Healthy Skepticism Library item: 1571

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Edelman S.
CONTRA-DECEPTION
The New York Post 2005 May 9;

Full text:

New questions about the safety of a trendy contraceptive patch have been raised with revelations that the maker’s chief researcher faked data in previous scientific studies.

In the mid-1990s, Dr. Andrew Friedman admitted fabricating 80 percent of patient data and altering files in three studies of hormonal drugs for women.

He was banned for three years from government-funded research for “scientific misconduct,” resigned from his post at a Harvard University-affiliated women’s hospital and lost his medical license in Massachusetts for a year.

Today, Friedman is senior director of clinical research at Ortho-McNeil Pharmaceutical in New Jersey, a subsidiary of Johnson & Johnson, which makes the Ortho-Evra birth-control patch.

The company hired Friedman in January 2000, after he disclosed his history, a company spokesman said.

“We made the decision to hire Dr. Friedman based on his performance as a consultant and overall reputation in the medical community, which was excellent,” spokesman Michael Beckerich said.

Friedman was not involved in clinical trials for the patch – but is now part of a team doing further research on the device and the dangerous blood clots it might cause, said Beckerich.

Patch users’ lawyers say Friedman’s role casts doubt over Ortho-Evra’s safety claims.

“It raises questions about the company’s credibility, its women’s health division and any new product coming out,” said Ray Chester, a Texas personal-injury attorney who is suing Ortho-McNeil.

Chester raises Friedman’s record in a lawsuit filed last month in Pittsburgh on behalf of two women, ages 21 and 43, who suffered debilitating blood clots while wearing the patch.

He filed another suit in Austin, Texas, last October for a 37-year-old mother of two left paralyzed after a massive stroke.

In the first fatality publicly linked to the patch, a Manhattan student and aspiring model, Zakiya Kennedy, 18, collapsed in a subway station in April 2004. The medical examiner ruled her death a side effect of the birth-control device.

Worn on the shoulder, buttocks or hip, the patch delivers pregnancy-blocking hormones into the bloodstream.

Ortho-McNeil has used supermodels, Olympic athletes and sexy ads to promote the device, touted as more convenient than the daily pill.

Chester’s suits call the patch “defective” and “unreasonably dangerous” – more so than oral contraceptives, which also can cause clots and heart attacks.