Policy and Medicine

Massachusetts S2660 – The Sun is Shining in San Diego

Recently, we reported that it would be cloudy for the Massachusetts delegation at BIO 2008. Massachusetts S2660 – San Diego Here We Come.

According to the State News Service, The controversial Senate plan (S 2660) which forbids gifts from pharmaceutical companies to health care workers appears unlikely to survive intact, as Massachusetts state leaders have caught an earful from industry executives while attending an international biotechnology convention this week.

The plan’s leading proponent, Senate President Therese Murray, said researchers have told her the ban would prevent productive interactions between doctors and researchers who are trying to treat the same diseases.

“It’s something that we didn’t discuss when we did it, because we were looking purely at gifts to doctors,” Murray said in a telephone interview with the News Service. “But the fact is that some of these companies do bring researchers and doctors together to go over the latest research.”

“Through what we did, in their explaining, there are many things they won’t be able to do that are important to science,” she said.

Murray said she still wanted increased transparency requirements and an end to excessive gift-giving.

“If we can work out some kind of language that still allows the science but stops the egregious marketing, then I think we’ll be OK, but it’s going to take a little time,” she said.

Murray, Gov. Deval Patrick, and House Speaker Salvatore DiMasi urged an international audience of 250 people here Wednesday to forge business partnerships in Massachusetts.

While the majority of feedback about Massachusetts has been positive, DiMasi said, some pharmaceutical companies have voiced worries about the gift ban, which Murray has pushed as part of her health care cost control package.

The restriction would be the country’s strongest, forbidding all gifts of value from pharmaceutical company agents to health care workers or the workers’ families. The pharmaceutical industry has fought back, arguing the gifts often allow doctors to learn more about products, and that the ban would have a chilling effect on the industry’s growth here.

Murray reported that most of the pushback she has heard has come from research firms, saying, “It wasn’t Big Pharma, these are research scientists.”

She said prospective reforms could include requiring doctors who write in medical journals to disclose whether and how they were compensated. “There has to be transparency and there has to be some kind of language that protects the consumer, and the state, frankly,” she said.

One newspaper the Quincy Patriot Ledger notes that “Murray said she expects the House will release its version of the bill by the end of June, leaving only one month before lawmakers adjourn from formal sessions for the year on July 31.”

It is important for all state legislators considering these “gift bans” to consider the “unintended consequences “of such bills.  We applaud Senator Murray and the other leaders from Massachusetts for being open minded on this issue, and believe that they are now focused on the right things (better medicine and more transparency without penalizing scientific exchange of information).

   

Asked about the gift ban at a forum in Boston this morning, Patrick chief of staff Doug Rubin said the administration was taking a "wait-and-see approach" and picking up the issue would be “premature.”

Massachusetts S2660: Should Gifts Be Banned?

This week New England Cable Network aired an interesting debate: Should Gifts Be Banned?   Thomas Stossel, MD, Chief of Translational Medicine at Harvard was interviewed with Daniel Carlat, MD, community psychiatrist and critic of all ties to industry.

The opening of the program states:

The Senate has passed a ban on pharmaceutical company gifts to physicians. It applies to everything from free pens and notepads to free lunches and tickets. It argues that we all pay higher drug prices and perhaps take unnecessary drugs, because of the influence that gifts have on doctors.

But this is not a ban on just gifts, in the current definition of gifts it includes everything from support of continuing medical education to doctors, to investigator initiated research.

Several key points in the program included:

The effects of S2660 on Conventions in Boston (in the current definition any contributions for the educational event by industry including exhibit fees could be considered a gift to participants and thereby banned which would cost the state Billions in convention business).

The department of health will have to approve all payments to physicians for science and research.  This will tie up valuable resources in small research companies in justifying expenses to the state.

This is so “draconian” that it would ban Spanish language diabetes literature to be given out at community centers in Massachusetts.

A real question around this is: do these small “gifts” truly corrupt doctors.

In answer to this both panelists agreed:

“Medicine is so much better today than it was forty fifty years ago, if doctors were corrupted by gifts, these gains would be impossible.”

Enjoy the show: Should Gifts Be Banned?

Massachusetts S2660 -- Coming Soon

According to a Boston Globe editorial Massachusetts S2660 section 26 may be taken up sooner rather than later in the session : A far-reaching cost containment bill supported by Murray has cleared the Senate and is awaiting House action, which DiMasi (house speaker) promised is coming soon.

Of course they support the gift ban, as good for the state not bothering to explain all the implications of including everything including CME and research funding as a “gift”.

“gift ban .. provoked opposition from the catering industry” (our friends at restaurants to You are making a difference). 

In the editorial -- Drug companies would no longer be able to roll out “free lunches” to attract physicians  to informational meetings.  But a doctor’s prescription patterns should not be swayed, even a little bit, by food or other gifts.  There seems to be no consideration that perhaps this is not what is best for the economy of the state of Massachusetts.

The Globe Editorial board thinks “Murray’s proposal should become law”.  They even admit that “a ban on free lunches is nothing compared to the other changes that will be required to make health reform work.” 

The legislature should focus on what will make the reform work and leave the lunches to the catering industry. 

This is a call that the legislators need to hear from us soon.

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 1^st 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

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….

GSK Exec Expresses Concern to Massachusetts Leadership

This week, Christopher A. Viehbacher, president U.S. Pharmaceuticals GlaxoSmithKline, sent a letter to the leadership in Massachusetts  suggesting his firm might not invest as much in Massachusetts if “political developments” work to “devalue” its assets here. 

"Some Massachusettes political leaders, meanwhile, seam to go out of their way to attach and demonize an industry that those in other parts of the country are desperate to have." 

According to the Boston Herald, Glaxo Exec Blasts State the Governor and House leadership were stunned.

It’s important that the leadership of the State of Massachusetts understand the consequences of apdotion of Section 26 of S2660 to the pharmaceutical and medical device industries.  And especially the bill's negative impact on education and research in the Commonwealth of Massachusetts.

Impact of Massachusetts S2660 Section 26

In a departure from our typical postings we have been working to whittle down into one page sheets what Section 26 of S2660 will mean to Physicians, Patients and Researchers in the State of Massachusetts. The bill outlaws all gifts to physicians and the definition is quite expansive and includes anything related to marketing or services without direct contracts including CME.

This bill has implications nationwide in that many CME faculty and researchers come from Massachusetts.

Bellow are links to three documents to help you understand how this bill effects different groups:

S2660 Section 26 Impact on Physicians

S2660 Section 26 Impact on Clinical Research

S2660 Section 26 Impact on Patients

If you agree with our points, please alert your friends and business associates in Massachusetts, or if you live in the state, write a letter, call or email your state representative or the Speakers office.

Representative in Massachusetts or

the Speaker of the State House of Representatives. 

Massachusetts residents search for your district by city or town.

This bill passed the State Senate 36-0 on April 17th and is moving quickly through the State House.

To track bill process of 2660 in State House

Massachusetts – Smelling Very Fishy

Senate Bill 2650 has been renamed SB2660.

After re-reading the bill and discussions with friends on the ground in Massachusetts we discovered that S2660 chapter 268c. not only outlaws CME payments, honorarium, consulting and travel, but also requires reporting on all other payments or benefits given to healthcare providers by third parties, this includes research, scientific discovery, stock payments,  investigator expenses,…..  and does not allow companies to keep any “trade secrets” in the selection of experts.  This is not just for companies based in Massachusetts, but all companies all across America who utilize medical experts from the Boston Area.

The Bill States:

(a)(1) By July first of each year, every pharmaceutical or medical device manufacturing

company shall disclose to the department of public health the value, nature, purpose, and recipient of any fee, payment, subsidy, or other economic benefit not prohibited in Section 2, which is provided by the company, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or any other person in this state authorized to prescribe, dispense, or purchase prescription drugs or medical devices in this state. For each expenditure, the company must also identify the recipient and the recipient’s address, credentials, institutional affiliation, and state board or DEA numbers.

(b)(1) Information submitted to the department of public health pursuant to this section shall be a public record except to the extent that it includes information that is protected by state or federal law as a trade secret.

(2) Notwithstanding any other provision of law, the identity of health care practitioners and other recipients of gifts, payments and materials required to be reported in this chapter shall not constitute confidential information or trade secrets protected under this section.

This section alone would shut down Biotech in the State of Massachusetts, as one violation of remembering that you bought coffee for a doctors during an investigators meeting and you break the law, also all your investigators would be listed in a database for potential shaming and lawsuits…  I see no upside on this legislation.

This is a license for anti industry advocates to file violations for everything we do.

Your not welcome  here

Back on the education provisions under the proposed law, we would have to kick out Massachusetts doctors who attend all medical conventions that receive funds from exhibits or have supporters for the education because some nut will come around and note (Oh doctor s___ was at the meeting, the meeting received support from companies and had __ exhibitors)  we can fine all the companies who exhibited $5,000 for each doctor who attended from the state of Massachusetts, and all the doctors for each company that exhibited.  If just ten doctors came to the meeting from Massachusetts and ten companies had exhibits or support, we are looking at ($1,000,000) in potential fines as each company would be fined for each doctor that participated and each doctor would be fined for each company that supported the event.

Just for Fun

Guess who was exempt from all these restrictions – Journals - -my guess is that the editors of JAMA and NEJM (I guess you don’t want the Massachusetts medical society to be against the bill), have cut a deal get rid of everyone from the sponsorship system except them, the sames ones calling for a complete end to commerical support, how nice of them to do that, no double standard here only purity and money….

The bill states:

Nothing in the section shall: Prohibit the provision, distribution, dissemination, or receipt of peer reviewed academic, scientific or clinical information.   Nothing in this section shall prohibit the purchase of advertising in peer reviewed academic, scientific or clinical journals.

Massachusetts 2.0

The text of the amendments to Massachusetts Senate Bill 2526 (amendments) became available on Monday, and one of the amendments ( S2650 amendment on pharmaceutical conduct ) to replace the gifts to physicians portion of the bill  was worse than before, even though the ammendment takes out the criminal penalties (now $5,000 to each party involved in each infraction) .  The definition of gifts is very broad and encompassing. 

The devil is in the details, limiting “gifts” that sounds from the face of it like a good idea. The problem comes in how you define gift in this bill ( “Gift", a payment, entertainment, meals, travel, honorarium, subscription, advance, services or anything of value, unless consideration of equal or greater value is received and there is an explicit contract with specific deliverables which are  not related to marketing and are restricted to medical or scientific issues).

The words “not related to marketing and are restricted to medical or scientific issues” by leaving out education could mean CME,  the words not related to marketing could include “focus groups, consulting, dinner meetings, board fees, stock options including founders stock, promotional events, journal reprints, medical books….. (they have value).  Also there is no definition on what is meant by restricted to medical or scientific issues.

For CME it would be calamitous, lets say you are putting a program together and the best speaker in the country lives in Massachusetts, you would have to disqualify them simply because of where they live, or one step further, if you wanted to have the program in Massachusetts, you could fly in speakers from out of state, but not pay an honorarium to your faculty from within the state or perhaps the event itself may be illegal. (Perhaps this violates the first amendment on free speech and the right of the people peaceably to assemble).

The bill if passes as currently written, would be a disaster to the bio-tech industry of Massachusetts, and have devastating effects on the research institutions that make Boston the largest healthcare economy in the country. Relocation would be on the top of the minds of all research faculty, group practices and many of the biotech companies.

We estimate that this bill could disqualify as many as 20% of our faculty, as the ban covers all honorarium and travel, we would have no way to pay speakers from Massachusetts to travel to events, and no way to pay them for their time speaking.  If you think about it this includes all doctors from Harvard, Mass General, BU, The  Brigham and Women’s, this would limit access to some of the best faculty in the country.   

This bill  which encompasses all types of reforms, is a priority of the Senate President Therese Murray and time is short to help stop this coming tsunami.

On another note Medical Marketing and Media covered this story today with quotes from Thomas Sullivan and John Kamp.

http://www.mmm-online.com/State-Senate-approves-ban-on-gifts-to-physicians/article/109220/

Massachusetts – “Doctor -- Two year prison sentences for that pen”

Prescription drug regulations was part of the huge ” health care cost and quality bill” Massachusetts State Senate President Therese Murray introduced on . 

Of the bill she says: “This legislation represents a defining moment for the Commonwealth,” Senate President Therese Murray (D-Plymouth) said. “Our efforts today are crucial to the future vitality of our health care system and our economy”

The bill, S. 2526, includes a total ban on gifts -- the definition of  a "Gift", a payment, entertainment, meals, travel, honorarium, subscription, advance, services or anything of value, unless consideration of equal or greater value is received.

The bill states:  No pharmaceutical manufacturer agent shall knowingly and willfully offer or give to a physician, a member of a physician’s immediate family, a physician’s employee or agent, a health care facility or employee or agent of a health care facility, a gift of any value and no physician, a member of a physician’s immediate family, a physician’s employee or agent, a health care facility or employee or agent of a health care facility shall knowingly and willfully solicit or accept from any pharmaceutical manufacturer agent, a gift of any value.

Exempt payments are only for those not related to marketing, and restricted to medical or scientific purposes and contracted with specific deliverables.

A person who violates this chapter shall be punished by a fine of not more than $5,000 per violation or by imprisonment for not more than 2 years, or both. (the imprisonment penalty was pulled out of the final version).

The bill also promotes setting up a “academic detailing” program through Mass General and state licensure of pharmaceutical and device sales representatives.

The bill has passed the Senate on April 18^th, (36-0) was sent over to the state house with recommendation.  For up to date bill status:  http://www.mass.gov/legis/185history/s02526.htm Links to press release on the final bill:

A good counter article was published on April 17^th in the Boston globe titled “Conflicts Don’t Sicken Healthcare”  and highlighted in the Wall Street Journal Blog Harvard Doc’s: Bring on the Drug Reps.

This bill if passed will cause a flight of academic faculty to states with more favorable regulatory environments, and effectively shut down the biotech industry of Massachusetts.

Press Release Massachuettes Legislature  4-18-08

At least one state is planning to capitalize on this issue by preparing advertisements for the Boston area newspapers to attract bio-tech companies, prestigious group practices, and academic clinicians to come to a regulatory friendly state.