Thursday, May 4, 2006
By EILEEN STILWELL, Courier-Post Staff
TRENTON – Had Laurie Yorke known about the potential for harm to her son four years ago when a child psychiatrist prescribed Paxil, a popular antidepressant, to treat a single panic attack, she would have said, “No thanks.”
Instead, taking the drug as prescribed launched her adolescent son on a two-year emotional roller coaster that triggered two suicide attempts and outbursts of aggressive and psychotic behavior that forced the former “A” student out of school, she said.
The good news said Yorke, a registered nurse, is her son, Ryan, now 18, has survived, unlike many other adolescent Paxil users.
Yorke spoke passionately Wednesday at a press conference called to release a study on a deceptive marketing practice commonly used by drug companies.
Called Turning Medicine into Snake Oil, the study was produced by the New Jersey Public Interest Group.
Among its conclusions is that the Federal Drug Administration lacks the resources and power to adequately monitor the pharmaceutical industry. Therefore, New Jersey should help protect its residents by creating an online clinical trials directory that would require every drug maker to file every trial conducted on humans for any drug it wishes to sell in New Jersey. Companies would pay a fee for each posting. Failure to file results of any clinical trial — positive or negative — would trigger a substantial fine.
Maine is the only state, so far, to offer a modest directory, but Pennsylvania, California and North Carolina are exploring the possibilities. The FDA’s directory, www.clinicaltrials.gov < http://www.clinicaltrials.gov>, is voluntary.
“We can’t wait for the FDA to catch up. New Jersey is prime because we’re the drug capital of the world,” said Yorke of Clark Township, Union County.
Yorke finally got to read results of clinical trials on Paxil that had been suppressed by the manufacturer after New York Attorney General Eliot Spitzer sued GlaxoSmithKline for their release in 2004. When she did read them, the cloud of mystery around her son’s “bizarre behavior” lifted. His reactions had been within the realm of the predictable, according to the studies she read.
Gaile Renegar, a GlaxoSmithKline spokeswoman, said she had not read the study on deceptive advertising and therefore could not comment. The company’s U.S. headquarters is in Philadelphia.
The New Jersey consumer advocate group said withholding damaging data and promoting a drug to doctors and the public for unproven uses are pervasive practices in the industry, as evidenced by recent scandals involving Vioxx and OxyContin for pain; Accutane for acne; Neurontin for epilepsy and an antibiotic called Tindamax.
In addition, drug makers play a large role in continuing education for doctors and frequently provide doctors and their staffs with meals and other promotional giveaways.
Dr. Eileen M. Moynihan, a Woodbury rheumatologist, who is president of the New Jersey Medical Society, said medical schools need to do a better job in educating students about reliable testing protocols and interpreting results, so they are not easily led by drug salespeople. While employees of drug companies frequently speak at Medical Society functions, she said they are supposed to present the science in an unbiased fashion, or run the risk of not being invited back.
“We’re very down on accepting gifts and we would hope all our physicians would follow our guidelines, but we can’t be, nor should we want to be, in every office.”
Prescribing for “unproven uses” or off-label is a gray area, as are long-term consequences on new drugs when it comes to marketing protocols.
“When it’s a new drug, everybody knows what it’s to be used for,” Moynihan said. “Over time, its use can become blurred because of successes with certain patients with other conditions. If there is evidence that it’s safe and it works, it can be a double-edged sword for a doctor to make that call,” she added.
On Wednesday, the Hospital of the University of Pennsylvania in Philadelphia announced a crackdown on sales representatives, requiring them to make appointments to see doctors, instead of cruising the halls, and forbidding doctors from accepting gifts, even pens and note pads, during office hours.
In January the Journal of the American Medical Association published an article citing studies that show doctors who accept gifts and samples from drug representatives are more likely to prescribe those drugs to patients.
Reach Eileen Stilwell at (856) 486-2464 or email@example.com