Consumer groups warn about drug firm gifts to doctors

Eleven pharmaceutical firms paid Virginia doctors and other health professionals $7.8 million in 2010, according to a database created by the journalism organization ProPublica.

Some of the money paid for research that was vetted by medical review boards, but doctors also took in $5.2 million for speaking and consulting fees.

The ProPublica database attempts to provide transparency in a field where there can be a fine line between doctors who are too cozy with the drug industry, and those fulfilling a legitimate role as researchers and educators.

There has been growing concern about pharmaceutical payments to doctors. Consumer groups contend that payments, particularly those for promotional talks, gifts, meals and free samples, can cause doctors to be more likely to prescribe their patients medicines from those companies, and to overlook better or less expensive treatments.

Some doctors, though, say they play a role in educating their peers about medication options, and in informing the general public about diseases and the best treatment options.

Sorting it all out can be difficult, but transparency will be the new reality when a federal law goes into effect in 2013 requiring all drug and medical device companies to make the payments public. Some states already are strengthening their laws. For instance, Vermont, Minnesota and Massachusetts prohibit gifts from drug companies to doctors but allow fees for speaking and research.

"The bottom line is, this is an area where there's a lot of argument, debate and disagreement about what behavior is appropriate and what is not," said Dr. Thomas R. Pellegrino, associate dean for education at Eastern Virginia Medical School. "Years ago, drug and medical device companies would lavish doctors with gifts, travel, meals, trips to the Virgin Islands to learn about a certain drug. There's been a growing recognition that that sort of thing is inappropriate."

ProPublica first built the "Dollars for Docs" database in 2009 when some drug companies began releasing the information as a condition in settling lawsuits. Other companies have since joined in, and 40 percent now publicly disclose payments to doctors, according to ProPublica.

The Pharmaceutical Research and Manufacturers of America organization released a statement defending the industry in the days before the ProPublica database was updated on Sept. 7, saying physician speakers help their peers stay up-to-date on clinical data and medicines:

"Unfortunately, when taken out of context," the statement said, "publicly available information about physician interactions with biopharmaceutical companies does not convey the value of these relationships, which advance science and promote high-quality patient care."

The range of payments varies widely, with some doctors listed as receiving $1 in compensation while others received hundreds of thousands of dollars. ProPublica noted that one Santa Monica, Calif., doctor earned $270,825 from drug companies in 2010.

A Consumer Reports National Research Center poll released last year showed that about half of Americans said they would be concerned about the quality of care or advice they were given from a doctor who accepted as little as $500 from a drug company, and two-thirds said they'd be concerned if a doctor took $5,000 or less.

In South Hampton Roads, doctors received $1.16 million in payments from 11 drug companies in 2010. The biggest category was for speaking and consulting, at $831,380. Payments for research came in at $128,407.

Dr. William Yetter, a local psychiatrist, received $66,525 for speaking and consulting that year. He said in an email that he is concerned that the ProPublica database creates "the innuendo that docs who accept money are doing something sinister. I believe the pharmaceuticals have not defended themselves enough on how they do educate docs, provide free meds and cost reduction options to patients."

Yetter said he accepts payments for speaking to other doctors about particular drugs that he's been trained to use.

Dr. Robert Hansen, a pain-management physician who practices in a Bon Secours-affiliated office in Virginia Beach, received $60,950 from Johnson & Johnson and Lilly in 2010, according to the database. He said the money he receives pays him to teach other doctors ways the companies' medications can be used to treat pain.

"I would never support something that I didn't know, didn't use, and didn't think was helpful," Hansen said. "There's a tremendous need to know how to treat pain. It's terrifying how ignorant doctors are about pain.

"I don't think of myself as a shill for a company," he said. "I've turned down companies that I thought were not on the up-and-up or because I didn't believe in their medicine."

Physicians often receive drug company payments to talk about research they were involved in - particularly if the doctor is a well-known expert and the research is groundbreaking.

Sometimes the money can be attractive to doctors struggling with insurance programs such as Medicaid that don't fully reimburse their costs, said David M. Belde, vice president for mission and ethics with Bon Secours Virginia.

However, he said, "on balance most physicians will say, 'I want to practice the best and the most standard evidence-based practice. I don't want anything interrupting that. I particularly do not want outside interests to be telling me how to practice medicine.' "

Doctors associated with Bon Secours and other local health systems are governed by policies that require disclosure and approval of activities that could pose conflicts of interest.

Dr. David Maizel, president of Sentara Medical Group, said he looks at whether an activity will benefit the physician, the organization as a whole, or the patients.

"If we don't really see that the activity is bringing value to that group of stakeholders, then we will in fact say, 'No, we don't think that's a very good idea,' " Maizel said.

However, there's a limit to what Sentara Medical Group can require when physicians aren't representing the organization, he said.

"I can't tell people how to live their lives," Maizel said. "We hope that, with the guidelines we've provided people, they'll be able to make good choices and make good decisions. Up to this point, that has really proven to be the case."

Bon Secours officials are taking their oversight a step further by developing formal guidelines on vendor relationships for physicians in their medical groups, Belde said.

"A lot of research indicates that physicians do change their practice patterns based on their relationships with vendors," he said. "So if you have the potential of getting swayed by external gifts, external relationships - the potential for that, I think, is problematic."

Universities and medical institutes have also received money from drug companies, often for research. Eastern Virginia Medical School in Norfolk received $71,985 in 2010, according to the data. Virginia Commonwealth University received $203,778, and the University of Virginia $310,000.

Payments for university research are cleared through medical review boards and federal guidelines that monitor the ethics of such projects. The boards make sure patients are appropriately informed of the risks of a clinical trial and that the project is conducted in a way that would make the research valid. Research that stacks the deck in favor of the company's drug would not meet Federal Drug Administration regulations.

Pre-market approval is needed for drugs and to restrict that type of research would mean delaying development of lifesaving drug therapies, said Dr. Jerome F. Strauss III, dean of the Virginia Commonwealth School of Medicine.

Elizabeth Wiley, vice president for internal affairs at the American Medical Student Association, said research funds also should be scrutinized, because not all doctors belong to institutions that have medical review boards. In the past, she said, some doctors have been guilty of "ghostwriting" research for companies to cast their drugs in favorable lights.

Her organization began issuing a "PharmFree" report card in 2007 comparing conflict-of-interest policies regarding drug company payments to academic medical centers. The guide compares institutional policies on gifts, consulting and speaking fees, disclosure, samples and purchasing.

In 2008, only 14 percent of medical schools made an A or B grade. That rate increased to more than 50 percent on the most recent report, issued in December. The organization also has developed model policies.

Wiley said one of the easier changes for schools is developing a disclosure policy. But many schools have taken even stronger measures, such as prohibiting paid promotional speaking and accepting free drug samples, as well as interaction with sales representatives and industry-funded education.

Virginia Commonwealth University earned a B in 2010, up from an earlier D. The University of Virginia also made a B.

Strauss said VCU has tightened its policies during the past several years, and even started posting drug payments to affiliated doctors on the school's website.

He said VCU officials use the ProPublica database to check against disclosures their doctors submitted to the school to make sure all payments are reported: "It's a valuable public service," he said.

There have been instances of physicians being dismissed for not disclosing ties to the drug industry. The school is continually reviewing the issue. The most recent policy being reviewed prohibits using industry-prepared slides in class presentations.

Locally, Eastern Virginia Medical School earned a D on the 2010 scorecard, as did the Edward Via College of Osteopathic Medicine in Blacksburg.

EVMS has a model policy on disclosure, but not on consulting and speaking, according to the 2010 report. The PharmFree website's description noted: "Gifts are not meaningfully prohibited and use of language such as 'discouraged' in the vendor access policy does not adequately restrict their access to patient care areas."

But EVMS Dean Gerald Pepe said adjustments made to the ethics policy in June addressed many of those areas, and he believes the school will pull up its score this year. Gifts, entertainment and meals are now prohibited.

"The one place we didn't make significant change was in the area of drug samples," Pepe said in an email response. "Given that we care for many indigent patients, those samples are a benefit to them."

Local medical executives said they support the new law requiring disclosure, although they'd prefer including explanatory information along with dollar amounts.

"Physicians who have these external relationships need to be able to justify them in a way that makes sense to their patients and to the profession as a whole," said Belde of Bon Secours. "That, I think, is something that has largely been under cover."

Strauss said it can be tough for a patient to use public information to make medical decisions, but that generally, institutions and doctors who are transparent about disclosure prove they have nothing to hide.

Wiley suggests learning as much as possible about doctors using databases such as ProPublica.

"We advise people to make informed choices about who they select as a provider, and make sure the doctor-patient relationship is sacred and not driven by insidious marketing," Wiley said. "It's not necessarily the most obvious line to draw, but we believe there needs to be transparency."

Arthur Caplan, a bioethicist at the University of Pennsylvania, advises patients to follow a database check with questions to their doctors.

"Not every payment is a reason for panic, while some connections are so tight that you might not get all the options of a drug or device because your doctor is in a provider's pocket," Caplan said in an email response.

"As with so much in health care, asking questions is crucial."

Elizabeth Simpson, (757) 446-2635, elizabeth.simpson@pilotonline.com

Amy Jeter, (757) 446-2730, amy.jeter@pilotonline.com