Life Science Compliance Update

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20 posts from August 2008

August 29, 2008

ACCME Publishes 2007 Annual Report

Clip_image001                                                                                                      Courtesy FCG Institute

On Monday, we called for the ACCME to publish the ACCME Annual Report for 2007, the report showed up  and these are the results:

The overall size of the CME enterprise has grown by 6.5% in total income, 5.4% in physician participants and 20.8% in number of CME Activities.

Despite the increase in the overall size of CME, Commercial Support was only increased by 1.0%, and commerical support has not grown by any significant rate since 2003.

Commercial Support to Publishing/Education Companies was reduced by -$26.2 million or - 4.2%, Hospital/Healthcare systems by -$10.5 million, -18% and Schools of Medicine by -$13.2 million or- 5.1%.

Commercial Support for Medical Specialty Societies increased by $35.4 million or 18% and non profits increased to $28.9 million or 54.8%.

This information shows a trend that with the exception of non-profits commercial support overall is diminishing and that other sources of income for CME providers are slowly being developed.

CME drew in an additional 1 million participants of which 445,000 were physicians. 

Commercially supported CME though less as a percent of total buget in 2007, contributes to the training of a large number of physicians and allied health professionals; let’s hope the ACCME and others continue to recognize this important point.

Other Key Charts

ACCME - Percent Change in Commercial Support 


ACCME - Year over Year Learners Figure ACCME - Year over Year Activities and Hours Figure

August 28, 2008

Tonight Belongs to Barak Obama

Obama lays out challenge to McCain

America is a great country, where else could a 47 year old first term Senator raised by a single mom and grandparents, become one step away from the Presidency of the United States.   What a crowd.  What an inspiration for the country.  Tonight is a historical night and this night belongs to Barak Obama – Great Job for a Great Speech.  It makes me proud to be an American.

Massachusetts Incoming Faculty Orientation

Massachusetts School of Medicine

Medicine from the 1960’s Works

Dear Faculty Candidate:

We are excited that you are considering joining the Staff of Massachusetts School of Medicine.  This state has been a great one to practice medicine in.  We have had the privilege of having the most researchers and scientists of any state in the US.

The environment has been very conductive to sound research and we have participated in many clinical trials, drug and device development projects.  Our state is home to many pharmaceutical and device research centers as well, so if you later want to work for private industry the transition will be very easy.

Now some things have happened in the state we wanted to make you aware of: 

First earlier this year the State Senate President Therese Murray put forth a bill that would have penalized doctors for doing industry funded research with five year jail sentences under the guise of a “gift ban”.   She received much praise from the media and from the far left fringe groups that are attracted to the state; apparently they spend their summers on Cape Cod and Martha’s Vineyard and some had stayed over for the winter. When Senator Murray announced this bill, she promised to make new cleaner prisons to hold all the physicians in the state and clinics for patients to get medical care while visiting their doctors in prison 

The goal of this was to drive down the cost of medicine in the state (if you as a doctor are in prison or under threat of prison you will only write prescriptions for the medicines the state thinks your patients should receive and miracles of miracles those medicines are all generic). 

The Senate President is a little like your sick rich aunt who always has to get “her way” or have you written out of her “will”.

The good news is eventually she settled on $5,000 fines for each time you happen to initiate a research project and get the fortune of getting it funded.    She let all those other state senators know if they wanted to pass anything this year they better get in line with her, and get in line they did.

But then the State House jumped in and said wait a minute, lets have the pharmaceutical and device companies file with the state their codes of ethics and have them promise to keep them or face penalties for not certifying their correctness.

Well that sounded just fine to everyone, including the Governor, but it infuriated the Senate President Murray (she wanted her way).    So in conference committee (this is where the State House and Senate meet together in small committee to work out a bill) at four in the morning after a very long night, they compromised (actually she got her way), we will give the Senate President what she wants: $5,000 fines for doctors, if you happen to attend a program on a new drug or learn a new procedure and get paid for it.  Or if a company pays you for consulting on any products you develop, or if you get a meal or anything else paid for.  But wait there is more -- the state will also publish a “registry” of all monies you receive for research, consulting and the value of attending an educational event. This will be a public registry for your neighbors to look at, at any time.  All this information will be posted on an easy to use website, easily found, right with other registries like sex offenders.  

Oh there is no stopping your local  criminal from accessing that information as well, and the local trial lawyers are having a party at the pub in South Boston this week to celebrate access to this information (you will love the time you spend in court here defending yourself in product liability lawsuits, you will learn so much history from the time you spend in our courthouses).  If you do happen to leave us in a few years to join a biotech company you will have your entire salary posted on the website, we bet you can’t wait.   

The legislature did add a “academic detailing provision” where doctors can speak on behalf of the state in support of generic drugs.    But we at Mass College of Medicine won’t see any of this because it was all earmarked for Jerry Avorn, MD at Mass General who by coincidence has a company or shall we say moonlighting venture to do this with the same faculty he has at his group at Harvard.

The Governor had the opportunity to send the bill back to work on during the day, but the Governor was in no mood to fight Senator Murray. 

The Governor did promise to safeguard the confidentiality of companies’ trade secrets and proprietary information and protect against roadblocks to medical research or the education of health care providers.”  He keeps his word most of the time.

All of these efforts are designed to encourage you to only write generic drug prescriptions and save the state millions.

The deans at Mass College of Medicine love all this additional scrutiny and barriers that it will create for you to do your job. Our leadership grew up in the sixties and have long held that bio-pharmaceuticals are the best medications.

As a bonus in addition to all this information being tracked, we here at Mass School of Medicine are Pharma Free, so you won’t be doing any research or speaking anyway.  If you do, you have to report it to us and if you get an NIH grant you will have to report it to them.   

We want you to be aware that we take these fines seriously and will be taking away your tenure or all perks the university provides if for some reason you forget.   So Welcome to Massachusetts School of Medicine

-- we hope you don’t change your mind.


Dean Altruism

2008 Leave Us Way

Cheatham, MA 00012


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