I you have any doubt that the FDA is wholly owned and operated by the pharmaceutical industry, then read this article from the former head of the New England Journal of Medicine:
(This article was highlighted in the documentary)
MARCIA ANGELLTaking back the FDAhttp://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda/?rss_id=Most+PopularBy Marcia Angell | February 26, 2007
IT'S TIME to take the Food and Drug Administration back from the drug companies.Before a prescription drug can be sold, the manufacturer must conduct clinical trials to prove to the FDA that the drug is safe and effective. Without that, doctors have no way of knowing how good or bad a drug is. Just trying it out would be not only risky, but unreliable, since individual experience can be misleading. The scrutiny that this agency exists to provide is vital to our health.
But in 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.
In effect,
the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk.
Most tellingly,
the office that approves generic drugs is so small that approval time for generics is twice as long as for brand-name drugs. There is now a backlog of more than 800 generics. That delay is worth billions of dollars to the drug companies whose high prices depend on not having generic competition.
As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market. But the companies usually don't honor that commitment. Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started.
The FDA is strangely silent about this inexcusable dereliction. When questioned, it weakly protests that it doesn't have the authority to compel the research. In fact, it has enormous leverage, since it can withdraw drugs from the market.The FDA also
refuses to release unfavorable research results in its possession without the sponsoring company's permission. Here again, it contends not to have the authority to do so, but providing evidence of side-effects or negative results would seem to be an integral part of its job. It's no wonder that serious safety concerns about drugs such as Vioxx, Paxil, and Zyprexa have emerged very late in the day -- years after they were in widespread use.
The agency's coziness with industry is underscored by the composition of its 18 advisory committees -- outside experts who help evaluate drugs.
Incredibly, many of these advisers work as consultants for drug companies. Although they are supposed to recuse themselves if there is a direct conflict of interest, the FDA regularly grants exemptions from that requirement. Of the six members of the advisory committee that in 1999 recommended approving Vioxx -- the arthritis drug pulled from the market in 2004 because it caused heart attacks -- four had received waivers from the conflict-of-interest rule.
The FDA now behaves as though the pharmaceutical industry is its user, not the public. Fortunately, the user fee law is subject to renewal every five years, and this is one of those years.Congress should let the law die this time around and substitute its own support -- which ought to be increased. Other reforms recently proposed, such as administratively separating drug approval from safety surveillance, will not mean much as long as this law is in effect.
At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should.
Dr. Marcia Angell, a senior lecturer at Harvard Medical School, is a guest columnist.
© Copyright 2007 Globe Newspaper Company.
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Monday, April 06, 2009Dr Marcia Angell's prescription for the FDA http://pharmagossip.blogspot.com/2009/04/dr-marcia-angells-prescription-for-fda.htmlON MARCH 14, President Obama nominated
Margaret Hamburg to become commissioner of the FDA and appointed Joshua Sharfstein, a longtime critic of the pharmaceutical industry, as her principal deputy. Sharfstein, who does not need Senate approval, took over the agency as acting commissioner last week, pending Hamburg's confirmation. His appointment gives real hope that the FDA will stop kowtowing to the big drug companies. For too long the agency has behaved as though its job is to speed brand-name drugs to market, not to ensure that they are safe and effective. But while new leadership is crucial, more needs to be done.
First, Congress should repeal the Prescription Drug User Fee Act. This 1992 law, renewable every five years, authorizes drug companies to pay "user fees" to the FDA for every drug the agency considers for approval. That puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably - a bargain for drug companies. Drug companies should not be considered "users" of the FDA; the public is the user, and it alone should support the agency.
Second, consultants for drug companies should no longer be permitted to serve on FDA advisory panels. These panels consist of outside experts who advise the FDA on whether drugs should be approved, and their recommendations are nearly always followed. But many panel members double as paid consultants for drug companies. Although they are supposed to recuse themselves from decisions in which they have a large, direct financial interest, that requirement is often waived. There is no reason to tolerate any conflicts of interest in such key positions.
Third, the agency should see that the post-marketing studies it mandates are actually carried out. Some drugs are approved on condition that further studies are done after they are on the market, mainly to make sure there are no serious side-effects that did not show up in the pre-marketing clinical trials. Drug companies agree to these studies, but then renege on their commitments. More than 1,000 such studies haven't been started, thus exposing the public indefinitely to drugs of uncertain safety.
Fourth, the FDA should review generic drugs as fast as brand-name drugs. A key to lowering drug prices is to get generic drugs to market quickly after their brand-name counterparts lose their exclusive marketing rights. Drug companies want to delay the appearance of generic drugs as long as possible, and the FDA helps by taking roughly twice as long to approve them as to approve brand-name drugs.
Fifth, Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type. Most newly approved drugs are trivial variations of top-selling drugs on the market. Called "me-too" drugs, they are especially profitable, because they usually target ill-defined medical conditions - huge markets that are easily expanded. For example, there are now five drugs of the SSRI type (that is, with the same mechanism of action) to treat depression. Me-too drugs are approved if clinical trials show they are better than placebos, but they don't have to be compared with another drug of the same type. We simply don't know whether a new me-too drug is better or worse than the others, although they are always marketed as though they have some advantage.
Sixth, the FDA should stop approving me-too drugs on the basis of surrogate endpoints. A surrogate endpoint is a measurement that is thought to be related to a clinical outcome. For example, cholesterol level is a surrogate endpoint for heart attacks or strokes. But surrogate endpoints do not always have the expected predictive value. It makes sense to rely on them in clinical trials of drugs to treat serious conditions for which there are no existing treatments of the same type, because such trials are faster, even if sometimes misleading. But for me-too drugs, there is no rush and the FDA should insist on clinical endpoints.
Finally, the FDA should prohibit direct-to-consumer advertising for three years after drugs are approved. Every newly approved drug has been tested only under controlled conditions in relatively small numbers of patients. Once drugs come into widespread use, unanticipated risks may become apparent. In recent years, a record number of drugs have had to be withdrawn from the market because they turned out to be dangerous. If new drugs are heavily advertised, people may be unnecessarily exposed to risks.
It is time to restore the FDA to its purpose, which is to protect the public from unsafe food, drugs, and devices, not to accommodate the industries it regulates. The change in leadership is reason for optimism.
Dr. Marcia Angell is senior lecturer in social medicine at Harvard Medical School and author of "
The Truth About the Drug Companies: How They Deceive Us and What to Do About It." --------------------------------------
Update 2011:FDA Deputy Commissioner Sharfstein to Resign http://online.wsj.com/article/SB10001424052748704723104576061692596851936.htmlWASHINGTON—The Food and Drug Administration's No. 2 official is leaving the agency after a busy 21-month tenure that included clashes with drug and device makers over tougher regulation.
Deputy Commissioner Joshua Sharfstein, 41 years old, is taking the top public-health job for the state of Maryland, a spokesman for Maryland's governor said, with an announcement scheduled for Wednesday.
The FDA is losing a regulator who has pushed for a greater emphasis on drug safety. For example, he helped bring about an unusual review of the diabetes drug Avandia last year that resulted in much tighter curbs on its use. (Note: They BANNED it in Europe: it causes heart attacks)The departure could have an effect on the FDA's coming release of new guidelines on medical-device approvals. Any significant restrictions will likely cause a backlash in the device industry, which has allies among Republican House leaders.
The new chairman of the House oversight committee, Darrell Issa (R., Calif.), says he wants to take a closer look at FDA issues, having already chastised Dr. Sharfstein in a hearing last September over delays in the withdrawal of defective lots of the pain pill Motrin in 2009. Some House lawmakers also want to investigate the FDA's move in December to withdraw approval of the drug Avastin to treat breast cancer.
Dr. Sharfstein and FDA Commissioner Margaret "Peggy" Hamburg declined to discuss his departure.
After arriving in late March 2009, when he briefly served as acting commissioner, Dr. Sharfstein took on the FDA's device division, where a device for knee surgery had been cleared in late 2008 over the repeated objections of a half-dozen FDA scientists and managers.
His review, prompted by articles in The Wall Street Journal in 2009, led to the FDA's announcement that it planned to revoke the approval of the knee device. The FDA also said it would likely toughen guidelines for an abbreviated device-approval process that is popular with the industry.
Under Dr. Hamburg and Dr. Sharfstein, the agency is issuing more warning letters over manufacturing and marketing violations, while largely stopping the practice of letting companies spend months negotiating the content of these letters, according to industry lobbyists in Washington.
Another change that has alarmed the industry is the focus by the FDA on punishing individual executives and corporate lawyers, not just companies, over alleged wrongdoing. In November, a former lawyer for GlaxoSmithKline PLC was indicted in a Justice Department and FDA investigation into Glaxo marketing practices. The company has said it was cooperating with the government. The lawyer has pleaded not guilty.
Dr. Sharfstein's review of Avandia, the troubled diabetes drug, opened a rift with the longtime head of the FDA's drug division, Janet Woodcock, who had defended the drug as a useful option for patients. The sides came to a truce in September, with restrictions that all but ended new prescriptions of the drug while allowing patients still on it to continue to use it.Administration officials face restrictions if they leave to work for lobbying firms but not if they move to other government posts.
A physician and researcher, Dr. Sharfstein served as an aide to Rep. Henry Waxman (D., Calif.) and was public-health director for the city of Baltimore before joining the FDA.
His plans to take the Maryland job were reported earlier by CQ HealthBeat.
