Drug manufacturing’s innovation problem

By Nicholson Price

There’s a lot of talk and research about the drug industry, including its levels of innovation, its pricing patterns, transparency of clinical trials, industry changes over time, and how the industry is and should be regulated.  But one thing that usually flies way under the radar is the question of actually making drugs – cranking out capsules, tablets, aerosols, gels, and liquids day after day. We tend to think that manufacturing can be taken for granted, that it’s high quality, cheap, easy, high-tech, and unproblematic.

In a new paper up on SSRN and forthcoming in BC Law Review next year, I argue that these widely-held assumptions are wrong.  Drug companies tend to spend about twice as much on manufacturing as they do on R&D, and a lot of that is unnecessary.  Essentially, the industry wastes tens of billions of dollars per year on inefficient manufacturing techniques which have stayed largely unchanged for decades.  Increasing drug shortages, higher drug prices, and higher levels of drug recalls are the unfortunate result.  Read More

Intent, Legal Metaphysics, and the Regulation of Stuff

By Christopher Robertson

I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“.  The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions.  So I would love to get the feedback from BillofHealth readers.

Hamlin's Wizard Oil

One of the preliminary themes of the article is that the  Food, Drug, and Cosmetic Act is predicated on the drugmaker’s own intent that a substance be used to treat a disease.  The exact same chemical compound can be  sold for other purposes without any FDA oversight.  But once the drugmaker intends that the substance be used as a drug, it becomes a drug as a matter of law, and then each intended use must be proven as safe and effective to the FDA.  For example, turpentine has had this dual-life as a paint-thinner and as “Hamlin’s Wizard Oil,” for which “there is no sore it will not heal, no pain it will not subdue.”

This intent-based system of regulation sets up a confrontation with the First Amendment, since the drugmaker’s own speech is often the best evidence of its intent.  It is a pretty big confrontation too, since the intent concept is the very predicate for the entire FDA regulatory regime.  On the other hand, it is hard to conceive of an alternative threshold for what counts as a drug.  There was a time (e.g., the 1993 Mitchell case) when a ConLaw scholar could confidently say that such evidentiary use of speech presents no First Amendment problems at all, but the current Supreme Court has been eager to dispense with such formalisms (c.f., the 2012 Alvarez case).

In my research on this point, I found a few other intent-based regulations that metaphysically transform things into the objects of a regulatory regime.  For example, the distinction between whether the Federal Aviation Administration regulates your family station wagon depends on whether the carmaker intends it to fly.  (See note 20 of the paper.)  Perhaps a broader analysis is in order.  If the First Amendment undermines this mechanism of regulation, what other similar regulatory regimes may be threatened?

Are we really going to re-legislate healthcare reform?

By Christopher Robertson

A minority of the Members of Congress are threatening to cause the United States government to default on its debts, unless the majority members agree to repeal or defund the Affordable Care Act, which Congress passed just a few years ago.  There will presumably be some sort of negotiated solution.  I worry that the negotiation range is being defined in a skewed way, between one pole and a moderate status quo, which is already the result of a prior negotiation.  Seems like we have a one-way ratchet here.

My thought:  perhaps the negotiations should go both ways, so that the end-result is more balanced.  What if the Democrats made symmetric threats to cause default, unless:

  • Medicare is expanded to cover all the poor who do not qualify for Medicaid (filling the gap the Supreme Court created in its “coercion” opinion),
  • The Federal government creates a public health insurance option, to compete along with the corporate insurers (which was killed in final negotiations to pass the ACA),
  • The Federal government gets explicit authority to provide insurance subsidies in the health insurance exchanges it sets up for states that have refused, oh and, as a kicker,
  • Ronald Reagan International airport (DCA) is re-named Jimmy Carter International Airport.

Ok, that last one is silly, but it might make for a fun bargaining chip, since it symbolizes the strategic game that is now being played, as we re-legislate settled questions.  Positional bargaining is not pretty or enlightened, but if these chips can be traded, we might end up in the fallback position of keeping the Affordable Care Act as the negotiated compromise that it already is.  Of course, the ACA is also the default rule, which has a nice double meaning in this context.

Petrie-Flom Intern’s Weekly Round-Up: 9/15-9/20

By Fatima Mirza

The Whitehall Studies and Human Rights

By Nathaniel Counts

Professor M. G. Marmot et al. conducted two studies, Whitehall I and Whitehall II, in which they studied morbidity and mortality in the British civil service sector in the 1960s and the 1980s.  British civil servants are under the same plan with the National Health Service, so the studies controlled for access to healthcare.  But what these famous studies found was that morbidity and mortality still correlated with income.  Further research and analysis has concluded that it is job satisfaction and social status more so than income that determines health outcomes.  Does an individual feel like she has control over the work she does?  Is she stressed out a lot?  How does she feel about herself in relationship to those around her?  Does she feel healthy?  Does she like her life?  Those who feel in control of their lives, feel valued by society, and feel good about their health actually end up living longer and healthier lives on average compared to those who don’t share these beliefs.

Deep structural inequalities exist in every society, and social justice groups work toward greater social equality everywhere.  Does the notion that social inequalities are hurting people in a physiological way change the way we feel about the mission of equality?  Is health so fundamentally different that individuals who accept economic inequality might mobilize over health inequality?  It is certainly implicated in the right to a dignified life, a concept underpinning the human rights movement as whole.  It may be though that the social inequalities on their own terms are an equal evil, because the limitations on one’s abilities to pursue her interests are as inimical to human rights as worse health.

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“Mountain Dew Mouth:” A Critical Opportunity for Public Health Law

By Scott Burris

Last week, the American Journal of Public Health published a PHLR paper by Michelle Mello and colleagues calling for our field to identfy “critical opportunities” for public health law. Critical Opportunities are legal interventions that target important public health problems.  They may have a strong evidence base but be underutilized (like alcohol taxes that keep up with inflation). They may be ideas that appear to be working in practice, and have a plausible mechanism of effect, even if our evidence base still consists of early studies or reports from practice (like distributing naloxone to opioid users and their friends to reduce overdose death). And they may be innovations that are plausible because of how they appear to relate to the problem or because they are similar in mechanism to other legal interventions that have been proven to work (like restricting sales of single cigars).  The bottom line is that we can do a better job spreading the word about legal interventions that work and that policy makers and the public can get behind in states and localities around the country.

The Robert Wood Johnson Foundation has helped get the idea moving by supporting a series of videos in which public health lawyers, practitioners and researchers pitch their ideas for critical opportunities.  These are often done, like a Ted Talk, at meetings, and one of the audience favorites is Dana Singer’s pitch for action to deal with “Mountain Dew Mouth,” a term gaining in traction to name the devastating consequences of heavy consumption of sugary beverages, especially those with critic acid.  The issue is on the federal agenda as part of the debate about food stamps.  It’s a hard one: public health people see the terrible consequences of these products and think that ending the federal “subsidy” for them might reduce harm; SNAP advocates don’t like the idea of anyone telling poor people what to eat and drink; industry, well, you can guess. State and local beverage taxes are another option, and we know that taxes can reduce consumption of even addictive products.

NPR has a story on the problem and some of the solutions this week.  I’m glad to see more attention to this problem, because poor dental health can send anyone’s life on a harder course, and is a very big problem in Appalachia. If you don’t believe me, or even NPR, read Priscilla Harris’s paper and watch Dana’s critical ops video.

Daubert as a Problem for Psychiatrists

By Alex Stein

Most psychiatrists don’t know about it, but the switch from Frye to Daubert in the admission of expert testimony matters for them a lot. Psychiatrists treat patients with second-generation antipsychotics: Zyprexa, Risperdal, Clozaril, Seroquel, and similar drugs. A reputable, but still controversial, body of research links those drugs to tardive dyskinesia: a serious neurological disorder involving uncontrollable facial grimacing, repetitive tongue thrusting, and other untoward bodily movements. Under Frye, expert evidence can only be admitted upon showing that it received “standing and scientific recognition” from the relevant community of experts. Absence of a solid consensus disqualifies the evidence. Expert testimony linking tardive dyskinesia to antipsychotic drugs consequently would not be admissible under Frye. Under Daubert, however, it would go into evidence because its underlying research is grounded in scientific method and procedure that can be replicated, examined, and properly explained to the jury.

This is exactly what happened in a recent case decided by the United States District Court for the District of Columbia: Patteson v. Maloney— F.Supp.2d —-, 2013 WL 5133495 (D.D.C. 2013). Read More