Sunlight is a Weak Disinfectant

One of the most robust “memes” in contemporary law is the power of disclosure. In health law, disclosure comes up again and again: patients need to give “informed” consent, insurers are supposed to explain their policies clearly, and conflicts of interest, when not proscribed, should at the very least be exposed. But there are growing challenges to the disclosure meme, both within health law and without.

George Lowenstein and Peter Ubel note some problems with disclosure approaches in this article on the weaknesses of behavioral economics generally:

It seems that every week a new book or major newspaper article appears showing that irrational decision-making helped cause the housing bubble or the rise in health care costs. Such insights draw on behavioral economics, an increasingly popular field that incorporates elements from psychology to explain why people make seemingly irrational decisions, at least according to traditional economic theory and its emphasis on rational choice. . . . But the field has its limits. As policymakers use it to devise programs, it’s becoming clear that behavioral economics is being asked to solve problems it wasn’t meant to address.

[T]ake conflicts of interest in medicine. Despite volumes of research showing that pharmaceutical industry gifts distort decisions by doctors, the medical establishment has not mustered the will to bar such thinly disguised bribes, and the health care reform act fails to outlaw them. Instead, much like food labeling, the act includes “sunshine” provisions that will simply make information about these gifts available to the public. We have shifted the burden from industry, which has the power to change the way it does business, to the relatively uninformed and powerless consumer.

The same pattern can be seen in health care reform itself. The act promises to achieve the admirable goal of insuring most Americans, yet it fails to address the more fundamental problem of health care costs. . . . [T]he act tries to lower costs by promoting incentive programs that reward healthy behaviors. . . . [But s]tudies show that preventive medicine, even when it works, rarely saves money.

At its worst, disclosure can become merely pro forma; as Kafka (via Trudo Lemmens) puts it, “Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.” Omri Ben-Shahar has argued that disclosure is one of many aspects of consumer protection law with little real impact on individual welfare. As Amelia Flood reports,

Ben-Shahar, who spent last summer studying all the mandated disclosure statutes in Illinois, Michigan and California, argues that consumer protection advocates have gotten it wrong when it comes to mandating information access for consumers. He says consumers get lost in a sea of technical language, unread disclaimers and long-shot lawsuits. . . . According to Ben-Shahar, disclosures are of more use to consumer ratings groups like Zagat and Consumer’s Digest than they are to most consumers.

So perhaps there is some hope here: third-party aggregators and raters might use disclosures as part of an overall effort to rate various hospitals or doctors. The question then becomes–who shall pay (and rate) the raters? One irony here is that doctor rating sites have themselves been accused of being insufficiently transparent about the ways in which they evaluate physicians. New York Attorney General Cuomo even pursued the matter. His office eventually settled with insurers who ran rating sites. They pledged to “fully disclose to consumers and physicians all aspects of their ranking system.”

What’s the lesson here? First, that consumers are, by and large, too busy to process piecemeal disclosures by professionals like physicians and other health care providers. Second, third party raters can fill some of this information gap by aggregating information. Third, this process of aggregation and rating itself will likely need to be closely supervised by a good-faith regulator, lest it fail to take into account the full range of interests (and quality of information) proper for the task.

Too Much Transparency?

Interesting article in the Wall St. Journal Health blog regarding prospective legislation which would require full pricing disclosure by providers:

Yesterday, a House subcommittee held a hearing on three bills - two sponsored by Republicans, and one by a Democrat - aiming to pull back the veil on prices, the Hill reports. Provisions vary by bill, but include price transparency for hospitals, ambulatory surgical centers, pharmacies and vendors; more complete disclosure by insurance plans and more information on quality.

Here at Health Reform Watch we have written a number of posts calling for transparency, and perhaps most notably the Center for Health & Pharmaceutical Law & Policy has issued two White Papers in the last year calling for such in different aspects of medical relationships. The first White Paper called for broad reforms in the marketing of drugs and devices. Entitled, Drug and Device Promotion: Charting a Course for Policy Reform, the Center proposed legal and policy changes to address conflicts of interest in the relationship of medicine and industry. The Center’s recommendations included “making payments by drug and device companies to doctors transparent, with public disclosure by industry and physicians of their financial relationships.”

In its second White Paper, entitled Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight, “the Center proposed legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.” Obviously, transparency here too plays a large role in rooting out such conflicts and apprising potential research subjects of what may amount to vested interests in those who wish to recruit them for such studies.

In a sense, “Transparency” has become somewhat of a mantra. And rightfully so. The prospect of clandestine arrangements in medical care has a nefarious overtone that is well deserved. The ultimate nature of the doctor patient relationship is premised on trust. The doctor, by virtue of his education and profession, is privy to information the vast majority of us do not hold. In a sense, every diagnosis and prescription accepted is an article of faith. It is important to know that the doctor’s information has not been skewed by improprieties in research, and that the doctor’s ultimate diagnosis and prescription has not been skewed by a vested interest.

Generally speaking, except in cases of dire and/or unconscious emergency, the patient must assent to treatment. And assent must be premised on informed consent. A failure of assent, legally speaking, amounts to battery.  Arguably, a failure to disclose vested interests in a particular course of action or procedure can diminish, if not negate, the “informed” aspect of informed consent. Transparency is important.

But the WSJ article raises an issue worth considering as it regards Transparency and pricing: provider competitors in concentrated markets may, in seeing the exact numbers, find the opportunity to raise prices.

What struck us, though, was the concern voiced by Frank Pallone, chairman of the Energy and Commerce health subcommittee. “The concern I guess is about the unintended consequences of too much transparency,” he said, according to the Hill. How could more info on pricing and costs be a problem?

Pallone refers to a 2008 Congressional Budget Office brief on this very issue. It covers the benefits of transparency, but also the chief potential disadvantage: in concentrated markets, providers might look at their competitors’ prices and raise their own to match them. Here’s an excerpt from the prepared remarks of then-CBO Director Peter Orszag (now director of the Office of Management and Budget), discussing the findings before a Senate committee’s health reform summit:

On the consumer side, more than 80 percent of the population is covered by some form of health insurance, which insulates people from the full price of their health care, limiting their incentive to compare prices. Doctors and other health professionals often direct the decisions about what services to buy from whom, as patients may have little information on the care they need or the quality or value of that care. Moreover, for insured and uninsured people alike, awareness of prices will make little difference in emergencies or in the relatively small number of cases that account for a disproportionate share of overall health care spending.

On the provider side, more transparency would make information about the prices that hospitals, physicians, and drug companies charge insurers more visible, but whether such disclosure would lead to higher or lower prices for consumers on average is unclear and depends on the nature of competition in the relevant market. The markets for some health care services are highly concentrated, so increasing transparency in such markets could lead to higher, rather than lower, prices because higher prices are easier to maintain when the prices charged by each provider involved can be observed by all of the others. However, aggregated information or information on average prices would make it more difficult for providers to coordinate higher prices because individual providers’ prices would not be obvious. Whatever the effect on average prices, more transparent prices would probably reduce the range of prices.

In tact as the mantra of Transparency may be in regard to medical relationships, in a marketplace unfettered by fee regulation, Orszag’s  analysis and Frank Pallone’s concern regarding Transparency and pricing gives weight to the counter-intuitive prospect of “Too much Transparency.” We fail to consider such at our own peril.

Reform Rodeo

1. Duff Wilson of the New York Times discusses the lack of transparency with respect to industry’s payments to doctors.

2. John Halamka gives a nice overview of the various PPACA initiatives–including pilot programs–that involve HIT.

3. A group of lawyers discuss the impact that the recent Supreme Court decision in Citizens United could have on health care.

4. Matthew Holt at The Health Care Blog describes a new poll conducted about PHRs, and some of the results are surprising.

5. Health Affairs has a nice summary of a round table discussion on reforming CMS in the era of Don Berwick.

6. Jason Shafrin of the Health Care Economist gives an overview of a new paper by Basu and Philipson that question some of the common assumptions of the economics of comparative effectiveness research.

Further Calls for Increased Oversight on Medical Research & Physician Conflitcs of Interest

The Center for Health & Pharmaceutical Law & Policy has continued to focus on the implications of research funding in patients’ decisions to participate in clinical research, as well as the effects such funding can have on researcher behavior and research results.  In January 2009, the Center recommended that all financial relationships between industry and physicians be publicly disclosed by industry.  And just this month, the Center released its most recent White Paper, “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight.”

Similarly, in a November 17 letter to Francis Collins, 100 researchers, academics, and public policy analysts asked the NIH to “fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior” in order to determine the effects of industry-academic relationships on human health.  The letter implores the director of NIH to focus on “the research gap on the effect of conflicts of interest and commercial influence on medical decisionmaking” and to establish a mechanism for funding relevant research.

One of the primary concerns in the researchers’ letter is an issue also identified in a November OIG report, “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health,” which found that a majority of academic researchers’ conflicts of interest are unreported.   The report flags the potential for extensive conflicts between faculty members and their government-financed research.  In response, the US Senate Finance Committee recently sent letters to several universities requesting such information.  Just yesterday, Northwestern University’s Feinberg School of Medicine, reacting to national concern about physicians’ and researchers’ financial conflicts of interest, began posting external professional and industry relationships for approximately 2000 faculty members — including service on boards of directors, consulting and related activities, ownership or investment interests, royalties and inventor shares, and additional activities such as lectures and participation in scientific advisory boards and professional societies.

Further research is obviously necessary to determine how financial relationships influence — as the authors of the letter to NIH call it — “the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge.”  In the meantime, increased oversight of physician-industry relationships by the federal government to evaluate and oversee investigator or institutional conflicts of interest, both for research within and without academic medical centers, is necessary.

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Issues White Paper Calling for Major Reforms in the Financing and Oversight of Clinical Research

Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.

Kathleen Boozang, a dean who oversees the Law School’s Center, explains that “Some of the ways that drug and device trial sponsors pay the physicians who lead clinical trials can tempt them to recruit individuals for clinical trials who would be better off receiving conventional therapy. This is of particular concern if physicians encourage their own patients to enroll in trials that these same physicians are overseeing.”

Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does.  For some physician practices, conducting clinical trials represents a significant portion of their income.

According to Carl Coleman, a Seton Hall Law professor who collaborated on the White Paper, “A different kind of problem arises if people are enrolled in trials who don’t meet the criteria for who should participate - these individuals’ health can be put at risk, and their participation can skew the results of the trial, which is bad for everyone.”

Federal regulations in this area have not kept up with the rapid changes in how research occurs, and even those regulations that exist are poorly enforced, according to recent government studies.  Understanding that the collaboration among industry, government, and medicine in the pursuit of clinical research is critical to driving scientific progress, particularly as industry increasingly replaces the government as the primary source of research funding, the Center’s recommendations include:

1) Establishing a norm of financial neutrality between treatment and research. Ensuring that physicians receive comparable compensation for treatment and research will help ensure that their decisions to conduct research, as well as to recommend that a particular individual participate in a clinical trial, are grounded in reasons unrelated to their personal financial interests. This will be best accomplished, in the first instance through regulations that ban certain kinds of research compensation, and provide examples of acceptable payment methodologies that industry can follow. Reform by prosecution signals what practices government dislikes, but does not provide a clear vision of ideal approaches to managing conflicts of interest related to the conduct of research.

2) Establishing federal guidelines as to the principles or methodology by which to determine fair market value of physician time spent in clinical work. Federal regulations should be promulgated that establish a benchmark formula for determining fair market value of physicians’ time, effort and expenses for clinical research. Such regulations would promote the goal of financial neutrality between treatment and research. Physicians cannot be underpaid for research either - compensation for clinical trial work should therefore include reimbursement for any additional expenses that are unique to the research environment.

3) Banning payments with equity interests; disqualification of investigators who hold direct interests in the outcome of the research. Federal regulations should prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial. The law should preclude researchers who have investments that give them a direct interest in the outcome of the research from leading clinical trials.  Where absolutely necessary, such individuals might appropriately serve as consultants.

4) Banning payments of finder’s fees and bonuses for recruitment and retention of trial subjects. Certain forms of compensation create conflicts of interest that can incentivize investigators to enroll individuals in a clinical trial who are too healthy or too sick to participate, or to deemphasize information that might discourage individuals from consenting to trial enrollment. Federal law should ban such compensation methods, including finder’s fees and bonuses for meeting recruitment and retention goals.

5) Reforming federal regulations to compel and better guide the evaluation of relationships between industry and would-be physician investigators prior to the commencement of research.   The White Paper includes overlapping but sometimes distinctive recommendations for federal regulation to evaluate and oversee investigator or institutional conflicts of interest, both for research within and without academic medical centers.  Specific to research outside of academic medical centers, federal regulations should spell out clearly the obligation of community-based physicians acting as investigators or institutions acting on their behalf to report information about compensation for research and other financial interests to Institutional Review Boards.

Summarizing the importance of this White Paper, Boozang states, “The pharmaceutical and medical device industries save millions of lives each year with their innovations.  It is imperative that we maintain the integrity of research, and the public’s trust in the process.”

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices. The White Paper, “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” may be found here.

Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching, with a strong focus on clinical education. The Law School’s health law program has been ranked as one of the top programs in the country. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.

Communication and Transparency: An Answer to Our Health Care Woes?

This past week, I had the good fortune to attend two fascinating but very different — in terms of content and setting– talks by preeminent health experts.  The first was by Princeton University Professor Uwe Reinhardt at a Woodrow Wilson School of Public & International Affairs alumni event, entitled “The U.S. Economy and Health Care: Implications for Health.”  Professor Reinhardt spoke briefly and generally on health care and insurance reform, touching on the necessary changes on both the “demand side” (insurance reform) and the “supply side” (health care delivery). The second talk was by Dr. Atul Gawande as part of the New Yorker Magazine’s 10th Annual festival, entitled “The Death of the Master Builder: A Story of Risk, Medicine, and Skyscrapers.”  Dr. Gawande’s talk, in which he expounded his 2007 New Yorker article The Checklist, argued for the implementation of a basic 19-item surgical checklist, citing a marked reduction in complications from surgery (the World Health Organization’s 2009 Surgical Safety Checklist, implementation manual, and Guidelines for Safe Surgery are all available online).

Despite addressing very different issues, I took away from these two talks a very important message: little can be accomplished in fixing our broken health care system without communication and transparency, with which come increased accountability and discipline.

While addressing the changes necessary on the health care delivery side in order to fix health care, Professor Reinhardt called for “[g]reater transparency on, and accountability for, the use of resources and outcomes.”  As an example of such transparency, he cited his proposals as chair of the New Jersey Commission on Rationalizing Health Care Resources.  In its January 2008 report, the Commission recommended to Governor Corzine that New Jersey require that nonprofit hospitals’ governance documents– IRS form 990s (including financial reports and submissions), board composition, and meeting minutes– be made available to the public on the entities’ web pages (for-profit hospitals routinely post their annual financial reports and submissions to the SEC on their websites).  Such full transparency would ostensibly lead to increased accountability on the part of managers of non-profit hospitals by allowing the public insight into their finances and economics.

In his talk, Dr. Gawande focused on the fact that one of the most useful aspects of the checklist is the introduction step (”Before skin incision, the entire team (nurses, surgeons, anesthesia professionals, and any others participating in the care of the patient) orally: Confirms that all team members have been introduced by name and role.”).  According to Dr. Gawande, this simple introduction fosters discipline because when everyone knows their roles and fulfills their designated functions, coordination and trust are increased — and both are very important when time is short and the stakes are high.

Of course, these calls for increased communication and transparency are nothing new — and they pervade almost every aspect of health care reform and improved medical delivery.  For example, this summer, Tim Jost espoused the benefits of the public plan, but noted that no research comparable to the data that has emerged from the Dartmouth research group on variations in health care spending “can be done on the under 65 population because private insurers regard whatever data they have to be proprietary.”  He hopes that “a public plan could make anonymized data available to researchers and be open with its subscribers about coverage and utilization policies.”  Likewise, just last week, in his “Principles for the Homestretch” for health reform, Frank Pasquale called for more competition and transparency in insurance markets.  Moreover, appeals for greater communication and transparency, and, in turn, accountability and discipline, is indicative of the larger movement to the medical home model, which “provid[es] comprehensive primary care… that facilitates partnerships between individual patients, and their personal  physicians, and when appropriate, the patient’s family.”  Increased communication and sharing of information across health care providers has been known to reduce adverse drug-drug reactions, lower medical errors, and bring attention to alternative care possibilities.

It is important to note that increased communication and transparency is not a panacea for all of our health care woes — particularly without balancing openness with ways of addressing privacy concerns.  However, as I gleaned from the talks by Professor Reinhardt and Dr. Gawande, the evidence speaks to the value of a policy of openness in many aspects of health care and medical reform.

Alternative Revenue Stream for Private Practice Physicians – Research Investigator

Clinical research is the only way [for a physician in the managed care era] to make a boat payment, quips David Stark, M.D.

With increasing frequency, pharmaceutical and medical device companies are turning to physicians in private practice, rather than academic medical centers, to serve as investigators overseeing the 60,000-odd clinical trials each year, between 80 and 90% of which are funded by industry as opposed to, say, NIH. Academic medical centers are losing the “business,” having fallen from 63% to 26% as the site for clinical research between 1994 and 2004. While it might be argued that trials in the private practice setting produce superior results because they occur under circumstances that more closely resemble how the drug or device will actually be used if approved by the FDA, there are significant risks attendant to this phenomenon that have received too little attention.

The ultimate question is whether physicians can compartmentalize the competing incentives that exist in advising patients about whether to pursue conventional therapy or participate in a clinical trial. This is especially true if the physician is being handsomely compensated for each patient she recruits into a trial, and is exacerbated when the physician also has other financial relationships with the trial sponsor (the drug or device company) for, say, speaking and consulting gigs. Clinical Research in the Private Office Setting — Ethical Issues The recruitment process for clinical trials is the longest and most costly part of the process - prospective participants have to undergo testing to see if they qualify for the study, and federal law requires that they receive significant amounts of information and have ample opportunity to have their questions answered pre-enrollment. A per capita payment contingent upon successful enrollment of the patient will tempt a physician to fudge on this process and enroll unqualified subjects. This not only may put them at risk because they are too sick, but also skew the research results because they’re not sick enough. Bonuses for meeting enrollment goals only make it worse.

Without impugning physician integrity, how realistic it is for physicians to serve in the dual capacity of treating physician and researcher? Studies have repeatedly confirmed “therapeutic misconception” whereby study participants believe, no matter how clearly told to the contrary, that they are “patients” receiving treatment, rather than “subjects” of research who may be receiving a placebo or an experimental drug. This phenomenon is certainly exacerbated when the patient’s treating physician is doubling as the investigator of the clinical trial. Most patients continue to believe that their own personal physician would be driven solely by their best interests. Ironically, some people have more faith in an experimental intervention when they learn that the investigator has a “piece of the action.”

Obviously, significant policy and legal questions arise from this practice, and a more holistic approach to the question of the best way to encourage clinical trials while safeguarding the interests of trial subjects is beyond what I can attempt here. But one possible approach could be drawn from informed consent law — whether statutory or common law, which should require physician disclosure of conflicts of interest to patients. Imagine the beginning of a conversation between doctor and patient/potential research subject:

Doctor: “Just so you know, if you agree to participate in this clinical trial, I get paid $1000 by the manufacturer of the product being tested, but if you don’t, and you just want regular treatment, I’ll only get paid $60 by your insurance company. But, in fairness, that’s because a clinical trial is a lot more work for me….”

But to be honest, I don’t really believe in this solution either. Most recipients of this information either don’t understand it, or have no idea what to do with it, or both. Some fear that too much confusing information might kill trials altogether, which would be a terrible outcome. And there are certainly reasons to fear that such trials are becoming harder to run, to the point where they’re not worth the money. Ultimately, I guess, I want to control how physicians get paid to serve as investigators — the Goldilocks Solution — not too much, and not too little. I want them to be paid just right, so that they are willing to conduct clinical trials, but aren’t tempted to act other than in the patient’s best interest. Of course, what is just right and how to enforce it poses its own problems.

Seton Hall Law School, the author’s employer, is the recipient of grants, donations and endowments from the pharmaceutical industry. No part of the author’s compensation is funded by these gifts.

x-posted at Concurring Opinions

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Releases White Paper Recommending Reform of Drug and Device Promotion

Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for broad reforms in the marketing of drugs and devices. In a whitepaper, entitled, “Drug and Device Promotion: Charting a Course for Policy Reform,” the Center proposes legal and policy changes to address conflicts of interest in the relationship of medicine and industry. “The time is right for reform in the marketing of drugs and devices to doctors,” said Center Executive Director Tracy Miller. “Conflicts of interest have become pervasive in medical practice. Reform is needed to ensure that patients’ interests are at the heart of medical education, practice, and research,” she said.

The Center recommends: (1) making payments by drug and device companies to doctors transparent, with public disclosure by industry and physicians of their financial relationships; (2) adopting federal legislation to ban gifts, meals and other benefits provided to doctors as part of the current marketing model; (3) setting new policies to give FDA the authority to require studies of safety and efficacy of drugs and devices used off-label; and (4) undertaking a fundamental change in funding for continuing medical education to end industry support.

Moving to Transparency. The Center recommends that payments by drug and device companies to doctors should be publicly disclosed. “Transparency is critical to shore up public trust in physicians and the collaboration of industry and medicine,” said Tracy Miller. Transparency would also foster better practices by doctors and industry, advance government oversight, and provide information to the press and public. Pending federal legislation, the Physician Payments Sunshine Act, would require industry to disclose payments to doctors.

The Center supports this approach. It also recommends that states undertake disclosure by doctors, and decide how information about physician financial relationships with industry could best be shared with patients. Law Professor Kathleen Boozang adds that, “If doctors had to disclose payments from industry it would prompt them to examine their practices through the eyes of their patients and peers.”

Banning Gifts, Meals, Perks. The Center proposes adoption of federal legislation to ban the use of gifts, meals, and other perks to promote drugs and devices. The states have taken the lead to date–Massachusetts, California, Minnesota, and the District of Columbia have passed laws to limit or ban gifts and meals that are now routine in marketing practices. Concluding that industry self-regulation is not sufficient, the Center calls for national legislation to create uniform practices by industry and physicians. As urged by Professor Boozang, “the benefits of drugs and devices should drive promotion and physicians’ decision to prescribe, not a marketing model that depends on gifts and meals.”

Promoting Scientific Study of Off-Label Uses. The Center proposes that national policy should be redesigned to assure that physicians, patients and government have reliable information to make informed choices about off-label medications. Estimates suggest that as many as 40% of all prescriptions are for off-label uses. The FDA has recently issued guidelines to promote integrity and accuracy in medical articles that drug and device companies give to doctors. The Center urges that this policy guidance, while useful, does not go far enough to provide crucial information about the safety and efficacy of drugs and devices prescribed by doctors for uses other than those approved by the FDA.

The Center proposes giving FDA the authority to mandate scientific studies for off-label medications and devices that have high sales volumes or large profits but lack needed evidence of efficacy or safety. This would protect the interests of patients and advance sound choices about the risks, benefits, and economic value of off-label uses.

Reforming Funding for Continuing Medical Education (CME). Most states require physicians to undertake continuing medical education to maintain their medical license. The drug and device industry currently funds over half of the accredited CME courses available to physicians. The Center recommends that industry funding for continuing medical education should be phased out, and replaced by an educational process driven by physicians. As stated by Tracy Miller, “Physicians need to retake control of their professional education. CME should focus on doctors as professionals caring for the whole patient, not just as prescribers of drugs and devices.” While the transition to new funding occurs, the Center recommends that speakers at CME events should disclose more information about their financial interests, and physicians who are paid to promote drugs and devices should not speak at CME events about those products.

Factual Background for the Recommendations

• Ninety-four percent of physicians have some kind of financial relationship with industry, as reported in a major recent national study.

• Five states–Maine, Massachusetts, Minnesota, Vermont and West Virginia– have required industry to disclose financial relationships with physicians.

• As shown by a recent Congressional investigation of payments by industry to prominent psychiatrists, even at universities with strong disclosure policies, practices have not kept pace, leaving the public in the dark about financial ties between physicians and industry.

• Medications are widely used off-label, especially in certain fields such as psychiatry, pediatrics, and oncology. A recent study found that 73% of off-label uses lack evidence of efficacy.

• Commercial support for accredited CME, nearly all of it from drug and device manufacturers, grew from $302 million in 1998 to $1.2 billion in 2006.

Read Whitepaper here.

Bill Would Require Transparency of Physician Relationships with Pharma, Medical Device Companies

Yesterday Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) announced a bill (S 301) that would require pharmaceutical and medical device companies to publicly disclose any gifts and payments to physicians valued at $100 or more per calendar year, according to CQ Healthbeat.

The bill introduced yesterday requires companies to report such gifts and payments to the U.S. Department of Health & Human Services once per year. Similar legislation introduced last year would have required quarterly disclosure of gifts or payments over $25 per year.

Additionally, if passed, the legislation would pre-empt state laws that require disclosure of gifts and payments to physicians.

So far, the bill has gathered support from various sectors. Proponents of the bill argue that it will allow patients to “fully trust the relationship they have with their doctor.”

Representatives of the pharmaceutical and medical device industry have expressed support for a “uniform national standard . . . [as opposed to] a patchwork approach by all 50 states.”

It seems that the only group unlikely to support the proposed legislation is physicians. However, the bill allows for physicians to contest the reports made by pharmaceutical and medical device companies, which would be reviewed by Health & Human Services.