This is ... terrifying.

 

 

Military to Deploy on U.S. Soil to "Assist" with Pandemic Outbreak

Thursday, July 30, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor

(NaturalNews) Until now, what I'm about to tell you would have been easily dismissed as a conspiracy theory. It's the kind of story that you might expect from some extreme fringe blogger... the kind of story that never appears in the mainstream media. Only today, it did. And it's not a conspiracy theory, either.

CNN is reporting this evening that the U.S. military is gearing up to get involved in the H1N1 swine flu outbreak widely expected to strike the U.S. this fall. As CNN reports, "The U.S. military wants to establish regional teams of military personnel to assist civilian authorities in the event of a significant outbreak of the H1N1 virus this fall, according to Defense Department officials." (http://edition.cnn.com/2009/US/07/2...)

When it comes to the U.S. military, the word "assist," of course, could mean almost anything. Typically, the U.S. military offers assistance at the end of a rifle. This "assistance" could mean assisting with quarantines, assisting with rounding up infected people or assisting with arresting and imprisoning people who resist vaccine shots.

Just to make it even more interesting, this operation will include "personnel from all branches of the military" and it will involve cooperation with FEMA -- the Federal Emergency Management Agency. FEMA is the group of geniuses who handled the aftermath of Hurricane Katrina. They're the ones who confiscated firearms from law-abiding citizens defending their own homes, then thrust people into toxic temporary housing that caused neurological symptoms and breathing problems.

Internationally, FEMA is known as the Federal Emergency Laughing Stock Administration. But now, with H1N1 swine flu, FEMA will be backed by the power of highly-trained, heavily-armed military personnel.

Imagine one possible future in America...

There's a knock on your door. A peek through the window reveals two young soldiers in urban camo fatigues gripping M16 rifles slung across their chests. In front of them, an official-looking doctor person sports an N95 mask and carries a clipboard thick with ruffled papers.

Knock knock. "Is anyone home?"

One of the soldiers catches a glimpse of you peering through a sliver of curtain covering the living room window. "I've got movement." He tightens his grip on his rifle and elbows the soldier next to him. "Someone's home. Knock again."

Knock KNOCK. "We're here from the pandemic response team," insists the doc. "We're here to help. Open up or we'll be forced to come in."

Reluctantly, you inch towards the door and grip the doorknob with damp, sweaty hands. Your pulse pounds hard as you crack open the door.

But the doctor isn't in front of your door anymore. It's one of the soldiers -- the larger one -- and he wedges his foot between your door and its frame, prying it open and forcing his intimidating self into your doorway. "We're with FEMA. Please step away from the door."

"Our records show you haven't received the swine flu vaccine yet," squeaks the doctor from behind the bulk of the domineering soldier now squarely positioned in front of you. "We're here to administer your vaccine."

"I don't want a vaccine," you protest. "They're not safe."

The soldier chuckles, blurts out, "They're as safe as the U.S. government says they are."

The doctor peers out from behind his military companion and makes eye contact. "Sir, as you well know, vaccines have been required for all U.S. residents since President Obama's emergency pandemic declaration last month. Please extend your arm and we'll be on our way."

He produces a syringe and stabs it into a half-filled vaccine cylinder. As he pulls the plunger and liquid races into the syringe, you realize you have mere moments to make a decision. Will you willingly accept the vaccine and avoid being beaten, arrested or shot by the two armed enforcers at your door, or will you resist and pay the consequences?

"Please extend your arm now," the doctor says. The military grunt clenches his jaw, eyeing your hesitation with obvious scorn. He fingers the safety on his rifle and clears his throat...

... what will your choice be?

We're only here to help

That scenario might seem like fiction now, but it could unfold in America in the next few months. What seems outlandish today could become a police state reality before Christmas.

But this is no joke. These people are serious. Even the words tell too much: The order to approve all this is about to be signed by Defense Secretary Robert Gates, and it's called an "execution order."

So what, exactly, would military personnel be doing in your neighborhood in the event of a swine flu outbreak? The CNN story says they could assist with the "...testing of large numbers of viral samples from infected patients." There's nothing in the story about rounding people up, maintaining quarantine road blocks or cremating the infected bodies of the dead. These realities of a pandemic outbreak are better left unsaid if you're the U.S. military (or the mainstream media).

That's why the full story of what the U.S. military is planning for will never be told to the masses. It's too disturbing. But make no mistake: The military is planning for a worst-case scenario (that's what the military does), and a worst-case pandemic outbreak scenario would involve gunpoint-enforced isolation, military-enforced quarantine zones and most likely the forced vaccination of nearly everyone. Those who resist the vaccinations would be arrested (or detained) and injected at gunpoint, then set free back into the population.

Hollywood has already imagined some of what might happen in such a scenario. Rent the movie The Siege (Bruce Willis and Denzel Washington) to catch an imaginative glimpse of how the U.S. military might handle things in an "emergency situation." It's not a documentary, of course, but much of what it presents seems strangely on track with what's shaping up if a pandemic outbreak occurs.

The very fact that the military is now leaking this story to CNN says something all by itself: The U.S. military is preparing to be stationed on U.S. soil, and whatever freedoms you mistakenly think are guaranteed by the U.S. Constitution will be long gone by the time the soldiers arrive at your door.

Nice to see a little bit of justice done...

 

 

By LINDA A. JOHNSON (AP) – 22 hours ago

TRENTON, N.J. — Drugmaker Pfizer Inc. and the Nigerian government have resolved a long-running legal dispute over allegations children there were harmed in a 1996 Pfizer study of an experimental antibiotic during a meningitis outbreak.

The settlement calls for a $75 million payment by Pfizer, according to a person familiar with the negotiations.

That total includes about $35 million to be distributed among victims in the case, $30 million to improve health care in the Nigerian state of Kano, and about $10 million to cover that state's legal costs, according to the source, who requested anonymity because the talks have not been completed.

An official announcement was expected Thursday.

Eleven children died during the two-week test of Trovan, and others were left with brain damage, paralysis, blindness or slurred speech. The Nigerian government argued Pfizer was to blame, while the company countered that it followed proper procedures in the 200-patient study and that any harm was due to meningitis, a deadly bacterial disease endemic in Nigeria.

Kano state led a series of lawsuits against New York-based Pfizer seeking damages — initially requesting more than $5 billion.

The state government and Pfizer in May said they had a tentative agreement, not yet finalized, for Pfizer to pay a $75 million settlement.

Pfizer spokesman Chris Loder confirmed Wednesday that a resolution had been reached but declined to discuss details, saying the agreement was expected to be finalized Thursday.

The resolution "will avoid the continued cost and distraction of litigation, and can help improve and expand health care for the people of Nigeria," Loder said.

He said Pfizer stands by the 1996 study. It "was conducted with the approval of the Nigerian government, consent of the participants' parents or guardians, and was consistent with Nigerian law," he said.

Meanwhile, lawyer Richard Altshuler of West Haven, Conn., who said he represents 111 alleged victims jointly with another firm, has been trying to block the settlement, arguing the agreement would shortchange victims and send millions of dollars to Nigerian officials. Altshuler wants to sue Pfizer in the U.S. court system, where his clients might be awarded more money.

He filed legal documents in late May asking a Connecticut judge to halt the portion of the settlement talks that deal with compensation for his clients, but said a hearing on that has been postponed twice and now is set for Aug. 17.

"I think it's encouraging, and it may be a very significant step," he said late Wednesday, toward possible expeditious and amicable resolution of the cases he's handling in U.S. courts. He said he couldn't provide further details.

Loder, the Pfizer spokesman, said Altshuler has no legal basis to prevent Pfizer from negotiating with a foreign government.

He said the lawsuits filed in the U.S. "by purported Trovan study participants are separate and distinct from the cases filed in Nigeria, which the company has sought to settle for many months. The U.S. lawyers' complaints about interference with their cases are unfounded."

Trovan was approved by the U.S. Food and Drug Administration in December 1997.

However, after receiving reports of liver problems associated with long-term use of the drugs, the FDA in 1999 advised doctors to limit Trovan use to patients whose need outweigh those risks.

...instead of clean water initiatives and better access to health care in the developing world...

 

 

Crucell wins funding for malaria vaccine development

Big Pharma ... no matter what, they'll make their money.

 

 

Thursday, July 23 2009

Life After Eradication: Vaccines for Deceased Diseases 

By Cole Werble

Here’s a surprising fact from the annals of pharmaceutical product longevity: vaccines for diseases targeted for eradication actually outlive the diseases they are intended to prevent. In the case of polio, the number of vaccinations may actually increase substantially for the inactivated vaccine after eradication. That’s an opportunity for Sanofi-Pasteur and GlaxoSmithKline, but an opportunity with attendant challenges and responsibilities.

 

Vaccines can outlive the diseases they prevent and grow in importance after the virus that causes the disease is out of circulation.

That adds another twist to the special features and market characteristics that lend commercial interest to vaccines in areas that might not seem immediately attractive. (See “Vaccines Enter the New Age of Adjuvants,” The RPM Report, September 2006.)

One of the old adages about vaccines is that if they are successful they undo their commercial prospects. Once the underlying disease is eradicated, who will buy a vaccine? But that may not always be the case. The ongoing need for vaccines for the two diseases most interrupted by vaccines – smallpox and polio – puts that adage in a different perspective.

The markets for vaccines for eradicated diseases are not large by general pharma standards, but just the fact that demand can continue after eradication (and is projected in some cases to increase) has to make the projections for these products attractive anomalies for vaccine market planners.

In the case of smallpox, eradicated in 1979, the U.S. has been building stockpiles to cover two-thirds of the population since the increased concern about bioterrorism following the 9/11 attacks. The revival of interest in smallpox vaccinations has translated into two major contracts in the U.S. for Acambis: the most recent a 2008, 10-year deal worth a total of $425 million. Sanofi-Aventis picked up the contract through the purchase of Acambis in September 2008.

In the case of polio, where the final stages of eradication have dragged on for the past eight years, experts expect it will take over $300 million per year above current polio vaccination expenditures just to treat the developing world – about 50% more than is being spent annually in the developing world now.

Overall, in the developed and developing world, between 80 million and 425 million annual doses of inactivated vaccine may be needed to continue vaccinations and prevent recurrence of polio, when and if the world effort eventually eradicates the disease from wild virus. The current annual production capacity for the inactivated vaccine is about 120 million doses.

Production increases to reach the top end of the expected need for a post-eradication campaign would stand to benefit the two largest bulk producers of inactivated bulk vaccine: Sanofi-Pasteur (which says it is the largest producer) and GlaxoSmithKline.

Health Affairs Article Cites Transition To IPV As Key To Eradication

Columbia University economist Scott Barrett brings the need for a continued polio vaccine to light in an article in the most recent (July-August) issue of Health Affairs. Looking at the key steps in “The End Game in Polio Eradication,” Barrett highlights the important decisions that need to be made about selecting a vaccine for continued use, manufacturing it safely and at a cost-effective level and getting the world to switch to the chosen vaccine.

From Barrett’s point of view, vaccine issues are the most prominent among the ten “vulnerability points” or “weakest links” that could prevent final polio eradication.

“The current plan is for countries using oral [live-virus] polio vaccine after the wild viruses are certified as being eradicated,” Barrett told a July 14 Health Affairs meeting on international health issues. “All countries would [be expected to] synchronize the cessation of the use of the oral vaccine” which has risks associated with preparation and shedding of live virus. Barrett points out in his article that the oral vaccine (OPV) is cheaper than inactivated vaccine (IPV) and more effective in “smothering outbreaks,” but use of OPV increases the chances of future outbreaks from vaccine-derived virus.

“My fear is that this is a vulnerable policy” and very difficult to implement, Barrett said. “You really only need one country to say ‘we are not going to do it [switch to IPV],’” and that would continue to present the potential for breakthrough from the oral vaccine.

The financial burdens of switching from OPV to IPV in the developing world are real: IPV carries a per unit cost about 20 times greater than OPV, according to a recent study of the polio market conducted by the Oliver Wyman consulting firm for the Gates Foundation. “IPV manufacturing costs in the future will still be four to fifteen times the current price of OPV,” the Oliver Wyman report emphasizes.

Barrett notes that the developed world has already switched to IPV. The component is built into many of the new multi-combo pediatric vaccines for the U.S. market. The Centers for Disease Control Advisory Committee on Vaccine Practices (ACIP) just reiterated the recommended schedule for IPV vaccinations.

The developed world is “going to continue to use that vaccine after the viruses have been eradicated. The rich countries will be protected using the IPV.” Barrett expressed concern that “the poor countries won’t have anything. It won’t pay for them to switch to IPV.”

To address the vulnerability from stopping the OPV vaccine without an adequate transfer to IPV vaccine, Barrett said “we are going to need to think now about the policy post-eradication of substituting IPV for OPV for some period of time. We need to use IPV for some period of time, probably in the order of three to five years after OPV use has stopped.”

Calls for Alternate Producers

Barrett suggested that the wealthy countries and non-governmental sources like the Gates Fund could provide funds to cover IPV for the developing world after eradication or, alternatively, there could fund an effort to develop less costly IPV versions.

Barrett summarizes the alternatives: shifting production to developing countries; product and process innovation (reducing the dosage schedule, using fractional doses, adding an adjuvant); or developing an intradermal formulation.

The pressures for moving from established Western producers to local production will be great. “In a world in which live oral polio vaccination is prohibited and inactivated polio vaccine is very expensive,” Barrett writes in his article, “it seems inevitable that poor countries will want to produce their own supplies.”

Barrett notes, however, that moving away from established producers would add a new risk factor: “the risks associated with manufacturing inactivated polio vaccine in developing-country settings would have to be reduced for this to be an advantage overall.”

The Oliver Wyman report notes that the major IPV manufacturers are anticipating the increase in demand and “are investing or plan to invest in capacity expansions” which could lead to a straight-forward approach to increasing supply. The reports of increased investment by the existing manufacturers also serve as an effective deterrent to efforts to develop alternative dosages.

Sanofi and GSK are likely to get a lot of attention when the polio effort reaches eradication. The companies will have to manage pricing for very different markets for IPV, but that is a challenge that they face for many vaccines. GSK is making the establishment of a tiered price range a very public feature of its global vaccine activity – a position that chief exec Andrew Witty explained in an interview in a previous issue of Health Affairs. If the companies handle the production and pricing issues smoothly, they have an important opportunity with IPV: important to the image of the industry and to an extended product life.

So, when future headlines begin to focus on successful eradication, watch for the subtleties of how the vaccine producers have responded. As Barrett puts it succinctly: “Although the world’s attention today is understandably focused on eradicating the wild viruses, the ultimate success of the initiative will depend as much on the steps being taken now to improve the economics of inactivate polio vaccination.”

Oh, the comedy! Palo Alto is required to do an environmental impact study before expanding its plastic bag ban. Say what? Studying the environmental impact of banning an environmentally persistent piece of detritus that kills marine life, litters our landscape, and attracts and stores persistent organic pollutants? It's insanity to require the city of Palo Alto to spend money to prove that there won't be a net negative environmental impact of banning plastic bags--but it's the kind of insanity that Big Chemical has taken advantage of, time and again. <sigh>

 

 

Uploaded: Tuesday, July 28, 2009, 4:51 PM Palo Alto settles lawsuit over plastic bags City would keep its bag ban for supermarkets, but would do a full environmental review before adopting future bans

by Gennady Sheyner Palo Alto Weekly Staff

Palo Alto will have to conduct a lengthy environmental analysis should it choose to expand its campaign against plastic bags, according to a settlement the city reached this week with a regional coalition opposing the ban. Read the media release (PDF)

The settlement ends three months of negotiations between Palo Alto and the group SaveThePlasticBag.com. View the settlement (PDF)

The group, a San Francisco-based coalition of businesses and individuals, has maintained that Palo Alto's recent ordinance prohibiting plastic check-out bags at supermarkets is illegal because the city failed to prepare an environmental-impact report before adopting the ban in March.

The group formally filed its lawsuit against the city in April.

Under the settlement, the city will be able to maintain its ban. But any expansion of its scope would have to be accompanied by a complete environmental review.

The city's current ban applies to seven supermarkets, three of which had voluntarily stopped using plastic bags before the ban was adopted. Only Safeway, JJ&F Food Store, Andronico's and Mollie Stone's were required to stop using plastic check-out bags.

Stephen Joseph, the attorney representing SaveThePlasticBag.com, said the group is pleased with the settlement because it ensures that the city's ban on bags will not expand without a full review.

The City Council and staff have consistently indicated that they would like to ban plastic check-out bags from local pharmacies and other stores. The settlement essentially guarantees that the city's quest to expand its bag ban will take longer than officials had hoped.

"It's not worth fighting for two years over four stores," Joseph told the Weekly. "The important thing is that we've stopped the ban on all other stores, pending an environmental-impact report."

Don Larkin, Palo Alto assistant city attorney, said the settlement will not impede the city from expanding the scope of its ban on plastic bags.

"It's a good settlement. It'll still enable the City Council to reach all its goals; it'll just take a little longer," Larkin said.

Before enacting the ban in March, the city conducted considerable research on the ordinance's potential environmental impact, he said. Conducting a full environmental review in the future would take months, not years, he said.

In addition, other cities and agencies in the state are looking at similar bag bans, Larkin said. The city could join other municipalities in conducting legal and environmental research, making it more cost-effective in compiling an environmental-impact report.

 

UPDATE 2-Sanofi wins control of Indian vaccine firm Shantha

Of course, the American Chemistry Council is out there telling us there's not enough evidence, but the data speaks for itself. Kaiser Permanente has already switched its plastic tubing to phthalate-free. Ask your hospital to do the same.

 

 

Posted on Sun, Jul. 26, 2009

 

Chemical suspected in liver damage of premature newborns

The Associated Press

CHICAGO — A chemical used in many plastic products and already under scrutiny for potential health risks is suspected of raising the risk of liver problems in premature babies, according to a new study.

The small study in a German hospital suggests that a chemical known as a phthalate, used in some intravenous feeding bags and tubing, may raise chances for liver damage.

Rigorous research on phthalates’ effects in humans is lacking. There is no solid proof implicating DEHP, the phthalate studied.

Premature babies are often fed intravenously, a practice already known to increase liver problems. The new study, published today in the journal Pediatrics, says one possible reason is DEHP.

The researchers said their results show that hospitals treating newborns should turn to IV feeding equipment without DEHP. Some hospitals have already switched.

Steve Risotto of the American Chemistry Council, which represents chemical makers, disputed the results and said the study "doesn’t show any direct cause and effect."

 

Mylan Workers Overrode Drug Quality Controls

 

Internal report detailed 'pervasive' practice of ignoring safety procedures

Sunday, July 26, 2009

By Patricia Sabatini and Len Boselovic, Pittsburgh Post-Gazette

Bob Donaldson/Post-Gazette

The Mylan plant in Morgantown, W.Va.

MORGANTOWN, W.Va. -- Late this spring, Mylan Inc. took the unusual step of halting production at its sprawling generic drug manufacturing plant in Morgantown for an emergency meeting. Hundreds of employees, gathered in the cafeteria, were about to hear a bombshell.

Days earlier, Mylan learned two production workers had violated government-mandated quality control procedures intended to ensure the safety and effectiveness of prescription drugs. The company was launching a probe.

Publicly, Mylan officials have refused to discuss or even acknowledge the matter.

But according to a confidential internal report obtained by the Pittsburgh Post-Gazette, the company discovered that workers were routinely overriding computer-generated warnings about potential problems with the medications they were producing.

The violations of standard operating procedure at the world's third largest generic drug company, uncovered May 11, were "very serious," the report stated, involving "falsifying information" and "altering product."

The report said the practice was "pervasive," occurring on all three shifts at the plant, which makes roughly 19 billion doses of medication annually. The drugs are used to treat diabetes, high blood pressure, depression, cancer, epilepsy and other conditions.

The report did not say how long the unauthorized practice had been going on at the plant, which employs about 2,000. One worker interviewed by company investigators indicated it had been happening for at least two years.

Former Food and Drug Administration inspectors and industry consultants say the widespread breach of protocol raises troubling questions about the integrity and oversight of the plant's quality control operations.

"I've never before seen anything like this, that has reached this level of cheating," said James Akers, a longtime pharmaceutical industry consultant in Kansas City, Mo., who reviewed the document for the newspaper. "It certainly indicates a significant problem within their company."

Mylan's report offered conflicting and sometimes changing versions of what happened. When questioned by company investigators, most workers said they did not remember who showed them how to get around alerts designed to ensure drugs are properly made.

Although supervisors told the company they were unaware of what production workers were doing, some workers said supervisors were aware of the practice. At least one worker said supervisors directed her to break protocol.

Roughly a week after the breach was discovered, Mylan's quality assurance team had concluded that no medications were compromised, the report said. It did not say how the company made that determination.

In response to the breach, the report said, two union workers were suspended for 15 days and Mylan's quality team was to provide additional training and "evaluate the possibility" of revisions to the computerized quality control data management system used on the production line.

Company officials did not respond to requests for interviews for this story and did not respond to a series of questions faxed and e-mailed to Mylan's corporate offices in Cecil.

Last month, when Mylan officials learned that the newspaper had contacted several employees about the matter, CEO Robert Coury issued a memo reminding employees of the company's policy prohibiting unauthorized employees from talking with the news media.

Mylan's 'red screens'

The problem outlined in the report involved computer alarms known as "red screens." These alerts, triggered during the making of tablets and capsules, warn production workers that the medications may fail to meet specifications for weight, thickness or hardness, according to interviews with current and former Mylan employees. If the drug deviates from specifications, patients may not receive the proper dosage.

When a red screen occurs, workers are required to stop production and summon a quality control supervisor who launches an investigation to determine what triggered the alert and whether any drugs must be discarded, according to the report and interviews with employees. In some cases, the red screen turns out to be a false alarm of sorts. For example, it could be set off by a scale that needs to be recalibrated rather than an actual problem with the amount of active ingredient in the pills, and production resumes.

In any case, regulations require a written record of the investigation be compiled as part of the medication's batch record.

According to the internal report, workers admitted to ignoring protocol by clearing red screens on their own, deleting the record and keeping production rolling. When confronted by company investigators, these workers claimed they only did so after determining that the red screens weren't serious.

Two workers who said that the red screens they deleted weren't serious lied about other issues during the company's investigation, according to the report.

The report did not say how often red screens typically occur or exactly how often they were handled improperly. One production worker apparently deleted "five or six" red screens in a single shift, according to the report.

"Those judgments are not to be made by the people who are making [the tablets and capsules]," said Dr. Akers, the industry consultant who specializes in regulatory compliance. Overriding a red screen once is a serious problem and, according to the report, Mylan workers did it many times, he said.

The actions described in the report "certainly would not indicate a strong quality system or attention to detail regarding regulatory compliance" at the plant, Dr. Akers said.

FDA regulations require companies to develop and adhere to good manufacturing practices. Those practices involve a wide range of operational issues including personnel, training, facilities and equipment, quality and record keeping. For example, the regulations require drug companies to maintain a written statement of production and quality control procedures, document that the procedures are being followed and justify any deviation in writing. They require that changes in production and other records be made only by authorized personnel.

The agency also mandates that a company's quality control unit review production records to make sure that errors that occurred during production have been fully investigated and conclusions and follow-up actions were documented.

'The good, bad and ugly'

Martha Bennett, an industry consultant in Arizona and former investigator and senior compliance officer at the FDA, said Mylan's report described multiple serious FDA violations, including the falsification of batch production records. Batch records are important because they are used as the basis for an investigation if any drugs in the marketplace are suspected of causing problems, she said. Regulations also require computer systems be designed "so that operators can't do a go-around and delete information," Ms. Bennett said.

"The batch record is there to tell the story, the good, bad and ugly," said Robert Lewis, a regulatory consultant in Georgia and former FDA investigator who also reviewed Mylan's report. "Whenever there is a problem [during production] it should be noted and discussed and evaluated."

Experts said there was not enough information in the report to judge whether any drugs going out the door had been compromised.

The report described "serious [FDA] violations, no question about that," Ms. Bennett said. "To cheat, if you will, with an electronic record and say it is pervasive on all three shifts ... is very, very serious.

"But I can't determine from this report whether it's catastrophically serious," she said, meaning whether the breaches resulted in tainted medications.

Although workers were deleting red screens, the company likely would be able to perform a computer audit to access a permanent record showing when every red screen occurred, experts said. Indeed, Mylan's report indicates there was such a record.

To do the kind of thorough investigation that the FDA would want to see, experts said, the company should have identified all red screens that employees overrode improperly and determined what potential problem the quality control system was flagging. They said Mylan also should have tested samples from those drug lots -- samples the FDA requires drug makers to retain -- to ensure the medications met specifications.

The report did not state whether those steps were taken.

"I would have expected [Mylan] to have done that," Dr. Akers said.

The company's review should have extended back "to a point in time that could be set with a high-level of assurance that this is when [the unauthorized practice] started," Dr. Akers said. "You would want to go back to when this started and review all possible [drug] lots that were implicated," he said.

The report did not say how far back in time the company investigated. Portions of the report referred to specific red-screen incidents in April of this year.

Employees questioned

According to the report, Mylan began interviewing about two dozen employees about the matter on May 13, two days after the breach was discovered, and concluded the questioning on May 20. The investigation was closed two days later, according to the report, at which time quality assurance had "concluded that the quality of the product is not affected."

Ms. Bennett said she had "no idea" whether that would have been sufficient time to make that determination.

"They could have put everyone in the lab on this [investigation] 24 hours a day," she said.

Mr. Lewis said it was unlikely the company could conclude medications weren't tainted within two days of finishing interviews with employees.

"Interviews are usually the first step" in an investigation, he said. "Once you have an idea how pervasive [the problem] is, you begin to set up some type of investigation."

The report did not address why employees violated quality control regulations.

At least one worker broke protocol "to save time," the report stated. Later, the report concluded that "the root cause of this is unknown at this point."

Current and former employees told the newspaper the plant has been under intense pressure to boost productivity amid an internal debate about possibly moving production from Morgantown to India to cut costs. Mylan has a drug plant in the state of Maharashtra, about 115 miles northeast of the port city of Mumbai.

One worker told company investigators that when it came to clearing red screens without following proper procedures, the environment at the plant "was conducive." The report stated that she told investigators "this was OK to do."

A quality control supervisor told the company she felt the practice started by accident and became "something that they did daily in their job duties," the report stated.

Workers "had to know what they were doing was not right," the supervisor told the company.

One worker who denied deleting red screens told the company he was "aware that this is altering product and is very serious," the report said.

According to the report, a tablet press operator said he first learned about the practice in May when he was approached by a co-worker who told him: "If you have a red screen appear, I know how to get that to go away and [quality assurance] downstairs don't even know that is taking place."

A quality assurance manager on the midnight shift blew the whistle on the practice May 11, according to the report, when he ran "a report" and "saw there was a red screen and there was not an investigation created."

Mylan's investigation did not address a common question the experts had: Why didn't the company discover the breaches sooner?

"Why this report was suddenly being looked at [by the quality assurance manager], I don't know," Mr. Lewis said.

Said Dr. Akers: "If I were involved in the management of Mylan, I would be very concerned as to how this happened and why it was not caught sooner. ... Quality systems are designed to prevent this kind of thing from happening."

Call to hot line

Roughly a week after the quality assurance manager reported the practice, an anonymous caller to Mylan's ethics and compliance line alleged that the same manager plus six other managers and supervisors had given their passwords to production workers, making the unauthorized clearing of red screens possible, according to a written report on the call obtained by the Post-Gazette.

The caller stated that "employees had the passwords and cleared the red screen(s) and continued to run the product ... and did not fix the problems," according to that report.

Three days after that anonymous call, Mylan concluded that "employees were not given passwords from supervisors." Instead, they were able to clear red screens on their own by using the "right click" function of their computer mouse, the report said.

"Supervisors are unaware of this function," the report stated. "This process is being done on all three shifts."

Mr. Lewis said he was surprised that more people weren't held accountable considering the breaches were widespread.

"It seems like there would be more disciplinary action," he said.

"Any time that you may have a situation where employees manipulate the data or delete data or make a record look different than it should look ... it's extremely serious," he said.

Dr. Akers said he didn't understand why the two workers disciplined were not fired.

Wayne Mazanec, a former FDA investigator and assistant regional director who spent 33 years with the agency, said the actions of Mylan employees could be considered criminal.

"The repeated acts are each fraudulent in nature and are each subject to felonious considerations," he said in an e-mail to the newspaper after reviewing Mylan's report.

Federal court records show that since 2004, Mylan attempted to fire two union workers who admitted to violating quality control procedures at the Morgantown plant unrelated to the current problem. One case involved a female worker who placed three pieces of gum into an empty medicine bottle to send to co-workers down the packaging line. The other involved a worker who manipulated and falsified records when raw materials failed to meet specifications.

In each case, the employee was discharged and the union filed a grievance. When an arbitrator overturned the dismissals, Mylan appealed to federal court but lost and the employees were reinstated. In the lawsuit filed over the gum incident, Mylan maintained it had to fire the woman to protect the public from an "adulterated" product.

A product is considered adulterated when good manufacturing practices are violated, Mylan said in the suit. The company's complaint outlined the potential consequences of allowing such a product on the market.

"This clear violation of ... FDA's regulations could result in severe civil penalties for the drug manufacturer, including seizures, recalls, injunctions/consent decrees and warnings letters," Mylan stated.

Moreover, the FDA could reject or withdraw Mylan's permits to make drugs, consumers could file lawsuits and the company and its officials could face criminal prosecution, Mylan said in the suit.

In the current matter, Mylan's report did not say whether the company notified the FDA about the problems. The name of the agency was not mentioned in the report. An FDA spokesman said last week that the agency could only comment publicly about a breach in quality control if and when the agency had taken action against a company or an action was imminent.

Both Dr. Akers and Ms. Bennett said it would be their recommendation that Mylan contact regulators.

"It would be my advice to clients ... to volunteer the information to the agency rather than take the chance the FDA finds out on inspection," Ms. Bennett said. The agency typically inspects U.S. pharmaceutical plants once every two years, more often if there are consumer complaints or if the company has repeated infractions.

While Ms. Bennett said it was not clear whether the company would be required to report this event, "most good companies do because they would rather work with the agency rather than start out in a defensive mode."

Employees who provided information about the breaches to the newspaper did so on the condition that they remain anonymous. They said they feared losing their jobs at Mylan, one of the Morgantown region's largest and best-paying employers.

Some of them are bracing for more fallout.

"There's an overwhelming feeling this is not over," said a source close to the situation. "It's like a slow boil. Everyone is waiting to see what happens."

Patricia Sabatini can be reached at psabatini@post-gazette.com or 412-263-3066. Len Boselovic can be reached at lboselovic@post-gazette.com or 412-263-1941.

First published on July 26, 2009 at 12:00 am

Read more: http://www.post-gazette.com/pg/09207/986516-28.stm#ixzz0MUTjHFLC

 

We'll see if the public ever gets to read all of the relevant information about this dishonesty...

 

 

 

Given this, does this make sense?

 

Full articles below:

 

 

SCIENTIST FIRST TO CHARACTERIZE NOVEL SYNDROME OF ALLERGY, APRAXIA, MALABSORPTION

Newswise — A landmark study conducted by Children's Hospital & Research Center Oakland is the first to reveal a new syndrome in children that presents with a combination of allergy, apraxia and malabsorption. Autism spectrum disorders were variably present. Verbal apraxia has until now been understood to be a neurologically based speech disorder, although hints of other neurological soft signs have been described. The new study, led by Children's Hospital & Research Center Oakland scientist and pediatric emergency medicine physician, Claudia Morris, MD, and Marilyn C. Agin, MD, a neurodevelopmental pediatrician at Saint Vincent Medical Center in New York, however, suggests that the symptoms of verbal apraxia are, at least for a sub-group of children, part of a larger, multifactorial, neurologic syndrome involving food allergies/gluten-sensitivity and nutritional malabsorption.

"While it is critical to treat verbal apraxia symptoms that often include severe delays in expressive speech production with speech therapy, we need to start asking why these kids are having these problems in the first place so that we can identify mechanisms we can actually target to treat the cause of the symptoms," says Dr. Morris.

Published in the July/August issue of Alternative Therapies in Health and Medicine, the new study takes a major step toward identifying the potential mechanisms that may contribute to apraxia symptoms. In the study, Dr. Morris collected information from nearly 200 families with children who suffered from verbal apraxia in order to better characterize the symptoms and metabolic anomalies of a subset of children. The data clearly demonstrated a common cluster of allergy, apraxia and malabsorption, along with low muscle tone, poor coordination and sensory integration abnormalities. In addition, Dr. Morris was able to gather laboratory analyses in 26 of the children, which revealed low carnitine levels, abnormal celiac panels, gluten sensitivity, and vitamin D deficiency among others.

All children genetically screened carried an HLA gene associated with gluten sensitivity and celiac disease. "The sample size is still small and should be interpreted with caution," says Dr. Morris. "However this is of particular interest given the recent publication by Eaton and colleagues in the July 6 online edition of Pediatrics demonstrating a greater than 3-fold risk of autism in children born to mothers diagnosed with celiac disease. This brings some credibility to the anecdotal reports of gastrointestinal and behavioral improvements in children with autism spectrum disorders and/or verbal apraxia when eliminating gluten from their diets. Although the implications of these observations remain to be determined, this association and the utility of dietary modifications warrant further investigation, particularly if we can identify a genetically vulnerable group".

Most significantly, the data indicate that the neurologic dysfunction represented in the syndrome overlaps the symptoms of vitamin E deficiency. While low vitamin E bioavailability may occur due to a variety of different causes, neurological consequences are similar, regardless of the initiating trigger. The study suggests that vitamin E could be used as a safe nutritional intervention that may benefit some children. Growing evidence support the benefits of omega 3 fatty acid supplementation in a number of neurodevelopmental disorders. Anecdotally children with verbal apraxia will often demonstrate leaps in their speech production when taking high-quality fish oil. The addition of vitamin E to omega 3 fatty acid supplementation in this cohort of children induced benefits that exceeded those expected from just speech therapy alone, according to parental report.

"While data from a case series is by no means conclusive, the results clearly point to the need for further attention to this poorly understood disorder, and a placebo-controlled study to investigate the potential role of vitamin E and omega 3 supplementation in this group of children," says Dr. Morris.

She points out that it is equally important for children given an apraxia diagnosis to receive a more comprehensive metabolic evaluation than what is current practice. Many of the nutritional deficiencies like low carnitine, zinc and vitamin D are easily treated. By not addressing the nutritional deficiencies, the child will continue to suffer from significant medical consequences of those deficiencies. The first step is to identify and treat the deficiencies. The next step is to try to figure out why they have these deficiencies and a fat malabsorption syndrome in the first place. However, Dr. Morris does advise families to work closely with a physician rather than trying promising but unproven interventions on their own.

In the mean time, however, Dr. Morris's study provides the essential foundation for identifying the children who may need these treatments.

"By identifying these early red flags of the syndrome, we've provided a way to get these kids treatment at the earliest possible moment. While 75 percent of the time kids identified as late bloomers really are just that, 25 percent of the time there is a true pathologic condition. To miss it is to miss critically valuable time for early intervention. If a child has all these symptoms, chances are they are going to fall into the 25 percent who have a condition that needs further evaluation and treatment."

ABOUT CHILDREN'S HOSPITAL & RESEARCH CENTER OAKLAND

Children's Hospital & Research Center Oakland is Northern California's only freestanding and independent children's hospital. Children's is the leader in many pediatric specialties including neonatology, cardiology, neurosurgery and intensive care. The hospital is a designated Level 1 pediatric trauma center and has the largest pediatric critical care facility in the region. Children's Hospital has 190 licensed beds, 201 hospital-based physicians in 30 specialties, more than 2,611 employees and an operating budget of $312 million. Children's research arm, Children's Hospital Oakland Research Institute, is internationally renowned in bridging state of the art basic science and clinical research for the treatment and prevention of human disease. With about 300 staff members and an annual budget of approximately $50 million, CHORI is ranked among the top ten research institutes in National Institutes of Health funding to children's hospitals. CHORI is a leader in translational research, providing cures for diseases, developing new vaccines for infectious diseases and discovering new treatment protocols for previously fatal or debilitating conditions such as cancer, sickle cell disease and thalassemia, diabetes, asthma, HIV/AIDS, pediatric obesity, nutritional deficiencies, birth defects, hemophilia and cystic fibrosis.
 

DuPont was wrong (or lying) when the company projected the speed at which non-stick coatings and stain repellants break down into mutagenic compounds--wrong on the order of 100 TIMES! Yeah.

 

 

This will answer a big question that has been on a lot of people's minds... Here is the key piece of information, then the full article from Der Spiegel:

 

Jefferson: Don't you think there's something noteworthy about the fact that the WHO has changed its definition of pandemic? The old definition was a new virus, which went around quickly, for which you didn't have immunity, and which created a high morbidity and mortality rate. Now the last two have been dropped, and that's how swine flu has been categorized as a pandemic.

 

 

07/21/2009

 

INTERVIEW WITH EPIDEMIOLOGIST TOM JEFFERSON

'A Whole Industry Is Waiting For A Pandemic'

The world has been gripped with fears of swine flu in recent weeks. In an interview with SPIEGEL, epidemiologist Tom Jefferson speaks about dangerous fear-mongering, misguided, money-driven research and why we should all be washing our hands a lot more often.

 

JULY 22, 2009

A Fan of Camel Milk Struggles to Start a Drome-dairy

In North Carolina, Ms. Hinkle Promotes Hard-to-Get Beverage; Milking Martha

By LAUREN ETTER

RALEIGH, N.C. -- Millie Hinkle first tasted camel milk in the United Arab Emirates about 10 years ago. She had no idea the salty drink, still warm from the camel and served in an ornate bowl with a side of walnuts, would become an obsession.

"It has taken over my life," said the 57-year-old practitioner of natural medicine as she cruised down a tree-lined road here in her white SUV emblazoned with a camel.

Ms. Hinkle has drained her savings, slashed the number of hours she spends at her day job and started a company called Camel Milk USA. Her goal is to bring the milk, reputed to have healing and aphrodisiac powers, to the U.S. where it's been hard to get mainly because camels weren't listed in rules governing the sale of milk.

In April, Ms. Hinkle won initial approval from the National Conference on Interstate Milk Shipments, a nonprofit group, to market the milk. Now, she's awaiting approval from the U.S. Food and Drug Administration on some final details.

But there are several humps to overcome before camel milk is widely available in the U.S. For starters, there aren't many camels here. Those that are mainly work in circuses or live in zoos.

Another challenge: Camels don't much like to be milked. Camels can be cantankerous and persuading them to give up their milk can be part chore, part art. Camel experts say the animals are often ticklish around their udders and, without proper training, might lie down in the middle of being milked.

Camel milk is a centuries-old staple for nomadic tribes across the Middle East and Africa. It is also drunk by elderly men to enhance virility; by the sick to treat a variety of ailments; and by those who believe it has magical properties.

Ms. Hinkle said she's working with a large camel dairy in the Middle East that is interested in helping start a camel dairy in the U.S. She declined to name the dairy.

Most camel milking is still done by hand, but some modern dairies have gotten into the game. A dairy in Dubai called Emirates Industries for Camel Milk & Products sells camel-milk chocolate and camel milk under the brand "Camelicious." The milk comes in flavors including saffron and date.

The Camelicious dairy, opened in 2006, uses mechanized milking technology and trains camels to walk into the milking parlor. When the dairy first started, "the Bedouins said, 'No way will the animals enter that milking parlor,'" said Peter Nagy, the Hungarian farm manager there.

He and his wife, both veterinarians, solved the problem, he said, but "I cannot explain exactly how this was done." Mr. Nagy credits training by his wife: "A woman has a sixth sense" that allows her to "know how the animals feel."

Today, the Camelicious dairy has more than 1,500 camels. They are taken by the Bedouins on one-hour walks daily through the desert in a caravan formation. The dairy is working to develop higher-yielding milking camels. An average milking camel produces about two gallons of milk a day, Mr. Nagy said. Dairy cows produce around seven gallons a day.

In a 2006 report, the United Nations recommended camel milk as an area for Middle East economic development, saying that $10 billion in global sales "would be entirely within the realm of possibility."

Ms. Hinkle, who dons flowing white pantsuits and dangly gold earrings, sometimes tears up when talking about her quest. "I have to try to do what I can to help the most people," she said. "And for me this is it."

She said she was interested in becoming a physician as a young woman, but after being "poisoned" by lawn pesticides decided instead to study natural medicine. She opened her own clinic about 20 years ago in Raleigh, called Natural Health Resource Center. Here, from a second-floor office, she says she fields emails and calls from people who want camel milk as a health remedy and immigrants who crave the drink.

She gets a phone call almost every week from Abdirizak Mohamuod, a Somalian man in Minnesota who sells dried fruits and ethnic food. He says he has at least 70,000 Somalian customers in Minnesota who would buy it. "We would like to get the milk as soon as possible," he said.

Ms. Hinkle got her first taste of camel milk in the late 1990s while on a trip to the United Arab Emirates with her husband, who was then working for the state of North Carolina. As guests at the home of a member of the royal family, she recalls they were shown a lush backyard filled with racing camels and treated to fresh camel milk.

"I liked it OK," she said. But "it was one taste, and I never thought of it again."

Until three years ago. Her curiosity was piqued after reading about the benefits of camel's milk in an alternative-health magazine.

Camel milk has three times as much vitamin C as cow's milk and contains high amounts of iron, unsaturated fatty acids and B vitamins, according to the United Nation's Food and Agriculture Organization. Proponents tout it as an aid for everything from diabetes to autism. A biomedical research company in Belgium, called Ablynx, has been working on developing drugs based on antibodies found in camels and llamas, called nanobodies.

When Ms. Hinkle tried to buy camel milk in the U.S., she couldn't find any, which she found frustrating. "As I read more about camel milk, I thought 'I gotta get it here.'"

Her drive sent her before the National Conference on Interstate Milk Shipments, a nonprofit, industry-backed group formed in 1946 that oversees drafting of certain regulations that are then sent for FDA approval. She put together a proposal asking for camels to be included under the milk rules. The FDA recently gave tentative approval to cover camels, as well as reindeer, llamas, moose and donkeys under the rules.

An FDA spokesman said, "We wanted to improve the science basis in the definition" of milk coming from hooved mammals to include "species that may not have 'true hooves,'" such as camels.

Now, Ms. Hinkle is working to get FDA approval of a series of tests required to ensure the quality of camel milk. To do that, she needed samples. Larry Seibel, an animal breeder just north of Raleigh who specializes in white and spotted camels, agreed to help.

On a recent day, Mr. Seibel's wooded 85-acre reserve, called Ferncroft Farms, was abuzz with peacocks, munchkin cats, French bulldogs and a zebra. One of his 40 camels, named Martha, had recently given birth, providing a perfect milking opportunity since a camel tends to give up milk only with its baby nearby.

Martha, standing nearly 6 feet tall at the hump, moaned and kicked around hay in her barn. Her baby hungrily suckled her udders as a farmhand tiptoed around her and started milking.

Mr. Seibel petted Martha and cooed, "Good girl." Finally, Martha squirted her milk, which resembled a cappuccino, into a glass jar.

"Mission accomplished," said Ms. Hinkle.

Write to Lauren Etter at lauren.etter@wsj.com

You read the headlines all the time: they've "discovered the gene for" XYZ disease, yet you never read about the cure developed from this knowledge. Now read one scientist's views on why Francis Collins might take the NIH in the wrong direction with his obsession with genomics.

 

 

By Neil Greenspan

Too much optimism at NIH: Opinion One researcher's reservations about Francis Collins's nomination as head of the agency [Published 22nd July 2009 05:10 PM GMT]

 

I am not celebrating the nomination of Francis Collins to head the National Institutes of Health (NIH). My modest level of enthusiasm does not stem from concerns relating to his scientific accomplishments, administrative talent, political astuteness, or ability to communicate with average citizens, all of which are impressive. Nor do my reservations primarily follow from his religious commitments, although I disagree with a number of his assertions regarding the relationship between science and religion as well as some of his claims about the relative merits of evolution-related science versus non-scientific belief systems in explaining human behavior.

My concern about Dr. Collins assuming the leadership of the NIH relates principally to the content of his claims for the medical promise of genomics, especially pertaining to therapy, and his assertions regarding the coming era of personalized medicine, which have included a promise of what he termed "medical nirvana" in responding to one radio interviewer. Where some see his enthusiasm for genomics as merely "irrepressible optimism" (1), I see insufficient concern with informing the public about biomedical realities -- specifically, this should be done in a more balanced manner, preserving hope while not generating unrealizable expectations. As Gardiner Harris put it in The New York Times of July 9 (presumably conveying the views of scientists not willing to be identified), "Dr. Collins cannot be blamed for the unexpected scientific hurdles facing genetic research, but he played an important role in raising expectations impossibly high" (2).

So, before Dr. Collins takes the reins of the NIH, I would want to receive, and our representatives in Congress should demand, satisfactory explanations for many statements such as the following from an article he co-authored in the December 1999 Scientific American (3):

"Within 20 years, novel drugs will be available that derive from a detailed molecular understanding of common illnesses such as diabetes and high blood pressure. The drugs will target molecules logically and therefore be potent without significant side effects" [emphasis added].

This statement is surprising, and was so at its publication, regardless of the effectiveness of genomics in identifying genes associated with diseases. The notion of drugs without side-effects (even a single drug!), is scientifically dubious if not preposterous. Molecules can never be absolutely specific for other molecules (4) and even if molecular interactions were absolutely precise, the inhibition or activation of one cellular or physiological process frequently affects functionally linked processes not intentionally targeted by the therapy. Even those with no special training in or knowledge of biology or medicine should be skeptical of such a prediction if only because every drug they have ever taken or heard about has been associated with significant side effects at some doses in some people.

Consider the experience already in hand for drugs that target specific molecules "logically." While Vioxx worked as intended to inhibit a particular enzyme involved in inflammation, cyclooxygenase-2, it had a very long list of side effects including, most importantly for the lawsuits it engendered, increased risk for heart attack and stroke (5, 6). Epogen, an enormously profitable drug that effectively binds to a particular blood cell receptor, nevertheless has serious side effects, such as enhanced tumor growth in some cancer patients, some of which took years to fully appreciate (7).

Quoting further from the same paragraph quoted above:

"Drugs such as those for cancer will routinely be matched to a patient's likely response, as predicted by molecular fingerprinting. ... When people become sick, gene therapies and drug therapies will home in on individual genes, as they exist in individual people, making for precise, customized treatment."

Collins's enthusiastic pitch for the notion that in the future drugs will be matched to the genotypes of individual patients is supported by some current examples in which particular treatments are avoided for patients possessing particular genes or are varied in dosage as a function of genotype at one or a few loci. However, he tends not to acknowledge the limitations of even these examples.

An illustrative case is provided by the anti-retroviral drug, abacavir, used to treat AIDS. Abacavir causes a dangerous hypersensitivity reaction in patients with a particular gene involved in immune responses. However, based on recent studies, only about 55% of the individuals with the relevant gene are expected to exhibit the undesirable response on exposure to the drug (8, 9). Therefore, as many as 40-45% of those testing positive for the gene, and who could potentially use the drug safely, will receive an alternative agent. In other clinical situations, there may not be so many alternative agents of comparable effectiveness so that the inefficiency in such a genetic test, even if justified on balance, could incur its own costs in non-optimal treatment.

The bolder implication of pharmacogenomics hinted at in the above quote, that everyone will receive genotype-based customization of treatment for whatever ails them, is problematic in at least two fundamental respects. Scientifically, it is doubtful that safe and effective genotype-specific drugs will be found to meet every need. Financially, it is difficult to imagine that pharmaceutical companies will be willing to invest the massive sums required to create such drugs for ever smaller genetically-constrained markets.

Another disturbing aspect of Collins's genomic advocacy is his tendency, shared with some other proponents of genomics, to attribute to recent studies of human (or other) genomes insights that were in fact already arrived at through earlier genetics research. Consider the following quote from an article in The New Republic in 2001 (10): "Fortunately, ten years of intensive study of the human genome have provided ample evidence that these fears of genetic determinism are unwarranted." Anyone familiar with the term "genetic determinism" may have encountered one of the many articles or books (e.g., 11-13) that significantly predated the conclusion of the Human Genome Project and that were devoted to documenting the potentially complex relationships between genotypes and phenotypes.

Collins and his co-authors admit as much in what follows, but the statement quoted above will conceivably cause unwary readers to credit our understanding of the subsequently described instances of "genes not being everything" to the power of genomics. For example, the authors of the article note that sickle cell disease, initially regarded as a so-called single-gene defect, can vary in severity even though the same disease-associated alleles at the hemoglobin beta-chain locus are present (in two copies) in the individuals with the clinically more and less severe forms of the condition. This interesting and important insight can be traced back to a study from 1978 (14).

So, while Dr. Collins has many impressive credentials, talents, and skills relevant to directing the NIH, his tendency to make dubious claims for the future benefits of genomics is unsettling. The director of NIH should be a reliable and realistic source of medical information if the entire biomedical research enterprise is to remain credible. Therefore, in the future, Dr. Collins should harness his intellect to control his enthusiasm so that he is more realistic in his public pronouncements regarding improvements in medical care that will undoubtedly develop in part from new insights into human genetics and genomics.

Neil Greenspan is an immunologist and professor of pathology at the Case Western Reserve University School of Medicine and director of the Histocompatibility and Immunogenetics Laboratory of University Hospitals Case Medical Center. The opinions expressed above are solely his own and do not reflect official views of the institutions with which he is affiliated.

References:

1. J. Couzin-Frankel, "The promise of a cure: 20 years and counting," Science, 324:1504-07, 2009.

2. G. Harris, "Pick to lead health agency draws praise and some concern," The New York Times, July 9, 2009.

3. F.S. Collins and K.G. Jegalian, "Deciphering the code of life," Scientific American, 281:86-91, 1999.

4. B. Alberts et al., Molecular Biology of the Cell, Second Edition, Garland Publishing, Inc., New York & London, 1989, p. 94.

5. R.S. Bresalier et al., "Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial," N Engl J Med, 352:1092-102, 2005. Erratum in: N Engl J Med, 355:221, 2006.

6. L.E. Levesque et al., "Time variations in the risk of myocardial infarction among elderly users of COX-2 inhibitors," CMAJ, 174:1563-69, 2006.

7. M. Henke et al., "Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial," Lancet, 362:1255-60, 2003.

8. S. Mallal et al., "HLA-B 5701 screening for abacavir hypersensitivity," N Engl J Med, 358:568-79, 2008.

9. Personal communication, Simon Mallal, March 31, 2009.

10. F.S. Collins, L. Weiss, and K. Hudson, "Have no fear. Genes aren't everything," The New Republic, June 25, 2001.

11. R. Hubbard and E. Wald, Exploding the Gene Myth: How Genetic Information Is Produced and Manipulated by Scientists, Physicians, Employers, Insurance Companies, Educators, and Law Enforcers, Beacon Press, Boston, 1993.

12. R. Lewontin, Biology as Ideology: The Doctrine of DNA, HarperPerennial, New York, 1991.

13. R. Lewontin, The Triple Helix: Gene, Organism, Environment, Harvard University Press, Cambridge, MA, 2000.

14. R.P. Perrine et al., "Natural history of sickle cell anemia in Saudi Arabs. A study of 270 subjects," Ann Intern Med, 88:1-6, 1978.

Let's see whether results are ever reported in the mainstream media for this one, shall we? Let's see whether we read about anything beyond immunogenicity--like perhaps adverse events.

 

 

 

 

Monday, July 20 2009

FDA Is Playing Bigger Role In Product Launches: That May Not Be All Bad 

By Cole Werble

FDA’s new REMS post-marketing tools can still take a long time for the agency and sponsors to agree on during sponsors and they can add new burdens for sponsors in once they begin marketing. But they also may present a new opportunity for marketers to reach the medical community with launches. The Lilly/Daiichi launch of Effient (prasugrel) may test the positive aspects of FDA’s new foray into the commercial sphere.

 

FDA is going to be checking to make sure how many physicians Lilly/Daiichi reach in five key medical practice areas during the first two years of the launch of Effient (prasugrel).

The agency will also be checking to find out how effectively Lilly conveys proper use and safety messages about the new anti-clotting agent to those physicians

If those sound like extra burdens on the sponsors/marketers, they are. Marketers traditionally have to stick to approved labeling claims and face complaints from the agency if they go beyond labeled claims.

But, the new Risk Evaluation & Mitigation Strategies authority granted to FDA by the FDAAA Act of 2007 gives the agency the ability to tell sponsors where to provide safety messages and what special documents to take along as training/education materials – and then to collect information that allows FDA to back-check on how effectively the programs were conducted.

As part of its new post-marketing powers, FDA has informed both of the co-promoters that it expects to receive reports on who was detailed and how effective was the safety messaging details were after eighteen months (at the end of January 2011).

Lilly and Daiichi are co-promoting the new clot-busting product in the U.S. Both companies will commit detail forces to the launch. The product was approved by FDA on July 10.

Will REMS Get Lilly More Launch Attention?

As part of the plan to get the sponsors to collect information on the effectiveness of initial safety information, FDA is pressing the firms to visit physicians in five key areas (interventional cardiology, clinical cardiology, emergency medicine, internal medicine, and primary care).

The pressure from the regulator to spread the safety message broadly could actually help Lilly and Daiichi overcome some of the questions raised around the product during clinical trials and the prolonged year-and-a-half regulatory review prior to approval.

Lilly and Daiichi representatives will be carrying introduction materials – a Dear Doctor Letter and a Prescriber Brochure – specifically cited in a legally binding REMS plan and presumably worked out in conjunction with FDA.

The Lilly and Daiichi sales forces may just get a little more attention for their intro message than the typical new product launch. In essence, they will be coming to the doctor’s office with a message from FDA – beyond traditional labeling – with instructions about how and when to use the new product.

In the REMS communication plan imposed on Lilly and Daiichi, FDA is playing an increased role in the launch of the new product than the agency has traditionally played. Because of the size of the launch and visibility of the product, Effient is likely to help establish the new revised role of FDA as a monitor of messaging for other new products.

The REMS communication plan for Effient consists of a Dear Healthcare Provider letter and a prescriber brochure. The REMS does not establish “elements for safe use” – i.e. distribution or prescribing restrictions by specialty. The official REMS plan for Effient says that the prescriber brochure “will emphasize the key safety messages related to risk of bleeding associated with Effient and the importance of appropriate use and proper patient selection.” It also will convey suggested information for MDs to share with patients.

That description makes the brochure sound not much different from a Medication Guide, but it will be different because the Lilly sales force will be able to say that FDA is requiring them to deliver a separate, special document. Effient will also have a separate MedGuide.

The content of the REMS is limited to the known serious safety issue – bleeding, not the lingering concerns about cancer. The tumor question will be assessed in a mandatory postmarketing trial.

The communication requirements will last for the first two years of marketing. “This element of the REMS is not intended to continue over the lifetime of the product,” FDA says.

Lilly/Daiichi are obligated to provide periodic assessment reports on the distribution and dispensing of the REMS material, as well as a report on failures in getting out that material “and corrective actions taken to address non-compliance.” After the first assessment deadline at the end of January 2011, the product sales calls and messaging will be reviewed again in late July 2012 and late July 2016.

The sponsors are also obligated to conduct – and report back to FDA on – a survey of prescribers’ understanding of the safety messages and adherence to the boxed warning. Lilly/Daiichi must also prepare specific measures to increase awareness if the surveys indicate that prescribers are not complying. FDA will get a chance to review the survey protocol; it must be submitted to the agency 90 days before roll-out. Another survey will test patient understanding of the MedGuide.

another shocker...

 

 

State DEQ promises "tough questions" for Dow; agency reps snubbed by St. Charles Council

by Matt Scallan, The Times-Picayune

Tuesday July 21, 2009, 10:00 AM

A state Department of Environmental Quality official said Monday that an investigator has been at Dow Chemical's Hahnville plant nearly every day to investigate the cause of the the July 7 leak of ethyl acrylate fumes that irritated the noses eyes and throats of residents for miles around.

"He's meeting with Dow people and asking some very tough questions about what happened, how it happened and how can we prevent it from happening again," said Mike Alegro, manager of the DEQ's southeast regional office, Monday afternoon.

DEQ and Department of Health and Hospitals representatives attended Monday's Parish Council meeting to answer council questions at the invitation of New Sarpy Postmaster Michael Kernan, who said he and his wife were sickened by the fumes.

Kernan, who criticized the parish's decision not to evacuate Norco and New Sarpy and waited more than three hours to speak, told the council that the officials would not make statements, but would answer questions from the Council. None were asked, and the group left.

Council Chairman Terry Authment said only Kernan asked to be on the council's lengthy agenda.

The DEQ's remarks about enforcement came after an environmental watchdog group is charging that state DEQ officials allowed a problem with three previous leaks of the chemical, starting in October and ending June 15.

"These reports provide further information that Dow has had an ongoing problem with ethyl acrylate and apparently with this tank, and that the Department of Environmental Quality has known about it" said Randy Caruso, a Spatial Analyst for the Louisiana Bucket Brigade.

"Both Dow and DEQ have failed to take the appropriate steps to get to the root of the problem and protect the public," he said.

State officials said the July 7 release was well below the toxic threshold of 25 parts per million over an eight-hour period.

Dow Spokesman Tommy Faucheux said after the June 15 release from the 60-foot wide tank,
Dow officials began draining the vessel in order to inspect it for structural problems. A reaction in that tank, which was almost empty at the time, caused the July 7 release.

"We were trying to address the problem," Faucheux said.

The two other releases, in October 20, 2008 and April 22, occurred in two separate tanks, Faucheux said.

The DEQ's Alegro said Monday afternoon that regulated industries have to produce a detailed report unauthorized releases above reportable levels within 60 days of the incident, which allows the DEQ to conduct a "root cause analysis" to determine whether matter should be turned over to the agency's enforcement division.

"If it's an act of God, we usually don't, but if it was the result of a company not doing required maintenance, then we most likely would do that," he said.

The the initial report that Dow filed with the National Response Center, along with correspondence to parish agencies said a tank was being drained in the wake of a leak.

The Bucket Brigade accused the Louisiana Department of Environmental Quality was neglectful by not investigating a potential problem and that a report filed with the National Response Center shows that Dow had released ethyl acrylate on June 15. That is four ethyl acrylate releases over a 10-month span, the group said.

The report to the DEQ, filed on June 19th, notes a problem with a tank, in which a quantity of ethyl acrylate was released, but does not say how much.

Alegro said the deadline for Dow to submit its 60 day report has not passed and that information will be available.

...from the folks over at Natural News...

 

 

Farmed Fish Could Give Humans Mad Cow Disease

Tuesday, July 21, 2009 by: S. L. Baker, features writer

(NaturalNews) There is probably no illness that has more terrifying symptoms, or a more ghastly outcome, than variant Creutzfeldt-Jakob disease (vCJD) -- best known as mad cow disease. Abnormal proteins called prions found in brain tissue of cows suffering from bovine spongiform encephalopathy (BSE) can cause vCJD in humans who eat meat from the animals. These mad cow disease-causing prions can literally result in people losing their minds because the infectious particles eat away at the brain, leaving tiny sponge-like holes. There is no treatment available and death always follows.

With government regulations notoriously lax when it comes to testing for BSE in the food supply, many people have given up eating beef in hopes of protecting themselves from exposure to mad cow disease. But an article just published in the Journal of Alzheimer's Disease suggests there may be another ticking time bomb source of vCJD -- farmed fish.

In a paper entitled Bovine Spongiform Encephalopathy and Aquaculture, University of Kentucky neurologist Robert P. Friedland and colleagues point out that fish consumption is widely recommended because omega-3 fatty acids are known to reduce the risks of cardiovascular and Alzheimer's diseases. However, the scientists have doubts that the health benefits of farmed fish outweigh a potentially deadly danger. "We are concerned that consumption of farmed fish may provide a means of transmission of infectious prions from cows with bovine spongiform encephalopathy to humans, causing variant Creutzfeldt Jakob disease," they stated.

Dr. Friedland and his team point out that farmed fish are fed byproducts rendered from cows -- a totally unnatural source of food for fish. The risk of transmission of mad cow disease to humans who eat farmed fish would seem to be slim because there are often barriers between species that help prevent infections. But, according to the Journal of Alzheimer's Disease article, there are several reasons to be concerned about fish spreading mad cow to humans.

First, fish could be carriers of the disease from eating infected meat products, even though the fish themselves are not obviously infected or sick. In addition, it is possible that eating prion-infected cow parts could result in fish experiencing pathological changes that permit the prion infection to be transmitted between the two species. Based on these worrisome possibilities, the scientists are calling for government regulators to ban feeding cow meat or bone meal to fish until this common practice can be shown to be safe.

"We have not proven that it's possible for fish to transmit the disease to humans. Still, we believe that out of reasonable caution for public health, the practice of feeding rendered cows to fish should be prohibited. Fish do very well in the seas without eating cows," Friedland said in an interview with the Kentucky Post newspaper.

"The fact that no cases of Creutzfeldt Jakob disease have been linked to eating farmed fish does not assure that feeding rendered cow parts to fish is safe. The incubation period of these diseases may last for decades, which makes the association between feeding practices and infection difficult. Enhanced safeguards need to be put in place to protect the public," Friedland stated.

For more information:

http://www.j-alz.com/issues/17/vol1...

http://www.cdc.gov/ncidod/dvrd/bse/

http://www.kypost.com/news/local/st...

http://www.cdc.gov/ncidod/dvrd/vcjd...

...because Uncle Sam will be picking up the tab for anyone injured by the new vaccine. This article is somewhat poorly researched, because the Feds covered the pharmas for Gerald Ford's swine flu shot back in 1976, too.

 

 

By MIKE STOBBE (AP) – 1 day ago

ATLANTA — The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.

The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.

AP Medical Writer Lauran Neergaard contributed to this report from Washington.