- In England, a High Court judge ruled that a profoundly brain damaged 3-year-old boy in foster care should not be given life support when his condition deteriorates, despite the wishes of his birth mother.
- The lower house of the Swiss parliament declined to tighten controls on assisted suicide, which has been allowed in Switzerland since 1941 on a conditional basis.
- Health officials are warning that more people may be at risk from contaminated drugs made by the New England Compounding Center (NECC), a Massachusetts company linked to a growing meningitis outbreak. The FDA reported on October 15 that the company’s products used for open heart surgery and eye operations may have also caused other types of infection. The FDA’s reports regarding the meningitis outbreak can be found here.
- Health organizations wrote a letter to the president of the World Bank, Jim Yong Kim, urging him to support developing countries that want to introduce universal healthcare coverage.
- The Presidential Commission for the Study of Bioethical Issues released a report last week that set down principles for regulation and legislation in the whole genome sequencing field. The report pointed out that the regulatory safeguards are necessary in order to protect the patients’ privacy. The report is available online.
It’s Friday again! Enjoy the Yale Friday Newsletter (edited for our readership), with lots of great items this week.
- Tim Jost, The Internal Revenue Service’s Implementation and Administration of the Democrat’s Health Care Law, SSRN/Hastings Center Report
- Leslie Francis, When Patients Interact with EHRs: Problems of Privacy and Confidentiality, SSRN/Houston Journal of Health Law and Policy
- Ernest Young, Sorrell v. IMS Health and the End of the Constitutional Double Standard, SSRN/Vermont L.Rev.
- Michelle Mello & Glenn Cohen, The Taxing Power and the Public’s Health, NEJM
Cross-posted at HealthLawProfs
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.
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)
- I. Glenn Cohen, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard Law School
- Abigail Moncrieff, Boston University School of Law (and former PFC fellow)
- Sanford Levinson, University of Texas at Austin Law School
- John McDonough, Harvard School of Public Health
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