Doctors who accept gifts from drug companies are breathing a little easier with the news that four pharmaceutical sales executives were acquitted of federal corruption charges.
The EMD Serono executives were found not guilty of allegations they tried to bribe doctors in 1999 with an all-expenses-paid trip to a medical conference in Cannes, France, in exchange for prescribing Serostim, a human growth hormone that is used to treat muscle wasting in patients with AIDS.
Prosecutors claimed that Serono drug sales representatives offered lavish trips, gifts and kickbacks to physicians who wrote a minimum number of Serostim prescriptions. The industry spends more than $20 billion a year on marketing, or about 3% of $600 billion in total sales, experts estimate.
The government said that these salespeople were following orders from above to bribe the doctors, says Adam Hoffinger, a partner with Morrison & Foerster in Washington who represented one of the Serono defendants. The allegation was that we will send you to Cannes but only if you prescribe a certain number of Serostim prescriptions. Not a single doctor testified to that.
The Serono case is just the latest example of prosecutors who are determined to hold individual physicians accountable for going along with improper drug marketing plans, says Mark Pastin, president of the Health Ethics Trust, a not-for-profit that advices organizations on ethics and compliance. The provider and plan community has demanded this as they do not wish to be victimized by what they view as physicians under the influence of vendors, Pastin says. The lesson for doctors is that if you dont want to spend a good part of your life dealing with charges of this kind, be careful in what you accept from vendors.
After a two-week trial, in May a 12-person federal jury in U.S. District Court in Boston took three hours to find the former Serono executives not guilty of conspiracy, bribery and offering illegal remuneration in violation of the federal Anti-Kickback Act. Serono, which last year was acquired by Merck for $13 billion, is based in Rockland, Mass.
One positive message may be that making these kinds of things public may cause doctors to stop and think about taking the food, gifts or educational trip, says Eric Campbell, an assistant professor of medicine at Harvard Medical School.
In a recent study in the New England Journal of Medicine, Campbell found that 95% of doctors reported receiving gifts in 2004. Some 30% of doctors received free or subsidized CME meetings, which could include trips to conferences, he says.
Under the AMAs ethical guidelines, gifts to physicians should benefit patients and should not be of substantial value. In 2002, the Pharmaceutical Research and Manufacturers of America, or PhRMA, a drug industry trade organization, recommended that gifts should not exceed $100 in value.
Campbell says the AMA and PhRMA guidelines essentially allow doctors to manage gifts on an individual basis. The profession needs to do more thinking about it, he says. The AMA declined to comment on the case.
The methods that drug companies use to encourage the use of their medicines, appropriate or inappropriate, are diversified and largely successful in changing physician (prescribing) behavior, Campbell says.
Campbell says he doesnt believe it is ever appropriate for doctors to receive free trips. Drug companies say it is for education, but they are not in the education business, he says. We dont send engineering students to the south of France to learn. Why should we send doctors?
Campbell likened drug companies giving gifts to doctors to baseball owners giving gifts to umpires. If the Yankees were playing the Red Sox, would Yankee fans be comfortable if the umpires got free lunches from the Red Sox owners? he says. People would say No; you cant allow umpires to get free lunches from owners.
The acquittal of the four Serono executives followed several related events. In 2005, Serono pleaded guilty to five anti-kickback violations, including bribery charges. It agreed to pay the government $704 million, including more than $136 million in criminal penalties. In 2004, Adam Stupak, a former Serono sales director, pleaded guilty to kickback charges.
In a similar case in 2001, TAP Pharmaceutical Products, based in Lake Forest, Ill., agreed to pay $885 million to settle kickback charges. Like Serono, individual TAP executives in 2004 also were acquitted on similar charges.
Prosecutors tend to go after companies first ... and then they go after individuals, Hoffinger says.
Serostim was developed in the 90s to stop severe weight loss that had killed many AIDS patients. However, by the time Serostim came to market in 1996, the company faced stiff competition from newer AIDS drugsprotease inhibitors, the so-called drug cocktailjust entering the market.
Hoffinger acknowledges that Serono sales reps offered the free trips to a number of AIDS specialists for educational purposes. It is done all the time, he says. Hopefully they would come back and spread the gospel about the effectiveness of Serostim.