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What Congress done to the FDA in 1992

In 1992 the principle source of funds for the FDA became that which they collected from Big PhARMA for the approval of new drugs.  Needless to say the standards when to hell.  Of the 400 drugs approved between 93 and 03 only 15 were better than existing treatments/



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 for patients and agency’s efforts to monitor the ill-effects of drugs on the market are 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 not heart attacks.  Even if they occur at twice the normal rate, his sample of coronary events would likely be too small to notice; moreover he would probably attribute an increase to a random cluster, rather than the Statins.}  

      [T]his 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.”  


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. 



This means that 385 drugs confused doctors, increased risk of another VIOXX, were often more expensive than existing treatments, and made monitoring side effect much more difficult.  Free enterprise, which is about profits, at work.


Supervision is need, but not from government who are bribed through campaign contributions, but through an independent body of medical scientists comprised of those whose role is that of teaching and treatment, and basic research--and certain not involved in the testing for the pharmaceutical industry. 


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

Those who have a financial interest in the outcome manipulate the results, Major study finds that all 37 journal articles positive effects over stated; the average was 32%.