Government

Off-label probes are looking into physicians' role

A government crackdown on drug companies could have a chilling effect on doctors communicating about off-label drug uses, legal experts say.

By Amy Lynn Sorrel — Posted Aug. 21, 2006

Print  |   Email  |   Respond  |   Reprints  |   Like Facebook  |   Share Twitter  |   Tweet Linkedin

As pharmaceutical companies continue to come under fire for illegally promoting unapproved uses of their drugs, legal experts say that the government may now be shifting the spotlight onto physicians' role in manufacturers' off-label marketing.

The Federal Food, Drug and Cosmetic Act prohibits drugmakers from marketing medications for uses that are not approved by the Food and Drug Administration. Within the last three years, the Dept. of Justice has accused at least two companies of using doctors in illegal promotion tactics.

However, federal guidelines permit doctors to prescribe a drug for "off-label" uses and to independently share information with the medical community about its safety and efficacy through continuing medical education seminars, research publication or other peer-to-peer communications.

"What companies have done is scoured the landscape for doctors who are favorable to the off-label uses of a drug and then hired them to be speakers about a subject because the doctor is under no restriction in terms of the use or discussion of it," said nephrologist Jerome P. Kassirer, MD, a professor at Tufts University School of Medicine in Boston.

Drug companies are allowed to sponsor seminars where doctors are often paid to speak about a medication.

If doctors are not cautious about such arrangements, they could be inviting unexpected legal trouble and be held jointly liable with the manufacturer for illegal promotion, said Utah Assistant Attorney General David R. Stallard.

He pointed to the April indictment of Maryland psychiatrist Peter Gleason, MD. Federal prosecutors have accused Dr. Gleason of taking payments from and conspiring with Orphan Medical to promote its narcolepsy drug, Xyrem, for unproven and potentially dangerous uses.

Xyrem contains the depressant GHB, which the government has classified as a "date rape" drug. Prosecutors charge that through various speaking engagements, for which he accepted tens of thousands of dollars, Dr. Gleason led doctors to believe Xyrem was safe for treating pain and fatigue, among other conditions. Dr. Gleason could not be reached for comment, and his attorney, New York public defender David Loftis, was not available for comment.

The U.S. Attorney's office for the Eastern District of New York also declined comment but confirmed that Orphan Medical has not been charged in connection with Dr. Gleason.

While the focus up to now has been on the pharmaceutical makers, Stallard said, the Gleason case "likely represents a glimpse into the future. Federal enforcement is cracking down, and we can expect additional physicians to be charged."

The government is also taking a closer look at what doctors are saying about a drug. The concern is that physicians are straying from science to promote a medication from which they are profiting.

"There's a phalanx of government lawyers looking at whether or not physicians are being honest and truthful about the reasons they are prescribing these drugs," said attorney Reed Stephens, a pharmaceutical fraud expert and partner at the Washington, D.C.-based Sonnenschein, Nath & Rosenthal LLP.

While many doctors discuss scientific advances involving off-label drug use, what pushed Dr. Gleason into the danger zone were allegations that he was making false statements about Xyrem's unapproved benefits to get doctors to prescribe it, Stephens said.

"If that happens, then there is a link the government may choose to make to tie the doctor to the manufacturer and say the doctor is not working from an independent medical perspective," said Stephens, a former Dept. of Justice attorney.

AMA policy supports doctors' ability to prescribe medications for safe and effective unlabeled indications, and to freely share unbiased information about off-label uses based on peer-reviewed scientific evidence. If doctors are giving a presentation, they are legally and ethically required by Accreditation Council for Continuing Medical Education rules to inform their audience that they are discussing off-label use, said AMA Chair-elect Edward L. Langston, MD.

The increased scrutiny of drug companies should heighten doctors' vigilance in seeking out such documentation, he said. "Physicians must demand adherence to the ethical standards for use of peer-reviewed literature of off-label uses because there are legal and safety considerations."

Going too far?

Because patients can benefit when doctors share their knowledge about effective drug uses, some legal experts say that state and federal efforts may be overly aggressive in targeting physicians when the government provides no rules of the road for them.

"The real issue is whether or not physicians who are engaging in legitimate continuing medical education programs should feel free to discuss drugs in the full spectrum," said Boston health care attorney Robert A. Griffith. He represents Alabama neurologist David Longmire, MD, who has been named, along with Pfizer, in at least two state lawsuits alleging he fraudulently spoke about off-label use of the epilepsy drug Neurontin for pain treatment.

In 2004, Pfizer agreed to plead guilty and pay $430 million to state and federal authorities to settle allegations that the company, among other things, manipulated clinical data, misrepresented the nature of CME classes, and illegally paid doctors to research and promote Neurontin. Dr. Longmire denies any wrongdoing and says he was unaware that Pfizer's activities were illegal.

Griffith said lawsuits targeting physicians who speak at seminars are often used as a way to pressure pharmaceutical companies to settle, but it may have a "chilling effect" on doctors participating in educational meetings.

"You have to ask yourself, is there something the federal government could have written years ago that could have clarified" the boundaries for doctors in communicating about off-label uses, he said.

To protect themselves, "doctors need to be familiar with the product and aware of scientific literature and clinical trials out there if they are thinking about getting involved in relationships with manufacturers," Stephens said.

According to Utah's Stallard, "the only safe way for a physician to engage in off-label promotion is to assure that he or she receives no remuneration from the manufacturer."

Dr. Kassirer's answer is, "[Doctors] shouldn't do it."

Back to top


External links

Federal Food, Drug and Cosmetic Act, Food and Drug Administration (link)

Back to top


ADVERTISEMENT

ADVERTISE HERE


Featured
Read story

Confronting bias against obese patients

Medical educators are starting to raise awareness about how weight-related stigma can impair patient-physician communication and the treatment of obesity. Read story


Read story

Goodbye

American Medical News is ceasing publication after 55 years of serving physicians by keeping them informed of their rapidly changing profession. Read story


Read story

Policing medical practice employees after work

Doctors can try to regulate staff actions outside the office, but they must watch what they try to stamp out and how they do it. Read story


Read story

Diabetes prevention: Set on a course for lifestyle change

The YMCA's evidence-based program is helping prediabetic patients eat right, get active and lose weight. Read story


Read story

Medicaid's muddled preventive care picture

The health system reform law promises no-cost coverage of a lengthy list of screenings and other prevention services, but some beneficiaries still might miss out. Read story


Read story

How to get tax breaks for your medical practice

Federal, state and local governments offer doctors incentives because practices are recognized as economic engines. But physicians must know how and where to find them. Read story


Read story

Advance pay ACOs: A down payment on Medicare's future

Accountable care organizations that pay doctors up-front bring practice improvements, but it's unclear yet if program actuaries will see a return on investment. Read story


Read story

Physician liability: Your team, your legal risk

When health care team members drop the ball, it's often doctors who end up in court. How can physicians improve such care and avoid risks? Read story

  • Stay informed
  • Twitter
  • Facebook
  • RSS
  • LinkedIn