Integrity in Science Watch Week of 10/23/2006
VA Study: NIH Guidelines That Push Aggressive Statin Therapy Are Premature
Stifled Cancer Research Published after Industry-Funded Study Released
Cancer Groups Withdraw from Campaign Funded Solely by Drug Firm
Business Week: "Disclosure Is A Lousy Solution"
Odds and Ends
VA Study: NIH Guidelines That Push Aggressive Statin Therapy Are Premature The New York Times called the Hayward review "provocative" and a challenge to "mainstream medical thinking and the consensus among most cardiologists." In countering his view with a quote from Sidney C. Smith Jr., a University of North Carolina professor and former president of the American Heart Association, the Times failed to note that Smith received "institutional research support" from Merck, a manufacturer of statin drugs, while he was helping to write the 2004 guidelines.
Researchers have called into question the National Institute of Health guidelines that call for aggressive cholesterol lowering in people at high risk of heart attacks and strokes, or who have already suffered from these adverse events. Eight of the nine authors of the controversial 2004 guidelines had financial ties to manufacturers of statin drugs, which lower cholesterol. In a review published in the October 2006 Annals of Internal Medicine, University of Michigan researcher Rodney A. Hayward, who is associated with the Veterans Administration, and two colleagues said the "current clinical evidence does not support" the idea that aggressive statin therapy to achieve very low cholesterol levels for high-risk people "is beneficial or safe."
Stifled Cancer Research Published after Industry-Funded Study Released An IBM spokesperson said that Clapp's analysis misused the data and conflicted with their own 2005 study which showed "lower overall mortality and cancer incidence rates than the general population." The IBM study was led by Elizabeth Delzell, an epidemiology professor at the University of Alabama, Birmingham (see Integrity in Science database), who has conducted studies for numerous large firms and trade groups including Phillips 66, Ford Motor Company and Shell Oil.
An independent researcher last week finally published his study showing elevated cancer rates among workers at IBM manufacturing facilities. The company had fought the study's publication for two years while supporting a researcher whose study, which appeared a year ago, showed no elevated risk, according to the Wall Street Journal. The independent study was conducted by Richard Clapp, a Boston University professor of environmental health, who was hired by lawyers in California who were representing a number of IBM workers who had gotten cancer. Using employee health records from 1969-2001, Clapp found an increased rate of cancer deaths in both men and women compared to either the national average or deaths at other IBM manufacturing plants.
Cancer Groups Withdraw from Campaign Funded Solely by Drug Firm Meanwhile, top oncologists have criticized the Roche-funded study on which the initiative is based, which was conducted by the Karolinska Institute in Stockholm. That study linked patient survival to the amount governments spend on cancer drugs. Due to this initiative, "governments will no doubt be pressed to fund a big increase in expenditure on cancer drugs - on the entirely spurious grounds that such an increase has been proven to increase national survival rates," said Michel Coleman from the London School of Hygiene and Tropical Medicine.
The representatives of two European anti-cancer advocacy groups have pulled out from a major initiative funded entirely by one of the world's largest makers of anti-cancer drugs. Adamos Adamou, a Member of the European Parliament (MEP) who withdrew from the Cancer United board after attending one meeting, wrote a letter with two to other MEPs to the chair of the board, citing their concern "about the transparency of the...initiative." The chairman of the European Cancer Patients Coalition also asked to be removed from the board after she was listed as a member without her consent. Roche, a leading manufacturer of breast and lung cancer drugs, launched the Cancer United initiative last week in Brussels to bring together "all parties concerned with the care of all cancer patients...in Europe."
Business Week: "Disclosure Is A Lousy Solution"
Citing research from the Carnegie Mellon University business school, the latest issue of Business Weekonline says disclosure may actually exacerbate the problem of conflicts of interest in medicine. The January 2005 study in the Journal of Legal Studies said participants in a mock situation who disclosed conflicts exaggerated the advice they gave, "possibly because they felt the disclosures gave them moral license to lie." The sidebar was contained in a feature story about Columbia University heart specialist Martin B. Leon, who has numerous ties to manufacturers of surgical devices. Leon chairs the well-attended Transcatheter Cardiovascular Therapeutics (TCT) conference, which is meeting in Washington this week. The conference frequently features devices made by companies Leon either owns or with which Leon has financial ties. "In 2005 no fewer than 345, or 44%, of the more than 750 doctors and researchers who made presentations at TCT had received compensation from companies, some of whose products they evaluated at the conference," the story noted. This year the conference invited medical ethicists to give a half-hour presentation on conflict-of-interest issues to go along with the 704 hours of presentations.
Odds and Ends
Lester Crawford, former head of the Food and Drug Administration, pleaded guilty last week to making false statements and failing to disclose ownership of shares held in regulated biotech companies. The Justice Department charged Crawford with failing to sell that stock while he was deputy commissioner and commissioner. The indictment also alleged Crawford held shares in Pepsico, a soft drink and snack food company, while chairing an FDA working group on obesity that was reviewing calorie content labeling for soft drinks.
n its October 2, 2006 edition, Integrity in Science Watch incorrectly reported Alexander G. Logan's affiliation and his current status with the salt industry. He is a physician at Mt. Sinai Hospital in Toronto. While he received funding from the salt-using industry in the past, he is currently an unpaid adviser to the ILSI North America Technical Committee on Sodium, which comprises major manufacturers that use salt. We regret the errors.