Guest guest Posted April 3, 2001 Report Share Posted April 3, 2001 > http://cbsnews.com/now/story/0,1597,282816-412,00.shtml > > Drug Trial Dangers? > > Doctors Often Get Paid To Do Drug Trials > Drugs Can Sometimes Worsen Patients' Health > > April 1 > > CBS > Dr. Marcia Angell says money is at the root of drug trial abuses. > > (CBS) Patients taking experimental drugs in clinical trials often don't > know the doctors administering them are usually paid by drug companies - > and that the drugs can sometimes worsen their health, Steve Kroft > reports. > > Increasingly, the ones doing these studies are no longer PhD researchers > at large universities. They're family doctors looking for extra cash - > doctors like Fiddes, who had a small practice in southern > California. Lester was one of his study coordinators. She says > that he had 30 to 40 trials going during her time there. She says that > drug companies were paying him anywhere from $50,000 to $250,000 per > study. > > Dr. Fiddes eventually gave up treating patients altogether, because drug > companies were paying him more money to experiment on patients than HMOs > were paying him to heal them. > > Tom Parham was one of those patients. His family doctor, who was one of > Fiddes' partners, told him there may be some problems with his prostate, > and suggested he go see Dr. Fiddes to enroll in a study on an > experimental prostate medicine. > > The doctor neglected to tell Parham that his history of heart problems > put him at great risk if he took this medication. > > Lester says she noticed on Parham's records that he had this problem, > and says she told Dr. Fiddes. According to Lester, Dr. Fiddes said that > Parham could participate anyway. > > A few days later, Parham felt sluggish and went back to the doctor's > office. She took him off the medicine. A few days later, though, his > pulse dropped very low. He went to the hospital, where he was told he > needed a pacemaker immediately. > > To avoid getting into trouble with the government, Dr. Fiddes removed > any reference to Parham's " long history of bradycardia " from his medical > records. Parham had no idea this was going on behind the scenes, and he > certainly didn't know Dr. Fiddes and his partners were getting money for > turning him into a guinea pig. > > Finding patients like Parham, and keeping them, grew increasingly > difficult, especially as more and more studies rolled in. So, Lester > says, they started to lower their standards on who qualified for a > clinical trial. > > She says that in one high blood pressure study, they used people who > didn't have high blood pressure. > > In one arthritis study ,Dr. Fiddes was required to have a radiologist > read the X-rays of potential research subjects to verify that they had a > specific knee problem that was being studied. Dr. Fiddes could not find > enough patients who qualified, so he asked the company that was > sponsoring the drug trials if he could read the X-rays - they said yes. > > " All of a sudden, miraculously, all of the patients qualified for the > study, " Lester says. She says he falsified the data. > > Dr. Fiddes got even more creative. When he couldn't find patients with > ear infections for an antibiotic study, he just ordered up bacteria from > an outside lab and faked the specimens. > > Based on a hodgepodge of real and fake data, Dr. Fiddes wrote papers > that appeared in several reputable journals. Dr. Marcia Angell, former > editor of the New England Journal of Medicine, says cases like Dr. > Fiddes are disturbing, but unfortunately not isolated. > > Lester eventually blew the whistle, and after federal regulators raided > the office, Dr. Fiddes was convicted of " conspiracy " to commit fraud, > sentenced to 15 months in prison, and stripped of his medical license. > > Government officials who oversaw this case admit Dr. Fiddes may never > have been caught if Lester hadn't put her career on the line and come > forward. > > Dr. Greg Koski, who runs the government's Office of Human Research > Protection, says it's unfortunate but the system depends on > whistleblowers. Koski's agency was upgraded recently and he now reports > directly to the Secretary of Health and Human Services. The change was > made last year, he said, to make sure that cases like the one involving > Dr. Fiddes don't happen again. But his office has only 30 employees to > watch the entire industry. > > That industry involves about a million human research subjects. But > several recent government studies have found that not all these > so-called " volunteers " know what they're volunteering for, or even that > they're volunteering. > > The need for human study subjects has gotten so great that the > pharmaceutical industry has resisted virtually any regulation that would > make their job more difficult. Even major universities, which are > supposed to oversee their own research studies, often have a financial > stake in the drug being tested and stand to make millions in royalties > if that drug is approved. > > According to Dr. Koski, this creates a situation in which a university > stands to make millions of dollars on a drug that it partly owns. This > same university appoints a review board to evaluate it. > > That, says Dr. Koski, " is exactly why they're not the ones who should be > engaging in the research. Quote Link to comment Share on other sites More sharing options...
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