October 26

Worldwide Drug Industry Ailing – PhaRMA Giants Reeling Blockbuster Drugs Found Hazardous

Worldwide Drug Industry Ailing – PhaRMA Giants Reeling Blockbuster Drugs Found Hazardous

Sat, 18 Dec 2004

Daily headlines provide confirmatory evidence supporting what critics of the drug industry have been say:ing for years. First, as The New York Times notes in one of its 4 articles about the latest “unexpected” revelations of hazardous drug effects, “the $500 billion drug industry is stumbling badly in its core business of finding new medicines.” Second, FDA’s fast-track drug approval process, coupled with the absence of a mandatory post-marketing montioring system has put the nation’s consumers – especially the elderly and the young – at risk of becoming casualties of marketed drugs whose lethal effects are concealed.

Critics will dispute the opinion expressed in the Times editorial (below) “the best hope for an honest assessment of the risks of Celebrex lies with the FDA and its advisory committees.” The FDA and its industry rigged advisory committees have led to the approval of Celebrex and numerous other hazardous drugs. Indeed, the FDA and its advisory committee gave Prozac a clean bill of health in 1991, regarding suicidal and homicidal behavior triggered by the drug. In 2004 the agency had to recant and issue black box warnings precisely relating to a causal relationship between Prozac and the other antidepressants and an increased suicide risk. Unfortunately no antidepressant label to date includes a black box warning!

Not only is the FDA inadequate to the task of safeguarding the public from lethal and / or useless drugs, what’s worse is that senior FDA officials are either incredibly incompetent or their judgement is entirely clouded by industry’s marketing objectives. The Times quotes Dr. John K. Jenkins, director of F.D.A.’s office of new drugs acknowledging the obvious. Namely, he admits that the F.D.A.’s surveillance system is incapable of uncovering the kind of dangers associated with Vioxx, Bextra and Celebrex. His statement echoes the testimony of Dr. David Graham before the Senate Finance Committee two weeks ago. At that time, FDA officials used threats, intimidation, and libel to stop Dr. Graham, a sernior drug safety analyst at the FDA, from criticizing the agency’s performance in public.

However, Dr. Jenkins went on to make a mind-boggling statement: “I don’t see that [FDA’s incapacity] as a failure of the system. This is how drug approval and surveillance is done in the U.S.” If a CEO were to use that as an excuse for his company’s failure to perform, he would lose his job.

As long as the FDA is Œunder the influence,’ as long as the drug industry’s marketing fairy tales (i.e., deceptive advertisements) are permitted to flood the airwaves, we are all in danger of a doctor prescribing a lethal drug. The fact is, prescribed drugs pose far greater health hazards than illicit street drugs ever did, yet stringent law enforcement and prison penalties are applied only to those who disseminate drugs of abuse. Why are there no laws or enforcement mechanisms to protect us from the marketers of hazardous drugs that cause 100,000 preventable deaths each year?

In his testimony, Dr. Graham warned that at least five other drugs on the market that warrant scrutiny: the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent. The Celebrex trial, Dr. Graham noted, “is yet more evidence that the F.D.A.’s system for identifying the risks of drugs – both before and after approval – is inadequate.”

Dr. David Kessler, a former F.D.A. commissioner, claims many problems discovered about Vioxx, Celebrex and Bextra did not result from anything the F.D.A. had done. “It’s all through happenstance that we’re finding these problems,” Dr. Kessler said. “We need to take a very hard look at the agency’s drug surveillance system.”

Ironically, the first case of a sponsor suppressing negative findings of a clinical trial occurred under Dr. Kessler’s watch as FDA commissioner. The case involved Dr. Betty Dong of the University of California, San Francisco, whose study compared four forms of Levothyroxine (a medication used to replace thyroid hormone in patients with low levels of the hormone (hypothyroidism), found the four forms of levothyroxine (two brand name and two generic) to be “bioequivalent.” This finding did not please the sponsor, Knoll Pharmaceutical: the company prevented Dr. Dong from publishing her scientific findings after her paper was accepted for by the Journal of the American Medical Association following review by five peer reviewers. Knoll threatened to sue: UCSF caved in and in turn pressured Dr. Dong to withdraw the paper. This scenario has been repeated over and over again.

Most recently FDA managerial officials have been caught several times using underhanded, possibly illegal tactics in an effort to suppress the agency’s own medical officers from presenting negative scientific findings. In February, senior FDA officials embargoed Dr. Andrew Mosholder’s report of suicidal risks for children prescribed an SSRI antidepressant, and just last month, they tried to block Dr. Graham from publishing his findings about the lethal cardiac risks posed by Vioxx.

Two of Dr. Graham’s articles were accepted by major medical journals – The Lancet and the JAMA. Following the tradition set by Knoll Pharmaceuticals, FDA officials engaged in covert smear campaigns and bully tactics of intimidation. Dr. Galson publicly accused Dr. Graham of engaging in “junk science.” One wonders what science these senior FDA officials relied on when they claimed Vioxx was safe up until Merck’s withdrawal of the drug.

FDA’s failure to ensure that physicians and the public are provided accurate information reflecting scientific findings – as is the agency’s stated mission–has led drug companies to exploit the lacuna and to market dozens of lethal drugs with impunity.

Hazardous drugs have been promoted to the public in reassuring, seductive ads that promised wonders while failing to mention life-threatening risks – NYS Attorney Eliot Spitzer called such marketing tactics, FRAUD. Inasmuch as the FDA approval process fails to detect the true hazards associated with a new drug, The ALLIANCE FOR HUMAN RESEARCH PROTECTION calls for a moratorium on direct to consumer advertising for the first five years that a new drug is marketed.

When Merck withdrew Vioxx from the market, Pfizer seized the opportunity–despite the hazards of its own COX 2 pain killer–Pfizer mounted a major direct to consumer ad campaign for Celebrex “to get people to ask their doctors about the drug.” See: Boston Globe http://www.boston.com/business/articles/2004/10/20/pfizer_launching_expanded_ad_campaign_for_celebrex/

Eli Lilly’s Strattera ads continue to assure the public that the drug was “Proven Safe and Effective” “Six clinical trials have proven Strattera to be safe an effective in treating all symptoms of ADHD.” “Free Samples Available from Your Doctor” see: http://www.strattera.com/0_0_common/patient_stories.jsp

See: Bad Medicine for Pillmakers: Pricey Drug Trials Turn Up Few New Blockbusters By ALEX BERENSON, The New York Times , Dec. 18, 2004 A-1 http://www.nytimes.com/2004/12/18/business/18assess.html?hp&ex=1103432400&en=f1c28100fe5ebc9c&ei=5094&partner=homepage

See: Drug Trial Finds Big Health Risks in 2nd Painkiller By GARDINER HARRIS NYT, Dec 18, A-1 http://www.nytimes.com/2004/12/18/business/18celebrex.html

See: THE PATIENTS Problems May Send Many Patients Back to Good Old Aspirin By ANAHAD O’CONNOR and DENISE GRADY December 18, 2004 http://www.nytimes.com/2004/12/18/business/18care.html?oref=login&pagewanted=print&position

See: Celebrex Trial Halted After Finding Of Heart Risk FDA Chief Urges Patients To Ask About Alternatives By Marc Kaufman Washington Post, December 18, 2004; Page A01

See: Shares dive as drug giants halt key trials By Richard Irving, TimesOnLine (UK) December 18, 2004 http://business.timesonline.co.uk/article/0,,8209-1407558,00.html

See: Drug doubts From Mary Snow CNN International, December 17, 2004 http://edition.cnn.com/2004/US/12/17/drug.doubts/

See also: Hard to Swallow by Thomas Moore, The Washingtonian December 1997 http://www.washingtonian.com/health/hardtoswallow.html

December 18, 2004
New Doubts About Celebrex

Let’s hope that Pfizer isn’t falling into the same mind-set that Merck demonstrated when it stonewalled for years over the safety of its popular arthritis drug, Vioxx, only to yank it from the market when a convincing study found it raised the risk of cardiovascular problems. Yesterday Pfizer announced the results of a government-sponsored clinical trial, which showed that its own best-selling arthritis drug, Celebrex, more than doubled or tripled the risk of heart attacks, strokes and cardiovascular deaths, depending on the dosage.

The company found all sorts of ways to express uncertainty over the meaning of these findings, calling them “unexpected” and inconsistent with its own similar trial and other data. It pledged immediate steps to “fully understand” the results. Yet even before any more data comes in, it seems clear that patients and doctors must confront the possibility that this overhyped class of drugs, known as COX-2 inhibitors, may raise the risk of heart problems while offering at best only limited benefits for some patients. The Food and Drug Administration, notoriously weak in policing drugs already on the market, must step in to reduce the dangers.

Vioxx and Celebrex became blockbusters thanks to heavy promotional campaigns that propelled sales far beyond reason. The ads typically implied that the drugs provided exceptional pain relief, but in truth careful clinical trials showed that they were no better in that regard than such common pain relievers as Advil, Motrin and Aleve.

The presumed advantage of COX-2 inhibitors was that they might cut the rate of gastrointestinal side effects like ulcers and bleeding. But the evidence of any benefit is skimpy and seems to be offset by the heart risks that have driven Vioxx from the market. Those risks have also led to required new label warnings about Bextra, Pfizer’s other entry in the class, and left Celebrex under a cloud. This is a bizarre turn of events for drugs taken by millions of Americans in the belief that they were safer and more effective than older painkillers.

Pfizer said it would not pull Celebrex off the shelves, a stance that is not surprising given the profits generated by the drug, and the widespread belief in the industry that Merck only compounded its legal and financial problems by withdrawing Vioxx. But if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well.

The best hope for an honest assessment of the risks of Celebrex lies with the F.D.A. and its expert advisory committees. The agency has been sharply criticized of late for failing to protect the public adequately against unsafe drugs, especially after the drugs are already on the market. Its own reputation will be on the line as it ponders how tough to get about Celebrex in coming days.

Copyright 2004 The New York Times Company

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