Drug industry: No more free pens, pads or mugs

Starting in January, drug detailers will have a lighter load to carry when they visit physician offices. That is when new industry guidelines take effect that bar them from leaving behind drugmaker-branded pens, notepads, coffee mugs and other reminder items.

The ban, announced July 10, is the biggest change the Pharmaceutical Research and Manufacturers of America laid out in a revised code on interactions with physicians and other health professionals. The PhRMA code says reminder items "may foster misperceptions that company interactions with health care professionals are not based on informing them about medical and scientific issues."

Drug reps also will be barred from treating physicians to restaurant meals, though in-office meals accompanied by informational sessions will be permitted. They still will be allowed to give doctors educational items valued at $100 or less.

In 2006, drugmakers spent $6.7 billion, or about $8,000 per physician, on detailing, according to pharmaceutical market research firm IMS Health Inc. Pharmaceutical companies spent $4.8 billion on direct-to-consumer advertising and $463 million on professional journal ads, IMS said.

The code is voluntary, but PhRMA expects its members to follow it. Drugmakers, including AstraZeneca PLC, Eli Lilly and Co., Johnson & Johnson, Amgen Inc. and Merck & Co. Inc., quickly announced intentions to adhere to the guidelines.

The code replaces a 2002 version and comes amid intense scrutiny of industry-physician relations. Sen. Chuck Grassley (R, Iowa) has led the charge and is co-sponsor of the Physician Payments Sunshine Act of 2007.

A revision of the bill calls for requiring drugmakers to publicly report aggregate annual payments of more than $500 to doctors. The measure has earned PhRMA's support because it would preempt state disclosure laws in a handful of states. The AMA supports the measure, which is before the Senate Finance Committee.

The Massachusetts Senate approved a total ban on industry gifts to physicians last April. At press time, a House committee recommended that the ban be scrapped in favor of asking drugmakers to establish and disclose a marketing code of conduct.

PhRMA denied some critics' claims that its revisions were politically motivated. "No changes are made in a vacuum, but these changes are not intended to address any particular legislation at the state or federal level," said Diane Bieri, PhRMA senior vice president and general counsel. "The changes we made to our code were carefully considered and made to continue to demonstrate our commitment to responsible interactions with health care professionals."

Grassley welcomed the changes, but said they do not obviate the need for the Sunshine Act.

"These initiatives could have the effect of the industry knowing more about what's going on," Grassley said in a statement. "The next step is for the public to know what's going on with full disclosure. Congress needs to pass transparency legislation to make that happen."

AMA Board of Trustees Chair-elect Rebecca J. Patchin, MD, commended PhRMA's new rules for providing "strong, clear guidance."

In a statement, Dr. Patchin lauded the PhRMA code for embracing the idea of allowing doctors to restrict detailers' access to prescribing information. The AMA launched the Physician Data Restriction Program in July 2006 through contractual agreements with individual drugmakers. So far, about 15,000 physicians have enrolled in the opt-out program.

Dr. Patchin also praised PhRMA's guidelines on CME funding, which came on the heels of Pfizer Inc.'s announcement that it will stop funding commercial CME providers in an attempt to mitigate perceived conflicts of interest. Drugmakers following the guidelines would separate their CME grant-making and marketing operations, and develop objective criteria for grant decisions to avoid bias.

The AMA Council on Ethical and Judicial Affairs is studying how physicians should manage potential conflicts of interest posed by industry funding of medical education. The AMA policy on gifts from industry says that "modest meals" are OK, as are gifts worth less than $100 that benefit patients. It also says that "individual gifts of minimal value ... related to the physician's work," such as pens, are permissible. CEJA is re-examining its gifts policy.

Skeptics view changes as cosmetic

Critics of drugmakers' marketing techniques greeted the new code with deep skepticism.

The changes are "completely cosmetic" and "intended purely to fool the public into believing that PhRMA is taking this issue seriously," said Daniel J. Carlat, MD, assistant clinical professor of psychiatry at the Tufts University School of Medicine and a former drug firm-paid speaker.

"Pens, Post-it notes and mugs have never been the focus of critics of industry marketing tactics," he said in an e-mail. "That is chump change compared to the platters of food brought in to feed the entire office staff, which is done to cement a good relationship with the doctor and to ensure continuous access in order to deliver sales pitches."

He argued that drugmaker-paid speakers and consultants have much more sway over physician prescribing habits than drug reps.

PhRMA said companies following its code should place some cap "based on fair market value" on total annual compensation to individual speakers. Companies also should require physicians who serve on formulary or clinical practice guideline committees to disclose any pharmaceutical speaking and consulting arrangements.

Most physicians are more likely to encounter gifts on a smaller scale. Some observers said such reminder items do not pose a serious conflict of interest that harms patients.

"If I never see another Pfizer mug or Merck pen, I don't care," said Thomas P. Stossel, MD, who directs the division of translational medicine at Brigham and Women's Hospital in Boston. "But when we stop congratulating ourselves, what's going to be the difference for patients?"