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.

Upcoming Event: 11/01/12 Obamacare on Trial – Book talk and panel discussion with Einer Elhauge

Obamacare on Trial

Book talk and panel discussion by Einer Elhauge, Carroll and Milton Petrie Professor of Law, Harvard Law School (and founding director of the Petrie-Flom Center)

Panelists:

November 1, 2012, 6:00 pm

Wasserstein Hall, Milstein East A

Harvard Law School

1585 Mass Ave, Cambridge, MA

Sponsored by the Harvard Law School Library

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

Florida’s Constitutional Amendment on Healthcare: Why It Still Matters after the Supreme Court’s Healthcare Decision

By Katie Booth

This November, Floridians will vote on whether to amend the Florida constitution “to prohibit laws or rules from compelling any person or employer to purchase, obtain, or otherwise provide for health care coverage.” Similar constitutional amendments are on the ballot in Alabama and Wyoming and have already been adopted in Arizona, Oklahoma, and Ohio. While Florida’s proposed amendment has not received much attention after the Supreme Court’s decision to uphold the individual mandate requirement of the Affordable Care Act (“ACA”), these state constitutional amendments should not be written off entirely.

The Florida amendment could have some effect on the upcoming presidential election. Since the amendment is included on the ballot, it could help win votes for Romney and other Republican candidates by reminding undecided swing voters about the ACA as they are filling in the ballot. If the amendment passes—which requires sixty percent of the popular vote—it will almost certainly be seen as a referendum on the ACA that will give ammunition to Republicans in future elections.

The existence of these state amendments and other similar legislation also raises the stakes of future Supreme Court litigation over the ACA. While the Supreme Court may be loath to revisit the ACA anytime soon, opponents are likely to continue challenging different aspects of the ACA that have not yet been litigated. Some of these cases could eventually end up in the Supreme Court, especially if there is ambiguity around whether the ACA preempts certain aspects of state constitutional amendments.

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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.

Read More

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.

Medicaid Denials of Coverage for Prosthetic Devices: A Successful (for now) Challenge

By Leslie P. Francis

A recent Utah Court of Appeals decision is very much worth calling to the attention of those interested in access to health care and in disability rights. As financial pressures on Medicaid increase, and as Medicaid plays a increasingly important role in health reform, states are likely to consider ways of restricting services in order to manage costs. Alexander v. Choate, 469 U.S. 287 (1985), has long stood for the assumption that cutbacks in Medicaid funding are very difficult to challenge as disability discrimination.  In the near future, it will be critical for advocates on behalf of people with disabilities both to challenge this assumption and to consider other ways of arguing that funding cutbacks under the Medicaid program are legally problematic.

Conley v. Department of Health, Division of Medicaid and Health Financing, 2012 Ut. App. 274 (Sept. 27, 2012), is a challenge to the denial of benefits for “speech augmentative communication devices (SACDs)” for non-pregnant Medicaid recipients over the age of 21. These are electronic speech aids used by people with conditions such as cerebral palsy who cannot make themselves heard due to motor difficulties. The ALJ hearing the case had concluded that it was reasonable for the Utah Medicaid Program to provide these devices to persons under the age of 21 and to pregnant women, but not to others qualifying for Medicaid.  The ALJ’s reasoning was that federal regulations and case law allow state Medicaid to use a “utilization control procedure” in deciding what benefits to provide. Read More

New Scholars in Residence Program – A New Pilot Program for Public Health Lawyers

With funding from the Robert Wood Johnson Foundation, the Network for Public Health Law and the Foundation are establishing Scholars in Residence – a new pilot program for public health lawyers. The flyer for the Program is here.

Scholars in Residence is an exciting new opportunity for six public health law scholars who want to bring their expertise to the front lines of public health practice. The scholars will be affiliated with a host site such as a state, local or tribal health department for six months, including a minimum of one month on-site that may be completed during a sabbatical, a non-teaching semester or during the summer. Working with a mentor, Scholars in Residence participants will be able to shape their experience and develop a project that brings their unique expertise to a problem or issue confronting the host site. A full description of this program is available here.

Each scholar will receive a stipend of $34,000. The stipend will cover the fellowship award and all related expenses, including travel to and lodging at the host site, travel to and lodging at two required meetings – an orientation session in June 2013 and a graduation celebration in December 2013 – plus any additional direct costs incurred related to this program.

Professor Fran Miller of Boston University School of Law serves as the Faculty Lead for the Scholars in Residence program.

This pilot project will start recruiting in fall 2012 with the residency beginning in June 2013. Please contact Judy Schector for more information.

[Cross-posted from HealthLawProf Blog]