Policy and Medicine

AAMC and Prescription Project --Telling the Future

Wouldn't you like to look into a Chrystal ball and see the future, apparently telling the future is an art at the Prescription Project

On April 25^th, several days in advance of the Report of the AAMC Task Force on Industry Funding of Medical Education the Prescription Project released “Toolkits to Guide Hospitals and Medical Schools with Conflicts of Interest”

The guides follow the same flow as the recommendations coming out of the AAMC taskforce. . 

From the titles of the tool kit modules along with the recommendations in the tool kit it appears that they had significant time to digest the AAMC recommendations and take them several steps further to advance their cause (this to be expected).   

No wonder the Prescription Project was able to provide insights about the report for the New York Times article Group Urges Ban on Medical Giveaways prior to the public release of the report.

All participants in the taskforce signed an oath not to pre-release copies of the report until it became public.

It is disappointing that the AAMC /or some of their participants provided pre-release copies of the document to groups like the Prescription Project. 

The timing is also suspect, the AAMC told several academic physicians and taskforce participants that the report was coming out in mid June.  The Prescription Project must have been fully aware of the change in schedule by the AAMC, which suggests some one(s) at the AAMC gave them the heads up.  Perhaps their webmaster posted their tool kits on Friday, thinking the AAMC report would be released that day, and made a "mistake".

This type of coordination begs the question what role if any did the Prescription Project and the Institute of Medicine as a Profession have in developing the drafts of the report that were submitted to the taskforce.

If the process is to be open for some, it should be open for all.

I guess for AAMC and Prescription Project transparency goes one way or maybe they don't believe that tranparency applies to them, they say transparency is not enough, what if it is not at all.

Or perhaps they were just looking into their chrystal ball.

Open for Interpretation (ACCME Post March Board Notes)

The ACCME on April 17^th posted ACCME summary of March 08 board of directors meeting. 

Key Points:

A)     Expanding office (adding more office space)

B)      Has plenty of money ($5,000,000 in net assets)

C)      They are expanding their education initiatives to include physicians and other healthcare providers

D)     The board met with the Chief Council of the US HHS Office of Inspector General, and an assistant councilor (wouldn't it be interesting to know what they learned).

E)      Offered that the board agreed “that under some circumstances, organizations that are currently exempted from being considered an ACCME-defined commercial interest could become one when they own all or part of an entity that is aligned in partnership with a firm taking an FDA-regulated product to market. 

a.       This may mean that additional provider types (Hospitals, Universities, and Medical Societies) may in the future come under the same rules as medical communications companies and have to adopt firewall policies that are submitted and acceptable to the ACCME.  (See Ask ACCME Standards for Commercial Support 1: Independence)

b.      This was in response to a December 17, 2007 meeting by NAMMECC and the Coalition for Healthcare Communications with the ACCME senior leadership.

Quick Clip

Something positive to start your day,  In this morning’s Boston Globe an op-ed column by David A. Shaywitz, MD consultant and Dennis A.  Ausiello, MD the physician-in-chief of Mass General.  Titled: Scientific research with an asterisk. 

In addition this editorial received coverage from the Wall Street Journal Blog:

Harvard Doc: Academia Needs More Contact With Drug-makers

It is good to know that most physicians are resonable in their expectations of life.

AAMC Taskforce - Better than Reported

The AAMC Released today a comprehensive set of recommendations concerning conflict of interest and interaction with medical faculty at Universities.  The opponents of commercially supported CME (the Prescription Project, and Institute of Medicine as a Profession) took this report as an opportunity to bash our industry in the New York Times.  The report itself is significantly more balanced than the Gardner Harris Article.Group Urges Ban on Medical Giveaways

Report of the American Association of Medical Colleges Task Force on Industry Funding of Medical Education to the AAMC Executive Council (April 27, 2008)

Unlike previous reports on similar issue, this report starts out with the following pre-amble:

“An effective and principled partnership between academic medical centers and

various health industries is critical in order to realize fully the benefits of

biomedical research and ensure continued advances in the prevention, diagnosis,

and treatment of disease. Appropriate management of this partnership by both

academic medical centers and industry is crucial to ensure that it remains principled, thereby sustaining public trust in the proposition that both partners are fundamentally dedicated to the welfare of patients and the improvement of

public health”.

There was a section devoted to CME, and this is a summary of their recommendations.

For Continuing Medical Education (CME)

• Academic medical centers offering CME programs should develop audit

mechanisms to assure compliance with the standards of the Accreditation

Council for Continuing Medical Education (ACCME), including those with

respect to content validation and meals.

• Academic medical centers should establish a central CME office through which

all requests for industry support and receipt of funds for CME activity are

coordinated and overseen.

• To the extent that educational programs for physicians are supported by any

commercial entity, including pharmaceutical, device, equipment, and service

entities, the programs should be offered only by ACCME-accredited providers

according to ACCME standards.

In respect to CME these are all very reasonable recommendations, and most universities have already undertaken significant effort to achieve these goals.

The document covers many other things not directly related to CME including:

·         Gifts to individuals (Prohibiting)                                       

·         Pharmaceutical samples, (Central Distribution)

·         Site access by pharmaceutical representatives, (Limited to appointment or invitation, student participation limited, more MD’s, PhD’ and PharmD’s)

·         Site access by device manufacturer representatives, (credentialing, appointment or invitation, disclosure and consent of patients, student participation limited)

·         Participation in (Non CME) industry sponsored programs. (Discourage faculty, transparency of payment and fair market value, prohibit attendance, paying for attendance, accepting personal gifts)

·         Industry Sponsored Scholarships and other Educational Funds for Trainees (Giving Centrally, no Quid pro quo, selection sole responsibility of the university)

·         Food (only for ACCME-Accredited Events)

·         Travel (only for legitimate reimbursement or contractual services.

·         Ghostwriting (transparency of all involved in the process)

·         Purchasing (Disclosure of interest, and recuse from purchasing decisions in COI cases)

·         Boards of Directors, Advisory Boards and Consulting (Valuable and Compensation to Reflect Fair Market Value)

The report was accompanied by letters from the CEO’s of Pfizer, Eli Lilly stating that: 

·         They support all but one of the recommendations,

·         But do so without supporting all the arguments in the body of the report,

·         Issues addressed reflected perceptions rather than proven consequences

·         “We cannot agree with the report's suggestion that AMCs actively discourage academic physicians from participating in the defined speakers programs”

An additional letter from David Beier, President from Amgen stated:

Support of the explicit recommendations of the taskforce

“Our experience is that medical professionals who work in academic settings are dedicated professionals focused on the delivery of patient care and have not been inappropriately influenced in the manner, or to the degree represented in this report.

·         Engage healthcare professionals in appropriate fair-market value contractual relationships to participate in FDA Approved Speaker Programs.

·         Engage healthcare professionals as consultants with appropriate fair market value contractual relationships for defined interactions

·         Provide funding for Independent Medical Education to qualified recipients and, per a new policy, disclosing all Independent Medical Education and Healthcare Donations Publically

·         Deliver appropriate product and disease information to healthcare professionals via field based Representatives and Medial Liaisons.

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.

Connecticut: Just Information for Now

Connecticut Attorney General Richard Blumenthal, Brother of David Blumenthal and both

potential Clinton/Obama appointees, delivered strong rhetoric for a prohibition against drug company gifts and other benefits provided to doctors under the grounds that gifts may improperly influence health care decisions.

Blumenthal testified April 21 before the Connecticut State Public Health Committee "Marketing of Prescription Drugs" Informational Forum,  (Legislative staff made it clear this was simply an information forum not a hearing) that The pharmaceutical industry, hospitals and physicians groups have adopted "codes of ethics" to prevent conflicts of interest - but Blumenthal said these codes are virtually unenforceable and meaningless, and must be made law.

"We must stop improper impacts and influence of money on health care providers from the pharmaceutical drug companies," Blumenthal said. "Shocking recent disclosures about Merck's widespread ghost-writer reports - with payments to prestigious health care providers - vividly demonstrate the audacity of pharmaceutical drug company monetary influence.

He proposed the following recommendations be turned into Connecticut State Law:

• Prohibit any gifts, scholarships or other items in exchange for prescribing products, a commitment to continue prescribing products or to otherwise interfere with the independence of a health care provider's prescribing practices;
• Prohibit any gifts for the personal use of a health care provider;
• Prohibit any gifts to a health care provider for business use except for items of minimal value such as post-its, note pads, etc;
• Limit gifts for patient benefit to free samples of prescription drugs and items valued under $100;
• Prohibit any gifts or payments to health care providers for attending conferences but allow financial sponsorship of such conferences if the benefit of the sponsorship is distributed evenly among all attendees through reduced conference fees;
• Regulate payments to health care providers to serve as consultants, requiring written contracts, documentation of the criteria and the selection process for such consultants, articulation of the legitimate need for such consultant services; and
• Require all recipients of scholarships and other financial educational assistance to be selected by the participating academic or training institution and not the pharmaceutical company.

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/

California Dreaming

Last week the California State Assembly delayed AB 2821 (actually it was defeated on April 1, then offered for reconsideration, and the new hearing last week on April 15^th was canceled by the bill sponsor. I hope you got all that)

AB 2821 Bans all gifts greater than an aggregate $250.00 to physicians and requires disclosure filing annually of all gifts over $50.00 and the first annual report will be due December 31^st 2010.  CME is excluded as a gift, along with reasonable honorarium and faculty expenses.

It is interesting to note that in the sponsors presentation he has the miss-understanding that doctors still get gifts -- like trips, gift certificates, and parties.  And that today physicians are paid to attend CME events. (see public hearing analysis)

AB_2821_Text of Bill

AB2821  Bill Status

AB2821_Public_Hearing_Analysis 

CAL-PIRG (California Public Interest Research Group is the prime supporter of this bill in the California Legislature -- PIRG was founded by Ralph Nader)  All this commotion is in response to companies now filing compliance documents with the State of Californa to meet the guidelines of SB1765 which is now law in the state of california).

CalPirg_AB2821_Letter to Chairman

CalPIRG Report on Gifts to Physicians  (includes a chart by company of limits for gifts in California)

California Progress Report PIRG

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.

JAMA articles on Ghost writing and Study Results draws attention

Among other things the editorial calls for: 

"To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs."

These papers are based on the authors having testified in Vioxx trials and having access to vast volumes of discovery.  One paper claims that Merck found academic and company ghostwriters who had no involvement in the research.  The other alleges that Merck fiddled with the definition of deaths attributed to the drug in a Vioxx dementia trial. One of the papers is authored by Harlan Krumholz, MD a well paid expert witness for the plaintiff attorneys in these cases. He's published in the BMJ that Merck is guilty, contrary to the results of the majority of trials. 

Response from a friend....This is old news:

• If academics were ghost authors, that arguably is fraud (fabrication), and their institutions should discipline them appropriately;

• If one were to troll any research project, commercial or academic, with such retrospective detail, I shudder to think what could be found;

• The hysterical response from JAMA is absurd; two papers, even if true, do not document "increasing evidence of misrepresentation etc," and the severe oversight recommendations proposed by its editors.

• Bottom line is that if we are suffering from an epidemic of corruption, how could Merck have introduced statins, Gardasil, ARVs, etc., that seem to be effective and safe.

• If the "vast number of researchers are honest," why do we have to "distance commercial support from CME?"

Unfortunately the fuss inflames the COI witch hunt.

It took less than twenty four hours from release of the embargoed press release for members of the US Senate to issue press statements and letters to industry on articles printed in Today’s JAMA.

Senators Grassley and Kohl issued dueling press releases under the premise that this article proves the need for the Physician Payment Sunshine Act and the need for more transparency. (see attached)

Grassley went one step further in requesting information from the company (Merck) and their publication planning company on the practices that include perceived ghost writing.

The two Senators, Kohl and Grassely, have taken this opportunity to show the need for the Physician Payment Sunshine Act.  The timing of these and other recent articles is no doubt in preparation for a change in the White House, which ho doubt would aid passage of the PPSA.

Links to articles about issue in the Washington Post, the Wall Street Journal the Boston Globe, and the New York Times

Links to JAMA Papers:  Ghost  Writing, Mortality Data , Editorial Integrity in Science.

Merck’s Response

Bellow are the Senate Press Releases by Senators Kohl, and Grassley:

Jama Editorial Senator Kohl Press Release 4-15-08

Jama Editorial and letter to Merck - Senator Grassley press release 4-15-08.

In case you didn’t pick up a recent newspaper JAMA has just published a series of articles and an editorial concerning academic and company involvement in clinical trials, focused on data collected in the Merck Vioxx discovery by trial attorneys.