Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?

By Jonathan J. Darrow

Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness.  Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.”  The purported active ingredient? “[H]aemoglobin.”  (see Secret Remedies (1909), page 114).

While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride).  Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness).  FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.

Yet one need only walk through a crowded street to see that, if a baldness cure has truly arrived, a surprising number of people have not availed themselves of it. Is Propecia, then, not effective? Let us take a look at the official data. Read More

Twitter Round-Up 1/1-1/13

By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Tell Patients: It’s Not All About YOU

By Art Caplan [cross-posted on MedScape]

This flu season is proving to be a doozy. The Centers for Disease Control and Prevention (CDC) in Atlanta say that this is one of the worst flu seasons ever. The agency reported severe flu cases in 46 states during the last week of December 2012. Eighteen states are considered to be at epidemic levels.

Hospital emergency rooms are swamped with flu patients. Hospitalizations from the flu are already in the thousands. Days of work being lost are escalating rapidly.

Boston Mayor Thomas Menino has declared a public health emergency in that city because of a sharp rise in cases of flu. Boston has had nearly 700 confirmed cases of influenza since the season began last October. That is a 10-fold jump over the 70 confirmed cases in the previous year.

Eighteen children and infants are dead because of the flu this season. The CDC doesn’t track flu deaths of people over 18. But many more people who are in the highest-risk groups — the elderly, the immune-compromised, those who have respiratory or cardiac conditions — certainly have died over the past few months from the flu.

The best protection against the flu is a flu shot. This year the efficacy of the flu shot is about 70%. That’s not a great number, but it’s good enough to require that doctors and nurses make sure that their patients are vaccinated.

Keep reading . . .

Art Caplan on Liability for Non-Vaccinators

Art Caplan has a new article out in the Journal of Law, Medicine, and EthicsFree to choose but liable for the consequences: should non-vaccinators be penalized for the harm they do?” (subscription required)

Here’s the abstract: Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.

Art Caplan: Many needlessly getting steroid injections for back pain

In his latest MSNBC column, Art Caplan addresses a different angle of the fungal meningitis outbreak:

Many needlessly getting steroid injections for back pain, bioethicist says

The quest for relief from pain has now resulted in the deaths of 19 people and a total of 247 confirmed infections of fungal meningitis from tainted steroid injections. Thousands more who got the injections, made by the New England Compounding Center in Massachusetts, are worried that they too may wind up sick or dead.

The horrific outbreak has resulted in the outrage about a lack of oversight of the compounding pharmacy.

But, this tragedy has another aspect that is not getting sufficient attention. Why are so many Americans getting spinal injections?

Read More

Soda Industry Sues to Block NYC Ban on Sugar-Sweetened Beverage Sales

By Rebecca Haffajee

Sure enough, last Friday the American Beverage Association and others, represented by Latham & Watkins, sued to block Mayor Bloomberg’s ban on the sale of sugar-sweetened beverages larger than 16 oz at certain NYC vendors. The suit, filed in the NY Supreme Court, asserts that the Mayor bypassed the proper legislative process for governing NYC, instead imposing the ban by executive fiat. The petition cites the many proposals considered and rejected by the NY City Council and NY State Legislature with respect to sugar-sweetened beverage (e.g., excise taxes, restrictions on the use of food stamps, warning labels, and product placement rules) as evidence that the legislature has chosen not to act to restrict sales in this sphere. The petition also claims that the scope of the Dept. of Health (DOH) action here is unprecedented, despite the fact that the DOH banned the use of trans fats in foods and required calorie postings at enumerated food service establishments.

Several specific causes of action are alleged by the soda industry, including:

  • that the New York City Charter, in it’s general language, does not delegate the necessary enumerated powers to the DOH to implement such a ban;
  • that even if authority to enact the ban has been delegated by the legislative branch to the executive branch, such delegation is unconstitutional as in violation of the separation-of-powers doctrine (i.e., the legislature cannot cede its fundamental policy-making responsibility to an administrative agency); and
  • that the ban fails to pass rational basis review given it’s arbitrary features that are unrelated to it’s stated purpose (e.g., cutoff at 16 oz size, exclusion of alcohol, and application to certain food establishments but not grocery or conveniences stores).

The plaintiffs request that the court enjoin and permanently restrain the ban.  They also want a decision by Dec. 15, 2012, so that affected businesses can avoid expending funds to comply with the law (set to take effect March 12, 2013). A response from the DOH will be forthcoming before an eagerly awaited court decision. A Cleveland Judge recently sided with the city when it sued the State of Ohio for trying to preempt its regulation of trans fats. Cleveland, the Judge ruled, was within its powers under the State constitution. But this most recent soda ban challenge applies to a different state’s legislative scheme, and a finding in favor of the plaintiffs could render Major Bloomberg’s “War on Fat” via other initiatives also susceptible to challenge.

Home HIV Testing, partner screening, the medicalization of intimacy, and responsibility for health

As the New York Times reported this week, in an article entitled “Another Use for Rapid Home H.I.V. Test: Screening Sexual Partners,” some in the public health community are exploring the ramifications for a use of the new OraQuick home HIV test that the company has been somewhat coy about: using it to test a new partner before sex, which may be particularly likely in the gay community. On November 5, 2012, the Petrie-Flom Center (in collaboration with Fenway Institute and Center for Health Law and Policy Innovation) will be hosting a great live panel (open to the public) “Advances in HIV Prevention: Legal, Clinical, and Public Health Issues,” focused in part on the OraQuick test and also on Pre-Exposure Prophylaxis (Truvada). The event will also be webcast after the fact.

Unfortunately, I’ll be in Malaysia touring hospitals as part of the research on my new book on medical tourism during the event, but I thought I’d use this forum to share some of my thoughts/questions about the use of these tests for partner screening. Here they are in a few different boxes:

The Medicalization of Intimacy: Is there something problematic about intimate sexual conduct becoming a medicalized affair to some extent? We are not all the way to the scene in Gattaca where Uma Thurman plucks a hair from Ethan Hawke to genetically profile him before deciding whether to pursue him romantically, but this use of OraQuick does interpose a medical technology into a sexual relationship. Now there may (more on that below) be public health benefits such that the development is all-things-considered for the best, but is something lost when this happens? Perhaps a separate spheres concern when technology is used to replace trust/intimacy? Or is this overblown? How will this affect the personal lives of individuals with HIV, and is that relevant?

Overreliance and the Effect on other STIs: The Times Article suggests that the designers of the test have made a specific choice as to Type 1 v. Type 2 errors: “It is nearly 100 percent accurate when it indicates that someone is not infected and, in fact, is not. But it is only about 93 percent accurate when it says that someone is not infected and the person actually does have the virus, though the body is not yet producing the antibodies that the test detects.” Will individuals who do partner screening internalize these numbers or will they go right from a negative test to no condom use, not processing the 7% risk the test is incorrect? Moreover, even if correct, will the test lead to (a) internalization of poor sexual health practices (no condoms) that users will carry over to encounters where they do not use the test, and/or (b) the spreading of non-HIV STIs like gonorrhea (the New Yorker recently gave a terrifying account of the rise of antibiotic-resistant gonorrhea)? What is the tort liability for the company in one of these situations, if any? If we think some individuals will be bad decision-makers and put themselves at greater risk for non-HIV STIs (not saying the data is there, just asking “what if” or the sake of argument) should that be relevant as to whether such tests should be available/approved? Do the numbers matter? Or is it the case that if even one person might avoid an HIV infection that would outweigh, from a policy perspective, an increase in other STIs of a large size? Those who have followed my writing and blogging on health care rationing can probably guess where I stand on the issue…

Read More

What do we know about obesity and its prevention in the U.S.?

By Rebecca Haffajee

As many are aware, the New York City Board of Health recently approved Major Michael Bloomberg’s proposed ban on sugar-sweetened beverages (SSBs) over 16 ounces in size sold at city restaurants, delis, sports venues, movie theaters, and street carts. This “soda ban” is set to go into effect on March 12, 2013. It has been justified on the grounds that it will make headway in combating obesity in NYC.  It piggybacks on a number of other anti-obesity policies enacted in the City, including a transfat ban in restaurants, a requirement that chain restaurants post calorie information, initiatives to help low income residents buy fresh produce, and nutritional standards in schools. In this Blog, Katie Booth conducted a thorough legal analysis of whether the ban could be overturned, concluding that a plaintiff’s chances of waging a successful lawsuit are slim.  Meanwhile, robust commentary in the media and health journals has debated the legitimacy of the ban and government’s role in regulating SSBs and combating obesity.

So what do we know about obesity in the U.S. as a phenomenon, its causes, and possible interventions that work to combat its spread? Although the problem is far from simple, it’s useful to briefly compile the current evidence.

Read More

Rationing, Irrelevant Utilities, and Inter vs. Intrapersonal distribution

This blog post was prompted by discussions with Frances Kamm, Jonathan Wolff,  and others after a great presentation Jonathan gave on the Valuation of Life and Health in Government Policies.

To return to an issue I have discussed briefly in other work, the question is how we should count very small gains in health for large numbers of people, a sub-set of the aggregation problem.  As I put the problem in a footnote in my Article Beyond Best Interests, 96 Minn. L. Rev. 1187 (2012):

Utilitarians typically aggregate small harms to many people and count the sum. See, e.g., John Rawls, A Theory of Justice 23-24 (1971) (discussing the societal balance of present and future gains against present and future losses). The deontologist Frances Kamm has instead suggested that not all harms and benefits are equal, under what she calls the “Principle of Irrelevant Utility”: Suppose two almost identical individuals A and B are mortally ill and we have only enough serum to save one, but because of tiny differences in how much serum they need if we save A there will be enough serum left over to also cure person C’s sore throat, but if we save B there will not be. Kamm argues that it would be unjust in this circumstance to allocate the serum to A rather than B on this basis as opposed to holding a straight lottery between the two. If the sore throat is not enough to justify giving A preference over B when everything is equal, says Kamm, it is an “irrelevant utility” such that even if we could save not only C’s sore throat but a million such sore throats, for example, it would not matter; the utility bonus is irrelevant and therefore even aggregated in large quantities cannot count. Quite different, she claims, would be a case where in fact the serum enables us to save C’s leg, which would be a relevant utility. See F.M. Kamm, Morality, Mortality: Death and Whom to Save from It 144-63 (1993); Frances M. Kamm, To Whom?, 24 Hasting Ctr. Rep. 29, 31-32 (1994).

On the other hand, this principle may have counter-intuitive implications. To use an example suggested by John Broome, the National Health Service (the U.K.’s universal health care system) gives out millions of analgesics for headaches; at some level, due to health care rationing and fixed budgets, that means that someone’s life will not be saved.  John Broome, All Goods are Relevant, in WHO, Summary Measures of Population Health: Concepts, Ethics, Measurement and Applications 727, 727-28 (Christopher J.L. Murray et al. eds., 2002).

What came up over dinner, and I thought was particularly interesting, was the following question:

Read More

Are There Any Good Legal Arguments to Overturn the NYC “Soda Ban”?

By Katie Booth

New York City’s Board of Health has recently approved a ban on all sugar-sweetened drinks over sixteen ounces sold in restaurants, fast food chains, movie theaters, sports stadiums and food carts (with some exceptions). The ban does not prohibit consumers from buying multiple sixteen-ounce beverages or from buying over sixteen-ounce beverages at grocery or convenience stores. The ban has been lauded by some as an effort to curb obesity and criticized by others for doing too little or for invading personal liberty. Photos of members of the Board of Health snacking on junk food and drinking a thirty-two ounce beverage—at the meeting discussing the soda ban—have provided some comic relief in an otherwise heated debate. Now that the ban has passed, restaurant associations and beverage associations have claimed they are going to file suit. Do they have a case? Probably not.

One claim opponents can make is that the Board overstepped its authority by regulating soft drink container sizes. It is unclear if this claim would succeed. The Board of Health has broad authority under New York City’s Health Code, which states that “[s]ubject to the provisions of this Code or other applicable law, the Department may take such action as may become necessary to assure the maintenance of public health, the prevention of disease, or the safety of the City and its residents.” New York City will argue that the ban is “necessary to assure the maintenance of public health” in the face of an obesity epidemic, and will point to the apparent success of the City’s trans fat ban as evidence that such bans are effective in decreasing the intake of unhealthy foods. The beverage industry will likely respond that the ban is not “necessary” because it does not really address obesity—consumers can too easily evade the law by buying multiple smaller sodas or by buying sodas at convenience stores.

Read More