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Karl Loren Background

Researchers Backing Blockers
Received Corporate Funding

By ELYSE TANOUYE
Staff Reporter of THE WALL STREET JOURNAL

Researchers have fiercely debated the risks and benefits of calcium channel blockers, a class of drugs that treat hypertension and angina. Now, a new study shows that most of the scientists who have publicly supported the drugs over the past two years have undisclosed financial ties to the companies that make them.

The findings raise anew questions about the independence of doctors and researchers who accept drug-company funding, and the need to disclose such ties. Scientists have come to rely increasingly on corporate funding as federal funding has grown ever more elusive, but those who receive the corporate largess have long argued their findings aren't influenced by their funding sources.

The new study on the channel-blocker debate could cast doubt on such assertions. A Canadian research team, which publishes the results Thursday in the New England Journal of Medicine, studied 70 published articles on this class of drugs and found that 96% of the authors who supported calcium channel blockers had financial relationships with the drugs' makers. Among the researchers who published work critical of the calcium drugs, only 37% received financial support from the companies that make these products. Moreover, in only two cases among the 70 research papers did the scientists involved disclose their ties to drug companies.

The Canadian team stops short of contending that the private funding swayed the researchers' views and says the support of drug companies for medical education and research should continue. "Our point in the paper is not to say that opinions were overtly influenced by relationships," but to argue that such relationships should be publicly revealed outright to avoid suspicion, says University of Toronto professor Allan S. Detsky, who led the new study. But he concedes that "bias can be a much more subtle thing."

Some experts see a clear case of conflict of interest. "Physicians and researchers are human beings, and human beings respond to financial interests," says Alan Hillman, director of the University of Pennsylvania's Center for Health Policy in Philadelphia.

Simply disclosing the funding ties, he argues, isn't adequate. "Disclosure is a necessary step but totally insufficient to help anyone make decisions about the veracity of the research," Dr. Hillman says, adding that a watchdog consortium of public and private interests should be established to oversee and set rules for such funding relationships.

Bruce Psaty, a University of Washington researcher who is a leading critic of calcium channel blockers, says the conflict-of-interest issue "is an immensely important topic," and favors full disclosure. Yet he wasn't convinced the researchers were compromised. "In general, people don't change their views because they are getting paid. I think drug companies identify people who have views they want to promote."

Academic researchers commonly accept corporate funding in the form of grants for research, travel expenses, honorariums for speeches and payments for consulting. Drug companies typically fund research favorable to their products and reject studies that look likely to produce negative results, says Franz H. Messerli of Ochsner Clinic in New Orleans. Some even go one step further and fund studies that raise questions about a competing product.

The Canadian study is one of the first scientific reviews offering hard research into the nexus of scientists' financial backing and the views they hold. In 1994, one study found that the pharmaceutical industry's practice of giving physicians money to pay for travel, speaking or research expenses influenced their prescription recommendations. But very little has been done to examine the influence of corporate funding on scientific opinions.

The Canadian researchers focused on the calcium channel-blocker debate because of the extraordinary number of published opinions on the topic in medical journals and other medical media gave them a large enough sample to study.

Calcium channel blockers have annual U.S. sales of about $4 billion, with the leading brands including Pfizer Inc.'s Norvasc and Procardia XL, Hoechst AG's Cardizem CD, and Bayer AG's Adalat CC, according to IMS America, a market-research firm. But it was the older calcium channel blockers, no longer in wide use, that came under fire in studies that triggered the calcium channel blocker debate in 1995. Dr. Psaty and another researcher reported finding links between the older, fast-acting versions and a higher risk of heart attacks and higher death rates. But other scientists and drug makers have called the studies flawed and alarmist. An FDA panel ultimately cautioned against the use of just one older form of the channel blockers.

In assessing the resulting debate, the Canadian researchers asked scientists about their funding ties. They found that channel-blocker critics often lacked financial support from any drug makers.

The team studied 70 articles on the issue and classified them and their authors as supportive, neutral or critical of calcium channel blockers. A total of 23 of the 24, or 96%, participating authors who supported calcium channel blockers had financial relationships with manufacturers of those drugs, compared with 60% of the 15 neutral authors and 37% of the drugs' 30 critics.

But among the channel-blocker supporters, 88% of them also got financial support from companies that make products that compete with the controversial drugs, lending credence to the team's contention that the funding didn't dictate the public stance taken by the researchers questioned.

The latest study's design drew criticism, however, from some experts. Dr. Messerli of Ochsner Clinic says he declined to participate in the review because he found the approach "very simplistic and potentially misleading." He says he was one of the first authors to warn against the use of fast-acting calcium channel blockers, but those opinions were voiced before the study's time frame. Subsequent articles could be interpreted as supportive of the drugs because he believes the newer, longer-acting versions are safe, he says. He says he doesn't object to disclosing his financial ties to both makers of the calcium channel blockers and competing products.

Pfizer and Bayer said they agree that potential conflicts of interest should be disclosed. A Bayer spokesman said, "While there is the opportunity for problems and abuse, there are also a series of checks and balances in place" such as government review of drug claims and disclosure policies of medical journals. Pfizer added that "The overwhelming weight of scientific evidence today fully supports the safety of long-acting calcium channel blockers."

Dr. Detsky, the lead Canadian researcher, said he didn't intend for his study to stir the pot of the calcium channel blocker controversy. But he adds: "I'm interested in stirring up the pot on revealing sources of funding."