Global Policy Forum

Drug Industry Scandal a 'Crisis'


By Ritt Goldstein

Inter Press Service
October 2, 2004

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.

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. í  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 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 í  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 what "'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 í  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 í  into old-age facilities í  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."

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