Big Pharma may get blanket immunity from all side effects, deaths

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Try this on for size. It's about time we take the law into our own hands.... the Bush regime is out to kill you and protect the killer.

 

Big Pharma May be Handed Blanket Immunity for All Drug Side Effects, Deathshttp://www.naturalnews.com/024688.htmlMonday, November 03, 2008 by: David GutierrezKey concepts: The FDA, Estrogen and Side effects(NaturalNews) The Supreme Court may rule that pharmaceutical companies cannot be sued for dangerous or even deadly side effects from their drugs if those side effects arise from an FDA-approved use.Under a legal argument known as "pre-emption," the FDA's approval of a drug absolves companies of any responsibility if that drug later turns out to be dangerous, even if information was concealed from the FDA during the approval process. While courts have rejected this argument for decades, the winds appear to be shifting.In February, the Supreme Court ruled that makers of medical devices were indeed immune from state lawsuits if their devices had received FDA approval. But that decision hinged on the specific wording of the law that gives the FDA authority over medical devices, and the laws relating to drug regulation are not worded the same way.Even so, the Bush administration has been actively urging the courts to apply the same principle to drugs. The administration argues that only the FDA is equipped to regulate drugs and decide whether a product is safe, and that judges or juries are not able to make informed decisions on those matters.The FDA has also recently thrown its support behind pre-emption, reversing a longstanding, de-facto policy of viewing lawsuits as an extra layer of oversight to make up for the agency's time and budget constraints. Now the agency says that lawsuits over drug side effects could lead to a confusing state-by-state regulatory patchwork that would cause hardship to drug companies and discourage patients from taking certain medications.Drug companies are using the pre-emption argument as a legal defense in a wide variety of lawsuits, and the Supreme Court is expected to hear such a case, concerning the company Wyeth, in the fall. Before that, however, a lower federal court is expected to rule on whether pre-emption can be used to dismiss lawsuits by more than 3,000 women who claim that they were injured by using Johnson & Johnson's OrthoEvra birth control patch according to the instructions on the label.When Johnson & Johnson announced its plans for a birth control patch in 1996, one of the main benefits it claimed the product would provide was the ability to prevent pregnancies through lower doses of estrogen than birth control pills. High doses of estrogen are known to increase women's risks of blood clots, heart attacks, strokes and death.But company documents publicized as part of the lawsuits show that in 1999, the company discovered that the patch actually exposed women to significantly more estrogen than the pill, a total of 30 to 38 micrograms per day. Because only about half of the estrogen in a birth control pill actually enters the bloodstream, this means that women using the patch were getting as much estrogen each day as if they were taking a 76 microgram birth control pill.The FDA banned birth control pills containing more than 50 micrograms of estrogen in 1988.Rather than reporting this data to the FDA, however, the study's author instead applied a "correction factor," reducing the estrogen figures by 40 percent. Although the author claimed this was meant to adjust for differing rates of estrogen absorption, such a "correction" was a deviation from the study procedure previously submitted to the FDA.In the final report submitted to the FDA, Johnson & Johnson claimed that OrthoEvra exposed women to only 20 micrograms of estrogen per day. The "correction factor" was referenced only once in the 435-page study report, buried in a complex mathematical formula.According to internal company emails, other clinical trials conducted before approval suggested that women were experiencing side effects such as breast soreness and nausea due to high estrogen doses, but the company did not warn the FDA that the patch might be delivering more estrogen than advertised. Nor did it tell the agency about other studies, in 1999 and 2003, showing that the patch exposed women to more estrogen than the pill.When the FDA approved the product in 2001, Johnson & Johnson marketed it as releasing less estrogen than the pill, containing 20 micrograms per day.The label was not revised until a 2005 investigation by the FDA, following reports of deaths resulting from use of the drug. At that point, the FDA made Johnson & Johnson add a warning that the product "exposes women to higher levels of estrogen than most birth control pills."But the company always knew this to be the case, several lawsuits now allege, and is thus responsible for the side effects that resulted: heart attacks, strokes, and even deaths in those who used the patch as directed. Studies have since confirmed that women on the patch may have twice the blood clot risk of women taking birth control pills, and prescriptions have fallen 80 percent, from a high of 900,000 in March 2004 to only 187,000 in February 2007.But Johnson & Johnson claims that because the FDA approved the drug, the company cannot be held responsible for its effects.Janet Abaray, a lawyer for one of the plaintiffs, disagrees, saying the company took advantage of the agency's shortcomings."Johnson & Johnson knew that FDA. does not have the funding or the manpower to police drug companies," Abaray said.David Vladeck of Georgetown Law School agrees that the FDA has no ability to verify that drug companies are being truthful in their reports."These are scientists, not cops," he said.Chris Seeger, another plaintiffs' lawyer, said it would be a mistake to allow pre-emption to let the drug companies off the hook."Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin," he said.Sources for this story include: www.nytimes.com.

 

 

 

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Duke Stone

oleander soup

Wednesday, November 05, 2008 6:58 PM

Re: Rigged Trials: Drug Studies Favor The Manufacturer

 

 

 

 

 

Thanks

 

I am forwarding this information to my Federal and state elected representatives. and sent my third letter to the FDA today. What a crock.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Duke Stone ----- Dallas, Texas

info

--- On Wed, 11/5/08, Phillip Zachary <phil wrote:

Phillip Zachary <phil Rigged Trials: Drug Studies Favor The Manufactureroleander soup Date: Wednesday, November 5, 2008, 4:02 PM

 

 



 

 

 

 

 

FOR IMMEDIATE RELEASE Orthomolecular Medicine News Service, November 5, 2008

Rigged Trials: Drug Studies Favor The Manufacturer

(OMNS, November 5, 2008) If you have often suspected that drug studies are rigged by the pharmaceutical manufacturer, you are right. "Drug studies skewed toward study sponsors," reported The Washington Post. (1) "Industry-funded research often favors patent-holders, study finds." Specifically, the American Journal of Psychiatry study authors said, "In 90% of the studies, the reported overall outcome was in favor of the sponsor's drug. . . On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug." (2)

Marcia Angell, MD, former editor-in-chief of the New England Journal of Medicine, agrees. "Is there some way (drug) companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways, and it happens all the time." One "way to load the dice," she writes, "is to enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people. Because young people generally experience fewer side effects, drugs will look safer." Another of the "common ways to bias trials is to present only part of the data - the part that makes the product look good - and ignore the rest." She adds, "The most dramatic form of bias is out-and-out suppression of negative results." (3)

You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: "Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties" in 17 years. "The patent was based on NIH-funded research." That means you, the taxpayer, footed the bill. Harvard is in just as deep. In its own Faustian dealings with the drug companies, "a Harvard hospital has a deal that gives Novartis rights to discoveries that lead to new cancer drugs. . . Merck is building a twelve-story research facility next door to Harvard Medical School . . . In Harvard Medical School 's Dean's Report for 2003-4, the list of benefactors included about a dozen of the largest drug companies."

Clearly drug companies are more concerned with profits than with patients. The psychiatric drug market is a very big business. American doctors prescribe $10 billion worth of antipsychotic drugs every single year. The pharmaceutical industry, says Angell, is "primarily a marketing machine to sell drugs of dubious benefit." Big pharma is "taking us for a ride." And it is no mere jaunt around the park. Total drug industry worldwide sales are in excess of $500 billion per year, half of which are in North America. Profit margins are typically 20 per cent, so high that "the combined profits for the ten drug companies in the Fortune 500 were more than the profits for all the other 490 businesses put together."

But more cash does not buy more cures. In fact, said the Washington Post: "When the federal government recently compared a broader range of drugs in typical schizophrenia patients in a lengthy trial, the two medications that stood out were cheaper drugs not under patent." (1) It gets even more interesting when we broaden our list of treatment options to include nutrition. With the therapeutic use of vitamin supplements, the cost goes down much further, and the success rate goes way up. Orthomolecular (nutritional) therapy, says psychiatrist Abram Hoffer, MD, PhD, is many times more effective than drug therapy. He says that niacin (vitamin B-3) in sufficiently high doses is the most effective, least expensive, and safest treatment for schizophrenia and a number of other very serious mental illnesses. Hoffer and colleagues demonstrated this decades ago when, in the early 1950s, they successfully conducted the very first double-blind, placebo-controlled nutritional studies i! n the history of psychiatry. (4)

Niacin is a clinically proven therapy for serious mental illness, and yet the medical profession has delayed endorsing it for over fifty years. Instead, drug treatments dominate. But drugs are not doing the job. A double-blind study of schizophrenics showed that three-quarters of them stopped taking pharmaceutical medication either because of intolerability or inefficacy. That means that either the drug side effects were unbearable, or the drug just plain did not work. (5)

Perhaps drugs are not the answer because mental illness is not caused by drug deficiency. But much illness, especially mental illness, may indeed be caused by nutrient deficiency or nutrient dependency. Only nutrients can correct this problem. This not only makes sense, it has stood up to clinical trial again and again. (6) Vitamins like niacin are cheap, safe and effective. Modern "wonder drugs" are none of those. But they do make money. Especially when the drug makers control the research, the advertising, and the doctors. No wonder which approach you've heard more about.

We've all been carefully taught that drugs cure illness, not vitamins. The system is remarkably well-entrenched. 2.3 million Americans per year serve as human subjects for pharmaceutical company drug testing. Pharmaceutical companies set up patient support or advocacy groups to attract specific subjects for their clinical trials. Doctors are paid an average of $7,000 per patient for every patient they enroll in a drug study. Drug companies pay nearly two-thirds of the costs of continuing medical education. While the pharmaceutical industry's reach into education is bad enough, its grip on research is scandalous. For example: Drug company "publications strategies" have them "sponsor minimal research, prepare journal articles based on it, and pay academic researchers to put their names on those articles." So bad is it that Dr. Angell wrote an editorial in NEJM (7) entitled "Is Academic Medicine for Sale?" A reader wryly responded, "No. The current owner is very happy with i! t."

The result? "Bias is now rampant in drug trials. . . (Pharmaceutical) industry-sponsored research was nearly four times as likely to be favorable to the company's product as NIH-sponsored research." (3) Remember, "NIH-sponsored" means "taxpayer-funded. " And then, when they need to use a drug, those same taxpayers pay again, and way too much, for the drug they already paid out grant money to develop, in a rigged trial, for a high-profit company.

What a sweet system for the pharmaceutical industry.

References:

(1) Drug studies skewed toward study sponsors. Industry-funded research often favors patent-holders, study finds. Vedantam S. The Washington Post, April 11, 2006. http://www.msnbc. msn.com/id/ 12275329/ from/RS.5/ (2) Heres S, Davis J , Maino K, et al. Why Olanzapine Beats Risperidone, Risperidone Beats Quetiapine, and Quetiapine Beats Olanzapine: An Exploratory Analysis of Head-to-Head Comparison Studies of Second-Generation Antipsychotics. Am J Psychiatry 163:185-194, February 2006. http://ajp.psychiat ryonline. org/cgi/content/ full/163/ 2/185 (3) Angell M. The Truth about the Drug Companies. NY: Random House, 2004. (4) Hoffer A. Healing Schizophrenia. Complementary Vitamin & Drug Treatments. Ontario: CCNM Press (2004). ISBN-10: 1897025084; ISBN-13: 978-1897025086. Also: Vitamin B-3 and Schizophrenia: Discovery, Recovery, Controversy, by Abram Hoffer, MD. Quarry Press, Kingston, Ontario Canada (1998) ISBN 1-55082-079- 6. Reviewed at http://www.doctoryo urself.com/ review_hoffer_ B3.html List of publications by Abram Hoffer: http://www.doctoryo urself.com/ biblio_hoffer. html (5) Stroup TS, Lieberman JA, McEvoy JP et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611- 22. See also: Stroup TS, McEvoy JP, Swartz MS et al. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15- 31. (6) For free access to peer-reviewed nutrition therapy journal articles: http://orthomolecul ar.org/library/ jom (7) Angell M. Is academic medicine for sale? N Engl J Med. 2000 May 18;342(20):1516- 8.

Nutritional Medicine is Orthomolecular Medicine

Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomol ecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource.

Editorial Review Board:

Damien Downing, M.D. Steve Hickey, Ph.D. Abram Hoffer, M.D., Ph.D. James A. Jackson, PhD Bo H. Jonsson, MD, Ph.D Thomas Levy, M.D., J.D. Erik Paterson, M.D. Gert E. Shuitemaker, Ph.D.

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