Conflict of Interest Alleged Against FDA and Heparin Contamination

January 23, 2010, 7:00AM. By Gordon Gibb

Washington, DCAn allegation of conflict of interest that grew out of the heparin contamination case of 2008 is still very much alive today. While patients became ill and died from tainted heparin injections, the director of the FDA's Center for Drug Evaluation and Research found herself embroiled in controversy.

As summarized in the 1/21/10 edition of the Los Angeles Times, the heparin crisis was a result of the sudden and long-unexplained appearance of a contaminant in heparin, a blood thinner, made from ingredients sourced from China. The FDA's Janet Woodcock and her aides responded to the crisis by creating a task force charged with finding the source of the contamination.

The contaminant was soon identified through a scientific paper co-written by Woodcock and various collaborators that included scientists from Momenta Pharmaceuticals Inc, a Cambridge, MA-based drug company that was—and still is— a competitor in the market for what the Los Angeles Times described as a highly lucrative generic form of heparin.

A rival, Amphastar Pharmaceuticals Inc., cried foul. The Rancho Cucamonga, CA-based company contends that Woodcock should not have aligned herself with a company seeking FDA approval.

Here's why Amphastar is worried: Momenta filed its application to market a generic form of the heparin Lovenox in partnership with Sandoz, a unit of the Swiss drug manufacturer Novartis. Amphastar, a privately-held California company, filed its application two years before Momenta and feels that it deserves a head start over its rival, assuming both applications are given the nod. With its ties to Novartis, Momenta has far more marketing clout than the smaller Amphastar. The latter fears that it will be left in the dust if both applications are approved together.

Amphastar alleges that the FDA's collaboration with Momenta scientists at the height of the tainted heparin crisis could serve to tip the competition in Momenta's favor by way of rejecting the Amphastar bid.

There is much at stake. Sanofi Aventis US, the manufacturer of Lovenox, reported 2008 sales of $4.4 billion. That makes it the tenth-best-selling drug on the planet.

The FDA rejected Amphastar's formal complaint, and the pharmaceutical company has appealed the ruling.

In its defense, the FDA states through a spokesperson that Woodcock and the agency were in the midst of crisis. The agency, says Karen Riley, pulled together a team of experts under emergency conditions. "People were dying," Riley said. "We had to find an answer."

Momenta Chief Executive Craig Wheeler said his company was asked to help. "From my perspective, this is one of the best examples of unbiased collaboration between FDA, business and academia in a public health emergency," he stated.

However, the potential for conflict is very real in the heparin case, according to two experts with no particular axes to grind. "What's needed is transparency," said Dr. Wylie Burke, chair of the department of bioethics and humanities at the University of Washington School of Public Health. "I'd like more information on what their thinking was."

Josephine Johnston of the Hastings Center, a nonprofit bioethics think tank, points out that perception is everything. "Whether [Woodcock has] actually been influenced, it doesn't look good. Appearances matter a great deal if we're supposed to trust a process. FDA review is a classic example of a process that relies on trust."