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Healthy Skepticism Library item: 18832

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Edwards J
Drug Companies Urge Supreme Court to Let Them Stay Silent on Side Effects
BNet 2010 Oct 6
http://www.bnet.com/blog/drug-business/drug-companies-urge-supreme-court-to-let-them-stay-silent-on-side-effects/6002


Full text:

Unsurprisingly, many industrial lobby groups support Matrixx (MTXX) – maker of the sense-of-smell-killing cold “remedy” Zicam – in its U.S. Supreme Court fight to not reveal “adverse event reports” to investors. Among those groups are lobbyists for Big Pharma, the diet supplement business, the Natural Products Association and trial lawyers who defend big corporations.

Matrixx is not a friend to the Pharmaceutical Research and Manufacturers of America or any of these other non-drug companies. Matrixx makes the drug business look bad: Zicam is a potentially dangerous product that certainly does not cure the common cold, and its maker sat on hundreds of consumer complaints and adverse event reports from people complaining Zicam had robbed them of their ability to smell. Why would the great and the good of corporate America associate themselves with Matrixx in this fight?

Unfortunately, it’s because they, too, want to disclose less information about their products to investors, consumers, patients and doctors. They’re all arguing that too much information is bad for consumers and “confusing” to investors.

The question in the case is whether Matrixx had a duty to disclose all the adverse event reports it had received regarding Zicam even though those reports may have been statistically insignificant.

On its face it’s a reasonable argument: If information is literally insignificant, then disclosing all of it seems unnecessary and burdensome. But, as we know from the Zicam case, “significance” – even statistical significance – is in the eye of the beholder. The FDA yanked Zicam from the market after only 130 reports of anosmia. That turned out to be the tip of the iceberg; the FDA recalled the product because those few adverse event reports alerted it to the fact that there was not “any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective.”

More seriously, the Avandia controversy – in which GlaxoSmithKline (GSK) is alleged to have manipulated data to make the diabetes drug appear safer than it was – shows just how slippery statistical significance can be if it’s being judge by the company that depends upon it.

There’s a sinister tinge to many of the amici briefs filed by these lobbyists. Matrixx’s brief literally argues that:

Adverse event reports are not reliable indicators of a causal link between product use and the reported event.

That’s literally untrue. Adverse event reports are one of the few ways to link drug use to side effects. Sure, the raw reports must be sifted and filtered to identify only the relevant cases and not the random “noise” of consumer mistakes. But to suggest there’s no link at all is just wrong. AERs are the starting point for anyone trying to figure out whether a drug is dangerous.

Not requiring disclosure of AERs leaves the “significance” decision entirely in the hands of companies who have a vested interest in playing down those reports. It also leaves investors, doctors and patients with no information on which to make independent judgments about drug safety.

The drug lobby group PhRMA should be worried that it has been joined by the Natural Products Association, the Consumer Healthcare Products Association and the Council for Responsible Nutrition. Combined, these groups represent most of the diet supplement business – an entire industry based largely on making health claims that are unsupported by science because of a loophole in the law.

Adverse event reports are one of the only early warning systems patients and doctors have in place to alert them to potential problems with drugs. Investors aren’t completely stupid; they can tell the difference between a normal level of background AERs and an unusual rate of complaints. But if Matrixx gets its way, Big Pharma will get one more way to hide problems with its products.

 

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...to influence multinational corporations effectively, the efforts of governments will have to be complemented by others, notably the many voluntary organisations that have shown they can effectively represent society’s public-health interests…
A small group known as Healthy Skepticism; formerly the Medical Lobby for Appropriate Marketing) has consistently and insistently drawn the attention of producers to promotional malpractice, calling for (and often securing) correction. These organisations [Healthy Skepticism, Médecins Sans Frontières and Health Action International] are small, but they are capable; they bear malice towards no one, and they are inscrutably honest. If industry is indeed persuaded to face up to its social responsibilities in the coming years it may well be because of these associations and others like them.
- Dukes MN. Accountability of the pharmaceutical industry. Lancet. 2002 Nov 23; 360(9346)1682-4.