Drug Firm Relations Probed
For years, drug companies have given hospitals and their doctors thousands of dollars in educational grants - money that pays for lunchtime lectures, expensive medical books, and conference speakers. Federal prosecutors are looking into whether drug companies have been using these grants, in some cases, to try to influence doctors at leading hospitals to prescribe their medications to patients, attorneys said.
If true, such behavior would be illegal under federal anti-kickback laws and may play a role in skyrocketing prescription drug costs.
While investigators have been probing drug marketing practices broadly in the medical profession, attorneys believe prosecutors are particularly interested in teaching hospitals because they are centers of influence that train the nation's future physicians.
The investigations, most led by the US attorney in Boston, come at a time when large hospitals already are adopting stricter rules about when to accept educational grants from drug makers, money that many department chiefs have embraced to supplement budgets. Massachusetts General Hospital's department of medicine last year barred companies from buying lunches for residents during noon lectures, while Beth Israel Deaconess Medical Center is considering establishing a committee to review educational grants, rather than allowing physicians to decide for themselves.
"There's a shift
going on," said Leon Goldman, compliance officer at Beth Israel Deaconess.
"There's been a general sense among physicians that industry money
doesn't affect their judgment . . . [but] we're learning through more
studies it does affect judgment, and people are seeing the amount of money
being spent by companies is more than they believed."
The stakes for hospitals are extremely high. A medical center convicted of violating anti-kickback laws could no longer treat Medicare patients, a prohibition that could bankrupt many hospitals.
Defense attorneys did not know how many subpoenas federal investigators have sent out, but said they are generally information-gathering requests that could be used in criminal or civil cases.
"More than to get a big dollar settlement, it's to make a point," said Thomas Crane of Mintz Levin in Boston, who said he has seen an increase in subpoenas nationally but wouldn't discuss specific cases. "These are premier international institutions, and many question whether the US attorney's office wants to hold them to a higher standard."
In one case, prosecutors investigating how AstraZeneca promoted its top-selling ulcer drugs, Prilosec and Nexium, subpoenaed Tufts-New England Medical Center in Boston last fall, according to company filings with regulators. AstraZeneca salespeople were trying to persuade the hospital to switch from Prilosec, which was about to lose its patent, to Nexium, a new version of the drug, on the hospital formulary - a list of drugs the medical center allows doctors to give to patients - said William Gouveia, pharmacy director at the hospital. At the same time, the company gave educational grants to a physicians' group at the hospital to pay for speakers on topics of their choosing, he said.
In the end, however, the medical center formulary committee decided against Nexium and placed a cheaper drug, Wyeth Pharmaceuticals' Protonix, on its list of allowed drugs. Gouveia said if the educational grants were intended as inducements, they didn't work. AstraZeneca executives and the US attorney's office would not comment on a pending investigation.
Michael Fee of Ropes & Gray in Boston, the hospital's attorney, said educational grants are common at hospitals and permitted under new federal guidelines, as long as they are not intended to influence sales and are for legitimate educational purposes. "The fact that grants are going on, I don't think there's anything wrong with that," said Fee, who has seen an increase of subpoenas to teaching hospitals nationally. "The government's concern should be whether the grant is tied to sales, and that's where the proof is lacking."
Attorneys would not say where prosecutors have sent subpoenas. Executives at Mass. General, Brigham and Women's Hospital, and the Boston Medical Center said they had not received subpoenas related to drug company marketing. A spokeswoman at Beth Israel Deaconess said the hospital would not comment.
Even as drug firm money continues to flow into hospitals, many in Boston and across the country are adopting stricter policies about when to accept educational grants. The federal government in April issued new guidelines for pharmaceutical marketing, saying companies should award grants through departments other than sales, and that they should have no control over topics or speakers. Some hospitals are revising policies to comply with these guidelines, while others are struggling to determine when educational grants cross the line from being nominal to substantial, and how to insulate doctors who choose hospital formularies from industry influence.
Tufts-New England Medical Center a year ago began requiring physicians on the formulary committee to disclose their relationships with drug companies - and recuse themselves from voting if they have a conflict, Gouveia said.
Last year, Dr. Dennis Ausiello, physician in chief at Mass. General, told drug companies they could no longer buy lunches for residents in the MGH department of medicine during noon educational lectures. Residents were concerned that the lunches reflected negatively on the profession and asked Ausiello to review the practice. He said one factor, in particular, made up his mind: The lunches were paid for not by the companies' research or scientific departments, but by their marketing departments. "While that isn't necessarily all bad, it has the perception of being tainted," he said.
Ausiello drew a distinction between the lunches and a program he set up three years ago with funding from four drug companies that allows Harvard Medical School students to take a year off for training in clinical research. Merck & Co., GlaxoSmithKline, Pharmacia (now merged with Pfizer Inc.), and Novartis donated $800,000 a year each for five years. He negotiated with the presidents of the companies, not the marketing departments. He said he makes annual trips to the companies to tell executives how the program is going, but they don't participate in the selection of students or researchers.
"You have to look at the context in which the funding occurs," Ausiello said. "We share the common goal of producing more clinical researchers."
Not all physicians agree with stricter oversight. Dr. Michael Wolfe, chief of gastroenterology at Boston Medical Center, said drug companies may no longer sponsor and buy lunch for individual grand rounds, which are daily medical lectures that occur in all teaching hospitals. He still allows drug companies to donate money for grand rounds, but puts it all into a general pool, so companies cannot sponsor specific lectures that relate to their products - a change he's not happy about.
"What's happening now, in general, is a witch hunt," he said. " Doctors are being treated very differently from any other profession. We're being treated as if we have no morals or common sense."
Educational grants still are part of the fabric - and budgets - of teaching hospitals. Earlier this month, Beth Israel Deaconess held a cancer education day called Celebration of Life. About 15 percent of the $100,000 cost was paid for by drug companies, which did not have input into speakers or content, said Hester Hill Schnipper, chief of oncology social work. Roche Pharmaceuticals donated $5,000, allowing it to be the sponsor of Harvard University president Lawrence Summers' keynote address.
And several months
ago, another drug firm invited nurse midwives at Brigham and Women's to
an educational dinner at Davio's restaurant in Boston - an event one nurse
promoted to colleagues on hospital e-mail. Hospital executives said nurses
may attend dinners on their own time, but that they can't use hospital
e-mail to promote a drug firm event.