.

“But they apparently didn’t take into account the potential of the timing in the CRA to overturn some of these things.”

Bush administration spokesmen dispute such a dour characterization of the administration’s efforts, saying that most rules now in the pipeline have been in the public eye and subject to public comment for several years.

“This president set out with a very aggressive en­­vironment­al agenda when he took office – and this is the culmination of this work,” says Jon­­­athan Schra­der, a spokesman for the Envi­ron­mental Protection Agency. “Some of the New Source Review work [part of the Clean Air Act] was set out as long ago as 2004…. None of this is a surprise. It’s the culmination of years of work … to keep the environment clean and safe.”

Some dimensions of the Bush rule-writing push are beginning to emerge.

Between Nov. 1 and Nov. 20, at least 47 new federal rules from the En­­viron­­mental Protection Agency, the Depart­ment of Interior, and the De­part­ment of Energy were being reviewed by the Of­­fice of Management and Budget, according to Ms. de Rugy’s tally of OMB data. Of those, 15 are “economically significant” rules – that is, having an impact of $100 million or more, she says.

At that rate, there could be more than 70 economically significant rules enacted between Nov. 1 and Jan. 20, the day President-elect Obama takes office, de Rugy says. By comparison, just eight economically significant regulations were reviewed by OMB during the same period a year ago. Under President Clinton, the OMB reviewed 49 economically significant rules between Nov. 1, 2000 and Jan. 20, 2001, when George W. Bush took office.

If President Bush keeps to that pace, the Obama administration may be faced with hundreds of rules that could come under CRA review. There have been 307 rules enacted by those three federal agencies alone since July, 63 of them economically significant, de Rugy says.

“There’s a lot that the president can do using his executive authority without waiting for congressional action, and I think we will see the president do that,” said John Podesta, Obama’s transition chief, in a FOX TV network interview.

For those rules that have already been published, reversing them won’t be easy. And even the CRA has a downside. It must be used wisely or it may do more harm than good. For one thing, once the CRA has been used to repeal a rule, the agency cannot reintroduce a modified rule on that issue, potentially leaving legislative and enforcement gaps, de Rugy notes.

It’s also unclear whether CRA allows many rules to be bundled together so they can be voted on to reverse them en masse. They may have to be addressed one at a time, which is de Rugy’s interpretation of the law.

That could be a problem, given the landslide of last-minute rules that seems to be coming.

“The Bush administration is working in a way that it hopes to be more effective in cementing these rules in place,” says Matt Madia, regulatory policy analyst for OMB Watch, a liberal-leaning government watchdog group. “It’s going to be more difficult for the Obama administration to do anything, so it’s going to be in the hands of Congress.

Proposed rules on environment

The Bush administration is preparing to put scores of new rules on the books in its waning days, a phenomenon known as “midnight regulation.” Several dozen rules regarding environmental issues are involved, including some that could have major impacts.

Here are some of the more controversial proposed rules, according to OMB Watch, a liberal-leaning government-watchdog group in Washington:

Mountaintop mining. The proposed new rule would allow mining companies to dump rock and dirt from mountaintop-­removal mining closer to rivers and streams.

Endangered species consultation. The rule would alter implementation of the Endangered Species Act by letting federal land-use managers approve projects like highways, mining, or logging without consulting federal habitat managers and biological health experts responsible for species protection. Currently, consultation is required.

Air pollution near national parks. The proposed rule would ease current restrictions that make it difficult for power plants to operate near national parks and wilderness areas.
Runoff and air pollution from factory farms. Under new rules, factory farms could let their runoff pollute waterways without a permit. (The rule circumvents the Clean Water Act, allowing for self-regulation.) Another rule would exempt factory farms from reporting air pollution emissions from animal waste.

New Source Review changes. The rule would change the Environmental Protection Agency’s New Source Review program, which requires new facilities or renovating facilities to install better pollution-control technology, by making fewer facilities subject to its requirements.

Environmental impacts of fishery decisions. The rule would transfer the responsibility for examining the environmental impacts of federal ocean-management decisions from federal employees to advisory groups that represent regional fishing interests. The rule would also make it tougher for the public to participate in the environmental assessment process required by the National Environmental Policy Act.

http://www.usatoday.com/news/health/2008-11-25-congress-phthalate-ban_N.htm

Lawmakers push government to enforce chemical ban in toys

Congress in August passed a landmark consumer safety law that raises standards for toys and virtually bans several hormone-like chemicals called phthalates in products for children under 12.

Lawmakers wanted toys with the controversial chemicals to be off the market when the law takes effect Feb. 10, according to a statement from Sen. Dianne Feinstein, D-Calif., co-author of the ban.

Last week, however, a staff attorney at the agency responsible for carrying out the new regulations — the Consumer Product Safety Commission — released a legal opinion stating that stores may continue to sell toys with phthalates, as long as those items were made before Feb. 10. That could allow toys with phthalates to remain on the shelves for years, with no way for parents to know which toys contain the chemicals, Feinstein says.

Feinstein and others are concerned about phthalates — which are found in countless consumer products, from shower curtains to raincoats — because studies show they affect the hormone system. An October study, for example, found that baby boys born to mothers with high phthalate levels were more likely than others to have undescended testicles and small penises. Scientists say people can be exposed to phthalates through dust, and that babies can be exposed by chewing on toys such as rubber bathtub ducks.

The safety commission's general counsel, Cheryl Falvey, has said that lawmaker's intentions weren't clear.

In a letter sent to the safety commission on Monday, Feinstein and three members of the House of Representatives called on Falvey to reverse her decision. Sen. Barbara Boxer, D-Calif., has written a similar letter.

Falvey's interpretation of the safety bill "is harmful to our children and a blatant disregard for the law," Boxer said in a statement. "Ms. Falvey's claim that our intent was not clear is a pathetic and transparent attempt to avoid enforcing this law. It is beyond me that as they exit the scene, this administration is still carrying out its malicious actions to weaken environmental protection for our families."

Julie Vallese, a spokeswoman for the safety commission, says her agency is committed to protecting children from dangerous chemicals. But she says the agency has to carry out the law as it's written. New safety standards, she says, have never applied to items produced before those standards go into effect.

"The authors of the legislation should have done their homework," Vallese said in an e-mail. And although Falvey had no comment, Vallese notes that Falvey is a "career" government employee, not a political appointee. "Senator Boxer should know better than to attack the hard work and dedication of career employees."

Of course the company won't admit any wrongdoing, but I think we all know what's up here, don't we?

http://www.google.com/hostednews/ap/article/ALeqM5hgMbA-YQm5Z3B6_jlHONvHDLKwYAD94M7G3G0

Some good news, some bad, actually. The FDA is considering requiring drug-pushers to include a phone number for side effect reporting on TV drug ads; the agency is also in danger of becoming a "failed institution," according to a former executive. I second that emotion! I also hope the side effect phone number goes to the US government and not to drug companies, because although I don't trust the FDA, I trust Big Pharma even less...

http://www.washingtonpost.com/wp-dyn/content/article/2008/11/25/AR2008112502219.html

Ailing FDA May Need a Major Overhaul, Officials and Groups Say

By Rob Stein

Washington Post Staff Writer
Wednesday, November 26, 2008; Page A02

The Obama administration will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries.

Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.

But morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.

"FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."

Alarm about the agency began to spike after a series of highly publicized incidents, including the discovery that the painkiller Vioxx caused heart attacks. That has been followed by other safety issues, including questions about the widely used diabetes medication Avandia and several psychiatric drugs.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

At the same time, there has been increasing alarm about the agency's ability to protect the food supply -- concerns highlighted by recent major outbreaks of E. coli infection in spinach and salmonella in spinach and peppers. That has prompted calls to split the agency in two -- with one dedicated to drugs and the other to food.

"Food safety tends to get short shrift," said Christopher Waldrop of the Consumer Federation of America. "The drug side tends to get much more attention than the food side. Food is equally important and needs to get the attention it deserves."

Both the food and drug parts of the FDA's responsibilities have been hobbled by its inability to adequately monitor goods pouring into the United States from around the world, including food, drugs and raw materials, many say. Such concerns were highlighted by contaminated toothpaste from China; tainted pet food that killed hundreds of dogs and cats; and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.

"The agency is still stuck at the border," said Carl R. Nielsen, who was in charge of the FDA's import operations for the last six of his 28 years at the agency. "There has to be radical reorganization -- no doubt about that."

Although the FDA has started opening offices overseas to try to better police safety standards at the source, experts say much more needs to be done. For starters, the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems, which are woefully antiquated and disjointed, Nielsen and others said.

"It's still largely a paper-driven agency," Nielsen said. "The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today."

The FDA has also been one of the many federal agencies where Bush administration critics say ideology has trumped science, citing the long delay in approving the over-the-counter sale of the emergency contraceptive Plan B.

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Questions have also been raised about the agency's handling of suspected toxins such as bisphenol A in baby bottles and other products. And internal dissension has erupted publicly from the usually hermetically sealed agency. Last week, the House Energy and Commerce Committee released a letter from FDA scientists complaining about "serious misconduct" by top managers who oversee medical devices.

The turmoil comes as the FDA is facing a host of new demands, including the next wave of drugs and other products resulting from breakthroughs in genetics, nanotechnology and bioengineered foods, among others. And Congress may give the FDA the power to regulate tobacco for the first time.

"This would be a totally new regulatory responsibility that the FDA doesn't have expertise in," said Mark B. McClellan, who led the agency in President George W. Bush's first term.

While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.

"There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources," McClellan said. "The most important thing is overall effective leadership that leads in a way that establishes public trust."

Many hope the new administration will quickly name a new FDA commissioner -- a post that has frequently been left in the hands of acting commissioners for long periods. An acting commissioner ran the agency for more than half of the past eight years.

"The FDA can't be left to drift," said Hubbard, the former official. "There's a lack of leadership when a caretaker is in charge, and the FDA can't afford that."

* * *

http://www.google.com/hostednews/ap/article/ALeqM5j3-F1p4HIlUjQ1OHdqpvoISZNphAD94M48801

http://therpmreport.com/Free/9c594f11-fdc1-49b3-b5d5-dfb4fc3ba922.aspx?utm_source=RPMel

Sunday, November 23 2008

Surprise! Drug Approvals Increase in 2008 

By Michael McCaughan

Its official: FDA’s drug center has approved more new molecules in 2008 than it did in 2007—despite missed user fee deadlines, a regulatory posture defined as “safety first” and a general perception that its never been harder to get drugs to market. Maybe there is an upside to the new regulatory system after all.

 

Missed user fee deadlines. Multiple cycle reviews. A regulatory posture defined by the phrase “Safety First.” Complex new legislation. Understaffed, overworked review divisions. A hostile Congress eager to second-guess any and every decision. Divergent viewpoints built into the review process. Demands for more advisory committees with fewer conflicts of interest.

No wonder it is harder than ever to get drugs through FDA.

Maybe not.

The approval of Eisai’s antiseizure medicine Banzel (rufinamide) on November 14 marked a quiet milestone for FDA’s Center for Drug Evaluation & Research, the group charged with reviewing all new drugs and most therapeutic biologics: it was the 18th new molecule approved by the agency this year.

That matched the full year tally for 2007, and then with two more approvals the week of Nov. 21, CDER officially moved ahead of last year’s total, with six weeks still left in the year.

Don’t run out and buy all the champagne quite yet: remember, 2007 was the single worst year for new drug approvals in a quarter century. Improving on that performance is hardly cause for a parade.

But it is good news nevertheless. As recently as July, it looked like FDA might be on track for yet another new low in output: with only six approvals in the first half of the year—one fewer than the first half of 2007.

Well, the pace has picked up (as we predicted it would). And with at least 10 more applications still pending with a shot at approvals this year, it may turn out that 2008 is the best single year for approvals since 2004. (CDER approved 36 novel products that year. Don't expect miracles: five or six more approvals maybe, but 18 more approvals in the next six weeks is out of the question.)

Even a really strong finish by FDA in 2008 wouldn’t mean that much in the grand scheme of things. After all, 2004 was just a one-year blip in what has been a prolonged drought in new product approvals—at least compared to the 1990s. What industry needs is not one big year, but a long term, sustained increase in the output of new products coming to market.

Still, the thought that FDA will end up approving more drugs this year than last offers a much needed sign of hope for the biopharma industry. Maybe—just maybe—the new era in drug regulation ushered in by the FDA Amendments Act of 2007 won’t be so bad after all.

Industry accepted FDAAA as a tough but necessary trade, hoping that the tighter safety regulation would give FDA more confidence to approve drugs that would otherwise languish at the agency. There’s no question about the tougher regulation: as “The Pink Sheet” reported, about one-third of new molecule approvals have a formal Risk Evaluation & Mitigation Strategy attached to them, and more than half have mandatory post-marketing study requirements.

Its impossible to say for sure whether the other half of the trade will come to pass, but at least the trend is in the right direction.

In fact, Banzel may be the perfect emblem for the year 2008. It was a multi-cycle review (the application was first submitted almost exactly three years ago); it slipped passed the final review deadline (Eisai’s resubmission was due for action on Aug. 29); and the approval carries with it a formal REMS requirement as well as some mandatory post-marketing trials.

But it is approved for marketing. And, despite everything, that is something that seems to be happening a bit more often this year than last....

Maybe yet another reason the Atkins diet works...

http://news.yahoo.com/s/nm/20081124/hl_nm/us_high_protein

High-protein meals may help overweight burn fat

By Amy Norton Amy Norton – Mon Nov 24, 11:39 am ET

NEW YORK (Reuters Health) – Higher-protein meals may help overweight and obese people burn more fat, the results of a small study suggest.

Research has shown that overweight people are less efficient at burning fat after a meal than thinner people are. In the new study, Australian researchers looked at whether the protein composition of a meal affects that weight-related gap.

They found that overweight men and women burned more post-meal fat when they ate a high-protein breakfast and lunch than when they had lower-protein meals. That is, the added protein seemed to modify the fat-burning deficit seen in heavy individuals.

"Our research suggests that people with higher body fat burn fat better after a high-protein meal than people with lower levels of body fat," lead researcher Dr. Marijka Batterham, of the University of Wollongong in New South Wales told Reuters Health.

A number of studies have suggested that high-protein diets may help people shed weight more easily -- possibly, in part, because protein suppresses appetite better than fat or carbohydrates do.

The current study did not look at weight loss, so it's not possible to tell whether the increased fat-burning seen in overweight participants would translate into fewer pounds over time, Batterham said.

But answering that question, she said, will be the next step.

The findings, published in the journal Nutrition & Dietetics, are based on 18 adults whose post-meal metabolism was tested on 3 separate days. The average age was 40 years, eight subjects were overweight, six subjects had a normal weight, and four were obese.

On day one, they were given a "control" breakfast and lunch composed of 58 percent carbohydrates and 14 percent protein. On the other 2 days, their meals were more balanced, with about one third of calories coming from protein and another third from carbohydrates.

In the 8 hours after the control meal, the investigators found that overweight and obese participants burned less fat than their thinner counterparts did. But that gap was closed when participants ate the higher-protein meals.

The protein-rich meals contained low-fat dairy, lean meat and eggs, along with bread and vegetables as carbohydrate sources. Batterham said she and her colleagues are now testing whether vegetarian sources of protein have similar effects on overweight adults' fat metabolism.

In general, experts recommend that people looking to bulk up the protein in their diets choose their sources carefully -- eschewing bacon and butter in favor of foods like fish, poultry, low-fat dairy, beans and nuts. SOURCE: Nutrition & Dietetics, December 2008

Ethanol... Let's let big companies get government subsidies to create bioengineered crops that could cross-pollinate with other crops (as well as killing honeybees) so they can sell us ethanol to feed our gas-guzzling SUVs. What a great idea. Then you hear about how genetically engineered crops are going to help end starvation in Africa. Excuse me while I go have a hearty chuckle. Anyone hear about any Africans getting more food out of corn that's grown for ethanol?

http://www.reuters.com/article/marketsNews/idUSN2453150420081124

USDA seeks comment on biotech corn tied to ethanol

It's nice to see more of this stuff coming to light. Chuck Grassley is doing his job--actually, he's doing the job the FDA should have done and the AMA should be doing, but thank goodness someone's doing it.

http://www.nytimes.com/2008/11/25/health/25psych.html?_r=1&bl&ex=1227762000&en=ab700f6adb9c70e5&ei=5087%0A

Research Center Tied to Drug Company

When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were “solely in the advancement of medical treatment through rigorous and objective study.”

But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J.” The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.

Dr. Biederman’s work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.

Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.

Massachusetts General said in a statement Monday that it took the accusations related to the research center “very seriously” and intended “to investigate these issues thoroughly.”

Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.

Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.

Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson, claiming that their children were injured after taking the medicines; they also claim that the companies minimized the risks of the drugs.

As part of the lawsuits, plaintiffs’ lawyers have demanded millions of documents from the companies. Nearly all have been provided under judicial seals, but a select few that mentioned Dr. Biederman became public after plaintiffs’ lawyers sought a judge’s order to require Dr. Biederman to be interviewed by them under oath.

In a motion filed two weeks ago, lawyers for the families argued that they should be allowed to interview Dr. Biederman under oath because his work had been crucial to the widespread acceptance of pediatric uses of antipsychotic medicines. To support this contention, the lawyers included more than two dozen documents, among them e-mail messages from Johnson & Johnson that mentioned Dr. Biederman. A judge has yet to rule on the request.

The documents offer an unusual glimpse into the delicate relationship that drug makers have with influential doctors.

In a November 1999 e-mail message, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman as payment for a lecture he gave at the University of Connecticut.

“Dr. Biederman is not someone to jerk around,” Mr. Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”

Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”

A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.

A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and “move forward the commercial goals of J.& J.,” court documents said.

“We strongly believe,” the report stated, “that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.

“Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events.”

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company “multiple times to propose the creation” of the center. “The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in” children and adolescents.

Documents show that Johnson & Johnson gave the center $700,000 in 2002 alone. Massachusetts General said in its statement on Monday that grant agreements indicated the center “was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”

A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson, said it helped finance the research center in 2002 “with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a Johnson & Johnson executive, included a brief abstract of a study of Risperdal in children with disruptive behavior disorder. The message said the study was intended to be presented at the 2002 annual meeting of the American Academy of Child and Adolescent Psychiatry.

“We have generated a review abstract,” Dr. Pandina wrote, “but I must review this longer abstract before passing this along.”

One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly. “So, if you could,” Dr. Pandina added, “please give some thought to how to handle this issue if it occurs.”

The draft abstract that Dr. Pandina put in the e-mail message, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as the author so the company could present the study to the conference, according to the message.

“I will review this morning,” responded Dr. Biederman, according to the documents. “I will be happy to sign the forms if you could kindly send them to me.” The documents do not make clear whether he approved the final summary of the brief abstract in similar form or asked to read the longer report on the study.

Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as the author. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it.

In June, a Congressional investigation revealed that Dr. Biederman had failed to report to Harvard at least $1.4 million in outside income from Johnson & Johnson and other makers of antipsychotic medicines.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked by Senator Charles E. Grassley, an Iowa Republican who is leading the Congressional inquiry, to check again, Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr. Grassley that it paid $58,169 to Dr. Biederman in 2001.

A Harvard spokesman, David J. Cameron, said Monday that the university was still reviewing Mr. Grassley’s accusations against Dr. Biederman. Mr. Cameron added that the university had not seen the drug company documents in question and that it was not directly involved in the child psychiatry center at Massachusetts General. Calls to Dr. Biederman were not returned.

Bravo to the whistleblowers!

This is the link to the whole article:
 
http://www.naturalnews.com/024910.HTML
 
 
 
 
 
 
 
Interesting happenings at the FDA:
 
 
 
NaturalNews) A group of scientists working in the FDA's Center for 
 
Devices and Radiological Health division has revolted against the 
 
Corrupt managers of its own department, accusing them of committing 
 
Crimes by claiming, "There is extensive documentary evidence that 
 
Managers at CDRH have corrupted and interfered with the scientific 
 
Review of medical devices."
 
 
 
Read the letter yourself here (PDF):
 
http://energycommerce.house.gov/Press_1...
 
 
 
The letter from the FDA's own scientists goes on to say, "It is 
 
Evident that managers at CDRH have deviated from FDA's mission to 
 
Identify and address underlying problems with medical devices before 
 
They cause irreparable harm, and this deviation has placed the 
 
American people at risk."
 
 
 
Congressman John, Dingell, chair of the committee which received the 
 
Letter, went on to charge that these FDA bureaucrats "approved or 
 
Cleared medical device applications in gross violation of laws and 
 
Regulations..." (http://energycommerce.house.gov/Press_1...)

That means they're bad for your unborn baby. The EWG has been reporting on this stuff forever (and their scientists have been digging into it and stirring the s***, thank God). Just say, "No" to chemicals of all kinds, and not just while you're pregnant. Do you really need that toxic home fragrance set?

Oh, and check out the comment from jack*** Tim Edgar from the plastic industry. He says he doubts the results of the study because it "asks a group of ladies to try to remember what they might have been subjected to prior to giving birth." No, see, Tim, the "ladies" worked at beauty salons where the chemicals to which they were exposed were easily discovered through purchase records. Also, if you use Aqua Net at your job every day, you're unlikely to forget it (an unlikely to say you did use it, if you did not). It's kind of like asking me if I used a computer at the place I worked when I was pregnant.

http://www.abcnews.go.com/Technology/Health/story?id=6309940&page=1

Not just for sale--already sold. These articles (from 2002) say it all, really, especially the first one. More are available here. A friend of mine recently told me that she doesn't think the mainstream medical journals are under the thumb of Big Pharma. I'm not sure what else you call it when every one of the doctors who writes drug reviews for your publication is paid up to $10,000 per year by each of the major pharmaceutical companies.

Oh, and Hi there, American College of Physicians in Philly! I hope you like what you're reading. Maybe it will change the way you practice medicine.


* * *


abcnews.go.com/sections/wnt/DailyNews/NEJM_policychange020612.html

The New England Journal of Medicine will announce Thursday that it has given up finding truly independent doctors to write and review articles and editorials for it, as a result of the financial ties physicians have with so many drug companies in the United States The Journal says the drug companies' reach is just too deep. In 2000, the drug industry sponsored more than 314,000 events for physicians — everything from luncheons to getaway weekends — at a cost of almost $2 billion. On top of that, many doctors accept speaking and consulting fees that link them to drug companies. No publication in this country influences the way your doctor treats an illness more than the New England Journal of Medicine. Since 1812, the Journal has scrutinized and published thousands of clinical studies. These "review" articles on drug therapy that can be pivotal. They tell doctors the strengths and weaknesses of new medications for everything form high blood pressure to obesity to cancer.

Now, the Journal will allow these critical evaluations to be written by people with financial ties to drug companies. "This change will allow us to recruit the best authors, the people who have experience with new treatments to write these editorials and review articles," said Dr. Jeffrey Drazen, the medical journal's editor-in-chief. Under the new policy, doctors writing reviews in the Journal can accept up to $10,000 a year from each drug company in speaking fees and consulting fees.

Concerns About Possible Bias
Not everyone thinks this is such a good idea.
"So if a doctor is doing that kind of business with four or five companies, he or she can get as much [as] $40- to 50,000 a year and not violate the new New England Journal policy," said Dr. Sidney Wolfe, the director of the Public Citizen Health Research Group, one of the country's largest medical consumer groups.

"The bias introduced by drug companies paying writers of review articles a large amount of money can have the consequence of slanting articles and influencing physicians in a way that isn't really in the best interests of their patients," said Wolfe. The Journal, in a letter to its readers, says the policy change is necessary because it simply could not find enough qualified authors who did not already have ties to drug companies.

"There are areas where we simply have not published anything because we didn't think we could get a person who was good to write in an area that had absolutely no interaction with a commercial entity," said Drazen. But Jerome Kassirer, who was the Journal's editor between 1991 and 1999, says he had no problem finding independent authors.

"There's a lot of depth in academic medicine, sufficient depth, so that it's almost always possible to find a first-class person to write an editorial or review article in which they do not have a conflict of interest," said Kassirer, now a professor at the Tufts University School of Medicine. Some doctors are concerned that by relaxing conflict-of-interest standards, the Journal is reducing the prestige and influence that it has taken 190 years to build.
 

Influencing Doctors

By Brian Ross and David W. Scott

Feb. 21
— It was doctors' night out last June at the world-renowned Museum of Modern Art in New York City, and the Saturday night party, put on by Pfizer Inc., was lavish.

The event was strictly private, closed to reporters, as the pharmaceutical company entertained a very select list of doctors and their guests. But Primetime's undercover cameras saw the kind of big-money splurge that some say drives up the cost of prescription drugs and corrupts the practice of medicine.

Further investigation into the $6 billion spent by drug companies for what they say is a way to educate doctors showed that tactics like lavish gifts and trips are surprisingly common. "It's embarrassing, it's extravagant and it's unethical," said Dr. Arnold Relman, a Harvard Medical School professor and the former editor of the New England Journal of Medicine. "It makes the doctor feel beholden … it suborns the judgment of the doctor."

But doctors seemed thrilled to have been invited for a weekend in New York City with some seminars along the way, with all expenses paid by Pfizer on behalf of one of its drugs, Viagra.

One Small-Town Doctor: $10,000 in Goodies

Few doctors were willing to talk publicly about their relationships with pharmaceutical companies, but one upstate New York doctor was willing to come forward. "It's very tempting and they just keep anteing it up. And it's getting harder to say no," said Dr. Rudy Mueller. "I feel in some ways it's kind of like bribery."

Disgusted by how the free gifts and trips add to the high price of medicine, and moved by the plight of patients forced to skip needed medication, Mueller agreed to provide Primetime with a rare glimpse of the astounding number of drug company freebies he was offered by various drug companies in a four-month period. He was presented with an estimated $10,000 worth, including an all-expenses-paid trip to a resort in Florida, dinner cruises, hockey game tickets, a ski trip for the family, Omaha steaks, a day at a spa and free computer equipment.

"It changes your prescribing behavior. You just sort of get caught up in it," said Mueller, who said he was offered a cash payment of $2,000 for putting four patients on the latest drug for high cholesterol. The company called this a clinical study; Mueller called it a bounty. "I've never been offered money before," he said. "I don't remember that 10, 15 years ago." Though Mueller normally declines the offers, he agreed to attend a dinner, which Primetime secretly taped. Not only were the doctors wined and dined, but each was also offered a payment of $150 for just showing up to listen to a pitch for a new asthma treatment for children. The company called it "an honorarium," but Mueller saw it differently. "Again, it's bribery," he said. "This is very effective marketing."

There's a wide range in value of the free gifts offered to doctors — from lavish trips to free Mother's Day flower bouquets for doctors willing to hear a pitch about a new osteoporosis medicine. In the latter example, when asked whether a floral shop was the most effective place for a discussion on pharmaceuticals, one of the representatives said, "I'm sorry, we're not allowed to comment on anything."

Detail Men

The goodies are dispensed by an army of drug company representatives known as detail men and women, of whom there are 82,000 nationwide. It's the job of the detail people to quietly befriend doctors, keeping close track of which doctors take the free gifts and then determining which drugs the doctors later prescribe. "I think it's sleaze," said Relman. "Anybody who's been in that position knows that yes, those gifts, $60, $100, $40, again and again, do influence your attitude about that company … and will influence the prescriptions that you write."

And the multibillion-dollar drug company blitz extends throughout the profession, even at the yearly gathering of one of the most prestigious medical groups, the American College of Physicians. It was like a carnival: Doctors could be seen taking free massages, free food, free portraits, free Walkman players, free basketballs, and from one company pushing a new antacid drug, free fire extinguishers.

Many doctors say it's no different than any other business or convention, and that it doesn't affect their medical judgment. But that's not the view of the new president of the American College of Physicians, Dr. William Hall, who says anything beyond a pen or a mug could have an impact.

"Whether we like it or not, it can cloud our clinical judgment," he said. "Unequivocally, I would say that."

So why are some of the very practices Hall publicly criticizes permitted at his group's supposedly scholarly convention? "I think there it's a situation where every physician is going to have to balance what's right or wrong," said Hall. "We are concerned about it.," he added, saying that at some point the system may be changed.

But right now, Hall's group receives $2 million a year from the drug companies to have their exhibition booths at the convention, yet another example of how the big drug companies spend billions to influence doctors in this country.

"The basic mistake we're making with our health-care system now is that we regard it as just another business. And it's clearly not just another business. Patients, sick patients and worried patients, are not like ordinary consumers," said Relman. "Doctors ought to be incorruptible … That's the doctor's sacred obligation. They're being corrupted and undermined by this kind of salesmanship."
 

http://www.drugawareness.org/Drug_Firms_Still_Lavish_Pr.html
 


Drug Firms Still Lavish Pricey Gifts On Doctors

By Bill Brubaker
Washington Post Staff Writer
Saturday, January 19, 2002; Page E01  

A week ago last night, about two dozen doctors gathered for cocktails and dinner at the Plaza Hotel in New York, guests of a pharmaceutical company that planned to solicit their "advice" and "feedback" on the treatment and management of depression. The doctors didn't have to rush home after dinner. Forest Laboratories Inc. treated them to an overnight stay at the Plaza, where even the least desirable rooms -- those without Central Park views -- go for about $250 a night.

Saturday morning, after a free breakfast, the doctors participated in a four-hour discussion about depression, which can be treated with Forest's best-selling product, Celexa. Then, after a free lunch, each doctor was offered a token of Forest's appreciation: a check for $500. The Plaza event, and a more modest one that Pfizer Inc. sponsored Jan. 11 at the Improv comedy club in downtown Washington, illustrate how the harmaceutical industry spends an estimated $2 billion a year on events for doctors in the United States.

Despite a barrage of direct-to-consumer ads for drugs, only doctors can write the prescriptions needed for a sale.

Drugmakers have been wining and dining physicians for years, and the practice has been controversial enough to prompt periodic reviews by Congress and the American Medical Association. The issue was raised again Wednesday when board members from the AMA and the Pharmaceutical Research and Manufacturers of America, an industry trade group, met in Washington.

Timothy T. Flaherty, a Wisconsin radiologist and chairman of the AMA's board of trustees, said he's satisfied with the association's 12-year-old ethical guidelines on gifts. But, he said yesterday, "this is an issue that may be reopened." The guidelines say physicians should accept gifts worth only "in the general range of $100" and that serve a "genuine educational function" and "entail a benefit to patients." Last summer, the AMA launched a campaign -- funded largely by the pharmaceutical industry -- to reeducate the nation's 700,000 doctors on ethics.

The guidelines offer some wiggle room. Doctors who have been deemed "advisers" to drug companies, if only for a few hours, can accept honorariums and travel perks, for example. Forest Laboratories calls its advisers advertising/marketing consultants" in the confidentiality agreements they are asked to sign. Rep. Fortney "Pete" Stark (D-Calif.), who introduced a bill that would eliminate corporate tax deductions for perks given to doctors, called the AMA guidelines "window dressing."

"It's 'how to play golf often without having to call attention to the fact that the pharmaceutical companies are paying your greens fees,' " Stark said. A study published in 2000 in the AMA's journal concluded that doctors who have regular interactions with drug companies are influenced in their prescribing behavior by the gifts and perks they accept.

"From a business point of view, the drug companies do this because it works," said Julia Frank, a Washington psychiatrist. Critics say the practice helps drive up the use of expensive prescription drugs, a major factor in the escalating cost of health insurance. Pharmaceutical company executives say frequent interaction with doctors is necessary to gain insights into how their drugs can be more effective. "We don't have -- on staff -- doctors with all of the expertise in the areas that we work," Forest President Kenneth E. Goodman said before the meeting at the Plaza. "When we have a product where we are designing clinical studies . . . we go to outside experts to seek their advice.

"We might share with them clinical data and talk about . . . how could this be positioned in the market? You know, is this good data from a marketing standpoint? Is there something that would cause you to prescribe this product for your patients?" Ultimately, drug company executives say, the perks and gifts they give to doctors can boost corporate profits.

"Although Celexa is a product with a highly favorable profile for the treatment of depression, product virtues do not produce sales unless prescribers are informed and reminded of them," Forest Chairman, Howard Solomon, wrote in a letter to shareholders, published in the company's 2001 annual report. "And in markets with powerful competitors with immense budgets, it requires competitive budgets and super-competitive skills and highly motivated representatives to convey product information."

Forest reported profits of $215 million for its last fiscal year -- an increase of 91 percent over the previous year, with Celexa its biggest money-maker. The antidepressant competes against Eli Lilly's Prozac (now available in a generic form) and Pfizer's Zoloft, among others. Nothing in the AMA guidelines discourages doctors from accepting as many free breakfasts, lunches or dinners as they want.

Typical is the "evening of education and fun" Pfizer offered Washington-area doctors Jan. 11 at the Improv. Pfizer's invitation said the evening would begin with a reception, dinner and lecture on "antimicrobials and the treatment of respiratory tract infections." Then the lights would go down for Kathleen Matigan -- "voted female comic of the year."

The AMA guidelines say free meals must be "modest" and have an educational component.

How does the AMA define "modest"?

"It's a meal that you would typically go out to on a Tuesday night with your family," said Andrew M. Thomas, a physician and Ohio State University educator who is a member of the AMA's working group on ethical guidelines. "Probably not something that's at a five-star restaurant." The guidelines do not rule out five-star treatment -- or honorariums -- for doctors who provide "genuine" -- not "token" -- services as company advisers.

"The drug companies have invented this terminology -- advisory committee -- to get around the AMA guidelines," said Richard J. Brown, a retired New York psychiatrist. "Putting the doctors on an advisory committee avoids the ethical issue. You know, it's like you're on board with them." Brown is a critic of freebies, yet he makes the free-dinner rounds. "I no longer treat patients or write prescriptions so I am not influenced in that sense," he said. He recalled a "summit" in southern California last year, sponsored by Wyeth, at the Ritz-Carlton, Laguna Niguel in Dana Point, Calif. "They paid for a weekend at this resort plus air transportation -- ah, the whole schmeer," he said. "They spared nothing. It was just outrageous. They also gave me -- are you seated? -- $2,000 to attend."

The summit was called to announce new clinical data on Effexor XR, an antidepressant. All 120 guests were Wyeth "advisers," though some didn't serve in that capacity at the event, company spokesman Douglas Petkus said. Petkus said that while Wyeth supports the AMA's ethics campaign, "the guidelines are not specific enough to be a practical guide for everyday practice in our industry." Some doctors say drug companies are more interested in promoting products than gaining clinical insights.

"I don't think it's appropriate for doctors to even accept trivial gifts from these companies," said Dan C. English, a retired surgeon who taught bioethics at the Georgetown and the University of Maryland medical schools. "These gifts are an attempt to influence physicians to prescribe and overprescribe based on what the companies have done for them." Others say the perks don't influence them at all. "Doctors will do what's best for their patients," the AMA's Thomas said.

Stanley S. Moles, a Largo, Fla., cardiologist, doubts that many doctors would prescribe a drug based on information they got over a prime-rib dinner. "The guy that's giving the talk has been paid by the company to give that report," he said. "These guys are biased." Moles said he routinely declines invitations to such events. "I'm invited almost every day to a fine gathering to hear a 30-minute talk," he said. Thursday night, he had invitations to two dinners in Tampa -- at Ruth's Chris Steak House (Merck & Co. Inc.) and Fleming's Prime Steakhouse and Wine Bar (GlaxoSmithKline).

Moles chuckled. "Well, I did go to one about three years ago. They bugged me and bugged me and in a weak moment with a pretty sales rep I told her: 'I'll only go if you send a limo with a bottle of champagne.' And Merck sent a limo with a bottle of champagne and I took another cardiologist to an Italian restaurant in Tampa."

Gregory Reaves, a Merck spokesman, said such limo rides are not permitted under the company's gift-giving policy. What is permitted? "I can't discuss this," Reaves said, "because of the competitive and strategic activities that we deal with."  
 

    Physicians' behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary.

    Chren MM, Landefeld CS.

    Department of Dermatology, Cleveland (Ohio) Veterans Affairs Medical Center, University Hospitals of Cleveland 44106.

    OBJECTIVE--It is controversial whether physicians' interactions with drug companies affect their behavior. To test the null hypothesis, that such interactions are not associated with physician behavior, we studied one behavior: requesting that a drug be added to a hospital formulary. DESIGN--Nested case-control study. SETTING--University hospital. PARTICIPANTS--Full-time attending physicians. Case physicians were all 40 physicians who requested a formulary addition from January 1989 through October 1990. Control physicians were 80 randomly selected physicians who had not made requests. MAIN EXPOSURE MEASURE--Physician interactions with drug companies, as determined by survey of physicians (response rate, 88% [105/120]). RESULTS--Physicians who had requested that drugs be added to the formulary interacted with drug companies more often than other physicians; for example, they were more likely to have accepted money from companies to attend or speak at educational symposia or to perform research (odds ratio [OR], 5.1; 95% confidence interval [CI], 2.0 to 13.2). Furthermore, physicians were more likely than other physicians to have requested that drugs manufactured by specific companies be added to the formulary if they had met with pharmaceutical representatives from those companies (OR, 13.2; 95% CI, 4.8 to 36.3) or had accepted money from those companies (OR, 19.2; 95% CI, 2.3 to 156.9). These associations were consistent in multivariable analyses controlling for potentially confounding factors. Moreover, physicians were more likely to have requested formulary additions made by the companies whose pharmaceutical representatives they had met (OR, 4.9; 95% CI, 3.2 to 7.4) or from whom they had accepted money (OR, 1.7; 95% CI, 1.0 to 2.7) than they were to have requested drugs made by other companies. CONCLUSION--Requests by physicians that drugs be added to a hospital formulary were strongly and specifically associated with the physicians' interactions with the companies manufacturing the drugs.

    PMID: 8309031 [PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?
cmd=retrieve&db=pubmed&list_ui
ds=8309031&dopt=Abstract"Entrez-PubMed

 

http://bmj.com/cgi/content/full/324/7334/383/a

Authors of guidelines have strong links with drugs industry
Alison Tonks, Bristol

Most guidelines on clinical practice are written by experts with undisclosed links to the pharmaceutical industry, researchers from Toronto, Canada, say in an article in the journal of the American Medical Association (JAMA 2002;287:612-7[Medline]).

In a survey of nearly 200 authors of 44 clinical guidelines, 87% of respondents admitted to financial links with one or more pharmaceutical companies. Over half of the authors had been paid to conduct research, over a third had been an employee or consultant, and two thirds had received fees for speaking. On average each respondent had links with 10 companies, including companies whose products they recommended in guidelines. Only one of the 44 guidelines carried a declaration of the authors' competing interests.

"I'm not at all surprised by these findings," says Dr Bob Goodman, internist at Columbia University in New York and founder of No Free Lunch, the campaign for independent prescribing. "Other studies have already shown extensive links between physicians, researchers, and even policy makers and the pharmaceutical industry. It's particularly worrying, though, in the case of practice guidelines. These documents are widely distributed and intended to change physicians' practice.

"Any influence of a drug company on an individual author is multiplied thousands of times. Worse, there's a subjective element to the recommendations in clinical guidelines that makes them particularly vulnerable to bias."

Most (93%) of the study's respondents said their relationships with pharmaceutical companies did not affect their recommendations on treatment. But evidence cited by the researchers makes it clear that accepting money from drug companies alters prescribing, drives requests for additions to hospital formularies, and contributes to publication bias. The researchers were unable to check whether authors' financial interests influenced the treatments recommended in guidelines, because there were too few independent guidelines in the sample to make a meaningful comparison.

The study looked at guidelines on the management of 10 common diseases, including asthma, coronary artery disease, heart failure, depression, and peptic ulcer. All the guidelines were endorsed by professional societies in North America or Europe and were published between 1990 and 1999.

The researchers contacted 192 authors, but only 52% responded, despite a second mailing. They blame the low response rate on authors' reluctance to admit to links with drug companies and speculate that those who did not reply had even more to declare than those who did. If so, the links between authors of guidelines and the drugs industry are even more widespread than the study indicates, they conclude.

The researchers want a formal process built in to guideline development that forces authors to declare their financial interests. They also want written declarations of competing interests on every guideline.

Thought this might be interesting as well. Please do note all the references.


Just as the recent literature on professionalism ignores history, it slights  the structural barriers, apart from managed care, to the accomplishment of  the principles of professionalism. Most of the authors, for example, pay  little attention to the interactions between pharmaceutical companies and  physicians or the influence of such companies on undergraduate medical education and residency training. Despite the evidence that this influence is  far-reaching, the few analysts who do remark on the issue fail to convey its importance. Pellegrino and Relman,1 for example, assert that contributions from pharmaceutical companies should not dominate the budgets of professional  associations. But they do not cite the data showing how extensive these contributions are or discuss what the associations might have to do to survive without them. To select one example from an organization that specifies in its budget reports the contributions of pharmaceutical companies, all 21 major donors to the American Academy of Family Physicians in 1995 were drug companies.9 If more professional societies divulged information about such contributions, this example might be multiplied many times over. There is also substantial evidence that gifts from pharmaceutical companies (such as subsidies for meetings and travel) influence the prescribing practices and formulary choices of physicians.10 A discussion of threats to professionalism that does not address the influence of pharmaceutical companies omits a critical consideration, one that, unlike managed care, is largely subject to the control of physicians.

http://content.nejm.org/cgi/content/full/342/17/1284?ijkey=1cdZD.PCVPsgI
 

http://www.suntimes.com/cgi-bin/print.cgi
Ties to drug company raise vaccine questions

January 27, 2002

BY JIM RITTER HEALTH REPORTER

Next fall, thousands of Illinois schoolchildren are likely to have to get a chickenpox vaccine, under orders from the state health department. The department followed the recommendation of a panel of experts, its Immunization Advisory Committee, while rejecting the advice of others who thought the decision should be left to parents and pediatricians.  But in what critics consider a conflict of interest, 5 of the committee's 18 members have financial ties to Merck, which makes the chickenpox vaccine.

Two members of the committee have given talks for Merck, receiving up to $750 per speech. A third member directs a nonprofit group that has received $20,000 in grant money from the company. And two other members own stock in Merck, including one who has owned as much as $16,000 worth.

Though only one of these five members of the committee participated in the vote to recommend making the vaccine mandatory, the others participated inthe discussion, committee member Fran Eaton said.

Last year, the Illinois House and Senate unanimously passed a bill that would have banned anyone with financial ties to pharmaceutical companies from serving on the committee. But Gov. Ryan, who has received $9,000 in campaign contributions from Merck, vetoed the bill, and the Senate failed to override the veto. The bill was sponsored by Sen. Patrick O'Malley (R-Palos Park), who is running for governor.

Since 1994, Merck has contributed $75,050 to political candidates in Illinois, including Ryan.

Merck spokesman Christopher Loder said Merck seeks to "have a voice in the debate about the most effective means to achieve the goal of improving the state of health care." Mandating the chickenpox vaccine, he said, "is good public policy." When Ryan vetoed the bill last year, he said the restrictions on financial ties to drug companies would have severely limited the number of pediatricians, infectious disease specialists and other experts who could serve on the committee. Ryan noted that members are required to disclose financial interests in drug companies that exceed $5,000 and abstain from votes if they have a conflict of interest.

"The people who do this work are principled people," said committee member Robyn Gabel, executive director of the Illinois Maternal and Child Health Coalition. "The amount of money they get from the companies is not enough to do something that is harmful." But critics say the financial ties damage the committee's credibility. "It's outrageous that Gov. Ryan vetoed this," said Dr. Linda Shelton, an Oak Lawn pediatrician. "If you have even the appearance of impropriety, people won't trust you."

On the federal level, members of committees that advise the Food and Drug Administration and the Centers for Disease Control and Prevention on vaccine policy also often have conflicts of interest, according to a report of the House Government Reform Committee. The FDA approves vaccines, and the CDC issues guidelines for their use. The federal report examined the financial interests of expert advisers who endorsed a rotavirus vaccine to prevent childhood diarrhea. Shortly after the vaccine was approved, it was pulled from the market after being linked to severe bowel obstructions in babies that caused vomiting and bloody stools and sometimes required surgery.

The House committee report documented that members of the FDA and CDC advisory committees held stock in vaccine companies, owned vaccine patents, received grants and research funds from vaccine manufacturers and were paid speaking and consulting fees. Some of these members abstained from the vote to approve the rotavirus vaccine, but still participated in committee discussions, the report said.

"We've taken a good hard look at whether the pharmaceutical industry has too much influence over these committees," said committee chairman Dan Burton (R-Ind.) "From the evidence we found, I think they do."

The issue is part of a larger debate over whether the pharmaceutical industry wields too much clout over the nation's medical practices and health policy. Drug companies routinely give doctors free meals, medical textbooks, drug samples and generous speaking and consulting fees. Companies that develop new drugs pay for the studies that determine whether the drugs will be approved for use. Drug companies also are a major source of advertising dollars for medical journals, and they help pay for medical conferences.

Eaton, a non-medical member of the state immunization advisory committee and the only member to vote against the chickenpox vaccine, said she was "amazed at the number of lobbyists from pharmaceutical companies that attend these meetings." Industry representatives, she added, are on a first-name basis with committee members and sometimes participate in discussions.

In April 2000, the committee voted 6-1 to recommend requiring the chickenpox vaccine. Seven members were absent, three abstained and one recused himself, citing a conflict of interest. Eight months later, the health department received conflicting advice. The state Board of Health voted 4-3 against making the vaccine mandatory. Health board member Ernst Ott said people who attended three public hearings expressed overwhelming opposition to requiring the vaccine. And board member Colin McRae said there is no "far-reaching public health issue" to justify a mandatory vaccine.

Last October, Dr. John Lumpkin, the state's public health director, decided to make the vaccine mandatory. He said he weighed the advice from both committees, along with recommendations in favor of the vaccine from the CDC, the American Academy of Pediatrics, the American Academy of Family Physicians and his staff.

"It would not be fair to say that one committee had more weight than the other," said Lumpkin, whose order still must be reviewed by a legislative committee. "It was the sum total of all the information and recommendations."
 

This is a fantastic idea. I am not in any way affiliated with it, but I saw it online and figured I'd pass along the information.


About GiveWell

GiveWell started as a group of donors looking to accomplish as much as possible with our own giving.  We found that very little information is publicly available about what charities do and whether it works - even though individual donors (people without foundations) give over 100x as much every year as Bill Gates, and over 6x as much as all foundations combined.  We raised startup funds from our former coworkers; in our first year, we published public charity recommendations for equality of opportunity in the U.S. as well as international aid (see www.givewell.net/research-summary), and were featured in the New York Times and Wall Street Journal (seewww.givewell.net/press).

One of my closest friends loves the Sly Stallone movie Lock Up. It may be his favorite film. In it, Stallone plays Frank Leone, a man who has committed a fairly minor crime and is near the end of his prison sentence when he is transferred from his cushy prison to a tougher one run by Warden Drumgoole (Donald Sutherland). One of the other inmates at Warden Drumgoole's prison advises Frank, "DTA, man. Don't trust anybody."

Here are just a couple of reasons that's great advice for us when we're reading some new study about health, or when you hear a government official or a nutritionist tell you that he's not worried about sodium benzoate in soda:

http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040005&ct=1

Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles

Lenard I. Lesser^1¤, Cara B. Ebbeling¹, Merrill Goozner², David Wypij^3,4, David S. Ludwig^1*

1 Department of Medicine, Children's Hospital, Boston, Massachusetts, United States of America, 2 The Center for Science in the Public Interest, Washington, D. C., United States of America, 3 Department of Cardiology, Children's Hospital, Boston, Massachusetts, United States of America, 4 Clinical Research Program, Children's Hospital, Boston, Massachusetts, United States of America

Funding: This study was supported by a grant from the Charles H. Hood Foundation (Boston, Massachusetts, United States) and discretionary funds from the Department of Medicine, Children's Hospital Boston (Massachusetts, United States) to DSL. LIL was supported by a medical student research fellowship from the University of Rochester School of Medicine and Dentistry (Rochester, New York, United States). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: DSL is author of a book on childhood obesity (Ending the Food Fight).

Academic Editor: Martijn Katan, Vrije Universiteit Amsterdam, The Netherlands

Citation: Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007) Relationship between Funding Source and Conclusion among Nutrition-Related Scientific Articles. PLoS Med 4(1): e5 doi:10.1371/journal.pmed.0040005

Received: August 16, 2006; Accepted: October 30, 2006; Published: January 9, 2007

Copyright: © 2007 Lesser et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abbreviations: CI, confidence interval; OR, odds ratio

* To whom correspondence should be addressed. E-mail: david.ludwig@childrens.harvard.edu

¤ Current address: Tufts University Family Medicine Residency, Malden, Massachusetts, United States of America

Introduction

The extent of industrial funding for pharmaceutical research, and its implications for public health, have been extensively considered in recent years. Moses et al. reported that pharmaceutical firms provided 30% of the almost $100 billion spent on biomedical research in the United States in 2004 [1]. These expenditures raise concerns about the integrity of pharmaceutical research [2]. A meta-analysis by Bekelman et al. of 37 original quantitative studies of bias in pharmaceutical research found significant association between industry sponsorship and pro-industry conclusions (odds ratio [OR] 3.6; 95% confidence interval [CI], 2.63 to 4.91) [3].

In contrast, little information is available regarding the prevalence or impact of funding by the food industry on nutrition research. Whereas bias in pharmaceutical research could have an adverse effect on the health of millions of individuals who take medications, bias in nutrition research could have an adverse effect on the health of everyone. Findings of nutrition research influence the formulation of governmental and professional dietary guidelines, the design of public health interventions, and regulation of food product health claims. In addition, these findings may receive widespread publicity in the popular media, directly affecting consumer behavior.

Nestle examined a convenience sample of 11 studies from food, beverage, or supplement companies, reporting that “it [was] difficult to find studies that did not come to conclusions favoring the sponsor's commercial interest” [4]. Levine et al. found that authors taking a supportive compared to a critical or neutral position on the fat substitute olestra were much more likely to have a financial relationship with the manufacturer (80% versus 11% or 21%, respectively; p < 0.001) [5]. However, a systematic investigation of bias in nutrition research has not been conducted.

The aim of this study was to examine financial sponsorship of nutrition-related scientific articles, and whether sponsorship affects published conclusions. We hypothesized that scientific articles funded exclusively by the food industry or affiliated organizations would be more likely to have favorable conclusions than articles without industry-associated sponsorship. In 2003, approximately 10,000 nutrition-related scientific articles were published on many foods and nutrients, examining a variety of endpoints relating to numerous health states, and employing widely varying study designs (Medline literature search using the terms “nutrition” or “food” or “beverage,” limited to 2003, conducted on 15 March 2006). To avoid the methodological challenges arising from such great heterogeneity, we chose to focus our investigation on soft drinks, juices, and milk. The health risks and benefits of these three beverages have been the subject of much recent controversy, and the beverage industry is large and highly profitable, arguably creating an environment in which scientific bias might occur.

Methods

Design Overview

To avoid potential bias in our study design, coinvestigators independently selected articles for inclusion, analyzed article conclusions, and examined financial sponsors. Article conclusions were classified as “favorable,” “neutral,” or “unfavorable” by two coinvestigators who had no knowledge of financial sponsors. Funding source was classified as “all industry,” “no industry,” “mixed,” or “not stated” by another coinvestigator who had no knowledge of article conclusions. In addition, relationship of sponsors to the beverage being studied was characterized according to whether a favorable finding would have “benefit,” “no relationship,” or “antagonism” to apparent financial interests. Then, associations between funding source and article conclusion were calculated, with adjustment for relevant covariates in some models.

Selection of Articles

We aimed to take the broadest view of the literature within the area of beverages and health, and therefore included a range of article types in the categories of interventional studies, observational studies, and scientific reviews. Scientific reviews—but not commentaries, editorials, or letters—were included because these articles are abundant, often cited, and potentially influential, and generally presumed to be objective. (However, we found very few scientific reviews that declared a source of funding; therefore, the numerical contribution of these articles to analyses of potential bias was small. We also conducted an analysis with scientific reviews excluded, focusing on only interventional studies.)

Articles included in this study were initially identified by the study coordinator (LIL) using OVID-Medline literature searches. The literature searches were designed in consultation with a medical librarian to have high sensitivity and intermediate specificity for inclusion criteria using the following terms to identify articles focusing on the beverages of interest: soft drinks, carbonated beverages; fruit juice, apple juice, orange juice, prune juice, cranberry juice, grapefruit juice, grape juice, guava juice, pear juice, pineapple juice, vegetable juice, carrot juice, tomato juice; milk. Additional terms for health and disease states of interest were included in the searches.

We used six inclusion criteria for study articles: (1) The topic relates directly to soft drinks, juices, or milk, or an inherent component of one of these beverages (e.g., calcium in milk). (2) At least one main endpoint relates directly to health, disease, or a disease marker. For example, an article demonstrating a health benefit of antioxidants in juice would be included, whereas an article describing manufacturing techniques to maximize antioxidant concentrations in juice would be excluded. (3) The article involves or considers research with humans or clinical materials derived from humans. (4) Conclusions relate directly to the beverage under study. For example, an article examining the effect of dietary calcium on bone mineral density would be included only if implications to the health effects of milk consumption are stated explicitly. (5) The article is classified as an interventional study, an observational study, or a scientific review according to standardized criteria listed below (see Assessment of Covariates). Articles in the categories of commentaries, editorials, letters, and miscellaneous were excluded. (6) The article was published in the 5-y period between 1 January 1999 and 31 December 2003.

Articles identified by literature search were then examined individually by the study coordinator and removed if any inclusion criteria were not met. Several additional articles were removed from the study for the following reasons: article was coauthored by one of the coinvestigators involved in this study (to avoid potential bias); one of the coinvestigators involved in classifying article conclusions had previous knowledge of the article's sponsorship (also to avoid potential bias): or both coinvestigators involved in classifying article conclusions determined that all inclusion criteria were not met. (A list of included articles is available from the authors upon request.)

Classification of Article Conclusions

The study coordinator provided two coinvestigators (CBE and DSL) with each article's abstract and discussion/conclusion section (as available). The coinvestigators were given no information relating to the identity of the article (e.g., journal, title, authors) or to financial sponsorship. When electronic documents were available, a simple text file was utilized. For articles without electronic versions, photocopies were made that excluded or obscured any identifying information. The coinvestigators classified article conclusions independently and then met to resolve discrepancies, using the categories outlined below.

Favorable—if both coinvestigators agreed that: (1) the conclusions suggested beneficial health effects or absence of expected adverse health effects, and (2) no statements were made that cast the product in a negative light.

Unfavorable—if both coinvestigators agreed that: (1) the conclusions suggested adverse health effects or absence of expected beneficial health effects, and (2) no statements were made that cast the product in a positive light.

Neutral—if the coinvestigators agreed that the conclusions were neither favorable nor unfavorable, or if the coinvestigators could not agree on classification.

Characterization of Financial Sponsorship

The study coordinator examined each article (and supplemental material, if relevant) in its entirety for information about financial sponsorship. A coinvestigator (MG) was given a list of all sponsors of each article linked to the type of beverage under study (soft drinks, juice, or milk). The coinvestigator was given no further information relating to the identity of the article (e.g., journal, title, authors) or to its methods or results.

The coinvestigator used generally available information, obtained in part by Internet searches, to characterize each sponsor as: (1) industry—including for profit and nonprofit affiliations (e.g., US National Dairy Council), (2) industry-associated—including governmental agencies that work with industry to promote consumption of specific foods or commodities (e.g., US Department of Agriculture), (3) nonindustry—including governmental agencies with no industry association (e.g., US National Institutes of Health), university, and independent foundations, philanthropies, and other nonprofit organizations, and (4) unknown. Funding source was then classified for each article as outlined below.

All industry—if all sponsors were classified as category (1) above.

No industry—if all sponsors were classified as category (3) above.

Mixed—if any sponsor was classified as category (2) or (4) above, or if the article had sponsors that were classified into more than one category.

We considered the possibility that an industry sponsor might fund a study or scientific review examining a competitor's product. For example, milk and soft drink consumption are reciprocally related among children [6]; thus, a negative conclusion relating to soft drinks would arguably be advantageous to a dairy-affiliated organization. For this reason, the relationship of a financial sponsor to the beverage under study was characterized as outlined below.

Benefit—if a positive finding appeared to be in its commercial interest.

Antagonism—if a negative finding appeared to be in its commercial interest.

No relationship—if the sponsor appeared to have no commercial interest at stake.

Unknown—if commercial interest could not be determined.

Sponsors with no association or affiliation with the food industry (e.g., government, university, independent nonprofit) were characterized as “no relationship.” No articles in the “all industry” category had sponsorship that was characterized as “no relationship” or as “unknown,” nor did any have multiple sponsors in different categories. Thus, each “all industry” article could be subcategorized as “benefit” or “antagonism.”

Assessment of Covariates

Three covariates were examined: publication year (available from Medline), article type, and potential author conflict.

Article type was classified according to the following definitions: interventional study—if humans consumed, or if human tissue was exposed to, a food or food component with the intention of measuring a biological response; observational study—if data were collected on participants without the intervention of the investigators; and scientific review—if no original data were reported and if published research was analyzed in a systematic fashion.

Potential author conflicts for each article were identified if an explicit statement to this effect was made in the article about any author; or if a coinvestigator (MG) determined that the declared affiliation for any author might benefit from a positive conclusion relating to the beverage under consideration.

Statistical Treatment

To evaluate changes over time in the percentage of articles with declared funding, we used the Mantel-Haenszel chi-square test for trend and exact binomial 95% CIs.

For analyses of the relationship between conclusion and funding source, we focused on the most discrete categories of funding: all industry—benefit, no industry, and all industry—antagonism. Studies with mixed funding were excluded because they represent a heterogeneous group, with different proportions of industry funding, potentially obscuring underlying relationships. Studies with no listed funding were also excluded from these analyses.

We evaluated the association between article conclusion (favorable, neutral, and unfavorable) and funding source using an exact linear-by-linear association test, pooling all article types. When evaluating this association for only interventional studies, we used Fisher's exact test, collapsing articles with favorable and neutral conclusions.

Using logistic regression analysis, we calculated ORs of conclusions for all industry compared to no industry funding. We computed two sets of ORs, one collapsing articles with a favorable or neutral conclusion and the other eliminating those with a neutral conclusion. Adjusted analyses controlled for relevant covariates, including publication year, beverage type, and potential author conflict of interests. One all industry—antagonism article was categorized as unfavorable, a situation in which the sponsor was perceived to benefit from a negative conclusion about a competitor's product (see above). Therefore, we considered this article as favorable to the sponsor's interests, and reclassified it as such for the purpose of calculating ORs, per a priori hypothesis.

We used p < 0.05 (two-tailed) as a criterion for statistical significance. Computations were performed using software packages (SAS Institute, http://www.sas.com; Cytel, http://www.cytel.com; Stata Corporation, http://www.stata.com).

Role of the Funding Source

The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Results

Figure 1 depicts the flow diagram for inclusion of articles in the study. A total of 538 articles were retrieved in the searches, of which 332 were excluded. Descriptive data for the remaining 206 articles are presented in Table 1. Financial sponsorship was declared in 111 articles (54%). As shown in Figure 2, the proportion of articles disclosing sponsorship increased significantly from 1999 to 2003 (p for trend = 0.004). Considering all years together, 62% of interventional articles, 67% of observational articles, and 19% of scientific reviews indicated a funding source. Of those that reported sponsorship, 22% had all industry support, 47% had no industry support, and 32% had mixed funding.

Overall, article conclusion was significantly related to funding source, as shown in Table 2 (p = 0.037). Among interventional studies, those with all industry compared to no industry support were much less likely to have an unfavorable conclusion (0% versus 37%; p = 0.009) (Table 3).

The OR for a favorable or neutral versus unfavorable conclusion, comparing all industry to no industry support, was 6.18 (95% CI, 1.20 to 31.92) after adjustment for relevant covariates (Table 4). For the same comparison eliminating neutral articles, the OR was 7.61 (95% CI, 1.27 to 45.73).

Discussion

The main finding of this study is that scientific articles about commonly consumed beverages funded entirely by industry were approximately four to eight times more likely to be favorable to the financial interests of the sponsors than articles without industry-related funding. Of particular interest, none of the interventional studies with all industry support had an unfavorable conclusion. Our study also documented industry sponsorship was very common during the study period, indicating considerable potential for introduction of bias into the biomedical literature. In view of the high consumption rates of these beverages, especially among children, the public health implications of this bias could be substantial.

The strengths of this study include a systematic method for identifying articles using objective criteria, a multi-level review process in which separate groups of coinvestigators collected data about conclusions and sponsorships without access to information that might bias judgment, and examination of a dynamic period in financial disclosure, during which the proportion of articles indicating funding had increased.

The primary limitation of the study is that we included only articles pertaining to three beverage categories; thus, the generalizability of our findings to other areas of nutrition is unknown. Because the articles varied greatly in approach, we were unable to collect meaningful information about factors that might reveal specific causes of bias, such as study quality. In addition, we made no attempt to obtain independent information about study sponsorship beyond that declared in the articles, nor did we assess other types of financial support, such as provision of supplies. Inaccurate or incomplete information about financial sponsorship may have caused us to underestimate the true magnitude of the relationship between conclusion and funding source. During the study period, declaration of financial support remained incomplete, especially for scientific reviews.

Studies of research supported by the pharmaceutical industry have suggested several ways that bias might be introduced into clinical trials [7–9], and some of these might apply to nutrition research. We speculate that our findings may relate to one or more of the following possibilities: (1) Industrial sponsors may fund only those studies that they believe will present their products in a favorable light, or their competitors' products in an unfavorable light. In support of this possibility, all studies funded entirely by industry were characterized as “benefit” or “antagonism” with regard to the product under study (none were characterized as “no relationship”). That is, industrial organizations do not seem to sponsor articles about products in which they have no financial interest. (2) Investigators might formulate hypotheses, design studies, or analyze data in ways that are consistent with the financial interests of their industrial sponsors. (3) Industrial sponsors or investigators may choose to delay or not publish findings that have negative implications to the sponsor's product. (4) Authors of scientific reviews may search and interpret the literature selectively, in ways consistent with the sponsor's interests. (5) Scientific reviews arising from industry-supported scientific symposia, often published as journal supplements, may over- or under-represent certain viewpoints, if presenters whose opinions conflict with the sponsor's financial interests are not invited to participate.

Some might question the significance of our findings, arguing that no investigator could ever be completely free of bias. We agree that financial conflict is not the only cause of bias. Indeed, the hallmark of modern scientific method, the a priori hypothesis, indicates a preconceived notion of how an experiment will unfold. Moreover, long-standing scientific viewpoints, career considerations, and even political opinions might color study design or interpretation. However, these types of individual bias tend to cancel themselves out among large groups of scientists over the long term. While one investigator's career may rise on a cherished theory, another's may rise by debunking that theory. We contend that financial conflict of interest is qualitatively different, producing selective bias that acts consistently in one direction over time. This contention receives support from a study by Kjaergard and Als-Nielsen, who found that authors' financial competing interests, but not their other competing interests, biased the conclusions of clinical trials [8].

If the findings of our study are supported by additional research, several ways to reduce bias among nutrition articles could be considered, including voluntary refusal by scientists to accept industrial support, regulations by academic institutions ensuring that publication decisions and editorial control remain with the researcher, and more stringent policies by journals for publication of industry-sponsored studies and scientific reviews. Ultimately, increased government and other independent support for nutrition research will diminish the attractiveness of industry funding to investigators and dilute any bias resulting from publication of industry-funded science.

Acknowledgments

We thank Dr. David Blumenthal for stimulating discussions and Dr. Martin Lesser for statistical advice. We thank Alison Clapp, medical librarian, for help in designing the literature searches, and Michael Leidig for logistical support.

Author contributions. LIL and CBE participated equally in study design, data collection, analyses, and drafting of the manuscript. MG collected and analyzed data, and helped revise the manuscript. DW provided statistical advice, and helped revise the manuscript. DSL was the principal investigator, supervised the study, and helped write the manuscript.

References

1. Moses H 3rd, Dorsey ER, Matheson DH, Thier SO (2005) Financial anatomy of biomedical research. JAMA 294: 1333–1342. Find this article online
2. Blumenthal D (2003) Academic-industrial relationships in the life sciences. N Engl J Med 349: 2452–2459. Find this article online
3. Bekelman JE, Li Y, Gross CP (2003) Scope and impact of financial conflicts of interest in biomedical research: A systematic review. JAMA 289: 454–465. Find this article online
4. Nestle M (2001) Food company sponsorship of nutrition research and professional activities: A conflict of interest? Public Health Nutr 4: 1015–1022. Find this article online
5. Levine J, Gussow JD, Hastings D, Eccher A (2003) Authors' financial relationships with the food and beverage industry and their published positions on the fat substitute olestra. Am J Public Health 93: 664–669. Find this article online
6. Striegel-Moore RH, Thompson D, Affenito SG, Franko DL, Obarzanek E, et al. (2006) Correlates of beverage intake in adolescent girls: The National Heart, Lung, and Blood Institute Growth and Health Study. J Pediatr 148: 183–187. Find this article online
7. Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, et al. (2000) The uncertainty principle and industry-sponsored research. Lancet 356: 635–638. Find this article online
8. Kjaergard LL, Als-Nielsen B (2002) Association between competing interests and authors' conclusions: Epidemiological study of randomised clinical trials published in the BMJ. BMJ 325: 249. Find this article online
9. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL (2003) Association of funding and conclusions in randomized drug trials: A reflection of treatment effect or adverse events? JAMA 290: 921–928. Find this article online

* * *
http://www.eatright.org/cps/rde/xchg/ada/hs.xsl/media_16174_ENU_HTML.htm

American Dietetic Association Welcomes The Coca-Cola Company as an ADA Partner

FOR RELEASE MARCH 3, 2008

Media contact:  Jennifer Starkey      
800/877-1600, ext. 4802
media@eatright.org

CHICAGO — The American Dietetic Association, the nation’s largest organization of food and nutrition professionals, announced March 1 that The Coca-Cola Company has become an ADA Partner in the Association’s corporate relations sponsorship program. The program provides Partners a national platform via ADA events and programs with prominent access to key influencers, thought leaders and decision makers in the food and nutrition marketplace.

The Coca-Cola Company’s Beverage Institute for Health & Wellness team of physicians, PhD-level nutrition scientists and registered dietitians serve as a resource for health professionals and others interested in the science of beverages and their role in health and living well. The Coca-Cola Company will share research findings with ADA members in forums such as professional meetings and scientific publications, to augment the body of knowledge around consumer motivation and health behaviors. To improve understanding of consumer behavior and motivation around healthy living, The Coca-Cola Company will also share its consumer research and expertise with ADA members.

“The Coca-Cola Company and the American Dietetic Association are committed to helping people enjoy healthy lifestyles,” said registered dietitian and ADA President Connie B. Diekman. “Registered dietitians fill an important role in educating the public on food and nutrition. We look forward to working together to develop education programs that help consumers through a combination of a balanced eating plan and regular physical activity.”

“Our partnership with the American Dietetic Association is central to our efforts to continually provide innovative options and information that address consumers’ ever-changing tastes and that meet their hydration needs,” said Rhona Applebaum, vice president and chief scientific and regulatory officer at The Coca-Cola Company. “Like ADA, Coca-Cola understands that a healthy lifestyle involves balancing many different elements — staying physically active, consuming a balanced diet, getting enough rest — and even keeping a positive attitude. We are proud to partner with ADA to help provide Americans with information that allows them to make informed decisions about their personal well-being.”

About the American Dietetic Association
With more than 67,000 members, the American Dietetic Association is the nation’s largest organization of food and nutrition professionals. Approximately 75 percent of ADA’s members are registered dietitians and four percent are dietetic technicians, registered. Other members include clinical and community food and nutrition professionals, consultants, food service managers, educators, researchers, dietetic technicians and students. Nearly half of all ADA members hold advanced academic degrees. ADA serves the public by promoting optimal nutrition, health and well-being. To locate a registered dietitian in your area, visit the American Dietetic Association at www.eatright.org.  

About The Coca-Cola Company
The world’s largest beverage company, The Coca-Cola Company markets more than 400 brands including soft drinks, juices, waters, teas, coffees, energy and sports drinks in more than 200 countries. The Beverage Institute for Health & Wellness is part of the Company’s ongoing commitment to product innovation and nutrition education, helping to meet changing consumer wellness needs through beverages and serving as a resource for health professionals and others interested in the science of beverages and their role in healthful living. To learn more about The Coca-Cola Company, The Beverage Institute and how the Company’s sustainable growth initiatives are improving lives, conserving water, reducing energy use and turning packaging waste into valuable resource, visit www.thecoca-colacompany.com. ###

In a contest to see who can be the worst human being on the planet, the American Academy of Pediatrics' "NY Immunize" group wrote a letter to NY Representative Carolyn Maloney, a Democrat who has the courage to sponsor a bill that would authorize a study comparing health outcomes (including autism) for vaccinated and unvaccinated children. Since Congress is on Big Pharma's payroll (check out www.opensecrets.org if you don't believe me), the bill has not yet been brought to a vote. Still, Big Pharma (and their puppet, the AAP) is scared, and is really working it to both intimidate Rep. Maloney and pimp Rotateq patent-holder Paul Offit's book at the same time. In his book, Offit libels JB Handley, falsifies a story about an autism dad, and and dismisses any connection between vaccines and autism without accounting for the numerous studies providing evidence to the contrary, like Mady Hornig's thimerosal-induced autistic mice, Laura Hewitsen's vaccine-induced autistic monkeys, and the original data set from the IOM's much-publicized 2004 report on thimerosal and autism.

Pediatricians, ask yourself if you want to be represented by people who employ tactics like these.

Here's the letter:

September 24, 2008

Congressperson Carolyn Maloney
1651 3 Avenue, Suite 31 1
New York, NY 101 28-3679

Dear Congressperson Maloney

We are concerned about misinformation you may have heard at a recent briefing presenting the non-scientific, irrational proposals espoused by David Kirby, and the Age of Autism with regard to a supposed link between autism and vaccines. Vaccines save lives.  Study after study has shown absolutely no link between vaccines and autism.

As pediatricians, teachers, nurses, child care providers and parents across New York State and in your District, we are very aware of the struggles that the families of children with autism face and the challenges that test the children themselves. In your position as a political leader, it is important that you have the information you need to support the science, the research and the continued work toward identifyirg the causes, triggers and evidence based treatment for children with autism and autism spectrum disorders.
All of the research, including the most recent and exhaustive study done by the Columbia University School of Public Health, has proven no link between vaccines and autism. And yet a few people, some of whom are making a great deal of money from the suffering and false hope of frightened parents, continue to beat the drum for this discredited position. Many others offer dangerous and unscientific approaches to "cures."

We urge you to stand with us against the forces working to bring irrational fears and "junk science" into the world of children's health. As you know, immunizationasre one of our greatest public health victories along with clean water.

Childhood diseases that can kill and maim our children are just a plane ride away, and yet the anti-immunization groups continue to push for less and less protection for our children. Just this year the Centers for Disease Control reported the largest outbreak of measles in decades. New York was one of the states that experienced a significant outbreak of serious disease. You might also be interested in knowing that the measles that was imported into the US came, not from the third world, but from Europe and from Israel: Developed areas that are experiencing significant outbreaks of disease due to weak public health policy.

We highly recommend that you read Dr. Paul Offit's recent, very well reviewed book, Autism's False Prophets. We have included a review from The Wall Street Journal and an editorial from the New York Times. We will be contacting your local District Office to schedule a time to come in and talk with you about this very important issue. We know you want to work with us to help protect the children of New York and the children across the country.

Sincerely,

Elie Ward, MSW
Co-Chair, NYS Immunization Coalition
Enclosures (2)

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I find this hilarious (and awful). The FDA has issued yet another warning letter to medical device maker C.R. Bard, citing crappy manufacturing practices. In this letter, the FDA also scolds Bard for not taking its warning letters seriously. Well, why should they? They receive letters all the time, like July, October, and November of this year, just to name three incidents from the FIRST PAGE ONLY of internet search results. There don't seem to be any negative repercussions, so Bard continues its bad GMP (bad "good manufacturing practices," hahahahaha) as BAU (business as usual). Good job, FDA, for being like the substitute teacher or the babysitter to whom no one listens because everyone knows that her threats are empty.

http://www.fdanews.com/newsletter/article?issueId=12161&articleId=112374

FDAnews Device Daily Bulletin

...think of this. I think most people regard doctors as near-saints. Psychology researcher Gerd Gigerenzer says that one of our key learned instincts (or "gut feelings," as he calls them in his book of the same name) is "If you see a white coat, trust it."

Nothing could be further from a good idea. Doctors are just service providers like mechanics, who might be screwing you on that new transmission you really didn't need. I'm sure you've all heard stories from friends who moved to a big city after college and were told by a dentist that they needed several fillings, all of which were noted by a subsequent dentist to be too shallow to have been real cavities. The problem is that most poor medical decision-making is the result of far more insidious biases. For example, doctors are terrified of being sued for not finding prostate cancer and breast cancer, so they routinely recommend potentially harmful and/or painful diagnostic tests for these illnesses, even for patients for whom the risk of having the cancer is small, and despite the fact that most prostate cancers are not life- or health-threatening in the patient's lifetime.

Then you have the fact that most medical journals take tons of advertising money from Big Pharma. Which studies do you think they print? Universities receive billions in donations from Big Pharma. Which studies do you think they undertake? The FDA, the CDC, the VA, and countless other government agencies have a lot to lose by letting a study reveal their negligence (see the recent report on Gulf War Syndrome), so they pay shills like the Institutes of Medicine to perform studies and then tailor the results to their liking.

If this all sounds too far-fetched to believe, consider the current financial crisis in the United States. It wasn't all the result of Hector in San Diego lying about his income on a no-doc loan. The dishonesty ran far deeper than that, to the point of financial services firms creating synthetic sub-prime mortgage contracts in order to fulfill demand by investors for this kind of debt instrument. Here's what Michael Lewis found out:

http://www.portfolio.com/news-markets/national-news/portfolio/2008/11/11/The-End-of-Wall-Streets-Boom

The End

To this day, the willingness of a Wall Street investment bank to pay me hundreds of thousands of dollars to dispense investment advice to grownups remains a mystery to me. I was 24 years old, with no experience of, or particular interest in, guessing which stocks and bonds would rise and which would fall. The essential function of Wall Street is to allocate capital—to decide who should get it and who should not. Believe me when I tell you that I hadn’t the first clue.

I’d never taken an accounting course, never run a business, never even had savings of my own to manage. I stumbled into a job at Salomon Brothers in 1985 and stumbled out much richer three years later, and even though I wrote a book about the experience, the whole thing still strikes me as preposterous—which is one of the reasons the money was so easy to walk away from. I figured the situation was unsustainable. Sooner rather than later, someone was going to identify me, along with a lot of people more or less like me, as a fraud. Sooner rather than later, there would come a Great Reckoning when Wall Street would wake up and hundreds if not thousands of young people like me, who had no business making huge bets with other people’s money, would be expelled from finance.

When I sat down to write my account of the experience in 1989—Liar’s Poker, it was called—it was in the spirit of a young man who thought he was getting out while the getting was good. I was merely scribbling down a message on my way out and stuffing it into a bottle for those who would pass through these parts in the far distant future.

Unless some insider got all of this down on paper, I figured, no future human would believe that it happened.

I thought I was writing a period piece about the 1980s in America. Not for a moment did I suspect that the financial 1980s would last two full decades longer or that the difference in degree between Wall Street and ordinary life would swell into a difference in kind. I expected readers of the future to be outraged that back in 1986, the C.E.O. of Salomon Brothers, John Gutfreund, was paid $3.1 million; I expected them to gape in horror when I reported that one of our traders, Howie Rubin, had moved to Merrill Lynch, where he lost $250 million; I assumed they’d be shocked to learn that a Wall Street C.E.O. had only the vaguest idea of the risks his traders were running. What I didn’t expect was that any future reader would look on my experience and say, “How quaint.”

I had no great agenda, apart from telling what I took to be a remarkable tale, but if you got a few drinks in me and then asked what effect I thought my book would have on the world, I might have said something like, “I hope that college students trying to figure out what to do with their lives will read it and decide that it’s silly to phony it up and abandon their passions to become financiers.” I hoped that some bright kid at, say, Ohio State University who really wanted to be an oceanographer would read my book, spurn the offer from Morgan Stanley, and set out to sea.

Somehow that message failed to come across. Six months after Liar’s Poker was published, I was knee-deep in letters from students at Ohio State who wanted to know if I had any other secrets to share about Wall Street. They’d read my book as a how-to manual.

In the two decades since then, I had been waiting for the end of Wall Street. The outrageous bonuses, the slender returns to shareholders, the never-ending scandals, the bursting of the internet bubble, the crisis following the collapse of Long-Term Capital Management: Over and over again, the big Wall Street investment banks would be, in some narrow way, discredited. Yet they just kept on growing, along with the sums of money that they doled out to 26-year-olds to perform tasks of no obvious social utility. The rebellion by American youth against the money culture never happened. Why bother to overturn your parents’ world when you can buy it, slice it up into tranches, and sell off the pieces?

At some point, I gave up waiting for the end. There was no scandal or reversal, I assumed, that could sink the system.

Then came Meredith Whitney with news. Whitney was an obscure analyst of financial firms for Oppenheimer Securities who, on October 31, 2007, ceased to be obscure. On that day, she predicted that Citigroup had so mismanaged its affairs that it would need to slash its dividend or go bust. It’s never entirely clear on any given day what causes what in the stock market, but it was pretty obvious that on October 31, Meredith Whitney caused the market in financial stocks to crash. By the end of the trading day, a woman whom basically no one had ever heard of had shaved $369 billion off the value of financial firms in the market. Four days later, Citigroup’s C.E.O., Chuck Prince, resigned. In January, Citigroup slashed its dividend.

From that moment, Whitney became E.F. Hutton: When she spoke, people listened. Her message was clear. If you want to know what these Wall Street firms are really worth, take a hard look at the crappy assets they bought with huge sums of ­borrowed money, and imagine what they’d fetch in a fire sale. The vast assemblages of highly paid people inside the firms were essentially worth nothing. For better than a year now, Whitney has responded to the claims by bankers and brokers that they had put their problems behind them with this write-down or that capital raise with a claim of her own: You’re wrong. You’re still not facing up to how badly you have mismanaged your business.

Rivals accused Whitney of being overrated; bloggers accused her of being lucky. What she was, mainly, was right. But it’s true that she was, in part, guessing. There was no way she could have known what was going to happen to these Wall Street firms. The C.E.O.’s themselves didn’t know.

Now, obviously, Meredith Whitney didn’t sink Wall Street. She just expressed most clearly and loudly a view that was, in retrospect, far more seditious to the financial order than, say, Eliot Spitzer’s campaign against Wall Street corruption. If mere scandal could have destroyed the big Wall Street investment banks, they’d have vanished long ago. This woman wasn’t saying that Wall Street bankers were corrupt. She was saying they were stupid. These people whose job it was to allocate capital apparently didn’t even know how to manage their own.

At some point, I could no longer contain myself: I called Whitney. This was back in March, when Wall Street’s fate still hung in the balance. I thought, If she’s right, then this really could be the end of Wall Street as we’ve known it. I was curious to see if she made sense but also to know where this young woman who was crashing the stock market with her every utterance had come from.

It turned out that she made a great deal of sense and that she’d arrived on Wall Street in 1993, from the Brown University history department. “I got to New York, and I didn’t even know research existed,” she says. She’d wound up at Oppenheimer and had the most incredible piece of luck: to be trained by a man who helped her establish not merely a career but a worldview. His name, she says, was Steve Eisman.

Eisman had moved on, but they kept in touch. “After I made the Citi call,” she says, “one of the best things that happened was when Steve called and told me how proud he was of me.”

Having never heard of Eisman, I didn’t think anything of this. But a few months later, I called Whitney again and asked her, as I was asking others, whom she knew who had anticipated the cataclysm and set themselves up to make a fortune from it. There’s a long list of people who now say they saw it coming all along but a far shorter one of people who actually did. Of those, even fewer had the nerve to bet on their vision. It’s not easy to stand apart from mass hysteria—to believe that most of what’s in the financial news is wrong or distorted, to believe that most important financial people are either lying or deluded—without actually being insane. A handful of people had been inside the black box, understood how it worked, and bet on it blowing up. Whitney rattled off a list with a half-dozen names on it. At the top was Steve Eisman.

Steve Eisman entered finance about the time I exited it. He’d grown up in New York City and gone to a Jewish day school, the University of Pennsylvania, and Harvard Law School. In 1991, he was a 30-year-old corporate lawyer. “I hated it,” he says. “I hated being a lawyer. My parents worked as brokers at Oppenheimer. They managed to finagle me a job. It’s not pretty, but that’s what happened.”

He was hired as a junior equity analyst, a helpmate who didn’t actually offer his opinions. That changed in December 1991, less than a year into his new job, when a subprime mortgage lender called Ames Financial went public and no one at Oppenheimer particularly cared to express an opinion about it. One of Oppenheimer’s investment bankers stomped around the research department looking for anyone who knew anything about the mortgage business. Recalls Eisman: “I’m a junior analyst and just trying to figure out which end is up, but I told him that as a lawyer I’d worked on a deal for the Money Store.” He was promptly appointed the lead analyst for Ames Financial. “What I didn’t tell him was that my job had been to proofread the ­documents and that I hadn’t understood a word of the fucking things.”

Ames Financial belonged to a category of firms known as nonbank financial institutions. The category didn’t include J.P. Morgan, but it did encompass many little-known companies that one way or another were involved in the early-1990s boom in subprime mortgage lending—the lower class of American finance.

The second company for which Eisman was given sole responsibility was Lomas Financial, which had just emerged from bankruptcy. “I put a sell rating on the thing because it was a piece of shit,” Eisman says. “I didn’t know that you weren’t supposed to put a sell rating on companies. I thought there were three boxes—buy, hold, sell—and you could pick the one you thought you should.” He was pressured generally to be a bit more upbeat, but upbeat wasn’t Steve Eisman’s style. Upbeat and Eisman didn’t occupy the same planet. A hedge fund manager who counts Eisman as a friend set out to explain him to me but quit a minute into it. After describing how Eisman exposed various important people as either liars or idiots, the hedge fund manager started to laugh. “He’s sort of a prick in a way, but he’s smart and honest and fearless.”

“A lot of people don’t get Steve,” Whitney says. “But the people who get him love him.” Eisman stuck to his sell rating on Lomas Financial, even after the company announced that investors needn’t worry about its financial condition, as it had hedged its market risk. “The single greatest line I ever wrote as an analyst,” says Eisman, “was after Lomas said they were hedged.” He recited the line from memory: “ ‘The Lomas Financial Corp. is a perfectly hedged financial institution: It loses money in every conceivable interest-rate environment.’ I enjoyed writing that sentence more than any sentence I ever wrote.” A few months after he’d delivered that line in his report, Lomas Financial returned to bankruptcy.

Eisman wasn’t, in short, an analyst with a sunny disposition who expected the best of his fellow financial man and the companies he created. “You have to understand,” Eisman says in his defense, “I did subprime first. I lived with the worst first. These guys lied to infinity. What I learned from that experience was that Wall Street didn’t give a shit what it sold.”

Harboring suspicions about ­people’s morals and telling investors that companies don’t deserve their capital wasn’t, in the 1990s or at any other time, the fast track to success on Wall Street. Eisman quit Oppenheimer in 2001 to work as an analyst at a hedge fund, but what he really wanted to do was run money. FrontPoint Partners, another hedge fund, hired him in 2004 to invest in financial stocks. Eisman’s brief was to evaluate Wall Street banks, homebuilders, mortgage originators, and any company (General Electric or General Motors, for instance) with a big financial-services division—anyone who touched American finance. An insurance company backed him with $50 million, a paltry sum. “Basically, we tried to raise money and didn't really do it,” Eisman says.

Instead of money, he attracted people whose worldviews were as shaded as his own—Vincent Daniel, for instance, who became a partner and an analyst in charge of the mortgage sector. Now 36, Daniel grew up a lower-middle-class kid in Queens. One of his first jobs, as a junior accountant at Arthur Andersen, was to audit Salomon Brothers’ books. “It was shocking,” he says. “No one could explain to me what they were doing.” He left accounting in the middle of the internet boom to become a research analyst, looking at companies that made subprime loans. “I was the only guy I knew covering companies that were all going to go bust,” he says. “I saw how the sausage was made in the economy, and it was really freaky.”

Danny Moses, who became Eisman’s head trader, was another who shared his perspective. Raised in Georgia, Moses, the son of a finance professor, was a bit less fatalistic than Daniel or Eisman, but he nevertheless shared a general sense that bad things can and do happen. When a Wall Street firm helped him get into a trade that seemed perfect in every way, he said to the salesman, “I appreciate this, but I just want to know one thing: How are you going to screw me?”

Heh heh heh, c’mon. We’d never do that, the trader started to say, but Moses was politely insistent: We both know that unadulterated good things like this trade don’t just happen between little hedge funds and big Wall Street firms. I’ll do it, but only after you explain to me how you are going to screw me. And the salesman explained how he was going to screw him. And Moses did the trade.

Both Daniel and Moses enjoyed, immensely, working with Steve Eisman. He put a fine point on the absurdity they saw everywhere around them. “Steve’s fun to take to any Wall Street meeting,” Daniel says. “Because he’ll say ‘Explain that to me’ 30 different times. Or ‘Could you explain that more, in English?’ Because once you do that, there’s a few things you learn. For a start, you figure out if they even know what they’re talking about. And a lot of times, they don’t!”

At the end of 2004, Eisman, Moses, and Daniel shared a sense that unhealthy things were going on in the U.S. housing market: Lots of firms were lending money to people who shouldn’t have been borrowing it. They thought Alan Greenspan’s decision after the internet bust to lower interest rates to 1 percent was a travesty that would lead to some terrible day of reckoning. Neither of these insights was entirely original. Ivy Zelman, at the time the housing-market analyst at Credit Suisse, had seen the bubble forming very early on. There’s a simple measure of sanity in housing prices: the ratio of median home price to income. Historically, it runs around 3 to 1; by late 2004, it had risen nationally to 4 to 1. “All these people were saying it was nearly as high in some other countries,” Zelman says. “But the problem wasn’t just that it was 4 to 1. In Los Angeles, it was 10 to 1, and in Miami, 8.5 to 1. And then you coupled that with the buyers. They weren’t real buyers. They were speculators.” Zelman alienated clients with her pessimism, but she couldn’t pretend everything was good. “It wasn’t that hard in hindsight to see it,” she says. “It was very hard to know when it would stop.” Zelman spoke occasionally with Eisman and always left these conversations feeling better about her views and worse about the world. “You needed the occasional assurance that you weren’t nuts,” she says. She wasn’t nuts. The world was.

By the spring of 2005, FrontPoint was fairly convinced that something was very screwed up not merely in a handful of companies but in the financial underpinnings of the entire U.S. mortgage market. In 2000, there had been $130 billion in subprime mortgage lending, with $55 billion of that repackaged as mortgage bonds. But in 2005, there was $625 billion in subprime mortgage loans, $507 billion of which found its way into mortgage bonds. Eisman couldn’t understand who was making all these loans or why. He had a from-the-ground-up understanding of both the U.S. housing market and Wall Street. But he’d spent his life in the stock market, and it was clear that the stock market was, in this story, largely irrelevant. “What most people don’t realize is that the fixed-income world dwarfs the equity world,” he says. “The equity world is like a fucking zit compared with the bond market.” He shorted companies that originated subprime loans, like New Century and Indy Mac, and companies that built the houses bought with the loans, such as Toll Brothers. Smart as these trades proved to be, they weren’t entirely satisfying. These companies paid high dividends, and their shares were often expensive to borrow; selling them short was a costly proposition.

Enter Greg Lippman, a mortgage-bond trader at Deutsche Bank. He arrived at FrontPoint bearing a 66-page presentation that described a better way for the fund to put its view of both Wall Street and the U.S. housing market into action. The smart trade, Lippman argued, was to sell short not New Century’s stock but its bonds that were backed by the subprime loans it had made. Eisman hadn’t known this was even possible—because until recently, it hadn’t been. But Lippman, along with traders at other Wall Street investment banks, had created a way to short the subprime bond market with precision.

Here’s where financial technology became suddenly, urgently relevant. The typical mortgage bond was still structured in much the same way it had been when I worked at Salomon Brothers. The loans went into a trust that was designed to pay off its investors not all at once but according to their rankings. The investors in the top tranche, rated AAA, received the first payment from the trust and, because their investment was the least risky, received the lowest interest rate on their money. The investors who held the trusts’ BBB tranche got the last payments—and bore the brunt of the first defaults. Because they were taking the most risk, they received the highest return. Eisman wanted to bet that some subprime borrowers would default, causing the trust to suffer losses. The way to express this view was to short the BBB tranche. The trouble was that the BBB tranche was only a tiny slice of the deal.

But the scarcity of truly crappy subprime-mortgage bonds no longer mattered. The big Wall Street firms had just made it possible to short even the tiniest and most obscure subprime-mortgage-backed bond by creating, in effect, a market of side bets. Instead of shorting the actual BBB bond, you could now enter into an agreement for a credit-default swap with Deutsche Bank or Goldman Sachs. It cost money to make this side bet, but nothing like what it cost to short the stocks, and the upside was far greater.  

The arrangement bore the same relation to actual finance as fantasy football bears to the N.F.L. Eisman was perplexed in particular about why Wall Street firms would be coming to him and asking him to sell short. “What Lippman did, to his credit, was he came around several times to me and said, ‘Short this market,’ ” Eisman says. “In my entire life, I never saw a sell-side guy come in and say, ‘Short my market.’”

And short Eisman did—then he tried to get his mind around what he’d just done so he could do it better. He’d call over to a big firm and ask for a list of mortgage bonds from all over the country. The juiciest shorts—the bonds ultimately backed by the mortgages most likely to default—had several characteristics. They’d be in what Wall Street people were now calling the sand states: Arizona, California, Florida, Nevada. The loans would have been made by one of the more dubious mortgage lenders; Long Beach Financial, wholly owned by Washington Mutual, was a great example. Long Beach Financial was moving money out the door as fast as it could, few questions asked, in loans built to self-destruct. It specialized in asking home­owners with bad credit and no proof of income to put no money down and defer interest payments for as long as possible. In Bakersfield, California, a Mexican strawberry picker with an income of $14,000 and no English was lent every penny he needed to buy a house for $720,000.

More generally, the subprime market tapped a tranche of the American public that did not typically have anything to do with Wall Street. Lenders were making loans to people who, based on their credit ratings, were less creditworthy than 71 percent of the population. Eisman knew some of these people. One day, his housekeeper, a South American woman, told him that she was planning to buy a townhouse in Queens. “The price was absurd, and they were giving her a low-down-payment option-ARM,” says Eisman, who talked her into taking out a conventional fixed-rate mortgage. Next, the baby nurse he’d hired back in 1997 to take care of his newborn twin daughters phoned him. “She was this lovely woman from Jamaica,” he says. “One day she calls me and says she and her sister own five townhouses in Queens. I said, ‘How did that happen?’ ” It happened because after they bought the first one and its value rose, the lenders came and suggested they refinance and take out $250,000, which they used to buy another one. Then the price of that one rose too, and they repeated the experiment. “By the time they were done,” Eisman says, “they owned five of them, the market was falling, and they couldn’t make any of the payments.”

In retrospect, pretty much all of the riskiest subprime-backed bonds were worth betting against; they would all one day be worth zero. But at the time Eisman began to do it, in the fall of 2006, that wasn’t clear. He and his team set out to find the smelliest pile of loans they could so that they could make side bets against them with Goldman Sachs or Deutsche Bank. What they were doing, oddly enough, was the analysis of subprime lending that should have been done before the loans were made: Which poor Americans were likely to jump which way with their finances? How much did home prices need to fall for these loans to blow up? (It turned out they didn’t have to fall; they merely needed to stay flat.) The default rate in Georgia was five times higher than that in Florida even though the two states had the same unemployment rate. Why? Indiana had a 25 percent default rate; California’s was only 5 percent. Why?

Moses actually flew down to Miami and wandered around neighborhoods built with subprime loans to see how bad things were. “He’d call me and say, ‘Oh my God, this is a calamity here,’ ” recalls Eisman. All that was required for the BBB bonds to go to zero was for the default rate on the underlying loans to reach 14 percent. Eisman thought that, in certain sections of the country, it would go far, far higher.

The funny thing, looking back on it, is how long it took for even someone who predicted the disaster to grasp its root causes. They were learning about this on the fly, shorting the bonds and then trying to figure out what they had done. Eisman knew subprime lenders could be scumbags. What he underestimated was the total unabashed complicity of the upper class of American capitalism. For instance, he knew that the big Wall Street investment banks took huge piles of loans that in and of themselves might be rated BBB, threw them into a trust, carved the trust into tranches, and wound up with 60 percent of the new total being rated AAA.

But he couldn’t figure out exactly how the rating agencies justified turning BBB loans into AAA-rated bonds. “I didn’t understand how they were turning all this garbage into gold,” he says. He brought some of the bond people from Goldman Sachs, Lehman Brothers, and UBS over for a visit. “We always asked the same question,” says Eisman. “Where are the rating agencies in all of this? And I’d always get the same reaction. It was a smirk.” He called Standard & Poor’s and asked what would happen to default rates if real estate prices fell. The man at S&P couldn’t say; its model for home prices had no ability to accept a negative number. “They were just assuming home prices would keep going up,” Eisman says.

As an investor, Eisman was allowed on the quarterly conference calls held by Moody’s but not allowed to ask questions. The people at Moody’s were polite about their brush-off, however. The C.E.O. even invited Eisman and his team to his office for a visit in June 2007. By then, Eisman was so certain that the world had been turned upside down that he just assumed this guy must know it too. “But we’re sitting there,” Daniel recalls, “and he says to us, like he actually means it, ‘I truly believe that our rating will prove accurate.’ And Steve shoots up in his chair and asks, ‘What did you just say?’ as if the guy had just uttered the most preposterous statement in the history of finance. He repeated it. And Eisman just laughed at him.”

“With all due respect, sir,” Daniel told the C.E.O. deferentially as they left the meeting, “you’re delusional.”
This wasn’t Fitch or even S&P. This was Moody’s, the aristocrats of the rating business, 20 percent owned by Warren Buffett. And the company’s C.E.O. was being told he was either a fool or a crook by one Vincent Daniel, from Queens.

A full nine months earlier, Daniel and ­Moses had flown to Orlando for an industry conference. It had a grand title—the American Securitization Forum—but it was essentially a trade show for the ­subprime-mortgage business: the people who originated subprime mortgages, the Wall Street firms that packaged and sold subprime mortgages, the fund managers who invested in nothing but subprime-mortgage-backed bonds, the agencies that rated subprime-­mortgage bonds, the lawyers who did whatever the lawyers did. Daniel and Moses thought they were paying a courtesy call on a cottage industry, but the cottage had become a castle. “There were like 6,000 people there,” Daniel says. “There were so many people being fed by this industry. The entire fixed-income department of each brokerage firm is built on this. Everyone there was the long side of the trade. The wrong side of the trade. And then there was us. That’s when the picture really started to become clearer, and we started to get more cynical, if that was possible. We went back home and said to Steve, ‘You gotta see this.’ ”

Eisman, Daniel, and Moses then flew out to Las Vegas for an even bigger subprime conference. By now, Eisman knew everything he needed to know about the quality of the loans being made. He still didn’t fully understand how the apparatus worked, but he knew that Wall Street had built a doomsday machine. He was at once opportunistic and outraged.

Their first stop was a speech given by the C.E.O. of Option One, the mortgage originator owned by H&R Block. When the guy got to the part of his speech about Option One’s subprime-loan portfolio, he claimed to be expecting a modest default rate of 5 percent. Eisman raised his hand. Moses and Daniel sank into their chairs. “It wasn’t a Q&A,” says Moses. “The guy was giving a speech. He sees Steve’s hand and says, ‘Yes?’”

“Would you say that 5 percent is a probability or a possibility?” Eisman asked.

A probability, said the C.E.O., and he continued his speech.
Eisman had his hand up in the air again, waving it around. Oh, no, Moses thought. “The one thing Steve always says,” Daniel explains, “is you must assume they are lying to you. They will always lie to you.” Moses and Daniel both knew what Eisman thought of these subprime lenders but didn’t see the need for him to express it here in this manner. For Eisman wasn’t raising his hand to ask a question. He had his thumb and index finger in a big circle. He was using his fingers to speak on his behalf. Zero! they said.

 “Yes?” the C.E.O. said, obviously irritated. “Is that another question?”

“No,” said Eisman. “It’s a zero. There is zero probability that your default rate will be 5 percent.” The losses on subprime loans would be much, much greater. Before the guy could reply, Eisman’s cell phone rang. Instead of shutting it off, Eisman reached into his pocket and answered it. “Excuse me,” he said, standing up. “But I need to take this call.” And with that, he walked out.

Eisman’s willingness to be abrasive in order to get to the heart of the matter was obvious to all; what was harder to see was his credulity: He actually wanted to believe in the system. As quick as he was to cry bullshit when he saw it, he was still shocked by bad behavior. That night in Vegas, he was seated at dinner beside a really nice guy who invested in mortgage C.D.O.’s—collateralized debt obligations. By then, Eisman thought he knew what he needed to know about C.D.O.’s. He didn’t, it turned out.

Later, when I sit down with Eisman, the very first thing he wants to explain is the importance of the mezzanine C.D.O. What you notice first about Eisman is his lips. He holds them pursed, waiting to speak. The second thing you notice is his short, light hair, cropped in a manner that suggests he cut it himself while thinking about something else. “You have to understand this,” he says. “This was the engine of doom.” Then he draws a picture of several towers of debt. The first tower is made of the original subprime loans that had been piled together. At the top of this tower is the AAA tranche, just below it the AA tranche, and so on down to the riskiest, the BBB tranche—the bonds Eisman had shorted. But Wall Street had used these BBB tranches—the worst of the worst—to build yet another tower of bonds: a “particularly egregious” C.D.O. The reason they did this was that the rating agencies, presented with the pile of bonds backed by dubious loans, would pronounce most of them AAA. These bonds could then be sold to investors—pension funds, insurance companies—who were allowed to invest only in highly rated securities. “I cannot fucking believe this is allowed—I must have said that a thousand times in the past two years,” Eisman says.

His dinner companion in Las Vegas ran a fund of about $15 billion and managed C.D.O.’s backed by the BBB tranche of a mortgage bond, or as Eisman puts it, “the equivalent of three levels of dog shit lower than the original bonds.”

FrontPoint had spent a lot of time digging around in the dog shit and knew that the default rates were already sufficient to wipe out this guy’s entire portfolio. “God, you must be having a hard time,” Eisman told his dinner companion.

“No,” the guy said, “I’ve sold everything out.”

After taking a fee, he passed them on to other investors. His job was to be the C.D.O. “expert,” but he actually didn’t spend any time at all thinking about what was in the C.D.O.’s. “He managed the C.D.O.’s,” says Eisman, “but managed what? I was just appalled. People would pay up to have someone manage their C.D.O.’s—as if this moron was helping you. I thought, You prick, you don’t give a fuck about the investors in this thing.”

Whatever rising anger Eisman felt was offset by the man’s genial disposition. Not only did he not mind that Eisman took a dim view of his C.D.O.’s; he saw it as a basis for friendship. “Then he said something that blew my mind,” Eisman tells me. “He says, ‘I love guys like you who short my market. Without you, I don’t have anything to buy.’ ”

That’s when Eisman finally got it. Here he’d been making these side bets with Goldman Sachs and Deutsche Bank on the fate of the BBB tranche without fully understanding why those firms were so eager to make the bets. Now he saw. There weren’t enough Americans with shitty credit taking out loans to satisfy investors’ appetite for the end product. The firms used Eisman’s bet to synthesize more of them. Here, then, was the difference between fantasy finance and fantasy football: When a fantasy player drafts Peyton Manning, he doesn’t create a second Peyton Manning to inflate the league’s stats. But when Eisman bought a credit-default swap, he enabled Deutsche Bank to create another bond identical in every respect but one to the original. The only difference was that there was no actual homebuyer or borrower. The only assets backing the bonds were the side bets Eisman and others made with firms like Goldman Sachs. Eisman, in effect, was paying to Goldman the interest on a subprime mortgage. In fact, there was no mortgage at all. “They weren’t satisfied getting lots of unqualified borrowers to borrow money to buy a house they couldn’t afford,” Eisman says. “They were creating them out of whole cloth. One hundred times over! That’s why the losses are so much greater than the loans. But that’s when I realized they needed us to keep the machine running. I was like, This is allowed?”

This particular dinner was hosted by Deutsche Bank, whose head trader, Greg Lippman, was the fellow who had introduced Eisman to the subprime bond market. Eisman went and found Lippman, pointed back to his own dinner companion, and said, “I want to short him.” Lippman thought he was joking; he wasn’t. “Greg, I want to short his paper,” Eisman repeated. “Sight unseen.”

Eisman started out running a $60 million equity fund but was now short around $600 million of various ­subprime-related securities. In the spring of 2007, the market strengthened. But, says Eisman, “credit quality always gets better in March and April. And the reason it always gets better in March and April is that people get their tax refunds. You would think people in the securitization world would know this. We just thought that was moronic.”

He was already short the stocks of mortgage originators and the homebuilders. Now he took short positions in the rating agencies—“they were making 10 times more rating C.D.O.’s than they were rating G.M. bonds, and it was all going to end”—and, finally, the biggest Wall Street firms because of their exposure to C.D.O.’s. He wasn’t allowed to short Morgan Stanley because it owned a stake in his fund. But he shorted UBS, Lehman Brothers, and a few others. Not long after that, FrontPoint had a visit from Sanford C. Bernstein’s Brad Hintz, a prominent analyst who covered Wall Street firms. Hintz wanted to know what Eisman was up to. “We just shorted Merrill Lynch,” Eisman told him.

“Why?” asked Hintz.

“We have a simple thesis,” Eisman explained. “There is going to be a calamity, and whenever there is a calamity, Merrill is there.” When it came time to bankrupt Orange County with bad advice, Merrill was there. When the internet went bust, Merrill was there. Way back in the 1980s, when the first bond trader was let off his leash and lost hundreds of millions of dollars, Merrill was there to take the hit. That was Eisman’s logic—the logic of Wall Street’s pecking order. Goldman Sachs was the big kid who ran the games in this neighborhood. Merrill Lynch was the little fat kid assigned the least pleasant roles, just happy to be a part of things. The game, as Eisman saw it, was Crack the Whip. He assumed Merrill Lynch had taken its assigned place at the end of the chain.

There was only one thing that bothered Eisman, and it continued to trouble him as late as May 2007. “The thing we couldn’t figure out is: It’s so obvious. Why hasn’t everyone else figured out that the machine is done?” Eisman had long subscribed to Grant’s Interest Rate Observer, a newsletter famous in Wall Street circles and obscure outside them. Jim Grant, its editor, had been prophesying doom ever since the great debt cycle began, in the mid-1980s. In late 2006, he decided to investigate these things called C.D.O.’s. Or rather, he had asked his young assistant, Dan Gertner, a chemical engineer with an M.B.A., to see if he could understand them. Gertner went off with the documents that purported to explain C.D.O.’s to potential investors and for several days sweated and groaned and heaved and suffered. “Then he came back,” says Grant, “and said, ‘I can’t figure this thing out.’ And I said, ‘I think we have our story.’ ”

Eisman read Grant’s piece as independent confirmation of what he knew in his bones about the C.D.O.’s he had shorted. “When I read it, I thought, Oh my God. This is like owning a gold mine. When I read that, I was the only guy in the equity world who almost had an orgasm.”

On July 19, 2007, the same day that Federal Reserve Chairman Ben Bernanke told the U.S. Senate that he anticipated as much as $100 billion in losses in the subprime-mortgage market, FrontPoint did something unusual: It hosted its own conference call. It had had calls with its tiny population of investors, but this time FrontPoint opened it up. Steve Eisman had become a poorly kept secret. Five hundred people called in to hear what he had to say, and another 500 logged on afterward to listen to a recording of it. He explained the strange alchemy of the C.D.O. and said that he expected losses of up to $300 billion from this sliver of the market alone. To evaluate the situation, he urged his audience to “just throw your model in the garbage can. The models are all backward-looking.

The models don’t have any idea of what this world has become…. For the first time in their lives, people in the asset-backed-securitization world are actually having to think.” He explained that the rating agencies were morally bankrupt and living in fear of becoming actually bankrupt. “The rating agencies are scared to death,” he said. “They’re scared to death about doing nothing because they’ll look like fools if they do nothing.”

On September 18, 2008, Danny Moses came to work as usual at 6:30 a.m. Earlier that week, Lehman Brothers had filed for bankruptcy. The day before, the Dow had fallen 449 points to its lowest level in four years. Overnight, European governments announced a ban on short-selling, but that served as faint warning for what happened next.

At the market opening in the U.S., everything—every financial asset—went into free fall. “All hell was breaking loose in a way I had never seen in my career,” Moses says. FrontPoint was net short the market, so this total collapse should have given Moses pleasure. He might have been forgiven if he stood up and cheered. After all, he’d been betting for two years that this sort of thing could happen, and now it was, more dramatically than he had ever imagined. Instead, he felt this terrifying shudder run through him. He had maybe 100 trades on, and he worked hard to keep a handle on them all. “I spent my morning trying to control all this energy and all this information,” he says, “and I lost control. I looked at the screens. I was staring into the abyss. The end. I felt this shooting pain in my head. I don’t get headaches. At first, I thought I was having an aneurysm.”

Moses stood up, wobbled, then turned to Daniel and said, “I gotta leave. Get out of here. Now.” Daniel thought about calling an ambulance but instead took Moses out for a walk.

Outside it was gorgeous, the blue sky reaching down through the tall buildings and warming the soul. Eisman was at a Goldman Sachs conference for hedge fund managers, raising capital. Moses and Daniel got him on the phone, and he left the conference and met them on the steps of St. Patrick’s Cathedral. “We just sat there,” Moses says. “Watching the people pass.”

This was what they had been waiting for: total collapse. “The investment-banking industry is fucked,” Eisman had told me a few weeks earlier. “These guys are only beginning to understand how fucked they are. It’s like being a Scholastic, prior to Newton. Newton comes along, and one morning you wake up: ‘Holy shit, I’m wrong!’ ” Now Lehman Brothers had vanished, Merrill had surrendered, and Goldman Sachs and Morgan Stanley were just a week away from ceasing to be investment banks. The investment banks were not just fucked; they were extinct.

Not so for hedge fund managers who had seen it coming. “As we sat there, we were weirdly calm,” Moses says. “We felt insulated from the whole market reality. It was an out-of-body experience. We just sat and watched the people pass and talked about what might happen next. How many of these people were going to lose their jobs. Who was going to rent these buildings after all the Wall Street firms collapsed.” Eisman was appalled. “Look,” he said. “I’m short. I don’t want the country to go into a depression. I just want it to fucking deleverage.” He had tried a thousand times in a thousand ways to explain how screwed up the business was, and no one wanted to hear it. “That Wall Street has gone down because of this is justice,” he says. “They fucked people. They built a castle to rip people off. Not once in all these years have I come across a person inside a big Wall Street firm who was having a crisis of conscience.”

Truth to tell, there wasn’t a whole lot of hand-wringing inside FrontPoint either. The only one among them who wrestled a bit with his conscience was Daniel. “Vinny, being from Queens, needs to see the dark side of everything,” Eisman says. To which Daniel replies, “The way we thought about it was, ‘By shorting this market we’re creating the liquidity to keep the market going.’ ”

“It was like feeding the monster,” Eisman says of the market for subprime bonds. “We fed the monster until it blew up.”

About the time they were sitting on the steps of the midtown cathedral, I sat in a booth in a restaurant on the East Side, waiting for John Gutfreund to arrive for lunch, and wondered, among other things, why any restaurant would seat side by side two men without the slightest interest in touching each other.

There was an umbilical cord running from the belly of the exploded beast back to the financial 1980s. A friend of mine created the first mortgage derivative in 1986, a year after we left the Salomon Brothers trading program. (“The problem isn’t the tools,” he likes to say. “It’s who is using the tools. Derivatives are like guns.”)

When I published my book, the 1980s were supposed to be ending. I received a lot of undeserved credit for my timing. The social disruption caused by the collapse of the savings-and-loan industry and the rise of hostile takeovers and leveraged buyouts had given way to a brief period of recriminations. Just as most students at Ohio State read Liar’s Poker as a manual, most TV and radio interviewers regarded me as a whistleblower. (The big exception was Geraldo Rivera. He put me on a show called “People Who Succeed Too Early in Life” along with some child actors who’d gone on to become drug addicts.) Anti-Wall Street feeling ran high—high enough for Rudy Giuliani to float a political career on it—but the result felt more like a witch hunt than an honest reappraisal of the financial order. The public lynchings of Gutfreund and junk-bond king Michael Milken were excuses not to deal with the disturbing forces underpinning their rise. Ditto the cleaning up of Wall Street’s trading culture. The surface rippled, but down below, in the depths, the bonus pool remained undisturbed. Wall Street firms would soon be frowning upon profanity, firing traders for so much as glancing at a stripper, and forcing male employees to treat women almost as equals. Lehman Brothers circa 2008 more closely resembled a normal corporation with solid American values than did any Wall Street firm circa 1985.

The changes were camouflage. They helped distract outsiders from the truly profane event: the growing misalignment of interests between the people who trafficked in financial risk and the wider culture.

I’d not seen Gutfreund since I quit Wall Street. I’d met him, nervously, a couple of times on the trading floor. A few months before I left, my bosses asked me to explain to Gutfreund what at the time seemed like exotic trades in derivatives I’d done with a European hedge fund. I tried. He claimed not to be smart enough to understand any of it, and I assumed that was how a Wall Street C.E.O. showed he was the boss, by rising above the details. There was no reason for him to remember any of these encounters, and he didn’t: When my book came out and became a public-relations nuisance to him, he told reporters we’d never met.

Over the years, I’d heard bits and pieces about Gutfreund. I knew that after he’d been forced to resign from Salomon Brothers he’d fallen on harder times. I heard later that a few years ago he’d sat on a panel about Wall Street at Columbia Business School. When his turn came to speak, he advised students to find something more meaningful to do with their lives. As he began to describe his career, he broke down and wept.

When I emailed him to invite him to lunch, he could not have been more polite or more gracious. That attitude persisted as he was escorted to the table, made chitchat with the owner, and ordered his food. He’d lost a half-step and was more deliberate in his movements, but otherwise he was completely recognizable. The same veneer of denatured courtliness masked the same animal need to see the world as it was, rather than as it should be.

We spent 20 minutes or so determining that our presence at the same lunch table was not going to cause the earth to explode. We discovered we had a mutual acquaintance in New Orleans. We agreed that the Wall Street C.E.O. had no real ability to keep track of the frantic innovation occurring inside his firm. (“I didn’t understand all the product lines, and they don’t either,” he said.) We agreed, further, that the chief of the Wall Street investment bank had little control over his subordinates. (“They’re buttering you up and then doing whatever the fuck they want to do.”) He thought the cause of the financial crisis was “simple. Greed on both sides—greed of investors and the greed of the bankers.” I thought it was more complicated. Greed on Wall Street was a given—almost an obligation. The problem was the system of incentives that channeled the greed.

But I didn’t argue with him. For just as you revert to being about nine years old when you visit your parents, you revert to total subordination when you are in the presence of your former C.E.O. John Gutfreund was still the King of Wall Street, and I was still a geek. He spoke in declarative statements; I spoke in questions.

But as he spoke, my eyes kept drifting to his hands. His alarmingly thick and meaty hands. They weren’t the hands of a soft Wall Street banker but of a boxer. I looked up. The boxer was smiling—though it was less a smile than a placeholder expression. And he was saying, very deliberately, “Your…fucking…book.”

I smiled back, though it wasn’t quite a smile.

“Your fucking book destroyed my career, and it made yours,” he said.

I didn’t think of it that way and said so, sort of.

“Why did you ask me to lunch?” he asked, though pleasantly. He was genuinely curious.

You can’t really tell someone that you asked him to lunch to let him know that you don’t think of him as evil. Nor can you tell him that you asked him to lunch because you thought that you could trace the biggest financial crisis in the history of the world back to a decision he had made. John Gutfreund did violence to the Wall Street social order—and got himself dubbed the King of Wall Street—when he turned Salomon Brothers from a private partnership into Wall Street’s first public corporation. He ignored the outrage of Salomon’s retired partners. (“I was disgusted by his materialism,” William Salomon, the son of the firm’s founder, who had made Gutfreund C.E.O. only after he’d promised never to sell the firm, had told me.) He lifted a giant middle finger at the moral disapproval of his fellow Wall Street C.E.O.’s. And he seized the day. He and the other partners not only made a quick killing; they transferred the ultimate financial risk from themselves to their shareholders. It didn’t, in the end, make a great deal of sense for the shareholders. (A share of Salomon Brothers purchased when I arrived on the trading floor, in 1986, at a then market price of $42, would be worth 2.26 shares of Citigroup today—market value: $27.) But it made fantastic sense for the investment bankers.

From that moment, though, the Wall Street firm became a black box. The shareholders who financed the risks had no real understanding of what the risk takers were doing, and as the risk-taking grew ever more complex, their understanding diminished. The moment Salomon Brothers demonstrated the potential gains to be had by the investment bank as public corporation, the psychological foundations of Wall Street shifted from trust to blind faith.

No investment bank owned by its employees would have levered itself 35 to 1 or bought and held $50 billion in mezzanine C.D.O.’s. I doubt any partnership would have sought to game the rating agencies or leap into bed with loan sharks or even allow mezzanine C.D.O.’s to be sold to its customers. The hoped-for short-term gain would not have justified the long-term hit.

No partnership, for that matter, would have hired me or anyone remotely like me. Was there ever any correlation between the ability to get in and out of Princeton and a talent for taking financial risk?

Now I asked Gutfreund about his biggest decision. “Yes,” he said. “They—the heads of the other Wall Street firms—all said what an awful thing it was to go public and how could you do such a thing. But when the temptation arose, they all gave in to it.” He agreed that the main effect of turning a partnership into a corporation was to transfer the financial risk to the shareholders. “When things go wrong, it’s their problem,” he said—and obviously not theirs alone. When a Wall Street investment bank screwed up badly enough, its risks became the problem of the U.S. government. “It’s laissez-faire until you get in deep shit,” he said, with a half chuckle. He was out of the game.

It was now all someone else’s fault.

He watched me curiously as I scribbled down his words. “What’s this for?” he asked.

I told him I thought it might be worth revisiting the world I’d described in Liar’s Poker, now that it was finally dying. Maybe bring out a 20th-anniversary edition.

“That’s nauseating,” he said.

Hard as it was for him to enjoy my company, it was harder for me not to enjoy his. He was still tough, as straight and blunt as a butcher. He’d helped create a monster, but he still had in him a lot of the old Wall Street, where people said things like “A man’s word is his bond.” On that Wall Street, people didn’t walk out of their firms and cause trouble for their former bosses by writing books about them. “No,” he said, “I think we can agree about this: Your fucking book destroyed my career, and it made yours.” With that, the former king of a former Wall Street lifted the plate that held his appetizer and asked sweetly, “Would you like a deviled egg?”

Until that moment, I hadn’t paid much attention to what he’d been eating. Now I saw he’d ordered the best thing in the house, this gorgeous frothy confection of an earlier age. Who ever dreamed up the deviled egg? Who knew that a simple egg could be made so complicated and yet so appealing? I reached over and took one. Something for nothing. It never loses its charm.