August 3, 2012
Legal Barriers to Effective Pain Control (Part One)
The under-treatment of pain continues to be a significant public health problem in the United States. According to a 2008 article in the Annals of Oncology, “Nearly one of two patients with cancer pain is undertreated. “ Moreover, according to a report issued by the Institute of Medicine in in June 2011, “the medical costs of pain care and the economic costs related to disability days and lost wages and productivity amount to at least $560 billion to $635 billion annually. Because the range does not include costs associated with pain in children or military personnel, it is a conservative estimate.” Unfortunately, even as both acute and chronic pain is under-treated, opiods continue to be abused. According to FDA Commissioner Margaret A. Hamburg, MD, ““Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,”
Although the actual treatment of pain is a medical issue, the law plays a significant role. The FDA’s recent announcement of a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications” highlights the problem. The initiative “calls on 20 companies that manufacture painkillers to fund training courses for doctors that will be taught by medical education companies. The goal is to reduce the risk of addiction and other health problems associated with opioids, while ensuring access to the drugs for patients in pain.” These guidelines are, however, voluntary which is just fine with the American Academy of Family Physicians (AAFP) which rejects “mandatory “continuing medical education in pain control. But it doesn’t go far enough according to “a coalition of doctors and public health officials” which is “petitioning the Food and Drug Administration” to go beyond education and actually “change the prescription guidelines for opioid medicines” to make it much more difficult for doctors to prescribe “narcotic painkillers …in inappropriate cases. “The petitioners say the prescribing of opioids has increased over the past 15 years, in response to a campaign by Purdue Pharma and other pharmaceutical companies that exaggerated the benefits of painkillers, while minimizing the risk of their long term use.” The petition notes that, “Unfortunately, many clinicians are under the false impression that chronic opioid therapy is an evidence-based treatment for chronic non-cancer pain,” the petition says. “These misperceptions lead to over-prescribing and high dose prescribing. By implementing the label changes proposed in this petition, FDA has an opportunity to reduce harm caused to chronic pain patients as well as societal harm caused by diversion of prescribed opioids.”
The many conflicts of interest between the companies which manufacture these drugs, the doctors who want broad authority to use them, and the patients in need of pain control represent a serious problem and, I suggest, yet another example of the difficulty of providing wide-scale, quality care absent any ability to directly regulate the health care system.
August 1, 2012
Brustle: In the EU, it's immoral to patent stem cells obtained from destroying an embryo
Last fall, the European Court of Justice (Grand Chamber) interpreted Directive 98/44/EC of the European Parliament on the legal protection of biotechnological inventions to exclude from patentability stem cells obtained from the destruction of human embryos. The case was brought by Greenpeace and sought annulment of Oliver Brustle's patent on neural precursor cells and processes for their production. The German Bundesgerichtshof (Federal Court of Justice) referred the case to the ECJ for interpretation of Directive 98/44/EC. The ruling reasoned that embryos are not patentable and thus materials obtained through embryo destruction are not patentable. Brustle v. Greenpeace (18 October 2011), http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d0f130d5d4216b78fe284603bff3d470bbb043f5.e34KaxiLc3eQc40LaxqMbN4Oa3iSe0?text=&docid=111402&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=30577.
In the legal background of the decision is the TRIPS agreement provision that members may exclude from patentability inventions when their commercial exploitation would threaten public policy or morality. Article 53 of the Convention on the Grant of European Patents excludes from patentability inventions "the commercial exploitation of which would be contrary to 'ordre public' or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the contracting States." Directive 98/44/EC likewise emphasizes the non-patentability of inventions where commercial exploitation offends ordre public or morality. Article 6 of the Directive specifies that use of human embryos for industrial or commercial purposes violates ordre public or morality. Several assumptions were key to the ECJ ruling. The ECJ judged that the EU required a common standard for the definition of human embryo. The definition should be framed broadly rather than narrowly, to avoid encouraging a race to seek patents in the least restrictive jurisdictions. Patentability most be excluded whenever respect for human dignity could be affected. And dignity is affected by the treatment of any entity that could become a human being, including: "any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis." The ECJ left up to the referring court whether in light of current science stem cells themselves could become a human being and thus should be included within the ban.
Not surprisingly, the decision has generated significant controversy in the EU. Some see it as reflecting the influence of conservatives and the Catholic church, a potential harbinger of anti-abortion rulings to come. Others see it as likely to hamstring stemcell research within the EU. Still others see it as an important step in fighting unjustifiable commodification of human beings, a genuine achievement for human dignity.
Although the decision came down last fall, it has not yet been noted in this blog. I've used this post to call it to readers' attention as another illustration of the significant differences between EU and US approaches to the relationship between economic gain and research.
July 31, 2012
The $53 Finger Splint
On July 28, my home-town newspaper, the Spokane, Washington Spokesman-Review, reported a story that points out many of the perverse incentives in our current method of reimbursing health-care providers. James Munroe, 22 years old and unemployed, sliced his fingers in an accident. He is uninsured. His neighbor, Elizabetth Cobbs, a registered nurse, recognized that the cuts needed medical attention, but were not a life-threatening emergency. Being a good neighbor, a decent human being, and understanding the economics of health care which dictate that an emergency room is the most expensive place to get care, Cobbs took him to U.S. Healthworks' urgent care center, and guaranteed payment of what she thought would be around a $200 bill. Instead, the bill came to nearly $700, including a $179 "first-time patient fee," and $106 for two finger splints, which can reportedly be purchased for $6 each on-line.
What is wrong with this picture? First of all, Munroe and Cobbs would have been better off seeking care in the most expensive setting available, the hospital emergency room. Unlike U.S. Healthworks, the hospital is legally obligated to at least screen and stabilize Munroe, and is also required under state law to provide charity care and utilize it for people like Munroe. Although the bill would have been more than $700, Munroe and Cobbs would probably have paid very little, if any, of it. Instead, these costs would have been ultimately born by all of us, either through subsidies to the hospital made possible by our tax dollars, or through cost-shifting to those of us with insurance, who ultimately pay higher premiums to subsidize care to the uninsured.
Second, I am reasonably certain that no insured patient would have been billed $700 for these services. Insurers negotiate with providers for discounted prices; uninsured people are powerless to negotiate in this manner. Thus, the people who are least able to bear the costs of care, the uninsured, wind up with the highest bills. As Cobbs reportedly said, "There is a moral imperative here . . . Why are you charging $53 apiece for a $6 item?" The answer, unfortunately, is because they can, and it's all about profit for U.S. Healthworks. U.S. Healthworks is a for-profit company, which has just been acquired by the non-profit Dignity Health (formerly Catholic Healthcare West). Dignity Health will own U.S. Healthworks through a for-profit subsidiary. This will allow the moral imperative to continue to bow to U.S. Healthworks' profit imperative while Dignity can continue to tout its high-minded mission ""Delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and partnering with others in the community to improve the quality of life."
Is $53 for two finger plints "affordable?" Does this service and advocacy for the poor include unemployed 22 year-old James Munroe? And if it does, will Dignity communicate that message to its for-profit subsidiary, U.S. Healthworks? And should non-profit health care systems be able to limit their mission statements to apply to only to some parts of their enterprise? I would guess that given the publicity surrounding Munroe's situation, U.S. Healthworks will discount or write-off his bill. But what about all of the others in the same position, without neighbors like Cobbs or connections to the newspaper?
Cross-Posted on Healthy Interests
July 30, 2012
Health Care Disparities
Yesterday's New York Times Sunday Magazine provided a profound reminder about the disparities in health and health care in the U.S. While many Americans may have access to the best health care in the world, that is not the case for the rural poor in Mississippi. And giving them access to care is only a small part of the solution. The health care system does little to address the causes of illness that bring the rural poor to the hospital.
There are many troubling pieces of data in the article by Suzy Hansen. For example, a "Mississippi black man’s life expectancy is lower than the average American’s life expectancy was in 1960." And she cites one of the most important deficiencies in the U.S.: "American health care is not preventive, and it’s not a system."