ShareThisWhat are the pills in your medicine cabinet, and how do you know they are best for you?
When drug companies seek approval to market new medicines, they must show the U.S. Food and Drug Administration the results of all the tests they've run on volunteer patients -- at first on only a few, then on dozens, and finally on hundreds or sometimes thousands.
After winning approval, the companies typically sponsor reports of those tests in medical journal publications, which many doctors often rely on to determine whether to prescribe new drugs for their patients.
Now a skeptical team of medical investigators at the University of California San Francisco has accused the major drug companies of bias by distorting the results of their trials in those publications, making it hard for doctors to judge for themselves the pros and cons of prescribing new drugs.
As a result, the researchers say, patients may sometimes be taking medicines they don't need -- or with unwanted side effects -- that their doctors have prescribed on the basis of inadequate information.
The UCSF team, led by Lisa Bero of the medical center's Institute for Health Policy Studies, probed the details of 164 drug trials involving as many as 1,500 patients over a two-year period and then examined reports on those trials that were published in medical journals, as well as those that remained unpublished.
Their conclusions are published in the current issue of PLoS Medicine, an online medical journal.
"We found really important information from the official trial reports that were either not published at all or that stressed mostly the positive results of trials in the published versions," said Kristin Rising, a physician at the institute who did the major investigation and has now moved to the Boston University Medical Center.
"Doctors who prescribe new drugs -- or even older ones -- for their patients should have complete and unbiased information on those medicines before prescribing them," she said.
According to Bero, doctors frequently complain that they're left to rely on incomplete data from drug companies.
"I do think our findings are important for patients because their physicians may not have full and accurate information about the drugs they prescribe," she said.
In response to questions from the San Francisco Chronicle, a pharmaceutical industry leader disagreed with the researchers' conclusions.
Doctors who seek to make "appropriate prescribing decisions" on new drugs can find all the critical information they need in the detailed drug labels that the FDA has approved based on all the trials every drug has undergone, said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America.
According to Johnson, drug companies are required by law to post "a broad range of ongoing clinical trials and comprehensive information about those trials" on a registry maintained by the National Institutes of Health. The registry is at www.clinicaltrials.gov.
If this sounds like an in-house controversy, far removed from the bedside or the medicine cabinets of sick folks taking their prescriptions, it isn't. According to Rising, many doctors get their information about new drugs they prescribe either during visits from drug company representatives known in the trade as "detail men," or from articles published in major medical journals.
Drug companies may call on specialized companies to prepare articles for medical journals on new medicines that have won FDA approval, with the articles emphasizing the trials' positive reports, and bearing the names of physicians who have participated in the trials as the authors, researchers say. The journal articles may also be written by drug company physicians involved in developing the new medicines.
"I'm just amazed at how many doctors will prescribe a new drug right away and depend only on what they read in the company's own summaries of trial results or on articles in medical journals that may be incomplete," said Thomas Bodenheimer, a physician at San Francisco General Hospital who was previously in private practice for 23 years.
"Practicing docs are not getting all the information about new drugs we need, and the information we are getting favors the new drug, with the studies almost always funded and controlled by the company making the drug," he said.
E-mail David Perlman at dperlman(at)sfchronicle.com. For more stories visit scrippsnews.com.
Must credit the San Francisco Chronicle
