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October 22 More on Overdiagnosis and Overtreatment of Breast and Prostate CancerCancer Society, in Shift, Has Concerns on Screenings
By GINA KOLATA
Published: October 20, 2009
The American Cancer Society, which has long been a staunch defender of most cancer screening, is now saying that the benefits of detecting many cancers, especially breast and prostate, have been overstated.
It is quietly working on a message, to put on its Web site early next year, to emphasize that screening for breast and prostate cancer and certain other cancers can come with a real risk of overtreating many small cancers while missing cancers that are deadly. “We don’t want people to panic,” said Dr. Otis Brawley, chief medical officer of the cancer society. “But I’m admitting that American medicine has overpromised when it comes to screening. The advantages to screening have been exaggerated.” Prostate cancer screening has long been problematic. The cancer society, which with more than two million volunteers is one of the nation’s largest voluntary health agencies, does not advocate testing for all men. And many researchers point out that the PSA prostate cancer screening test has not been shown to prevent prostate cancer deaths. There has been much less public debate about mammograms. Studies from the 1960s to the 1980s found that they reduced the death rate from breast cancer by up to 20 percent. The cancer society’s decision to reconsider its message about the risks as well as potential benefits of screening was spurred in part by an analysis published Wednesday in The Journal of the American Medical Association, Dr. Brawley said. In it, researchers report a 40 percent increase in breast cancer diagnoses and a near doubling of early stage cancers, but just a 10 percent decline in cancers that have spread beyond the breast to the lymph nodes or elsewhere in the body. With prostate cancer, the situation is similar, the researchers report. If breast and prostate cancer screening really fulfilled their promise, the researchers note, cancers that once were found late, when they were often incurable, would now be found early, when they could be cured. A large increase in early cancers would be balanced by a commensurate decline in late-stage cancers. That is what happened with screening for colon and cervical cancers. But not with breast and prostate cancer. Still, the researchers and others say, they do not think all screening will — or should — go away. Instead, they say that when people make a decision about being screened, they should understand what is known about the risks and benefits. For now, those risks are not emphasized in the cancer society’s mammogram message which states that a mammogram is “one of the best things a woman can do to protect her health.” Dr. Brawley says mammograms can prevent some cancer deaths. However, he says, “If a woman says, ‘I don’t want it,’ I would not think badly of her but I would like her to get it.” But some, like Colin Begg, a biostatistician at Memorial Sloan-Kettering Cancer Center in New York, worry that the increased discussion of screening’s risks is going to confuse the public and make people turn away from screening, mammography in particular. “I am concerned that the complex view of a changing landscape will be distilled by the public into yet another ‘screening does not work’ headline,” Dr. Begg said. “The fact that population screening is no panacea does not mean that it is useless,” he added. The new analysis — by Dr. Laura Esserman, a professor of surgery and radiology at the University of California, San Francisco, and director of the Carol Frank Buck Breast Care Center there, and Dr. Ian Thompson, professor and chairman of the department of urology at The University of Texas Health Science Center, San Antonio — finds that prostate cancer screening and breast cancer screening are not so different. Both have a problem that runs counter to everything people have been told about cancer: They are finding cancers that do not need to be found because they would never spread and kill or even be noticed if left alone. That has led to a huge increase in cancer diagnoses because, without screening, those innocuous cancers would go undetected. At the same time, both screening tests are not making much of a dent in the number of cancers that are deadly. That may be because many lethal breast cancers grow so fast they spring up between mammograms. And the deadly prostate ones have already spread at the time of cancer screening. The dilemma for breast and prostate screening is that it is not usually clear which tumors need aggressive treatment and which can be left alone. And one reason that is not clear, some say, is that studying it has not been much of a priority. “The issue here is, as we look at cancer medicine over the last 35 or 40 years, we have always worked to treat cancer or to find cancer early,” Dr. Brawley said. “And we never sat back and actually thought, ‘Are we treating the cancers that need to be treated?’ ” The very idea that some cancers are not dangerous and some might actually go away on their own can be hard to swallow, researchers say. “It is so counterintuitive that it raises debate every time it comes up and every time it has been observed,” said Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health. It was first raised as a theoretical possibility in the 1970s, Dr. Kramer said. Then it was documented in a rare pediatric cancer, but was dismissed as something peculiar to that cancer. Then it was discovered in common cancers as well, but it is still not always accepted or appreciated, he said. But finding those insignificant cancers is the reason the breast and prostate cancer rates soared when screening was introduced, Dr. Kramer said. And those cancers, he said, are the reason screening has the problem called overdiagnosis — labeling innocuous tumors cancer and treating them as though they could be lethal when in fact they are not dangerous. “Overdiagnosis is pure, unadulterated harm,” he said. Dr. Peter Albertsen, chief and program director of the urology division at the University of Connecticut Health Center, said that had not been an easy message to get across. “Politically, it’s almost unacceptable,” Dr. Albertsen said. “If you question overdiagnosis in breast cancer, you are against women. If you question overdiagnosis in prostate cancer, you are against men.” Dr. Esserman hopes that as research continues on how to advance beyond screening, distinguishing innocuous tumors from dangerous ones, people will be more realistic about what screening can do. “Someone may say, ‘I don’t want to be screened’ ” she said. “Another person may say, ‘Of course I want to be screened.’ Just like everything in medicine, there is no free lunch. For every intervention, there are complications and problems.” October 21 Vaccines for Addiction?Here's one that makes you say, "What the f***ety f***?" Preventing addiction via a vaccine... This can't possibly be the most practical or safe way to keep people from getting hooked on drugs. I almost can't believe someone is suggesting this.
U.S. backs vaccines for drug, nicotine addictionTue Oct 20, 2009 4:42pm EDT
* Drug abuse chief eyes vaccines as new treatment option * Nicotine vaccines could reach $2 billion market by 2016 By Julie Steenhuysen CHICAGO, Oct 20 (Reuters) - Hooked on cocaine or cigarettes? The U.S. government wants drug companies to make a vaccine for that. Convinced of the need for new and better treatments for addiction, the government is focusing its efforts on vaccine development as a new way to treat and possibly prevent addiction to a range of addictive substances. "It's a perspective that is very different from what we've operated on in the past," Dr. Nora Volkow, director of the National Institute on Drug Abuse told reporters this week at the Society for Neuroscience meeting in Chicago. Volkow said the agency intends to piggyback on the frenetic investment by drug companies in vaccine development, spurred by the need for new products and the runaway success of products like Merck's (MRK.N) Gardasil vaccine to prevent the virus that causes cervical cancer. "There is an enormous amount of research and development in vaccines for cancers and a wide variety of disorders," she said. "We can take advantage of those developments." But first Volkow has to tempt drug companies to develop the vaccines by funding costly clinical trials. Earlier this month, her agency, part of the National Institutes of Health, awarded Nabi Biopharmaceuticals (NABI.O) a $10 million grant -- the agency's largest ever -- for a late-stage clinical trial of Nabi's vaccine for nicotine addiction called NicVAX. Volkow said she did her homework before backing the Nabi vaccine to ensure it was significantly different from other products. "Nonetheless, when you are investing in something at this level, it can be very risky," she said. The vaccine is meant to stimulate the immune system to make antibodies against nicotine, blocking its rewarding effects and helping to prevent relapse in smokers trying to quit. TOUGH MARKET A similar anti-smoking vaccine by Cytos Biotechnology (CYTN.S) and Swiss drugmaker Novartis (NOVN.VX) last week missed its main goal in a midstage study, leading some analysts to question whether it can make it to market. "They are still looking at it but it has been very problematic," said Robert Wasserman, director of investment research at the investment banking firm Dawson James in Florida. "Vaccines are really tough," he said. "It's not for the faint of heart." Still, if it works, a nicotine vaccine could have a huge impact, Volkow said. "It's an international problem that kills 5 million individuals every year across the world," she said. The global market for smoking cessation is expected to reach $4.6 billion by 2016, and vaccines could account for $2 billion in sales, according to independent market research firm Datamonitor. Volkow said the same methods for making a nicotine vaccine could be used for other illicit substances. Her agency backed a study released this month of an anti-cocaine vaccine that helped block the high felt by 38 percent of addicts who took it. The vaccine was developed by Dr. Thomas Kosten of Baylor College of Medicine in Houston, who used a similar approach to make a nicotine vaccine now being tested in Europe by private equity firm Celtic Pharma. Volkow said drumming up drug company interest in vaccines for illicit drugs is a harder sell because of liability concerns, and the fact that drug abusers are stigmatized. "Unfortunately, when it comes to treatments for drug addiction ... most of the investment goes to the government," she said. (Editing by Mohammad Zargham) Did You Need More Proof? High-Fructose Corn Syrup Is Bad for You...and may be bad for bees, and is subsidized by your tax dollars... let me count the ways I hate HFCS...
High-Fructose Corn Syrup Produces Toxic Chemical "HMF" When HeatedTuesday, October 20, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor(NaturalNews) If you know anything about the food supply, you know that honey bees are a crucial part of the food production chain. In the United States, they pollinate roughly one-third of all the crops we eat, and without them, we'd be facing a disastrous collapse in viable food production. That's why, when honey bees started to disappear a few years ago, scientists scrambled to find the root cause of the phenomenon, which has since been dubbed "Colony Collapse Disorder." The name is a bit of a misnomer, though. It's not really a "disorder." It's more of a poisoning. Or at least that's what we may be learning from new research that's just been published in the ACS' Journal of Agricultural and Food Chemistry (http://pubs.acs.org/stoken/presspac...). It's been difficult, of course, trying to determine the cause of colony collapse disorder. Some of the suggested theories for explaining the phenomenon included chemical contamination from pesticides, genetic contamination from genetically modified crops, changes in the Earth's magnetic field, climate change and air pollution. In an attempt to nail down some scientific answers, researchers from the USDA Agricultural Research Service in Tucson, Arizona joined with other researchers in New Orleans and the University of Wisconsin to check out another possible culprit: High-fructose corn syrup (HFCS). HFCS, as you may already know, is a processed, liquid sweetener used in disturbingly large amounts throughout the global food supply. You can find it in not just sodas, but pizza sauce, salad dressings and even whole wheat bread. It's in breakfast cereals, food bars, peanut butter, ketchup and a thousand other products. There are two reasons why you find HFCS in so many food products: 1) It's sweet. 2) It's cheap. It is for these same two reasons that high-fructose corn syrup is fed to honey bees. It provides them the sugar calories to stay active without resulting in a huge cost for the beekeeper. That's why HFCS has been used for decades as a food source for honey bees. But this very food source may, in fact, be poisoning the bees. HFCS forms hydroxymethylfurfuralWhat these USDA researchers discovered is that when HFCS is heated, it forms hydroxymethylfurfural (HMF), a chemical that can kill honey bees. The production of HMF during cooking rose in parallel to the temperatures to which HFCS was exposed.To put it plainly, when you cook HFCS, it becomes contaminated with HMF. And according to the research, levels of HMF "jumped dramatically" when temperatures rose above 120 degrees Fahrenheit (which isn't very hot, by the way). This is similar to the way in which browning or frying carbohydrates produces acrylamides, a cancer-causing chemical that's also ubiquitous in the food supply. (http://www.naturalnews.com/acrylami...) The upshot is that HMF could be part of the reason why honey bees are dying off. Feeding a chemical contaminant to your bees, after all, doesn't sound like a good way to support their long-term health. But if HFCS has been fed to honey bees for decades, why the sudden collapse of bee populations in just the last few years? We don't know the answers to that yet, but HMF is likely only part of the picture. It could be that honey bees are already stressed from pesticides, GM crops and other environmental sources. With their chemical burdens already maxed out, one additional dietary stressor might have just pushed them over the edge. There's a limit, of course, to how much chemical stress any biological organism can tolerate, and honey bees appear to have been pushed one chemical too far. Perhaps hydroxymethylfurfural will one day be known as "the chemical that killed the honey bees." You can read a bit more about this chemical on Wikipedia: (http://en.wikipedia.org/wiki/Hydrox...). Could HMF harm humans, too?Beyond the issue of honey bees, this research on HFCS and HMF raises some potentially serious questions about the use of the ingredient in the human food supply:Is HMF toxic to humans? If it kills honey bees, could it damage the brains of children? Could it disrupt normal neurological function in the human body? And if so, might this help explain why so much research links HFCS to diabetes and obesity? The researchers from this particular study stated that "...the data from this study are important for human health as well." They also went on to state two very important facts you need to be aware of: Fact #1) HMF has been linked to DNA damage in humans. (See citation below.) Fact #2) When HMF breaks down in the human body, it breaks down into substances that may be even more harmful than the HMF itself. (Similar to the way in which aspartame breaks down into formaldehyde, formic acid and other potentially harmful chemicals.) These are bombshell revelations about the potential dangers of high-fructose corn syrup. There's no such thing as "raw" or "cold-pressed" HFCS. It's all subjected to high temperatures during processing, meaning that all HFCS may be generating some level of the HMF contaminant before it's even put into foods. And then, once it's added to manufactured food items, it's often cooked again! This second cooking could theoretically generate even more HMF, further contaminating the food with potentially dangerous chemicals. Perhaps when you eat HFCS, you're consuming a chemical that "scrambles" health intracellular communication, causing physiological disruptions that, if allowed to continue for long enough, are expressed as diseases like "diabetes" or "obesity." We don't know this for sure, but it's a question that clearly needs to be asked... especially given the tremendous quantities of HFCS currently consumed in the diets of mainstream consumers. How to protect yourselfThere are two ways to protect yourself from all this:#1) Don't eat (or drink) high-fructose corn syrup! This is seemingly the easiest way to avoid the potential danger here, but it does require a level of vigilance with the reading of food labels. HFCS is found in many products you would never suspect, so you've got to watch for it carefully. #2) Don't eat cooked, processed foods! Work more raw foods into your diet and greatly reduce your consumption of factory foods. And finally, don't believe the spin of the HFCS industry. Those lobbying groups will always insist HFCS is perfectly safe, regardless of what research concludes otherwise. They act a lot like Big Tobacco, in my opinion, criticizing good research while promoting a product that can contribute to the decline of health among those who consume it. The sooner we get HFCS out of the diet of both humans and honey bees, the better off we'll all be in the long run. In my view, eating raw, dehydrated cane juice crystals is far better for you than eating cooked, contaminated HFCS. Sources for this story include: "Formation of Hydroxymethylfurfural in Domestic High-Fructose Corn Syrup and Its Toxicity to the Honey Bee (Apis mellifera)" http://pubs.acs.org/stoken/presspac... Durling, L. J.; Busk, L.; Hellman, B. E. Evaluation of the DNA damaging effect of the heat-induced food toxicant 5-hydroxymethylfurfural (HMF) in various cell lines with different activities of sulfotrasnferases Food Chem. Toxicol. 2009, 47 (4) 880– 884 Beware Attempts to Paint Prostate Cancer As STDCuz they don't stand up to scrutiny. Correlation, causation... so easy to mix them up!
Virus cancer link examined
Posted by Victoria Stern
[Entry posted at 16th October 2009 03:52 PM GMT]
New findings complicate recent evidence for a viral link to prostate cancer. Recent studies have found the virus, called xenotropic murine leukemia virus-related virus (XMRV), in a disproportionate number of cancer tissue samples in men with prostate cancer, but the latest report, published today (October 16) in Retrovirology, detected no sign of XMRV in tissue samples from almost 600 prostate cancer patients.
"The association [of XMRV] to prostate cancer will require many large screening studies done on various populations across the world," Joseph DeRisi, a biochemist and biophysicist at the University of California, San Francisco, who was not involved in the study, said in an email. "This would be one of many, and I don't expect everyone to get the same results." Prostate cancer is one of the leading causes of cancer deaths in men, but researchers have a limited understanding of what triggers it. In 2006, DeRisi and his colleagues were the first to identify XMRV infection as a potential risk factor, showing that the virus was present in up to 40% of the prostate tumor samples they studied. Last month, a study in PNAS reported that viral DNA or proteins were present in more than a quarter of 334 prostate cancer tissue samples they studied. XMRV is similar to viruses already known to cause cancer in animals, and these results led some to postulate that prostate cancer, like cervical cancer, may be a sexually transmitted disease. In the present study, researchers at the Robert Koch Institute and the medical school Charité - Universitätsmedizin Berlin in Germany collected tissue samples from 589 German prostate cancer patients between 2000 and 2006. They screened the patients' DNA and RNA for signs of XMRV using real-time PCR, a method for detecting and amplifying a specific sequence in a DNA or RNA sample, and also used assays to look for antibodies specific for XMRV. The study authors found that none of the tumor samples contained XMRV, and assays showed no XMRV antibodies in the blood. There are several other studies that have failed to find XMRV in prostate tumor samples. "Our results are in agreement with another study investigating the prevalence of the virus in German prostate cancer patients," Oliver Hohn of the Robert Koch Institute, the current study's first author, wrote in an email. In the 2008 study he referred to, XMRV was detected in only one of 105 prostate tumor samples. "Knowing these data, our results were not too surprising," Hohn said. In addition, he noted, researchers from Ireland reported at the 2008 European Association of Urology conference in Milan that they also found no XMRV in prostate cancer patients. "It is possible that the methods used may have missed detecting XMRV," said Robert Silverman, a cancer researcher at the Lerner Research Institute in Ohio and an author on last month's PNAS study. Silverman said that the PCR methods used in this paper are significantly less sensitive than the ones he has used in patient samples. Hohn, however, said that he and his team developed specific and highly sensitive PCR assays to detect the viral genome. Another explanation for the discrepancy between studies, noted Hohn, is that XMRV may be more prevalent in the US than in Germany. DeRisi agreed. "If this is a real infection, I highly doubt it would have globally uniform distribution," said DeRisi, who is also a Howard Hughes Medical Institute investigator. "So not finding it in Germany may imply that this could be geographically restricted or be transmitted in a way that is not occurring there." October 19 IBD Drugs Cause Cancer, But Will Remain Cornerstone of TreatmentBowel disease drugs increase cancer risk -- studySun Oct 18, 2009 7:01pm EDT
LONDON, Oct 19 (Reuters) - Some treatments for inflammatory bowel disease increase the risk of infection-related cancers, French scientists said on Monday, but the benefits of the drugs still outweigh the risks. Thiopurine drugs -- immunosuppressive medicines that inhibit the body's immune system -- are regularly used to treat inflammatory bowel disease, the researchers said, but can increase the risk of cancers linked to viral infections. Laurent Beaugerie and colleagues at the Saint-Antoine hospital in Paris looked at more than 19,000 patients with inflammatory bowel disease. Around 30 percent of the patients were taking thiopurines, 14 percent had stopped taking them and 56 percent had never taken them. Following up after almost 3 years, the researchers found 23 new cases of cancers -- one of Hodgkin's lymphoma and 22 of non-Hodgkin lymphoma. Statistical analysis showed that patients receiving thiopurines -- like azathioprine produced by several generic drugmakers and by GlaxoSmithKline (GSK.L) as Imuran -- had a more than five-fold increased risk of lymphoma compared with those who had never received the drugs, the researchers said in a study published in The Lancet journal. Older male patients with a longer history of inflammatory bowel disease also had increased lymphoma cancer risk. "The absolute cumulative risk...in young patients receiving a 10-year course of thiopurines remains low -- (less than 1 percent) -- and does not undermine the positive risk-benefit ratio of these drugs," the researchers wrote. But for elderly patients and for unlimited treatment periods, more studies were needed to assess the risk, they said. Commenting on the study, Geert D'Haens of the Imelda GI Clinical Research Centre and Paul Rutgeerts University Hospital Gasthuisberg, both in Belgium, said doctors should be cautious in prescribing thiopurines for prolonged periods. But they said that despite the slightly increased risk of lymphoma, the drugs would "probably remain one of the cornerstones of treatment." (Reporting by Kate Kelland; Editing by Charles Dick) Pfizer PfinedAre you taking any of these drugs? For what?
Pfizer Pays Record $1.3 Billion Penalty for Drug Misbranding
By Cary O’Reilly Oct. 17 (Bloomberg) -- A unit of Pfizer Inc., the world’s largest drugmaker, was sentenced to pay $1.3 billion in penalties for misbranding medicines, including the largest criminal fine ever imposed in the U.S. U.S. District Judge Douglas Woodlock in Boston ordered Pfizer’s Pharmacia & Upjohn unit to pay a $1.2 billion criminal fine and forfeit $105 million, Acting U.S. Attorney Michael Loucks said in a statement. The fine, over sales practices for a painkiller since pulled from the market, is the biggest piece of a record $2.3 billion settlement announced last month between the U.S. Justice Department and New York-based Pfizer. The deal includes $1 billion in civil penalties, the largest non-criminal fraud case against a drugmaker, the Justice Department said. The criminal case revolved around allegations that the painkiller Bextra and three other medicines were promoted for uses other than those approved by the U.S. Food and Drug Administration. The government, which pays for medicines through several health programs, started a criminal probe after private whistleblowers filed lawsuits in three states. The four-year investigation uncovered a range of practices, including kickback payments to doctors in the sale of nine other drugs, among them the impotence drug Viagra and cholesterol pill Lipitor, officials said. Pfizer, which had $48.3 billion in revenue last year, reported in January that it took a fourth-quarter charge of $2.3 billion to cover the preliminary agreement. The company has said it would have no additional charges from the case. “Today’s hearing is the last step in a process to bring final closure to the settlement agreement with the U.S. Department of Justice that was announced on Sept. 2, 2009,” the New York-based company said yesterday in a statement. Pfizer gained 11 cents to $17.77 in New York Stock Exchange composite trading. The shares have risen 5.1 percent over the past year. The lead civil case is Collins v. Pfizer Inc., 04-11780, U.S. District Court, District of Massachusetts (Boston). To contact the reporters responsible for this story: Cary O’Reilly in Washington at caryoreilly@bloomberg.net Last Updated: October 17, 2009 00:01 EDTOctober 16 FDA Apologizes to Procter & GambleI guess the check cleared. This is the most bizarre thing ever: the FDA posted a letter on its website that was (supposedly) a warning issued to Procter & Gamble about the way it was marketing its Vicks + vitamin C product. Today, however, the FDA says that it posted the letter on its website by accident, and that it never actually issued any warning to P&G. Who in the what now? Then where did the letter come from?
FDA posted Vicks notice in errorThe Enquirer • October 15, 2009
The U.S. Food and Drug Administration now says it never issued a warning letter to Procter & gamble over P&G's Vicks product. A warning letter appeared on the FDA's Web site Wednesday warning P&G against adding vitamin C to some of its Vicks formulas. P&G issued a statement Wednesday saying, "We believe we are marketing within the FDA regulations and will work with the FDA to resolve the concern together." But Thursday, the FDA said the letter was posted online due to an internal error and that no warning was actually issued to the company. "The agency regrets any confusion caused by the posting," FDA spokesman Chris Kelly said in a statement. He said the FDA would not comment further. "We'll work with the FDA to see if we can gain more information," said P&G spokesperson Crystal Harrell. Peter Hotez Is the New Paul OffitI guess the newspapers have figured out that it looks weird that Paul Offit is the only guy willing to say that vaccines are always safe and that autism is purely genetic. Now they've found another quote machine in Peter Hotez, the holder of patents for two hookworm vaccines. (I wonder if/when we'll see them on the CDC's recommended schedule for all American children.)
Here he talks about how his daughter's regressive autism had nothing to do with her vaccinations, and gets confused between prevention of diseases through improving the quality of life for the poor, and vaccinating the hell out of healthy middle-class children: "Peter Hotez told his wife it was amazing how much attention the media was paying to unfounded fears, when it paid so little attention to neglected diseases affecting the poor in the United States and other countries."
Here he says that there is nothing to worry about when DC police were accidentally given double the dose of H1N1 vaccine: "When we're doing clinical testing to determine the safety of the influenza vaccine, human volunteers will often get twice the normal dose -- three times the normal dose. So we know this vaccine is safe in twice (or three times) the normal dose. This should not present any unusual problems at all." October 14 Left or Right, Smart People Know the Flu Shot is Bull****You probably already heard Rush Limbaugh telling Kathleen Sebelius to shove her swine flu shot. Well, here's a similar perspective (but with more detail and more finesse) from the left. Click through the link to read the full article. I don't want to steal these writers' stuff, so I'm only including a sample:
Health November 2009 Atlantic Whether this season’s swine flu turns
out to be deadly or mild, most experts agree that it’s only a matter of time before we’re hit by a truly devastating flu pandemic—one that might kill more people worldwide than have died of the plague and aids combined. In the U.S., the main lines of defense are pharmaceutical—vaccines and antiviral drugs to limit the spread of flu and prevent people from dying from it. Yet now some flu experts are challenging the medical orthodoxy and arguing that for those most in need of protection, flu shots and antiviral drugs may provide little to none. So where does that leave us if a bad pandemic strikes? by Shannon Brownlee and Jeanne Lenzer Does the Vaccine Matter?
Drive too fast along Red Lion Road, beside Philadelphia’s Northeast
Airport, and you will miss the low-rise cement building where the biotech company MedImmune has been quietly pumping out swine flu vaccine at about a million doses a week. Through the summer and fall, workers wearing protective gear that covered them from head to toe brewed up batches of live, genetically modified flu virus. Robots then injected tiny doses of virus-laden fluid into glass vials, which were mounted into nasal spritzers, labeled, and readied for shipment at the direction of the Centers for Disease Control and Prevention, in Atlanta, which is helping to coordinate the nation’s pandemic-preparedness plan. In the most ambitious vaccination program the nation has mounted since the anti-polio campaign in the 1950s, the federal government has commissioned MedImmune and four other companies to produce enough vaccine to cover the entire U.S. population. Vaccination is central to the government’s plan for preventing deaths
from swine flu. The CDC has recommended that some 159 million adults and children receive either a swine flu shot or a dose of MedImmune’s nasal vaccine this year. Shots are offered in doctors’ offices, hospitals, airports, pharmacies, schools, polling places, shopping malls, and big-box stores like Wal-Mart. In August, New York state required all health-care workers to get both seasonal and swine flu shots. To further protect the populace, the federal government has spent upwards of $3billion stockpiling millions of doses of antiviral drugs like Tamiflu—which are being used both to prevent swine flu and to treat those who fall ill. But what if everything we think we know about fighting influenza is
wrong? What if flu vaccines do not protect people from dying—particularly the elderly, who account for 90 percent of deaths from seasonal flu? And what if the expensive antiviral drugs that the government has stockpiled over the past few years also have little, if any, power to reduce the number of people who die or are hospitalized? The U.S. government—with the support of leaders in the public-health and medical communities—has put its faith in the power of vaccines and antiviral drugs to limit the spread and lethality of swine flu. Other plans to contain the pandemic seem anemic by comparison. Yet some top flu researchers are deeply skeptical of both flu vaccines and antivirals. Like the engineers who warned for years about the levees of New Orleans, these experts caution that our defenses may be flawed, and quite possibly useless against a truly lethal flu. And that unless we are willing to ask fundamental questions about the science behind flu vaccines and antiviral drugs, we could find ourselves, in a bad epidemic, as helpless as the citizens of New Orleans during Hurricane Katrina. ...
We think we have the flu anytime we fall ill with an
ailment that brings on headache, malaise, fever, coughing, sneezing, and that achy feeling as if we’ve been sleeping on a bed of rocks, but researchers have found that at most half, and perhaps as few as 7 or 8 percent, of such cases are actually caused by an influenza virus in any given year. More than 200 known viruses and other pathogens can cause the suite of symptoms known as “influenza-like illness”; respiratory syncytial virus, bocavirus, coronavirus, and rhinovirus are just a few of the bugs that can make a person feel rotten. And depending on the season, in up to two-thirds of the cases of flu-like illness, no cause at all can be found. ...
But while vaccines for, say, whooping cough and polio clearly and
dramatically reduced death rates from those diseases, the impact of flu vaccine has been harder to determine. Flu comes and goes with the seasons, and often it does not kill people directly, but rather contributes to death by making the body more susceptible to secondary infections like pneumonia or bronchitis. For this reason, researchers studying the impact of flu vaccination typically look at deaths from all causes during flu season, and compare the vaccinated and unvaccinated populations. Such comparisons have shown a dramatic difference in mortality between
these two groups: study after study has found that people who get a flu shot in the fall are about half as likely to die that winter—from any cause—as people who do not. Get your flu shot each year, the literature suggests, and you will dramatically reduce your chance of dying during flu season. Yet in the view of several vaccine skeptics, this claim is suspicious
on its face. Influenza causes only a small minority of all deaths in the U.S., even among senior citizens, and even after adding in the deaths to which flu might have contributed indirectly. When researchers from the National Institute of Allergy and Infectious Diseases included all deaths from illnesses that flu aggravates, like lung disease or chronic heart failure, they found that flu accounts for, at most, 10 percent of winter deaths among the elderly. So how could flu vaccine possibly reduce total deaths by half? Tom Jefferson, a physician based in Rome and the head of the Vaccines Field at the Cochrane Collaboration, a highly respected international network of researchers who appraise medical evidence, says: “For a vaccine to reduce mortality by 50 percent and up to 90 percent in some studies means it has to prevent deaths not just from influenza, but also from falls, fires, heart disease, strokes, and car accidents. That’s not a vaccine, that’s a miracle.” ...
The estimate of 50 percent mortality reduction is based on “cohort
studies,” which compare death rates in large groups, or cohorts, of people who choose to be vaccinated, against death rates in groups who don’t. But people who choose to be vaccinated may differ in many important respects from people who go unvaccinated—and those differences can influence the chance of death during flu season. Education, lifestyle, income, and many other “confounding” factors can come into play, and as a result, cohort studies are notoriously prone to bias. ...
When Lisa Jackson, a physician and senior investigator with the Group
Health Research Center, in Seattle, began wondering aloud to colleagues if maybe something was amiss with the estimate of 50 percent mortality reduction for people who get flu vaccine, the response she got sounded more like doctrine than science. “People told me, ‘No good can come of [asking] this,’” she says. “‘Potentially a lot of bad could happen’ for me professionally by raising any criticism that might dissuade people from getting vaccinated, because of course, ‘We know that vaccine works.’ This was the prevailing wisdom.” ...
Jackson’s findings showed that outside of flu season, the baseline risk of death among people who did not get vaccinated was approximately 60 percent higher than among those who did, lending support to the hypothesis that on average, healthy people chose to get the vaccine, while the “frail elderly” didn’t or couldn’t. In fact, the healthy-user effect explained the entire benefit that other researchers were attributing to flu vaccine, suggesting that the vaccine itself might not reduce mortality at all... October 13 In Pennsylvania, Clean Air Comes at the Expense of Clean WaterI'm glad I don't live in Pittsburgh, but I'm not sure what the solution to this problem is. Nuclear energy? Differently designed scrubbers? Designated waste dumping grounds that somehow don't pollute groundwater? Ugh. I just know this isn't good.
Cleansing the Air at the Expense of Waterways
Published: October 12, 2009
MASONTOWN, Pa. — For years, residents here complained about the yellow smoke pouring from the tall chimneys of the nearby coal-fired power plant, which left a film on their cars and pebbles of coal waste in their yards. Five states — including New York and New Jersey — sued the plant’s owner, Allegheny Energy, claiming the air pollution was causing respiratory diseases and acid rain. So three years ago, when Allegheny Energy decided to install scrubbers to clean the plant’s air emissions, environmentalists were overjoyed. The technology would spray water and chemicals through the plant’s chimneys, trapping more than 150,000 tons of pollutants each year before they escaped into the sky. But the cleaner air has come at a cost. Each day since the equipment was switched on in June, the company has dumped tens of thousands of gallons of wastewater containing chemicals from the scrubbing process into the Monongahela River, which provides drinking water to 350,000 people and flows into Pittsburgh, 40 miles to the north. “It’s like they decided to spare us having to breathe in these poisons, but now we have to drink them instead,” said Philip Coleman, who lives about 15 miles from the plant and has asked a state judge to toughen the facility’s pollution regulations. “We can’t escape.” Even as a growing number of coal-burning power plants around the nation have moved to reduce their air emissions, many of them are creating another problem: water pollution. Power plants are the nation’s biggest producer of toxic waste, surpassing industries like plastic and paint manufacturing and chemical plants, according to a New York Times analysis of Environmental Protection Agency data. Much power plant waste once went into the sky, but because of toughened air pollution laws, it now often goes into lakes and rivers, or into landfills that have leaked into nearby groundwater, say regulators and environmentalists. Officials at the plant here in southwest Pennsylvania — named Hatfield’s Ferry — say it does not pose any health or environmental risks because they have installed equipment to limit the toxins the facility releases into the Monongahela River and elsewhere. But as the number of scrubbers around the nation increases, environmentalists — including those in Pennsylvania — have become worried. The Environmental Protection Agency projects that by next year, roughly 50 percent of coal-generated electricity in the United States will come from plants that use scrubbers or similar technologies, creating vast new sources of wastewater. Yet no federal regulations specifically govern the disposal of power plant discharges into waterways or landfills. Some regulators have used laws like the Clean Water Act to combat such pollution. But those laws can prove inadequate, say regulators, because they do not mandate limits on the most dangerous chemicals in power plant waste, like arsenic and lead. For instance, only one in 43 power plants and other electric utilities across the nation must limit how much barium they dump into nearby waterways, according to a Times analysis of E.P.A. records. Barium, which is commonly found in power plant waste and scrubber wastewater, has been linked to heart problems and diseases in other organs. Even when power plant emissions are regulated by the Clean Water Act, plants have often violated that law without paying fines or facing other penalties. Ninety percent of 313 coal-fired power plants that have violated the Clean Water Act since 2004 were not fined or otherwise sanctioned by federal or state regulators, according to a Times analysis of Environmental Protection Agency records. (An interactive database of power plant violations around the nation is available at www.nytimes.com/coalplants.) Fines for Plants Modest Other plants have paid only modest fines. For instance, Hatfield’s Ferry has violated the Clean Water Act 33 times since 2006. For those violations, the company paid less than $26,000. During that same period, the plant’s parent company earned $1.1 billion. “We know that coal waste is so dangerous that we don’t want it in the air, and that’s why we’ve told power plants they have to install scrubbers,” said Senator Barbara Boxer, the California Democrat who is chairwoman of the Senate Committee on Environment and Public Works. “So why are they dumping the same waste into people’s water?” Though the Environmental Protection Agency promised earlier this decade to consider new regulations on power plant waste — and reiterated that pledge after a Tennessee dam break sent 1.1 billion gallons of coal waste into farms and homes last year — federal regulators have yet to issue any major new rules. One reason is that some state governments have long fought new federal regulations, often at the behest of energy executives, say environmentalists and regulators. The counties surrounding Hatfield’s Ferry, which are home to multiple universities, are an example of what hangs in the balance as this debate plays out. Last year, when Hatfield’s Ferry asked the state for permission to dump scrubber wastewater into the Monongahela River, the Pennsylvania Department of Environmental Protection approved the request with proposed limits on some chemicals. But state officials placed no limits on water discharges of arsenic, aluminum, boron, chromium, manganese, nickel or other chemicals that have been linked to health risks, all of which have been detected in the plant’s wastewater samples, according to state documents. Records show, and company officials concede, that Hatfield’s Ferry is already dumping scrubber wastewater into the Monongahela that violates the state’s few proposed pollution rules. Moreover, those rules have been suspended until a judge decides on the plant’s appeal of the proposed limits. “You can get used to the plant, and the noise and soot on your cars,” said Father Rodney Torbic, the priest at the St. George Serbian Orthodox Church, across the road from Hatfield’s Ferry. “But I see people suffering every day because of this pollution.” Officials at Hatfield’s Ferry say there is no reason for residents to be concerned. They say that lawsuits against the plant are without merit, and that they have installed a $25 million water treatment plant that removes many of the toxic particles and solids from scrubber wastewater. The solids are put into a 106-acre landfill that contains a synthetic liner to prevent leaks. Officials say that the plant’s pollution does not pose any risk. Limits on arsenic, aluminum, barium, boron, cadmium, chromium, manganese and nickel are not appropriate, the company wrote in a statement, because the plant’s wastewater is not likely to cause the Monongahela River to exceed safety levels for those contaminants. “Allegheny has installed state-of-the-art scrubbers, state-of-the-art wastewater treatment, and state-of-the-art synthetic liners,” the company wrote in a statement. “We operate to be in compliance with all environmental laws and will continue to do so.” The plant’s water treatment facility, however, does not remove all dissolved metals and chemicals, many of which go into the river, executives concede. An analysis of records from other plants with scrubbers indicates that such wastewater often contains high concentrations of dissolved arsenic, barium, boron, iron, manganese, cadmium, magnesium and other heavy metals that have been shown to contribute to cancer, organ failures and other diseases. Company officials say the emissions by the plant will not pose health risks, because they will be diluted in the river. Though synthetic liners are generally considered effective at preventing leaks, environmentalists note that the Hatfield’s Ferry landfill is less than a mile uphill from the river, and that over time, other types of liners have proven less reliable than initially hoped. The Environmental Protection Agency, in a statement last month, said it planned to revise standards for water discharges from coal-fired power plants like Hatfield’s Ferry. Agency studies have concluded that “current regulations, which were issued in 1982, have not kept pace with changes that have occurred in the electric power industry,” officials wrote. But some environmentalists and lawmakers say that such rules will not be enough, and that new laws are needed that force plants to use more expensive technologies that essentially eliminate toxic discharges. Cleaning Up Pollution “It’s really important to set a precedent that tells power plants that they need to genuinely clean up pollution, rather than just shift it from the air to the water,” said Abigail Dillen, a lawyer with the law firm Earthjustice, which represents two advocacy organizations, the Environmental Integrity Project and the Citizens Coal Council, in asking a Pennsylvania court to toughen regulations on Hatfield’s Ferry. Ms. Dillen, like other environmentalists, has urged courts and lawmakers to force plants to adopt “zero discharge” treatment facilities, which are more expensive but can eliminate most pollution. State officials say they have established appropriate water pollution limits for Hatfield’s Ferry, and have strict standards for landfill disposal. “We asked the plant for estimates on how much of various pollutants they are likely to emit, and based on those estimates, we set limits that are protective of the Monongahela,” said Ron Schwartz, a state environmental official. “We have asked them to monitor some chemicals, including arsenic, and if levels grow too high, we may intervene.” However, environmental groups have argued in court documents and interviews that Hatfield’s Ferry probably will emit dangerous chemicals, and that they fear the state is unlikely to intervene. Similar problems have emerged elsewhere. Twenty-one power plants in 10 states, including Alabama, Kentucky, North Carolina and Ohio, have dumped arsenic into rivers or other waters at concentrations as much as 18 times the federal drinking water standard, according to a Times analysis of E.P.A. data. In Florida, Georgia, Illinois, Indiana, Maryland, North Carolina, Ohio, Wisconsin and elsewhere, power plants have dumped other chemicals at dangerous concentrations. Few of those plants have ever been sanctioned for those emissions, nor were their discharge permits altered to prevent future pollution. Records indicate that power plant landfills and other disposal practices have polluted groundwater in more than a dozen states, contaminating the water in some towns with toxic chemicals. A 2007 report published by the E.P.A. suggested that people living near some power plant landfills faced a cancer risk 2,000 times higher than federal health standards. Lobbyists Block Controls In 2000, Environmental Protection Agency officials tried to issue stricter controls on power plant waste. But a lobbying campaign by the coal and power industries, as well as public officials in 13 states, blocked the effort. In 2008 alone, according to campaign finance reports, power companies donated $20 million to the political campaigns of federal lawmakers, almost evenly divided between Democrats and Republicans. In interviews, E.P.A. officials said that toughening pollution rules for power plants was among their top priorities. Last month, the agency announced it was moving forward on new rules regulating greenhouse gas emissions from hundreds of power plants and other large industrial facilities. Lisa P. Jackson, who was confirmed to head the agency in January, has said she would determine by the end of the year whether certain power plant byproducts should be treated as hazardous waste, which would subject them to tougher regulations. But for now, there are no new rules on power plant waste. And many states are trying to dissuade Ms. Jackson from creating new regulations, according to state and federal regulators, because they worry that new rules will burden overworked regulators, and because power plants have pressured local politicians to fight greater regulation. For instance, Pennsylvania has opposed designating the waste from Hatfield’s Ferry and other power plants as hazardous. In a statement, the Department of Environmental Protection said the state had “sufficient state and federal laws and regulations at our disposal to control wastewater discharges at levels protective of the environment and public health.” But residents living near power plants disagree. “Americans want cheap electricity, but those of us who live around power plants are the ones who have to pay for it,” Mr. Coleman said. “It’s like being in the third world.” October 11 Infant Hepatitis B Vaccination: Because Your Baby May End up on Tenth AvenueMaybe if you weren't around Manhattan in the 1980s, you don't know that 10th Avenue was the center of the universe for prostitution. Now, I guess I should say something like, "because your baby may grow up to work Hunts Point." Anyway, here (thanks to JB Handley) is the US government's official line on why they practically force babies to receive hepatitis B vaccinations on the day they're born:
Question: Why then, did the ACIP establish a policy mandating that newborn babies not at risk of the disease be automatically administered the 3-shot Hepatitis B vaccine as their first involuntary indoctrination into the pediatric care of America?
Answer: Here is that rationale from the original ACIP 1991 statement establishing the official vaccination policy "Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination ..." "In the United States, most infections occur among adults and adolescents ... The recommended strategy for preventing these infections has been the selective vaccination of persons with identified risk factors ... However, this strategy has not lowered the incidence of Hepatitis B, primarily because vaccinating persons engaged in high-risk behaviors, life-styles, or occupations before they become infected generally has not been feasible ... Efforts to vaccinate persons in the major risk groups have had limited success. For example, programs directed at injecting drug users failed to motivate them to receive three doses of vaccine ... In the United States it has become evident that HBV transmission cannot be prevented through vaccinating only the groups at high risk of infection ... In the long term, universal infant vaccination would eliminate the need for vaccinating adolescents and high-risk adults ... Hepatitis B vaccination is recommended for all infants, regardless of the HBsAg status of the mother ... The first dose can be administered during the newborn period, preferably before the infant is discharged from the hospital, but no later than when the infant is 2 months of age ..." (emphasis added). So in the CDC and ACIP's own words, almost every newborn U.S. baby is now greeted on its entry into the world by a vaccine injection against a sexually transmitted disease for which the baby is not at risk -- because they couldn't get the junkies, prostitutes, homosexuals and promiscuous heterosexuals to take the vaccine. That is the essence of the Hepatitis B universal vaccination program. October 10 GSK Cashes in on Pandemic HysteriaScroll down to read the full article, and to see what some concerned doctors are doing in response.
Glaxo's Big Bet on Battling Pandemics
By JEANNE WHALENLONDON -- GlaxoSmithKline PLC has spent five years fashioning itself into a one-stop pandemic shop. Now, as the swine-flu virus sweeps the globe, the U.K.-based drug giant will find out whether the world is buying. Glaxo began delivering doses of its new H1N1 vaccine this week, the biggest push so far in its multipronged effort to combat, and cash in on, virulent virus strains. The company has spent more than $3.2 billion on research, acquisitions and extra manufacturing in anticipation of a flu pandemic. Ranging from vaccines and antiviral drugs to medicated face masks and diagnostic tools, Glaxo's portfolio sets it apart from rivals that have tended to focus on one aspect of flu-fighting, such as Sanofi-Aventis SA, which makes vaccines, and Roche Holding AG, which makes the antiviral drug Tamiflu. "Short of putting beds in the labs, we are throwing just about every resource we've got into this situation," says Chief Executive Andrew Witty. With the new H1N1 strain sparking concern around the world, the company has faced some accusations of profiteering. This summer, Britain's Evening Standard newspaper said Glaxo was set to charge the U.K. about $10 for a shot it claimed cost only $1.60 to make. The politics of pandemic shots are also tricky, because global vaccine supplies can't meet global demand: Antipoverty group Oxfam has said poorer countries will have limited access to vaccines because many wealthy nations have pre-ordered shots from Glaxo and other makers. Mr. Witty responds that Glaxo is donating 50 million swine-flu shots to the World Health Organization for use in poor countries. That, combined with the high cost of research and production, makes Glaxo's prices fair, he says. Glaxo confirms that the richest countries pay about $10 per shot. It won't disclose its profit margins but says they aren't as high as the British paper reported. Glaxo's bet is risky because flu pandemics, in which a new or rare virus spreads easily around a large swath of the globe, are relatively rare. "That's the danger of being in this business -- you can't count on demand next year," says Gbola Amusa, a pharmaceutical analyst with UBS in London. So far, the gamble appears to be paying off. On Tuesday, Glaxo said governments around the globe have ordered 440 million doses of its swine-flu vaccine, which it aims to deliver this year and early in 2010. That represents a 50% increase in orders since the company last disclosed its totals, in August, and could represent revenues of some $4 billion, Citigroup said in a research note Tuesday. Glaxo's global sales last year were about $39 billion. Glaxo has also received an order from the U.S. for about $250 million worth of bulk-vaccine ingredients and "pandemic products." Sales of antiviral Relenza, the company's rival to Tamiflu, spiked to about $96 million in the second quarter of the year, from less than $5 million a year earlier. Glaxo's strategy reflects how drug makers are pushing beyond prescription pills as valuable patents expire. The company has faced competition from makers of low-cost generic drugs on several of its big sellers, including antidepressant Wellbutrin and epilepsy drug Lamictal. A business built on vaccines is less likely to be undercut by low-cost producers: Vaccines are complicated to make, factories are expensive to build and maintain, and demand for flu shots can be fickle. Mr. Witty believes that with governments becoming more concerned about pandemics, the business has staying power. "We're more than well aware that people don't want to see companies somehow exploiting this situation," the CEO said at a recent press briefing. "We're not trying to generate here some crazy level of profit -- but equally, our shareholders wouldn't want us to do this for anything other than a return." Glaxo's flu strategy is rooted in the last global flu scare. In 2004, the H5N1 virus was killing scores of birds in Asia. Though it didn't spread quickly from human to human, it killed about half the people it infected. In September of that year, the U.S. Department of Health and Human Services summoned a Glaxo research official to Washington to give a briefing on Relenza, which Glaxo has sold since the late 1990s to ease the symptoms of seasonal flu. Mike Ossi, an infectious disease expert at Glaxo, recalls telling officials that animal studies suggested Relenza might work against the H5N1 strain, though there had been no human studies. Still, Dr. Ossi recalls, the health officials kept asking: "How much can you make, and how fast?" That helped crystallize Glaxo's focus. Then-Chief Executive Jean-Pierre Garnier tapped a lieutenant, David Stout, to assemble a team to focus on pandemic flu. The group started opening new production lines for Relenza in Australia, France and the U.S., says Dr. Ossi, who was part of the team. In 2005, the U.S. government placed a large order for Relenza. Other countries followed. Glaxo also raced to develop an avian-flu vaccine. At its main vaccine center in Rixensart, Belgium, researchers already knew the basic flu-shot recipe: They would isolate the H5N1 virus, allow it to multiply in a hospitable environment -- chicken eggs -- then kill the viruses and blend them together to form the main ingredient in flu vaccine, called antigen. The challenge was that it takes months to make antigen, and Glaxo's vaccine plants couldn't make unlimited amounts. Should an avian-flu outbreak turn into a pandemic, Glaxo would need to stretch its antigen supply. Also, the company wanted to make a vaccine that would protect people even if the H5N1 virus mutated into new forms, says Thomas Breuer, chief medical officer in Glaxo's vaccine division. The answer to both of these problems, Glaxo decided, was an adjuvant -- a booster ingredient that makes antigen more powerful. In the summer of 2005, Glaxo paid about $300 million for a Washington state company that made the adjuvant it wanted. Glaxo increased its potential flu-vaccine output, doubling capacity at a plant in Germany. In September 2005, it announced plans to buy a Canadian flu-vaccine maker, ID Biomedical Corp., for about $1.4 billion. The investments helped make Glaxo a leading flu-shot maker. France's Sanofi is considered the flu-vaccine industry's biggest producer, followed by Novartis AG of Switzerland and Glaxo. Other large producers are AstraZeneca PLC of the U.K. and CSL Ltd. of Australia. With its bird-flu vaccine in hand, Glaxo started promoting the shots hard, says David Fedson, a vaccine expert who once worked for Aventis Pasteur MSD, a vaccine venture now partly owned by Sanofi. The U.S., Switzerland and Finland ordered H5N1 vaccine from Glaxo, helping it sell about $230 million worth in 2007 -- nearly as much as the company's sales of seasonal-flu vaccine that year. Bird flu continued to spread, slowly, among humans. But it failed to be classified a pandemic. In 2008, Glaxo's sales of H5N1 vaccine fell, to about $105 million. Glaxo kept pushing. It signed contracts with governments, promising to supply millions of doses of vaccine should an H5N1 pandemic -- or any other flu pandemic -- arise. Sweden says it signed such an advance-purchase agreement with Glaxo in late 2007. Denmark, Switzerland and others signed similar deals. In May 2008, Mr. Witty took over as Glaxo's chief executive and put even more focus on flu. He aimed to make Glaxo a "one-stop shop" for managing influenza, and reorganized Glaxo's marketing effort to emphasize the "integrated package of products and services" the company could offer governments, says Peter Cook, chief executive of Biota, an Australian company that developed Relenza and licensed the rights to Glaxo. Throughout 2008, as bird flu continued to circulate, Glaxo representatives made frequent house calls to countries' health ministries. At a flu conference in September, Glaxo issued new data on a test of its H5N1 vaccine, arguing that the shots were still valuable to damp a pandemic's impact should one emerge. When swine flu surfaced in Mexico and the U.S. in April, Glaxo quickly shifted gears. It says it asked governments how much Relenza they needed, and switched on spare factories to churn out more. It also started building new production lines with the aim of tripling overall Relenza production, to more than 190 million packs a year. Glaxo also doubled the number of people working on pandemic flu vaccines in order to develop an H1N1 shot quickly, Dr. Breuer says. Vaccine-unit members called the governments that had signed advanced-purchase deals. Many activated the orders. As the swine-flu virus spread, Glaxo flu experts intensified their visits to national health ministries. Some in the industry say the company walked a fine line between educating government officials and making a hard sell. Glaxo says its visits are aimed at telling governments about the changing state of the swine-flu virus and about the company's progress making vaccine and Relenza. "It's not selling," says Jean Stephenne, head of Glaxo's vaccines business. "You are bringing a public-health solution." Glaxo is supplying H1N1 vaccine or vaccine ingredients to the U.S., the U.K., France, Germany, Canada and other countries. Last month, it said that in a clinical trial, one dose of its vaccine with adjuvant gave more than 98% of people a high level of protection against the swine-flu virus. Glaxo sought other angles on the pandemic. From its talks with governments, it saw officials were worried about keeping key workers healthy during a pandemic -- "doctors, nurses, people who work in power plants," says Eddie Gray, president of Glaxo's pharmaceutical business in Europe. Glaxo decided that a quick flu-diagnosis tool could help hospitals and other workplaces determine whether workers were infected. "We talked to some [governments] and said, 'Does this sound like something you'd be generally interested in?'" Mr. Gray recalls. The answer was yes. In July, Glaxo announced a deal with Enigma Diagnostics, a U.K. company, to develop a machine that would diagnose flu viruses from swab samples in 60 minutes or less. The partners aim to get the kit on the market by early 2011. [NOTE: THIS MEANS YOU'LL SEE ANOTHER BIG "PANDEMIC" EMERGE IN A COUPLE OF YEARS, SO GSK CAN SELL THESE PUPPIES...] One of Glaxo's R&D scientists came up with another idea: medicated face masks. When swine-flu fear kicked in this spring, some people sought to protect themselves by donning standard surgical masks in public. Glaxo produced Actiprotect, a mask with a coating that it says helps block viruses by killing them on contact. The company says its own tests have shown the mask kills more than 99% of many types of flu viruses within a minute of contact. Glaxo is pitching the masks as useful for health-care workers and others, and says it has so far sold 15 million to various governments. The company declined to say how much the masks cost and says it is still deciding whether to offer them to consumers. * * * http://www.naturalnews.com/027205_vaccines_swine_flu_the_FDA.html Urgent lawsuit filed against FDA to halt swine flu vaccines; claims FDA violated federal lawFriday, October 09, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor (NaturalNews) Health freedom attorney Jim Turner is filing a lawsuit in Washington D.C. mid-day Friday in an urgent effort to halt the distribution of the swine flu vaccine in America. On behalf of plaintiffs Dr. Gary Null and other licensed health care workers of New York State, the lawsuit charges that the FDA violated the law in its hasty approval of four swine flu vaccines by failing to scientifically determine neither the safety nor efficacy of the vaccines. Vaccine / adjuvant combination has never been properly testedThe vaccine / adjuvant combination being referred to as the "swine flu vaccine" has apparently never been safety tested or approved by the FDA. In fact, in many cases the vaccine is being sent to clinics, pharmacies and other health establishments separately from the adjuvant chemical, leaving it up to each local vaccine retailer to properly mix the vaccine with the adjuvant, according to information provided by Turner. With hundreds of millions of Americans potentially being targeted with this vaccine, the potential for improper mixing, improper dosages, and human error is alarming. Billions of dollars are at stakeWhy, then, did the FDA apparently violate the law and push these vaccines into full public distribution without securing the safety testing required by law? Turner suspects a profit motive may be involved: "They're charging $24.95 to get a vaccine. Multiplied by 100 million people, that's a lot of money. If you do the whole society, you're talking about several billion dollars." About health freedom attorney Jim TurnerJim Turner, with Citizens for Health (www.Citizens.org), is one of the most accomplished and respected health freedom attorneys practicing today. His firm, Swankin & Turner, represents businesses and individuals on a variety of regulatory issues relating to foods, drugs and health. BPA Makes Girls BadShocking that an endocrine disruptor would have a hormonal effect on girls!
Study finds link between BPA, behavior of toddlersOctober 8, 2009 By SARAH AVERY. McClatchy Newspapers RALEIGH, N.C. - Pre-birth exposure to a chemical widely used in plastics appears to be linked to more aggressive behavior in little girls, according to research published this week by a scientist at the University of North Carolina, Chapel Hill. The findings, which are preliminary, are the first to connect behavior problems in humans with the chemical bisphenol A, a key component of plastic bottles, the liners inside canned goods and medical devices. Some have called for curbs on BPA, and Canada last year became the first country to ban BPA in baby bottles. Afterward, Wal-Mart and Toys R Us announced they would stock only BPA-free baby bottles, toys and baby food containers. Earlier this year, Suffolk became the first county in the United States to ban the use of BPA in baby bottles and sippy cups. BPA leaches from plastic and is detectable at some level in nearly everyone's system. Scientists began to raise concerns about BPA because of its tendency to mimic estrogen, a hormone that plays a key role in establishing the sex differences in the brains of developing fetuses. Studies in mice have shown fetal BPA exposure can abolish or reverse inherent behavioral differences between the sexes - specifically, females act more aggressively - and those studies prompted questions about what the chemical does to humans. The American Chemistry Council and BPA plastics manufacturers in Europe and Japan cite studies showing the chemical additive is safe. The groups note BPA doesn't appear to cause cancer, and that "the potential human exposure to BPA from polycarbonate plastic and epoxy resin food contact applications is minimal and poses no known risk to human health." Joe Braun, a doctoral student in epidemiology at the UNC Gillings School of Global Public Health and one of the authors of the aggression study published in the journal Environmental Health Perspectives, said researchers began examining the effects of BPA two years ago with a group of pregnant women enrolled in a larger study into lead. The researchers measured BPA levels in urine samples from 249 women at three different times during their pregnancies: At 16 weeks, 26 weeks and birth. Later, they observed the women's children at age 2, using a standard behavioral test. They found women who had the highest concentrations of BPA at 16 weeks of pregnancy were inclined to have more aggressive, hyperactive 2-year-old daughters. There was no statistically significant change of behavior among the boys, although there was some evidence of heightened anxiety and depression. "It's an intriguing finding that suggests the need for more research in this field, especially with prenatal exposure and the timing of exposures," Braun said. Timing is especially important from a regulation standpoint. The work of Braun's team suggests the time to limit exposure is in the womb - maybe even before many women know they are pregnant. October 08 Why Genetic Testing Doesn't Work--and How They'll Pretend It DoesThis is a funny article. Basically, different labs use different DNA markers to judge whether an individual carries a risk for passing on a particular disease, so different labs will give you different results as to whether you are a carrier. "Genome pioneer" J. Craig Venter says that labs should come up with a core set of markers *so that their findings are in agreement.* Not that the findings would be any more accurate, mind you--they'd just be consistent with each other. Fan-tastic!
Google-Backed DNA Testers Don’t Always Agree on Genetic Profile
By Pat Wechsler Oct. 7 (Bloomberg) -- Navigenics Inc. and 23andMe Inc. both market DNA tests to consumers to uncover genetic predispositions for diseases. The companies don’t always come up with the same answers, according to J. Craig Venter, the genome pioneer. The two testers agreed only two-thirds of the time when making risk predictions for five individuals on their chances of contracting 13 diseases, including breast cancer and diabetes, Venter and three other genetic researchers said today in an opinion article in the journal Nature. As scientists including Venter aim to usher in an era of personalized medicine based on individuals’ biological differences, companies such as 23andMe and Navigenics already offer tests that plumb people’s genetic makeup. The article’s authors said “the nascent industry” could improve predictions by developing a consensus on how to do the analyses. “Genetic testing can improve lifestyle choices and increase preventive screening,” Venter and colleagues wrote in Nature. “However, understanding of the genetic contribution to human disease is far from complete.” Genes are the basic hereditary units containing information needed by the body to make proteins and sustain life. Researchers look for so-called genetic markers, or sequences of DNA with links to specific traits. Discrepancies in the analyses arose because the companies focused on different markers when calculating the probability of a person’s developing a particular illness or condition, according to the article. Venter recommended that the companies agree on a core set to achieve more-consistent results. ‘Great Ideal’ The proposal is a “great ideal, but difficult to implement in practice,” said Andro Hsu, 23andMe’s science and policy liaison. He said he has taken part in discussions sponsored by the Personalized Medicine Coalition, a Washington-based nonprofit advocacy group, on which markers and statistical methods to use. “We had a pretty difficult time agreeing,” Hsu said in an e-mail today. “It would be nice if there were a third-party to score associations,” or assess the strength of links between markers and traits. “At Navigenics we have always been focused on promoting industry standard setting, and we welcome the input of our industry colleagues,” said Amy DuRoss, Navigenics vice president of business and policy affairs, in an e-mail today. “All of the differences in methodology are transparent and visible on each companies’ websites. Since then, we have continued to work with industry groups and patient advocates to produce industry guides and establish standards.” Direct to Consumers Genetic testing companies sell directly to consumers. 23andMe, based in Mountain View, California, was started in 2007 by Anne Wojcicki, wife of Sergey Brin, the cofounder of Google Inc. Google, the operator of the most popular search engine, has invested at least $6.5 million since 2007 in Wojcicki’s company, according to regulatory filings. Brin loaned 23andMe $10 million in June, filings show. Navigenics, of Foster City, California, also received money from Mountain View-based Google. Other genetic testing competitors include deCode Genetics Inc., based in Reykjavik, Iceland, and Pathway Genomics Corp. of San Diego. Customers looking to have their DNA analyzed must provide DNA testers with saliva or a cheek swab. The sample is then scanned for 500,000 to 1 million markers, according to the article. This kind of analysis provides data that may be useful in determining the probability of developing diseases and in suggesting drugs or treatments. Prices At Navigenics, a comprehensive test costs $999, according to the company Web site. At 23andMe, unlimited access to health, disease and trait reports costs $399, according to its Web site. For $99, a customer can get access to 100 reports. Venter and the other authors also said users of tests sometimes can make lifestyle changes that decrease the chance of getting a disease for which the genetic analysis suggests a high risk. Venter is known for developing a technique for discovering and sequencing genes -- and for decoding the human genome. He now pursues his research at the J. Craig Venter Institute, with offices in San Diego and in Rockville, Maryland. Skeptics in the scientific community doubt the value of the gene-testing services in their current form, said Pauline Ng, the lead author of the Nature article and a researcher at the Venter institute. In 2008, states including California and New York sought to crack down on genetic testing. California decided to require Navigenics and 23andMe to obtain licenses in order to solicit specimens from customers. “These are recreational tests and are not meant for diagnostic purposes,” Ng said. “I thought it would be interesting to see if there were differences. I expected the predictions to match.” To contact the reporter on this story: Pat Wechsler in New York at pwechsler@bloomberg.net. Last Updated: October 7, 2009 13:25 EDTIs Your Drug on the Risky List?UPDATE 3-Cancer, bowel drugs on U.S. FDA safety scrutiny list
Wed Oct 7, 2009 6:59pm EDT
* FDA probing potential risks from more than a dozen drugs * List does not mean drug caused problem - FDA (Adds Medicis comment paragraphs 10-12) By Lisa Richwine WASHINGTON, Oct 7 (Reuters) - More than a dozen drugs including a cancer therapy and a bowel medicine are under early scrutiny for potential side effects, U.S. regulators said in a quarterly list released on Thursday. The Food and Drug Administration said it was investigating cases of liver failure in patients treated with Pfizer Inc's (PFE.N) cancer drug Sutent. The agency also is reviewing gastrointestinal perforation reported with Relistor, a drug from Wyeth (WYE.N) and Progenics Pharmaceuticals (PGNX.O) for treating opioid-induced constipation. Appearing on the list "means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk," the agency said. The FDA releases a quarterly list of safety probes as part of an effort to inform the public about early investigations of potential side effects that have been reported. The list released on Thursday covers issues identified between January and March 2009. Pfizer said in a statement it would "work with the FDA to assess the reports (on Sutent) and determine a path forward." In clinical trials, liver failure was seen in less than 1 percent of patients with solid tumors who were treated with Sutent, the company said. "We stand behind the safety and efficacy of Sutent," Pfizer said. The drug is approved for treating advanced kidney cancer and a digestive cancer known as gastrointestinal stromal tumor. On Relistor, Wyeth and Progenics "are engaged in discussions with the FDA" regarding intestinal perforations that were reported and "continue to monitor this issue closely," Wyeth spokeswoman Gwen Fisher said. The FDA also said it was probing King Pharmaceuticals' (KG.N) Flector pain patch for hypersensitivity reactions and Medicis Pharmaceutical Corp's (MRX.N) Solodyn antibiotic for autoimmune disorders in pediatric patients. Solodyn is approved for treating red, pus-filled pimples and bumps from moderate to severe acne. Dr. Ira Lawrence, chief medical officer at Medicis, said Solodyn was part of a class of minocycline antibiotics that "have been used for many years for the treatment of acne and other diseases with an excellent safety record." "It's very important to understand these are potential concerns" listed by the FDA and the agency was not suggesting that doctors stop prescribing the drugs, Lawrence added. He said the company did not promote Solodyn for patients under age 12. A King official could not immediately be reached for comment on Flector. The list was posted here. (Reporting by Lisa Richwine, editing by Carol Bishopric) Grinding Up Babies to Produce Universal Vaccine for CancerYup, only embryonic stem cells will work to prevent cancer--not induced pluripotent cells. And yes, these ground-up babies are part of the development of a UNIVERSAL CANCER VACCINE!!
Raise your hand if you smell some scientists exaggerating their accomplishments... or if you're a little bit concerned about immunizing the human body against itself. Tricking the body into thinking that cancer is present, when it's not? Tell me again why that's a good idea--and why natural immune boosters such as astralagus and vitamin D aren't enough...
Stem Cell Research Offers Hope for Colon Cancer Vaccine
WEDNESDAY, Oct. 7 (HealthDay News) -- Human stem cells may provide a means of creating a vaccine against colon cancer and other types of cancers, say American and Chinese scientists. "Cancer and stem cells share many molecular and biological features. By immunizing the host with stem cells, we are able to 'fool' the immune system to believe that cancer cells are present and thus to initiate a tumor-combating immune program," Dr. Zihai Li, of the University of Connecticut Stem Cell Institute, said in a news release. The research by Li and colleagues is the first to make the connection between human stem cells and colon cancer vaccination. It has long been believed that immunizing people with embryonic materials may trigger an anti-tumor response by the immune system, but this theory has never advanced beyond animal research. The finding that human stem cells may help immunize against colon cancer is new and unexpected, the study authors pointed out. In this study, the researchers vaccinated mice with human embryonic stem cells and found that the mice developed a consistent immune response against colon cancer cells. The vaccinated mice showed a dramatic decline in tumor growth, compared with non-vaccinated mice. While human embryonic stem cells triggered an immune response, artificially induced pluripotent stem cells did not, a finding that challenges the theory that induced pluripotent stem cells are the same as human embryonic stem cells and may replace them at the forefront of stem cell research, Li and colleagues said. The study was published online Oct. 7 in the journal Stem Cells. "Although we have only tested the protection against colon cancer, we believe that stem cells might be useful for generating an immune response against a broad spectrum of cancers, thus serving as a universal cancer vaccine," co-author Dr. Bei Liu said in the news release. October 07 No Such Thing as an Autism GeneI'm paraphrasing, of course, but check out Mark Blaxill's full post on Age of Autism here, and a sample below:
...During review of this manuscript, another genome-wide association study was published which identified significant association to SNPs on chromosome 5p14. Although there was significant overlap between study samples, each of these scans contained a large set of unique families, so we sought to evaluate independent evidence of the top SNP (rs4307059) reported at 5p14…[W]e observed no support for association at this locus..[and instead found a gene transmission frequency] in favour of the minor allele, a trend in the opposite direction as reported.
In other words, paraphrasing the words of Cool Hand Luke, what we’ve got here is a failure to replicate. “We observed a similar frequency of deletions and duplications of the 16p11.2 locus in the ASD cases (~0.3%) as previously reported; however the CNV frequency in the control subjects at this locus was also comparable to that of the cases.” In other words, the rate of mutation was no different between autism cases and controls and the Harvard group may simply not have had a large enough sample to detect such a low rate of mutations in the normal controls, where the CHOP group found plenty of deletions. EPA Finally Decides to Check out Toxic Atrazine...because it's really important that everyone's lawn be that scary-bright green. We just moved to the suburbs about a year and a half ago, and I have had to rebuff the ChemLawn--oh, excuse me, it's TruGreen now--guys three times already. Unless they're offering to hand-weed my lawn, I'm not interested in anything they're selling.
Regulators Plan to Study Risks of Atrazine
Published: October 7, 2009
The Environmental Protection Agency plans to conduct a new study about the potential health risks of atrazine, a widely used weedkiller that recent research suggests may be more dangerous to humans than previously thought. Atrazine — a herbicide often used on corn fields, golf courses and even lawns — has become one of the most common contaminants in American drinking water. For years, the E.P.A. has decided against acting on calls to ban the chemical from environmental activists and some scientists who argued that runoff was polluting ecosystems and harming animals. More recently, new studies have suggested that atrazine in drinking water is associated with birth defects, low birth weights and reproductive problems among humans, even at concentrations that meet current federal standards. The E.P.A. is expected to announce on Wednesday that it will conduct a new evaluation of the pesticide to assess any possible links between atrazine and cancer, as well as other health problems, such as premature births. The E.P.A. may determine that new restrictions are necessary. The decision by E.P.A.’s administrator, Lisa P. Jackson, who took over the agency in January, is a significant departure from the policies of the E.P.A. under President George W. Bush. For years, agency officials said that atrazine in drinking water posed almost no risk to humans or the environment. As recently as this summer, E.P.A. staff members argued that current regulations were adequate. “We’re going to use our scientific resources in a new and more aggressive way regarding atrazine,” said Stephen A. Owens, who was recently confirmed as E.P.A. assistant administrator for prevention, pesticides and toxic substances. “There are new scientific findings that deserve attention, and we’re going to engage our scientific panels in actively reviewing the work of this office under previous administrations,” he added. “We have a question: Did the decisions made in previous administrations use all the available science?” A representative of atrazine’s largest manufacturer, the Swiss company Syngenta, said that she had not been fully briefed on the E.P.A.’s announcement. However, the spokeswoman, Sherry Ford, said, “we expect a positive outcome for atrazine at the end of this process.” Ms. Ford added that the company “stands behind the safety of atrazine, which has undergone extensive testing. We are a science-based company, and we expect the E.P.A. to make sound decisions based on science, no matter which administration is currently in power.” Observers say the E.P.A.’s announcement signals a significant shift. “This is a dramatic change,” said Linda Birnbaum, director of the National Institute of Environmental Health Sciences, part of the Department of Health and Human Services. “There is growing evidence that atrazine could be a hazard to human health. This is a strong signal that the world is changing for some of the most widely used chemicals.” Atrazine has become a lightning rod in disputes over how the E.P.A. has used scientific findings to regulate chemicals and toxins. The agency was sued in 2003 by an environmental advocacy organization, the Natural Resources Defense Council, amid claims that regulators had ignored studies showing that atrazine was dangerous to some animals. In August, The New York Times reported on recent epidemiological studies that suggested small amounts of atrazine in drinking water, including levels considered safe by federal standards, might be associated with birth defects — including skull and facial malformations and misshapen limbs — as well as premature births and low birth weights in newborns. E.P.A. officials said those studies, as well as recent papers reviewing numerous studies that showed that atrazine interferes with the development and hormone systems of some animals, played a role in their decision to re-evaluate the chemical. A Times analysis of E.P.A. records also found that in some American towns, atrazine concentrations in drinking water had spiked sharply, sometimes for as long as a month. Though the E.P.A. and Syngenta were aware of those spikes, they often did not promptly warn local water systems, and the reports produced by local regulators and distributed to residents often failed to reflect those higher concentrations. Interviews with local water officials indicated that many of them were unaware that atrazine concentrations sometimes jumped sharply in their communities. But officials in other communities have grown concerned. Water systems in six states — Illinois, Indiana, Iowa, Kansas, Mississippi and Ohio — recently sued atrazine’s manufacturers to force them to pay for removing the chemical from drinking water. The E.P.A. is expected to announce on Wednesday four meetings over the coming year of the agency’s independent scientific advisory panel that will focus on atrazine. October 06 In Yet Another Shocker, the HIV Vaccine Trials Aren't Going WellNot even as well as the guys running them are trying to get you to believe. What's wrong with condoms, exactly, and why are we spending so much time and money on a vaccine for HIV when safe sex does the job?
The exciting results of the HIV vaccine trial in Thailand are being questioned. Although the initial report stated a significant 31% decrease in HIV infection for those that received the vaccine over those that received a placebo, a second analysis (which eliminates those subjects who did not follow the study's strict protocols) may be less optimistic.
According to ScienceInsider, many leading HIV/AIDS researchers are concerned about this discrepancy. A report issued by the AIDS Vaccine Advocacy Coalition issued a report[/url] similarly stressed the importance of both analyses. The complete results are to be released at an international AIDS vaccine conference in Paris later this month. Will they support the initial claim that this is the first ever effective (albeit modestly so) HIV vaccine? Or will they bash the hopes that this initial claim gave HIV/AIDS researchers and the rest of the world? --Jef Akst, Associate Editor, The Scientist * * *
October 5, 2009Unrevealed Analysis Weakens Claim of AIDS Vaccine "Success"
by Jon Cohen When the U.S. Army and its collaborators in Thailand announced at press conferences on 24 September that a large clinical trial of an AIDS vaccine had lowered the rate of new HIV infections by about one-third, researchers were surprised and encouraged. Although it was only a modest reduction, it was the first positive result from any AIDS vaccine trial. Now some researchers who have seen more of the data in confidential briefings are complaining that a fuller analysis undermines even cautious claims of success, and they are raising questions about the way the results were announced. The press conference and press releases discussed an analysis that included all 16,000 people who participated in the trial, except for seven who were infected before receiving any doses of the two vaccines that were used in combination. Seventy-four people in the placebo arm of the study became infected with HIV, while the similarly sized vaccinated group only had 51 infections—a 31.2% efficacy. The analysis indicated that there was about a 96% level of confidence that the effect was real and not due to chance—just above the 95% cutoff that is widely used as a measure of statistical significance. In the private briefings, researchers learned that a second analysis, which is usually performed in vaccine studies and was part of the Thai study’s design, also found that vaccine recipients had fewer infections, but the reduction was not statistically significant and the level of efficacy was slightly lower. This analysis eliminated people in both groups who did not rigorously follow the protocols. “Anything that really works, you’ll have enough robustness in results to be significant with both analyses,” says Douglas Richman, an AIDS researcher at the University of California, San Diego, a longtime critic of the study. Richman did not discuss the specific results with Science. “The press conference was not a scholarly, rigorously honest presentation,” said one leading HIV/AIDS investigator, who like others asked that his name not be used. “It doesn’t meet the standards that have been set for other trials, and it doesn’t fully present the borderline results. It’s wrong.” Two biostatisticians who specialize in HIV prevention trials and have not seen the data, said that the results from all participants are the more important data, but they were puzzled that the press conference did not include the analysis that excluded those who didn’t follow the protocols. “I think if people saw [the two analyses] diverging in a vaccine study, they’d have a lot of questions,” says David Glidden, a biostatician at the University of California, San Francisco. Colonels Nelson Michael and Jerome Kim, researchers with the U.S. Army who helped run the study, strongly objected to the assertion that they gave the data a positive spin. “We needed to get enough information out so we could give the world community a fair glimpse of what we’ve learned,” said Michael. He notes that in addition to showing select researchers a fuller presentation of the data, a paper under review at the New England Journal of Medicine describes both analyses, and all the findings will be discussed on 20 October at an open AIDS vaccine meeting in Paris. “We tried very carefully to make sure that message was crystal clear,” said Michael. “There’s now hope. But that said, we’ve tried to be very careful not to oversell this.” Several researchers wonder why the data were even released publicly before the Paris meeting. People running the trial learned the results on 10 September, and Michael said there was concern that the information would leak before 20 October. Thai collaborators asked for the 24 September date, Mahidol Day, which commemorates the passing of the current king’s father, a clinician who studied public health at Harvard University. The debate over the way the results were presented will have no immediate practical impact because even under the most optimistic assessment, the vaccine offered too little protection to be a serious candidate for widespread use. But a modest success, even one that is marginally significant, may point the way to new vaccine strategies. “I think that the field is energized,” said Kim. “Everyone should wait until the data are out.” Several critics point out that a press conference 2 years ago about another AIDS vaccine efficacy trial—which was prematurely stopped because the product clearly was not working—researchers reported both analyses (subs. req). What is more, the AIDS Vaccine Advocacy Coalition, a nonprofit that issued a report about interpreting the Thai results before the data were unveiled at the press conference, stressed the importance of both. “The safest route is to report both ... and to analyze any difference,” the report states. “Advocates’ take-home message: no matter what the headlines say, a single number is not the full result.” |
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