Friday, August 31, 2012
This new book by Karen Sharp, Blood Medicine: Blowing the Whistle on One of the Deadliest Prescription Drugs Ever tells the story of Mark Duxberry and Dean McClennan, two pharmaceutical reps who became concerned because they felt that their employer, Johnson & Johnson, was asking them to sell doctors a drug intended to improve the lives of patients undergoing chemotherapy and kidney dialysis but instead was apparently shortening their lives. The book is apparently deeply critical of not just the pharmaceutical company but the slowness of regulators to respond to the reports of unexpected deaths.
I haven’t read it yet, but both from my experience at the Connecticut Attorney General’s Office and the research I’ve been doing over the past five years it reflects the sad truth that for all we benefit from the courage of those insiders who bring forward information of public importance, the experience is almost uniformly bad for the whistleblower--even when like here they are ultimately vindicated and in this case even compensated. This is an important story to tell and I will be evaluating it for use in a class on pharmaceutical law I’m developing.
It comes as no surprise that presidential candidate Mitt Romney has promised to "repeal or replace" the Affordable Care Act, despite the fact that he was the architect of the Massachusetts state law upon which the ACA built its foundations. It is impossible to know if such a promise will come to fruition, especially before the election, but supporters of the law would be foolish not to take such a platform seriously. After all, the determination and money that drove the challenges to the minimum coverage provision and the Medicaid expansion seem to be, if anything, more energized after the NFIB decision. Even though the law's challengers failed to strike down the individual mandate, the five more conservative members of the Court adopted the novel constitutional arguments made against both the individual mandate and the Medicaid expansion, leaving plenty of room for future challenges. And, some of those challenges are already brewing, such as the maintenance of effort fight in Maine, the challenges to coverage of contraception with no copayment, and challenges to providing tax subsidies for private insurance through federally-run exchanges.
I've noted the issues raised by financialization in nursing homes, billing & payment systems, and hospital chains before on blogs. I wanted to present a few paragraphs from a recent book review (of Robert Shiller's Finance and the Good Society), which explore the problems raised by the finance sector's interaction with pharma:
A Ph.D. cancer researcher with ten years of experience tends to make about $110,000 to $160,000 annually; a banker specializing in mergers and acquisitions, about $2 million. Top hedge fund managers make billions of dollars annually. The disparity fails to rankle Shiller, since the “scientists are mostly living comfortably doing what they really want to do.”
Unless, of course, they’re among the thousands of drug developers laid off by pharmaceutical firms, which have been pressured by Wall Street to focus on “core competencies” and cut R&D. Last year, investment managers punished Merck for investing in research, while rewarding Pfizer for cutting it dramatically. Investors and analysts also questioned R&D levels at Lilly and Amgen. The constant pressure for quarterly earnings makes each cut to scientific investment seem rational when it occurs, but its consequences are devastating in the long run.
Shiller is eager to praise financiers for funding innovation, but barely mentions the asset-stripping and short-term thinking that have devastated many industries over the past two decades. A study from the New Economics Foundation recently estimated that leading London bankers “destroy £7 of social value for every pound in value they generate.” In the United States, the Kauffman Foundation concluded that an “expanding financial sector” is “depleting [the] pool of potential high growth company founders.” Why go to the trouble of developing a new product or service when you can take on much less risk (and probably net a far bigger return) as a financier deciding which company merits investment? Whatever one thinks of their methods, at least the NEF and Kauffman are asking tough questions about finance’s role vis-à-vis the real economy of goods and services.
Whether we are contemplating drug shortages or lack of innovation in antibiotics, we should always complement critiques of policy failures with critical examination of the methods of those at the commanding heights of the economy. Contemporary finance is agnostic to human outcomes. We should not be surprised if it generates some troubling ones in health care.
Insurance market reforms under the Affordable Care Act are designed to . . . shed the current system in which health plans have an incentive to enroll healthier people while avoiding the sick. One of the arrangements that will make the new system workable is risk adjustment—-a process by which health insurance plans will be compensated based on the underlying health status of the people they enroll, and therefore protected against losing money by covering people with highcost conditions.
But implementing risk adjustment could prove challenging. The statistical methods used in risk adjustment are technically complex. There are questions about the ability of the states, which have to carry out the risk adjustment, to collect accurate data and implement methodologies that result in fair payments to plans.Perhaps redundant Wall Street quants could step into these roles? The brief notes that "Health insurance plans having costs at least 3 percent more than target projections will receive payments that have been assessed from plans having costs at least 3 percent less than projections." The program is one more step toward a utility model for insurers--a welcome change that should be considered throughout the financial sector. [FP]
Thursday, August 30, 2012
Wednesday, August 29, 2012
Within the past two weeks, major "right to die" events have occurred in the UK. On August 16, the High Court in London issued a decision rejecting assisted suicide, Nicklinson and Ministry of Justice,  EWHC 2381 (Admin), http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWHC/Admin/2012/2381.html&query=suicide&method=boolean (16/08/2012). Two patients, both almost completely paralyzed as a result of strokes, had sued to have assistance in suicide without risks of prosecution for those helping them.
AM's (pseudonymized initials) stroke occurred in 2008; since that time, he has been almost entirely unable to move. Now age 47, AM can communicate through small eye and head movements and can be fed orally. AM wishes to go to Dignitas in Switzerland for suicide assistance. His wife is unwilling to support AM for this purpose, as she opposes it. However, she is willing to go with him to provide comfort, if others are available to provide the service. In the litigation, AM sought clarification that anyone assisting him would not be prosecuted in England under the policy of the Director of Public Prosecutions (DPP).
Tony Nicklinson's circumstances are somewhat different. His stroke occurred in 2005; he communicates by blinking in response to letters held on a Perspex board and by using an eye blink computer. Although Nicklinson estimates that with help he could travel to Dignitas, he is unable to swallow and so would require euthanasia services rather than assisted suicide--services which Dignitas does not provide. Nicklinson, now age 58, has been a vocal advocate for euthanasia for several years. Nicklinson sought a declaration that a physician providing him with assistance in dying would not be liable for prosecution.
In the UK, it is an offense to encourage or assist the suicide of another; the punishment may be imprisonment for up to 14 years. Prosecutions for the offense of assisted suicide require the consent of the DPP. DPP current policy identifies factors tending in favor of prosecution, including that the suspect was acting in the capacity of physician, other health care provider, or professional carer. Factors tending against prosecution include the victim's voluntary, clear, settled and informed decision; compassionate motivation; and report to the police. Although an interim policy had included that the victim had a "terminal illness; or a severe and incurable physical disability; or a severe degenerative physical condition; from which there was no possibility of recovery," this factor was excluded from the final policy as a result of concerns from the disability community. The claimants sought clarification of the DPP policy so that those assisting them with dying would not face prosecution. They also sought determination of whether an adverse determination would be compatible with article 8 of the European Convention on Human Rights, respect for private and family life.
In ruling against Nicklinson and AM, the High Court determined that each sought major changes in the law. These changes, the judges wrote, were for the legislature and not for the courts to make. With respect to Article 8, the Court observed that there had been no rulings that a ban on voluntary euthanasia violated the Convention and that member states were permitted to decide whether it was for courts or the legislature to determine prosecutorial policy.
On August 22, 2012, Tony Nicklinson died. His death was attributed to pneumonia. Reportedly, he had refused all nutrition since the High Court decision as well as any treatment for the pneumonia,http://www.guardian.co.uk/uk/2012/aug/22/tony-nicklinson-right-to-die-case .
Tuesday, August 28, 2012
Profits and Kickbacks
Drug manufacturers are entitled to make a reasonable return on their investments in developing new drugs (that is the purpose of the patent monopoly, after all). But this practice definitely raises prescription drug spending unnecessarily, and is particularly trouplesome when this strategy to maintain profits takes the place of developing new drugs to replace the profits that are lost when a drug goes off-patent. The coupons are also coupled in many cases with "lifestyle" programs, such as Pfizer's "Lipitor for You" program, which includes coaching, health advice and recipes. It is illegal to give Medicare and Medicaid patients discounts to entice them to buy a particular product or use a particular service or health-care provider, under the Anti-Kickback Statute. But apparently waste in the name of maintaining private profits beyond the time the law says you are entitled to them is perfectly fine. Why?
Cross-posted on Healthy Interests
Monday, August 27, 2012
While the U.S. Court of Appeals for the Sixth Circuit upheld the Food and Drug Administration's graphic warnings for cigarette packages in March, the D.C. Circuit last week found them to be an unconstitutional infringement of the first amendment rights of tobacco companies.
The Sixth Circuit applied the Supreme Court's very deferential standard for regulation of commercial speech when the government protects consumers from being misled by companies' promotional activities by requiring the companies to disclose specific information about their products or services. The D.C. Circuit, however, concluded that the deferential standard did not apply to the graphic warnings. According to the D.C. Circuit, the warnings do not compensate for any misleading advertising by tobacco compaines. Hence, the tougher standard for restrictions of commercial speech should apply.
With the circuit split, we can expect the Supreme Court to take up the issue.
Sunday, August 26, 2012
A former director of Connecticut Department of Environmental Protection once told me that West Nile Disease would be easier to manage if the name was less exotic and people were less scared. That was ten years ago—and the problem now isn’t the name. Here in Texas we have several counties already declaring a public health emergency—and that’s during a terrible drought. For those of you interested in following the outbreak and the response to it here is a link to the non-intuitively named Texas Department of State Health Services. Here’s a map of where deaths of been reported. So far, the rate of both illness and fatality are relatively low, but the response of afflicted communities to spray pesticides from the air raises a classic public health dilemma: weighing the needs of the few v. the needs of the many.
From a public health point of view, the question is whether the cure for mosquito borne illness, spraying pesticides or even putting them on your body, is worse than disease. The science on the danger to adults varies, but the EPA has warned that children are especially vulnerable because they are growing. In regard to that, it’s instructive to remember the foundational case in public health: Jacobson v. Massachusetts. In Jacobson , the Supreme Court recognized the existence of a Police Power that enabled states to require citizens to be vaccinated against small pox even when there was a genuine difference of scientific opinion on whether the danger of the vaccine justified the risk. The Court said it would only interfere with a state’s exercise of its police power “Only if a statute purporting to have been enacted to protect the public health, the public morals, or the public safety, has no real or substantial relation to those objects, or is, beyond all question, a plain, palpable invasion of rights secured by the fundamental law.”
The problem of deadly mosquito borne diseases isn’t going away and is likely to become worse. West Nile is only one of many similar viruses causing harm across the United States. It also seems likely that we will soon be seeing U.S. acquired cases of malaria or perhaps even dengue fever along with other and until now exotic and deadly diseases. It’s a situation worth keeping an eye on—and the Department of Defense, which is responsible for implementing the National Strategy on Biosurveillance is currently ramping up to do.
Friday, August 24, 2012
Michael Bailit et al, Shared-Savings Payment Arrangements in Health Care: Six Case Studies, Commonwealth Fund
Michelle M. Mello et al, Ethical Considerations in Studying Drug Safety — The Institute of Medicine Report, NEJM
Thursday, August 23, 2012
Having just completed the first week of classes, I am enjoying the energy that the return of students brings to the building. But, I am also remembering how hard it is to introduce students to the healthcare system (non-system, really). For those who also feel challenged by the introductory phase of health law classes, here's something that may help: the New England Journal of Medicine has posted a 45 minute documentary entitled Getting Better regarding the ways in which the American healthcare system has changed over the last 200 years. NEJM's description:
Getting Better is a 45-minute documentary video that tells three remarkable stories of medical progress — in surgery, leukemia, and HIV/AIDS. Atul Gawande, Vincent DeVita,
Tony Fauci, Paul Farmer, and other prominent experts explore research, clinical
practice, and patient care, and how health care has continued to get better
over the past 200 years.
The first third of the video, narrated by Dr. Atul Gawande, is a particularly nice snapshot of the sea changes in medicine and surgery that have occurred within the last 200 years. Publication of scientific findings probably plays a larger role in the story line than is necessary, but it is good to be reminded of the advances that have occurred so recently and that were true game changers (such as aseptic surgery).
Wednesday, August 22, 2012
Yesterday a three judge panel of the DC Circuit struck down the EPA's Cross-State Air Pollution Rule, known as the “Good Neighbor Rule,” which required utilities in 28 states and the District of Columbia to install new pollution controls. The basis of the ruling was that the agency overstepped its authority by issuing standards before states had a chance to develop their own. The panel also concluded that the emissions reductions were greater than necessary.
The panel in essence substituted their judgment on whether the restrictions were excessive, ignoring their responsibility to grant the agency due deference. This calls into question the court's political objectivity. Indeed, articles reporting on the decision in the L.A. Times, CNN, and the Washington Post implied there may be some political views at play by pointing out that the deciding votes in the 2-1 decision were Bush era appointees. Indeed, a Reuters article commented that The ruling “will likely be cheered by Republicans, who have made the EPA and President Barack Obama's environmental policies a main campaign theme ahead of November elections.” The emissions reductions were estimated to prevent 13,000 to 34,000 premature deaths each year. For an overview on the history and purpose of the rule, click here.
Herewith my update on the Myriad gene patent case.
In response to the Supreme Court's remand in light of the Mayo v. Prometheus decision (132 S.Ct. 1289 (2012)), the Federal Circuit held oral argument on July 20 and issued its decision on August 16, 2012, Ass'n for Molecular Pathology v. United States PTO, 2012 U.S. App. LEXIS 17679 (August 16, 2012). At issue were fifteen composition and method patent claims held by Myriad with respect to the BRCA1 and BRCA2 genes, genes implicated in breast cancer. The district court had held the claims invalid under section 101 of the Patent Act as patent-ineligible products of nature or scientific laws. The Supreme Court's remand had asked the Federal Circuit to reconsider its reversal of the district court in light of Mayo.
In its most recent decision, the Federal Circuit largely reaffirmed its earlier analysis. One type of patent at issue was Myriad's composition claims to isolated DNA molecules. The Federal Circuit's earlier decision had concluded that Myriad's composition claims were valid, Association for Molecular Pathology v. United States PTO, 653 F.3d 1329 (2011). In the new judgment of the Federal Circuit, Mayo did not question composition patents generally; the question for resolution was whether the Myriad patents claimed patent-ineligible products of nature. The Federal Circuit held that they did not, that although they were made from biological materials they were non-naturally occurring and man-made. Nor are they laws of nature. In reaching this conclusion, the Federal Circuit reasoned that the isolated genes were not merely "purified" versions of natural substances, but "distinct chemical entities." The Federal Circuit rejected the government's suggested "magic microscope" test under which if an imaginary microscope could focus on the claimed isolated bit of DNA, it was not patent eligible. Instead, relying on Charkrabarty, it analyzed whether the isolated molecules were "markedly different" from what is found in nature. Whether chemical entities that convey genetic information warrant special treatment under the patent law, the court said, was a question for the legislature, not for the courts under the current statutory regime.
One set of Myriad's method patent claims consisted of analyzing and comparing DNA sequences. For these patents, the analytic question is whether these patents merely state scientific laws and thus are ineligible for patenting. The Federal Circuit had earlier concluded that these patent claims were invalid and this decision also did not change. These were patents consisting of comparing one sequence to another and merely reflected abstract mental processes and thus were ineligible. However, the Federal Circuit continued to hold that a different type of method claim, that of screening potential cancer therapeutics through changes in cell growth rates of transformed cells, was patentable. The Federal Circuit's reasoning was that this patent used "transformed" cells with "enhanced function and utility" to draw the therapeutic conclusion and hence did not simply apply a law of nature.
For anyone not thoroughly worried by Maryn McKenna's book Superbug: The Fatal Menace of MRSA, there's a Klebsiella story in the Wall Street Journal that will scare even the most fearless hospital-goer:
An outbreak of antibiotic-resistant bacteria raced through a top research hospital at the National Institutes of Health last summer, killing six patients and possibly contributing to the deaths of five others, researchers reported today. . . . The outbreak began in June of 2011, when a 43-year-old female patient with a history of multiple drug-resistant infections was transferred from a New York City hospital.
Although the patient was admitted into an isolation area, a Klebsiella pneumonia infection she had brought with her into the hospital soon leapt to at least three other patients. The NIH did not identify the New York hospital. The outbreak was brought under control by the end of the year. . . . [The story] underscores how health-care facilities are responsible for outbreaks, a broad problem that experts say leaves as many as 100,000 Americans dead each year. . . .
Hospitals have resisted efforts to require mandatory reporting of infection rates, in part because of the longstanding difficulties of establishing whether patients arrive with infections. An article in the Journal for Healthcare Quality earlier this year said 21 states have adopted public reporting requirements for hospital infections.
One of my students wrote an excellent paper calling for "universal screening for MRSA ... to be done for all hospital admissions in order to treat MRSA in hospitals and decrease the rate of MRSA within the community." Other steps are also necessary in relation to microbial infections. One wonders what it will take so see far more serious and coordinated responses to the threat. Kevin Outterson has written several excellent articles on growing antibiotic resistance, noting that antibiotics are uniquely susceptible to losing power due to overuse--but even a legal category for antibiotics as a whole could be overbroad, because of the unique properties of each microbe. I hope that scholarship like his helps inform a broader public policy response to this latent crisis.
SIU is seeking to fill its Garwin Distinguished Professorship, here.
The Southern Illinois University School of Law is seeking nominations and applications for the Garwin Distinguished Professor of Law and Medicine for the 2013-14 academic year. Established in 1996, the Garwin Professorship is funded in part by a grant from the Garwin Family Foundation which was established in 1993 for the purposes of fostering education and academic research. Support for the position includes a competitive salary, benefits, travel allowance, housing for one year, and a research assistant.
Great opportunity to spend time with a very collegial group! [NPT]
Tuesday, August 21, 2012
Monday, August 20, 2012
People with health care insurance have better health than people who do not, but questions persist whether the better health reflects access to coverage or other factors that correlate with insurance coverage. In a recent study comparing three states that substantially expanded adult Medicaid eligibility with neighboring states that did not implement expansions, researchers found that the Medicaid expansions were associated with a reduction in death rates (as previously discussed on this blog). However, other studies have not demonstrated much benefit from access to coverage. In a study reported in the current issue of the Journal of the American Geriatrics Society, researchers did not find reductions in deaths from any cause or in hospitalizations for cardiovascular disease for persons who received financial assistance to cover the "doughnut" hole in Medicare's prescription drug program. As data come in from the Oregon lottery for access to Medicaid, we will be in a better position to assess the benefits for health from access to health care coverage.
Saturday, August 18, 2012
The University of Memphis Cecil C. Humphreys School of Law, here, is seeking the founding Director for its new Center for Health Law. The position announcement notes:
The Director’s responsibilities will include strategic planning, fundraising, curriculum development, maintenance and growth of relationships with relevant local, national, and international scholarly and professional associations, scholarship production, teaching, and mentoring.
The Law School seeks to expand its health-law curriculum and related health-law opportunities for the purpose of assuming the leading role in the MidSouth in training health-care lawyers, promoting scholarship and discussion concerning health-care law and policy, and providing pro bono health care-related legal services to low-income individuals. This initiative is aligned with the University’s increasing emphasis on health-related education, demonstrated, inter alia, by the recent founding of the School of Public Health and a significant expansion of the School of Nursing.
Sounds like a great opportunity! Steven Mulroy, here, is chairing the search.
Friday, August 17, 2012
A recent column by Pauline Chen in the New York Times exposing the culture of bullying that is still very much a part of medical education generated an outstanding number of comments from medical professionals affirming her facts (yes, indeed there is still a lot of bullying) as well as those insisting that it is only through instilling fear within a rigid hierarchy that patient’s lives can be saved. Reading them leads me to consider how much harm this “hidden curriculum” actually does not just to doctors themselves and their individual patients, but to society as a whole as we struggle with the ever rising cost of health care.
Many of us in health law have written before about medical education and most articles include the phrase “hidden curriculum” to mean what medical students learn when they leave the classroom and go forth into their years of clinical training. See Amy Campbell, “Teaching Law in Medical Schools: First, Reflect.” Journal of Law, Medicine & Ethics. 2012; 40(2); It has also been blamed by ethicists who point out that whatever work is done in the classroom teaching empathy and professionalism is untaught on the wards. (I’ve written about this too-here ). See Christopher Johnson Here’s an interesting article from Academic Medicine showing how medical students’ attitudes about accepting gifts from pharmaceutical companies changes when they move from classroom to clinic. , Here’s another one talking about unfounded bias against family medicine physicians.
Here’s another, perhaps less discussed, bad thing that comes from the hidden curriculum: defensive medicine! Uwe Reinhardt, Princeton health economist (which is like saying that Alfred Einstein was Princeton Physicist), is often quoted as saying that defensive medicine raises the cost of health care—and he does say that. But with more nuance that a short quote allows. Here’s a fuller explanation in an interview in which he reviews some factors related to the cost of health care, and refers to defensive medicine as a “psychological” factor. And psychological it is—along the lines of fear of alien abduction. Medical malpractice law suits are rare events for most physicians, and, as David Hyman, Charles Silver, Bernard Black and Myungho Paik point out, even rarer in states like Texas which has essentially eliminated them through Tort Reform. See more of their work here, here, and here. Tom Baker, author of the Medical Malpractice Myth, has written extensively about how beliefs about malpractice are mostly unfounded (and I have tried to convey this message too).
I’m in the preliminary stages of designing a study to look for the roots of this fear within the hidden curriculum. It’s my been my experience as someone who teaches in both a medical and law school, that much of the fear doctors have of lawyers comes from the hidden curriculum. We are often used as “the monster under the bed” to scare young doctors. Some of the bullying Dr. Chen refers to takes the form of threats of malpractice. But what if instilling disproportionate fear of malpractice not only poisons patient/doctor relationships but also raises the cost of health care for everyone?
So what can we do to change the hidden curriculum and the harm it causes? The first step is to recognize it. One of my favorite themes among comments Dr. Chen’s article elicited is that since doctors “are the only” professionals who hold the lives of others in their hands, those entering into medical training must accept abuse or not be doctors.
Well, interestingly there are some other professions that hold peoples’ lives in their hands and one of them is the airline industry. Moreover, this is an industry which has transformed its training and its operating procedures in order to get rid of exactly the kind of hierarchy that now exists in medicine and which has been found to be a direct contributing factor in airline fatalities. The story is well told by Malcolm Gladwell in a New Yorker essay and summarized in this WSJ blog post. If the military and the airline industry can change the way it trains pilots, we, faced with similar issues of safety and cost, should be able to change the way we change doctors.
Chris Robertson et al, Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence, JLME
John Z. Ayanian and Philip J. Van der Wees, Tackling Rising Health Care Costs in Massachusetts, NEJM
Joanna C. Schwartz, A Dose of Reality for Medical Malpractice Reform, SSRN