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Institute slams FDA on drug safety


Musical chair leadership has left agency in disarray

How about AIDS? Maybe IOM should look at NIAID too?

Hot news two days in a row in the Times: the FDA is on the hot seat, accused of dereliction of duty and letting unsafe drugs onto the market in a damning report it paid the Institute of Medicine $3 million for, following the Merck arthritis drug Vioxx debacle. In this case, the FDA bureaucrats have been poorly rewarded for their patronage, since the IOM has roasted them, demonstrating the problems are systemic.

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

Gardiner Harris’ story Study Condemns F.D.A.’s Handling of Drug Safety has been moved from the Business Section of the Times yesterday to the front page top right and expanded today (Sat Sep 23), so it is unlikely to be missed by anyone important in Washington or New York City.

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The New York Times

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September 23, 2006

Study Condemns F.D.A.’s Handling of Drug Safety

By GARDINER HARRIS

WASHINGTON, Sept. 22 — The nation’s system for ensuring the safety of medicines needs major changes, advertising of new drugs should be restricted, and consumers should be wary of drugs that have only recently been approved, according to a long-anticipated study of drug safety.

The report by the Institute of Medicine, part of the National Academy of Sciences, is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the government’s oversight. The debate heated up in September 2004 when Merck withdrew its popular arthritis drug Vioxx after studies showed that it doubled the risks of heart attacks.

Several senators have already proposed significant changes, some of which the report seems to endorse.

The report’s conclusions are often damning. It describes the Food and Drug Administration as rife with internal squabbles and hobbled by underfinancing, poor management and outdated regulations.

“Every organization has its share of dysfunctions, unhappy staff members and internal disputes,” the report said. But panel members said that they were deeply concerned about the agency’s “organizational health” and its ability to ensure the safety of the nation’s drug supply.

The report made these recommendations, most of which would require Congressional authorization:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

In a telephone conference with reporters on Friday, top F.D.A. officials struck an awkward balance between thanking the institute for its work and defending their own leadership. They said they needed to study the report before deciding which of its recommendations to endorse.

“While considerable work has been done over the past two years to improve our approach to drug safety, work still needs to be done,” said Dr. Andrew C. von Eschenbach, the acting commissioner of the agency and the nominee for commissioner.

An internal e-mail message sent Friday to agency staff members by Dr. Sandra L. Kweder, deputy director of the Office of New Drugs, was blunter, bemoaning the report’s criticism of what it described as the agency’s dysfunctional culture.

“It is a long, inflammatory section of the report that will certainly generate the most public attention and hit our people hard,” Dr. Kweder wrote, according to a copy provided to The New York Times.

Agency critics were elated.

“The new report validates what the watchdog community has been saying for the last two years,” said Senator Charles E. Grassley, Republican of Iowa, who as chairman of the Senate Finance Committee has overseen investigations into drug safety problems. “Problems are systemic, and solutions must reflect a new mind-set by the agency leadership.”

The drug industry, through its trade organization, reacted warily. “Though there is always room for improvements, it would be a mistake to accept the notion that the F.D.A. drug safety system is seriously flawed,” said Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America.

The Institute of Medicine is a nonprofit organization created by Congress to advise the federal government on health issues. The report was issued by the Committee on the Assessment of the United States Drug Safety System, led by Sheila P. Burke, deputy secretary and chief operating officer of the Smithsonian Institution.

The report described fierce disagreements between those who approve drugs and those who study their effects after approval, disputes that repeated F.D.A. efforts have not resolved. Indeed, managers’ failure to address such disagreements competently “has played an important role in damaging the credibility” of the agency, it said.

Critics of the food and drug agency have long been divided into two warring camps. Some say the agency fails to approve life-saving medicines quickly enough, while others say that it is so intent on rapid approvals that it fails to ensure the safety of the drugs.

The institute’s report champions the latter view by calling for greater caution. It suggests that one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

“Some also have serious concerns that the regulator has been ‘captured’ by industry it regulates, that the agency is less willing to use the regulatory authority at its disposal,” the report said, criticizing the agency’s regulatory tools as “all-or-nothing.”

“The agency needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs, or to compel additional studies in the actual patient populations who take the drug after its approval,” it said.

The pharmaceutical industry is likely to fight at least some of the proposals, said Charlie Cook, a Washington political analyst.

“One should never underestimate the influence of the drug industry,” Mr. Cook said. “But I would think that at least the outlines of many of these recommendations would have a decent chance of getting through Congress.”

Senators Michael B. Enzi, Republican of Wyoming and chairman of the Health, Education, Labor and Pensions Committee, and Edward M. Kennedy of Massachusetts, the ranking Democrat on the committee, have jointly proposed a bill that would undertake at least some of the changes advocated by the report.

Another bill, sponsored by Senator Grassley and Senator Christopher J. Dodd, Democrat of Connecticut, offers similar proposals.

There is little chance that Congress will act on any of these proposals before next year, when it must reauthorize the 1992 financing deal with the drug industry. Negotiations between the drug industry and agency about the parameters of that deal are already under way.

Despite its fierce criticisms, the report may bolster the confirmation prospects of Dr. von Eschenbach. A Senate committee approved his nomination on Wednesday, but two Republican senators have vowed to block it.

Over the past 10 years, no commissioner has served more than two years, though the term is open-ended. The report deplored this “lack of stable leadership.”

“Without stable leadership strongly and visibly committed to drug safety, all other efforts to improve the effectiveness of the agency or position it effectively for the future will be seriously, if not fatally, compromised,” the report states.

It recommends that the commissioner be nominated for a six-year term, but such a change may not solve the problem of early exits. President Bush has nominated two past commissioners. The first left for another job within the administration; the second left amid accusations of financial improprieties.

The report recommends that Michael O. Leavitt, the secretary of health and human services, appoint an independent board to advise the commissioner “to implement and sustain the changes necessary to transform” the agency’s culture.

It rejects suggestions by Mr. Grassley and others that the F.D.A. create a center for drug safety to monitor drugs after approval.

“Achieving a balanced approach to the assessment of risks and benefits would be greatly complicated, or even compromised, if two separate organizations were working in isolation from one another,” the report concludes.

The F.D.A. asked the Institute of Medicine to review its drug safety system shortly after the Vioxx withdrawal in 2004, and the agency has agreed to pay $3 million for the study.

The original had this nice paragraph in it, subsequently cut but only to expand the point and drive it home:

Couched in formal language and careful footnotes, the report’s boring exterior belies an incendiary heart. With each page, it paints a devastating picture of a dysfunctional agency that is unable to ensure the safety of the nation’s drug supply.

Also it appears that Gardiner has now come into possession of a frantic email from one of the FDA’s cats in the hot seat, responding to the report.

An internal e-mail message sent Friday to agency staff members by Dr. Sandra L. Kweder, deputy director of the Office of New Drugs, was blunter, bemoaning the report’s criticism of what it described as the agency’s dysfunctional culture.

“It is a long, inflammatory section of the report that will certainly generate the most public attention and hit our people hard,” Dr. Kweder wrote, according to a copy provided to The New York Times.

One of the arrangements which has made the FDA and the industry it is meant to watch all too cosy is a deal from 1992 where the drug companies pay millions to hurry their permits through:

…one of the agency’s biggest problems is a deal struck in 1992 between Congress and the drug industry in which drug makers agreed to pay millions in fees to speed reviews. This deal has increased pressures on drug reviewers to act quickly, and it has limited “the ability of reviewers to examine safety signals as thoroughly as they might like,” the report said.

Nice understatement, very discreet. This rather blatant fee setup is under review right now but nothing is likely to be done until next year. Here are the main recommendations of the report on ways to tighten up the reins, which the industry lobbyists now have six months to undermine:

¶Newly approved drugs should display a black triangle on their labels for two years to warn consumers that their safety is more uncertain than that of older drugs.

¶Drug advertisements should be restricted during this initial period.

¶The F.D.A. should be given the authority to issue fines, injunctions and withdrawals when drug makers fail — as they often do — to complete required safety studies.

¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.

¶The F.D.A. commissioner should be appointed to a six-year term.

¶Drug makers should be required to post publicly the results of nearly all human drug trials.

The one we like best is this one: “¶The F.D.A. should thoroughly review the safety of drugs at least once every five years.” Yes, sir. Maybe whenever our federal watchdog shapes up again and gets its bite back it will do more than give the HIV∫AIDS drug companies a free pass, as it has for twenty years, riding on the scientifically blind gay activist support for untested drugs and itself blindly willing despite all signs of trouble to go along with clinical trials that have not once included a placebo controlled, ARV free group.

Or has the FDA now abandoned all oversight to the NIAID, which as Harper’s glaringly exposed in Celia Farber’s stunning article in March this year Out of Control: AIDS and the corruption of medical scienceis in bed with the drug companies with the lights out?

Drugs are key to HIV∫AIDS’ heart of worms

Certainly someone should reexamine the regulatory performance with regard to HIV∫AIDS drugs, whoever retains any responsibility in this regard, since now more than one study indicates that ARV drugs kill at least half the AIDS patients who die in the first year of medication with HAART, instead of rescuing them from sickness and death.

In fact, the atrocious performance of the drugs in AIDS is the key to exposing the clay feet of the paradigm, as Harper’s intimated and we will demonstrate in our next post.

Given that it is the NIAID who bears the responsibility for the way ARV trials have been conducted, and even for rewriting and even reversing their results, as Harper’s reported, maybe the FDA could redeem itself by spending the money for a review and calling on Celia Farber as a highly paid expert consultant, since she has amassed a pile of damning material in this regard, and still hasn’t been paid properly for her twenty years of public service in this regard. NIAID off-and-on employee Harvey Fishbein could also be a consultant, if Dr Fauci can be persuaded to let him.

Come on guys, pay the IOM another $3 million for an independent study on that topic, if you are still on speaking terms after this, which we hope you are. After all, the IOM report was exceedingly polite about your talents:

The Committee believes the staff of the Food and Drug Administration, and of the Center for Drug Evaluation and Research in particular, to be a dedicated and talented group of public servants who currently lack the organization and resources to address all of the challenges before them and perform their crucial role of advancing and protecting public health in an increasing complex environment. We believe that the Congress needs to ensure that the Center for Drug Evaluation and Research is given the authority and assets (human, financial, technological, etc.) it requires. The Center’s leaders have to be prepared to address the underlying cultural problems that divide and impair the optimal functioning of Center staff and effectively use the existing and new authorities and resources to achieve the Center’s public health and regulatory mission.

Sooner or later, the abysmal state of HIV∫AIDS medication, which is a can of worms which cannot be hidden away in the technical literature forever, and which itself reveals the horrendous truth behind the scenes in this disgraceful chapter in US science and medicine, will be brought to light. So why not cover yourselves with glory and do it now?

Oh, you would prefer not to grasp the nettle just now, thank you? We understand.

Well, NAR stands ready to shoulder the burden. Next post coming up, and we’ll make it a brief summary of the report that the Institute of Medicine would do if only NIAID director Anthony Fauci was not staring them down and waving the bureaucratic equivalent of a baseball bat.

Here is where the text of the report The Future of Drug Safety: Promoting and Protecting the Health of the Public can be read on line.

Here’s a good quote, straight from the introduction, emphasizing how important it is to the drug industry itself that public confidence in the safety of drugs should be high:

Almost every morning’s newspaper and each evening’s television newscasts include a new and more disturbing episode of pharmacological crisis and medical mayhem in the United States” (Markel, 2005). “. . .

The FDA has become synonymous with drug safety. In a sense, `FDA approved’ is the brand that the entire $216 billion U.S. drug market is founded upon. Dilute the confidence of the public in the agency, and many billions of dollars in current and potential sales vanish overnight. That’s exactly what’s happening right now in the wake of the biggest drug withdrawal ever” (Herper, 2005).

The recent highly-publicized controversies surrounding the safety of some drugs have contributed to a public perception that the drug safety system is in crisis. It seems fair to say that this perception has created an opportunity for a thorough evaluation of the U.S. drug safety system.

News media coverage and congressional examination of the Center for Drug Evaluation and Research’s (CDER) handling of safety concerns have raised questions about the review and approval process and whether it has become so accelerated that adequate attention may not be given to safety, and about the completeness and timeliness of risk communication to the public.

Questions also surfaced about the independence of the scientific expertise relied on by Food and Drug Administration (FDA) (i.e., conflict of interest on the its advisory committees) and about the possibility of undue industry influence related to CDER’s increasing dependence on Prescription Drug User Fee Act (PDUFA) funding.

4 Responses to “Institute slams FDA on drug safety”

  1. Martin Kessler Says:

    As long as the majority of people that the ARVs are killing are the disenfranchised and unpopular minorities (gays, drug addicts, blacks in South Africa, etc.), there will be no investigation like there was in the Merck/Vioxx case. The promoters of ARVs know this and are still spreading the fear and stigma. The elite worry more about the fate of Pluto as a disenfrachised planet than about those people. Maybe the CDC’s quest to test everyone might just change that given the over 70 non-AIDS related conditions that would yield a positive result and the fact that HIV just hasn’t been isolated in vivo from anyone.

  2. mark Says:

    It is also interesting that the FDA will pull non-HIV drugs when they kill a few folks, i.e., Tysabri for MS and Vioxx for arthritis, but make no attempt to stem the tide of ARVs when they are similarly toxic, i.e., nevirapine or AZT.

  3. truthseeker Says:

    Pharma Bawd at Moment of Science has posted a reaction to finding herself listed under “Misleading” in the right hand margin here, but luckily she doesn’t seem particularly worried to find herself in company with the New Tork Times, National Academy and Aetiology.

    Apparently she is not aware of the eternal verity of science, which is that all bad ideas are the conventional wisdom in science until better ones come along.

    Of course, HIV∫AIDS is rather an extreme example.

  4. truthseeker Says:

    Added trivial note: Pharma Bawd has removed a perfectly polite comment we wrote to her post in passing last night, which (just in case the post itself disappears too) is/was as follows:

    —-
    Moment of Science

    What Schools Today Really Need is: A Moment of Science.
    Sunday, September 24, 2006
    We Must be Doing Something Right!!
    Take a look at this!

    We are now listed on New AIDS Review’s list of

    “Sites/Pages (Misleading)”

    We share this illustrious honor with a number of crackpot sites I’ve never heard of:

    Aetiology
    NIH Division of AIDS
    National Institute of Allergy and Infectious Disease Fact Sheet
    The National Academy of Sciences
    Nature
    Science
    The New York Times
    and others.

    I notice Mark Chu-Carroll, the Golden God of nerds, at Good Math Bad Math only merited an “Other (Mixed)” categorization. No doubt this is because nobody at New AIDS Review can follow his arguments to their conclusion to realize that Mark is not impressed with HIV denialist arguments.

    It’s not too surprising that they haven’t figured this out, given that, in another display of their critical thinking skills, New AIDS Review lists the National Academy of Sciences under the “(Misleading)” heading, while the publication of that august body, Proceedings of the National Academy of Sciences, falls under their ”(Accurate/Helpful)” sites.

    Anyway gentleman, thank you for taking notice of us. It is both an honor and a privilege.

    You are far too kind!
    The only blog inspired by a Bumper Sticker.

    —-
    Evidently Pharma Bawd decided our mild comment was too compromising to keep up, though all we did was congratulate her on being a distinguished blogger, and explain that her misleading rating was due to her cheerleading attitude towards the HIV∫AIDS paradigm and her inaccurate claims in dealing with the topic, as dealt with in our recent post and comments. If she wished to argue she could always comment again, we pointed out.

    We also wrote we stood by our distinction between the National Academy of Sciences (Misleading) and the Proceedings (Accurate) and suggested she might benefit from reading the Duesberg pieces in the Proceedings.

    Seems this response to her remarks about the low level of our critical thinking etc spoiled her triumph though it is hard to see why. But the censorship of such a mild response seems worth noting. The level of confidence of these lady Web critics of HIV∫AIDS dissent must be rather low, if they censor so readily, we conclude. Just as Anthony Fauci reveals lack of confidence in the paradigm in his own twenty two years of banning media review of the claim.

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