Bibliography

Safety of RecomBinant Factor VII

Off-label use of recombinant activated Factor VII to treat life-threatening bleeding increases the risk of arterial, but not venous, thrombotic events. That was the conclusion of an analysis of 35 randomized trials of the product (NovoSeveno; Novo Nordisk). Given its focus, the report does not discuss how many lives were saved by use of the protein. The reference is Levi M, Levy JH, Andersen HF, Truloff D. Safety of recombinant activated Factor VII in randomized clinical trials. N Engl J Med 2010;363:1791–800; editorial comment at Aledort LM. Off-label use of recombinant activated Factor VII—safe or not safe? N Engl J Med 2010; 363:1853–4.

Groups Withdraw From Sustainable Agriculture Effort

Several organizations, including the Biotechnology Industry Organization, have withdrawn from the Leonardo Academy's attempt to establish a National Sustainable Agriculture Standard Initiative within the American National Standards Institute. The groups said the Initiative as now constituted is controlled by environmentalists, organic farmers, and other opponents of genetic manipulation of plants.

In a letter, BIO said “[t]hese groups have neither the vision nor desire to speak for mainstream agriculture and the 95 per cent of farmers who will be materially affected by any resulting standard.” An earlier letter noted that the government agencies that deal with agriculture and trade have been excluded from the program. BIO and the other groups said they intended to establish their own sustainable agriculture project.

The story appears in the BIO November 2010 E-Newsletter.

Recourse for Organic Farmers

Organic farmers whose crops have been contaminated by genetically modified plants from nearby fields should consider filing private nuisance lawsuits against the source of the plants. That is the recommendation from Amanda L. Kool, an associate at Nixon Peabody, LLP, in an article in 50(4) Jurimetrics 453 (2010). Such suits “allow[] the court to balance the interests of the farmer, the patent owner, and society as a whole … in a way that fits the distinct characteristics of the case at hand.” The title of the article is Halting pig in the parlor patents: nuisance law as a tool to redress crop contamination.

Separate Standard for Biotechnology, Pharma Patents

Biotechnology and pharma face unique problems in writing patents capable of withstanding challenge, as reviewed by Lawrence M. Green, a shareholder in Wolf, Greenfield & Sacks, PC, in a webinar. The requirement for both a written description and enablement “continues to place a burden upon the patent drafter, or anyone defending such a patent, to make sure that there are sufficient data in the application, or to make certain that there is sufficient structural discussion or definition to support generic claims to composition or compounds. … The more cutting edge the technology, the more that is required … .”

The full webinar and the PowerPoint slides can be downloaded from www.wolfgreenfield.com/newsstand/events_seminars-312

Scientific Review of Interest

A new technique for identifying genetic contributors to complex traits is the genome-wide association study. Among the disorders thus far explored in this way are Crohn's disease, schizophrenia, age-related macular degeneration, and type 2 diabetes. The technique and its potential are reviewed by Manolio TA. Genome-wide association studies and assessment of the risk of disease. N Engl J Med 2010;363:166–76.

Constitutionality of New Healthcare Law

Is the new health care law unconstitutional? Sara Rosenbaum, J.D., believes that it obviously is, as discussed in A “broader regulatory scheme”—the constitutionality of health care reform, published in N Engl J Med 2010;363:1881–3. “The fundamental goal of [the new law] is no less than the preservation of the U.S. health care system.” The courts that have heard challenges so far have disagreed on the question.

Does Market Exclusivity Help Create New Drugs?

Can market-exclusivity incentives promote innovation in drug development? Aaron S. Kesselheim, M.D., J.D., M.P.H., says it can if handled properly. He reviews the history and accomplishments of the Bayh-Dole Act, the Orphan Drug Act, the Waxman-Hatch Act, the Prescription Drug User Fee Act, and the FDA Modernization Act (Pediatric Exclusivity Extension). He notes, however, that there can be secondary consequences that are not always desirable. The User Fee Act sped the market introduction of drugs but also led to the clearance of some products that had to be withdrawn when safety concerns unrecognized during clinical trials surfaced after the drug was in general use. “It would be useful to consider such costs before enacting this kind of legislation.” The article is Kesselheim AS. Using market-exclusivity incentives to promote pharmaceutical innovation. N Engl J Med 2010;363:1855–62.

Important Role for Regulatory Science

In the Shattuck Lecture for 2010, US Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., speaks of the need for regulatory science—“the science of the assessment and evaluation of the safety, effectiveness, potency, quality, and performance of a product.” Academia and industry must collaborate with FDA to bring this about. Hamburg MA. Innovation, regulation, and the FDA. N Engl J Med 2010;363:2228–32.