by John M. Curtis
(310) 204-8700

Copyright July 18, 2004
All Rights Reserved.

ecommending new guidelines for lowering cholesterol, the American Heart Assn. teamed up the nation's biggest drug makers, urging physicians to prescribe cholesterol-lowering drugs called statins to reduce LDL [low density lipoprotein] to 70. Dropping the benchmark number from 100 to 70, adds about 7-million new patients to the 36 million already taking statin drugs—increasing sales by 20%. Statin drugs currently account for about $26 billion in worldwide sales. Lowering the benchmark for prescriptions adds hefty profits to drug makers seeking to augment the bottom line. Bristol-Myers Squibb's Pravachol and Pfizer's Lipitor account for about half of the cholesterol-lowering business. Consumer groups blasted the new guidelines, citing egregious conflicts of interest with nine-of-ten top experts urging changes, earning rich rewards from drug companies.

      Conflicts of interest about changing cholesterol guidelines parallel flagrant doubling-dipping at the National Institutes of Health, where the nation's premier researchers often collect two salaries: One from the government and one from drug companies. When researchers get paid twice, it's more difficult to preserve the kind of objectivity needed to guarantee the purity of scientific research. Several reputable studies show that double-dipping influences the outcome of drug studies—a dangerous contaminant to scientific research. Dr. James Cleemans, one of the ten experts recommending lowering LDL levels and coordinator of National Cholesterol Education Program, urged lowering LDL, despite getting nothing from drug companies. “It doesn't mean their research is wrong,” said Cleemans, insisting that reducing LDL is a good thing regardless of the ethics.

      Researchers can't maintain integrity of science while simultaneous getting kickbacks from drug companies. Giving stock options and other lucrative incentives to senior researchers affects the outcome of scientific research. National Institutes of Health Director Dr. Elias A. Zerhouni has been put on notice by a Blue Ribbon Panel to stop egregious conflicts of interest. “I can't stand having the appearance of conflict or uncertainty in our rules that lead to a loss of trust in what we do,” said Zerhouni, not admitting that he created the permissive atmosphere allowing NIH scientists to run amuck. Recent guidance on cholesterol now has to be scrutinized in light of undue influence on researchers from drug companies. “It's outrageous they didn't provide disclosure of the conflicts of interest,” said Merrill Goozner, spokesman for the Center for Science in the Public Interest.

      Growing concerns about drug companies paying off scientists and compromising scientific research at the NIH prompted the General Accounting Office, the investigative wing of Congress, to let the House Oversight and Investigations Subcommittee to take a close look at unethical practices at the NIH. Of special concern is the failure to disclose financial relationships between NIH scientists and drug companies. Drug makers currently give scientists lucrative consulting arrangements, stipends, open market shares, stock options and other financial incentives. “We know that there are financial relationships at all levels, not just at the top, and the taxpayers deserve to know the extent of those relationships,” said Rep. Henry A. Waxman, urging the Blue Ribbon Panel to require the NIH to disclose all inappropriate financial relationships that might influence scientific research.

      Failing to disclose inappropriate financial relationships is the least of the problems at the NIH. It's the culture of entitlement that sees nothing wrong with double-dipping, collecting two salaries and a host of other fringe benefits, including stock options. Dr. Sidney Wolfe, co-founder of Public Citizen's Health Research Group, said disclosure is only one small part of restoring credibility. “These people should be disqualified from being the principal authors of publications that have the imprimatur of the government on it,” said Wolfe, especially concerned about that new cholesterol guidelines would give statin drugs to millions of patients. At the rate things are going, every man, woman and child would take statin drugs together with nutrition and exercise. Merck and Bristol-Myers Squibb are already seeking FDA approval to offer low-dose statin drugs over-the-counter.

      Allowing drug companies to pay research employees at the NIH creates uncertainty about the integrity of scientific research. Whether it's ethical or not, drug companies have far too much influence not only at the NIH but at research universities, professional journals, newspapers and, yes, even the Food and Drug Administration, the government's key watchdog agency for assuring drug safety and effectiveness. Revelations about egregious conflicts of interest at the NIH open legitimate questions about whether current protocols for prescribing cholesterol-reducing statin drugs were unduly influenced by drug makers. With certain manufacturers pushing the FDA to get statin drugs over-the-counter, adverse side effects need to be weighed carefully against any alleged preventive benefits. Today's fast-and-loose financial deals at the NIH only muddy the waters.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

©1999-2002 Discobolos Consulting Services, Inc.
(310) 204-8300
All Rights Reserved.