07.06.11

The Supreme Court’s Decision in Sorrell v. IMS Health and Public Health

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This post authored by O’Neill Institute Research Assistant and rising Georgetown Law 2L, Dinesh Kumar.

In a 6-3 decision on June 23, the Supreme Court ruled unconstitutional a Vermont law prohibiting pharmacies from selling prescriber-identifiable drug information to “data mining” companies.  These companies aggregate and sell this data (which doesn’t identify patients) to pharmaceutical companies, which promote sales through targeted “detailing” of doctors’ offices.  The plaintiffs-respondents (which included PhRMA as well as major data miners IMS Health, SDI, and Source Healthcare Analytics) argued that the law curtailed their First Amendment commercial speech rights by impeding the ability of drug companies to interface with doctors, and the Court agreed.  

Noting that the law particularly targeted industry detailing (i.e., the law did not prevent healthcare research organizations or journalists from using the data), Justice Kennedy in the majority opinion said the law discriminated on the basis of the speaker and content of the speech—a fundamental First Amendment violation.  Kennedy was also disturbed by Vermont’s contention that detailing should be curbed because it was too effective in influencing doctors’ treatment decisions: “[F]ear that speech might persuade provides no lawful basis for quieting it.”

The Court upheld the opinion of the Second Circuit, which had previously overturned a district court ruling that the law was constitutional.  Two other laws banning data-mining that predate Vermont’s, in Maine and New Hampshire, had been upheld by the First Circuit in recent years, but the Supreme Court had not taken up the issue until Sorrell.  The Maine and New Hampshire laws are virtually identical to Vermont’s in regards to the scope and purpose of their restrictions on the sale of prescriber-identifiable date. Read More

Posted in National Healthcare, Uncategorized; Tagged: , , , .

06.25.11

Documenting the Food Safety Crisis—Discovering “the Jungle” in China

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A third-year graduate student in Shanghai launched a database of food safety incidents in China last week. The database was established by 34 volunteers within one month. During the research process, the volunteers read 17,268 relevant news articles (10 million Chinese characters in total) and made 2849 entries into the database.

The database has an interesting name “throw out of the window” (zhi chu chuang wai). The name, according to the student, comes from the anecdote that former U.S. President Theodore Roosevelt threw his breakfast sausage out of the window when he read Sinclair’s book “The Jungle”, an event that promoted the passage of Pure Food and Drug Act.

I was surprised by the efficiency of this team because gathering the information of food safety incidents was one of the goals that I had. However, I gave up because first, there were so many incidents that relying on myself to collect was impossible and more importantly, I felt so disheartened when I realized how unsafe the food I used to eat for 25 years was. My project director asked me to write a memo on China’s food safety incidents in 2010 and I already felt sick. So there is no need to express my admiration to the team for their courage.

My western colleagues seem concerned about food borne disease outbreaks such as E coli O104:H4 in Germany or Salmonella in the States. The causes of the outbreaks are likely the improperly processed food.

In China, however, at least in the recent incidents, the causes are additives which are used excessively, or even worse, substances that are for industrial uses. Read More

Posted in Global Health, Uncategorized; Tagged: , , .

06.23.11

Looking the Other Way: Mental Health in a Nation Fixated on Healthcare

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Last week, DC police forcefully entered a man’s home and fatally shot him, twice.  Jean Louis, a mentally ill 55-year-old, had resided in the same apartment for over thirty years.  His neighbors knew him to be alternately friendly and erratic, but on the day of his death, he had neither hurt anyone nor committed a crime.  In fact, he had been attempting to ward off mental health authorities, resisting residential treatment.  When police arrived on the scene, he allegedly used a self-sharpened screwdriver to keep them at bay, locking himself in his home and lunging forward when they broke through the door.  After killing Mr. Louis, police claimed that they feared he was armed, despite the fact that they crossed his threshold thinking he was unconscious. They found no weapons in the apartment.

The scene raises a number of deeply troubling issues.  Why was Mr. Louis’s patent disease left unmanaged for years?  Why was he killed, instead of treated for his illness, as he would have been if afflicted with cancer, diabetes, or heart failure?  Moreover, why is there no outrage?

Perhaps because the tragedy is, astoundingly, not astounding.  Mr. Louis’s death generated a measly two news clippings; his story is just one in a million.  In fact, most of the mentally ill are left without care.  Federal law prohibits hospitals from turning away patients in dire need, regardless of ability to pay.  Yet mentally ill patients who seek urgent care, but cannot afford admission into a private hospital, are often discharged after just a few days, even if they are a clear danger to themselves or others.  Emergency room doctors report that finding an open bed in a mental health unit is often impossible, leaving desperately ill patients to fend for themselves.  Prisons are home to three times as many mentally ill individuals as treatment facilities; many of these inmates cycle from jail cells to the streets and back again, without obtaining care.  Even our veterans suffering from crippling post-traumatic stress disorder are placed on waiting lists that do not turn over for months, and sometimes years.  In fact, the 9th Circuit recently concluded that the Dept. of Veterans Affairs’ “unchecked incompetence” is so severe as to violate the statutory and constitutional rights of these often suicidal patients. Read More

Posted in National Healthcare, Uncategorized; Tagged: , , , .

06.18.11

Promises of Progress from the High-Level AIDS Summit at UN

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At last week’s high-level United Nations AIDS review, world leaders adopted a Political Declaration that indeed included a commitment to having 15 million people on AIDS treatment by 2015, among other targets aimed at real progress. Along with the commitment on AIDS treatment, the other headline from the conference was the commitment to work towards eliminating vertical transmission by 2015.

Importantly, the Declaration also specifically addressed the need for enhanced prevention efforts among marginalized populations, including men who have sex with men and people who inject drugs. This was the first of a high-level UN declaration on HIV/AIDS explicitly mentioned men who have sex with men. The Declaration also set a target of reducing HIV transmission among people who inject drugs by 50% by 2015 — though some advocates were concerned about how the Declaration addressed this population, as UNAIDS has called for the elimination of this mode of transmission. More troubling, the Declaration only weakly called for countries to give “consideration to, as appropriate,” harm reduction programs, despite their proven effectiveness. The science is clear; the Declaration had no reason for being timid.

The Declaration also included other commitments that, if adhered to, will advance human rights of discriminated against groups, including helping to meet the needs of women and girls, and promoting their full enjoyment of human rights. And states committed “to national HIV and AIDS strategies that promote and protect human rights, including programmes aimed at eliminating stigma and discrimination against people living with and affected by HIV, including their families, including through sensitizing the police and judges, training health-care workers in non-discrimination, confidentiality and informed consent, supporting national human rights learning campaigns, legal literacy and legal services, as well as monitoring the impact of the legal environment on HIV prevention, treatment, care and support.” It is critical that these efforts encompass all marginalized populations at heightened risk of HIV infection.

The Declaration committed countries “to redouble efforts to strengthen health systems, including primary health care.” This is a necessary part of the expanded AIDS response.

The question now is whether the political will and funding will follow these commitments — which included increasing AIDS funding. If so, the world will have made real progress by 2015 in fighting AIDS and advancing human rights. If not, then the failure to keep the promises of 2011 will be another stain on the global conscience.

Posted in Global Health, Uncategorized, WHO; Tagged: , , .

06.15.11

The Future of Food Safety

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Food safety issues are once again in the news.  A large outbreak of E. coli O104:H4, centered in Germany, has sickened more than 3,000 people and killed 35.  After a lengthy investigation, German public health authorities believe the source of the E. coli to be bean and seed sprouts.

This recent outbreak highlights the need for strengthened national and international food safety regulation.  The United States took a large step toward improving food safety earlier this year by enacting the FDA Food Safety Modernization Act (FSMA). In a recent Commentary in the Journal of the American Medical Association, O’Neill Institute Faculty Director Larry Gostin and I addressed the improvements that the FSMA will bring to the U.S.’s food safety system.

As noted in the Commentary, food safety regulation is complex and improving safety requires efforts aimed at primary prevention, surveillance, and response.  The FSMA has been lauded for giving the FDA new mandatory recall authority for food, an enforcement tool it had lacked to date.  Though mandatory recall authority is an enormous boon for the FDA, the current crisis in Germany highlights the importance of a comprehensive “farm-to-table” food safety system.  Mandatory recalls can clearly only be applied when the source of the infection is known.  For this latest outbreak, identifying the source of the outbreak proved difficult.  By requiring producers to adopt preventive control plans and increasing inspections for production facilities, the FSMA moves the FDA toward a preventive approach to food safety. Read More

Posted in FDA, Uncategorized; Tagged: , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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