The Food and Drug Administration has fired off warning letters to 17 companies including Nestle, Beech-nut, and Dreyers Grand Ice Cream, directing them to correct food product labels that run afoul of the Federal Food, Drug, and Cosmetic Act. The violations included unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “health,” that have strict, regulatory definitions. Companies that received warning letters have 15 business days to inform the FDA of the steps they will take to correct their labeling.
Wednesday, March 17, 2010
In an article posted on the WSJ Health Blog, James A. White asks and answers the following questions:
What’s a doctor worth to a hospital in terms of annual revenue? And what specialties average the most and the least in hospital revenue generation? The answer to the first question averages about $1.54 million a year, based on 114 U.S. hospital responding to a survey by physician recruiters Merritt Hawkins. That’s up slightly from the $1.5 million a year per doc that hospitals averaged in revenue in 2007, the last time the recruiting outfit took the survey. (Revenue here means net inpatient and outpatient dollars derived from referrals, tests and procedures done in the hospital.)
Merritt Hawkins also asked about revenue generation in the last 12 months by 17 doctor specialties. Not all 114 hospitals replied for all specialists but below are the averages for the responses received. Also included is a list of average annual salaries that came from other Merritt Hawkins data:
Hospital Annual Revenue per Doctor by Specialty
|Specialty||Avg. Revenue||Avg. Salary|
January 16, 2010 to March 17, 2010
Monday, March 15, 2010
A White Paper called Conflicts of Interest in Clincial Trial Recruitment & Enrollment: A Call for Increased Oversight by The Center for Health & Pharmaceutical Law & Policy at Seton Hall Law School (Kathleen M. Boozang, Carl H. Coleman, Tracy E. Miller, Kate Greenwood, Valerie Gutmann, Simone Handler-Hutchinson, and Catherine Finizio) has been posted on SSRN. The abstract reads:
This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.
For the first time, scientists have fully emptied the Cowpea mosaic virus of its genetic material rendering it non-infectious. Particles of the virus can now be used as nano luggage that carries therapeutic agents directly to diseased cells. The paper entitled Cowpea Mosaic Virus Unmodified Empty Virus-Like Particles Can Be Loaded with Metal and Metal Oxide was published in the specialized nanotechnology journal Small. A ScienceDaily article explains the implications of this research:
[S]cientists have succeeded in growing empty particles derived from a plant virus and have made them carry useful chemicals. The external surface of these nano containers could be decorated with molecules that guide them to where they are needed in the body, before the chemical load is discharged to exert its effect on diseased cells. The containers are particles of the Cowpea mosaic virus, which is ideally suited for designing biomaterial at the nanoscale.
Scientists have previously tried to empty virus particles of their genetic material using irradiation or chemical treatment. Though successful in rendering the particles non-infectious, these methods have not fully emptied the particles.
One application could be in cancer treatment. Integrins are molecules that appear on cancer cells. The virus particles could be coated externally with peptides that bind to integrins. This would mean the particles seek out cancer cells to the exclusion of healthy cells. Once bound to the cancer cell, the virus particle would release an anti-cancer agent that has been carried as an internal cargo. Some current drugs damage healthy cells as well as the cancer, leading to hair loss and other side effects. This technology could deliver the drug in a more targeted way.
Saturday, March 6, 2010
The Pepperdine Law Review is hosting a symposium on April 16th, 2010 entitled Does the World Still Need United States Tort Law? Or Did it Ever? The symposium will examine the present and future influence of United States tort law on other nations in light of globalization’s rise and United States tort law’s concurrent retrenchment on many fronts.
Some of the symposium speakers include Roger Alford (Pepperdine), Michael Bidart (Shernoff, Bidart & Echeverria), Ellen Bublick (University of Arizona), Richard L. Cupp (Pepperdine), John C.P. Goldberg (Harvard), Michael D. Green (Wake Forest), Ellen S. Pryor (SMU), Robert L. Rabin (Stanford), Michael L. Rustad (Suffolk), Victor E. Schwartz (Shook, Hardy & Bacon), Marshall S. Shapo (Northwestern), and Stephen D. Sugarman (Boalt Hall). International scholars speaking at the symposium include Peter Cane (Australian National University), Bruce Feldthusen (University of Ottawa), Lewis N. Klar (University of Alberta), the Honorable Allen M. Linden (Pepperdine; former judge of the Federal Court of Appeal of Canada), and Jane Stapleton (University of Texas). The Honorable Allen M. Linden will be honored at the symposium for his enormous contributions as a tort law scholar and teacher both in Canada and in the United States.
Thursday, March 4, 2010
A small study suggets that a new genetic test by Interleukin Genetics Inc. may help dieters pick the best diet: a low-fat diet, one that cuts carbohydrates or a more balanced approach. Reuters reports that
[t]he small study of about 140 overweight or obese women showed that those on diets "appropriate" for their genetic makeup lost more weight than those on less appropriate diets, researchers told an American Heart Association meeting. 'The potential of using genetic information to achieve this magnitude of weight loss without pharmaceutical intervention would be important in helping to solve the pervasive problem of excessive weight in our society,' Christopher Gardner at Stanford University in California, who worked on the study, said in a statement.
Massachusetts-based Interleukin's test looks for mutations in three genes, known as FABP2, PPARG and ADRB2. The company says that 39 percent of white Americans have the low-fat genotype, 45 percent have the type that responds best to a diet low in processed carbohydrates and 16 percent have the gene mutation that helps them lose weight best on a balanced diet.
'Individuals on genotype-appropriate diets lost 5.3 percent of body weight compared to individuals on diets not matched to their genotype, who experienced only 2.3 percent weight loss,' the researchers wrote in a presentation prepared ahead of the conference. 'The weight loss differences were even stronger when considering the individuals who were trying to follow the lowest carbohydrate (Atkins) and the lowest fat (Ornish) diets: 6.8 percent weight loss for those whose genotype matched the diet they were following versus 1.4 percent for those not matched to their genotype.'
Should government fund safe human enhancements for the hereditary contribution to good looks or athletic prowess or IQ? Is there reason to restrict genetic interventions that would create chickens without the nesting instincts that agitate normal chickens confined to life in a battery cage? Or cows with stunted emotions that would feel less fear as they were led off to slaughter? Or pigs with no legs, better suited to a sedentary existence as bacon-to-be? Some philosophers argue that political decisions about such practices, to be legitimate, must be made without reference to reasons that arise from within controversial worldviews. They believe that society is arranged best when governed by principles that leave citizens free to pursue their own views about what gives life value. So the reasons that public officials give to justify state action must not privilege some moral or religious beliefs over others.
This is a mistake, for two reasons. First, it is conceptually incoherent for the state to stay neutral toward genetic engineering because any strategy that legislators might choose depends for its plausibility on an answer to the underlying normative questions these practices presuppose. Second, the bracketing of formative moral commitments would unduly diminish the character of public deliberation about these questions. What we should do about offspring enhancement depends on why the natural lottery matters to us. And whether we should re-fashion animals to suit our uses for them depends on whether “animal nature” is worth preserving. But these are precisely the sort of controversial moral questions that a neutral state excludes as legitimate grounds for political debate and policy decisions. It might be replied that it is unrealistic to expect citizens in a diverse society to reach agreement on normative issues as contentious as the value of animal nature or the qualities of character worth promoting in a modern democracy.
The truth in this reply is that there is no assurance that agreement will follow from public discourse about the moral status of genetic engineering of humans and animals. Nor might such discourse even lead people to have any greater understanding or respect for those views with which they disagree. But people who hold conflicting values can engage in rational moral dialogue about matters of public policy. And it is possible for people who disagree about controversial technological advances to persuade one another, at least for a time, that some moral views about, for example, genetic engineering, are more reasonable than other views. The price of excluding substantive moral arguments from political debate should not be overlooked. The risk of seeking neutral justification for policy decisions about genetic engineering is that future generations and our own will be subject to a course of action that we cannot plausibly endorse or coherently defend.
A new study estimates the total economic impact of foodborne illness across the nation to be a combined $152 billion annually. To obtain a copy of the report, visit www.MakeOurFoodSafe.org. The interactive online map that graphically represents this cost information for every state in the nation is available at www.MakeOurFoodSafe.org/cost_map. According to ScienceDaily
[t]he Produce Safety Project, an initiative of The Pew Charitable Trusts at Georgetown University, published the report, Health-Related Costs from Foodborne Illness in the United States.... The report ranks states according to their total costs related to foodborne illness and cost per case for an individual, which is $1,850 on average nationwide. The ten states with the highest costs per case are: Hawaii, Florida, Connecticut, Pennsylvania, South Carolina, the District of Columbia, Mississippi, New York, Massachusetts and New Jersey.
The Centers for Disease Control and Prevention (CDC) estimates that approximately 76 million new cases of food-related illness -- resulting in 5,000 deaths and 325,000 hospitalizations -- occur in the United States each year. Continuing outbreaks every year show that this is not a problem that is going away.
The release of the report comes as the U.S. Senate may soon vote on comprehensive food-safety legislation. The U.S. House of Representatives passed its food-safety bill (H.R. 2749) last July, and just before Thanksgiving, the U.S. Senate Committee on Health, Education, Labor & Pensions unanimously approved the FDA Food Safety Modernization Act (S. 510).
Wednesday, March 3, 2010
End-of-Life Medical Decision-Making: The Use of Surrogate Selection to Resolve Intractable Medical Futility Disputes
This article reviews the strengths and weaknesses of “surrogate selection” as a solution to intractable medical futility disputes. It concludes that while surrogate selection is an increasingly viable solution, it remains only a partial solution because it is often difficult or impossible to demonstrate that a surrogate demanding non-recommended end-of-life medical treatment is acting outside the scope of her authority.
ScienceDaily reports on a study published in the Archives of Internal Medicine that investigates two common conditions caused by hospital-acquired infections (HAIs). The study reveals that these two HAI alone killed 48,000 people and ramped up health care costs by $8.1 billion in 2006.
This is the largest nationally representative study to date of the toll taken by sepsis and pneumonia, two conditions often caused by deadly microbes, including the antibiotic-resistant bacteria MRSA. Such infections can lead to longer hospital stays, serious complications and even death.
'In many cases, these conditions could have been avoided with better infection control in hospitals,' said Ramanan Laxminarayan, Ph.D., principal investigator for Extending the Cure, a project examining antibiotic resistance based at the Washington, D.C. think-tank Resources for the Future.
'Infections that are acquired during the course of a hospital stay cost the United States a staggering amount in terms of lives lost and health care costs,' he said. 'Hospitals and other health care providers must act now to protect patients from this growing menace.'
In 2002, the Centers for Disease Control and Prevention estimated that all hospital-acquired infections were associated with 99,000 deaths per year. While the Extending the Cure study looked at only two of the most common and serious conditions caused by these infections, it also calculated deaths actually caused by, rather than just associated with, infections patients get in the hospital.
In an open letter to the food industry dated March 3, FDA Commissioner Margaret Hamburg stated that
[t]oday, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States .... I have made improving the scientific accuracy and usefulness of food labeling one of my priorities ....
Tuesday, March 2, 2010
The applicability in the NICU of the futility provision of Texas's Advance Directives Act and its relationship to the Baby Doe rules are reasonably straightforward. Nonetheless, many comments have been written about Texas's so-called “futility law,” some of them complimentary and others, not so much. The most serious critiques of the Texas futility provision, however, are based upon assumptions that result from a fundamental misreading of the law. After a brief discussion of the futility provision and its principal features, this Essay examines the misunderstandings that plague many critiques of the law and then offer a list of proposed amendments to the law that address some of the actual deficiencies in the futility provision.
Anna F. Triponel (Jones Day) has posted on SSRN Global Fund to Fight Aids, Tuberculosis and Malaria: A New Legal and Conceptual Framework for Providing International Development Aid. Here is the first part of the Abstract:
Over the past decade, the development community has witnessed the unprecedented proliferation of innovative mechanisms designed to fund specific global issues. Usually initiated as partnerships between governments, intergovernmental organizations, the private sector, and civil society, these funding instruments address global public goods such as health, environment, and microfinance. These include the Consultative Group on International Agricultural Research, the Global Environment Facility, the Consultative Group to Assist the Poor, the GAVI Alliance, the Education for All – Fast Track Initiative, and the Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund).
The appearance of these multilateral funding mechanisms on the international scene has changed the understanding of development. This creation of new vehicles for development funding has also resulted in increased scrutiny of the ways these programs operate to draw lessons for the creation and management of subsequent programs. This article presents the key innovative features of the Global Fund and how these have adapted to changing circumstances since its creation in 2002.
This short comment argues that both cost-benefit analysis (CBA) and cost-effectiveness analysis (CEA) should be seen as imperfect tools for evaluating health policy. This is true, not only for extra-welfarists, but even for welfarists, since both CBA and CEA can deviate from the use of social welfare functions (SWF). A simple model is provided to illustrate the divergence between CBA, CEA, and the SWF approach. With this insight in mind, the comment considers the appropriate role of contingent-valuation studies.
Monday, March 1, 2010
Much like tort reform, the debate over pending legislation on biotech drugs - and particularly regulatory supplements to patent protection - has taken on a significance that dwarfs its impact on overall health care expenditures. Under the pending Health Care Reform legislation, Congress would enact two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics, which are the analogues of generics for conventional drugs. Second, establishment of a twelve-year “data exclusivity” period during which clinical testing data collected by brand-name producers could not be used by competitors to satisfy FDA testing requirements. While the abbreviated FDA approval process enjoys broad support, the data-exclusivity provision has been hotly contested, including strong opposition from the Federal Trade Commission.
We argue that regulatory data exclusivity is a sideshow. Current estimates find that the effect of data exclusivity on health care expenditures would be trivial. For this and other reasons, any potential benefit to patients that might result from a shorter period of data exclusivity would be outweighed by the financial risks to the biotech industry, and particularly the negative impacts on investments in research and development. More importantly, we believe that the current focus on data exclusivity is misplaced. Weak competition in markets for biotech drugs poses a much greater and longer-term problem for patient access - without effective competition, pricing of many biotech drugs will remain high indefinitely. The most important issue for Congress to address ought to be minimizing the barriers to market entry for manufacturers of follow-on biologics after the relevant patent terms and data exclusivity end. We close the article by suggesting a variety of ways in which this objective could be met.
The LA Times reports that the Food and Drug Administration and the National Institutes of Health have announced a partnership to collaborate on regulating new products and procedures that arise out of advanced research. Together, the NIH and FDA will make at total of $6.75 million in grants for regulatory science research over a three-year period.
The new partnership will promote the development of testing and other tools that FDA regulators need in order to assess drugs and other products coming from fields such as genomics, nanotechnology and stem cell therapy. Officials from both agencies said laboratory science leading to treatments had vastly outdistanced regulatory science, which develops the methods to evaluate the safety and quality of those treatments.
FDA Commissioner Margaret Hamburg compared the imbalance to the arms of a rower. "We have allowed the arm of regulatory science to become weak and underdeveloped," Hamburg said at a news briefing. If not corrected, "instead of pulling us into an exalted future, we will row in circles."
The NIH-FDA collaboration includes the formation of a six-member council of top scientists from both agencies to make sure that the latest science is incorporated into the regulatory review process.
The annual meeting of the The American Association for the Advancement of Science, held on February 17, explored the implications for agriculture of the projected growth of the world's population to 9 billion people by 2030. A significant challenge will be to provide enough food to meet demand.
According to a ScienceDaily report on the event
[Rod] Hill [a University of Idaho animal scientist] and Larry Branen, a University of Idaho food scientist, organized a symposium during the American Association for the Advancement of Science anual meeting to explore ways biotechnology could provide healthy and plentiful animal-based foods to meet future demands.
Synthetic biology, nanotechnology, genetic engineering and other applications of biotechnology -- and the public's role in determining their acceptable uses -- were all addressed by panelists during the session.