Earlier this year, the flibanserin pill, aka “,” was introduced to the market, generating tons of headlines. After many years in which the plain old (male) Viagra was the sole sexual stimulator in the market, flibanserin was finally approved last August, following an 18-6 vote by the FDA advisory committee.
Before approval, flibanserin was rejected twice, and reports say that even members on the advisory board who voted in favor still had misgivings despite their final decision. Their concerns were driven by doubts regarding flibanserin’s effectiveness to treat low sexual drives. Trials showed that women who took the pill ‘earned’ only 0.7 “sexually satisfying events” in a month, whereas the drop-out rate due to negative side effects was relatively high – 14%. The side effects associated with flibanserin are low blood pressure, dizziness and such.
So what made this low cost-benefit ratio get the advisory committee’s approval the third time around? Some credit mass political campaigns promoted by women’s organizations claiming to advocate women’s interests. One position advocated by the organizations presented the pill as a treatment for a legit medical problem called HSDD (hypoactive sexual desire disorder), and it was said to be a step towards realization of women’s sexuality. The other side of the debate pushed back against what they perceive as medicalizing another realm of women’s sexuality and subjecting it (again) to the gaze of the male expert.
Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.
First, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Read More
Today the Supreme Court granted review in seven challenges to the accommodation offered to those with religious objections to the Affordable Care Act’s contraceptive coverage regulations. I won’t rehash my earlierposts about why I (and seven of eight federal appeals courts) think that these challenges, brought under the Religious Freedom Restoration Act, are bunk. For now, a few observations about the cases and today’s cert grants:
1. These cases involve challenges to a religious accommodation, not the coverage requirement itself. In Burwell v. Hobby Lobby Stores, the Supreme Court said that the government couldn’t enforce the contraceptive coverage regulations against for-profit corporations with religious objections. The Court pointed to a less-restrictive alternative: the accommodation, offered to nonprofit organizations, through which the organization submits a written objection and government arranges for the objector’s insurance company or plan administrator to provide the coverage at no cost to either the objector or its employees. The plaintiffs in these cases are challenging the accommodation itself. By analogy, this is like a conscientious objector challenging the process for opting out of the draft.
2. Oddly enough, Hobby Lobby didn’t officially resolve RFRA challenges to the accommodation. You might think that since the Supreme Court’s decision in Hobby Lobby pointed to the accommodation as the less-restrictive alternative, then the Court must have also made clear that the accommodation itself complied with RFRA. But the majority opinion did not do so. Instead, after pointing to the accommodation as a less-restrictive alternative, the majority said, “We do not decide today whether an approach of this type complies with RFRA for purposes of all religious claims.”
3. And/But: Justice Kennedy, the deciding vote in Hobby Lobby, suggested more clearly that the accommodation complies with RFRA. Although he joined the majority opinion, Justice Kennedy also wrote separately and appeared to bless the accommodation. Here’s what he said:
“That accommodation equally furthers the Government’s interest but does not impinge on the plaintiffs’ religious beliefs.”
“Yet neither may that same [free exercise] unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling. In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here.”
If Justice Kennedy holds to his view in Hobby Lobby, then the plaintiffs in these cases will probably lose.
4. Although the plaintiffs in these cases are nonprofit organizations, the result will affect employees of for-profit corporations. As instructed by the Supreme Court in Hobby Lobby, the government extended the accommodation to closely held for-profit corporations such as Hobby Lobby. But neither Hobby Lobby nor the other for-profit plaintiffs have said that they will accept the accommodation, and most of them are represented by the same organizations representing the nonprofit challengers to the accommodation. So if the Supreme Court doesn’t uphold the accommodation as applied to nonprofit organizations, employees of objecting for-profit corporations will almost certainly go entirely without contraceptive coverage as well.
5. “[Y]ou are not entitled to your own facts….” Today the Becket Fund, which represents Little Sisters of the Poor and several other plaintiffs, issued a press release entitled “High Court to decide if Government can force nuns to provide contraceptives.” This is false—full stop. Under the accommodation, contraceptives are provided by the employer’s insurance company or plan administrator; employers aren’t paying for the insurance coverage, let alone handing out the insurance coverage, let alone handing out contraceptives themselves. Whether or not you think that the accommodation resolves employers’ religious objections, it is simply not true that—as a matter of fact—objecting nuns are required “to provide contraceptives.” (This is not, I should add, the first time that the Becket Fund has made this claim in a press release.) I will be curious to see whether Becket Fund repeats this claim in its briefs to the Court.
Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”
A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.
There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.
A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.
Here’s where it gets ugly.
Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.
The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Read More
In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.
In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.
On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.
In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.
As flu season begins, we are bombarded by ubiquitous reminders to get our flu shot. So, it is a good opportunity to reflect on how we provide vaccines to our fellow citizens 65 and older. By law, Medicare Part B covers 4 preventive vaccines (flu, two pneumococcal, and hepatitis B for medium-to high-risk patients). Part D picks up the rest, namely shingles, TDaP, and any other commercially available vaccine. But, that’s where the trouble begins.
When Congress passed Part D, the vaccines recommended for those 65 or older were basically covered by Part B. Now, they aren’t. In 2006, the zoster (or shingles) vaccine came onto the market. In 2010, the recommendations for the TDaP (the P for pertussis or whooping cough being the most relevant here) changed to include the elderly.
But, so what, they’re still covered, right? Read More
This morning I saw an announcement about a new initiative called “Law Enforcement Leaders to Reduce Crime and Incarceration” and thought it was an important thing to share on this blog. This alliance consists of 120 top current/former police commissioners and prosecutors, including both district attorneys and state attorneys general. These law enforcement leaders have come together to influence legislation and public opinion around mass incarceration. Their first project: supporting the Sentencing Reform and Corrections Act of 2015, a bipartisan bill currently moving through the Senate. This issue matters because there are currently over 2.2 million people in American prisons and jails.
Why is criminal justice a health policy issue? Well, there are many reasons, but let’s start with the fact that the largest mental health provider in the United States is the Cook County Jail. This does not reflect well on our criminal justice policy or our health policy.
Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along , a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.
Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.
Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.
Artemisinin, a drug used to treat malaria, has been a recent topic of public discussion after its discovery was recognized with the Nobel Prize in Physiology or Medicine on October 5. The 2015 prize was awarded to three researchers who developed treatments for parasite-caused diseases, with half the award going to Youyou Tu, who is credited with the discovery of artemisinin. Artemisinin has benefited hundreds of millions of people around the world. Yet the recognition for artemisinin’s discovery comes at a time when public health officials are becoming more concerned about its ongoing effectiveness and struggling to implement policies to slow the spread of artemisinin resistance. Read More
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