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36 posts from April 2009

April 30, 2009

IOM Conflict of Interest: The Buzz Around Town

This week there have articles, commentaries and statements flying around due to the release of the Institute of Medicine Report on Conflict of Interest, in Medical Research, Education and Practice.

Some of the Key quotations include:

PhRMA:  Statement on Institute of Medicine Report

Throughout the report the IOM writers elude to a misnomer that the major expense at pharmaceutical companies are devoted to marketing than research, as a basis for their recommendations.   This statement may be true of the IT industry but nor reflective of pharmaceutical companies.

PhRMA’s statement clarifies that “America’s pharmaceutical research companies spend far more on research and development (R&D) than on marketing. In 2007, pharmaceutical companies invested $63.2 billion on R&D of new medicines, while spending around $11.5 billion on promotional activity directed to physicians, journal advertising and consumer advertising, according to IMS Health. Last year, pharmaceutical companies spent a record $65.2 billion on R&D.

“According to the Congressional Budget Office (CBO), America’s pharmaceutical research companies are ‘one of the most research-intensive industries in the United States.’ Pharmaceutical firms invest as much as five times more in research and development, relative to their sales, than the average U.S. manufacturing firm, CBO states. 

Recommendations by IOM and others can also help advance ethical, professional relationships.  But it is important to balance the need to manage potential conflicts of interest against the possibility that overly restrictive policies – for example, prohibitions on physicians’ use of drug samples or on the availability of industry funding for CME – could have negative consequences for patient care.”

Senator Grassley:  Institute of Medicine Report on Conflict of Interest

“It’s a shot in the arm to the reform movement to have the prestige and policy heft of the

Institute of Medicine on the side of transparency.  The more disclosure, the better, for holding the system accountable and building public confidence in medical research and practice.”

New England Journal of Medicine: Controlling Conflicts of Interest

This is an extremely pro-regulatory article and the Author Robert Steinbrook, who presented before the IOM committee, does a good job summarizing the report at the end, you can tell that he is hopeful that many of the recommendations though conflicted (the committee kept going back and forth in the document) will be adopted.

Although specific recommendations may be criticized as either too strong or too weak, the IOM's overall proposals are comprehensive and — if adopted — would most likely have substantial effects on individual physicians and medical institutions. However, there has been no shortage of previous reports and calls for change; the new report lists 16 of the "more prominent reports" that were released between 2001 and 2008 alone. So the institute's proposals could merely provide more fodder for discussion — or perhaps mark a turning point in controlling conflicts of interest in medicine.

New York Times: Institute of Medicine Calls for Doctors to Stop Accepting Gifts from Drug Makers

Of course Gardiner Harris of the New York times came out with an article that the IOM report represents vindication for all things anti industry collaboration

In a scolding report, the nation’s most influential medical advisory group said doctors should stop taking much of the money, gifts and free drug samples they routinely accept from drug and device companies.

One interesting note is the quote from David Rothman:“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable,” said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Conflicts of interest in medicine are no longer acceptable.”

The opening sentence of the IOM report states:  Patients and the public benefit when physicians, researchers, collaborate with pharmaceutical, medical device and biotechnology companies to develop products that benefit individual and public health.

This is not exactly the same sentiment that Dr. Rothman portrays, he has staked his living on the COI debate for years, they did not go for the sever restrictions he has been calling for, perhaps this is a wakeup call that even Ethic’s purists can come to the same conclusions that he has in his Institute of Medicine as Profession reports, notice he uses a similar sounding name as IOM just to give himself more credibility, never quite getting to the truth.

Wall Street Journal: Institute Urges Strict Curbs on Medical Industry Perks

The Institute of Medicine recommended Tuesday that doctors, medical schools, professional groups and drug makers make far-reaching changes to prevent industry gifts and payments from influencing patient care and research.

Thomas Stossel, a professor at Harvard Medical School, criticized the proposal to cutback industry funding of doctor education because it would deprive physicians of a valuable source of up-to-date information about valuable treatments.

"There is no evidence for the need of these regulations," said Dr. Stossel, who said he has started companies and worked with industry. "It's high-end welfare for the ethicists and maybe job security for the academic administrators," he added.

Associated Press: Medical experts want crackdown on drugmaker money

Millions of dollars in gifts, travel and consulting fees from the pharmaceutical industry should be eliminated to stop companies from influencing how doctors practice medicine, a report by the government's top medical advisers says.

The sweeping recommendations from the Institute of Medicine call on medical professionals — from university professors to family doctors — to shun financial arrangements with companies that have flourished over the past three decades.

Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices "erode public trust while providing no meaningful benefits to patients or society," institute panel chair Dr. Bernard Lo said in a statement.

The report calls on medical schools, hospitals and physician groups to:

  • Publicly report funding they receive from companies.
  • Not accept free meals, gifts or other items from companies.
  • Prohibit doctors who have a financial conflicts of interest from testing new therapies on people.

Perhaps the most vigorously defended practice is company support for so-called continuing medical education conferences, where doctors learn about the latest treatments. Most state medical boards require physicians to attend a certain number of sessions each year to maintain their licenses.

While the panel stopped short of calling for a ban on industry-funded education, it stated that "a new system of funding ... should be developed that is free of industry influence

The AP story is accurate in the visceral nature of the press conference.

Jack Lewin, MD Chief Executive Officer of the American College of Cardiology was Quoted in every article:

"The acceleration of science is going to make it tougher and tougher for physicians, nurses and other health care professionals to stay current," said Dr. Jack Lewin, President of the American College of Cardiology.

In addition there is a great interview with Dr. Lewin and story on MedPage Today, I think he is leading the charge at medical societies to make changes that don’t hinder the advancement of science and risk patient care.

 

April 29, 2009

IOM Conflict of Interest: Medical Societies Respond to Report


The American College of Cardiology, American College of Emergency Physicians, American College of Radiology, American College of Rheumatology, American Gastroenterological Association, and American Society of Plastic Surgeons Issued a joint statement at the IOM press briefing on Conflict of Interest in Washington DC.

The statement calls for increased public support and shows the value of collaboration with industry to provide educational programs for their members.  They also recognize that philanthropic and government support is limited. 

Recently there have been a number of proposals to dramatically reduce or eliminate industry support for the activities of medical professional societies. In April, an article published in the Journal of the American Medical Association called for medical associations to sever most funding from industry, with the exception of journal advertising and exhibit hall fees. The Institute of Medicine is releasing a report today that also addresses these issues.

 

Medical professional societies can and do have ethical, positive relationships with industry, as do others in federal and state government and the foundation community. But public funding, particularly in the current economic climate, for education, quality initiatives and research is limited. Foundation and other such philanthropic support can only go so far.

 

Without continued external support from industry, our societies will be unable to provide the same level of outstanding education and cutting-edge science that has advanced the quality of patient care in this country. Moreover, as funding and reimbursements tighten, medical practices and practitioners are likely to fall further behind in offering the most current, evidence-based care to patients as the pace of scientific progress accelerates.

 

We would welcome more public support, however unlikely, for advancing quality, evidence-based care, and translation of science into clinical care guidelines. But, in the absence of public funding, industry funding can be separated from product bias and be firewall-protected to —

 

(1) support continuing medical education as a means to improve quality of care and outcomes;

 

(2) accelerate translation of science to the clinical care setting;

 

(3) support needed scientific and clinical research, as well as career development of young scientists;

 

(4) improve communication to patients about the benefits and risks of pharmaceutical/medical device products and equipment;

 

(5) improve patient and physician adherence and compliance; and

 

(6) address gaps in patient communication and education.

 

We are committed to the very highest ethical standards. We strive for responsible, transparent relationships, in which industry support has no influence on educational content, quality measures or scientific research. Our societies adhere to Accreditation Council for Continuing Medical Education standards, and we each have stringent internal policies that ensure that our educational and scientific content remain unbiased.

 

 Our industry supporters also adhere to guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed). Their guidelines reinforce the fact that interactions with health care professionals are designed to enhance the practice of medicine and benefit patients.

 

We are considering the development of an ad hoc self-funded coalition for medical associations to develop and articulate best practices and a common code of ethics for managing relationships with industry. Such core principles would include Transparency, Patient Centeredness, Active Management of Conflicts of Interest, and Accountability and Reporting.

We must and will continue to manage our relationships with industry responsibly, ethically and always in the best interests of patients. Until new sources of public funding for education and research are identified, these relationships will remain vital to the quality of care in the United States.

These medical societies recognize the value of collaboration with industry to improve their services to physicians for education and support.

Perhaps the ethicists at IOM forgot that practicing physicians need all the help they can get in providing high quality patient care, and right now the government is not stepping up to the plate to provide that support.

April 27, 2009

Institute of Medicine: Conflict of Interest in Medical, Research, Education and Practice

The Institute of Medicine: Conflict of Interest In Medical Research, Education and Practice Full Report  and Press Release  came out today and the report is over 300 pages long.

The report though lengthy is a re-hash of many of the themes we have seen from conflict of interest experts in the past few years, but the recommendations are presented with noticeable restraint.  It is clear that they have given consideration to what will happen if we pull out all industry ties with industry and that will be very difficult. 

Unfortunately their press conference on the report was a frontal assualt on all industry relationships with physicians and the presenters all conflict of interest experts (no practicing physicians), were on a one upmanship journey to see who is the most anti industry.

Bellow is a summary of the policy recommendations, which are not intended for the general reading audience.

Policy Recommendations:

3.1 Calls on all institutions engaged in these activities to establish conflict of interest policies and create conflict of interest committees to evaluate and manage conflicts.

 

3.2 Focuses on the essential policy step of requiring physicians, researchers, and senior officials to disclose to their institutions their financial relationships with industry. 

 

3.3 Calls for the standardization of disclosures with the goals of providing institutions with the specific information that they need to assess relationships while reducing the reporting burdens on physicians and researchers.

 

3.4 Calls for the U.S. Congress to create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities.

 

Research:

 

4.1 Calls for a general rule that researchers may not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. Exceptions should be allowed only if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research.

Education:

 5.1: Therefore calls on academic medical centers to prohibit faculty, students, residents, and fellows from accepting gifts (including meals), making presentations that are controlled by industry, and claiming authorship for ghostwritten publications. This restriction is not intended to exclude the acceptance of scientific materials from industry scientists under-appropriate material transfer agreements or the payment of reasonable honoraria to speakers who present their own material. Recommendation 5.1 also calls for restrictions on the acceptance of pharmaceutical samples and visits by drug and medical device sales representatives

5.2 Calls on academic medical centers and teaching hospitals, as part of their educational mission, to provide education on the avoidance of conflicts of interest and the management of relationships with pharmaceutical and medical device industry representatives. Organizations that accredit medical schools and residency programs should develop standards to reinforce this

recommendation.

5.3 Calls for a broad-based consensus development process to propose a new system of funding accredited continuing medical education that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education.

Some members of the committee supported a total end to industry funding, but others were concerned about the potential for unintended harm from such a ban. The committee recognized that changes in the current system likely would substantially reduce industry funding for accredited continuing medical education. Even if education providers trim their expenses, the costs of accredited continuing medical education would likely increase for many physicians, which could be an economic burden for some physicians, for example, those in rural areas.

 

Practice

6.1 (for faculty, students, residents, and fellows). Independent assessment of the evidence and the practice of evidence-based medicine are core competencies for physicians in clinical practice as well as academic practice; relationships with industry should not undermine those competencies.

 

6.2 Calls for further revisions to industry practices to be consistent with those outlined in Recommendation 6.1

 

Guidelines:

 

7.1 Calls on groups that develop guidelines not to accept direct funding for guideline development from industry and generally to exclude individuals with conflicts of interest from guideline development panels.

 

7.2 Calls for organizations that have an interest in the use of evidence based clinical practice guidelines to establish incentives to encourage the developers of guidelines to adopt the committee’s recommendations.

 

Institutions

 

8.1 Calls for the boards of trustees of institutions to establish a conflict of interest committee to make judgments about institutional relationships with industry, including the relationships of senior officials.

 

8.2 Calls for NIH to develop regulations requiring institutions covered by the 1995 PHS regulations to adopt institutional conflict of interest policies.

 

Supporting Organizations:

 

9.1 Proposes that groups such as accrediting organizations, public and private health insurers, and associations of medical journal editors develop incentives to make institutions more accountable for preventing, identifying, and managing conflicts of interest.

 

9.2, Calls for more research to assess the positive and negative consequences of

conflict of interest policies and provide a stronger evidence base for improving conflict of interest policies and their application

Overall this is a full throttled rehash of conflict of interest recommendations and it is clear from the tables that there is not a lot of evidence to back it up.   This report also could be tilted the economic stimulus package for conflict of interest experts, and the creation of conflict of interest jobs throughout the medical community.

The report also basically re-enforces the changes that PhRMA and AdvaMED have made with their codes of conduct, and the AAMC report on conflict of interest in medical education.

We will have a lot more to say once we work our way through the entire report….

The Institute of Medicine:

Conflict of Interest In Medical Research, Education and Practice Full Report  

Press Release 

Recommendations

Report Brief

IOM Press Conference (Audio)

Newsletter


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