Rules Shine Light on Drug Firms' Ties to Doctors

Monday, April 23, 2012 - 10:25

This article originally appeared in the April 21, 2012 edition of the Daily Hampshire Gazette.

By Kristin Palpini

Staff Writer

Helen Carcio, a South Deerfield nurse practitioner, says she's on a mission to educate other health professionals about treatment for overactive bladders - a quest paid for, in part, by Pfizer, the maker of a drug that treats the condition.

She is among 16 area medical professionals who have received anywhere from $280 to $254,000 from pharmaceutical companies for making speeches, consulting, doing research and for travel and meals, according to recently released documentation about medical professionals' financial arrangements with pharmaceutical companies.

Carcio, founder and director of the Health & Continence Institute, is a member of Pfizer's national speakers bureau. The drug company pays her $1,000 to $1,500 per event to speak about overactive bladders. In 2010 she spoke to medical professionals at 11 events.

From July 2009 through 2010, Pfizer paid Carcio $11,649 for consulting, speaking and travel expenses. She also earned $3,750 in 2009 speaking on behalf of GlaxoSmithKline.

Carcio said she lectures for Pfizer because many medical professionals don't understand overactive bladders.

"I'm trying to take it out of the closet, to talk to providers that are clueless that something can be done about it," she said. "First you want to get people better, and the majority of us want to be paid for it, but mainly we want to be helpful."

While legal, the cash relationship between doctors and pharmaceutical/medical device representatives raises questions about conflicts of interest and other ethical issues, leading to federal legislation that will soon require public disclosure of these kinds of transactions.

• How this story was developed

• How much area doctors were paid

Carcio is concerned about how people might interpret her relationship with Pfizer.

"I have a passion for making sure women are not incontinent. The more I raise awareness the better, but it's a Catch-22," she said. "I'd hate for someone to think I'm on the take, that I'm doing it for the money."

Carcio says she's one of the good ones.

"Some do it for the money," she said of medical professionals who speak on behalf of drug companies. "Some make $150,000 in a year. That would bother me."

Among the drug companies that have paid Valley doctors are GlaxoSmithKline, Pfizer, Novartis, Eli Lilly, Johnson & Johnson and Merck. In 2010, Massachusetts doctors received $64 million from pharmaceutical companies, according to the Massachusetts Prescription Reform Coalition, an arm of the Boston-based advocacy group Health Care for All.

The financial relationships between drug companies and doctors will soon be even more transparent. Legislation for the 2010 federal health care overhaul included the Physician Payment Sunshine Act, which will require drug companies to disclose payments to medical professionals. The details of the act are still being worked out by the Centers for Medicare and Medicaid Services.

The first report detailing the who, what, where, when and how much of financial arrangements between doctors and pharmaceutical companies will be issued in September 2013. In the meantime, 12 drug companies are already providing this information either voluntarily or as the result of legal settlements. ProPublica, a nonprofit investigative news outlet, has compiled the payments into a searchable, though incomplete, database.

Since 2008, the Massachusetts Executive Office of Health and Human Services has been tracking cash transactions between medical professionals and drug and medical device companies through the state's gift ban law. Proponents of the Sunshine Act contend that it's important to make such relationships clear. They say money from drug companies could influence a doctor's treatment decisions, even if only on a subconscious level.

According to an article titled "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" published in the Journal of the American Medical Association, studies have shown that physicians who meet with drug representatives are more likely to prescribe the drugs the representatives are promoting and decrease the number of generic prescriptions they write.

Alyssa Vangeli, a policy analyst for the Massachusetts Prescription Reform Coalition, said physicians and other health care providers who prescribe medications almost always have the best interest of the patient in mind, "but any kind of payment or financial transaction could potentially influence a doctor," she said.

"Patients should never have to wonder if their doctor prescribed something because it was best for me or they've recently been taken out to an expensive meal by a pharmaceutical company pushing a certain drug," said Vangeli.

Area doctors, however, say they are not influenced by money, gifts or meals.

"I can only speak for myself," said Jonathan Bayuk, an allergist and clinical immunologist with offices in Florence, Springfield, and Westfield, "but I've never been persuaded by a sandwich to change how I take care of patients."

Marketing with wide reach, the pharmaceutical/medical device industry spends an estimated $20 billion to $57 billion annually to market its products. According to the Pew Research Center, detailing--face-to-face encounters between doctors and representatives--is the largest industry marketing expenditure after pharmaceutical samples.

Most doctors engage in some form of detailing. More than 90 percent of physicians have some kind of relationship with a drug company representative, according to "A National Survey of Physician-Industry Relationships," a 2007 article in the New England Journal of Medicine. The survey reported that, in one year, nearly 80 percent of doctors nationwide received drug samples, 83 percent accepted food or drinks in the workplace, 26 percent received reimbursement or were subsidized for continued medical education, 18 percent were paid for consulting services, 16 percent were paid to speak at events, 9 percent sat on advisory boards and 3 percent enrolled patients in clinical trials.

Since 2008, Massachusetts doctors have been barred by state law from accepting samples, food, drinks or entertainment.

For the most part, Valley doctors who have received money from pharmaceutical companies are being paid to lecture at informational events. Some area physicians have spoken at more than 60 events in a single year, according to the Massachusetts Executive Office of Health and Human Services.

Several local medical officials have been hired as consultants and a few received money for research. Bayuk, for example, has spoken at scores of medical events, and said such engagements can range from small-scale affairs to large conferences. From 2009 to March 2011, Bayuk received at least $124,550 from pharmaceutical companies, mostly compensation for speaking engagements.

Typically pharmaceutical companies ask doctors to speak about the diseases and conditions the drug targets, not about the drug itself. Medical professionals also must follow U.S. Food and Drug Administration regulations about how they talk about drugs. For example, a drug's risk factors must be addressed.

But Alison Bass, author of Side Effects, a book about the suppression of unfavorable research on the antidepressant Paxil, says that typically a speaker will mention a drug manufactured by the sponsoring pharmaceutical firm, saying it is an effective treatment for the disease.

Bass, a journalism professor at Mount Holyoke College in South Hadley, said doctors may be sincere in their endorsements of drugs, based on the data presented in clinical trials. But she maintains these trials are often flawed.

Drug researchers are more likely to report positive outcomes when a pharmaceutical firm pays for the study, Bass said. Studies that show negative results may go unpublished, or may even be falsified to present a better outcome.

That was the case with Paxil, Bass said. Brown University professor Martin Keller was paid hundreds of thousands of dollars by SmithKline Beecham (now GlaxoSmithKline) to perform research on Paxil's effect on teenagers. Teen participants who reported having suicidal thoughts were miscoded and counted as "noncompliant," Bass said.

Court documents filed in 2008 in lawsuits against GlaxoSmithKline revealed that adolescents were six times more likely to become suicidal after taking Paxil.

"Money is too influential," said Bass. She maintains the government, not drug companies, should pay for clinical trials.

From 2009 through March 2011, Bayuk earned speaker's fees from AstraZeneca, GlaxoSmithKline, and Novartis. He said drug companies and the medical community both benefit when he talks at an event. The drug companies spread awareness of their products, and his peers learn of advances in the field. Bayuk said his medical decisions are in no way influenced by speakers fees he is paid from drug companies.

"Not me, but there are some," he said. He also noted that when speaking, he may discuss several competing treatment options. Bayuk says he sees no point in documenting pharmaceutical-physician relationships.

"It's a total waste of time and money," he said. "There's been no impropriety done by me, and I think that's the truth for 99.9 percent of physicians."

"I'm a young guy," he continued. "Maybe in the past there was a problem, but I've never seen one. ... There's nothing wrong with disclosing exactly what happens."

Disclosure can be confusing. But disclosing exactly what happens can be tricky, and it's one of the sticking points the Centers for Medicare and Medicaid Services are taking comments on as they work on the law's language. For example, research money is a category that can both compensate a doctor as well as pay for patient care and supplies. Reporting that a doctor received research money could imply that the entire amount was compensation for his work.

Pharmaceutical interest groups and disclosure advocates agree: Financial transactions between pharmaceutical companies and doctors need to be reported with context.

"Patients need to understand that a relationship between their physician and a company does not mean their physician is compromised," Kate Connors, a spokeswoman for the pharmaceutical industry interest group PhRMA, said in an email. "If anything, they should know that their physician is seen as an expert in his or her field."

The CME Coalition, a lobbying group for continuing medical education providers, notes that the potential for misinterpretation could encourage doctors to forgo educational opportunities. Dennis J. Rosen, an Amherst pediatrician, is concerned about how people will look at payments he has received from drug companies.

Rosen, who has been treating children with learning, emotional and attention problems for 42 years, received a total of $254,965 in speaking and consulting fees from Novartis and Shire Pharmaceuticals in 2009 and 2010. He said he ended those relationships more than a year ago because he no longer has time for speaking engagements.

But he called his work with drug companies "meaningful and educational," and said it benefited doctors, and subsequently, their patients. When he spoke, Rosen said, he was "fair and honest" about the use of drugs for particular disorders.

The money is not an indication of impropriety, he said.

"I don't play favorites," Rosen said of prescriptions. "I use whatever is necessary."

Kristin Palpini can be contacted at kpalpini@gazettenet.com.

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