Tudamorf
12-15-2008, 12:54 PM
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/12/14/MNKF14GTLO.DTL&tsp=1UCSF says reports on drug trials skew positive
(12-14) 19:02 PST SAN FRANCISCO -- What are the pills in your medicine cabinet, and how do you know they're 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 UCSF 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 the 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.
Negative findings omitted
The UCSF team, led by Lisa A. 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and then examined reports on those trials that were published in medical journals, as well as those that remained unpublished.
"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.
Trials posted online
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.
But in a commentary on the study published in the same issue of PLoS Medicine, An-Wen Chan, a Mayo Clinic physician who studies drug approval policies, said the UCSF investigators' findings show "bias, spin and misreporting" by the industry.
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.
The issue has long been controversial and has been raised before in studies of individual drugs and how doctors prescribe them, but this is a detailed look at the issue, involving a large number of new drugs tested and a large number of patients.
Publishing discrepancies
According to the study by Bero, Rising and Peter Bacchetti, UCSF director of biostatistics, not all trial results that were submitted to the FDA by drug companies were published in medical journals. When they were published, there were often many discrepancies between the results the FDA received and the published data, the study found.
One-fourth of the results from trials testing the effectiveness of new drugs were not published at all within five years after the FDA approved them, the researchers found.
Furthermore, drug trials showing "favorable" results were five times more likely to be published than trial results that showed "unfavorable results," the UCSF team said. In other words, the publication of drug trial results can often give doctors a more favorable view of a new drug's safety and effectiveness than information the drug manufacturer has submitted to the FDA, according to the researchers.
Even information on new drugs that doctors can find in the journals they read is often "incomplete and potentially biased," the UCSF team concluded.Consider that next time your doctor pushes the latest and greatest (and most expensive) drug. The drug company sponsors trials, which already biases the results, gets the FDA's rubber stamp, conceals any negative data, and encourages doctors to push the drugs.
Everyone in the chain is just looking to make money off of you, and no one is really looking out for your safety.
(12-14) 19:02 PST SAN FRANCISCO -- What are the pills in your medicine cabinet, and how do you know they're 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 UCSF 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 the 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.
Negative findings omitted
The UCSF team, led by Lisa A. 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.
"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.
Trials posted online
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.
But in a commentary on the study published in the same issue of PLoS Medicine, An-Wen Chan, a Mayo Clinic physician who studies drug approval policies, said the UCSF investigators' findings show "bias, spin and misreporting" by the industry.
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.
The issue has long been controversial and has been raised before in studies of individual drugs and how doctors prescribe them, but this is a detailed look at the issue, involving a large number of new drugs tested and a large number of patients.
Publishing discrepancies
According to the study by Bero, Rising and Peter Bacchetti, UCSF director of biostatistics, not all trial results that were submitted to the FDA by drug companies were published in medical journals. When they were published, there were often many discrepancies between the results the FDA received and the published data, the study found.
One-fourth of the results from trials testing the effectiveness of new drugs were not published at all within five years after the FDA approved them, the researchers found.
Furthermore, drug trials showing "favorable" results were five times more likely to be published than trial results that showed "unfavorable results," the UCSF team said. In other words, the publication of drug trial results can often give doctors a more favorable view of a new drug's safety and effectiveness than information the drug manufacturer has submitted to the FDA, according to the researchers.
Even information on new drugs that doctors can find in the journals they read is often "incomplete and potentially biased," the UCSF team concluded.Consider that next time your doctor pushes the latest and greatest (and most expensive) drug. The drug company sponsors trials, which already biases the results, gets the FDA's rubber stamp, conceals any negative data, and encourages doctors to push the drugs.
Everyone in the chain is just looking to make money off of you, and no one is really looking out for your safety.