Policy and Medicine

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….

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.

Sunshine in the Senate - Organizations Line Up Behind it

PhRMA and AvaMed and several companies including  Merck and AstraZeneca line up behind revised Physician Payment Sunshine Act. 

In addition to press releases the organizations sent letters to Senator’s Grassley and Kohl announcing their endorsement: PhRMA’s endorsement letter  AdvaMed’s endorsement letter.  This is following up from Eli Lilly’s endorsement last week.

Senator’s Grassley and Kohl see these endorsements as very positive:

This movement toward transparency is good for the system.  It fosters accountability by empowering consumers and other watchdogs,” Grassley said.  “The kind of support that continues to grow from industry leaders contributes in an important way to achieving new nationwide requirements.  Requiring disclosure of payments to doctors doesn’t mean that anything has to change, and if there’s nothing to hide, there’s no reason to worry.  The legislation we’re working to get passed would apply to drug makers and medical device manufacturers of every size.  It would make information about payments to doctors, and not just big payments, available to the public in a user-friendly way.  It builds on and improves the important state-level

initiatives that revealed important concerns and set the stage for federal reform.”

This is different that the previously introduced Act in that:

·         Reporting Starts in 2011 vs. Immediately

·         Excludes gifts and consulting of less than $25.00 and requires reporting of aggregate of over $500/year.  Previously required reporting of all gifts over $25.00

·         Limits fines to $50,000/year for non intentional violations and $250,000/year for intentional violations

·         Requires reporting by all companies regardless of revenue, previous bill applied to companies with revenue of $100 million or greater.

·         Provides pre-emption of state laws, so that current state laws on disclosure would be invalidated upon enactment of this law.

·         Delayed reporting for product development and clinical investigations by two years, this proprietary research.

·         Exempts

o   Sample

o   Educational materials for patients

o   Training and other Education

o   Transfers not acting in a professional capacity

o   Loans for equipment purchases

o   Warrantees

o   Discounts

o   Anything bellow $25.00 indexed to CPI

o   In kind items used in charity care

So what does this mean for CME?

Education is included in the first section only to capture education that is not intended for patient benefit. Education intended to benefit patients is excluded.

We understand this may exempt CME – in that that companies only have to report direct payments to physicians/physician practices, as well as payments that are directed by a physician to another entity or on behalf of a physician. 

So if a company is directed by Physician A to make a payment to a CME provider, that would be reportable.  If a company makes a payment to a CME provider to specifically pay for the attendance of Physician B, that would be reportable.  But if a company makes a payment to a CME provider that is for general use by the CME provider and is not tied to a specific physician, that would not be reportable.  We are working to gain further understanding of this issue.

This is a much different track than the House version, which would have no limit on fine, includes CME and would eliminate tax exemption for marketing upon the first violation weather intentional or not.

For other articles we have written on this topic:

Physician Payment "Sunshine -Version 3.0"

House Introduces Sunshine Act – adds guilt by association and one strike and your out.

AMA CEJA -- NAAMECC and the Coalition Respond

The Coalition for Healthcare Communication and the leading CME professional organization of private CME providers, the North American Association of Medical Education and Communication Companies (NAAMECC), issued letter to the AMA urging delegates of the American Medical Association to revise or reject Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine

Here is a summary of the letter:

We read with great interest the recent. We appreciate and support several of the report’s summary statements regarding education, including:

•   The need for physicians to “maintain their clinical knowledge and skills through continuing medical education and other professional development activities.”

•   The need to “sustain ongoing, productive relationships with the pharmaceutical,biotechnology, and medical device companies” in order to “promote continued innovation and improvement in patient care,” and

•   The requirement to “provide clinical training which ensures that current and future generations of physicians are competent and caring.”

While the Council, NAAMECC and the Coalition share several mutual goals, they requested that the report and its specific amendments and recommended changes be referred back to CEJA for significant modification, because of critical concerns with accuracy and validity in three main areas, as follows:

1.    The report findings promote a significant misunderstanding and confusion regarding the dramatic differences between certified CME and other non-certified “education” cited.

The report terms a variety of activities as “professional education” such as “industry marketing and promotional activities, personal expenses associated with attendance at meetings, educational travel grants for medical students, free lunches…These activities are lumped in with certified CME (Continuing Medical Education), when in fact they are significantly different.  The report concludes that since, for example, receiving a free lunch looks like it might affect a doctor’s professional judgment, we should eliminate any connection between companies which are set up to make a profit from medical communication and innovation and training medical professionals.

The report appears to ignore the fact that commercially supported, certified CME is managed by professionals whose organizations must comply with ACCME (Accreditation Council for Continuing Medical Education) accreditation requirements.

2.    The report includes possible misinterpretation and/or misuse of data and conclusions, especially regarding the few instances of data that specifically address certified CME.

The CEJA report cites three studies implying that commercial support for continuing education is bad for the system. Two of them pre-date the ACCME Standards for Commercial Support of CME activities. While the initial Standards for Commercial Support were developed in 1992, the report cites a 1988 study stating that physicians prescribe a company drug more often “after attending a company-supported CME event.”  The CEJA report also cites a 1986 study stating that CME programs “give more favorable treatment to company products” than other programs.

(Note: Even these two reports scarcely seem like a reason to make a sweeping financial and policy change.  For instance, in terms of the 1988 study, is it possible that the doctors prescribed a drug more often because they became aware of its benefits; and hadn’t been before?  Would we prevent a seed company from supporting an agricultural innovation seminar because following the seminar more farmers were aware of the yields from that particular variety of seed?)

However, the “smoking gun” report used by the CEJA states: “One study estimated that for every $1.00 industry spent on CME programs and other meetings yielded on average $3.56 in increased revenue.” Yet the study cited has very little to do with certified CME.

In fact, the figures quoted in the study cover “Physician Meetings & Events,” which include such non-CME activities: teleconferences, videoconferences, third party: (conducted by a moderator) focus groups or personal interviews. The study cited never mentions the term “CME” in any of the “Physician Meetings & Events” listed. The study objectives are to “measure the ROIs for detailing (DET), direct-to-consumer advertising (DTC), medical journal advertising (JAD), and physician meeting & events (PME).” It is clear from the list of PME’s that these include marketing meeting and promotional education activities that are not, in fact, certified CME activities.

3. It offers no alternatives.

The report lacks a detailed proposal to insure the proposed elimination of $1 billion in certified CME funding would improve the quality of certified CME.

I encourage you to read the full letter.

But it might be more appropriate to say: “Will this change really improve medical care and increase the spread of innovation?”

AMA CEJA -- Points of Consideration

We have reviewed the CEJA  recomendations and the following is a quick list of points on why this is such a bad recomedation.  First though there are some points in that ulitmately we both want the same things:

• The need for physicians to “maintain their clinical knowledge and skills through continuing medical education and other professional development activities.”

• The need to “sustain ongoing, productive relationships with the pharmaceutical, biotechnology, and medical device companies” in order to “promote continued innovation and improvement in patient care.”

• The requirement to “provide clinical training which ensures that current and future generations of physicians are competent and caring.”

We also see some areas that should be addressed:

·         The CEJA committee ignores the vast body of existing ethical codes, accreditation rules and government  regulation around CME including the ACCME, FDA, HHS OIG, US and  State Attorney General enforcement, as well as existing CEJA codes.

·         The CEJA Committee failed to recognize the significant differences between Certified CME and non accredited promotional activities.

o   The CEJA report ignores the significant progress over the past decade by ACCME and the industry to ensure the independence of providers of CME from industry funders.

o   It is a document that fails to recognize it’s own “bias, ” including failure to demonstrate fair balance in the reference articles it selected and arguments that it makes. 

·         This policy if adopted likely would create a serious challenge to AMA in keeping existing and recruiting new members.   While physician members expect AMA to protect their best interest and the interest of their patients, this document fails to show how the recommendations would improve their practice and improve patient care.  

·         The policy would negatively affect the income of many current and potential AMA members. 

·         Payment for full cost of all certified CME would be an additional financial burden to physicians and reduce the quality of available CME.

·         The Research Methodology of the report was below the AMA and industry standard for evidence based decision making, particularly insufficient to warrant justification for changing an entire system of post graduate medical education. 

·         The report ignores the value of cooperation between industry and physicians.

·         This proposal will adversely affect major constituencies of the AMA, including specialty societies, hospitals and state societies.

·         Adoption of the report would put the AMA in direct conflict with the most significant recommendations of AAMC’s similar recent report on conflict of interest.

AMA CEJA -- Let's ignore our members

The AMA Committee on Ethical and Judicial Affairs (CEJA) released recommendations that physicians, universities and medical societies must not accept commercial support of educational activities.  Industry Support of Professional Education in Medicine.  These recomendations seem to have ignore significant constituencies at the AMA.

Their recomendations are as follows:

(1) Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities. Examples of such activities include, but are not limited to, industry funding for:

(a) Residency positions and clinical fellowships;

(b) Didactic educational programs, such as live or web-based continuing medical education activities:

(c) Physician speakers’ bureaus; and

(d) Travel, lodging, and amenities for participants of clinically relevant educational programming.

(2) One exception to no industry support of professional education is when new diagnostic or therapeutic devices and techniques are introduced. Given the requirement for technical training on how to use new devices, industry representatives may have to play an educational role because they could be the only available teachers. But once expertise in the use of previously new devices has developed within the professional community, continuing industry involvement in educating practitioners is no longer warranted. Technical assistance or support that industry representatives may provide physicians in the context of patient care (e.g., helping a surgeon in the operating room select the appropriately sized prosthesis components) is not considered professional education and is not ethically inappropriate.

(3) Medical schools and teaching hospitals are learning environments for future physicians at a critical, formative phase in their careers. These institutions have special responsibilities to create and foster learning and work environments that instill professional values, norms, and expectations. They must limit, to the greatest extent possible, industry marketing and promotional activities on their campuses. Examples of such activities include, but are not limited to:

(a) Free food and other industry gifts for trainees and faculty, and

(b) Detailing visits by industry representatives.

Medical schools and teaching hospitals have a further responsibility to educate trainees about how to interact with industry and their representatives, especially if and when trainees choose to engage industry in varying capacities after residency and fellowship training.

(4) The medical profession must work together to:

(a) Identify the most effective modes of instruction and evaluation for physician learners, then;

(b) More efficiently develop and disseminate educational programming that serves the educational needs of all physicians, especially for those who have difficulty accessing continuing medical education (such as those who practice in rural areas); and

(c) Obtain more noncommercial funding of professional education activities.

It is unfortunate that the members of CEJA have elected to completely shut down all arelationships with industry, and failed to see the value of such relationships in patient care.

This recomendation will be voted on at the upcomming AMA meeting June 15-18th in Chicago.  According to knowledgeable sources, CEJA recommendations are regularly rejected or sent back for more work.

Let’s hope the AMA delegates recognize the value of commercial support in helping to providing quality education to their members.  And soundly rejects such a measure.

New York Governor Jumps on the “Gifts to Physicians” Ferry

Governor Paterson of New York announced he is introducing a ban on gifts to physicians.  Though the bill is not available couple of key points:

A)   Ban gifts and payments from drug companies to physicians and other prescribers in excess of $50 per year

B)   Require practitioners who make presentations at Continuing Medical Education (CME) events to disclose any financial relationship they have with drug companies

C)   Require pharmacy benefit managers (PBMs) to disclose information to health plans, doctors and patients.

a.    the actual utilization of drugs by the health plan’s participants;

b.    every policy or practice of the PBM that presents an actual or potential conflict of interest with the health plan;

c.    Any increase in the net price to the health plan for a covered drug and the reason for the increase;

d.    all contracts and agreements entered into by the PBM with a network pharmacy and with any pharmaceutical manufacturer. To prevent PBMs from switching patients to more expensive drugs without the patient’s knowledge and without providing adequate information to the practitioner, the bill requires notification to patients and the provision of relevant clinical and financial information to prescribers before drug switches can be made.

This bill was endorsed by the New York, AARP, Consumer Union, Business and Labor Coalition, and Citizen action.   It is worth noting that the bill is designed to fix problems already addressed:  For CME disclosure it is a ACCME requirement to disclose your relationships. From our expierence it is working, doctors take disclosure very seriously. 

For PBM’s, I don’t know of a single instance where pharmacists are switching patients to brand drugs without their knowlege, but stories every day of un notified switches to gernerics.  This morning, I recieved an email, outlining how it was almost impossible to get a brand drug,  the pharmacist kept switching all his prescriptions to generics.  Even when the doctor writes medically necessary on the prescription, often the pharmacy will not have the branded drug in stock, so they will fill with generic. 

The ban on gifts is also suspect in that the definition for gifts almost always includes services and consulting. 

If you want to read more here is the Reuters Article

So here we go again…..

Macy Report -- Filled in the Blanks

The Macy Foundation published their full proceedings of the conference Continuing Education in the Health Professions:  Improving Healthcare through Lifelong Learning, six months after the initial release of the Macy Foundation’s controversial Chairman’s Conference Summary.

They filled in the blanks with two reports in one: 

A)   Report on how to improve continuing education in the health professions

B)   Report on why continuing education should live free of the burden of raising money for their activities and other encumbrances such as competition from private education companies.

The document opens with a letter from the Macy Foundation President, June Osborn, MD, who seems like a very kind person and who was convinced to do the conference by Susan Fletcher, MD.  She is retiring this year and wanted to go out with memorable report. Susan wrote a note about how she desires that this report is very influential and pontificated. She wanted to repeat the Flexner Report of 1911, a tall undertaking, given they had only three days in Bermuda to do it.

The conference summary (previously released) which we have written on extensively about (Macy Report -- The World is Flat, and Macy Foundation Conference Summary – Tip of the Iceberg?). Not sure how you summarize something that is not done, but they had an IOM event to present this at.

The two reports are:

Report A) Approaches to knowledge development – what works and what does not.

With the exception of the Up-to-date commercial in the middle (no product messages here).  The report goes into detail on how physicians learn and what questions we should be asking ourselves the stuff of good education.

Report B) Financing Continuing Education: Who, How and Why

They go into great detail on the breakdown of finances of CME programs. Some of their figures are based on how they chose to do the math, as opposed to actual figures.  Much of this is a re-hash of old arguments on why physicians should avoid any contact with industry.

They ended up with a discussion on how to change the system of learning, and a lot of this is good stuff.  It is a shame that on one hand they say – look what we could do with additional resources and on the other we despise the resources we have.

Couple of thoughts…

I spoke with one of the chapter writers yesterday and they were clear that

·         Many of the attendees were not in agreement with the anti-industry sentiments and tone of the program.

·         The chairman and steering committee had a pre-determined anti-industry agenda and were not going to deviate from that agenda.

·         This document is really just a report about what happened at their meeting in Bermuda, plus some additional work.

·         The prestigious list at the end of the document are the list of those who attended the meeting, (kind of like this is a list of who attended the any meeting that broke up into working groups) nothing more than that.

Ultimately, it is doubtful it will have the same effect as the Flexner report on Medical Education -- the seminal event that Susan Fletcher, MD was hoping for. 

We need to keep in mind that it is the prerogative of academia to pontificate about their vision of utopia.  Bermuda must have been a great place to do it.

Pfizer Publishes Grants

Pfizer published a list of grants that were given in first quarter 08, this included all charitable and educational grants. 

They had announced in March in a letter to Senator Grassley that this was a work in process.  This is a growing trend in our industry started by Eli Lilly and is being considered by most of the major pharmaceutical companies. 

“We want to bring greater transparency to the way we partner with leading medical, scientific and patient organizations,” said Jeffrey B. Kindler, Chairman and Chief Executive Officer of Pfizer. “Detailing these grants and charitable contributions is an important part of our ongoing transparency drive.”

From first reading of the grants and recipients, these disclosures show just how committed companies are to helping society and include grants for Aids projects in Africa, Malaria Patient Education and Treatment, and a large initiative (approximately 1/3^rd of Grant funds) by the California Academy of Family Physicians and others on reducing smoking to improve public health.

If we disclose, perhaps the outside world will better understand the value of what is being done to educate healthcare providers and others and the value to the medical and patient community.  Click the link for a full listing of recipients and accompanying press release .