Weighing Risks in a Pediatric Anthrax Vaccine Clinical Trial

by Brendan Abel, JD

Countless regulations have been enacted over the past 35 years to protect children from unnecessary clinical testing. Federal regulations, the Belmont Report, and professional guidelines all state that children should be enrolled in clinical trials only when the research is a high imperative. Federal research regulations insist that absent a potential for direct benefit to the participating child, research should take place only if there is “minimal risk” or “minor increase over minimal risk.”

Thus, it was surprising that one year ago, the National Biodefense Science Board (NBSB), an advisory panel to the Secretary of Health and Human Services, recommended that HHS develop and implement a study of pre-exposure anthrax vaccine in pediatric populations. Such a vaccine would subject children to risks with little potential for therapeutic benefit. The matter is now in front of the President’s Commission for the Study of Bioethical Issues, at the request of Secretary Kathleen Sebelius, who in May visited the Commission to ask for advice regarding the ethical issues raised by this potential study. The  Commission’s recommendation is expected early next year.

Much of the controversy surrounding anthrax-vaccine testing in the pediatric population relates to the issue of timing. Since the vaccine can be used either prophylactically or as a post-exposure treatment, the government is considering whether children should be tested now to determine safety, efficacy, and dosing levels in a structured, controlled environment, or whether it is best to avoid subjecting children to the risks of the testing and to face an (unlikely) anthrax attack without the knowledge that would be gained from such a study.

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FDA Reprimands Genentech for “Drastically Overstat[ing] the Efficacy of Tarceva”

by Jonathan J. Darrow

On October 3, 2012, the FDA’s Division of Professional Drug Promotion issued an untitled letter to Genentech in connection with its cancer drug Tarceva.  Tarceva (erlotinib) was approved in 2004 for the treatment of non-small cell lung cancer, and has since been approved, in combination with Gemzar (gemcitabine), for the treatment of pancreatic cancer. Its approval letter reported a tumor response that was 9 times greater with Tarceva than with placebo (0.9% in placebo versus 8.9% in Tarceva), but relatively modest improvements in 1-year survival rates: approximately 8 of 10 patients on placebo did not survive 1 year, while about 7 of 10 patients on Tarceva did not survive (see page 6, line 102 of the approval letter).  A 2005 New York Times article was less than enthusiastic about Tarceva’s efficacy, noting that it (along with several other cancer drugs that were new at the time) “help[s] most patients only marginally . . . .”  Despite its modest efficacy, Tarceva was reported in the same New York Times article to cost almost $31,000 per year.  A number of patents are listed in the FDA’s Orange Book as covering Tarceva until 2020.

The recent untitled letter accused Genentech’s promotional materials of misleadingly indicating that Tarceva in combination with gemcitabine extended overall survival by 3.7 months in comparison with gemcitabine alone, when the actual increase in survival was only about 12 days.  The FDA characterized the discrepancy as “drastically overstat[ing] the efficacy of Tarceva.”  (The figure of 3.7 months was derived, according to the FDA, “from a retrospective, exploratory subgroup analysis that does not provide substantial evidence to support the efficacy claims cited . . . .”). In addition, the front cover of one of the promotional materials in question contained an image of an hourglass positioned on its side, presented with the claim: “Extending survival for moments that matter.”  Although the claim with its associated image may be literally true (“moments” is left undefined), the FDA characterized the image and claim as “drastically overstat[ing] the overall survival benefit for patients” because it “strongly suggests that time is standing still for the cancer patient because of Tarceva therapy.”  The FDA noted a number of other instances of misleading overstatement of efficacy or minimization of risk.

The October 3 Tarceva letter brings to 23 the total number of Drug Marketing and Advertising Warning Letters (and untitled letters) listed by the FDA’s Office of Drug Promotion as having been sent this year.

NIH + NFL = PHLR

By Scott Burris, JD

The National Football League has given the National Institutes of Health $30 million for research on traumatic brain injury. There is much we don’t know about the causes, effects, prevention and treatment of sports-related brain injury – but that doesn’t mean that we should put all our eggs into the basket of biomedical research. Since Washington state pioneered its youth-sports brain injury prevention model-law in 2009, 40 states have passed laws setting out rules aimed at the problem (We’re tracking these on LawAtlas, the new PHLR policy surveillance portal). Most of these laws work by promoting identification of concussions, regulating the athlete’s return to play, and educating parents and coaches.

To put it another way, the nation, through a majority of its state legislatures, has embarked on a major initiative to reduce sports-related injuries. Tens of millions of people will be affected in some way – athletes, parents and coaches. Limited school-based resources will be consumed to comply with these laws. And, most importantly, people worried about the problem will, to some extent, rely on implementation of these laws to protect student athletes.

If this public health intervention were a drug or a new technique for changing behavior, its efficacy would be rigorously tested by government-funded research. Why should things be different because this possibly magic bullet happens to be based in the law? So far, the CDC has funded implementation case studies of youth sports concussion laws in Washington and Massachusetts. PHLR is funding a more in-depth study in Washington, with results expected next year.

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Using the Taxing Power for Public Health

By Scott Burris

In a Perspective in this week’s New England Journal of Medicine, Michelle Mello and Glenn Cohen, both professors at Harvard, write about the prospects for using the constitutional Taxing Power to adopt innovative laws to advance public health objectives.  Cueing off the Supreme Court’s decision in the Affordable Care Act litigation, Mello — who is also a member of PHLR’s Methods Core — and Cohen write that the Court appears to have opened the door for “more targeted, assertive interventions to promote public health” under the Taxing Power than Congress has previously pursued. “For example, instead of merely taxing tobacco sales, the federal government could require individuals to pay a tax penalty unless they declare that they haven’t used tobacco products during the year. It could give a tax credit to people who submit documentation that their bodymass index is in the normal range or has decreased during the year or to diabetic persons who document that their glycated hemoglobin levels are controlled. It could tax individuals who fail to purchase gym memberships. …These strategies depart from traditional uses of taxes by targeting omissions and noncommercial activities that are important drivers of chronic disease.”  Read the full article online at the New England Journal of Medicine online.

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.

Regulating Compounding Pharmacies: Why An Increased FDA Role Shouldn’t Be Our Default Option

By Patrick O’Leary

A friend and I were having a conversation about health policy the other day when he observed that drug regulators like FDA face an impossible task in terms of public expectations: as consumers, we expect the drugs we take to be 100% safe, 100% of the time. Of course, no regulator, no matter how powerful or well funded, could deliver on that expectation, and the reality is that FDA operates under a variety of limitations, both fiscal and legal.

The current deadly meningitis outbreak linked to contaminated injections made by a Massachusetts compounding pharmacy shocks us and upsets our expectation that the drugs we take to get better will not, at the very least, cause us harm. Responding reflexively to this crisis, many in the media and in Washington have already started to call for greater federal oversight. This is a natural impulse, but one that merits cool-headed consideration. FDA is an agency that already has a broad statutory mandate and limited resources. Enforcement resources are slim enough that the agency’s response to an HHS report this month finding rampant violation of dietary supplement-labeling laws was simply to say that the agency would “address the recommendations as its resources and priorities allow.” Before we add still further to FDA’s crowded plate at a time when it is already facing a potential budget crisis (and it is worth noting that according to at least one former FDA chief counsel and congressional testimony by agency officials, FDA already possesses the authority to regulate pharmacies like the one involved in the outbreak and historically has done so), it is worth asking whether FDA enforcement is the only or best solution to the problem.

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Upcoming Event: Human Rights and the Social Determinants of Health, November 1-2, 2012 at Northeastern University

Human Rights and the Social Determinants of Health
Thursday, November 1, 2012, 1-5:30pm
Friday, November 2, 2012, 12-1:30pm
Northeastern University School of Law
Dockster Hall
65 Forsyth Street, Boston

The Program on Human Rights and the Global Economy (PHRGE) and the Program on Health Policy and Law at Northeastern University School of Law are hosting an event entitled “Human Rights and the Social Determinants of Health” on November  1 and November 2, 2012. The keynote speaker will be Dr. Ichiro Kawachi, from the Harvard School of Public Health. The event will also feature a special presentation by Sir Michael Marmot of University College London. Marmot is known internationally as a pioneer in the field of the social determinants of health.  For further information, please contact Sasha Varasano

 

Good news and bad news about gun laws, mental illness and violence — Part 3

This is Part 3 in a three-part series on gun laws, mental illness and violence in the United States. Read Part 1 and Part 2.

By Jeffrey Swanson, PhD

So what can the law do about gun violence?  The US Supreme Court’s decisions in District of Columbia v. Heller, 554 U.S. 570 (2008) and McDonald v. Chicago, 561 U.S. 3025 (2010) made it pretty clear that legal solutions to our nation’s firearm violence problem do not include “getting rid of the guns,” but do include preventing dangerous people from getting their hands on them.

So, the difficult question of whether our nation’s gun laws are capturing the right “dangerous people” remains crucial, and it invites a prior question: Whose criteria are we talking about?

Variations in law and policy among the states and between federal and state statutes mean that the same person with a severe mental illness might be disqualified from buying a gun in one state but not in another. Functional incapacity stemming from a psychiatric disorder may or may not lead to firearm disqualification, depending on how various applicable laws and policies define it in different contexts.

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FDA’s New Dance with Big Pharma: Are Patients the Band?

Efthimios Parasidis

One week prior to the Supreme Court’s landmark ruling in the health care cases, Democrats and Republicans overwhelmingly voted in favor of health-related legislation (387-5 House; 96-1 Senate).  Industry and HHS were quick to congratulate our elected officials on a triumphant bipartisan achievement, while the FDA enthusiastically welcomed its latest collaboration with Big Pharma.  Lobby groups boasted of their ability to “craft” legislation with FDA and praised the “unprecedented level of public input” into the new law.

We should all be concerned.

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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.

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