PhRMA code gets decoded

July 17, 2008 – 11:41 am

I have been remiss about posting earlier this week, but the magazine layout cycle has begun again, and there are pages to read and meetings to attend. But there was a lot of news toward the end of last week and the beginning of this one, primarily the unveiling of PhRMA’s new codes of conduct for pharmaceutical marketers; FDA deciding against a black-box warning for epilepsy medications; FDA ordering that certain antibiotics should get black-box warnings; the elimination of the proposed pharmaceutical gift ban in Massachusetts; and the United Kingdom’s Medicines and Healthcare products Regulatory Agency publishing a draft guidance on how consumer sites for healthcare services can avoid promoting specific medicines. And shaking up the generics industry a bit, the Justice Department has accused the Indian company Ranbaxy of lying about the quality of its medicines. Ranbaxy rushed to assure investors that its deal with Daiichi Sankyo will not be affected by the investigation. GlaxoSmithKline is making cuts to its consumer division and moving employees from Pennsylvania to New Jersey; and Teva is being rumored to buy Barr Pharmaceuticals.

PhRMA’s new ethics code “business as usual?”

Those who ascribe to the ideology espoused by folks such as Dr. Daniel Carlat seem to think so. At the Carlat Psychiatry Blog, Dr. Carlat shared his satirical take on the new code. “This fictitious document is rumored to be circulating in redacted and top secret email accounts among pharmaceutical executives,” he says. “Read it and weep.”

The Q&A explains that the code will have no real impact on marketing activities, since “the most effective marketing tactics, in terms of ROI (return on investment), are: CME (continuing medical education), promotional speaker’s programs, lunches provided to targeted physicians and staff, and big ticket “educational” gifts, such as $100 textbooks and subscriptions to journals,” and that the decision to ban tchotchkes was “based on feedback from drug reps in the field” because the pens, pads, etc. were “taking up valuable trunk space in their cars, limiting our ability to provide free samples and cherry-picked articles.” As far as restaurant meals are concerned, the Q&A says the ban “applies only to presentations provided by drug reps, not by hired gun physicians. The public doesn’t realize that physicians never wanted to go out to a restaurant with drug reps anyway, because it was a complete waste of their time.”

An anonymous commenter took some issue with this post. “Academics in psychiatry have already been implicated in blatant coverups of their conflict of interest and, even as we write, Senator Grassley is investigating the American Psychiatric Association,” this commenter says. “The very situation that you decry - in continuing medical education, research and elsewhere - is only happening because of the greed of your own colleagues.”

Dr. Carlat obliquely acknowledges this comment in another post, in which he explains that the APA was investigating conflicts of interest among its members long before Charles Grassley’s letter went out. (Meanwhile, at the Cutting Edge Info Blog, Elio Evangelista defends the payments between companies and doctors as an age old practice that does not mean anything controversial.)

Thomas Sullivan at the Policy and Medicine blog lauds the new code. “Overall this is an important step in meeting the expectations of the public, and policy makers,” Mr. Sullivan says. “This is a very clear and concise document that provides a roadmap for ethical interactions with healthcare professionals. These guidelines go along way to showing legislators that the pharmaceutical industry is serious about making sure they meet high ethical guidelines.”

At the Bioethics Blog, guest blogger Summer Johnson, Ph.D., says the code doesn’t quite go far enough. “Moreover, the pharmaceutical industry did not totally buy into the argument about small gifts because their new code does not prohibit bringing meals to doctor’s offices — yet disallows dinners with docs,” she says. “This half-step (the lunch vs. dinner distinction) would appear to be a step in the right direction, but the broad clause of ‘occasional meals’ for ‘informing [doctors] about medical and scientific issues’ allowed in physician’s offices are clauses so vague as to leave enormous discretion for the industry to continue to woo healthcare providers over pizzas and paninis. … let’s hope that this is the end of the pharmaceutical industry’s free lunch, even if they still can give free lunches to healthcare providers.”

At DrugWonks, Peter Pitts says “the Tchatchke Intifada” represents “the caving in by the pharmaceutical industry to misguided political pressure. Silly in the instance of pens and coffee mugs perhaps – but what comes next? A ‘voluntary moratorium’ on DTC advertising? The demonization of published articles on the off-label uses of medicines? It’s a long list.” (Meanwhile, Dr. Robert Goldberg snipes at Senator Grassley about his investigation of the American Psychiatric Association.)

Dr. Howard Brody at Hooked: Medicine, Ethics, and Pharma says with the new code, “PhRMA now admits a serious integrity and credibility problem.” Additionally, he points out that PhRMA seems to be be a bit more serious about getting companies to comply with the code, by posting the names of companies who comply on the Website and require certification of compliance as a requirement to be listed. “You might say this is mostly toothless but it at least offers a few more appearances of teeth than was present in the old code,” he says.

But Dr. Brody also takes a look at the code in the larger context, saying that the ones reponsible in the field from day to day — the sales reps and their district managers — may be the true block in how the code is applied. “The reps get paid their bonuses based on one thing only — how much of the drug they sell,” he says. “The district managers get their bonuses, and do not get fired, based on one thing only — how much of the drug they sell. If you write a code of ethics that restricts their freedom to get docs to prescribe more of their drugs, you are asking these people to forgo their bonuses and to risk getting fired. … As soon as I hear of a drug rep getting paid a bonus based on degree of adherence to the PhRMA code of ethics, instead of sales quantity, then I will start to believe that this industry leopard intends to change its spots. Until then, don’t call me.” The Prescription Project also brought up these compliance concerns in its response to the code.

Jack Friday at Pharma Gossip posts that AstraZeneca has introduced its own program in training staff in a new code of conduct. He links to the site, AZethics.com, where AstraZeneca employees may anonymously report ethics violations.

At the Pharma Marketing Blog, John Mack asks readers to tell him their opinion of the pharma marketing code. And he gets some interesting answers when he asks readers to think of any scenario that may need to be reviewed by PhRMA to determine if it is permissible under the guidelines. (Incidentally, I don’t think 99.9% of the women in the industry depicted in the graphic wouldn’t be able to tell you what hemoglobin is, nevermind what it does.)

And speaking of industry perception, Rich Meyer at DTC marketing has a Dilbert cartoon he’d like to share with you. Sometimes images speak louder than words.

Besides the companies that provide promotional items, there is another “victim” of the elimination of all those little gifts: say goodbye to the Drug Rep Toys blog. This doctor had not posted since May, but now there really won’t be any future posts.

At Pathophilia, Dr. Barbara Martin reviews the code and offers a suggestion to those in withdrawal for drug-rep swag: “type ‘drug rep’ in the eBay search box.” A ton of auctions, mostly for pens, are up as of this search. My favorite: the Sonata lava lamp nightlight (which got snapped up soon after I saw it, thus just the pic to show you). But most swag-o-licious was this optical laptop mouse for Procrit. Let the bidding wars begin!

Around and about …

The blogger at Pharm-Aid references the problems in the Indian pharmaceutical industry that led to Ranbaxy’s problems with the U.S. government. “It would be unfair (and irresponsible) of me to say that all problems in the industry are from firms with Indian origin, or that all Indian firms are committing criminal acts,” this blogger says. “However, even a casual observer of the pharmaceutical industry couldn’t help but notice this trend. As quickly as the FDA has moved to crack down on problems in China, they should be moving even faster in India — the lives of millions of people depend on it.”

At Health + Vision, E. Michael Scott says the first-quarter 2008 downturn in prescriptions should be another wakeup call for the industry. “It is time for the US biopharmaceutical industry to get itself out of the ‘basic care’ business — unless of course it truly believes that we can develop revolutionary products that can actually manage things like hypertension, diabetes, and asthma with a quantum leap in quality over current therapies, most of which either are or soon will be available generically,” he says. “The opportunities to develop and market high value, inventive products that can address real unmet needs in smaller but well-defined market segments are still vast. Such products will not need the huge sales forces and administrative overhead that have characterized ‘big pharma’ for the past 20 years. They need creative thinking, high levels of efficiency in product development and commercialization, and transparent data that support appropriate use of the products.” In other words, biotech?

At Clinical Psychology and Psychiatry: A Closer Look, the blogger picks up this post at Pharmalot by Ed Silverman as a jumping point to talk more in-depth about Martin Keller and whether the new dean of medicine at Brown University should be concerned. “Let me be clear: I’m not advocating that the new Dean do anything in particular,” this blogger says. “I’m not calling for Keller to be canned or anything of the like. However, if I were a Dean (God forbid), then I would be concerned about well-documented issues with one of my big-name faculty, particularly because these issues go to the heart of scientific integrity.”

Although Thomas Sullivan at the Policy and Medicine Blog bids farewell to the proposed Massachusetts gift ban here, he urges state residents to encourage the state Senate not override the state House’s actions and keep the gift ban. So the issue is not quite dead yet …

Who says information about lab equipment has to be boring? Agilent Technology has an online commercial, a hilarious little musical video about mass spectometry. Applied Biosystems has its own music video, this one about PCR machines. And Invitrogen has its own spots for the “NCode Rapid miRNA Labeling System,” featuring burly Angus and bagpipe-playing Dougal.

At the Pharma Blogosphere, John Mack wonders if employers are cracking down on blogs written by pharma employees. I too mourn the blog death of Pharma Giles.

Dr. Derek Lowe again shows us again that in the R&D world, just because you know something exists, you don’t know exactly how it works, in this case, G-coupled-protein-receptors.

And speaking of clinical developments, Peter Pitts at DrugWonks picks up a story about an advance in hepatitis C research.

There is much-needed defense of the pharmaceutical industry at the In Vivo Blog, where Michael McCaughan picks up a statement by Peter Hotez, the director of the Global Network for Neglected Tropical Diseases, during the appointment of former Health & Human Services Secretary Tommy Thompson as the non-profit partnership’s new global ambassador: “‘The pharmaceutical companies are really the good guys.’” But Mr. McCaughan also says, “We would add another reason for industry to pay attention to tropical diseases: a new incentive program that rewards sponsors of drugs approved to treat a qualifying condition with a priority review voucher — good, in theory at least, for a faster FDA review of another, more commercially vital, project.”