Drug Industry Scandal a 'Crisis'

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Drug Industry Scandal a 'Crisis'

by Ritt Goldstein Wednesday October 06, 2004 at 01:18 PM

 

http://www.thunderbay.indymedia.org/news/2004/10/15787.php

Vast numbers of dead, the compromising of key elements within the medical

community and its regulatory structures, the blind pursuit of billions of

dollars in corporate profits -- all have surfaced in a detonating

pharmaceutical industry scandal of global dimension.

 

 

Drug Industry Scandal a 'Crisis'

 

Ritt Goldstein

http://www.ipsnews.net/africa/print.asp?idnews=25716

 

Vast numbers of dead, the compromising of key elements within the medical

community and its regulatory structures, the blind pursuit of billions of

dollars in corporate profits -- all have surfaced in a detonating

pharmaceutical industry scandal of global dimension.

 

STOCKHOLM, Oct 4 (IPS) - The suicide deaths of numerous young people,

despite the existence of information that could have precluded them, sparked

the revelations. But a far broader, systemic and devastating problem has

emerged regarding the full spectrum of newer prescription medications.

 

" It's a general healthcare crisis, I think, at this point in time, " famed

British drug scientist and psychiatrist David Healy said in an interview.

 

" If the pharmaceutical companies in this area -- in the area of a hazard

like a child being made suicidal by these drugs -- if they're prepared to

sweep a thing like this under the carpet, then there isn't anyone taking any

other drugs who can really be confident. "

 

On Sep. 29 Merck & Co withdrew its popular arthritis drug Vioxx from the

market, acknowledging it caused increased risk of stroke and heart attack.

Just a month earlier the firm had strongly disagreed with a study by U.S.

regulatory agency the Food and Drug Administration (FDA) that had revealed

such problems, reported the Associated Press.

 

Since the late 1990s, the number of drugs either pulled from the U.S. market

or given a " black box " label (a warning of side-effects that could lead to

death or serious injury) has " mushroomed, " according to Dr Joel Lexchin,

professor in the School of Public Health Policy and Management at Toronto's

York University.

 

" A lot of people, including me, are attributing that to faster approvals in

the U.S. ... faster reviews by FDA officials have resulted in drugs getting

onto the market which shouldn't have, " Lexchin told IPS, commenting on newer

medicines generally.

 

On Sep. 30 business magazine 'Forbes' noted that in Vioxx's five years on

the market, 84 million people have used it, four million are presently

taking it, and that safety concerns first emerged in 2001. " Is there

equivalent data on other drugs? It's not clear, " 'Forbes' added.

 

Death estimates and resurfacing medical studies are now providing another

kind of clarity, one of horrific proportion.

 

The highly respected British medical journal, 'The Lancet', published a

report on a 1998 study by University of Toronto researchers showing that

adverse drug reactions (ADRs) are " a leading cause of death. " It noted the

study examined " only ADRs attributed to drugs that were 'properly prescribed

and administered'. "

 

The study's authors suggested, " many adverse reactions result from the use

of drugs with unavoidably high toxicity, " and that medicine " cannot expect

to reduce this burden until drug-induced illness is actually defined as a

problem. "

 

In the May 1 2002 issue of the 'Journal of the American Medical Association'

(JAMA), five physicians from Harvard Medical School reported adverse drug

reactions " are believed to be a leading cause of death in the United

States. "

 

The authors urged the FDA to raise " its threshold for approving new drugs

when safe, effective therapies already exist, or when the new drug treats a

benign condition " , citing the " frequent introduction " of drugs where serious

side-effects occur.

 

And they emphatically advised that " clinicians should avoid using new drugs

when older, similarly efficacious agents are available. "

 

Lexchin, who consults on pharmaceutical policy for groups such as the World

Health Organisation (WHO) and governments including Australia and Canada,

estimated that in the last five years, " biased research, suppression of

negative studies, over-publication of positive studies and, all their (the

pharmaceutical industry's) promotional activities, which includes their

funding of continuing medical education, " has meant, yearly, " one death per

1,500 people " in the general population.

 

That translates into 6,670 deaths a year for every 10 million of a nation's

populace.

 

For perspective, about 3,000 people died in the 9/11 terrorist attacks on

New York and the Pentagon.

 

In contrast, the 1998 'Lancet' article viewed it likely that adverse drug

reactions " could account for more than 100,000 (in-hospital alone) deaths in

the USA each year, making them the fourth commonest cause of death. "

 

The figures are likely " much the same " throughout the developed world, it

added.

 

On Sep. 9 the 'Washington Post' reported that the U.S. House of

Representatives energy and commerce subcommittee for oversight and

investigations was holding hearings on the pharmaceutical industry, in

response to " the growing outcry over suppressed medical studies. "

 

The California legislature held a hearing in August on the potential link

between anti-depressant drugs and suicide. According to State Senator Tom

Torlakson, " our offices were deluged with requests to testify from family

members of suicide victims. "

 

Speaking to the questions surrounding clinical trials, which test a

medication's effectiveness and safety, the group representing the U.S. drug

industry, the Pharmaceutical Research And Manufacturers of America (PhRMA),

noted on Sep. 9 that its board had approved principles to be used in the

conduct and reporting of clinical trials two years ago.

 

" These principles express the commitment of PhRMA member companies to

communicate the results of all hypothesis-testing clinical trials, both

positive and negative, for drugs that are on the market, " a PhRMA vice

president said.

 

PhRMA represents industry firms " which are devoted to inventing medicines

that allow patients to live longer, healthier and more productive lives, "

added the prepared statement.

 

No one from PhRMA was immediately available for comment for this article.

 

Similar to the Enron accounting scandal in the United States, the present

prescription-drug debacle appears to be a matter of systemic corruption,

including a gross and widespread failure within the regulatory process.

Unlike Enron, enormous fatalities have resulted, though no criminal charges

regarding these deaths have yet been announced.

 

On Sep. 21, UK newspaper 'The Guardian' reported that the drugs Seroxat and

Prozac " can make people homicidal, " according to results of drug trials

revealed by Healy.

 

The paper described him as " an expert on psychiatric drugs from north Wales

whose warnings that the drugs (SSRI antidepressants) could cause suicide ...

led to the entire class of drugs, except Prozac, being banned last year (in

the UK) from use in children. "

 

Healy's recent book, 'Let Them Eat Prozac,' examines the " divide between the

research " and the " 'spin' that the marketing divisions of the pharmaceutical

companies put on. "

 

Speaking to antidepressants, he added, " the published data for Prozac, Paxil

and Zoloft all claim that these drugs reduce the likelihood of people going

on to harm themselves ... the raw data from these clinical trials indicates

that the drugs are more linked to people going on to harm themselves, " the

exact opposite of what had been claimed.

 

On Sep. 14 the FDA's medical advisory group decided that antidepressants

should come with a " black box warning " that they can " spur suicidal

behaviour in children and teenagers. "

 

Psychiatric medications are leading drug industry money makers.

 

Last year, U.S. sales of just the class of antidepressants known as SSRIs

(including Prozac, Paxil, Zoloft, Seroxat) were reported at 10.9 billion

dollars. In 2002 the Fortune 500's 10 drug companies' combined profits of

35.9 billion dollars surpassed the combined profits of the remaining 490

firms together, (33.7 billion dollars), according to MSNBC.

 

" The regulators aren't showing themselves to be on the side of the patient, "

said Healy. " If they think they are on the side of the patient, the way

they've generally handled the issues has come close to being incompetent. "

 

Of particular note, the Sep. 9 'Washington Post' article reported, " In

February, an internal agency report found that the medications (certain

antidepressants) were associated with an increased risk of suicidal

behaviour. Top FDA officials played down the report at the time and refused

to make it public until recently. "

 

A day later the paper reported that the FDA " repeatedly urged antidepressant

manufacturers not to disclose to physicians and the public that some

clinical trials of the medications in children found the drugs were no

better than sugar pills. "

 

According to Lexchin, " this is a reflection of the fact that the FDA seems

to have been captured by the industry it's supposed to be regulating. " He

sees the FDA as " looking after the interests of the pharmaceutical

companies, putting their interests above the interests of the general

public. "

 

During the 1990s, when the new wave of anti-psychotic drugs (including

Risperdal and Zyprexa) was approved by the FDA, it did so with the proviso

the drugs could not be marketed as superior to any existing anti-psychotic

medication in terms of " safety or effectiveness, " according to Dr John Read,

one of the Pacific's leading authorities on psychiatric medication, author

of 'Models of Madness' and director of clinical psychology at the University

of Auckland.

 

The drug companies " proceeded to totally ignore that and to market their

drugs at six to nine times the cost of the older drugs, " managing to " pull

off this incredible scam internationally, " Read added in an interview.

 

" There's a very powerful mythology out there that these drugs are used quite

rarely, and that they're only used on people diagnosed schizophrenic, " he

added.

 

But, warned Read, the pharmaceutical companies have " actually pushed the

market into younger people, ages five-10 ... into old-age facilities ... to

people who do not have the diagnosis of schizophrenia. "

 

Critics charge these drugs are often used as " chemical restraints, " to

subdue those who take them.

 

Read added caustically: " And why wouldn't they do that (expand the market

for their medications) -- the purpose of a company is to write a good return

for their shareholders. " (END/2004)