Policy and Medicine

Massachusetts S2660 -- Governor Remember Your Promise

The Boston Globe published are article on the angst that the life sciences industry of Massachusetts is having over the gift ban that Governor Patrick signed into law earlier this week Life sciences firms anxious about rules on gifts to doctors.

The law, signed by Governor Deval L. Patrick on Sunday, requires pharmaceutical companies and medical device makers to publicly disclose gifts and payments of more than $50 to healthcare professionals and places a ban on certain gifts, such as tickets to sporting events.

It also directs the Department of Public Health to draft extensive regulations restricting companies' marketing practices, using the national pharmaceutical industry's own voluntary "code of conduct" as a starting point. Violations would carry a penalty of $5,000.

But in a letter addressed to lawmakers, Patrick said the new rules are not intended to force companies to disclose confidential information, impede medical research, or block the training of healthcare providers, issues that have all been raised by industry groups and executives. And Patrick said he is confident the state health department could develop regulations consistent with both the law and the state's commitment to strengthen the life sciences sector, a statement that reassured some executives.

"All interested parties will have a full opportunity to participate and comment on the development of those regulations," Patrick said.

At least one company Smith and Nephew announced in the Globe:

They had been planning to expand a medical training facility in Andover to teach doctors how to use its latest tools, but has put the process on hold until it sees the final regulations.   The company wants to make sure the new rules do not bar it from reimbursing doctors for their time and travel expenses.

"We're hoping to work with them on the interpretation of the law so that it doesn't inhibit the industry's or companies' ability to educate surgeons,"

It is important to let the Governor’s office know that education of physicians and surgeons is necessary to the health of the patients in the state of Massachusetts and to stand firm on his promise:

“I am confident the Department of Public Health, pursuant to its regulatory authority, will safeguard the confidentiality of companies’ trade secrets and proprietary information and protect against roadblocks to medical research or the education of health care providers.”

Contact information for the Governor’s Office

The Governor promised to protect against roadblocks to medical research and education of healthcare providers, lets remind him to stick to his promise.

Massachusetts S2660 -- Governor Signs Gift Ban

Over the weekend the Governor of Massachusetts signed into law the Gift Ban. (Boston Globe Article Governor Signs Gift Ban).  As we described in a previous posting Massachusetts S2660 - Gift Ban is a Case Against Nightshift Work, and Massachusetts S2660: Confusing "compromise" on Massachusetts gift ban, this bill is a mess.

The Governor sent a signal that perhaps they would use discretion in meeting the bills requirements:

“This measure will set a marketing code of conduct to help ensure health care providers make choices about prescription drugs and medical devices for their patients based on therapeutic benefits and cost-effectiveness,” said Governor Patrick.  “I am confident the Department of Public Health, pursuant to its regulatory authority, will safeguard the confidentiality of companies’ trade secrets and proprietary information and protect against roadblocks to medical research or the education of health care providers.”

Several legislators are quoted in the Governors Press Release:

“I congratulate the Governor for his action today,” said Representative Pat Walrath (D-Stow), House Chair of the Health Care Financing Committee.  "This legislation lays a firm foundation for the serious kind of cost containment that is necessary if we are to realize the goals of health reform, and I look forward to a continued partnership with the administration as we implement the law."

"Biased marketing and financial inducements are destructive to the sacred doctor-patient relationship.  Evidence based academic detailing enhances this relationship.  Cost controls, disclosure and transparency are imperative as we demand universal access to quality healthcare.  I commend the Governor for standing firmly on the side of the patient and taxpayer," said Senator Mark Montigny, author of the gift ban legislation and a former chair of the Health Care Committee.

The proponents of the Bill Prescription Project, Daniel Carlat,  Blue Mass Group, and Massachusetts Healthcare for All are gloating over this bill.

This bill does nothing but pull resources from developing new medications and devices to filling out forms for the state and a boom to the compliance industry.

In the end, with the loss of high paying research jobs to the state, the state of Massachusetts will regret their decision.

Key Documents:

Governor Press Release

Text of Bill: Gift Ban

Boston Globe Article Governor Signs Gift Ban

Massachusetts S2660 - Gift Ban is a Case Against Nightshift Work

Massachusetts S2660: Confusing "compromise" on Massachusetts gift ban

Wall Street Journal Blog

Prescription Project

Daniel Carlat

Blue Mass Group,

Massachusetts Healthcare for All

 

Massachusetts S2660 -- Industry Sends Open Letter to Governor

This week Boston Globe ran a full page ad in the Boston Globe asking Governor Patrick to make the easy decision and send the Healthcare Containment Bill back to the Legislature.  Bellow is the text of the ad they ran.  It is important that we let the Governor know the grave consequences of such a draconian bill on the healthcare and medical research industry of Massachusetts. 

Also in an op-ed piece in the Globe, the heads of the Biotech and Medical Device councils argue the economic impact to the state will be massive:   New rules hamper life sciences effort

Every day, Governors across the country face difficult decisions. Today, when Governor Patrick arrives at work, he too will be confronted with a difficult decision. On the Governor’s desk sits legislation that could well determine the future of the life sciences industry in Massachusetts.

Over the past year the Governor, the Senate President, and the Speaker of the House have all spoken frequently and forcefully about the enormous importance of the life sciences industry to Massachusetts.

That message turned into an extraordinary collaboration between those three leaders that resulted in the recent passage of the landmark Life Sciences Bill. Indeed that bill, designed to secure Massachusetts’

standing as the epicenter of the life sciences industry, caught the attention of industry leaders across the nation and around the world. While some of the signatories listed below did not advocate for the bill,

it is with a unanimous voice that we join together now.

In fact, Governors everywhere, who have always been extremely envious of the Massachusetts’ Lif e Sciences sector, scrambled to keep pace. The reasons are found in the facts: 55,000 industry jobs in 2005 –

a payroll of over $5 billion across the biopharmaceutical industry – and 15,000 jobs expected by 2014, mostly in research and development. Not to mention the fact that annual aggregate revenues of this industry

in 2002 were $11.2 billion. While these economic impacts are extraordinary, the more basic human reason may simply be pride – this is an industry that develops products that save thousands of lives every

day, and it is being done in Massachusetts.

So, one might ask, what is the difficult decision facing Governor Patrick? Sitting on his desk is legislation

that may well undermine it all. That legislation, promoted by a few special interest groups, begins with a simple premise – demonize an industry and the thousands of professionals that comprise it, including

doctors, for being successful. They make arguments that are designed to appeal to our most basic emotions when they question the relationship between our doctors and industry. They say things that read well in

the press, but lack credibility. They want you to believe that your own doctor is more concerned about the industry, than he is or she is about you as a patient. Is our industry successful, absolutely! Is that

success used to create even better and more effective life saving medications, absolutely! Do we condone, or even tolerate, what they say is a corrupt relationship between our industry and your doctor,

absolutely not!

The Legislation awaiting the Governor’s decision not only demonizes the same industry that we have just spent one billion dollars trying to promote, it also will have a direct and immediate devastating impact on the lives of thousands of people across the Commonwealth. These are your family members, friends, neighbors and countless others who, desperate for a cure for some of today’s most catastrophic medical diagnoses, are enrolled in a clinical trial. These clinical trials, which frequently are a person’s last hope for survival, are the way that new, cutting-edge and potentially life saving treatments are developed.

The legislation that awaits Governor Patrick’s decision will significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts. The reason – the legislation requires the

companies that develop these new treatment options to disclose, to their competitors, the products and areas of research in which they are involved. The chilling effect that this will have on the life sciences

industry in Massachusetts could not be more obvious. The impact on the thousands of Massachusetts patients desperate for medical hope will be profound. Clinical trials being done today in Massachusetts

will most certainly only be available elsewhere tomorrow. The hope for so many patients, suffering so much, will be diminished.

Governor, as it turns out, today’s decision is easy.

Biotechnology Industry Organization

Massachusetts Biotechnology Council

Associated Industries of Massachusetts

Massachusetts High Technology Council

Cambridge Chamber of Commerce

Pharmaceutical Research and Manufacturers of America

Massachusetts S2660 - Gift Ban is a Case Against Nightshift Work

Have you ever thought … how does my brain work at 4:00 am after working all day; can I concentrate; can I make accurate decisions?

Well, the Massachusetts legislature has become a case study in what not to do at 4:00 am.  This is when they settled on their final gift ban disclosure legislation.

CME = Non CME

For instance, in their revisions to Section 14 of the Healthcare Cost Containment bill they define CME as Independent Medical Education that does not meet the Accreditation Council for Continuing Medical Education (ACCME’s) Standards for Commercial Support.  This is the exact opposite of the definition of CME. 

They also failed to recognize that not all healthcare providers receive CME.  CME is for MD’s only. This leaves out all the DO’s, nurses, nurse practitioner, physician assistants, pharmacists, technicians, caseworkers, hospitals administrators, those who have separate accrediting organizations and different rules than the ACCME standards for commercial support. 

Financial support for the cost of travel, lodging or other personal expense for non faculty attending a scientific conference  except in cases as determined by the department (ACCME rules don’t allow this any way, but the real shot on this one is against advisory boards).

Supervised Office Lunches

For meals, the rule is even more confusing.

Under these circumstances meals are prohibited:

·         As part of entertainment or recreational event; (The problem here is what if a pharmaceutical or device company is asked to support the “race for the cure” even national sponsorship would have to be discontinued. “How do you stop a doctor’s wife from participating” as this would be prohibited under this language)

·         That are offered without an informational presentation made by a pharmaceutical agent or without a pharmaceutical marketing agent being present (so if you are a device company, you better bring along a Pharma rep!)

·         That are offered, consumed or provided outside of the healthcare practitioners office or hospital setting, (so no meals at any restaurants, any outside event - so again "race for the cure" sponsorship is banned)

·         The provision of or payment for meals directly (not sure what this is) at any CME event, third-party scientific or educational conferences or professional meetings.  (I think this means that companies can pay the meals directly, but who knows since the language is very confusing).

Yes You Can

The code does allow for:

·         Distribution and Dissemination of “peer reviewed” academic, scientific or clinical information

·         Purchase of Advertising in peer reviewed journals

·         Drug Samples for the patients use

·         Professional or Consulting Services in connection with a “genunine” research project or clinical trial

·         Payment for expenses on technical training for medical devices

Who Knows

What is not disallowed or allowed are:

·         Market Research and Consulting

·         DTC and Professional Internet Advertising

·         Product Brochures – Product Materials

Training Your Children Well

There are also provisions for training employees on the code, annual audits of compliance to the code, policies and procedures for investigating instances of non-compliance with the marketing code of conduct and to take corrective action in response to non compliance, and identification of a compliance officer.  (This way the state can use the companies' own resources to investigate infractions.)

Report Everything

The Value Nature and Purpose of:

Any Fee, Payment Subsidy or other economic benefit with a value of at least $50, which the company provides directly or through its agents to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the commonwealth.

This will have a chilling effect to biotech industry in that every payment for consulting, research or anything else will be reported. A new company operating in the state will have to divulge who is doing their research well in advance of filing a patent.

Big Fines

Oh, by the way if you miss something, there is a $5,000 fine for each transaction, occurrence or event that violates this chapter. 

Massachusetts S2660: Confusing "compromise" on Massachusetts gift ban

     There was a confusing compromise leading to the passage of a modified gift ban by the Massachusetts legislature this week.

      The Associated Press reported Friday that the Massachusetts legislature passed and sent to the governor for signature a bill requiring pharmaceutical and medical device manufacturers to report gifts over $50 to health care practitioners. (See link at end of posting.) At the same time, the bill did outright ban certain types of gifts and meals.                  

      A major reason given for the bill was to slow health care spending increases. Only time will show if it can accomplish what it claims. The Massachusetts public healthy agency will have to write regulations and hire staff to enforce the bill. This diverts tax dollars from direct health care. Pharmaceutical and medical device companies will need to spend more time on record-keeping and filing reports. Certainly for most companies this will involve added expenses, which are passed on to the consumer in the form of higher prices! This hardly seems the right approach to bring down health care spending, or to increase the effectiveness of care! 

                                    

      The key contention of the bill’s supporters has yet to be demonstrated, that gifts from companies is the cause of higher spending on prescriptions.                              

      On the other hand, while there’s no mention of it in the Associated Press article, one concern of the bill’s opponents may lead to reconsideration of the law. The legislation itself and the regulations to implement the bill may have a “chilling effect” on medical research companies doing work in Massachusetts. Once they start pulling out of the state, will the legislature notice?                                                                  

      The final bill didn’t ban all gifts, as the earlier version of the bill, passed by Massachusetts State Senate, had done. However, the language is still sweeping, and gives the public health agency plenty of leeway to write broad regulations.  For instance, meals provided by a company to a health care practitioner “outside of the health care practitioner’s office or hospital” are banned, as are meals provided to a practitioner’s spouse (what if a couple work in the same office?). This sounds ridiculous, but the prohibition means a medical device company wouldn’t dare contribute to a civic pancake breakfast in a Massachusetts community for fear a local nurse or doctor would be in attendance.

       Or if a medical research company suggested several doctors meet for dinner, the company couldn’t pick up the tab. The prohibition is regardless of the $50 threshold!                                                                                  

Here’s the text of the legislation:

CHAPTER 111N

PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURER CONDUCT

Section 1.  As used in this chapter, the following words shall have the following meanings:

"Department", the department of public health. 

"Health care practitioner", a person who prescribes prescription drugs for any person and is licensed to provide health care, or a partnership or corporation comprised of such persons, or an officer, employee, agent or contractor of such person acting in the course and scope of his employment, agency or contract related to or in support of the provision of health care to individuals.

"Marketing code of conduct" practices and standards that govern the marketing and sale of prescription drugs or medical devices by a pharmaceutical or medical device manufacturing company to health care practitioners.

"Medical device", an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is: (1) recognized in the official National Formulary or the United States Pharmacopeia or any supplement thereto; (2) intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, in persons or animals; or (3) intended to affect the structure or function of the body of a person or animal, and which does not achieve its primary intended purposes through chemical action within or on such body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

"Person", a business, individual, corporation, union, association, firm, partnership, committee or other organization.

"Pharmaceutical or medical device manufacturer agent", a pharmaceutical or medical device marketer or any other person who for compensation or reward does any act to promote, oppose or influence the prescribing of a particular prescription drug, medical device, or category of prescription drugs or medical devices; provided, however, that "pharmaceutical or medical device manufacturer agent" shall not include a licensed pharmacist, licensed physician or any other licensed health care practitioner with authority to prescribe prescription drugs who is acting within the ordinary scope of the practice for which he is licensed.

"Pharmaceutical or medical device manufacturing company", any entity that participates in a commonwealth health care program and which is engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs or medical devices, either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, or any entity engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that

"pharmaceutical or medical device manufacturing company" shall not include a wholesale drug distributor licensed under section 36A of chapter 112 or a retail pharmacist registered under section 37 of said chapter 112.

"Pharmaceutical or medical device marketer", a person who, while employed by or under contract with a pharmaceutical or medical device manufacturing company that participates in a commonwealth health care program, engages in detailing, promotional activities or other marketing of prescription drugs or medical devices in the commonwealth to any physician, hospital, nursing home, pharmacist, health benefits plan administrator, other health care practitioner or person authorized to prescribe, dispense or purchase prescription drugs; provided, however, that the "pharmaceutical or medical device marketer" shall not include a wholesale drug distributor licensed under section 36A of chapter 112, a representative of such a distributor who promotes or otherwise markets the services of the wholesale drug distributor in connection with a prescription drug or a retail pharmacist registered under section 37 of said chapter 112 if such person is not engaging in such practices under contract with a manufacturing company.

"Physician", a person licensed to practice medicine by the board of registration in medicine under section 2 of chapter 112 who prescribes prescription drugs, or the physician's employees or agents.

"Prescription drugs", drugs upon which the manufacturer or distributor has placed or is required by federal law and regulations to place the following or a comparable warning: "Caution federal law prohibits dispensing without prescription".

Section 2.  Notwithstanding any general or special law to the contrary, the department shall adopt a standard marketing code of conduct for all pharmaceutical or medical device manufacturing companies that employ a person to sell or market prescription drugs or medical devices in the commonwealth.  The marketing code of conduct shall be based on applicable legal standards and incorporate principles of health care including, without limitation, requirements that the activities of the pharmaceutical or medical device manufacturer agents be intended to benefit patients, enhance the practice of medicine and not interfere with the independent judgment of health care practitioners. In promulgating regulations for a marketing code of conduct, the department adopt regulations that shall be no less restrictive than the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America and the Code on Interactions with Healthcare Professionals developed by the Advanced Medical Technology Association.

The marketing code of conduct adopted by the department shall not allow:

(1) the provision of or payment for meals for health care practitioners that:

           (a) are part of an entertainment or recreational event;

            (b) are offered without an informational presentation made by pharmaceutical marketing agent or without the pharmaceutical marketing agent being present;

            (c) are offered, consumed, or provided outside of the health care practitioner's office or hospital setting; or

            (d) are provided to a healthcare practitioner's spouse or other guest;

(2) the provision or payment of entertainment or recreational items of any value, including, but not limited to, tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips, to any health care practitioner who is not a salaried employee of the company;

(3) sponsorship or payment for continuing medical education, in this section referred to as CME, also known as independent medical education, that does not meet the Accreditation Council for Continuing Medical Education Standards For Commercial Support, or that provides payment directly to a health care practitioner;

(4) financial support for the costs of travel, lodging or other personal expenses of non-faculty healthcare practitioners attending any CME event, third-party scientific or educational conference, or professional meetings, either directly to the individuals participating in the event or indirectly to the event's sponsor, except in cases as determined by the department.

(5) funding to compensate for the time spent by health care practitioners participating in any CME

event, third-party scientific or educational conferences, or professional meetings;

(6) the provision of or payment for meals directly at any CME event, third-party scientific or educational conferences, or professional meetings;

(7) payments in cash or cash equivalents to healthcare practitioners either directly or indirectly, except as compensation for bona fide services;

(8) any grants, scholarships, subsidies, support, consulting contracts, or educational or practice related items to a healthcare practitioner in exchange for prescribing prescription drugs or using medical devices or for a commitment to continue prescribing prescription drugs or using medical devices.

The marketing code of conduct adopted by the department shall allow:

(1) the provision, distribution, dissemination or receipt of peer reviewed academic, scientific or clinical information;

(2) the purchase of advertising in peer reviewed academic, scientific or clinical journals;

(3) prescription drugs provided to a health care practitioner solely and exclusively for use by the health care practitioner's patients;

(4) compensation for the substantial professional or consulting services of a health care practitioner in connection with a genuine research project or a clinical trial;

(5) payment for reasonable expenses necessary for technical training on the use of a medical device if that expense is part of the vendor's purchase contract for the device.

The department shall update the marketing code of conduct no less than every two years. The department may promulgate regulations or other guidelines as necessary to implement this section.

Section 3. No pharmaceutical or medical device manufacturer company or pharmaceutical or medical device manufacturer agent shall knowingly and willfully violate the marketing code of conduct as adopted by the department.

Section 4.  (a)  A pharmaceutical or medical device manufacturing company that employs a person to sell or market a drug, medicine, or medical device in the commonwealth shall adopt and comply with the most recent marketing code of conduct as adopted by the department.

            (b)  A pharmaceutical or medical device manufacturing company that employs a person to sell or market prescription drugs or medical devices in the commonwealth shall adopt a training program to provide regular training to appropriate employees including, without limitation, all sales and marketing staff, on the marketing code of conduct.

            (c) A pharmaceutical or medical device manufacturing company that employs a person to sell or market prescription drugs or medical devices in the commonwealth shall conduct annual audits to monitor compliance with the marketing code of conduct.

            (d) A pharmaceutical or medical device manufacturing company that employs a person to sell or market a prescription drugs or medical devices in the commonwealth shall adopt policies and procedures for investigating instances of noncompliance with the marketing code of conduct and take corrective action in response to noncompliance and the reporting of instances of noncompliance to

the appropriate state authorities.

            (e) A pharmaceutical or medical device manufacturing company that employs a person to sell or market prescription drugs or medical devices in the commonwealth shall identify a compliance officer responsible for operating and monitoring the marketing code of conduct.

Section 5. A pharmaceutical or medical device manufacturing company that employs a person to sell or market prescription drugs or medical devices in the commonwealth shall annually submit to the department: (i) a description of its training program; (ii) a description of its investigation policies; (iii) the name, title, address, telephone number and electronic mail address of its compliance officer; and (iv) certification that it has conducted its annual audit and is in compliance with the marketing code of conduct.

Section 6.  (1) By July 1 of each year, every pharmaceutical or medical device manufacturing company that employs a person to sell or market a drug, medicine,chemical, device or appliance in the commonwealth shall disclose to the department of public health the value, nature, purpose and particular recipient of any fee, payment, subsidy or other economic benefit with a value of at least $50, which the company provides, directly or through its agents, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, health care practitioner or other person in the commonwealth authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the commonwealth.  The disclosure shall be accompanied by the payment of a fee, to be determined by the department, to pay the costs of administering this section.

(2) The department of public health shall make all disclosed data publicly available and easily searchable on its website.            

(3) The department of public health shall report to the attorney general any payment, entertainment, meals, travel, honorarium, subscription, advance, services or anything of value provided in violation of the market code of conduct as adopted by the department of public health.

Section 7.  This chapter shall be enforced by the attorney general, the district attorney with jurisdiction over a violation or the department of public health.

A person that violates this chapter shall be punished by a fine of not more than

$5,000 for each transaction, occurrence or event that violates this chapter.

http://www.boston.com/news/local/massachusetts/articles/2008/08/01/bill_requires_drug_companies_report_doctor_gifts/

Massachusetts S2660 -- Time to Encourage the State Senate

Today the Boston Globe reported that House OKs healthcare bill without ban on gifts

The Massachusetts State House passed the comprehensive medical reform bill without the ban on “gifts” to physicians.  They also delayed until 2009 the provision against the use of prescription data.  The state house also voted down an amendment that would have restored the original language of the State Senate bill.

The proponents of the “gift ban” are still trying to get the state senate to override the house and keep the “gift” ban.    One group Health Care for All, stated “We’re hopeful we’ll prevail and we’ll get a gift ban that may not look exactly what the Senate proposed, but is much stronger than what came out of the House today,”

Today if you live in the commonwealth of Massachusetts now is the time to let your State Senator know that you support the language of the State House for the Medical Reform Bill and the changes that they made for the gift ban. 

These changes represent responsible legislation and will continue to foster communincation to bring state of the art medicine to the citzens of Massachusetts.

Attached is a link to State Senate's contact information:

Link to: Massachusetts State Senate

Massachusetts Current Version of Bill: Massachusetts house bill 4974

Boston Globe Article: House OKs healthcare bill without ban on gifts

Massachusetts S2660 -- Gift Ban Goes Bye Bye

In a move that shows legislators in Massachusetts understand the need for manufactures and physicians to continue to work together to bring state of the art medicine to the patients in Massachusetts: A ban prohibiting manufactures from giving gifts and meals to doctors was removed from S 2660 by the Joint Committee on Healthcare Financing. The bill is now known as Massachusetts house bill 4974.

The new language includes:

-       Companies are required to adopt a marketing code of ethics, such as the PhRMA and AdvaMed Codes (similar to Nevada law). Section 111N, Chapter 112 (Page 20-23)

o   Training on the Code of Conduct to Employees

o   Annual Audits of Compliance to the Code

o   Policies in Place for Investigating and Reporting instances of Non-Compliance

o   Identification of the compliance officer at the company

-       Includes a ban on the sale of prescription data (identifying doctors or patients). Section 15, Chapter 112 (Page 23-26)

-       It also kept intact the Senate’s proposal for Academic Detailing (where doctors are paid by the state to go out and give talks on evidence based medicine and the benefits of generic drugs). Section 5, Chapter 111 (Page 12-13)

The committee also dropped requirements that drug and device firms disclose consulting and speaking fees to physicians.

Patricia Walrath, House Chairwomen of the Joint Committee on Health Care Financing told the Globe that her committee striped out the gift ban language because pharmaceutical and biotech leaders told law makers it could chill industry-funded educational conferences that bring doctors together with researchers.  “We were very concerned that the Senate language would deny (doctors and researchers) the kind of information they need, she said “One could interpret (the Senate’s Version to mean) they would not be able to get anything.”

The house is expecting to vote on this today.

One person who realy went out of his way to make a difference is Kevin Abt at ResturantsToYou.com, he put in perspective the effects that these types of proposed bans can have on small businesses throughout the country. 

This is a clear victory for the voices of reason, the new PhRMA code covers most of the concerns expressed by legislators and should serve as a model for other states. 

Massachusetts Current Version of Bill: Massachusetts house bill 4974

Wall Street Journal Blog:  Plan to Ban Industry Gifts to Docs Stalls in Massachusetts

Boston Globe: House panel drops ban on drug industry gifts to doctors

Pharmalot: Massachusetts Gift Ban Is Removed From Bill

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.