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10 March 2009

Supreme Court Refuses to Shield Drugmakers From Lawsuits

The ruling could have significant implications beyond drug manufacturing. Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.

The court, by a 6-to-3 vote, upheld a jury verdict of $6.7 million in favor of a musician from Vermont whose arm had to be amputated after she was injected with an antinausea drug. The drug’s manufacturer, Wyeth, had argued that its compliance with the Food and Drug Administration’s labeling requirements should immunize it from lawsuits.

Pharmaceutical companies were especially disappointed by Wednesday’s decision.

Ronald Rogers, a spokesman for Merck, said, “We believe state courts should not be second-guessing the doctors and scientists at the F.D.A.”


Merck was hit with several huge damage awards over its painkiller Vioxx before agreeing to a $4.85 billion settlement in 2007. Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause “mass confusion.”

The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v. Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesday’s decision addressed implied pre-emption, a different legal standard.

Drug companies and other businesses, supported by the Bush administration, had hoped the Vermont case would establish broader protections. They relied not on express language in a statute enacted by Congress, as in Riegel, but on what might be implied from federal regulatory standards and policies — in this case, from the drug agency’s authority to approve drug labels.

Producers of goods as different as antifreeze, fireworks, popcorn, cigarettes and light bulbs have sought to take refuge behind federal oversight in recent years to fend off litigation. After Wednesday’s decision, those efforts are most likely to succeed if they are based on express language in a Congressional statute or a specific regulatory action that makes compliance with state requirements impossible.

“This narrows the playing field,” for implied pre-emption arguments, Mark Herrmann, a corporate defense lawyer in Chicago, said of the decision. “This does not eliminate the playing field.”

Most drug company stocks, including Wyeth’s, closed up on Wednesday, as did the Dow Jones industrial average, which rose 150 points, breaking a long losing streak.

Catherine M. Sharkey, a law professor at New York University, said the decision does mean that “there is certainly a thumb on the scale against the more aggressive arguments for implied pre-emption.”

Justice John Paul Stevens, writing for the majority in Wednesday’s decision, Wyeth v. Levine, No. 06-1249, said Congress could have required pre-emption in the case but had not. “Evidently,” he said, “it determined that widely available state rights of action provided appropriate relief for injured consumers.”

Justice Stevens noted that Congress did adopt just such an express pre-emption provision for medical devices in the law at issue in the Riegel case.

Until a recent change in policy under the Bush administration, Justice Stevens wrote, the drug agency had welcomed state injury suits as a useful complement to federal regulation. But in “a dramatic change in position” in 2006, Justice Stevens said, the agency reversed that longstanding policy not withstanding its “limited resources to monitor the 11,000 drugs on the market.”

The agency’s new position, Justice Stevens wrote, “is entitled to no weight.” He was similarly dismissive of a brief supporting Wyeth filed by the Justice Department under former President George W. Bush, saying it was “undeserving of deference.”

Justice Stevens was joined by Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Stephen G. Breyer. Justice Clarence Thomas voted with the majority but did not adopt Justice Stevens’s reasoning, saying instead that he objected generally to “far-reaching implied pre-emption doctrines” that “wander far from the statutory text.”

Justice Samuel A. Alito Jr., writing for the three dissenters, said the court had done an about-face, “turning yesterday’s dissent into today’s majority opinion” and turning ordinary injury suits into a “frontal assault on the F.D.A.’s regulatory regime for drug labeling.”

“This case illustrates,” Justice Alito said, “that tragic facts make bad law.”

The case began in 2000, when Diana Levine, suffering from migraine headaches, visited a clinic. She was given injections of Demerol for the pain and Wyeth’s drug Phenergan for nausea.

If Phenergan is exposed to arterial blood, it can cause swift and irreversible gangrene. For that reason, it is usually administered by intramuscular injection or intravenous drip. This time, a physician’s assistant used a third method, injecting the drug into what she thought was a vein, a method known as “IV push.”

In the following weeks, Ms. Levine’s hand and forearm turned black, and they were amputated in two stages. She settled a lawsuit against the clinic and went to trial against Wyeth, claiming its warnings against IV-push administration were not strong enough.

She greeted Wednesday’s decision with elation. “Next to getting my hand back,” she said of the Supreme Court, “it’s the least they could have done and the best they could have done.”

Bert Rein, a lawyer for Wyeth, said the company had “fully complied with federal law in its labeling of Phenergan,” adding that the F.D.A. is “in the best position to weigh the risks and benefits of a medicine.”

Justice Alito said Wyeth had provided ample notice about the risk of gangrene in “six separate warnings,” some of them “in boldfaced font and all-capital letters,” on the drug label the F.D.A. had approved.

Justice Alito, writing for himself, Chief Justice John G. Roberts and Justice Antonin Scalia, added that juries see only the “tragic accident” before them and “are ill-equipped to perform the F.D.A.’s cost-benefit-balancing function.” The agency, by contrast, he wrote, “has the benefit of the long view” and “conveys its warnings with one voice.”

“After today’s ruling,” he said, “parochialism may prevail.”

Baby Bottle Companies Will Stop Using BPA

Connecticut's attorney general says six companies have agreed to stop manufacturing baby bottles that contain Bisphenol-A (BPA). Some studies have indicated that BPA may be harmful to infants.

Attorneys general from Connecticut, Delaware and New Jersey sent letters last October to 11 companies, asking them to stop using the chemical. Avent, Disney First Years, Gerber, Dr. Brown, Playtex and Evenflow have agreed to the request. The companies stopped manufacturing bottles with BPA a couple of weeks ago.

Suffolk County, NY, recently became the first county in the nation to vote on a ban of baby bottles and toddler sippy cups made with BPA.

25 February 2009

Eating Your Veggies: Not As Good For You?

If the economy isn't grim enough for you, just check out the February issue of the Journal of HortScience, which contains a report on the sorry state of American fruits and veggies. Apparently produce in the U.S. not only tastes worse than it did in your grandparents' days, it also contains fewer nutrients — at least according to Donald R. Davis, a former research associate with the Biochemical Institute at the University of Texas, Austin. Davis claims the average vegetable found in today's supermarket is anywhere from 5% to 40% lower in minerals (including magnesium, iron, calcium and zinc) than those harvested just 50 years ago.
Highlight Reel:

1. On the Difficulty of Comparing "Then" and "Now:" Davis is quick to note that historical data can sometimes be misleading, if not altogether inaccurate. Take early measurements of iron in foods: because scientists failed to sufficiently remove clinging soil, iron levels appeared unusually high in certain vegetables like spinach, (which gave rise to the myth that it contained exorbitant amounts of the mineral — a myth further propagated by the popular cartoon character, Popeye). Then again, good historical data provides the only real-world evidence of changes in foods over time, and such data does exist — one farm in Hertfordshire, England, for example, has archived its wheat samples since 1843.

2. On the So-Called "Dilution Effect:" Today's vegetables might be larger, but if you think that means they contain more nutrients, you'd be wrong. Davis writes that jumbo-sized produce contains more "dry matter" than anything else, which dilutes mineral concentrations. In other words, when it comes to growing food, less is more. Scientific papers have cited one of the first reports of this effect, a 1981 study by W.M. Jarrell and R.B. Beverly in Advances in Agronomy, more than 180 times since its publication, "suggesting that the effect is widely regarded as common knowledge." (See pictures of fruit.)

Less studied, though, is the "genetic dillution effect," in which selective breeding to increase crop yield has led to declines in protein, amino acids, and as many as six minerals in one study of commercial broccoli grown in 1996 and '97 in South Carolina. Because nearly 90% of dry matter is carbohydrates, "when breeders select for high yield, they are, in effect, selecting mostly for high carbohydrate with no assurance that dozens of other nutrients and thousands of phytochemicals will all increase in proportion to yield."

2. On the "Industrialization" of Agriculture: Thanks to the growing rise of chemical fertilizers and pesticides, modern crops are being harvested faster than ever before. But quick and early harvests mean the produce has less time to absorb nutrients either from synthesis or the soil, and minerals like potassium (the "K" in N-P-K fertilizers) often interfere with a plant's ability to take up nutrients. Monoculture farming practices — another hallmark of the Big Ag industry — have also led to soil-mineral depletion, which, in turn, affects the nutrient content of crops.

The Lowdown:

If you're still not buying the whole "organic-is-better" argument, this study might convince you otherwise. As Davis points out, more than three billion people around the world suffer from malnourishment and yet, ironically, efforts to increase food production have actually produced food that is less nourishing. Fruits seem to be less affected by genetic and environmental dilution, but one can't help but wonder how nutritionally bankrupt veggies can be avoided. Supplementing them is problematic, too: don't look to vitamin pills, as recent research indicates that those aren't very helpful either.

Vitamin Deficiency Underlies Tooth Decay

Malnutrition Causes Much More than Dental Disease

(OMNS, February 19, 2009) Cavities and gum diseases are not often regarded as serious diseases, yet they are epidemic throughout our society, from the youngest of children to the oldest of senior citizens. Research more than suggests that the same good nutrition that prevents cavities and gum diseases may also prevent other illnesses.

Dental caries and gum pathology are frequently associated with serious chronic health problems. Multiple independent studies published after 1990 document this. Cavities are associated with poor mental health [1-4]. Elderly individuals with dementia or Alzheimer's disease had an average of 7.8 teeth with fillings vs. an average of only 2.7 fillings for elderly individuals without dementia [1]. It is likely that the toxic heavy metal mercury, which makes up half of every amalgam filling, is a contributing factor.
A recent authoritative review showed a clear association between cavities and heart diseases [5]. More importantly, this same study showed that people with poor oral health, on average, lead shorter lives. The association between cavities and diabetes is also a subject of active, ongoing research [6-8]. Connections between heart disease, diabetes, and dental decay have been suspected for decades. Many of the scientists who called attention to this have proposed that diets high in sugar and refined carbohydrates were the common cause of these diseases [9-15].

Dental diseases, mental diseases, heart disease, infectious respiratory diseases, and heart disease are all at least partially caused by common failures in metabolism. Such failures are inevitable when there is a deficiency of essential nutrients, particularly vitamins D, C, and niacin.

There is especially strong evidence for a relationship between vitamin D deficiency and cavities. Dozens of studies were conducted in the 1930's and 1940's [16-27]. More than 90% of the studies concluded that supplementing children with vitamin D prevents cavities. Particularly impressive was a study published in 1941 demonstrated the preventative affect of "massive" doses of vitamin D [28]. And yet no subsequent studies in the scientific literature suggested a need to follow up and repeat this work.

Vitamin D deficiency is linked to respiratory infections, cancer, heart disease, diabetes and other ailments [29]. The evidence for vitamin C was reviewed by Linus Pauling [15], and the evidence for niacin was reviewed by Abram Hoffer [30].

Obtaining vitamins in sufficient doses to help prevent dental disease is safe and easily accomplished. Between 5,000 and 15,000 IU of vitamin D may be obtained from modest exposure to sunshine in the middle of the day. Recommending that people regularly use the capacity of their skin to make vitamin D is common sense. Certainly 1,000 to 2,000 IU per day of vitamin D in supplemental form is safe. 2,000 milligrams per day of vitamin C, and hundreds of milligrams per day of niacin, help prevent tooth and mouth troubles. Sick individuals, and those who are prone to cavities, will typically benefit by starting with higher doses of vitamin D, vitamin C, and niacin under the supervision of an orthomolecular physician.

We believe that individuals taking these nutrients, along with good dental care, will have dramatically fewer cavities and gum operations than individuals just getting good dental care. This idea is easily tested, and the time has come to do so.

References:

[1] B Ellefsen; P Holm-Pedersen; D E Morse; M. Schroll; B. Andersen; G. Waldemar. Caries Prevalence in Older Persons with and without Dementia. Journal of the American Geriatrics Society, Volume 56, Number 1, January 2008, 59-67(9).
[2] J M Chalmers, K D Carter, A J Spencer. Caries incidence and increments in community-living older adults with and without dementia. Australian Research Center for Population Oral Health, Dental School, The University of Adelaide, Adelaide 5005, Australia. Gerodontology Volume 19 Issue 2, 80 - 94.
[3] Friedlander, A.H.; Mahler, M.E. Major depressive disorder psychopathology, medical management and dental implications. Graduate Medical Education, Veterans Affairs Greater Los Angeles Healthcare System (14), Los Angeles, CA, USA. Journal of the American Dental Association (2001), 132(5), 629-638.
[4] Stewart, R.; et. al. Oral Health and Cognitive Function in the Third National Health and Nutrition Examination Survey (NHANES III), Psychosomatic Medicine 70:936-941 (2008).
[5] Meurman, J.H.; Sanz, M.;Janket, S. Oral infection and vascular disease. Institute of Dentistry, University of Helsinki, Finland. Vascular Disease Prevention (2007), 4(4), 260-267.
[6] Touger-Decker R, Sirois D A, Vernillo A T. Diabetes mellitus: Nutrition and oral health relationships. Department of Primary Care, School of Health-Related Professions, University of Medicine and Dentistry of New Jersey, Newark, NJ, USA. Editor(s): Touger-Decker, Riva. Nutrition and Oral Medicine (2005), 185-204.
[7] Diaz-Romero, R.; Casanova-Roman, R.; Beltran-Zuniga, M; Belmont-Padilla, J.; Mendez, J.; Avila-Rosas, H.. Oral Infections and Glycemic Control in Pregnant Type 2 Diabetics. Instituto Nacional de Perinatologia, Mexico City, Mex. Archives of Medical Research (2005), 36(1), 42-48.
[8] Twetman, S.; Johansson, I.; Birkhed, D.; Nederfors, T. Caries incidence in young type 1 diabetes mellitus patients in relation to metabolic control and caries-associated risk factors. Caries Research (2002), 36(1), 31-35.
[9] Bommer, S. Diseases of civilization and nutrition. Ernaehrungsforschung (1963), 7 598-612.
[10] Miler-Sosnkowska, M. Role of dietary carbohydrates in relation to their metabolism. Inst. Zywienia Czlowieka, Akad. Roln., Warsaw, Pol. Postepy Higieny i Medycyny Doswiadczalnej (1975), 29(4), 537-55.
[11] Cremer, H.D.; Eyer, H. Carbohydrates. Inst. Ernaehrungswiss. I, Univ. Giessen, Giessen, Fed. Rep. Ger. Ernaehrungs-Umschau (1975), 22(10), 291-3.
[12] Newberne, P.M.. Nutrition: summary of evidence. Sweeteners: Issues, uncertainties. Acad. Forum, 4th (1975), 76-85, 252-3.
[13] Heraud, G. Sucrose and nutritional pathology. Sucrerie Francaise (1979), 120(24), 21-6.
[14] Nuttall, F.Q.; Gannon, M.C.. Sucrose and disease. Diabetes Care (1981), 4(2), 305-10.
[15] Pauling, L. "How to Live Longer and Feel Better." W.H. Freeman and Company, 1986. Revised 2006, Oregon State University Press. http://oregonstate.edu/dept/press/g-h/LiveLonger.html
[16] Tisdall, F.F. The effect of nutrition on the primary teeth. Child Development (1937) 8(1), 102-4.
[17] McBeath, E.C. Nutrition and diet in relation to preventive dentistry. NY J. Dentistry (1938) 8; 17-21.
[17] McBeath, E.C.; Zucker, T.F. Role of vitamin D in the control of dental caries in children. Journal of Nutrition (1938) 15; 547-64.
[19] East, B. R. Nutrition and dental caries. American Journal of Public Health 1938. 28; 72-6.
[20] Mellanby, M. The role of nutrition as a factor in resistance to dental caries. British Dental Journal (1937), 62; 241-52.
[21] His Majesty's Stationery Office, London. The influence of diet on caries in children's teeth. Report of the Committee for the Investigation of Dental Disease (1936).
[22] McBeath, F.C. Vitamin D studies, 1933-1934. American Journal of Public Health (1934), 24 1028-30.
[23] Anderson, P. G.; Williams, C. H. M.; Halderson, H.; Summerfeldt, C.; Agnew, R. Influence of vitamin D in the prevention of dental caries. Journal of the American Dental Association (1934) 21; 1349-66.
[24] Day, C. D.; Sedwick, H. J. Fat-soluble vitamins and dental caries in children. Journal of Nutrition (1934) 8; 309-28.
[25] Agnew, M. C.; Agnew, R. G.; Tisdall, F. F. The production and prevention of dental caries. Journal of the American Dental Association, JADA (1933) 20; 193-212.
[26] Bennett, N. G.; et al. The influence of diet on caries in children's teeth. Special Report Series - Medical Research Council, UK (1931) No. 159, 19.
[27] Mellanby, M.; Pattison, C. L. The influence of a cereal-free diet rich in vitamin D and calcium on dental caries in children. British Medical Journal (1932) I 507-10.
[28] Brodsky, R. H.; Schick, B.; Vollmer, H.. Prevention of dental caries by massive doses of vitamin D. American Journal of Diseases of Children (1941) 62; 1183-7.
[29] http://www.vitamindcouncil.org/
[30] Hoffer A, Saul AW. Orthomolecular Medicine for Everyone. Laguna Beach, California, Basic Health Pub, 2008. http://www.doctoryourself.com/orthomolecular.html

$8 Million Award in First Solo Tobacco Trial

FORT LAUDERDALE, Fla. (AP) — A jury ordered Philip Morris to pay $8 million in damages to the widow of a smoker who died of lung cancer in a case that could set a standard for roughly 8,000 similar lawsuits in Florida.
The six jurors deliberated over two days before returning the award for Elaine Hess, 63, whose husband, Stuart Hess, died in 1997 at age 55 after decades as a chain smoker.

The award amounts to $3 million in compensatory damages and $5 million in punitive damages against Philip Morris USA, based in Richmond, Va., and a unit of the Altria Group.

“It wasn’t about the money from the beginning,” Mrs. Hess said after the verdict. “It was about doing the right thing. I just really hope this can help all the thousands of families who have also suffered.”

The Hess case was the first to go to trial since the Florida Supreme Court in 2006 voided a $145 billion jury award in another class-action case, the highest punitive damage award in American history. The court said each smoker’s case had to be decided individually, but let stand that jury’s findings that tobacco companies knowingly sold dangerous products and hid their risks.

“We plan to challenge the verdict in the trial court and, if necessary, on appeal,” said Murray Garnick, an Altria Client Services vice president and associate general counsel. “We do not believe today’s verdict is predictive of the outcome of future cases.”

The Hess case has been closely watched by the tobacco industry and by thousands of other Florida smokers and survivors who have sued.

The original class-action lawsuit was filed in 1994 by a Miami Beach pediatrician, Dr. Howard Engle, who had smoked for decades and could not quit. The class of smokers was estimated at up to 700,000 when the giant $145 billion award was issued in 2000.

Diet Could Reduce Onset Of Eye Disease By 20%, Expert Says

ScienceDaily (Feb. 18, 2009) — University of Liverpool scientists claim that the degeneration of sight, caused by a common eye disease, could be reduced by up to 20% by increasing the amount of fruit, vegetables and nuts in the diet.
Age-related Macular Degeneration (AMD) is the leading cause of blindness in the UK, with 45% of those registered as blind suffering from the disease. The condition results in a gradual loss of central vision, due to the failure of cells in the macular – the light sensitive membrane at the centre of the retina. There is currently no cure for the more common ‘dry’ form of the disease, which is suffered by 90% of AMD patients.

Professor Ian Grierson, Head of Ophthalmology at the University, has produced a comprehensive cooking guide called ‘Fruit for Vision’, designed to add fruit and vegetables into everyday meals. The recipes will help AMD sufferers slow down the degeneration process by increasing micronutrient, vitamin and antioxidant intake in the diet. Non-sufferers can also use the book to add fruit, nuts and vegetables into each meal to protect against the disease.

Professor Grierson said: “Poor eating habits have a huge impact on health in general and the health of your eyes is no exception. Eye problems such as AMD, cataract and even glaucoma can all be affected by what we eat. But a relatively minor change in diet - adding a little more fruit into our meals - can make a profound difference and can keep eye diseases like AMD at bay for up to 20% longer.

“There are of course other risk factors related to AMD such as age, light exposure, smoking and being overweight. But if we can improve the kind of food that we eat, we could dramatically reduce the number of people who may suffer from eye diseases in the future.”

Fruit for Vision is published by Indigo Creative Marketing and the Macular Disease Society.

About AMD

AMD occurs in two forms: - ‘Wet’ AMD, which is more severe, occurs when abnormal blood vessels grow within the eye. Bleeding and leaking from these vessels can cause rapid loss of vision. It is curable if caught soon enough, although treatment is extremely expensive. Dry AMD occurs as cells within the macular begin to die, leading to a build-up of waste products in a layer of cells below the retina. There is currently no cure for Dry AMD.

Forget the antioxidants? Researchers cast doubt on role of free radicals in aging

For more than 40 years, the prevailing explanation of why we get old has been tied to what is called oxidative stress. This theory postulates that when molecules like free radicals, oxygen ions and peroxides build up in cells, they overwhelm the cells' ability to repair the damage they cause, and the cells age.
An industry of "alternative" antioxidant therapies -- such as Vitamin E or CoQ10 supplements in megadose format --has sprung up as the result of this theory. However, clinical trials have not shown that these treatments have statistically significant effects.

And now researchers at McGill University, in a study published in the February issue of the journal PLoS Genetics, are calling the entire oxidative stress theory into question. Their results show that some organisms actually live longer when their ability to clean themselves of this toxic molecule buildup is partially disabled. Collectively, these molecules are known as reactive oxygen species, or ROS for short.

Dr. Siegfried Hekimi of McGill's Department of Biology, said most of the evidence for the oxidative stress theory is circumstantial, meaning oxidative stress could just as easily be a result of aging as its cause.

"The problem with the theory is that it's been based purely on correlative data, on the weight of evidence," explained Hekimi, McGill's Strathcona Chair of Zoology and Robert Archibald & Catherine Louise Campbell Chair in Developmental Biology. "It is true that the more an organism appears aged, whether in terms of disease, or appearance or anything you care to measure, the more it seems to be suffering from oxidative stress".

"This has really entrenched the theory," he continued, "because people think correlation is causation. But now this theory really is in the way of progress."

Hekimi and postdoctoral fellow Jeremy Van Raamsdonk studied mutant Caenorhabditis elegans worms. They progressively disabled five genes responsible for producing a group of proteins called superoxide dismutases (SODs), which detoxify one of the main ROS. Earlier studies seemed to show that decreased SOD production shortened an organism's lifespan, but Hekimi and Van Raamsdonk did not observe this. In fact, they found quite the opposite.

None of their mutant worms showed decreased lifespan compared to wild-type worms, even though oxidative stress was clearly raised. In fact, one variety actually displayed increased lifespan, the researchers said.

"The mutation that increases longevity affects the main SOD found in mitochondria inside the animals' cells," said Hekimi. "This is consistent with earlier findings that mitochondria are crucial to the aging process. It seems that reducing mitochondrial activity by damaging it with ROS will actually make worms live longer."

The researchers hasten to point out that they are not suggesting that oxidative stress is good for you.

"ROS undoubtedly cause damage to the body," Hekimi said. "However, they do not appear to be responsible for aging."

18 February 2009

How Vitamin D Inhibits Breast Cancer

Calcitrol, the active form of vitamin D, can induce a tumor-suppressing protein that can inhibit the growth of breast cancer cells.

Previous research had determined that increased serum levels of vitamin D are associated with an improved diagnosis in patients with breast cancer. However, little had been known about the factors that determine the effect of calcitrol on inhibiting breast cancer growth.

During the study, researchers examined the protein involved in the action that can reduce the growth of vitamin D in breast cancer cells. The research could provide a basis for the design of new cancer treatments.

Sources:
Science Daily February 5, 2009

Vaccine Studies: Under the Influence of Pharma

by Barbara Loe Fisher

If you take more than a casual look at the way the mass vaccination system in the U.S. works, you see that pharmaceutical companies marketing vaccines have a lot of clout. It was the pharmaceutical industry that told Congress in 1982 that they were going to leave the nation without vaccines if they didn't get liability protection but have opposed making it less difficult for vaccine victims to obtain federal compensation in the U.S. Court of Claims under a 1986 law that gave them liability protection. It is Pharma lobbyists, who bully the FDA into fast tracking vaccines like Gardasil and who sit at the CDC's policymaking tables urging that new vaccines be recommended for use by all children so they can persuade state legislators to mandate vaccines like influenza vaccine.
Today, a study published in the British Medical Journal reveals the clout that Big Pharma has in the world of medicine journal publishing, specifically the publishing of scientific articles about vaccines. In a Cochrane Collaboration review and analysis of published influenza vaccine studies conducted by Tom Jefferson, M.D., Ph.D. and his colleagues, they found that influenza vaccine studies sponsored by industry are treated more favorably by medical journals even when the studies are of poor quality.

Jefferson's analysis confirms that drug companies marketing vaccines have a major influence on what gets published and is said about vaccines in medical journals. It is no wonder that there are almost no studies published in the medical literature that call into question vaccine safety. The preferential treatment of Pharma-funded studies also explains why the risks of an inappropriately fast-tracked vaccine like Gardasil are underplayed in the medical literature and why a physician like Andrew Wakefield, M.D., who dared to publish a study in 1998 in a medical journal (The Lancet) calling for more scientific investigation into the possible link between MMR vaccine and regressive autism, has been mercilessly persecuted for more than a decade by both Pharma-funded special interest groups as well as public health officials maintaining close relationships with vaccine manufacturers.

Jefferson and his colleagues identified and assessed 274 published studies on influenza vaccines for their methodological quality and found no relationship between study quality, publication in prestige journals or their subsequent citation in other articles. They also found that most influenza vaccine studies are of poor quality but those with conclusions favorable to influenza vaccinations are of significantly lower methodological quality. The single most important factor determining where the studies were published or how much they were cited was sponsorship, with those partially or wholly funded by the pharmaceutical industry having higher visibility.

Dr. Jefferson commented, "The study shows that one of the levers for accessing prestige journals is the financial size of your sponsor. Pharma sponsors order many reprints of studies supporting their products, often with in house translations into many languages. They also purchase advertising space in the journal. Many publishers openly advertise these services on their website. It is time journals made a full disclosure of their sources of funding.

Earlier this week the National Vaccine Information Center (www.NVIC.org) called on the Obama Administration and Congress to investigate Gardasil vaccine risks. NVIC has long questioned the inappropriate influence of vaccine manufacturers in federal vaccine licensing and policymaking and state vaccine mandates. In 2006, Merck's Gardasil vaccine was fast tracked by the FDA at Merck's request and in 2007 Merck lobbyists mounted an aggressive lobbying campaign to get Gardasil mandated by state legislators for all sixth grade girls, which would have assured the big drug company a predictable market.

The Pharma lobbying effort in 2007 to get all states to mandate Gardasil failed but every other vaccine produced by drug companies and licensed by the FDA in the past quarter century has been mandated. Those new mandates were added to state vaccine laws by legislators and public health officials at the urging of vaccine manufacturer lobbyists and Pharma funded organizations touting vaccine studies published in the medical literature.

In the past three decades, the numbers of doses of government recommended vaccines for children and medical organizations like the American Academy of Pediatrics has tripled to 69 doses of 16 vaccines, with 48 doses of 14 vaccines targeted to children under age six. Pharma lobbyists have persuaded most states to pass laws requiring two to three dozen doses of most of the 16 government recommended vaccines. Last year New Jersey became the first state to mandate influenza vaccine for children attending daycare and school.

In the past few years, Dr. Jefferson has authored several independent reviews of influenza studies published in the medical literature for the Cochrane Collaboration, which have been published in the British Medical Journal, questioning the quality of published scientific evidence for influenza vaccine effectiveness and safety for the elderly as well as children.

Clearly, if the makers and marketers of vaccines can influence the quality and quantity of the scientific evidence published in the medical literature proving that vaccines are safe and effective -- evidence that is used by states to mandate vaccines and by the U.S. Court of Claims to deny compensation to vaccine injured children -- then Congress was wrong in 1986 to protect the makers and marketers of vaccines from liability for injuries and deaths caused by those vaccines.

Government vaccine recommendations, U.S. Court of Claims vaccine injury compensation awards and state vaccine mandates are justified on the strength of scientific published in medical journals. It is time for medical journals to disclose all financial ties to the pharmaceutical industry. It is time for studies questioning the safety and effectiveness of vaccines to receive a fair hearing in scientific journals rather than editors confining themselves to primarily publishing studies funded by the pharmaceutical industry maintaining that every vaccine is totally safe, effective and necessary.
Kudos to the British Medical Journal for having the integrity to publish Jefferson's comprehensive analysis of pharmaceutical money influence on vaccine studies published in the medical literature. Hopefully, this will be a wake-up call for the scientific community, Congress and the public to put an end to the undue influence the pharmaceutical industry has on the science and policy of mass vaccination in the U.S.

Omega-3 Fats Prevent the Medical Complications of Obesity

According to a recent study, diets rich in omega-3 fats can protect the liver from damage caused by obesity. This could help explain why some obese patients are more likely to suffer complications associated with obesity.

Lipids called protectins and resolvins, which are derived from omega-3 fats, can actually reduce the incidence of complications such as hepatic steatosis and insulin resistance.

Researchers studied several groups of mice with an altered gene which made them obese and diabetic. Mice given a diet rich in omega-3’s exhibited less hepatic inflammation and improved insulin tolerance.

Sources:
Eurekalert February 12, 2009

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