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  CommentaryThe FDA Under Attack

The FDA needs to show more concern for Americans and less concern for drug company profits.
By Mick Youther

A fast spreading hepatitis attack has killed 3 and sickened more than 500, the biggest outbreak of food-borne hepatitis A in the United States. Although this appears to be a local public health failure, it highlights that certain government agencies are failing in their mission to protect the public.

Like so many things in government, the Food and Drug Administration (FDA) probably started out with good intentions. Now it acts as though its primary function is to serve and protect the pharmaceutical industry’s profits.

• "They've lost their compass and they forget who it is that they are ultimately serving. Unfortunately the public pays for this, because the public believes that the FDA is watching the door, that they are the sentry."-- Dr. Lemuel A. Moye, University of Texas School of Public Health, FDA advisory committee (1995-99)

• "FDA used to serve a purpose. A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what's been swept under the rug."-- Dr. William L. Isley, Kansas City, Mo.

• “A survey conducted by watchdog group Public Citizen found that at least 27 medical officers whose job it is to review drugs were sometimes ‘made to shade their reviews to be more favorable toward a drug or to not present data adverse to a drug before an advisory committee.’”-- Bette Hileman, Chemical & Engineering News, 12/2/02

• “The [FDA] experts are supposed to be independent, but USA TODAY found that 54 percent of the time they have a direct financial interest in the drug or topic they are asked to evaluate.”-- USA Today, 9/25/00

• "Either you play games or you're going to be put off limits . . . a pariah. The people in charge don't say, 'Should we approve this drug?' They say, 'Hey, how can we get this drug approved?' "--Dr. John L. Gueriguian, a 19-year FDA medical officer

• “The [Prescription Drug Users Act] has brought in lots of industry cash...In return for its money, the industry got what it wanted: speedier reviews and more approved drugs.’ What the public got was unsafe drugs being approved only to be recalled after they killed people.”-- The International Coalition for Drug Awareness, 2/19/02

• “[Rep. Henry Waxman (D-CA)] notes that [the pharmaceutical] industry is not keeping promises to conduct further safety studies of newly marketed drugs: A report delivered to Congress in March shows that happens with only 37% of regular drugs, 15% of biotech products.”-- Cindy H. Dubin, Editor, Pharmaceutical Formulation and Quality, April/May 2002

• "It's shocking. How can you say, 'Release drugs to the market sooner,' and not know if they're killing people?.... It really is a dramatic statement of public priorities."-- Dr. Brian L. Strom, chairman of Epidemiology, University of Pennsylvania

• “Overall, the [pharmaceutical] industry has already spent more than $29 million in lobbying this year, more than any other industry, according to Political Money Line, a nonpartisan Washington Web site.”-- Frederic J. Frommer, AP, 10/14/03

• "… this committee and this Congress jump when the drug industry says 'jump'; it rushes to pass legislation when the drug industry wants it to pass legislation. But we better not talk about drug pricing or the impact of direct-to-consumer advertising on health care utilization. Those topics are taboo."-- Rep. Sherrod Brown (D-OH), 3/6/02

• “The United States is the only major country that allows the private inventor of a drug or medicine to patent the discovery, even if it was made with the help of a public grant, and to retain exclusive rights to its production and sale, thereby avoiding competition.”-- Wayne O'Leary, The Progressive Populist, 8/1/02

• “Industry prefers to sell drugs by prescription because they can charge more since insurance companies pay for them. Of course, industry doesn’t care about the uninsured who have no money to pay for the higher costs of drugs. These folks are solicited for clinical trials to test new drugs ‘without any cost’.”-- Alliance for Human Research Protection, 3/18/2002

• "Currently, taxpayers fund the development of drugs at the National Institutes of Health, which in turn sells the drug to a corporation for very little money…Once the drug company has control of the product, they charge an exorbitant amount of money to consumers."-- Joyce Marcel, Albion Monitor, 7/24/00

• “The FDA is responsible … for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”-- FDA Mission Statement, 11/10/03

The FDA needs to rededicate itself to this mission. The safety of food and drugs must be determined by unbiased testing conducted by unbiased researchers. If not, the FDA stamp of approval means nothing but trouble.

Mick Youther is an Instructor in the Department of Physiology at Southern Illinois University in Carbondale, IL

Posted Sunday, November 16, 2003


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