When “science” becomes a marketing tool for pharmaceuticals

There are many industries which play the “science as marketing game” but perhaps the most blatant are the pharmaceutical and medical industries. Sometimes researchers are just unwitting pawns in the marketing game but in a sense they are also at fault in being susceptible to becoming pawns. This cautionary tale about the diabetes drug Avandia reported in the Washington Post only enforces my view that since society invests the scientist with an aura of objective truth-seeking, then society must also demand a measure of responsibility and accountability from the scientist. And that can only happen if scientists have a measure of liability for the “product” they produce.

Research needs benevolent patrons. The scientists so funded then – or so the theory goes – objectively carry out experiments and develop theories to describe the world around us. The whims and prejudices of the researcher will always be present of course but the reproducibility of  experimental results and the checks and balances introduced by “peer review” should weed out the bad apples and debunk incorrect theories. Over time this is probably true though the checks and balances can be very slow to act. Science can follow the wrong path for many lifetimes. In spite of all the potential for “bad science” or pseudo-science, there is however some confidence that the “science” resulting from the research is as objective as it can be when the source of  the funding is public money, distributed in some transparent – but never perfect – way. Of course the use of public funds immediately pushes research funding into the political sphere and introduces the additional risk of “pseudoscience” being carried out to “prove” a pre-determined political agenda. Politically correct science is always suspect.

It is when research is commissioned and funded by commercial interests that yet another risk comes into play. “To be scientifically proven” has enormous brand value. Where research funding comes from a source which can gain large financial benefit from the sales of the product or the idea or the intellectual property which results from the research then the risk that the “research results” are skewed or selectively published in favour of the funder’s interests is quite significant. The research results are now just a means of tapping into the brand value of being “scientifically proven”. The so-called science becomes nothing more than part of a marketing campaign.

From the Washington Post:

Over a year-long period ending in August, NEJM  (New England Journal of Medicine) published 73 articles on original studies of new drugs, encompassing drugs approved by the FDA since 2000 and experimental drugs, according to a review by The Washington Post.

Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.

The New England Journal of Medicine is not alone in featuring research sponsored in large part by drug companies — it has become a common practice that reflects the growing role of industry money in research.

Years ago, the government funded a larger share of such experiments. But since about the mid-1980s, research funding by pharmaceutical firms has exceeded what the National Institutes of Health spends. Last year, the industry spent $39 billion on research in the United States while NIH spent $31 billion. …

….. When the company is footing the bill, the opportunities for bias are manifold: Company executives seeking to promote their drugs can design research that makes their products look better. They can select like-minded academics to perform the work. And they can run the statistics in ways that make their own drugs look better than they are. If troubling signs about a drug arise, they can steer clear of further exploration.

The article then goes into the disturbing case of GlaxoSmithKline and their diabetes drug Avandia which could raise cholestorol and cause heart trouble but where the potential for heart problems was known but essentially kept hidden. As this report shows “Indeed, the FDA has acknowledged that by 2007 more than 83,000 Avandia heart attack victims had experienced this severe cardiovascular event as a direct result of the drug’s serious side effects.”

For drugmaker GlaxoSmithKline, the 17-page article in the New England Journal of Medicine represented a coup. The 2006 report described a trial that compared three diabetes drugs and concluded that Avandia, the company’s new drug, performed best. ..

 ….. The outlines of the Avandia case — in which the drug’s dangers had been recognized within the company long before the FDA pulled it from retail shelves — are well known.

But the way that company officials employed academics — and the prestige of the nation’s top journal — to promote the idea that the drug was safe has received little public scrutiny, and a full account offers a window into the corporate decisions underlying today’s drug research.

When suspicions were raised by Steven Nissen

To see whether his suspicions were warranted, Nissen, with colleague Kathy Wolski, set out to assemble the data from every trial of Avandia that they could find. The more data they had, the more likely they could accurately gauge the risks. The drugmaker refused Nissen’s requests for data, but because of litigation brought by Eliot Spitzer, then New York’s attorney general, the company had been forced to make some of it public. In all, he discovered the summaries of 42 trials — 35 of them unpublished. Most of them had been sponsored by Glaxo.

After analysis, the results were stark: Avandia raised the risks of heart attack by 43 percent and of death from heart problems by 64 percent. Those findings would stand up. But the reach of the pharmaceutical companies to influence the science would create three more years of uncertainty. …..

Avandia has not been withdrawn. It is not available over the counter but is still available on prescription. GlaxoSmithKline has settled most of its law suits out of court and is reported to have provided over $6.4 billion to settle the claims.

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