Massachusetts reached a significant milestone today in the effort to both measure and manage the extent of pharmaceutical and medical device marketing to prescribers.  The state’s Public Health Council today passed strong regulations that limit gifts and payments to prescribers, and disclose others, completing the  state’s enforceable code of conduct passed last summer.  The code, required to be at least as strong as the PhRMA and AdvaMed voluntary codes, is arguably the strongest in the nation; Minnesota’s first-in-nation gift ban does not apply to medical device companies; Massachusetts’ does. And unlike Minnesota’s standing law, the disclosure info will be posted on a public and easily-searchable database for consumers and researchers.

Among the highlights of the final regulations:

-DPH included trainees in the ban on direct payments for scholarships, CME, and other travel payments. This is a good news for the state of unbiased medical education at Massachusetts many academic medical centers.

-The Council had a good debate on prescription drug samples, and will do further study of the issue of samples as marketing tools and revisit the issue next year.

-DPH interpreted the $50 limit as a floor, meaning gifts under $50 not expressly banned in the law would not have to be disclosed. Since pens, pads, and tchotchkes are banned, this means that a lot of in-office drug lunches will fly under the radar.

-Bona fide payments to investigators for research will not have to be disclosed, but those payments for trials with marketing purposes, such as seeding trials, must be.

Seeding trials, if you’ll recall, are clinical trials whose scientific purpose is tenuous at best: “a marketing trial with a marketing objective,” in the words of the authors of a paper on the Vioxx ADVANTAGE seeding trial. Unlike other, scientifically rigorous clinical trials, seeding trials are primarily designed and carried out by marketing departments with the goal to get doctors to start using their drugs — kind of like beta-testing for gadgets and computer programs, or the little bags of free granola that come wrapped in the Sunday paper. Except with powerful, sometimes lethal pharmaceuticals.

An Internal Merck slide outlined the lead role of Merck’s marketing department in the ADVANTAGE trial: •    Design protocol and oversee execution of trial •    Select investigator sites •    Run investigator meetings •    Choose and manage CRO •    Perform data analyses •    Prepare publications

Historically, drug companies have not been upfront about what a clinically valuable trial and what is a seeding one – after all, what doctor or patient would sign up for a clinical trial that she knew was designed only to create product loyalty? The Council showed a good understanding of the complexity of the issue, and made it clear it that DPH and the Attorney General’s office will be actively seeking signs of such illegitimate trials and sanction companies that don’t disclose them.  And reports today of a Massachusetts-based investigator who fraudulently published 21 clinical trials on the use of painkillers like Celebrex for post-operative pain – studies funded by Pfizer – highlights anew the public interest in knowing a clinical trial’s legitimacy and money trail.

Requiring companies to report all research payments is the failsafe way to ensure such marketing-based trials are recognized and disclosed, and we would have liked to see the Council stand by that original standard. Still, we are encouraged by the Council’s recognition that the corporate marketing aims of seeding trials undermine safe and effective drugs for state residents.

As we prepare for the regs to go into effect July 1, we’ll explore, along with others, ways to identify seeding or other questionable trials in a way that is valuable to regulators who will be protecting Bay State patients by monitoring drug and device payments to doctors.