It started Wednesday, Sept. 28 when the Microbicide Trials Network—a clinical trials network funded by the U.S. National Institutes of Health (NIH)—announced that one arm of its VOICE study was being discontinued for futility. VOICE follows 5000 sexually active, HIV-negative women in Uganda, South Africa and Zimbabwe, testing the safety and effectiveness of HIV prevention strategies involving antiretroviral drugs. Each of these two strategies has shown promise in other research: antiretroviral pills (pre-exposure prophylaxis or “PrEP”) and a vaginal gel microbicide. Originally VOICE contained five arms: (1) a 1% tenofovir gel microbicide, the same one that showed efficacy in the CAPRISA 004 study, but used daily instead of just before and after intercourse; (2) a placebo gel; (3) tenofovir pills; (4) Truvada pills (a combination of tenofovir and emtricitabine); and (5) a placebo pill.
After a recent peek at the ongoing data, the study’s data safety monitoring board recommended closing the oral tenofovir arm. While the other two ARV arms continue, indicating at least a chance that those products are working as expected, the announcement evoked bad memories of last April, when Family Health International (now FHI 360) announced that the FEM-PrEP study was being closed early for futility. In that study—another large, well-funded and apparently well-run trial—oral Truvada could not demonstrate efficacy in preventing HIV acquisition among women. The FEM-PrEP result has widely been considered an outlier, not enough to convince anybody that PrEP doesn’t work among women—but, while VOICE could still show efficacy for Truvada, the closure of the tenofovir arm is not good news for PrEP as a possible strategy in women. Read More
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With Starbucks Venti in hand to ease the pain of waking up at 6:00 a.m. and the 45 degree weather, I eagerly lined up this morning to hear oral arguments at the Supreme Court with fellow health law fans, associates too far down the food chain to earn a seat at the counsel table, Mormon missionaries, a jury consultant, the Supreme Court’s biggest fan, and a (seemingly less eager) high school group. Before the Court was Douglas v. Independent Living Center. This case arose after the California government responded to the state’s 2008 “fiscal crisis” by cutting Medicaid provider reimbursement rates by 10%. Providers and beneficiaries claimed that the rate cut contravened the equal access provision, which states that Medicaid provider payments “must be sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”
At issue before the Supreme Court is whether Medicaid beneficiaries and providers have a private right of action to challenge state budget cuts affecting access to health services. The 9th Circuit Court found that the plaintiffs could challenge the rate cut under the Supremacy Clause, granting an injunction to enjoin the rate reduction pending the resolution of the litigation. More broadly, this case raises several significant policy issues including the protection of vulnerable Medicaid beneficiaries, governmental health sector accountability, federalism and the status of co-operative funding programs, and institutional competence to adjudicate matters of complex social policy. Read More
The United Nation’s High-Level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases (NCDs), convened at UN Headquarters September 19-20, brought with it high expectations. The only previous UN General Assembly Special Sessions on a health issue had been on HIV/AIDS, with the first, in 2001, credited with helping spur the global AIDS response. NCDs – the four categories that the summit addressed being heart disease, cancer, diabetes, and chronic respiratory illnesses – already are responsible for more than 60% deaths globally [Political Declaration, para. 14], and are the leading cause of death even in many developing countries. They are on track to be responsible for 70% of deaths in developing countries by 2020 [Abdesslam Boutayeb and Saber Boutayeb, “The Burden of Non Communicable Diseases in Developing Countries,” International Journal for Equity in Health 4(1) (2005): 2].
Until now low on the global health agenda – consider that a mere 3% of WHO’s 2010-2011 budget was programmed to address NCDs – NCDs are certainly worthy of a special session at the United Nations. The question is, will the summit mobilize a global response against NCDs?
The honest answer may be the least satisfying: time will tell. Read More
This post was authored by O’Neill Institute research assistant and second-year Georgetown University Law Center student Dinesh Kumar.
For more information on all of the pending challenges to the Affordable Care Act, visit http://www.healthlawandlitigation.com. The website, a joint effort by the O’Neill Institute and the National Health Law Program, tracks the progress of litigation through the federal courts and provides a compendium of related academic literature.
On the morning of September 23, 2011, a crowd of about 150 members of the press and public filed steadily into the E. Barrett Prettyman Federal Courthouse to hear oral arguments for Seven-Sky v. Holder, the latest challenge to the Affordable Care Act (ACA) to be heard at the circuit level.
As with the other ACA cases, Seven-Sky focused on the constitutionality of the ACA’s minimum coverage provision (a.k.a. the “individual mandate”), which requires all U.S. citizens and legal residents to purchase health insurance or, beginning in 2014, pay a fine to the IRS that increases annually. Three appellate courts had previously ruled in three different ways. The Sixth Circuit upheld the individual mandate in Thomas More Law Center v. Obama, the Eleventh Circuit struck it down in Florida v. HHS, and the Fourth Circuit rejected the challenge outright in Liberty University v. Geithner, saying the court had no jurisdiction to hear the case under the Anti-Injunction Act (more on the AIA later). In a fourth case, Virginia v. Sebelius, the Fourth Circuit said the state of Virginia had no standing to bring suit. Read More
The direct translation of an old Chinese saying is “people regard food as their heaven” (min yi shi wei tian, or food is what matters to people). However, the average person’s heaven seems broken in the Middle Kingdom. Chinese people still feel insecure about what they eat on a daily basis because nowadays food safety incidents are more frequent than ever.
Recently, the main character on the stage is refined trench oil. It is used as industrial oil in developed countries, yet in China, it hides in restaurant dishes. News media discover that small restaurants in different provinces mix cooking oil with refined trench oil, which contains tens of carcinogens as a way to reduce costs. A professor said that the chance of encountering refined trench oil when you dine out is 10%.
Chinese government agencies started another special campaign against refined trench oil. As usual, several suspects were put into jail. However, it is hard to find refined trench oil through normal lab tests under the national standard for cooking oil, which does not include indicators referring to any illegal substance. Read More
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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.