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FDA dependent on drug companies--consequences

Congress with the coaching of the pharmaceutical companies in 1992 passed legislation designed to increase profits by changing the role of the FDA.





Gardiner Harris New Your Times News Service

Sand Diego Union-Tribune, 12/6/04, page A1


Dozens of former and current FDA officials, outside scientists, and advocates of patients spoke critically of the agency’s efforts to monitor the ill effects of drugs on the market.  It is a shadow of what they should be because the White House and Congress forced a shotgun marriage between the agency and industry years ago [1992] for the rich dowry that industry offered [campaign contributions]. 


        Under the 1992 agreement the industry pledged to give the agency millions—this year, $200 million—but only if the agency spent a specified level of money on approvals of new drugs.  Since then, as congressional support sank, the agency has cut everything else but new drug reviews.  In the past 11 years, spending on reviews has increased from about half to more than four-fifths of the agency drug center’s budget.  Among the priorities that took the worst hit was ensuring the safety of the drugs that patients are already taking. . . . The FDA cannot require drug makers to undertake new safety tests once a drug is approved, so tracking the safety of drugs already on the market is the agency’s responsibility. . . . Indeed, the agency now relies almost entirely on the willingness of drug makers to report problems that crop up after a drug has been approved to ensure the safety of the nation’s drug supply.  {This means that unless they start receiving letters from doctors about repeated side affects, the drug company won’t know of the problem.  It is easy for a doctor to recognize in patients taking one of the Statins dissolving muscles as being drug induced, but very few side effects are so unique or so common as to be noticed.  Moreover, drug companies have consistently acted to suppress information concerning adverse effect.  There is a conflict between safety and their profits—jk.} 


          This dependency has gradually worn away at the agency’s willingness to confront drug makers, making it timid and leaving patients vulnerable.  “This is not just about dollars,” said Dr. Jerry Avron, a professor at Harvard Medical School and the author of Powerful Medicines, “it is a cultural issue in which the agency feels it can’t pressure drug makers.”

Vioxx May Have Caused 140,000 Heart Attacks

Jan 26 '05

Food and Drug Administration safety reviewer David Graham estimates that Merck's Vioxx may have caused as many as 140,000 heart attacks in the U.S. before it was withdrawn last September. His estimate was published in the British medical journal Lancet.

The study was based on records of 1.4 million members of Kaiser Permanente, the largest U.S. nonprofit insurer, with 6 million members in California. Many of the cases may have been fatal, Graham said.

A Merck spokesman said the estimate of harm from Vioxx was "speculation." Determinations of Vioxx's potential role in patients' cardiovascular problems "can only be made on a case by case basis," he said.

The publication of Graham's findings is expected to intensify the drug-safety debate that has swept Washington since the Vioxx withdrawal. Graham and other critics accuse the FDA of being too slow to ban or tighten regulations on medicines that cause serious side effects.

Researchers compared the incidence of heart attacks and sudden cardiac death for patients taking Vioxx with those on Pfizer's Celebrex, a similar painkiller, and over-the-counter medications.

Applying the findings across the U.S. population, "We arrived at the estimate of 88,000 to 140,000 patients that had a heart attack in the U.S. because they used Vioxx" after it was introduced in 1999, Graham said.

Portions of the study had been disclosed earlier. Graham said in Nov. 18 testimony before the Senate Finance Committee that between 88,000 and 139,000 heart attacks may have been linked to Vioxx.

Merck withdrew Vioxx after a company study showed that patients taking it for 18 months or longer had twice the risk of heart attacks and strokes -- 1.5 percent -- as those taking a placebo.

Graham said his bosses at the FDA at one point threatened to fire him as associate director for science and medicine in the agency's Office of Drug Safety if he published the findings.

The study found that Vioxx, given at the standard dose, increases the risk of heart attack by about 50 percent, compared with Pfizer's Celebrex, and more than triples the risk of heart attacks when given at high doses. The two drugs suppress the body's production of the Cox-2 enzyme, which is linked to pain and swelling.

People taking Vioxx had a 34 percent higher chance of heart disease compared with those taking other painkillers including Celebrex, naproxen and ibuprofen, the study found.

Patients taking naproxen, a generic painkiller sold as Aleve by Bayer AG, had a 14 percent increase in heart risk compared with some other painkillers such as ibuprofen, the study showed. Previous trials had suggested naproxen may protect against cardiac disease.

Copyright 2003-2005 Inc. All Rights Reserved.


Downfall of a Super drug VIOXX

AARP Bulletin 11/04

Katharine Greider, p. 16

Though the news about Vioxx surprised many patients, debate about its heart safety began among medical researchers not long after the drug hit the market.  Cardiologists from the Cleveland Clinc published an analysis in 2001 showing that the clinical trial that demonstrated Vioox’s ability to lower chances of bleeding also revealed a fivefold increase in heart attacks among Vioxx versus Naproxen [However a study of Naproxen was stopped after three years when it was noticed that patients taking naproxen…. About 50% more such cardiovascular events in the Naproxen arm of the study than in the placebo division, at  Thus the increase is more than 5-fold].  Several observationl studies reinforced the finding.  But Merck argued that Vioxx only appeared to promote heart attacks because, in comparison, protected against them.

                In 2001 the FDA required Me4rck to add a warning of possible heart effects to the Vioxx label and cited the company for minimizing the cardiovascular risks in some of its promotions.  Among these was a May 2001 press release headlined “Merck confirms Favorable Cardiovascular Safety Profile of Vioxx.”  In its warning letter to Merck, the FDA called the claim “simply incomprehensible.”


NIH Stops Study of Celebrex, Naproxen

Health-AP from

By PAUL RECER, AP Science Writer                                    12/20/4

WASHINGTON - A study testing whether Celebrex or naproxen would reduce the risk of Alzheimer's disease (news - web sites) was halted Monday after researchers noted an increase in heart attack and stroke among participants who were taking naproxen, an over-the-counter pain reliever on the market for nearly 30 years. Officials at the National Institutes of Health (news - web sites) said the study was stopped after three years when it was noticed that patients taking naproxen, sold under the brand name Aleve, had a 50 percent greater incidence of cardiovascular events — heart attack or stroke — than patients taking placebo. Another factor, officials said, was the announcement last week that advertising for Celebrex was being halted after a study found that high doses of the drug was associated with an increase in heart attack risk. Data from the Alzheimer's study, however, did not indicate an increased risk for heart attack or stroke.

Celebrex and naproxen are both pain relievers commonly used to treat arthritis. Naproxen has been approved for sale, first as a prescription and then as an over-the-counter drug, since 1976.

Efforts to obtain reaction Monday night produced no answers at phone numbers for Bayer Healthcare, the maker of Aleve, a popular version of naproxen.  Dr. Sandra Kweder of the Food and Drug Administration (news - web sites) said the NIH study is the first to show that naproxen might increase the risk of heart attack or stroke.   "We agree that this is confusing," she said. The FDA (news - web sites) will closely evaluate the findings from the NIH study, said Kweder, but that no new regulatory action with naproxen is expected within the next few days.  She said patients who routinely take naproxen should follow the drug directions carefully, including the instruction not to take it for more than 10 days, and to consult a doctor if there continues to be pain.  The Alzheimer's disease study was being conducted by the National Institute on Aging, an arm of the NIH. It called for 2,500 patients, aged 70 or older and who had a family history of Alzheimer's, to take either Celebrex, naproxen or placebo.

The group was divided and each division, or arm, was assigned to receive one of the drugs or placebo. The drugs were blinded, which means the patients did not know which medication they were taking.   The goal was to determine if the pain-relieving drugs lowered the risk of developing Alzheimer's disease. The study started three years ago and was to continue for a few more years. Officials said the patients in the study will be monitored for developing Alzheimer's, but will not be given the test drugs.  Dr. Elias A. Zerhouni, the director of the National Institutes of Health, said the study linking heart attack to Celebrex last week was a major factor in deciding to suspend the Alzheimer's study.  He said there was a question whether patients in the study would continue to take their medicine since they knew they might be taking Celebrex.

Suspending the study, Zerhouni said, "is the prudent thing to do."   John Breitner of the Veterans Affairs medical facility in Seattle and the University of Washington, an investigator in the trial, said only preliminary data is available. But he said it suggests that about 70 patients of the 2,500 suffered stroke or heart attack, including 23 deaths, and that there were about 50 percent more such events in the naproxen arm of the study than in the placebo division.




In 02 California Skeptics began publishing articles which covered the significant cancer-preventive benefits of aspirin and we warned about possible serious side affects of other NSAIDs.  Now VIOXX, Naproxin, and Celebrex have proven the warning accurate.  Over 150,000 people have died from those 3 and like drugs. Read about the disaster.  Moreover, as for stomach bleeding, a coated aspirin is as safe as the expensive alternatives. 


Pharmaceutical industry data


Scientific Evidence:  Oregon Drug Effectiveness Review Report, December 2004.  Prices:  Median of price range for 30-day supply of pills from AARP analysis of retail prices during November 2004.  [For scanned picture]



New medicines 1975 to 1997 licensed world wide was 1,223 of which only 4 were developed by the pharmaceutical industry R&D activities—source Journal of the American Medical Association


Indian, one of the few developing countries which has a pharmaceutical industry spends only 2% of its revenue on R&D ($152 million), while the major pharmaceutical companies spend 15.6 ($33.2 billion)—source Organization of Pharmaceutical Producers of India.   


Cost per year of saving a life by malaria vaccine $15; through chemotherapy for breast cancer $58,000.


The market for pharmaceuticals in low-income countries is small. 







Europe & Middle East



Asia - Pacific






Sources:  Pharmaceutical Manufactures Association 2004; World Health Organization 2004


Disease burden as cause of death:  33% in poor countries, 2.5% in rich countries.






Lower respiratory infections






Diarrheal disease









Source:  WHO Global Burden of Disease, 2004 project




Stats from end of year (04) MSTL (Medical Technology Stock Letter):


Of the 400 drugs approved from 98 to 03, only 53 were of new compounds and only 15 were shown to be better than existing treatments. 


With each new drug there is a chance of duplicating the VIOXX experience.




1.          3/4th of the profits go towards marketing—all those TV adds, magazine adds, perks to doctors, soft money to politicians, medical journal adds, and like.

2.          Of the research most of it is market driven; mainly in the form of trying to make a knockoff of a competitor’s drug.  This brings us back to the opening numbers where the knockoff is with a few exceptions not significantly better than the existing drug.

3.      The funding arrangement passed by Congress in 1992 entails that that most of the funds raised by the FDA from the drug companies and it is for the very drugs that they are reviewing (  There is nothing left for comparative studies are long-term follow ups.

4.          With so many drugs on the market, doctors are less likely to knowingly select between the choices.


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