Worldwide Drug Industry Ailing_PhaRMA Giants Reeling Blockbuster Drugs Found Hazardous

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness and Full Disclosure

<http://www.ahrp.org> www.ahrp.org

FYI

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. K. ,

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. 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. 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 'under 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. 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. 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>

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 & e

n=f1c28100fe5ebc9c & ei=5094 & partner=homepage>

http://www.nytimes.com/2004/12/18/business/18assess.html?hp & ex=1103432400 & en

=f1c28100fe5ebc9c & ei=5094 & partner=homepage

TSee: 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>

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 & pagewante

d=print & position>

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 Irving,

TimesOnLine (UK) December 18, 2004

<http://business.timesonline.co.uk/article/0,,8209-1407558,00.html>

http://business.timesonline.co.uk/article/0,,8209-1407558,00.html

See: Drug doubts From Snow CNN International, December 17, 2004

<http://edition.cnn.com/2004/US/12/17/drug.doubts/>

http://edition.cnn.com/2004/US/12/17/drug.doubts/

See also: Hard to Swallow by , The Washingtonian December 1997

http://www.washingtonian.com/health/hardtoswallow.html

<http://www.nytimes.com/2004/12/18/opinion/18sat1.html?pagewanted=print & posi

tion>

http://www.nytimes.com/2004/12/18/opinion/18sat1.html?pagewanted=print & posit

ion=

THE NEW YORK TIMES

December 18, 2004

EDITORIAL

New Doubts About Celebrex

LLet'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.

<http://www.nytimes.com/ref/membercenter/help/copyright.html> Copyright

2004 The New York Times Company <http://www.nytco.com/>