Life Science Compliance Update

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20 posts from May 2008

May 30, 2008

Massachusetts S2660 – San Diego Here We Come

Summer in San Diego is so pleasant, warm weather, clear sky - a perfect place for a conference.  So what would make it cloudy for the Massachusetts delegation at the Bio 2008 International Convention meeting in mid June in San Diego? Perhaps it is the proposed  Section 26 of S2660 which according to the AP "Strictly interpreted, the `anything-of-value' ban could bring clinical trials to a halt in Massachusetts, severely cut into necessary and mandated continuing educational studies undertaken by physicians and mean that fewer new medicines are readily available to patients in the state that is the global hub of medical innovation", the Massachusetts Biotechnology Council wrote in their May 1st letter to state legislators.  This is the same ban that Senate President Therese Murray has been pushing for and her version included two year prison sentences for Massachusetts physicians.

Actually, this is the same conference where last year Governor Patrick announced his one billion dollars over ten years, Life Sciences Initiative when the conference was in Boston.  According to his spokesman, Governor Patrick supports the overall bill but is undecided around the gift ban.

The Associated Press had a great article earlier this month around the issue so here goes:

Biotech sees Mass. lawmakers as friends, foes

May 29, 2008

Massachusetts S2660 -- Unintended Consequences

This week Kevin Abt, founder of Restaurants toYou.com, a corporate catering service in Stoughton, Mass. sent letters to Massachusetts legislators outlining the economic impact of S2660 section 26 to just one additional industry, “the restaurant industry”. 

This does not take into account the lost jobs due to conventions being forced to leave the state or the devastation it would have upon clinical research in the commonwealth due to the restrictive nature of the proposed laws.

Restaurants toYou service delivers meals from relatively modest independent restaurants and small chains-in towns like Brockton, Stoughton, Natick, Waltham and Framingham; restaurants like Polcari's, Nocera's (owners of  The Chateau chain), Sunset Grill, Baker's Best, Not Your Average Joe's, Maxi's Deli, Panera Bread, etc.

In his letter Abt says “Since when has a business lunch been at the risk of being outlawed in America?  How could we think that the most highly educated people in the world, the Doctors, could be manipulated by the offer of a ham sandwich and chips from a pharmaceutical or medical device company sales agent?”

Instead, the opposite is true. Doctors routinely ask these reps to go do more research for them, at no cost to the doctor, so that they can have additional information for their individual analysis that they will use to make decisions regarding their patients.

He went on to outline how just one simple aspect of this bill would affect jobs in Massachusetts:

“And how will the Massachusetts economy react to the loss of over $40,000,000 of food sales from local restaurants and delicatessens that are currently the makers of these simple sandwiches and salads for the doctor's "Lunch and Learns"?”

We are not talking about big time expensive dinners as our opponents would like you to believe:

“These doctors are eating sandwiches in the kitchenettes of their office delivered from the corner restaurant, not surf and turf at Morton's. Typical breakfasts and lunches cost $8 to $20 per person with taxes and delivery, not the $60-per-plate meals some must think these companies are buying for doctors in order to get them to see their products.”

The loss of $20,000 per year in food sales from each of over 2,000 pharmaceutical or medical device company sales representatives in Massachusetts alone will hammer the food service industry, resulting in lost jobs, closed restaurants, and lost sales taxes.

In response one legislator stated:

“Thank you for your insights on unintended consequences of the potential prohibition against companies providing doctors with gifts…. I understand your concern about a meal but would compare the doctor being influenced by a meal to a legislator being influenced by a meal. We have the same rules.

The issue is clear that pharmaceutical companies do provide doctors with substantial "incentives" to promote their products. 

Those incentives range from meals to trips to far off places, etc. It is also clear that the cost of those perks is passed on to the patients and others in the health care system.

As we seek to lower the cost of health care, I believe this is an important step.”

Trips to far off places as a gift are a thing of the past, since adoption of the PhRMA code and the AvaMed Code. It is unfortunate that this perception still exists.  Also, it is not clear that any real monies will be saved in the system, if healthcare companies are banned from explaining about their products over lunch.

It is a pity that the legislator is willing to accept “unintended consequences”, devastating small town employers, simply to punish the pharmaceutical and device industries for practices that were ended over five years ago.

This puts it in perspective, that we must speak up against these radical bills, and say enough already.  It is time to begin true dialog with legislators so that they gain an understanding of what is a gift and what is not.

I think next week I am ordering through Restaurants toYou.com and you should do the same….

May 28, 2008

AMA CEJA - Is financial support by disinterested parties the answer?

A basic question needs to be addressed in considering the report of the Council on Ethical and Judicial Affairs of the AMA Industry Support of Professional Education in Medicine

Here it is: 

Why is commercial support of Continuing Medical Education bad?

For instance, if electric transmission equipment companies contribute money to support the costs of holding a summer short course for utility executives, or concrete supply companies support a seminar for practicing civil engineers, would anyone even raise an eyebrow?

“Medicine is different – it involves life and death decisions,” might be the response. There’s no question medicine is unique in the pressures and decisions practitioners face.

But it’s not the only profession involved in protecting people.  For instance, consider the decisions which led to Northeast blackout of 2003 or the collapse of the bridge in Minneapolis.  Those were made by utility executives and civil engineers.

Asking medical device companies to support a summer short course for utility executives might eliminate any possibility of the appearance of bias – but it also requires that we ignore the make-up of human beings and their organizations. Humans support and engage with what they’re interested in – what they’re passionate about. Can we really ask disinterested third parties (whether taxpayers or other sources of funding) to support all continuing education because someone thinks they should? 

Or going beyond that – can we limit people’s expression of their interests and passions?  Doesn’t the CEJA report in effect say: You can’t teach or support continuing education because you’re interested in the subject. 

What do you think the right choice is disinterested or interested parties supporting education, you may want to ask the citizens of Minneapolis, they may have a new perspective.

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