Policy and Medicine

Association of Clinical Researchers and Educators: Nature Medicine Highlights First Meeting

 

 

Today in Nature Medicine is a news story titled:  Conflict of Interest Rules Seen by Some as Too Stringent.  In the article they outline how increasing public and congressional scrutiny has lead major medical intuitions (Johns Hopkins’, Partners Healthcare and others) to adopt strict conflict of interest policies.  .  States (Vermont and Massachusetts) have also jumped on board with gift bans.  

 

The call for conflict of interest reform has been spearheaded, in large part, by Senator Charles Grassley, the ranking Republican on the Senate Finance Committee and cosponsor of a bill that would require drug and device makers to report any money paid to doctors that exceeds $100 a year.  “The issue for me Conflict of interest rules seen by some as too stringent is transparency and the accountability that comes with transparency,” he said in an email to Nature Medicine. “The more support there is for timely and accurate disclosure of financial relationships, the better. It tells people there’s nothing to hide.”

 

Most of these rules move way beyond transparency and often those policies have unintended consequences.  Many physicians argue that they do more harm than good, stifling innovation and hurting patient care. 

 

“I personally think the pendulum has swung past where it had to go,” says James Thrall, radiologist-in-chief at Massachusetts General Hospital. “Without robust interaction between practicing physicians and industry, no new technology will become available.”

 

Avi Markowitz, chief of oncology and hematology at the University of Texas Medical Branch (UTMB) in Galveston, will join Stossel as one of the speakers at the ACRE Meeting. He says many of the rules serve to harm patients rather than protecting them. For example, Markowitz has several cancer patients who are taking Sanofi Aventis’s chemotherapy drug Eloxatin (oxaliplatin). A common side effect is peripheral neuropathy, a condition that causes tingling in a person’s fingers and toes when they are exposed to cold.

 

Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.

 

No one denies that some people have abused the system. But Markowitz says that the entire field is being punished for the actions of “a couple of Bernie Madoffs.” There is nothing inherently evil about interacting with industry, yet doctors are being treated like “villains,” he says. “If you’re in the medical care field, you are guilty until proven innocent.”

 

Harvard is also home to the reform movement’s most outspoken critic: Thomas Stossel, a hematologist and director of translational medicine at Brigham and Women’s Hospital in Boston. For the past several years, Stossel has been speaking out against those who seek to curb ties between industry and the medical profession, people he calls ‘pharma-scolds’. Now he is working to instigate a counteroffensive. In July, he and his colleagues will launch a new organization aimed at emphasizing the value of physician industry interactions. The Association of Clinical Researchers and Educators is scheduled to hold its kickoff meeting 23 July at Brigham and Women’s Hospital.

 

Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.

 

ACRE Annual Meeting – July 23^rd, 2009 – Bornstein Amphitheater -- Brigham and Women’s Hospital

Health Care Reform: Baucus Continues to Champion Bi-Partisan Reform

With the Senate Finance Committee still trying to deliberate in a ‘bi-partisan’ fashion to create a health care reform bill, their passed deadline is moving farther away.  As a result, Senate Majority Leader Harry Reid (D-NV) met with ranking member Chuck Grassley (R-IA) on Wednesday morning to discuss whether there is a bipartisan way forward on health care reform. As Reid begins “to directly manage the health care reform negotiations,” he also strongly urged Finance Chairman Max Baucus (D-MT) to focus on the main objective: being able to have a bill on Obama’s desk by October.

 According to Roll Call, the Majority Leader told Baucus to “stop chasing Grassley's vote on a health care bill” because he is losing critical Democratic support by sacrificing certain provisions.  Consequently, Reid is also trying to tame media reports and speculation by requesting to meet with GOP Senators on the Finance Committee such as Mike Enzi (R-WY), Orrin Hatch (R-UT) and Olympia Snowe (R-ME). Yet Republican sources assert that Senator Grassley requested the meeting.

These disagreements over how to finance health care reform and whether to include a government-run insurance option have kept Baucus and Grassley working closely together since January. The Majority Leader noted that paying for health care reform by taxing health benefits is a nonstarter for most Democrats. As a result, it is still uncertain whether Reid’s new involvement in telling Baucus he will lose Democratic votes will play into the final Finance bill. According to Politico, Reid's involvement blew “a gigantic hole in efforts to find $1 trillion to pay for health reform - and set off a scramble Wednesday to come up with a replacement for the suddenly missing $320 billion over 10 years.”

Mean while, the Senate Health, Education, Labor and Pensions Committee continues to mark up a partisan Democratic bill that lacks GOP support, but has the force of Senator Kennedy (D-MA). While the House used a three-committee system to create their version, Finance Committee delays have prevented the two Senate Committees from merging their bills together. So what is taking Baucus so long?

The jurisdiction of the Finance Committee is overwhelming. If there was one lesson we can remember from American Government its ‘power of the purse,’ and Senator Baucus is the hand the reaches into that purse. His entire career as a politician and history as a Senator will ride on the success or failure of the way he crafts his bill, and the final agreements and compromises he establishes.

Creating bi-partisan support is not only realistic but necessary in order to make sure this reform is permanent, and effective, which means better and more affordable care for Americans. Other Senators and citizens should applaud Mr. Baucus for his firmness on trying to please all the parties involved. We do not need another ‘midnight’ printed Recovery Act that is not effective.

Health Care Reform: AMA -- Public Option on the Table

While it seemed like a new President of the United States was going to have the biggest impact on health care reform, the new president of the American Medical Association (AMA) seems to be getting similar attention as well. Last week, Dr. J. James Rohack told CNN that the AMA supports an "American model" that includes both "a private system and a public system, working together." Essentially, he acknowledged the groups openness to a government-funded health insurance option for people without coverage, even though the AMA told a Senate committee in May 2009 that it did not support a government-sponsored public health insurance option:

"The AMA does not believe that creating a public health insurance option ... is the best way to expand health insurance coverage and lower costs across the health care system," because a public insurance plan could lead to "an explosion of costs that would need to be absorbed by taxpayers."

The new AMA president mentioned that the Federal Employee Health Benefit Program—available to Congress and other federal employees—could be expanded as a public option. He believed that in doing so, Congress could avoid creating a new program. But how does Dr. Rohack plan to staff this existing program for 45 million more people when America is already in a severe shortage of doctors, nurses and health care providers? How are we going to pay for all of this staff and training?

Even more perplexing, Rohack noted the AMA’s opposition to expanding Medicare coverage into a broader general public plan. In fact, he noted that the plan is "going broke" and fails to cover the costs of participating doctors. Yet what does he expect will happen when 45 million people are added to the existing program? Does he think the government will be able to manage the program better with 45 million people then they could with over 40 years of Medicare experience?

With the backdrop of President Obama reaching out to town hall meetings to push his own health care agenda, Rohack said 2009 is "the year we need to have affordable health insurance coverage for all Americans." Furthermore, he advocated for a reformed system that must include “access for everyone, the freedom to choose your doctor, and the freedom for doctors to provide the best possible care.” In addition, he also stressed efficiency measures such as electronic record-keeping to reduce administrative costs, as well as protection for doctors from excessive malpractice lawsuits.

Consequently, this drastic shift in AMA the public option can only mean a few things: either Congress is cutting a deal with doctors on including certain carrots in health care reform, or they are threatening specific sticks to scare them. Whatever the backdoor scenario is doctors need to get a more concentrated and collected voice, instead of just a newly ambitious president.  Before doctors can start worrying about treating more patients under an existing program, they need to prioritize.

NIH Transparency: Grassley and Kohl Weigh In

 

Senators Chuck Grassley and Herb Kohl today weighed in on transparency at the National Institutes of Health (NIH), urging the federal agency to take steps to increase transparency of federally funded biomedical research. 

 

They are responding to the fact that NIH is seeking public comment as it considers changes to its disclosure policy, and the senators made specific recommendations related to both individual researchers and academic institutions who receive NIH grants. 

 

 According to Senators Grassley and Kohl “In January 2008, the HHS OIG released a report which found that NIH provided almost no oversight of its extramural funds”  “With almost $24 billion in extramural funds distributed by NIH each year, and in light of the additional $10 billion provided by the American Reinvestment and Recovery Act to fund research grants, it is imperative that NIH properly fulfills its mission to advance the public’s welfare and makes responsible use of the funding provided.”

 

The senators suggested that researchers be required to report their outside income to the nearest $1000, and that universities be required to complete a plan to manage the researcher’s potential conflicts of interest. Finally, they maintained that both the disclosures and the plan be available to the public via the NIH website.

 

In February, Grassley and Kohl filed an amendment to the American Reinvestment and Recovery Act (ARRA) which would have placed new requirements on institutions receiving NIH grants.  The amendment was not included in the final bill.

 

For the past two years, Grassley and Kohl have collaborated to push for increased transparency in financial relationships between physicians and the drug, device and biologic industries. As part of that effort, they have championed the Physician Payments Sunshine Act (S. 301) to require these industries to publicly report payments and gifts to doctors. Recently, identical provisions to those in S.301 were included in the health care reform discussion documents released by the Senate Finance Committee. Similar provisions were included in the House draft bill as well. 

 

This is a reasonable proposal, and NIH should consider it thoughtfully. 

 

The NIH does however, needs to be careful and not lose sight of the goal for the NIH which is to fund the basic science which in turn becomes useful medications and procedures.  It is important not to be completely focused on potential harm (conflict of interest) and lose out on the use of researchers who are developing needed medications.    The next step to this could be to ban all physicians with any ties to industry.   

 

All proposals should be though out in light of time to administer and the cost to implement the program versus the benefits that may be gained by implementing them.

 

Letter from Grassley and Kohl to NIH 7-07-09

SACME Posts Responses to ACCME and CEJA

The Society of Academic Continuing Medical Education (SACME) recently published their responses to the ACCME and AMA CEJA.

Overall both documents reflected a call for a uniform system of CME and not to have two separate systems of CME based on commercial support.  They are also both supportive towards commercial support of CME activities.

To the ACCME they wrote:

·         There should be one standard for CME accreditation. Creating a system where there are two categories has the potential to create the impression that commercially supported CME is somehow inferior to that receiving no commercial support. As such, it would then inappropriately imply that commercially supported CME is biased.

 

·         A dual system of accreditation would add confusion, complication and additional bureaucracy to an already cumbersome system.

 

·         There are currently providers who do not accept any commercial support or who have programs that do not accept commercial support. These activities can be promoted as such without the need for another accreditation standard.

 

·         Under the existing Standards for Commercial Support, high quality CME activities are produced everyday by providers that accept unrestricted educational grants.

 

To the CEJA Committee they wrote:

 

·         Much of the discussion on bias in CME and the influence of CME on a physician's prescribing patterns is drawn from analyses of CME  activities that occurred prior to significant changes in the regulatory landscape of CME.

 

·         There is no mention of the June 2008 report commissioned by the ACCME, The

Relationship between Commercial Support and Bias in Continuing Medical Education Activities: A Review of the Literature which found that there is no empirical evidence to support or refute the hypothesis that CME activities are biased".

 

·         There is no discussion of how the field of CME has evolved. The very issues cited  by the outdated research led to the implementation of the first ACCME Standards of Commercial Support in 1992, and development of the CEJA Opinion 8.061 Gifts to Physicians from Industry. Since then, the current ACCME Standards for Commercial Support™ 2004, coupled with FDA restrictions (7), guidance from the OIG , the new codes of conduct from PhRMA, AdvaMed, and stricter institutional policies on faculty interaction with industry, have further strengthened the environment in which CME is produced.

 

·         Based on the issues raised above, the CEJA recommendation of a framework of "ethically preferable" and "ethically permissible" continuing medical education activities creates a false dichotomy between providers that accept commercial support and those who do not. Implicit in this dichotomy is the perception that commercially supported CME is inherently biased.

 

·         The term "ethically permissible" is in error. The 2004 SCS, Standard 3 indicates that a provider "cannot be required to by a commercial interest to accept advice or services concerning teachers, authors, or participants or other education matters, including content, from a commercial interest as conditions of contributing funds or services." If there is any language in a LOA that even suggests industry input or control of content, accredited providers are prohibited from signing that LOA. Further elaboration by the ACCME has indicated that CME providers may not even solicit suggestions on content or speakers from a commercial supporter nor ask a supporter to verify whether scientific content in a CME activity is accurate.

 

·         Additionally, within the recommendation of what is "ethically permissible", there is language that is vague and confusing. For instance, how can a physician determine which CME provider is "overly reliant" on commercial support and which is not?

 

Overall both statements are firm that academic medical systems prefer to work under the current system of CME as opposed to setting up dual CME systems.  The amount of paperwork that is required is now enormous and there is a frustration with all these proposed changes which are taking place while still trying to implement the current changes in the rules. 

 

CEJA was rejected by the AMA House of Delegates and we will know more in the fall on the ACCME call for comment.

 

Society of Academic Continuing Medical Education

 

Response to AMA CEJA

Response to ACCME Call for Comment Spring 09

The Physician-Industry Relationship: Lessons from the Minnesota Experience

 

Keeping up with the growing trend of publications on Physician-Industry relations, an endocrinologist from the University of Minnesota Medical School published a refreshing perspective.

 

In an article published in the Journal Endocrine Practice  “The Physician-Industry Relationship: Lessons From the Minnesota Experience,” Dr. J. Michael Gonzalez-Campoy outlines some of his positive dealings between academia and industry. He asserts that excellent patient care requires “…a healthy working relationship between physicians…biotechnology companies, and pharmaceutical companies.”

 

He also acknowledges that doctors have a duality of interest, which includes protecting the patient-physician relationship, and pursing other scientific endeavors for public health and regulatory activities in order to advance science.

 

Seemingly, while the report describes some laws on physician-industry tie, none of these laws challenge whether physicians should be paid for work they do outside the patient-physician relationship. The report also declares that federal and state laws significantly delay the dissemination of pharmaceutical and device product information to physicians, causing harm to patients.

 

Consequently, these laws have created a lack of access to the marketing side of pharmaceutical and biotechnology companies. This prevents physicians and medical school programs the ability to learn about new and emerging treatments. There are also unintended consequences from the changes in the physician-industry relationship such as patient harm:

 

-       Caused by the delay of implementing newer, better treatments.

-       Caused by the implication that pharmacotherapy is hurtful, which leads patients to withdraw from treatment.

-       Caused by forcing patients to choose older, cheaper medications when newer alternatives are better.

-       Caused by damaging the education of medical students and physicians in training when academic institutions deprive them of any given source of information, including marketing information.

-       Caused by the negative media portrayal of physicians and industry.

-       Caused by marketing shifts to direct-to-consumer messages.

 

Furthermore, “there is no conflict in physicians learning about new products.” Moreover there is no conflict of interest for new indications from the Food and Drug Administration or new warnings once safety data are released.

 

In addition, the overwhelming majority of physicians have access to a well-rounded knowledge base of all products and representatives in a drug category. This allows for the multiplicity of interest (not conflict of interest) to exist and leads to patient benefit. Similarly, physicians do not just choose pharmaceuticals based on a sales pitch. Doctors make decisions on the basis of science, patient choice and budgets, and because it appears that the benefits outweigh the risks.

 

Similarly, gifts do not influence prescribing habits to favor a product in a drug category because physicians accept these items from all companies. In fact, when a change in prescribing habits is seen, it’s usually “highly desirable and directly leads to patient benefit,” as seen in the new generation of insulin products. Likewise, the highest amounts of earnings reported frequently correspond to physicians whose institutions are awarded research grants.

 

PAYMENT TO PHYSICIANS FOR WORK DONE

 

The report also acknowledges that the work done with pharmaceutical and biotechnology companies, which benefits patients, cannot be exempted from the work product of physicians because:

 

-       There must be physicians involved in every stage of drug and biotechnology development.

-       Researchers who are primarily involved in research and development are ideally poised to educate their peers.

 

In fact, the research from industry and physicians have advanced science, led directly to improved patient care, led to better quality and quantity of life for our patients. Specifically, almost every medication and technology we use today is a result of these relationships, and “there is no way that we would be this far advanced in American medicine if it were not for that working relationship.”

 

As a result, physician income from industry or technology companies represents one revenue stream, and it should not be distinguished from other sources of income such as federal grants, endowments, etc. Even the AMA asserted that “the elimination of commercial support from certified CME activities would not guarantee the elimination of commercial bias from these activities.”

 

Additionally, industry grants have helped academic medical centers develop medical education, and the cost of medical publications that keep physicians updated has been traditionally defrayed by sales of ads from industry.

 

On the other hand, managed care and health maintenance organizations (HMOs) and their formularies represent a true conflict of interest for physicians. These groups are restricted to choices when they know that treatment alternatives are better for the individual patient, depriving them of personalized care.

 

Ultimately, the unintended consequence of propagating that professional relationships with industry are wrong, and will create an attitude for future generations of physicians that will shy away from clinical research and education. Dr. Gonzalez has hit the nail dead on its head: industry and physician relations are not only necessary, they are essential to providing better patient care outcomes, advances in medicine, and better medical education.

Letters from Grassley: Chasing Journals Ghosts Writers

Senator Chuck Grassley has asked eight leading medical journals to describe their policies and practices regarding ghostwriting.

 

Grassley said his inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals.   

 

“Public dollars and the public trust are at stake in the practice of medicine, and the information that is shared in these journals can influence decisions made by doctors and their patients,” Grassley said.  “Transparency can do a lot of good in building confidence that there’s nothing to hide, and that applies to how expert opinion is presented in public forums like these journals provide.”

 

What the Senator’s staff  (who ghost wrote the letter) failed to understand is that almost all journals have adopted strict policies on ghost writing and transparency and all of them are easily found on their internet sites (see links)( it took me all of ten minutes to find them, but who’s counting):
 

·         American Journal of Medicine,

·         The Annals of Internal Medicine,

·         The Annual Review of Medicine,

·         The Archives of Internal Medicine,

·         Nature Medicine,

·         PLoS Medicine,

·         The Journal of the American Medical Association, and

·         The New England Journal of Medicine.

 

In December, Grassley wrote to Wyeth and DesignWrite, a medical education and communications company, regarding allegations that Wyeth hired DesignWrite to draft articles promoting the company’s hormone therapy products and seek academic investigators to sign on as the primary authors. 

 

The Senator is asking each journal for the following information:

1. What is the journal’s position regarding the practice of ghostwriting? 

2. Does the journal have any written policies regarding ghostwritten articles?  If so, please provide a copy of those policies.

3. Is an author who submits an article for publication required to disclose to the journal the direct or indirect involvement of any drug or device company or other third party in the development and/or writing of the article?

4. What are the journal’s policies or practices regarding public disclosure of the involvement of any drug or device company or other third party in the development and/or writing of a journal article, in particular when the listed authors are not affiliated with the company or third party?

5.    Since 2004, has the journal taken action against any author for failing to disclose the involvement of a third party in the development and/or drafting of a manuscript?  If so, please provide details.

And of course they have until July 22^nd  just three weeks to respond.

 

Every journal of any repute stands against ghostwriting and guest authoring.  Over the last 8 years or so, editors and journals have adopted increasingly strict policies to determine valid authorship, including asking manuscript authors to fill out increasingly-detailed forms about their role on a paper.  

 

Many check boxes now get done; attestations made, and so on.  Organizations of  journal editors and publishers ICMJE and ISMPP  have published guidelines clearly calling for recognition of contributions to medical papers, ranging from full authors to those whose efforts are a bit less and don't meet full authorship criteria - e.g. they receive acknowledgment.  

 

Organizations of medical writers - U.S. (AMWA), European (EMWA) also support full disclosure of writers' efforts, source of funding, etc..

Editors basically take what they are told - they don't have investigative resources (or authority), and unless a third party comes forth with information, an editor has no way to know whether or not a named author really "did' what they say they did, or if some hired writer wrote most of the paper.  (And let's not overlook the common practice in academia of putting colleagues on papers as authors based on a short conversation in the hall, or supplying a reagent for a lab test, etc. or the practice of getting your assistants to write your papers without naming them.  These are viewed as 'acceptable' because the guest authoring is not occurring due to payments by a pharmaceutical company...  Do you think this is “ghost writing,” it is still dishonest and every bit as wrong).  

Some companies did some of the sort of ghostwriting that Grassley is asking about previously; our understanding is that all have moved a long way from it by now.

In his letter the Senator stated that previously, Grassley had written to Merck and Scientific Therapeutics Information, a medical publishing company, regarding similar allegations reported in the Journal of the American Medical Association related to articles on Merck’s VIOXX studies.

 

What the Senator failed to take into account is that most of the articles quoted in the JAMA paper were from the mid-to- late 90s; and things changed enormously in the 2001-2003 timeframe.  Two of the authors were paid > $300,000 and (over the course of 15-20 years), more than $20 MILLION by plaintiffs attorneys including Mark Lanier - but the editors at JAMA did not seem to feel that any of that needed to be disclosed to readers of JAMA, and so it goes.

  

In some respect this is embarrassing for the senator to send out such letters and a press release with no thought that this information is so readily available on the web.  In the future a simple web search or phone call could have answered his questions without casting negative dispersions on the journals reputations.  

 

I realize the senators staff would like to gain understanding of what is happening, but sending out press releases that you are “Investigating a journal, doctor or medical school”  based on no evidence, just so you can get a couple of lines in the Sunday NY Times, is shameful.

Senator Grassley Letter to Medical Publishers

Data Mining: Supreme Court Refuses to Hear IMS Appeal of New Hampshire Law

According to the Rutland Herald and IMS Health,  on Monday, June 29, 2009, the United States Supreme Court denied granting writ of certiorari (refused to hear) in the case of IMS Health vs. Ayotte, the U.S. Court of Appeals First Circuit ruling that upheld a New Hampshire law restricting the commercial use of prescriber-identifiable data.

 

That decision reversed a lower court’s decision that had previously ruled such restrictions were in violation of the First Amendment’s protection of commercial speech. The appellate court, instead, ruled that the First Amendment afforded no such protection to the gathering, analysis or publication of data for commercial purposes, and that restriction of such data was not an abridgment of free speech. With the U.S. Supreme Court declining to review, that decision stands and the New Hampshire law remains in effect.

 

This decision denies access to vital information for prescription drug marketers and has effects on such FDA mandated practices as REM’s programs and warning letters to prescribers.     

 

It is worth noting that one of the largest beneficiaries from the sale of prescription data information is the American Medical Association and for the most part they have been quite on this issue.

 

The courts may yet pick up this case next year if there becomes a circuit split decision with the Vermont case currently working its way through the courts. So, this is not necessarily the last time we will hear about this case.

Now with this decision state legislatures will be empowered to pass data mining restrictions as a competition will ensue.

 

Links to documents from IMS

 

HB 1346 Blocks Access to Critical Healthcare Information

·         Appeals Court Ruling Severely Undermines Speech Rights

·         Joint Statement by IMS and SDI re: Rehearing of Appeals Court Decision on New Hampshire Prescription Info Law

·         Joint Statement by IMS and SDI re: Appeals Court Decision Overturning Federal Court Rejection of New Hampshire Prescription Info Law

·         Joint Statement by IMS and Verispan re: New Hampshire's Appeal of Federal Court Rejection of Prescription Info Law

·         Press Release:  New Hampshire Law Banning Commercial Use of Prescription Information Declared Unconstitutional

·         Final Order on Legal Complaint Filed by IMS and Verispan

·         Final Legislation: HB 1346

·         Legal Complaint Filed by IMS and Verispan

·         Press Release: Companies File Suit Challenging New Hampshire Law

·         Independent Experts Available to Discuss Implications of HB 1346

·         Position Paper: HB 1346 is Wrong Prescription for New Hampshire

·         Press Release: Washington Legal Foundation

·         Working Paper: Washington Legal Foundation - The 1st Amendment and Prescriber Identifiable Data

Prescription Information Benefits Public Health

·         News Release: Information Policy Institute Finds Restrictions on Provider-Identified Healthcare Data Are Anti-Competitive and Will Not Lower Drug Prices

·         Case Studies: Issues and Outcomes

·         IMS Health IQ: Evidence-Based Healthcare

·         IMS Commitment to Information Stewardship

Physicians Control Prescribing Decisions

·         AMA Position Paper: Restriction of Prescription Data

·         AMA Prescribing Data Restriction Program: Article in Pharmaceutical Executive

Amicus Briefs in Support of Plaintiffs (IMS and Verispan)

·         Brief of AMICI CURIAE eHealth Initiative, National Alliance for Health Information Technology, and Surescripts, LLC

·         Amicus Curiae Brief - Washington Legal Foundation

·         Amicus Curiae Brief - Coalition for Healthcare Communications

·         Amicus Curiae Brief - Wolters Kluwer Health

·         Amicus Brief - The National Association of Chain Drug Stores

·         Amicus Brief - Wolters Kluwer Health

·         Amicus Brief - eHI-NAHIT - SureScripts

·         Amicus Brief - Coalition for Healthcare Communications

·         Amicus Brief - NACDS

·         Amicus Brief - Washington Legal Foundation

Media Coverage

·         The Battle of New Hampshire

·         New Hampshire Union Leader - “New Hampshire Gets an Overdose of Unintended Consequences” – By Fred Cate, Professor, Indiana University School of Law-Bloomington

·         Pharmaceutical Executive Direct - “Prescribing Data: It’s a Matter of Free Speech” - By Beth Herskovits, Pharmaceutical Executive Direct

·         Pharmaceutical Executive - “From the Editor: Undecided.” By Patrick Clinton, Editor, Pharmaceutical Executive

·         New Hampshire Business Review - “The Wrong Prescription for N.H.” – By John Kamp, Executive Director, Coalition for Healthcare Communications, New York, New York

·         Pharmaceutical Executive - “Freedom of Information: IMS and Verispan sue New Hampshire to buy prescriber data—and to protect the data sellers’ free-speech rights.” – By Beth Herskovits, Pharmaceutical Executive

FDA Advertising & Promotion Manual - “Companies Challenge New Hampshire Data Law"

Massachusetts Code of Conduct: Massachusetts and Vermont’s Gift Ban and Reporting Begins – Compliance Resources

On July 1^st the Massachusetts and Vermont’s gift bans and registry of payments to physicians came into effect. 

The Wall Street Journal featured an article outlining how these laws which take place today will have impact on the state of healthcare in Massachusetts.

These laws are the most restrictive in the country and the Massachusetts law is perhaps the most nuanced with restrictions on some things like coffee and tea, but not on others meals in your office accompanied by a presentation from a sales rep.

Most companies operating in the Commonwealth of Massachusetts who sell any medical products and have payments to physicians or healthcare entities (hospitals, nursing homes, pharmacies) will be required to pay a $2,000 fee, plus implement a compliance program and adopt a code of conduct.   The rules apply to practitioners from Massachusetts even if they are visiting your facility in other countries.

As late as the afternoon of June 30th, the Massachusetts Department of Public Health has issued their third round of Questions and Answers on the code.

We have put together a list of resources that you may find useful in understanding the new laws.

Commonwealth of Massachusetts

Frequently asked questions: 

June   30, 2009

May    22, 2009

March 11, 2009

Statute, Regulation, Public Health Memorandum

William Mandell, JD (Peirce & Mandell, LLP)

Medical Conventions in Boston: The Massachusetts Hospitality Industry Responds to the Healthcare Marketing Law: Summary of the New Massachusetts Law, 2009 Healthcare Convention & Exhibitors Association Annual Meeting, June 14, 2009  (PowerPoint for Convention Managers and CME providers)

The Final DPH Pharmaceutical and Medical Device Manufacturer Conduct Regulations: The Industry Perspective, by William M. Mandell, Boston Bar Association Health Law Reporter, Summer 2009

McDermott Will and Emery:

Massachusetts Enacts Final Rules Governing Pharmaceutical and Medical Device Manufacturer Conduct: Manufacturers Must Prepare for a New Regime of State , May 2009

Foley and Lardner, LLP

Massachusetts Legislation Concerning Proposed Pharmaceutical Gift Ban – Implications for Pharmaceutical, Biotech and Medical Device Manufacturers (PowerPoint) (January 2009)

Sidley Austin LLP

Vermont Bans Most Gifts to Healthcare Providers; Law’s Reach Now Extends to Medical Device Manufacturers

Global Life Sciences: US-Healthcare Update
June 26, 2009

Previous Articles:

Massachusetts Pharmaceutical and Medical Device Manufacture's Code of Conduct: Final Version (March 11, 2009)

Massachusetts Pharmaceutical and Device Manufactures Marketing Code of Conduct: Physician Incentives Officially Exempted  (June 8, 2009)

Massachusetts Pharmaceutical and Medical Device Manufacture Code of Conduct: State Q&A’s Plus Analysis (June 1, 2009)

IOM: Comparative Effectivenes Recommendations – Top Down Bureaucracy at Its Best

 

In the midst of all the chaos surrounding the economic downfall, Americans overlooked a key component of the American Recovery and Reinvestment Act (ARRA): the Comparative Effectiveness Research Council.

 

The purpose of the Council is to determine what drugs are more/less effective than similar drugs.

 

One of the provisions of ARRA was for the Institute of Medicine to recommend a list of priority topics to be the initial focus of a new national investment in comparative effectiveness research. As a result, the Institutes of Medicine recently published a report titled: Initial National Priorities for Comparative Effectiveness Research.

The report was supported by funds from the Agency on Healthcare Research and Quality, the National Acad­emies President’s Fund, and the Robert Wood Johnson Foundation.

 

The IOM committee identified three report objectives: 1) establish a working definition of CER, 2) develop a priority list of research topics to be undertaken with ARRA funding using broad stakeholder input, and 3) identify the necessary requirements to support a robust and sustainable CER enterprise.

 

The report also outlines 100 Initial Priority Topics for Comparative Effectiveness Research. Within the list the topics are listed by quartile (groups of 25), with the first quartile having the highest priority.

The 100 topics were selected from some 2,600 suggestions, with 17 suggestions coming from device companies and 11 from pharmaceutical/biotechnology firms. Some of the comparative effectiveness research projects in the first quartile are:

-          hearing loss in children and adults; upper endoscopy utilization; care coordination programs, such as the medical home; Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis; health care associated infections (HAI); prostate cancer.

 

Some of the more disturbing suggestions from IOM include prioritizing lower back pain; yoga; homeless care; and even acne ahead of or at the same level as pediatric cancer.

 

Is this really what the government is going to use or is this just a suggestion to them from the IOM?

 

Does the government really assume that the higher priority is to save money and produce better outcomes researching low back pain versus pediatric cancer?  

In addition, the new report, offers recommendations for the $400 million given to the Department of Health and Human Services from ARRA, according to the Wall Street Journal. Conversely, the Institute of Medicine stated it did not consider cost in its assessment of priorities.

Dr. Harold Sox, editor of the Annals of Internal Medicine and co-chairman of the committee that picked the priorities noted that committee did no include cost because it was "a very big topic, and one that we knew we didn't have sufficient time to deal with.  Others noted that "the focus of comparative effectiveness research is that it leads to better care, not cheaper care."

Accordingly, research on these and future topics will not yield real improvements unless the results are adopted by health care providers and organizations and integrated into clinical practice. Dr. Cox further said that:

“Conducting high-quality research and implementing the results pose major challenges, and thus "it is going to take awhile" before the impact of the research is seen in hospitals and doctors' offices.

Ultimately, comparative effectiveness research is an “ongoing process to accommodate new treatments and changes in practice. As a result some people believe that as comparative research develops, this council will make decisions based on cost, especially since IOM did not consider cost.

How can Congress and IOM consider whether medicine is going to be more effective when the results from this research will make care unaffordable to Americans, and degrade the health care system further?

Top down recommendations always favor the elite vs. the needy.   Would it not be better to randomly survey a select group of healthcare providers and patients to come up with what is needed as opposed to Washington bureaucrats deciding what is best for patients.

IOM and Congress need to realize one crucial factor when determining their priorities for comparative effectiveness research: although recommendations can and should be made, flexibility is essential for the individual physician to prescribe what he or she feels best for the individual patient.

Interactive CER Priority List

Witness Testimony from Stakeholder Meeting

Press Release