Who's Minding the Drug Store?

But remember, we don't actually sell our products. All of the resources we put into "sales and marketing" is really to make sure that physicians and patients are fully aware of all the information around the risks and benefits of the medicines we are offering. And then we leave it to the doctor and the patient to decide what is the best option for them. – Pfizer CEO Hank McKinnell, interviewed by CNN's Aaron Brown, Dec. 20, 2004 How will the public remember science in the early 21st century? If 2004 was any guide, science may be recalled as a field in which principles were overtaken by filthy lucre. It became even more fashionable than ever in 2004 to slam pharmaceutical companies at every turn for allowing the lure of profits to influence how they conducted research and interpreted data. To name a few episodes: the prolonged reexamination of the controversial evidence that selective serotonin reuptake inhibitors (SSRIs) cause suicide attempts in children; Warner-Lambert, now owned by Pfizer, pleading guilty in May to fraudulently promoting off-label uses of Neurontin (gabapentin), and paying $430 million in fines; Merck's pulling of the COX-2 inhibitor, Vioxx, from the market; and the ensuing debacle over Pfizer's Celebrex, in the same drug class. A recent story in the Los Angeles Times ' excellent series on the conflicts of interest at the National Institutes of Health reminded us that the reputation of the basic science community is also at risk.1 The Times reported that several key NIH decision makers, looked upon as neutral when it comes to making recommendations on drugs and products, had taken hundreds of thousands of dollars in consulting fees from companies. The news will not be much of a surprise to The Scientist readers who have been following our coverage of the issue online in The Scientist Daily News. It's sometimes not hard to see why drug companies have taken the heat, as the above quote from Pfizer CEO Hank McKinnell, seeming to take a page from the National Rifle Association's playbook, demonstrates. Guns, after all, don't kill people; people kill people. There's some logic in blaming these huge corporations' flexing of their financial muscles for what's ailing the public perception of science. But these big companies are publicly traded and will be severely punished for any alleged or real transgressions. Pfizer's stock – and, one might guess, McKinnell's net worth – fell more than 20% on the day the company announced it was canceling a trial of higher-than-average doses of Celebrex in patients with adenomas because of an increased risk of cardiovascular events. The lawsuits that stockholders and patients have filed against Merck, and those that are likely to be filed against Pfizer, may dog those companies for years. The truth is, blaming drug companies here is foolish. It's like blaming a fox for eating the chickens when the farmer leaves the coop door open. The real problem is the farmer, in this case, the government. It's time for real regulation and better oversight. The FDA, however, seems to have allowed money to color how it regulates. The 1992 Prescription Drug User Fee Act, which allows drug manufacturers to pay fees to expedite the review process, has come under scrutiny for whether it allows approvals that don't hold up, once more safety data is obtained. The NIH has taken some steps, including enactment of a one-year moratorium on consulting by its scientists. And despite the fact that this ban could actually improve the public's perception of the clinical guidance its doctors receive from the NIH, many scientists are bitterly opposed to it. Lest we be accused of neglecting the obvious, we should mention that the buck could also stop with such scientists, whom, it must be admitted, are the chickens in our analogy. Money has no power if scientists refuse to take it. Meet This Issue's Writers Richard A. Cherwitz says he became a professor because he believed "that academe was one of the few environments in which change is governed by the rigor of ideas rather than political whim." But he soon found that universities are quite resistant to change. That's led him to urge his colleagues to step out of the seclusion of their ivory towers and become engaged in society – a project he discusses in this issue's Opinion (p. 10). When he's not studying "The Magnificent Seven," the seven-helical G protein-coupled receptors (see p. 22), Thomas P. Sakmar focuses on his wonderful three: his 2-year-old twin daughters Charlotte and Juliette, and son William, age 6 months. Contemporary novels, histories, and historical biographies, he says, have given way to "board books" such as The Runaway Bunny and Goodnight Moon. Edward R. Burns learned about intellectual property the hard way when, as he puts it, he "fell victim to the naiveté of the young, foolish and eager" some 20 years ago. Having invented a medical device, but not yet patented it, he contacted a company to gauge their interest. "The design was taken, commercialized and made highly successful with neither my university nor I being able to live on the easy street of royalties." Read how he's profited from that experience on page 41. Karen Hopkin, who contributes regularly to Scientific American, writes about Yuri Lazebnik (p. 52) in this issue. She first met Labeznik while writing a review of the Cold Spring Harbor cafeteria for the Annals of Improbable Research. Lazebnik professed a fondness for the desserts, which he noted could vary in size by two standard deviations but have since reverted to the mean.

Who's Minding the Drug Store?

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Richard Gallagher

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January 2005

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