The recent decision by GlaxoSmithKline to stop paying physicians to promote its drugs and reform other marketing practices represents progress, Big Pharma critics told Medscape Medical News, but some said the company can’t stop there.
"It’s another step forward in the evolution of the relationship between physicians and the pharmaceutical industry," said Molly Cooke, MD, president of the American College of Physicians (ACP). "It makes all kinds of sense to separate marketing from education."
Likewise, Adriane Fugh-Berman, MD, director of PharmedOut, a project to educate physicians about inappropriate pharmaceutical marketing practices, called the GlaxoSmithKline decision "a solid step in the right direction." However, Dr. Fugh-Berman said that it would be "real progress" if the company went further and stopped funding continuing medical education (CME).
"Physicians need to take back medical education and stop expecting industry to fund it," said Dr. Fugh-Berman.
At issue is the influence that well-heeled drug companies have on the prescribing habits of physicians. Some physicians have viewed the companies as benign benefactors, whether it comes to drug samples, free lunches for the office staff, or speaking fees. Others have called on their profession to stop accepting what they deem to be bribes to promote or prescribe a company’s products.
On December 17, GlaxoSmithKline announced that it will stop paying clinicians to speak to their colleagues about its products or disease areas by the beginning of 2016. It also plans to cease footing the bill for physicians to attend medical conferences. Pharmaceutical companies had voluntarily stopped funding conference attendance in the United States a few years back, but the practice persists elsewhere in the world.
In another reform, GlaxoSmithKline said that it will no longer compensate its sales representatives (aka "drug reps") around the world based on individual sales — think prescriptions generated — by the beginning of 2015. Rather, their pay will reflect their technical knowledge, the quality of their service to clinicians, and the overall performance of the company.
The company first introduced this compensation scheme in the United States in 2011 as part of its "Patient First" initiative. Up until then, individual sales had determined bonuses, company spokesperson Mary Anne Rhyne told Medscape Medical News. Physicians told GlaxoSmithKline that they liked how the new arrangement changed their experience with drug reps, according to Rhyne.
"They felt they had more objective conversations as opposed to the drug rep pushing a particular drug, and [doctors] were leading the conversations," she said. The softer approach persuaded some physicians who had closed their office doors to drug reps to reopen them.
Reforms "Long Overdue"
To pediatrician Philip Pizzo, MD, at Stanford (California) University School of Medicine, the new GlaxoSmithKline policies are "long overdue," as he was quoted as saying in a medical-school blog. The former medical-school dean was an early voice for keeping the pharmaceutical industry at arm’s length. Under his direction, in 2006, Stanford prohibited physicians from receiving drug samples and industry gifts, and made patient care and medical school facilities off-limits to reps from drug and device makers except by appointment.
”Over the years industry has invested many billions of dollars in influencing physician behavior," Dr. Pizzo told Medscape Medical News. "It is almost imponderable to believe that these investments would have been continued if they didn’t have the desired impact."
Another veteran of the Big Pharma wars questions the timing of GlaxoSmithKline’s decision not to pay physician educators. Such speaking gigs are on the wane, at least in his experience, said Gary Sobelson, MD, a family physician in Concord, New Hampshire.
"I used to get invitations to these events at least several times a week," said Dr. Sobelson, who does not see drug reps. "Now it’s 5 to 10 per year."
Dr. Sobelson nevertheless commended the company for its new policies. "Any effort to improve the perceived unethical behavior of pharmaceutical companies has got to be a good thing," he said.
Dr. Sobelson is a former president of the New Hampshire Medical Society, which lobbied for a 2006 state law to prevent drug companies from using prescription data for marketing purposes if the physician is identified. His association and others argued that drug reps shouldn’t be privy to confidential information that helps them tailor sales pitches. The law later was deemed an unconstitutional infringement of free speech when the US Supreme Court struck down a similar law in Vermont in 2011.
More qualified praise for the GlaxoSmithKline announcement comes from medical ethicist Howard Brody, MD, author of the book Hooked: Ethics, the Medical Professional, and the Pharmaceutical Industry.
"My reaction is mixed — cautiously positive," said Dr. Brody, director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston. "Every time the drug industry has said it will reform itself, it [has been] smoke and mirrors."
Tarnished Reputation
There are reasons why Dr. Brody and others view GlaxoSmithKline"s new marketing policies with skepticism as well as hope. Its track record for trustworthiness is tarnished.
In July, the security minister in China announced that company executives in that country confessed to offering bribes to physicians, medical association, hospitals, and others on a massive scale to boost drug sales. Those executives "appear to have acted outside of our processes and controls which breaches Chinese law," Abbas Hussain, the company’s president for Europe, Japan, emerging markets, and Asia Pacific, said in a statement posted on the GlaxoSmithKline Web site. "We have zero tolerance for any behavior of this nature."
In 2012, GlaxoSmithKline pleaded guilty in the United States to criminal misdemeanor charges of failing to report negative safety data to the US Food and Drug Administration about the diabetes drug rosiglitazone (Avandia) and promoting off-label uses of the antidepressants paroxetine ( Paxil) and bupropion (Wellbutrin) to physicians. The company illegally pushed paroxetine for pediatric depression and bupropion for treating weight loss, sexual dysfunction, and other disorders.
In addition, GlaxoSmithKline settled civil charges that included illegally promoting off-label uses of paroxetine, bupropion, and 3 other drugs as well as paying doctors kickbacks for prescribing them. In all, the company agreed to pay the government $3 billion in what federal prosecutors called the largest healthcare fraud settlement in US history. GlaxoSmithKline also signed a 5-year corporate integrity agreement that requires it to pay its sales force in ways that do not tempt them to break the law. If they go astray, the government can dock the compensation of company executives. GlaxoSmithKline chalked up the criminal and civil charges to misdeeds of an earlier era and management team.
Company spokesperson Rhyne said the new marketing policies announced last week do not stem from these 2 legal developments. Nor are they designed to preempt the new Sunshine Act, which require drug and device makers to report their payments to individual physicians. CMS will post the first year"s worth of this data by September 2014. Rhyne said the new policies are the latest in an evolutionary series of changes to make the company’s business dealings more transparent.
Others think the Sunshine Act nevertheless pressured the company to curtail its financial dealings with physicians.
"They can see the handwriting on the wall just as well as anyone else," said the ACP’s Dr. Cooke.
"A Mutual-Deception Dance"
Not everything about GlaxoSmithKline’s financial dealings with physicians is changing. The drug company said it would continue to pay "appropriate fees" to physicians engaged in company-sponsored clinical research, advisory activities, and market research.
The ACP’s Dr. Cooke, for one, doesn’t automatically look askance at that.
"There are absolutely legitimate relationships between physicians...and the pharmaceutical industry," she told Medscape Medical News. Drug companies that make HIV drugs, for example, seek guidance from clinicians like her who treat patients with HIV. "They ask questions such as, "What are the 3 biggest problems with HIV chemotherapy?" These kinds of exchanges are completely wholesome."
GlaxoSmithKline also said it will continue to award no-strings-attached educational grants to providers of CME, another source of controversy. PharmedOut, the group organized to limit the influence of the pharmaceutical industry on physicians, wants drug companies out of CME.
"People don’t seem to realize there are marketing messages in CME," PharmedOut’s Dr. Adriane Fugh-Berman told Medscape Medical News. CME, she said, can prepare the market for a new drug by claiming that the disease it treats is underdiagnosed, or that existing treatments are inferior or in short supply.
GlaxoSmithKline has attempted to deflect such criticism. In 2009, the company announced that it would stop funding CME provided by for-profit entities that include "medical education and communication companies" (such as the educational arm of Medscape).
Instead, GlaxoSmithKline would award CME grants only to academic medical centers and their affiliated teaching and patient care institutions along with national medical societies, all in the name of improving CME quality.
For medical ethicist Dr. Howard Brody, GlaxoSmithKline’s next reform after this month’s announcement should be "across-the-board transparency" that extends to the company’s business plan and its scientific data, now treated as proprietary information.
This transparency, said Dr. Brody, runs counter to the lack of honesty that has characterized the relationship between drug companies and physicians.
"The fundamental idea is that we’re bribing you [to prescribe this drug] and at the same time we’re bending over backwards so you don’t think you’re being bribed," said Dr. Brody, giving what he considers to be the industry perspective. "We love you; we’re only giving you [samples] because you’re such a wonderful guy. And we respect you as a scientist, so there’s no way you would ever be swayed by mere advertising.
"It’s a weird kind of dance that goes on between the drug rep and the doc, a mutual-deception dance," he said. "Docs buy into it and they"re seduced by it."
Total transparency would result in a relationship that physicians and drug reps could talk about with pride, said Dr. Brody. "But as long as it’s got to be hidden and covered over, as long as you have to put lipstick on the pig, something’s wrong."
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