Whistleblower doctor comments on his case that helped expose illegal marketing of Topamax

Doctor is one of few physicians to blow whistle on pharma industry

WASHINGTON, April 29, 2010 -- One of the two whistleblower lawsuits that is being settled as part of Ortho-McNeil-Janssen Pharmaceuticals Inc.'s and Ortho-McNeil Pharmaceutical LLC's $81 million settlement announced today was filed by Dr. Gary R. Spivack, a psychiatrist from northern Virginia.

Below are statements from:

  • Dr. Spivack, who is one of the few doctors to blow the whistle on the pharma industry.
  • Erika A. Kelton, a Washington, DC, attorney with Phillips & Cohen LLP, which represents the whistleblower. Ms. Kelton and her law firm also represented the whistleblower in a qui tam lawsuit that exposed Pfizer's illegal marketing of the painkiller Bextra for "off-label" uses that endangered patients' lives and health. Pfizer last year paid a record-setting $1.8 billion to settle that case and a related criminal charge as part of a global settlement totaling $2.3 billion.

Resources (links):

  • The "qui tam" lawsuit filed by Phillips & Cohen on behalf of Dr. Spivack.
  • The settlement agreement between Ortho-McNeil, the U.S. Department of Justice and the whistleblowers.

Statement from Dr. Gary R. Spivack:
"I found it outrageous that Ortho-McNeil would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patents' health. Doctors need impartial and accurate information to make decisions on the best treatment for their patients, but that's not what Ortho-McNeil provided."

Statement from attorney Erika A. Kelton of Phillips & Cohen LLP:
"Pharma companies pay doctors 'consulting fees' and other inducements because that money tends to make doctors more willing to prescribe their products based on information from pharma companies. But we've seen numerous instances in recent years where pharma companies have misled doctors, putting profits ahead of patient safety."

"The government -- particularly Assistant U.S. Attorney Zachary Cunha and Trial Attorney Colin Huntley -- did a great job investigating and resolving this significant matter."

About Dr. Spivack's qui tam case:
The FDA had approved Topamax only to treat certain conditions: as therapy for patients that suffer from certain types of seizures. Dr. Spivack alleged in his qui tam lawsuit that Ortho-McNeil paid doctors kickbacks to encourage them to prescribe Topamax for a wide range of "off-label" uses - such as for weight loss, alcohol dependence, eating disorders and mood and anxiety disorders -- despite serious risks to patients' health. "Off-label" uses are those uses that haven't been approved by the Federal Drug Administration.

Dr. Spivack became aware of Ortho-McNeil's national campaign to promote the use of Topamax for off-label uses when he attended a "Psychiatry Consultants' Conference" sponsored by the pharma company. Attendees were paid $500 each or more as "consultants" to attend the meeting and listen to company presentations.

The vast majority of presentations at the conference concerned off-label uses of Topamax and claims about the effectiveness of Topamax for unapproved uses. Under the FDA law, drug manufacturers are prohibited from making exaggerated, unsupported or misleading claims as to the efficacy of their drugs.

Phillips & Cohen filed Dr. Spivack's qui tam case, brought under the False Claims Act, in December 2003 in federal district court in New York City. Case citation: United States ex rel. Spivack v. Johnson & Johnson and Ortho-McNeil Pharmaceutical, Inc., Civil Action No. 04-11886-WGY.