HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, April 30, 2011

Worth Reading This Week

Bryan A. Liang & Tim Mackey, Off Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access and Limiting Inappropriate Pharmaceutical Marketing, SSRN/University of Michigan Journal of Law Reform

Jennifer L. Skeem & John Monahan, Current Directions in Violence Risk Assessment, SSRN/Current Directions in Psychological Science

Margo Kaplan, Restoring Reason to HIV-Exposure Laws, SSRN/Indiana L.J.

Samantha Godwin, Bad Science Makes Bad Law: How Deference Afforded to Psychiatry Undermines Civil Liberties, SSRN



April 30, 2011 | Permalink | Comments (0) | TrackBack (0)

D.C. Circuit Removes Bar to Federal Funding for Embryonic Stem Cell Research

By a 2-1 vote, a panel on the D.C. Circuit overrode an opinion issued last year against federal funding for research on embryonic stem cells.  The district court had read the Dickey-Wicker Amendment’s ban on the use of federal funds for research in which embryos are destroyed to apply to research which can be connected to the destruction of embryos.  The appellate panel, on the other hand, concluded that it was reasonable for the NIH to interpret Dickey-Wicker as applying only to research in which the embryos are destroyed.  Since later research on embryonic stem cells does not entail concurrent destruction of embryos, the NIH had decided that Dickey-Wicker did not apply.  Besides its decision on the interpretation of Dickey-Wicker, the opinion includes an analysis of standards for preliminary injunctions and for judicial review of administrative agency actions.


April 30, 2011 | Permalink | Comments (0) | TrackBack (0)

Thursday, April 28, 2011

Guest Blogger Leslie Francis: Supreme Court Hears Oral Argument in Sorrell

Francis-Leslie Sorrell v. IMS Health Inc. was argued before the U.S. Supreme Court on April 26th. The issue in the highly-publicized case is whether Vermont’s statute concerning the sale of provider-identifiable prescribing information is an unconstitutional limitation on speech.  Vermont’s Prescription Confidentiality Law, 18 Vt. Stat. Ann. § 4631 (2011), prohibits the sale of provider-identifying information to data miners for marketing purposes unless the provider opts in to the practice.   Vermont advanced three state interests in support of the statute:  protecting the privacy of physicians and indirectly of patients, reducing health care costs, and protecting patient safety. The Second Circuit, applying the Central Hudson test for commercial speech,  concluded that the statute did not further the state’s interests in a sufficiently direct manner.  This decision, Vermont claimed, failed to recognize the state’s very strong interest in protecting privacy, especially when the pharmacies are required by the state to collect the information in the first place.  In this regard, Vermont’s petition for certiorari implores, “the Second Circuit's decision invalidating Vermont's law calls into question the constitutionality of numerous federal and state laws that protect information privacy by restricting access to or use of private information.”

It should be noted that the First Circuit had upheld New Hampshire’s Prescription Information Law, which prohibited the transfer of prescription information containing provider-identifiable or patient-identifiable information for any commercial purpose, with limited exceptions, see N.H. RSA 318:47-f(2011),  IMS Health Inc. v. Ayotte, 550 F.3d 42 (Cir. 2008); and Maine’s prohibition on the sale of provider-identifiable prescription information regarding physicians who file for confidentiality protection, 22 M.R.S. 1711-E (2011), IMS Health Inc. v. Mills, 616 F.3d 7 (2010). 

A decision in the Sorrell case is, unsurprisingly, expected by the end of the Supreme Court’s term in late June or early July.  It is of course risky to predict how the Court will rule, so I will not.  (But four Justices appeared sympathetic to the view that the case was about defending commercial speech—Chief Justice Roberts, Justice Alito, Justice Kennedy, and Justice Scalia—and four asked questions that brought out strengths of the State’s argument, while noting limits as well—Justice Breyer, Justice Ginsburg, Justice Kagan, and Justice Sotomayor.  Justice Thomas was silent as is his wont during oral argument.) Those concerned with the implications of any decision for the privacy rights of patients or consumers—or for that matter health care providers—would do well, however, to pay attention to several themes in the oral argument.

First, there’s a difference between privacy and autonomy.  The State argued that the statute protects privacy by giving physicians control over certain uses of information about them.  Critical Justices did not see the statute in this way.  Instead, they pressed the concern that the statute aimed to make certain types of speech—marketing communications to physicians—more difficult.  Justice Kennedy asked whether physician-identifiable prescription information could be sold for research and was told by Bridget Asay, arguing the case for the State, that although it was not, it potentially could be (subject to other Vermont statutory restraints).  Chief Justice Roberts asked Thomas Goldstein (a sympathetic voice, as he was arguing for the respondents) whether the statute would permit data aggregators to sell provider-identifiable information to journalists interested in exposing physicians who prescribe a great deal of controversial medications, and was told that it would.   Petitioners were hard pressed to explain how the statute protects privacy when it requires an opt-in for one, but not for other, uses.  They replied by understanding privacy as autonomy in the sense of control over particular uses. Despite the analogy to HIPAA, which also singles out a group of opt-in uses, critical Justices seemed unconvinced.  (Careful readers will note that the value at issue here really is confidentiality—control over how information is shared—not privacy; and if the Justices had recognized this, they might have been more sympathetic to the view that some forms of control might be important to people when other forms are not.)

Second, opt-in is not opt-out.  Justice Sotomayor asked why a statutory design that allowed providers to opt-out of the commercial use of their identifiable prescribing information wouldn’t be less restrictive and serve the state’s interests equally well.  There seemed to be general agreement among all participants that opt-out mechanisms offered to consumers, such as “do not call” and, potentially, “do not track,” would be constitutional.  On this reasoning, the Court’s grant of cert. because of a conflict between the First and the Second Circuits would be somewhat misleading; the First Circuit upheld an opt-out statute (Maine’s) and a more general prohibition (New Hampshire’s), rather than Vermont’s targeted opt-in statute.

Third, more may be less. A number of the Justices were troubled by the statute’s targeting of a particular use of the information for the opt-in requirement.  Ironically, it may be that more general prohibitions on information sales (perhaps with limited exceptions as for certain research) would be constitutional, when opt-ins for certain uses are not.  Another strategy may be state laws concerning data ownership. Justice Ginsburg asked Edwin Kneedler, Deputy Solicitor General arguing as amicus for Vermont, who owns the data.  She was told that the data was in the possession of the pharmacy and that the state has recognized that the physician also has a stake in the information.  Presumably, states could do more to recognize property rights in data for both providers and their patients.

Fourth, there may be some real play for deceptive or unfair trade practice law in this area. Justice Breyer asked—just as a hypothetical—whether it would be constitutional for the FTC to (after appropriately studying the evidence) to determine that it was a deceptive trade practice to market drugs to physicians on the basis of information about their prior prescribing history, because this information is irrelevant to the safety and efficacy of the drug.  Mr. Goldstein was pressed to admit that the FTC, or Vermont, could prohibit “false” (but not “biased”) speech as a deceptive trade practice.

Fifth, bad reasons are worse than no reasons. Arguing for Vermont, Ms. Asay took particularly pointed questions about the state’s goals in enacting the statute.  During her rebuttal, she was pressed by Chief Justice Roberts to explain that the statutory finding that “does seem to say that the State is doing this because it doesn’t like an imbalance in the marketplace of ideas” was adopted in support of the statute in a different, more sweeping form.  In general, the Justices seemed more inclined to accept legislative findings in support of privacy (as they conceived of it) rather than Vermont’s asserted interests in reducing health care costs and promoting patient safety.  Justice Ginsburg, for example, asked why pursuing these goals isn’t really just “lowering the decibel level” of one speaker. 

Sixth, there may be more protection for data in the hands of the state than for data in private hands.  Vermont tried to make the argument that because the government required the information to be collected in order for prescriptions to be filled, this was an especially favorable case for regulation.  The Justices appeared unconvinced by the efforts to draw the analogy between state-required data collection, and state collection of data itself. 

Finally, I can’t resist noting two quite unpleasant features of the oral argument.  “Prescribers” were identified with physicians, although the statute specifically defines them as any “individual allowed by law to prescribe and administer prescription drugs in the course of professional practice.”  And physicians were always referred to with the male pronoun.


- Leslie Francis


April 28, 2011 | Permalink | Comments (0) | TrackBack (0)

Rethinking Sorrell v. IMS Health: Privacy as a First Amendment Value

This week the Supreme Court heard oral arguments in Sorrell v. IMS Health. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain "physician-identified" medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients' Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont's restrictions.**  

Even if the Court ends up ignoring the NEJM brief and overturning Vermont's statute, the opinion should be the beginning of a long argument about the proper interpretation of the First Amendment in medical contexts.

Privacy Promotes Free Expression

Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment. 

There is an old tension between privacy and the First Amendment, best crystallized in Eugene Volokh's effort to characterize privacy protections as the troubling right to stop others from speaking about you. Neil Richards hasdissected the flaws in Volokh's Lochneresque effort to reduce the complex societal dynamics of fair data practices to Hohfeldian trump cards held by individuals and corporations. Societies reasonably conclude that certain types of data shouldn't influence certain types of decisions all the time. And courts have acquiesced, allowing much "of the vast universe of speech [to] remain[] untouched (and thus unprotected) by the First Amendment."

No algorithm can decide what information, or access to information, is protected by the First Amendment. That's a matter of values, and there aremany normative foundations for protecting free expression, including the promotion of personal autonomy, democracy, and truth. An emerging field of scholarship has demonstrated that all those values are promoted by well-crafted privacy laws.

For example, Katherine Strandburg has called for First Amendment regulation of "relational surveillance," including "attempts to use [traffic data] about communications to ferret out suspect groups and investigate their membership and structure:" 


Despite the rising importance of digitally mediated association, current Fourth Amendment and statutory schemes provide only weak checks on government. The potential to chill association through overreaching relational surveillance is great. . . . [T]he First Amendment's freedom of association guarantees can and do provide a proper framework for regulating relational surveillance and suggests how these guarantees might apply to particular forms of analysis of traffic data.

As Danielle Citron and I have documented, this kind of surveillance has already had troubling chilling effects for political groups on both left and right. Our co-blogger Dan Solove has also argued convincingly that "there are doctrinal, historical, and normative justifications for developing" First Amendment-based limits on the "countless searches and seizures involving people's private papers, the books they read, the websites they surf, and the pen names they use when writing anonymously." Marc Jonathan Blitz has explored the intersection of free speech and privacy values in Stanley v. Georgia, a case that guaranteed First Amendment protection for obscene materials "when read or viewed by a person in her own home." Paul Schwartz paved the way for much of this work.

The "Privacy as a First Amendment Value" scholarship has so far focused on deterring undue state surveillance, and the casual observer of Sorrell might believe that the same concerns are not raised by IMS Health's data collection. However, the state of Vermont is the very entity requiring collection of the prescription data, as Judge Debra Ann Livingston's eloquent dissent (in thecase granted cert) highlights: 

Vermont's law regulates the dissemination of confidential information---specifically, PI data-and the process by which it is collected and sold. Because section 17 [the challenged law] targets that process rather than . . . [publishing and promotion] itself, understanding the sequence of events section 17 regulates---that is, the process by which PI data travels from the prescription pad to the hands of a pharmaceutical detailer---“is crucial to understanding the statute's legal status.”
Pursuant to Vermont law, every time a pharmacy fills a prescription within the state, it is required to collect certain information about the doctor, the patient, and the medication being prescribed. . . .Troubled by this sequence of events whereby otherwise confidential information ends up in the hands of pharmaceutical detailers. . . .Vermont enacted its prescription confidentiality law. [citations omitted]

In other words, Vermont is trying to control a process of information creation that the state itself began. In his work on the new "information sharing environment" in the anti-terror field, Jon Michaels has shown that private data collection can be almost effortlessly merged with public files to monitor (and ultimately deter) "suspect" advocacy. Just as civil liberties groups have called on more careful and calibrated information sharing between homeland security forces and private data miners, there are also compelling reasons to manage the private sector uses of medical records forced into being by state action.

But even if the state did not force pharmacies to keep these records, there would still be an important free expression rationale for allowing a state to keep them private. Vermont has many rural areas, and it is easy to imagine scenarios where a doctor only treats one or a few patients for sensitive medical conditions. Will a person in small village hesitate to join a mental illness support group on Facebook, once she is aware that a data miner knows that there is only one person on psychotropic drugs in her town? The technological tools for matching digital records are staggering. State restrictions on the use of that data (or other forms of tracking) can be an important step toward giving individuals a chance to form and express opinions and affiliations in peace---without fearing an endlessly ramifying series of classifications made and opportunities possibly denied, on account of faceless and secretive data miners.

Tit for Tat for IMS

The secrecy of the data mining business itself should weigh heavily in the minds of the justices as they consider Sorrell. If the data miners win, privacy interests should follow up the case by lobbying states to force data miners to disclose exactly how they maintain their databases, all the terms of their contracts with clients, and business strategies. If the companies quickly squelch such legislation with trade secrecy claims, they should respect individuals who conceive of themselves as businesses, and consider their medical data among the most important of their "trade secrets." 

The Reply Brief from Vermont calls out those challenging its prescriber data law for an opportunistic embrace of the "transparency" mantle: 

[W]hile respondents and their amici claim to advocate “transparency,” the commercial trade of prescription data is anything but open. Pharmacies do not tell doctors their information is sold for marketing. Data vendors do not allow dissemination of their “proprietary” data.

The secrecy of the data mining business directly motivates state efforts to limit how much data it can gather. If the state can't understand exactly how credit scoring companies rank and evaluate customers, it has interest in preventing them from even gathering certain suspect data in order to avoid that data's misuse. Similarly, in the medical context, the state has no idea what treatment will be given to certain areas once physician-identified data about them is released. One legal expert recently warned that employers “may develop complex scoring algorithms based on electronic health records to determine which individuals are likely to be high-risk and high-cost workers.” What if the same sort of stigmatizing characterizations are raised to the community level, with marketers selling (possibly inaccurate or otherwise unvetted) aggregate characterizations of prescription drug use on a community-by-community level? The state has a strong interest in delaying the dawn of a brave new world of medical record-based characterizations until far more robust infrastructures assuring data accuracy and accountability are developed. 

Individuals often do not realize the multiple paths medical data can take in order to get into critical databases. Recently contributors to the medical website found that “Nielsen Co., [a] media-research firm . . . was ‘scraping,’ or copying, every single message off PatientsLikeMe's private online forums.” Had the virtual break-in not been detected, health attributes connected to usernames (which, in turn, can often be linked to real identities) could have spread into numerous databases. All those harboring health data ought to have some certified indication of its legitimate provenance. Such certifications should be regularly audited. Data should not be allowed to persist without certification of its provenance. Until those types of protection are in place, it is in the state's interest to tightly regulate the transfer of health data, much of which the state itself required to be created.

Balancing Interests in Free Expression

While IMS v. Sorrell is often characterized as a direct clash between privacy and the First Amendment, it is better characterized as a more complex struggle over the ethical conduct of commerce, medicine, and marketing. There are First Amendment values that favor Vermont's enterprise, and those which support the efforts of IMS Health to gather physician-identified data. But only one side in the case is serious about constructing a balanced and thoughtful reconciliation of the interests of patient, physician, pharma, and marketing stakeholders here. Vermont's statute may not be perfect, but it at least tries to promote that balance. A victory for the plaintiffs would only accelerate our current trend toward an information environment where powerful corporations create unaccountable databases about individuals and their communities, while cloaking their own practices in trade secrecy.

* "Physician-identified" means that the personally identifiable information about patients is (supposed to be) stripped out of the data, and the data is only associated with particular anonymous patients of particular doctors. One of the key issues in the case is a factual question: how effective is deidentification? Orentlicher observes that, "While the patient’s name is not retrieved [during data aggregation], the data miner does assign a unique number to the patient so that future prescriptions for the patient can be analyzed together." The NEJM brief notes that advances in computer science have compromised extant security techniques, “casting serious doubt on the power of anonymization” and lesser de-identification technologies. Paul Ohm, Broken Promises of Privacy: Responding to the Surprising Failures of Anonymization, 57 UCLA L. Rev. 1701 (2010).

**For the record, the question presented is "Whether a law that restricts access to information in nonpublic prescription drug records and affords prescribers the right to consent before their identifying information in prescription drug records is sold or used in marketing runs afoul of the First Amendment."


X-Posted: Concurring Opinions.

April 28, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, April 27, 2011

Guest Blogger Thomas L. Hafemeister: Postpartum Depression and Women Who Kill Their Children

Increasing attention is being given to the occurrence of postpartum depression and postpartum psychosis, driven by reports of women who have killed their infants a relatively short time after birth.  

 For example, in Lakeview, Illinois, a North Side neighborhood of Chicago, a thirty-year-old woman who was reportedly suffering from severe postpartum depression was charged this month with first-degree murder in the suffocation death of her eight-month-old son in February of this year.  The woman had a college degree, no prior criminal history, and the Illinois child protective services agency had apparently not received any prior reports of child abuse or neglect as it had no contact with the family preceding this incident.  Jason Meisner, Cops: Lakeview Woman Suffocated 8-month-old Son, Chic. Trib., Apr. 14, 2011.

Conjecture has also swirled about the mental state of Lashanda Armstrong, who drove her minivan off a boat ramp in Newburgh, New York, on April 12th, killing herself and three of her four children, ages five, two, and eleven months, with a ten-year-old child able to roll down a window as the vehicle hit the water and escape.  James Barron, Woman Tells of Boy’s Plea for Help After 4 Drownings, N.Y. Times, Apr. 13, 2011. This event has sparked a discussion of how often mothers kill their children, what causes it, and how it can be prevented.  For a widely circulated report, see Jocelyn Noveck, Moms Killing Kids Not Nearly as Rare as We Think, Assoc. Press, Apr. 16, 2011.  

Probably the most well-known related case involved Andrea Yates, who drowned her five young children, ages six months to seven years, in the bathtub of her suburban home outside Houston in 2001.  Yates had been suffering for years from very severe postpartum depression and psychosis, with a psychiatrist urging her after the birth of her fourth child not to have any more children.  Her initial conviction of capitol murder and a sentence of life imprisonment was overturned on appeal.  At her second trial, Yates was found not guilty by reason of insanity and committed to a state psychiatric facility, where she remains today.  Associated Press, Woman Not Guilty in Retrial in the Deaths of Her 5 Children, N.Y. Times, July 27, 2006.  See also Christine Michalopoulos, Filling in the Holes of the Insanity Defense: The Andrea Yates Case and the Need for a New Prong, 10 Va. J. Soc. Pol’y & L. 383 (2002-03; Kristine Esme Nelson, Postpartum Psychosis and Women Who Kill Their Children: Making the Punishment Fit the Crime, 23(2) Dev. Mental Health L. 23, 36 (2004) (“The American legal system as it currently exists is not equipped to respond in an appropriate fashion to these crimes.”).  

In 2010, as part of The Patient Protection and Affordable Care Act (PPACA), section 2952, entitled “Support, Education, and Research for Postpartum Depression,” was enacted.  This provision was based on the Melanie Blocker Stokes MOTHERS Act, a bill that had been stalled in Congress for a number of years, in part because of concerns that it would result in mandatory mental health screening for all new mothers.  As enacted, however, it has a much narrower scope.  This section encourages the Secretary of Health and Human services “to continue activities on postpartum depression or postpartum psychosis . . . , including research to expand the understanding of the causes of, and treatments for, postpartum conditions.”  Activities that are encouraged include “[t]he development of improved screening and diagnostic techniques” and “[i]nformation and education programs for health care professionals and the public.”  Congress authorized $3 million to support these activities for fiscal year 2010.  It also charged the Secretary to conduct a study on the benefits of screening for postpartum conditions and to submit a related report to Congress within two years of the enactment of this bill.  For the text of just this portion of the PPACA, see, Melanie Blocker Stokes MOTHERS Act Signed Into Law!, Mar. 21, 2010.  For the PPACA in full, see here.  

An associated Congressional Report states, 

In the United States, there may be as many as 800,000 new cases of postpartum conditions each year. . . . Postpartum depression occurs after 10% to 15% of all deliveries and after 26% to 32% of all adolescent deliveries.  The majority of patients suffer from this illness for more than 6 months and, if untreated, 25% of patients are still depressed a year later. . . . The most severe postpartum condition is postpartum psychosis.  A comparatively rare disease, it complicates only 0.1% to 0.2% of deliveries. 

H.R. Rep. No. 111-48, at 4-5 (2009. 

This provision had been pursued in memory of Melanie Stokes, who committed suicide in 2001, three after giving birth to a daughter.  Stokes, in her late 30s, managed a sales team at a pharmaceutical company and was married to a urologic surgeon.  The couple had tried for several years to get pregnant and Stokes purportedly greeted the news with joy.  However, after giving birth to her child, she was unresponsive when the doctor told her that her new child was a girl and within days began talking of killing herself.  Hospitalized four times, she threw herself from the twelfth floor of a hotel a week after her last discharge.  Lisa Pevtzow, Law Gives $3 Million to Educate, Research Post-Partum Depression: Dedicated Mom Spent Nine Years Working to Pass ‘Melanie’s Law’, Chic. Trib., May 21, 2010.

Historically, a diagnosis of postpartum depression has received limited weight in conjunction with criminal justice proceedings.  A ruling by the Iowa Supreme Court suggests that courts may be changing their views somewhat.  The court noted that the defendant in this case, Heidi Anfinson, had told officers that she had left her two-week-old son alone in the bathtub so that she could use the telephone in another room.  When she returned, the baby had drowned.  Panicked, she took the body, drove it to a nearby lake, left it in the water, and drove home.  Anfinson pled not guilty to charges of first-degree murder and child endangerment.  Although her lawyer was aware that Anfinson probably suffered from postpartum depression following her son’s birth, the lawyer summarily dismissed the notion that this condition could used in her defense.  Further, he failed to investigate Anfinson’s medical history, or the extent of her symptoms and how they might otherwise explain behavior the jury might find unnatural or unforgiveable.  Although the first trial resulted in a mistrial as the jury was unable to reach a unanimous decision, the jury at a second trial convicted her of second-degree murder. 

On appeal, Anfinson argued that she had received ineffective assistance of counsel.  Upon reviewing the matter, the Iowa Supreme Court determined that Anfinson’s attorney was aware of the probability that she suffered from postpartum depression after her child’s birth, but “categorically rejected any suggestion that this condition be explored in her defense.”  The court acknowledged that the evidence of postpartum depression would not have qualified Anfinson for either an insanity or diminished responsibility defense in this particular instance, but determined that it likely would have affected the outcome of her case by bolstering her claim that the death was accidental and by explaining to the jury why a mother would neglect her newborn while it was in the bathtub, why she would irrationally bury the body in a lake following the drowning, and why she would appear emotionless about the ordeal when questioned later that day.  Courts are generally reluctant to find a lawyer’s assistance ineffective when it reflects a tactical decision; however, the court in this case determined that the lawyer’s decision to present no evidence of postpartum depression called into doubt the fairness of the outcome of Anfinson’s trial and remanded the case for a new trial.  Anfinson v. State, 758 N.W.2d 496 (Iowa 2008),

Anfinson ultimately entered into a plea in October of 2009, a week before her third trial was scheduled to begin.  Her original conviction carried a fifty-year mandatory sentence.  Under her plea, she received a fifty-year non-mandatory sentence.  With time already served, it was reported that she could be paroled within one to four years., Plea Bargain Reached (Oct. 28, 2009).  This website also provides links to accounts by Anfinson’s husband, sister, and brother-in-law. 

--Thomas L. Hafemeister

April 27, 2011 | Permalink | Comments (0) | TrackBack (0)

New Zoonosis: Armadillo Passes Leprosy to Humans

The Great Beyond, the blog published by the journal Nature, reports on a new zoonosis - armadillos can pass on Hansen's disease, commonly known as leprosy, to humans. 

New genetic evidence confirms a long held suspicion that the armadillo, the official small state mammal of Texas, can pass leprosy to humans. The finding should give clinicians a reason to watch for the disease in patients, say researchers, and hopefully lead to earlier diagnosis of the disease.

“There is no need to slaughter the animals or get panicked,” says Pushpendra Singh, a molecular microbiologist at École polytechnique fédérale de Lausanne (EPFL) in Switzerland and a co-author on the paper published 28 April in The New England Journal of Medicine. “But we proved something which was hypothesized for a long time.”

Leprosy (otherwise known as Hansen's disease) is a highly stigmatized disease caused by the bacterium Mycobacterium leprae and is rare in the United States. Around 150 cases are diagnosed in the US each year, a third of which appear to be contracted locally. Contrary to popular belief, leprosy is treatable with antibiotics and doesn't cause lasting damage as long as it’s caught early. Roughly 95% of humans are immune to the disease, which is so uncommon in the US that when cases do arise, many physicians do not recognize it immediately.


April 27, 2011 | Permalink | Comments (0) | TrackBack (0)

Tuesday, April 26, 2011

Senate Takes Aim at Fracking Health Concerns

Concerns about the health effects of fracking – the controversial method of extracting oil and gas from shale rock formations using explosives – may lead to new legislation.

The concerns arise from reports of contamination arising from operations, and the fact that fracking has received special waivers from environmental regulation. The Energy Policy Act of 2005 excluded hydraulic fracturing for oil and gas production from permitting under the Safe Drinking Water Act’s (SDWA) Underground Injection Control (UIC) Program. In testimony before at Senate Committee hearing on Environment and Public Works on April 12th, the Environmental Protection Agency (EPA) admitted that fracking can cause:

  • stress on surface water and groundwater supplies from the withdrawal of large volumes of water used in drilling and hydraulic fracturing;
  • potential contamination of drinking water aquifers resulting from faulty well construction and completion;
  • compromised water quality due to challenges with managing and disposing of contaminated wastewaters, known as flowback and produced water, where contaminants could include organic chemicals, metals, salts and radionuclides; and
  • impaired air quality from hazardous air pollutants such as benzene and the potent greenhouse gas methane.

Last Year, the House of Representatives directed the EPA to conduct a study of fracking to “to better understand any potential impacts of hydraulic fracturing on drinking water and groundwater.” The study has been initiated and a final report is expected in late 2012.

Depending on the results of the study, lawmakers are poised to take action. In an opening statement at the hearing, Senator Benjamin Cardin (D-MD) said: “We need to put the environmental cop back on the beat, take aggressive action against the bad actors in the industry and earn back the public’s confidence.  The promise of natural gas will be a promise unfulfilled if the human health and environmental impacts are not properly safe-guarded. It’s long past time that they were.”


April 26, 2011 | Permalink | Comments (0) | TrackBack (0)

Monday, April 25, 2011

No Expedited Appeal

The court's order is short, "The petition for a writ of certiorari before judgment is denied" and wasn't a surprise, but the Supreme Court's decision in Virginia, ex rel. Cuccinelli v. Sibelius means that the 4th Circuit will hear the health reform case in May as scheduled. Story from Politico, here or L.A. Times, here. [NPT]


April 25, 2011 | Permalink | Comments (0) | TrackBack (0)

The Family Practice

A poignant mini-documentary on a Maryland doctor's general practice, available from the New York Times here. From the rows of paper files to the tight patient schedule to the comments about viability of such a practice today there seem to be plenty of places one could take a basic health law class after viewing this. [NPT] 

April 25, 2011 | Permalink | Comments (0) | TrackBack (0)