Sunday, May 27, 2012
Health Law Prof Blog is starting a new feature to keep readers updated on some of the many changes in health law degree and certificate programs across the country over the past year or so. If you have health law degree or certificate program updates, please send them to me, Katharine Van Tassel at email@example.com or, after June 30, at firstname.lastname@example.org and I will post them for you.
As the new director of Hamline University's Health Law Institute (HLI), one of our two guest bloggers for the month of May, Thaddeus Pope, has agreed to kick-off this new column by posting this entry:
It is hard to believe that I am already more than halfway through my guest blogging visit, here, at the Health Law Professors blog. I have written about my scholarship. And, next week, I will write about combining scholarship with service and advocacy. This week, I want to write about the program that I now direct: Hamline University’s Health Law Institute(HLI).
At HLI, we offer specialized courses, clinics, and externships that instill real-life health law experience in our students. Recently, we were excited to recognize 21 Hamline Law graduates who have earned their General Health Law Certificate and/or Health Care Compliance Certificate.
Plus, through our National Speaker Series, Symposia, CLE events, and Online Health Care Compliance Certificate for working professionals, we take education beyond law students to the Upper Midwest’s stellar health care community of lawyers, managers, compliance officers, and policy makers. The strengths of our program have not gone unrecognized. HLI has again been ranked as a top 20 health law program in the U. S. News and World Report 2013 Edition.
This summer, we are again offering five compact Health Law courses on our Saint Paul, Minnesota campus for both students and working professionals. The courses are
Health Care Compliance Summer Institute (May 29 - June 7)
- Elder Law (June 16 – 21)
- Unhealthy Choices (June 23 – 28)
- Health Care Reform: Insurance, Exchanges, & Mandates (June 8 – 10)
- Health Care Reform: A New Age of Regulatory Enforcement (June 11 – 14)
This summer, we are also excited to launch our Online Health Care Compliance Certificate Program, via iPad. This is a one-year program designed for working professionals. Once students complete this program they are eligible to sit for the Certified in Healthcare Compliance (CHC) Exam to demonstrate both that they have the requisite knowledge and that they meet the national standards set by the Compliance Certification Board (CCB).
And beyond this summer, we have an exciting fall semester, including: (1) a panel discussing the Supreme Court decision in DHHS v. Florida (Sept. 12); (2) competing in the National Health Law Moot Court Competition (Nov. 2); (3) a law review Symposium on Legal & Medical Issues in End-of-Life Care (Nov. 9); (4) in conjunction with a special performance of Expiration Date at the Landmark Center (Nov. 8).
If you are going to be in Saint Paul during the upcoming academic year (or if you would like to visit), please let me know. We are always looking for engaging speakers and diverse faculty visitors. I look forward to hearing from you.
Guest Blogger Nicole Huberfeld: Hidden Responsibilities for Hospital Boards in New Public Benefit Rules
New regulatory regimes often contain both intended and unintended effects. The example I have in mind is PPACA section 9007, entitled “Additional Requirements for Charitable Hospitals,” which I discussed briefly in my first post. This section requires tax-exempt hospitals to prove their public benefit by four mechanisms, described by the IRS thus:
Section 501(r)… imposes new requirements on 501(c)(3) organizations that operate one or more hospital facilities (hospital organizations). Each 501(c)(3) hospital organization is required to meet four general requirements on a facility-by-facility basis:
- adopt and implement written financial assistance and emergency medical care policies,
- limit charges for emergency or other medically necessary care,
- comply with new billing and collection restrictions, and
- conduct a community health needs assessment (CHNA) at least once every three years.
These requirements seem to respond to critiques from Senator Grassley and others that tax-exempt hospitals had stopped earning their subsidy from the federal government (which, arguably, had been a downward slope since the IRS issued Revenue Ruling 69-545 creating the ‘community benefit’ standard after Medicare and Medicaid were enacted in 1965). The new §501(r) will begin to reattach the concept of free care for the poor to federal charitable status.
In the wake of the JPMorgan Chase revelations (scandal?) and renewed discussion regarding the Volcker Rule, one can’t help but think that a collateral consequence of §9007 may be to place additional, potential conflict-creating duties on hospital board members. Hospital boards will be responsible for implementing new financial assistance policies, reviewing charges for certain medical care, ensuring their hospital(s) do not improperly collect debts, and conducting community health needs assessments; but that’s not all. The CHNA in particular seems to be a potential sticking point for boards, as the public health-driven concept could be at odds with the board’s drive to ensure the mission of the hospital is fulfilled.
For example, what if the CHNA determines that untreated STDs are a major issue in the community and an educational campaign regarding “safe-sex” is warranted, but the tax-exempt entity is a Catholic hospital. If the board ignores the CHNA, it may violate its duty of care if it does not adopt an “implementation strategy” as required by 501(r)(3)(A); but, if the board implements the strategy to conduct safe-sex education, it may run afoul of its mission as a Catholic hospital and violate its duty of obedience. Either way, board members face potential liability, and the hospital faces potential excise taxes. Though I think the new community benefit rule is generally a good idea, I wonder if we are asking too much of hospital boards. Thoughts?
Thursday, May 24, 2012
I’ll be speaking on privacy and fair data practices at an upcoming conference. Health information law is a very exciting field. Lawyers, doctors, and start-ups are re-thinking health care as an information industry. The relationships between privacy, “big data,” and trade secrecy will bear a great deal of attention in coming years.
Software-based automation has raised living standards dramatically. It makes factories more efficient, renders vast amounts of information accessible, and daily improves quality of life in barely noticed ways. To realize these types of advances in health care, government and NGOs have begun to catalyze better data collection, retention, and analysis. Life sciences companies need to report more data on drugs and devices. Hospitals and doctors are incentivized to use electronic health records via stimulus funding and rulemaking based on the HITECH Act’s meaningful use and certification requirements.
All these development raise many questions, which I try to address in my seminar, Health Information, Privacy, and Innovation. If any of our readers is interested in a syllabus, I'd be happy to send one. Topics for the class are posed below:
How will traditional intellectual property laws interact with initiatives to make health care more of an information industry? Will the increasing need for cooperation and sharing of information alter the landscape of trade secrecy and other IP protections that have often siloed health data? Will providers find alternative funding sources for the collection, retention, and analysis of data, as some traditional IP protections appear increasingly outdated in a world of “big data” and market-driven transparency?
Medical privacy law has focused on assuring the privacy, security, and accuracy of medical data. The post-ACA landscape will include more concern about balancing privacy, innovation, access, and cost-control. Advanced information technology has raised a number of new questions. Beyond HIPAA and HITECH regulation, consumer protection law plays an important role in these fields. (For example, the FTC recently required firms that “score” the health status of individuals based on their pharmacy records to disclose these records to scored individuals.)
Patients are opting to personalize their health records with the help of cloud computing firms; what law governs this digital migration? There is increasing concern about the role of “incidental findings” in medical research and practice; how will regulators and professional groups address them? When employers demand access to employee health records, in what ways can they use them to profile the employee?
We also need to examine the legal aspects of data portability, integrity, and accuracy. When two health records conflict, which takes priority? What is “meaningful use” of an electronic health records system, and how will regulators and vendors assure interoperability between systems? The course will also cover innovators’ efforts to protect their health data systems using contracts, technology, trade secrecy, patents, and copyright, and “improvers’” efforts to circumvent those legal and technological barriers to openness.
Finally, what are pharmaceutical companies’ past and present strategies regarding the disclosure of their research, including non-publication of adverse results and ghostwriting of positive outcomes? Will a “reproducible research” movement, popular in the hard sciences, reach pharmaceutical firms? Insurer data will also be a target of reformers (including trade-secret protection of prices paid to hospitals, conflicts over the interpretation of disclosure requirements in the ACA, and state regulation of insurer-run doctor-rating sites). Quality improvement and pilot programs will need good provider and insurer data–how we will ensure they have them?
Thursday, May 17, 2012
A number of news outlets have reported today that the U.S. Conference of Catholic Bishops is increasing its attack on PPACA’s definition of preventive health services to include contraception. The AP reports:
U.S. Roman Catholic bishops are rejecting the Obama administration's plan to accommodate faith groups that object to the birth control mandate. The bishops said in a statement Tuesday to Health and Human Services that the prospective new rules don't do enough to protect religious liberty. The mandate requires employers to provide health insurance that includes birth control for workers. The plan sparked protests from faith leaders because it included most religious nonprofits such as hospitals and colleges. President Barack Obama offered a compromise. He said insurers would bear the cost of the birth control instead of religious employers. However, the bishops argue that the compromise still makes their insurance plans a conduit for contraceptives. The administration is reviewing public comments before making any final decision.
This ongoing fight is notable for a number of reasons, one of which is that Dr. John Rock, an inventor of the birth-control pill, was a religious Catholic who firmly believed that the progestin-based function of the pill fit neatly within the Church’s idea of “natural” methods for preventing conception. Malcolm Gladwell wrote for the New Yorker in 2000:
The key fact was that the Pill's ingredients duplicated what could be found in the body naturally. And in that naturalness he saw enormous theological significance.
In 1951, for example, Pope Pius XII had sanctioned the rhythm method for Catholics because he deemed it a "natural" method of regulating procreation: it didn't kill the sperm, like a spermicide, or frustrate the normal process of procreation, like a diaphragm, or mutilate the organs, like sterilization. Rock knew all about the rhythm method. In the nineteen-thirties, at the Free Hospital for Women, in Brookline, he had started the country's first rhythm clinic for educating Catholic couples in natural contraception. But how did the rhythm method work? It worked by limiting sex to the safe period that progestin created. And how did the Pill work? It worked by using progestin to extend the safe period to the entire month. It didn't mutilate the reproductive organs, or damage any natural process. "Indeed," Rock wrote, oral contraceptives "may be characterized as a 'pill-established safe period,' and would seem to carry the same moral implications" as the rhythm method. The Pill was, to Rock, no more than "an adjunct to nature."
The Church rejected Dr. Rock’s pill, which apparently greatly surprised him. And, of course, Catholic women, like other women of reproductive age, have embraced the pill. As the Guttmacher Institute reports:
Among all women who are at risk of unintended pregnancy, 69% (including 68% of Catholics) are currently using a highly effective contraceptive method—male or female sterilization, the IUD, the pill or another hormonal method. Another 14% (15% among Catholics) are relying on condoms, and 5% (4% among Catholics) are relying on other methods, such as withdrawal. Only 1% of all women at risk of unintended pregnancy (2% of Catholics) use natural family planning, the only method of contraception sanctioned by the Catholic hierarchy.
The American Congress of Obstetricians and Gynecologists for years has fought to have contraception defined as preventive healthcare for women and describes contraception as “vital to women’s health and well-being.” Many will be watching closely to see how Secretary Sebelius responds to the Bishops.
Tuesday, May 15, 2012
I am delighted to be speaking at the Fourteenth Annual SIH/SIU Health Policy Institute later this week and honored to be included in a great group of speakers, here. I've been asked to do a summary of how we got to the current state of "Meaningful Use" (MU) and provide a critical analysis of the subsidy program. Obviously this has both quantitative and qualitative aspects. The former inquiry has been particularly challenging; I have been faced with a veritable soup of confusing data. For example, exactly what are the data in all those charts about the growth of EMR utilization, are they providers who have registered for MU, or attested, or received funds? When you read about the numbers of providers who have adopted EMRs is that limited to eligible providers and to users of certified technologies?
Moving to more qualitative aspects, exactly what technologies are being used? Are these smart EMRs that are integrated with sophisticated prescribing and clinical decision support technologies, or the EMR version of dumb-phones? And when a study notes a strong uptick in meaningful use, is that for real, or have the providers been able to punt on some of the harder objectives or report on measures with extremely low numbers of participating data subjects? It strikes me that there's still a lot of government and industry cheerleading going on out there, abetted by cherry-picked data.
I am also trying to move beyond the MU weeds and reflect on the thorny safety/regulatory issues as well as the still unsolved privacy and security questions. You have probably read about the value of "big data," and if not this McKinsey report is a fine primer. I confess that I had to look up what a zettabyte of data was! I will also try and reflect on ACA, EMR-based research, and future conceptions of health data, at least until the moderator loses patience and pulls the power from my slide deck. Maybe I'll see you there! [NPT]
Thursday, May 10, 2012
Stacey Tovino, All Illnesses are (Not) Created Equal: Reforming Federal Mental Health Insurance Law, SSRN/Harv. J. Leg.
Gregg Bloche, Beyond the “R Word”? Medicine's New Frugality, NEJM
Wednesday, May 9, 2012
With the close of the spring semester, the thoughts of most law professors turn to scholarship, to that “big” summer writing project. Not me. My summer is, instead, committed to a series of smaller research and writing projects.
Over the past two years, I have found myself publishing more in medical and bioethics journals, and less in traditional law reviews. For example, of nine (9) new articles that I have published, so far in 2012, only one was in a traditional law review. The others were in book chapters, JAMA, Chest, Am. J. Bioethics, and other journals. In 2013, I plan to tip the balance back toward traditional law reviews (and a book: Pulling the Plug: The Legal History of Medically Managed Death). But I want to comment on the largely non-traditional composition of my current scholarship portfolio.
While law reviews are targeted primarily to other law professors (and sometimes to lawyers and judges), medical and bioethics journals are targeted primarily to “front line” health care providers. I enjoy writing for this audience. After all, much of health care law is implemented, on a day-to-day basis, directly by medical providers without the involvement of lawyers. I hope that my scholarship helps these providers better understand the law for which they (alone) are primarily responsible.
Let me provide a specific example. This winter, I published an article titled “The Unbefriended: Making Healthcare Decisions for Patients without Surrogates” in The Journal of Clinical Ethics. The “unbefriended” or “unrepresented” patient is one of the most vulnerable in society. Unfortunately, in healthcare facilities across the United States, there are thousands of incapacitated patients and residents who have no reasonably available surrogate. Who can consent to needed medical treatment for these individuals? Who should? The legally authorized options vary significantly from jurisdiction to jurisdiction. Furthermore, frustrated with the practicability of the main default option, guardianship, many facilities have developed various extralegal mechanisms. Other facilities, sticking within the letter of the law, violate their ethical and medical obligations to unbefriended patients. To give guidance to these facilities, I synthesized and organized the complete range of legal and non-legal approaches.
I could have published this manuscript as a law review article. Indeed, at over 20,000 words, The Journal of Clinical Ethics published it in two parts. If traditional law reviews were better indexed on Medline, then I might not have made this placement decision. But I wanted to reach the clinicians for whom the issue was most relevant.
Many thanks to Katharine and the other editors for allowing me to crash their party this month. One of the major arguments against severability in the Patient Protection and Affordable Care Act (PPACA) litigation is that the law addresses many problems in many different ways, thus the minimum coverage provision should be severed if the Court decides (against precedent) that Congress has exceeded its commerce power. The legislation is extensive and does address diverse healthcare concerns, but it seems unfortunate that the United States had to take the position that its law does not hang together as a whole. What government would choose to explain such significant legislation in this way? Just two of today’s many health-related news items, which themselves appear disconnected, indicate how it is not such a stretch for PPACA to be described as addressing longstanding, related problems in American medicine.
First, Governor John Hickenlooper signed Colorado Senate Bill 134 today, a law that directs Colorado hospitals to take a number of steps toward financial transparency, fairness, and bill planning before they can resort to collection agencies. The Denver Post reports that the “prime impacts” of the law will be:
- Hospitals cannot charge the uninsured covered by the bill more than the lowest negotiated price offered to insurance companies or other third parties.
- All hospitals must make financial-assistance information obvious to consumers online, posted in the hospital and printed on bills.
- The hospitals must try to help low-income patients set up an extended payment plan before they are referred to collection agents.
Colorado’s new law echoes PPACA Section 9007, entitled “Additional Requirements for Charitable Hospitals.” After many years of attempting to require more concrete provision of and evidence of charity care from tax-exempt hospitals, Congress has instituted requirements that 501(c)(3) hospitals refrain from aggressive collection practices unless they introduce “financial assistance polic[ies]” and determine whether the nonpaying patients are eligible for such assistance. In addition to strengthening the rules for obtaining the subsidy that is charitable status, this new policy could facilitate earlier, more treatable, and less costly care, as patients will not fear the bankruptcy that could result from receiving treatment.
Second, the Institute of Medicine has just issued a report providing a multifarious approach to obesity prevention and reversal, which the IOM summarizes as follows:
Left unchecked, obesity’s effects on health, health care costs, and our productivity as a nation could become catastrophic. The staggering human toll of obesity-related chronic disease and disability, and an annual cost of $190.2 billion for treating obesity-related illness, underscore the urgent need to strengthen prevention efforts in the United States. … The IOM evaluated prior obesity prevention strategies and identified recommendations to meet the following goals and accelerate progress:
Integrate physical activity every day in every way
Market what matters for a healthy life
Make healthy foods and beverages available everywhere
Activate employers and health care professionals
Strengthen schools as the heart of health
On their own, accomplishing any one of these might help speed up progress in preventing obesity, but together, their effects will be reinforced, amplified, and maximized.
The IOM’s report will aid those who seek the funding for obesity prevention that PPACA has made available through the Prevention and Public Health Fund and other mechanisms.
Neither the IOM report nor the new restrictions on tax-exempt hospitals is directly related to the “individual mandate,” but these stories are still connected. American health can be advanced by improving aspects of the system that have been disparate since the early 1900s: public health, hospital organization and behavior, and payment mechanisms. If obesity trends downward, then Americans will be healthier for not suffering the collateral diseases the IOM highlights (hypertension, diabetes, heart disease, etc.). And, when medical need arises, a patient is more likely to seek care, rather than waiting until a disease is more advanced and thus more expensive, if hospitals are fair in charging and collecting practices. Insurers will have more healthy bodies in the risk pool, which should help to keep premiums down. The various moving parts ease each others’ function.
This is not to say that the law is so cohesive that the individual mandate should not be severed; it would be bizarre to strike down such an extensive law over one element of its scheme. But, the Obama Administration seems to be missing the chance to tell a more coherent tale of its signature legislation.
The Health Law Prof Blog is pleased to introduce our second guest blogger for the month of May, Professor Nicole Huberfeld. Here is her short bio:
Nicole Huberfeld is Professor of Law at the University of Kentucky College of Law and Bioethics Associate at the University of Kentucky College of Medicine. Nicole teaches structural constitutional law and a variety of healthcare law courses. Her scholarship focuses on the cross-section of constitutional law and federal healthcare programs with a particular interest in federalism and Spending Clause jurisprudence. Her latest article, Post-Reform Medicaid before the Court: Discordant Advocacy Reflects Conflicting Attitudes, is forthcoming in the Annals of Health Law. She also published Federalizing Medicaid in the University of Pennsylvania Journal of Constitutional Law in December and a book review of The Politics of Medicaid with the Journal of Legal Medicine in March. She was the recipient of the Duncan Teaching Award, a nominee for the University of Kentucky Great Teacher Award, and a nominee for the ALI Young Scholars Medal. Previously, she was the Health Law Faculty Fellow at Seton Hall Law School. While at Seton Hall, she created and was Director of the Health Care Compliance Certification Program, which educates compliance officers of pharmaceutical and medical device companies in corporate and healthcare compliance. Prior to academic life, she practiced regulatory and transactional healthcare law in New York and New Jersey.
Tuesday, May 8, 2012
Einer Elhauge, Petrie Professor of Law at Harvard Law School and Founding Director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, has written a compelling series of articles in The New Republic citing solid evidence to rebut the claims of those who challenge the constitutionality of Obama Care’s individual mandate by asserting that purchase mandates are unprecedented. In the first of the series, If Health Insurance Mandates Are Unconstitutional, Why Did the Founding Fathers Back Them?, Professor Elhauge explains:
[t]he founding fathers, it turns out, passed several mandates of their own. In 1790, the very first Congress—which incidentally included 20 framers—passed a law that included a mandate: namely, a requirement that ship owners buy medical insurance for their seamen. This law was then signed by another framer: President George Washington. That’s right, the father of our country had no difficulty imposing a health insurance mandate.
That’s not all. In 1792, a Congress with 17 framers passed another statute that required all able-bodied men to buy firearms. Yes, we used to have not only a right to bear arms, but a federal duty to buy them. Four framers voted against this bill, but the others did not, and it was also signed by Washington. Some tried to repeal this gun purchase mandate on the grounds it was too onerous, but only one framer voted to repeal it.
Six years later, in 1798, Congress addressed the problem that the employer mandate to buy medical insurance for seamen covered drugs and physician services but not hospital stays. And you know what this Congress, with five framers serving in it, did? It enacted a federal law requiring the seamen to buy hospital insurance for themselves. That’s right, Congress enacted an individual mandate requiring the purchase of health insurance. And this act was signed by another founder, President John Adams.
For some time, observers criticized hospitals for billing their uninsured patients the rack rate while charging insured patients far less. Under the Affordable Care Act, hospitals must offer their uninsured patients discounts similar to those negotiated with insurers. But many uninsured patients have been billed in the past at hospital list prices. On Thursday, May 10, the Indiana Supreme Court will hear oral arguments on the question whether the high hospital rates for the uninsured were unreasonable and therefore unenforceable. The specific issue before the court is whether uninsured plaintiffs can bring their claim--the trial court had dismissed the case for failure to state a claim, and the court of appeals reversed..
Friday, May 4, 2012
The term “death panel” famously dates to the summer of 2009, when former Alaska Governor Sarah Palin used that term to refer to a provision in proposed health reform legislation (H.R. 3200, section 1233) that would have paid physicians (more than current reimbursement allows) to provide voluntary advance care planning (VACP) to Medicare beneficiaries. The characterization of VACP as “death panels” was later (correctly) denounced by PolitiFact, among others, as the “lie of the year.”
Still, the term has been employed somewhat more accurately (even if pejoratively) in other contexts. For example, the UK’s National Institute for Health and Clinical Excellence (NICE) makes healthcare coverage decisions that effectively impact who will live and who will die. And here in the United States, many charge that the Medicare IPAB will soon move (though currently statutorily barred) from merely insisting on cost effective treatment to outright denying expensive treatment. While usage of the term “death panels” is generally mere calumny, it is sometimes befitting.
I write this post to commemorate the 50th anniversary (1962 – 2012) of a genuine and infamous American “death panel”: the Admissions and Policy Committee of the Seattle Artificial Kidney Center at Seattle’s Swedish Hospital. In 1962, Swedish housed the only dialysis clinic in the country. But, even locally, there were more needy patients than Swedish could accommodate. The Seattle Committee’s job, as a famous Life Magazine article title described it, was to “decide who lives, who dies.” Consequently, it became known as the “God Committee” or “God Squad.” Over the following decade, other committees in other cities also decided who would, and who would not, get access to life-saving dialysis.
The dialysis committees disappeared after Congress expanded access in 1972, by authorizing the End Stage Renal Disease Program under Medicare. There was no longer a shortage of machines and facilities. But many other conditions of healthcare scarcity persist. For example, today, we have organ transplantation committees and hospital futility committees. There are all sorts of “death panels” in the United States. We need them. By acknowledging both their existence and their importance, we can better rationally, openly, and fairly grapple with the tragic choices that our society must make.
Jessica Gabel, Redeeming the Genetic Groupon: Efficacy, Ethics, and Exploitation in Marketing DNA to the Masses, SSRN/Miss. L.J.
David Blumenthal, Performance Improvement in Health Care — Seizing the Moment, NEJM
Susan Wolf et al, Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets, SSRN/Genetics in Medicine
Nadia Sawicki, Patient Protection and Decision Aid Quality: Regulatory and Tort Law Approaches, SSRN
The Commonwealth Fund has made available an important new report, Explaining High Health Care Spending in the United States: An International Comparison of Supply, Utilization, Prices, and Quality, here. The authors compare the cost and quality of healthcare in 13 industialized countries. Contrary to arguments frequently made this report finds that higher costs in the US are not due to higher income, the size of the elderly population, or smoking rates in the US. Rather the only positive correlations were, “higher prices and perhaps more readily accessible technology and greater obesity.” Unfortunately the same study confirmed prior research that “despite high costs, quality in the U.S. health care system is variable and not notably superior to the far less expensive systems in the other study countries.” [NPT]
Wednesday, May 2, 2012
A recent story emphasized the importance of filters in an era of information overload, and the need to develop better ways of processing complex information. Kerry Grens's article "Data Diving" emphasizes that "what lies untapped beneath the surface of published clinical trial analyses could rock the world of independent review."
[F]or the most part, [analysts] rely simply on publications in peer-reviewed journals. Such reviews are valuable to clinicians and health agencies for recommending treatment. But as several recent studies illustrate, they can be grossly limited and misleading. . . . [There is] an entire world of data that never sees the light of publication. “I have an evidence crisis,” [says Tom Jefferson of the Cochrane Collaboration]. “I’m not sure what to make of what I see in journals.” He offers an example: one publication of a Tamiflu trial was seven pages long. The corresponding clinical study report was 8,545 pages. . . .
Clinical study reports . . . are the most comprehensive descriptions of trials’ methodology and results . . . . They include details that might not make it into a published paper, such as the composition of the placebo used, the original protocol and any deviations from it, and descriptions of all the measures that were collected. But even clinical study reports include some level of synthesis. At the finest level of resolution are the raw, unabridged, patient-level data. Getting access to either set of results, outside of being trial sponsors or drug regulators, is a rarity. Robert Gibbons, the director of the Center for Health Statistics at the University of Chicago, had never seen a reanalysis of raw data by an independent team until a few years ago, when he himself was staring at the full results from Eli Lilly’s clinical trials of the blockbuster antidepressant Prozac.
There will be a growing imperative to open up all of the data as concerns about the reliability of publications continue to grow. (PS: I found the Grens story via the "Medical Skeptic" twitter feed; very interesting link feed.)
Tuesday, May 1, 2012
The Institute of Medicine issued a new report today, "Ethical and Scientific Issues in Studying the Safety of Approved Drugs." In the wake of problems that have arisen with drugs that needed to be pulled from the market, the IOM called for the collection and assessment of data about "a medication's benefit-risk profile throughout its entire 'life cycle' from approval until it is no longer marketed."