The New York Times
By GARDINER HARRIS
March 4, 2009
WASHINGTON — Federal health officials and prosecutors, frustrated that they have been unable to stop illegal kickbacks to doctors from drug and device companies, are investigating doctors who take money for using these products.
For years, prosecutors rarely pursued doctors because they believed that juries would sympathize with respected clinicians. But within a few months, officials plan to file civil and criminal charges against a number of surgeons who they say demanded profitable consulting agreements from device makers in exchange for using their products.
“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” said Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”
The move against doctors is part of a diverse campaign to curb industry marketing tactics that enrich doctors but increase health care costs and sometimes endanger patients. Taken together, the new measures are likely to transform the relationship between medicine and industry.
Over the past year, for instance, prosecutors have greatly increased fines that are collected as part of plea agreements with drug and device companies charged with illegal marketing tactics. In January, Eli Lilly announced it would pay a record fine of $1.4 billion to settle federal criminal charges that it illegally marketed Zyprexa, an antipsychotic medicine. Two weeks later, Pfizer announced that it had set aside $2.3 billion to pay an expected fine over charges that it illegally marketed Bextra, a painkiller that has been withdrawn from the market.
Michael J. Sullivan, the United States attorney for Massachusetts, said that prosecutors — after winning record fines from a record number of companies — realized that they needed to expand the scope of their targets.
“The strategy of looking at the companies alone was not completely successful in terms of our objective to deter health care fraud,” Mr. Sullivan said. “So it’s fair to say that the government is looking at evidence of criminal wrongdoing even by doctors.”
Besides jail time and fines, doctors convicted in the cases could lose their licenses for a time and be excluded from the federal Medicare and Medicaid programs, severely limiting their potential pool of patients.
Dr. Charles D. Rosen, an orthopedic surgeon and president of the Association for Medical Ethics, predicted that the pending cases would tarnish the entire profession. “The abuse of the public trust by the few will hurt the many,” Dr. Rosen said.
Also, as part of plea bargains, federal health officials are forcing a growing number of drug and device makers to post publicly all payments made to doctors who serve as consultants or speakers. Manufacturers have repeatedly used consulting payments in illegal schemes to persuade doctors to prescribe drugs or devices in inappropriate and unapproved ways, according to federal charges.
Prosecutors are hoping that public disclosures of the details of these agreements will make criminal conduct more difficult to conduct and easier to spot, and that they will discourage doctors from taking money and gifts from manufacturers at all.
“The rules of the game have changed,” said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “You’ve got to presume that anything you take from a drug or device company is going to be on a Web site. Your colleagues will know; your patients will know. That’s going to stop a lot of doctors from pocketing their gifts and funds.”
Since a substantial share of doctors accept money from drug or device makers, the public postings could have considerable effects.
In Minnesota, the state’s unique payment disclosure and gift limit law has led a growing number of academic and private medical centers to impose severe restrictions on industry marketing practices. Park Nicollet Health Services, one of the largest health systems in the state, banned all industry gifts and nearly all free drug samples and has made public all doctor consulting payments.
The Department of Health and Human Services inspector general’s power to require payment disclosures extends only to companies charged with wrongdoing. A bill sponsored by Senator Charles E. Grassley, Republican of Iowa, and Senator Herb Kohl, Democrat of Wisconsin, would mandate that all drug and device makers disclose such payments.
Companies that have announced their intentions to disclose payments to doctors even before the legislation is passed have won plaudits from ethicists and industry critics.
“Being more transparent by opening up our business to the public is an important step to building trust and confidence,” John C. Lechleiter, the chief executive of Eli Lilly, said in a speech in September to the Economic Club of Indiana.
On Feb. 9, the chief executive of Pfizer, Jeffrey B. Kindler, said the disclosures were part of the company’s commitment to increased transparency and would “earn the trust of patients and the public.”
Neither executive mentioned that prosecutors would soon require them to make such disclosures anyway. In addition to Eli Lilly and Pfizer, companies that have agreed to disclose payments to doctors include Merck, Cephalon, GlaxoSmithKline and Medtronic. Some executives contend that the disclosures will increase public support for the payments.
“Through greater transparency about the nature of these relationships, we will help people better understand how important they are to developing life-saving and enhancing products for patients who need them,” Bill Hawkins, the chairman and chief executive of Medtronic, said Tuesday.
But doctors who have seen details of their consulting deals made public say they have been tarred.
Dr. Richard Grimm, a Minnesota researcher, twice served on government-sponsored hypertension panels that create guidelines about when to prescribe blood pressure pills. But when state records revealed that he had earned more than $798,000 from drug companies from 1997 to 2005, invitations to serve on such panels dried up, he said.
“There’s this automatic assumption that if you make money from a drug company, you must be corrupt,” Dr. Grimm said.
Prosecutors are hoping the new measures will finally stop drug and device companies from repeatedly breaking the law.
Eli Lilly, for instance, pleaded guilty to illegal marketing charges in 1985 related to its arthritis drug Oraflex, in 2006 related to its osteoporosis drug Evista, and in January related to Zyprexa. In 2004, Pfizer paid a $430 million fine and pleaded guilty to criminal charges that it illegally marketed the epilepsy drug Neurontin, and it now faces similar charges over its marketing of Bextra.
A common problem in illegal drug and device marketing cases is doctors’ willingness to delude themselves into thinking that cash, lucrative trips and other kickbacks do not affect them, said Mr. Morris, the chief counsel.
“Somehow physicians think they’re different from the rest of us,” Mr. Morris said. “But money works on them just like everybody else.”
Mr. Sullivan, the United States attorney, said officials hoped to send a strong message to doctors. “I have been shocked at what appears to be willful blindness by folks in the physician community to the criminal conduct that corrupts the patient-physician relationship,” he said
Duff Wilson contributed reporting.