As of January 1, 2009 drug company sales representatives are no longer supposed to be distributing branded trinkets such as pens and pads to doctors. Hearing of this, I could not help thinking of the Trojan priest Laocoon. During the Trojan War Laocoon was rightfully suspicious of a certain wooden horse left by the Greeks on the beach. “I fear the Greeks even when they bring gifts,” he is quoted by Vergil as saying. Unfortunately, for his audacity (and for throwing a spear into the side of the Trojan Horse) he was punished by Minerva, protectress of the Greeks. She sent two sea serpents who, after eating Laocon’s two children, proceeded to devour him. I guess this illustrates the dangers of speaking truth to power.
The new rules are reflected in a revised Code on Interactions with Healthcare Professionals adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA). These regulations had been adopted in 2008, but did not go into effect until January 1. They cover a variety of ways in which pharmaceutical representatives can interact with physicians. For example while pharmaceutical representatives can provide meals if they are making a presentation, they can no longer: “provide any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any healthcare professional who is not a salaried employee of the company.”
With respect to branded trinkets the rules state:
Providing items for healthcare professionals’ use that do not advance disease or treatment education — even if they are practice-related items of minimal value (such as pens, note pads, mugs and similar “reminder” items with company or product logos) — may foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues. Such non-educational items should not be offered to healthcare professionals or members of their staff, even if they are accompanied by patient or physician educational materials.
Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs or tickets to a sporting event) likewise should not be offered.
Payments in cash or cash equivalents (such as gift certificates) should not be offered to healthcare professionals either directly or indirectly, except as compensation for bona fide services (as described in Sections 6 and 7). Cash or equivalent payments of any kind create a potential appearance of impropriety or conflict of interest.
It seems a big disingenous to think that providing branded mugs fosters just the “misperception” that interactions are not based strictly on the science. In fact, the very description of what is prohibited is a laundry of the unsavory types of interactions that have long characterized the work of drug reps. (See our previous posting Former Pharmaceutical Reps Tell All). The PharmedOut website has some interesting new videos in which drug reps discuss how they ply their trade.
So, is this really a “gift” from Big Pharma? Or a Trojan Horse? Or a bit of both? Here are some comments we have received as we have asked our colleagues what they think of these new rules.
1. This is big.
Activist groups, such as No Free Lunch, the National Physicians Alliance and Healthy Skepticism, have long wanted to see branded trinkets out of doctors’ offices. This has been reflected in efforts such as No Free Lunch’s Pen Amnesty and NPA’s Unbranded Doctor campaign. It really is quite meaningful that doctors are no longer allow their bodies and their workspaces to serve as barkers for the drug companies. This is big in that sense.
2. This is a small drop in a big bucket leaving the drug companies with many other ways to influence phyiscians and patients.
To put this change in context, it is useful to reflect on the overall size of drug promotion to physicians. According to a 2008 article by Marc-André Gagnon and Joel Lexchin in PLOS: “Pharmaceutical promotion in the United States in 2004 is as high as $57.5 billion compared to the figure of $27.7 billion given by IMS. Excluding direct-to-consumers advertising and promotion towards pharmacists, the industry spent around $61,000 in promotion per practicing physician.”
Well, $61K per doctor clearly is not buying trinkets. What kinds of things are not covered by this exclusion?
1. The industry is still a major player in continuing medical education for physicians. The role of big Pharma in CME was the subject of the August 30, 2008 British Medical Journal which reports that half of all CME is sponsored by pharmaceutical and medical device companies (see Roy Moynihan’s article: Is the relationship between pharma and medical education on the rocks?
2. The industry will still be allowed to give free samples for patients. [It would, of course, be so much nicer if they just took the $57.5 billion spent on advertising and lowered their prices.]
3. The industry can still produce patient education materials and pursue direct-to-consumer advertising. It is not clear if infomercials, like the dreadful CNN Accent Health (hosted by our future Surgeon-General Dr. Sanjay Gupta) will continue to be allowed.
4. Drug representatives will continue to be allowed to give “informational presentations” to physicians along with free lunches.
5. The drug company can still hire physician “experts” to serve as paid consultants and speakers. Members of committees which set drug formularies can be speakers and consultants as long as they disclose this to the drug company.
6. And drug companies can continue to gain access to the prescription history of individual physicians. This may be the Trojan Horse in this gift.
4. These voluntary limits may be intended to forestall legislation with a far wider impact.
Current practice allows the pharmaceutical companies to purchase information on drugs prescribed by individual doctors. This is done without the consent of the physician or the physician’s patients. The American Medical Association colludes with this policy by selling its Masterfile of physicians to the drug companies. Sales of the Masterfile amounted to $44.5 million in income for the AMA in 2005. (This information is drawn from an NPA issue brief). This arrangement has been described as making the drug company “a silent third party in the examining room.” Actually it’s more like the fourth party, because the insurance company also seems to be watching over every encounter. Further background can be found at the NPA site.
New Hampshire, Vermont and Maine have all banned the sale of such data to the pharmaceutical companies, see a posting by the Electronic Privacy Information Center. And a similar campaign is underway currently here in New York State.
In addition there are a number of laws on the books or proposed that would require physicians to make public any gifts or payments by drug companies. Impetus for these laws came from 2007 and 2008 hearings held by Iowa Senator Charles Grassey of the Special Committee on Aging.
Given all these threats, Big Pharma may have decided it was better to get rid of the trinkets.
5. Why didn’t this come from the doctors?
The drug companies are facing an increasingly hostile and critical international movement. Many of the most active members of this movement are physicians. But they seem a minority within medicine. The bulk of physicians seemed content to take trinkets. There was no mass movement of physicians to “unbrand.” And the AMA has been resistant to discontinuing its role in data-mining.
Whose side are we on anyway?
posted by Matt Anderson, MD