Finding an Understanding Between Doctors and Patients

A general perception has been that doctors choose their profession over their patients. The perception takes shape as medical professionals sometimes choose to protect their profession over the chance to improve the quality of medical care– whether doctors refusing to report a colleague’s mistake or perhaps even hindering the efforts of a doctor rating system.

So when medical mistakes occur and possible lawsuits are on the horizon, it’s no shock that medical professionals sometimes fail to own up to their mistakes–implementing instead a code of silence about the case to avoid or limit liability.  In a critical time when patients or family members are looking for answers, doctors can be unavailable to provide it for them. It would also not be a shock if, after any such information could be helpful to the patient, doctors did so under the advice of counsel.

However, a study has been recently reported by the NY Times which suggests that perhaps silence may not be the most prudent approach.  According the NY Times,

Since 2001, the University of Michigan Health System has handled patient injuries by initiating discussions with patients and families, conducting internal investigations and offering apologies with offers of compensation should those investigations reveal medical errors. To examine the repercussions of such an open disclosure with compensation policy, researchers analyzed the number of claims and lawsuits filed against the hospital system between 1995 and 2007, comparing data from before and after the policy took effect.

Contrary to fears that such transparency might worsen litigation, the researchers found that there were actually fewer lawsuits and claims after the hospital began its disclosure with compensation program. Moreover, the hospital system’s liability costs for lawsuits, patient compensation and legal fees dropped, and claims in general were resolved faster than ever before.

While it may seem counter-intuitive to admit fault from a litigation standpoint, these efforts at transparency and an acknowledgment have actually decreased the number of lawsuits.  Richard C. Boothman, who devised and carried out the disclosure program, says, “[w]hen you break that paradigm of litigation and give patients the chance to understand the human element of the other side — of the doctor and what they are struggling with — you find that people are far more forgiving and understanding than has been typically assumed.”

It’s an interesting proposition,  disclosure and accountability as both a means to litigation loss reduction and changing negative perceptions of the profession. In revealing the doctor’s ordeal– in disclosing the fault, one may move forward towards greater understanding between patients and doctors.

It’s also worth noting that additional disclosure methods are being studied.  The Wall Street Journal reports a study about a project, known as OpenNotes, where doctors share their notes with their patients electronically.  While doctors do complain that the OpenNotes may be burdensome, there are those who think it it may be worth the additional burden because it shows– perhaps whether or not the handwriting is decipherable–that doctors are willing to take the extra time to attempt to keep them informed.

But of course, it would better if patients actually understood their doctors. But this would be in stark contrast to a recent study we wrote about here on HRW last week. The study showed a woeful lack of communication (and a wide gap in perception) between hospital staff physicians and “their” patients:

• Only 18% of patients knew their main doctor by name.
• Sixty-seven per cent of doctors believed their patients knew them by name.
• Fifty-seven per cent of patients knew their diagnosis.
• Seventy-seven per cent of doctors believed their patients knew their diagnosis.
• Fifty-eight per cent of patients thought that physicians always explained things in a comprehensible way.
• Twenty-one per cent of doctors stated they always provided explanations of some kind.
• Sixty-six per cent of patients reported receiving a new medication in the hospital, 90% noted never being told of any adverse effects of these medications.
• Ninety-eight per cent of doctors stated that they at least sometimes discussed their patients’ fears and anxieties.
• Fifty-four per cent of patients said their doctors never did this.

RFID Tags for Nurses, then Everybody?

The recent City of Ontario v. Quon decision has had a mixed reception among privacy advocates. Though many are disappointed that employees’ privacy rights have once again been narrowed, some have discerned helpful dicta in the case. However, I worry that, whatever the drift of thought among swing justices, economic imperatives and cultural shifts will mean a lot less privacy in the workplace of the future. Health care in particular offers a few interesting bellwethers.

As an opinion piece by Theresa Brown explains, maintaining proper staffing levels in hospitals is becoming increasingly difficult. Surveillance systems are offering one way to address the problem; work can be performed more intensively and efficiently as it is recorded and studied. But such monitoring has many troubling implications, according to Torin Monahan (in his excellent book, Surveillance in a Time of Insecurity):

The tracking of people [via Radio Frequency Identification Tags] represents a . . . mechanism of surveillance and social control in hospital settings. This includes the tagging of patients and hospital staff. . . . When administrators demand the tagging of nurses themselves, the level of surveillance can become oppressive. . . . [because nurses face] labor intensification, job insecurity, undesired scrutiny, and privacy loss. . . . To date, such efforts at top-down micromanagement of staff by means of RFID have met with resistance. . . . One desired feature for nurses and others is an ‘off’ switch on each RFID badge so that they can take breaks without subjecting themselves to remote tracking. (122)

Like the “nannycam” employed by many a wary parent, the nurse-cam may be seen as a way to protect the vulnerable. It may also increase the accuracy of evidence in malpractice cases. On the other hand, inserting a tireless electronic eye to monitor what is already an extremely stressful job may create many unintended consequences, or deter people from going into nursing altogether. Even advocates of pervasive surveillance recognize these difficulties.

The increasing pressure to monitor what happens inside hospitals reminds me of a recent article by Thomas Goetz in Wired (no link yet) on Google co-founder Sergey Brin’s quest to find a cure for Parkinson’s disease. As Goetz describes it, a new form of “high-speed science” depends on rapid accumulation of as much data as possible:

In Brin’s way of thinking, each of our lives is a potential contribution to scientific insight. We all go about our days, making choices, eating things, taking medications, doing things—generating what is inelegantly called data exhaust. . . . With contemporary computing power, that data can be tracked and analyzed. “Any experience that we have or drug that we may take, all those things are individual pieces of information. Individually, they’re worthless, they’re anecdotal. But taken together they can be very powerful.” In computer science, the process of mining such large data sets for useful associations is known as a market-basket analysis.

Goetz has promoted this as a new way to “do science in the petabyte age.”
Read more

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.

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.

Consumer Protection in a Reformed Health Care & Insurance System

Implementation is critical to the success of translating universal coverage into access to appropriate health care for all.  Sound follow-through demands the design and execution of well-tailored consumer protection regulations. The first step is a prohibition of underwriting or rating decisions based on preexisting illness.  Insurers have agreed to this reform, as a quid pro quo for the millions of new customers they’ll get from coverage mandates.  Universal coverage and this prohibition of discrimination go together.  Insurers are right that it doesn’t make business sense to ignore preexisting illnesses if consumers can wait for illness to appear before contributing to the insurance pool.  They seem to agree that coverage mandates can adequately do the work of preexisting illness exclusions, rendering them superfluous.

Insurers’ position on non-discrimination would clearly change if folks like Rep. Tom Price (R. Ga.) have their way.  Price objects to mandates because they would allow the government to define “insurance” thereby disadvantaging some forms of currently-marketed coverage, such as bare-bones and HSA-linked consumer-driven products.  But underinsurance has been devastating the American middle class for years; real reform must establish basic levels of fiscal security, as well as medical coverage.  Representative Price’s attack on standards is, then, merely a back door attack on universal coverage.  It is a necessary package deal: either we have universal coverage with an end to preexisting illness exclusions, or markets will continue slicing and dicing “insurance,” leaving huge gaps in coverage. Read more

WaPo, Say it Ain’t So: Publisher Katharine Weymouth said to have offered lobbyists paid access to the Washington Post’s “Health Care Reporting and Editorial Staff”

It doesn’t happen often, but I am bereft of the power of speech. Fortunately, POLITICO is not– and as for what they have written? Res Ipsa Loquitur

POLITICO reports that:

Washington Post publisher Katharine Weymouth said today she was canceling plans for an exclusive “salon” at her home where for as much as $250,000, the Post offered lobbyists and association executives off-the-record access to “those powerful few” – Obama administration officials, members of Congress, and even the paper’s own reporters and editors.

The astonishing offer was detailed in a flier circulated Wednesday to a health care lobbyist, who provided it to a reporter because the lobbyist said he felt it was a conflict for the paper to charge for access to, as the flier says, its “health care reporting and editorial staff.”

With the Post newsroom in an uproar after POLITICO reported the solicitation, Weymouth and Executive Editor Marcus Brauchli both said today that they were not aware of the flier or the specifics of what it offered.

“This should never have happened,” Weymouth told Post media reporter Howard Kurtz. “The fliers got out and weren’t vetted. They didn’t represent at all what we were attempting to do. We’re not going to do any dinners that would impugn the integrity of the newsroom.”

“You cannot buy access to a Washington Post journalist,” Brauchli told POLITICO. Brauchli was named on the flier as one of the salon’s “Hosts and Discussion Leaders.”

Brauchli said in an interview that he understood the business side of the Post planned on holding dinners on policy and was scheduled to attend the July 21 dinner at Weymouth’s Washington home, but he said he had not seen the material promoting it until today. “The flier, and the description of these things, was not at all consistent with the preliminary conversations the newsroom had,” Brauchli said, adding that it was “absolutely impossible” the newsroom would participate in the kind of event described in the solicitation for the event.

“Underwriting Opportunity: An evening with the right people can alter the debate,” says the one-page flier. “Underwrite and participate in this intimate and exclusive Washington Post Salon, an off-the-record dinner and discussion at the home of CEO and Publisher Katharine Weymouth. … Bring your organization’s CEO or executive director literally to the table. Interact with key Obama administration and congressional leaders.”

The flier promised the dinner would be held in an intimate setting with no unseemly conflict between participants. “Spirited? Yes. Confrontational? No,” it said. “The relaxed setting in the home of Katharine Weymouth assures it. What is guaranteed is a collegial evening, with Obama administration officials, Congress members, business leaders, advocacy leaders and other select minds typically on the guest list of 20 or less. …

Brauchli emphasized that the newsroom had given specific parameters to the paper’s business staff that he said were apparently not followed. He said that for newsroom staffers to participate, they would have to be able to ask questions and that he would “reserve the right to allow any information or ideas that emerge from an event to shape or inform our coverage.” That directly contradicts the solicitation to potential sponsors, which billed the dinner as “off-the-record.”

Dr. Kuklo and the Larger Lesson: Transparency in Medical Research

[Ed. note: We are very pleased to welcome Valerie Gutmann, J.D. to the blog today. Valerie joined Seton Hall Law School in 2009 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Kirkland & Ellis LLP after having graduated from Harvard Law School, where she served as an author and Editor-in-Chief of the Recent Developments Section of the Journal on Law, Medicine, and Ethics. Prior to law school, Valerie worked at the National Academy of Sciences, the American Association for the Advancement of Science, and the ABA Coordinating Group on Bioethics & the Law. In 2001 she graduated from the Woodrow Wilson School of International Affairs and Public Policy at Princeton University, magna cum laude, where she was co-president of the Princeton Bioethics Forum.]

In a glaring example of the consequences of less-than full disclosure in research and publication, recent reports have shed light on Dr. Timothy R. Kuklo’s study of Infuse.  Dr. Kuklo’s article on the bone-growth protein manufactured by Medtronic Inc. was published by the British Journal of Bone & Joint Surgery in August 2008, and was retracted in March 2009, after an army investigation found that Dr. Kuklo’s study had misleadingly promoted Infuse as “strikingly” better and more efficacious than conventional bone grafts in repairing severely shattered shin bones of Americans injured in Iraq.  Kuklo has been accused of using “falsified information” that did not match with patient records and forging signatures of four doctors at Walter Reed Army Medical Center who he falsely claimed to be co-authors.  Dr. Kuklo also neglected to disclose his relationship with the company.

Dr. Kuklo, a former army surgeon at Walter Reed, is currently on leave from Washington University School of Medicine in St. Louis, where he was associate professor of orthopaedic surgery, specializing in cervical spine, spinal deformity, spinal tumors, and spine trauma.  From August 2006 through May 2009, Dr. Kuklo was a consultant to Medtronic, who recently announced that Dr. Kuklo’s consultancy contract was being suspended (some accounts controvert the alleged timeline, and Medtronic claims that it had no involvement in the study and did not depend on the study for government regulatory approval). While working for the army, Dr. Kuklo was also paid by Medtronic to speak on the company’s behalf at meetings and to train other doctors, and was a recipient of thousands of dollars worth of trips.  Military officials have stated that there are no records that Dr. Kuklo had sought or received permission to accept money to consult for medical product companies.

Last year, Senator Chuck Grassley (R, Iowa) called for an investigation into Dr. Kuklo’s study.  Senator Grassley requested information from Walter Reed, Washington University, Medtronic, and two medical journals.  He has also publically released a list provided by Medtronic of consultants for the Infuse product, on which Dr. Kuklo had suspiciously not been included.  Spokespeople for Medtronic noted that Dr. Kuklo was not on the list because he was a general consultant to the company, rather than specific to Infuse, although he has spoken on behalf of Infuse in the past.

The Kuklo case is further evidence of the implications of incomplete disclosure, which may lead physicians to make medical decisions without all the information that should be available to them.  As we have noted in the past, the Center for Health and Pharmaceutical Law & Policy has vigorously called for such reform in its 2009 whitepaper:

All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature.  Transparency in the relationship of industry and physicians would be a critical tool in this effort.

PhRMA Shows Its Committment to Transparency With Revised Principles on Conduct of Clinical Trials

The Pharmaceutical Research and Manufacturers of America (PhRMA) Board of Directors announced yesterday their unanimous endorsement of revised principles to increase transparency in medical research through their newly revised PhRMA Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results.  The revised principles are part of an effort to encourage behavior that benefits the healthcare community and the public through objectivity in research and strengthened transparency in medical studies.

PhRMA states that the Principles of Conduct, which are to take effect on October 1, 2009, will:

Fortify our commitment to patients and healthcare professionals by increasing transparency in clinical trials, enhancing standards for medical research authorship and improving disclosure to manage potential conflicts of interest in medical research.

The pharmaceutical and biotech industries have been under recent pressure to become more transparent, specifically concerning the disclosure and publication of clinical trial results, the disclosure of physician payments/reimbursement for conducting clinical trials, and authorship standards.

Read more

Unpublished 1997 Study Linked Drug to Weight Gain and Diabetes, Now Thousands Sue Claiming They Were Not Warned of Side Effects

The Washington Post reported today on the “silenced drug study” of AstraZeneca’s antipsychotic drug, Seroquel.   The study, known as Study 15, was conducted in 1997 and showed an increase in weight gain and diabetes among Seroquel users.  The results were never published and the information was not released to the public or physicians.  The study was, however, provided to the FDA but they did not have the authority to publish the results.  Seroquel was approved by the FDA in 1997 after they received the study’s findings.

AstraZeneca contends that they did disclose the drug’s health risks on the label, as required by the FDA.  Spokesperson Tony Jewell wrote in an email to The Washington Post that the results of Study 15 “did not identify any safety concerns.”  Study 15 compared Seroquel to another similar drug, Haldol.  Jewell also wrote that “A large proportion of patients dropped out in both groups, which the company felt made the results difficult to interpret.”

Over 9,000 lawsuits have been filed against the drug by patients who experienced weight gain, hyperglycemia and diabetes.  It is through these lawsuits that internal documents and details regarding the buried study have emerged.  Internal documents show that AstraZeneca was well aware of the results indicating significant weight gain and worked to spin the results favorably.  The company presented information that Seroquel caused patients to lose weight at two meetings in 1999. This data was based on a much smaller company-sponsored study even though AstraZeneca had concerns with the study and the doctor who conducted it.

The Washington Post says:

The saga of Study 15 has become a case study in how drug companies can control the publicly available research about their products, along with other practices that recently have prompted hand-wringing at universities and scientific journals, remonstrations by medical groups about conflicts of interest, and threats of exposure by trial lawyers and congressional watchdogs.

An obvious concern with unpublished or silenced studies is that they may lead physicians to make medical decisions without all the information that should be available to them.  As the Center for Health and Pharmaceutical Law & Policy recommends in its recently-released whitepaper:

All those engaged in medical research and publication, including medical professionals and institutions, medical journals, and industry, should undertake reforms to ensure the integrity of the medical literature.  Transparency in the relationship of industry and physicians would be critical tool in this effort.

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.