HealthLawProf Blog

SCOTUS: Action in 2 Pharm Patent Cases

From Monday's SCOTUSblog:

In [a] patent case, Laboratory Corp. of America v. Metabolite Laborities, Inc., et al. (04-607), the Court granted review of one of three questions presented. The case asks the Court to clarify the legal standard for patentability for a medical process. The question granted involves whether a patent may be granted on a process for detecting a scientific relationship between a medical test result and a medical condition in a patient -- in other words, whether a natural correlation between a scientific fact and a medical condition can be patented, or whether that is a phenomenon of nature that cannot be patented.

In another major patent law case, the Court asked for the views of the U.S. Solicitor General on Federal Trade Commission v. Schering-Plough (05-273). That case tests whether it is a violation of federal antitrust law for the maker of a brand-name drug to pay a potential maker of a competing generic drug to delay putting that alternative drug on the market. The Court had a similar issue before it last term, but denied review after the Justice Department said that the lower court there had gone too far in finding a "per se" violation of antitrust law in such a deal. In the Schering-Plough case, the 11th Circuit ruled that neither a rule-of-reason nor a per se mode of analysis was apprropriate in an antitrust case involving patents. There is no time limit for the Solicitor General to respond. (Justice Stephen G. Breyer is recused in the case.)

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Women's Health and Conservative Political Agenda

First, Plan B and now cervical cancer vaccine . . . .  According to the Washington Post, some members of the abstitence movement have made know that they have some concerns about a new cervical cancer vaccine.   The Post states,

A new vaccine that protects against cervical cancer has set up a clash between health advocates who want to use the shots aggressively to prevent thousands of malignancies and social conservatives who say immunizing teenagers could encourage sexual activity.. . . .

The vaccine protects women against strains of a ubiquitous germ called the human papilloma virus. Although many strains of the virus are innocuous, some can cause cancerous lesions on the cervix (the outer end of the uterus), making them the primary cause of this cancer in the United States. Cervical cancer strikes more than 10,000 U.S. women each year, killing more than 3,700.

The vaccine appears to be virtually 100 percent effective against two of the most common cancer-causing HPV strains. Merck, whose vaccine is further along, plans to ask the Food and Drug Administration by the end of the year for approval to sell the shots.

Exactly how the vaccine is used, however, will be largely determined by the Advisory Committee on Immunization Practices, a panel of experts assembled by the Centers for Disease Control and Prevention in Atlanta. The panel issues widely followed guidelines, including recommendations for childhood vaccines that become the basis for vaccination requirements set by public schools.

Officials of both companies noted that research indicates the best age to vaccinate would be just before puberty to make sure children are protected before they become sexually active. The vaccine would probably be targeted primarily at girls but could also be used on boys to limit the spread of the virus.

"If you really want to have cervical cancer rates fall as much as possible as quickly as possible, then you want as many people to get vaccinated as possible," said Mark Feinberg, Merck's vice president of medical affairs and policy, noting that "school mandates have been one of the most effective ways to increase immunization rates."

That is a view being pushed by cervical cancer experts and women's health advocates.

"I would like to see it that if you don't have your HPV vaccine, you can't start high school," said Juan Carlos Felix of the University of Southern California in Los Angeles, who leads the National Cervical Cancer Coalition's medical advisory panel.

At the ACIP meeting last week, panel members heard presentations about the pros and cons of vaccinating girls at various ages. A survey of 294 pediatricians presented at the meeting found that more than half were worried that parents of female patients might refuse the vaccine, and 11 percent of the doctors said they themselves thought vaccinating against a sexually transmitted disease "may encourage risky sexual behavior in my adolescent patients."

Conservative groups say they welcome the vaccine as an important public health tool but oppose making it mandatory.

"Some people have raised the issue of whether this vaccine may be sending an overall message to teenagers that, 'We expect you to be sexually active,' " said Reginald Finger, a doctor trained in public health who served as a medical analyst for Focus on the Family before being appointed to the ACIP in 2003, in a telephone interview.

"There are people who sense that it could cause people to feel like sexual behaviors are safer if they are vaccinated and may lead to more sexual behavior because they feel safe," said Finger, emphasizing that he does not endorse that position and is withholding judgment until the issue comes before the vaccine policy panel for a formal recommendation.

[bm]

Maine Docs Refuse to Force-Feed Prisoner

According to a recent article in the Bangor Daily News, James Emerson is a county jail inmate in Penobscot County who has been on a hunger strike for 17 days.  Subsisting on a diet of water and a few crackers, he has lost 20% of his body weight, which led a local judge to order the county sheriff to take him to Eastern Maine Medical Center (where I was born, more years ago than I would care to count) to get him fed against his will.  Once there, however, the hospital and its docs balked, saying the prisoner doesn't meet their medical criteria for insertion of an involuntary naso-gastric tube:

EMMC spokeswoman Jill McDonald said hospitals, in general, perform procedures only with the permission of the patient.

"We are not parties to court orders; we are under a different set of obligations," McDonald said late Friday night.

The whole field of incarceration and health care, including mental health treatments to make a patient competent to stand trial or to be punished, is fascinating.  Thanks to college classmate Rick Goggans for passing this story along.  I'll keep you posted on the results of this as the case unfolds.  [tm]

Political Agendas and Health

The Washington Post contains an article today discussing the new cervical cancer vaccine that should be available next year.  According to the Post, the vaccine appears to be almost 100 percent effective against the most common cancer-causing strains. By the end of the year, Merck hopes to be in the process of gaining FDA approval to sell the shots.  Sounds good to me --- but wait --- this vaccine might somehow encourage girls to have sex so we need to be extra careful not to make it mandatory . . . . . . 

Groups working to reduce the toll of the cancer are eagerly awaiting the vaccine and want it to become part of the standard roster of shots that children, especially girls, receive just before puberty.

Because the vaccine protects against a sexually transmitted virus, many conservatives oppose making it mandatory, citing fears that it could send a subtle message condoning sexual activity before marriage. Several leading groups that promote abstinence are meeting this week to formulate official policies on the vaccine. . . . .

The vaccine protects women against strains of a ubiquitous germ called the human papilloma virus. Although many strains of the virus are innocuous, some can cause cancerous lesions on the cervix (the outer end of the uterus), making them the primary cause of this cancer in the United States. Cervical cancer strikes more than 10,000 U.S. women each year, killing more than 3,700. . . .

Exactly how the vaccine is used, however, will be largely determined by the Advisory Committee on Immunization Practices, a panel of experts assembled by the Centers for Disease Control and Prevention in Atlanta. The panel issues widely followed guidelines, including recommendations for childhood vaccines that become the basis for vaccination requirements set by public schools.

Officials of both companies noted that research indicates the best age to vaccinate would be just before puberty to make sure children are protected before they become sexually active. The vaccine would probably be targeted primarily at girls but could also be used on boys to limit the spread of the virus.

"If you really want to have cervical cancer rates fall as much as possible as quickly as possible, then you want as many people to get vaccinated as possible," said Mark Feinberg, Merck's vice president of medical affairs and policy, noting that "school mandates have been one of the most effective ways to increase immunization rates."

That is a view being pushed by cervical cancer experts and women's health advocates.

"I would like to see it that if you don't have your HPV vaccine, you can't start high school," said Juan Carlos Felix of the University of Southern California in Los Angeles, who leads the National Cervical Cancer Coalition's medical advisory panel.

At the ACIP meeting last week, panel members heard presentations about the pros and cons of vaccinating girls at various ages. A survey of 294 pediatricians presented at the meeting found that more than half were worried that parents of female patients might refuse the vaccine, and 11 percent of the doctors said they themselves thought vaccinating against a sexually transmitted disease "may encourage risky sexual behavior in my adolescent patients."

Conservative groups say they welcome the vaccine as an important public health tool but oppose making it mandatory.

"Some people have raised the issue of whether this vaccine may be sending an overall message to teenagers that, 'We expect you to be sexually active,' " said Reginald Finger, a doctor trained in public health who served as a medical analyst for Focus on the Family before being appointed to the ACIP in 2003, in a telephone interview.

Someone please make this stop! [bm]

New Supreme Court Nomination

President Bush has nominated Judge Samuel A. Alito, Jr., who currently sits on the Third Circuit Court of Appeals.  Scotusblog has some further information here and here.

Leon Kass part 2 of Courtship

Leon Kass has published the second part of his The End of Courtship series.  I am not sure that this is a good career move for him to publish these pieces.  He comes across rather sexist (something I wasn't aware of previously).  Here is a small sample,

Her sexuality unlinked to procreation, its exercise no longer needs to be concerned with the character of her partner and whether he is suitable to be the father and co-rearer of her yet-to-be-born children. Female sexuality becomes, like male, unlinked to the future. The new woman's anthem: Girls just want to have fun. Ironically, but absolutely predictably, the chemicals devised to assist in family planning keep many a potential family from forming, at least with a proper matrimonial beginning.

[bm]

Boutique Medicine, Redux

There's a good article in today's NY Times about boutique (or concierge) medicine.  It raises the ethical and regulatory issues early and gets back to them later in the article in slightly more depth.  Overall, a pretty good, balanced piece.  [tm]

Walmart and Health Care Costs

The New York Times has a terrific piece on Walmart's health care woes.  Walmart's concerns about the high price of providing health care may encourage Congress to reform our health care system (or at least we can hope so).

As the nation's largest employer, Wal-Mart cannot help but be entangled in the increasingly contentious debate over how best to provide health care to working Americans. Many of the company's 1.3 million employees are drawn from the most vulnerable part of the national labor pool: people who can find only low-paying jobs, who frequently cannot afford health coverage and who have no ability to absorb the kind of bank-breaking inflation in medical costs the country has experienced since the late 1990's.

For various social and economic reasons - including limited access to preventive medical care - low-income workers and their families often have the greatest health care needs, with the least ability to meet them. The Wal-Mart quandary involves a fundamental national issue: Who, if anyone, should provide care to the bulk of Americans.

"Whose responsibility is this?" said Carolyn Watts, a health professor at the University of Washington. "Is it the government's responsibility or the employer's?"

As health care costs continue to soar well above the general rate of inflation, Professor Watts says the United States can no longer rely on employers to provide widespread coverage and needs to grapple with that new reality. "It's a very different social contract than we have had," she said.

The controversy over Wal-Mart's benefits may mask what some experts see as an unraveling of the employer-based system of health coverage. "These are indications of the gaps in the health care system that are exposed by Wal-Mart," said Len Nichols, a health economist at the New America Foundation, an independent public policy group in Washington. "You can't blame Wal-Mart."

[bm]

 

Pharmaceutical Companies Use Fiction to Deter Canadian Drugs

The Pharmaceutical Research and Manufacturers of America, or PhRMA decided to pay an author to pen a novel that potrays dangers from the re-importation of drugs from Canada.  The LA Times reports,

According to the proposal, PhRMA would pay Phoenix a six-figure sum for the marketing and production of a written-to-order fictional thriller. The plotline was what Hollywood would term high-concept — a group of shadowy terrorists conspires to murder thousands of Americans by poisoning the medicine they're importing from Canada to beat U.S. drug prices. (Think "True Lies" meets the Physicians Desk Reference.)

If this scenario sounds familiar, it's because PhRMA has tried to scare state legislatures and Congress out of giving Americans access to cheap Canadian drugs by warning that terrorists might poison the imports.

Viner duly hired an author, Julie Chrystyn, who in turn enlisted a friend, Kenin Spivak, to help with the writing. Spivak, 48, has an interesting resume: Over the years he has worked at Merrill Lynch, held top executive positions at MGM/UA and Premiere Radio Networks and invested with Michael Milken. Since 1998 he has been chairman and chief executive of Los Angeles-based Telemac Corp., which licenses billing and accounting programs to wireless network operators.

[bm]

Firday Funnies

Here is a funny cartoon video entitled, "A Democrat's Advice on What to do Now."  It doesn't relate to health law but with all the excitement in Washington, DC concerning indictments and such, it provides a nice laugh.  Thanks to taxlawprof!  [bm]

Harriet Miers Withdraws Her Nomination

CNN reports that Harriet Miers has withdrawn her nomination to be on the Supreme Court and the President has relunctantly accepted it.  The New York Times piece concerning this news is here.  I am not sure who will be up next.  I haven't heard any speculation yet as to who might be next.[bm]

Lester Crawford: Reasons for Resignation

The New York Times reports today of a possible reason for former FDA commissioner Lester Crawford's sudden resignation -- stock sales of FDA regulated companies.  The Times states,

Dr. Lester M. Crawford, the former commissioner of the Food and Drug Administration, or his wife sold shares in companies regulated by the agency in 2004, according to financial disclosure forms.

The sales may have played a role in Dr. Crawford's sudden resignation from the agency last month after only two months as its leader.

The latest disclosure form, signed by Dr. Crawford on June 28, shows that he or his wife sold shares in 2004 in companies including the Sysco Corporation, a large food supplier; Kimberly-Clark and Teleflex Inc., which have medical-products divisions; PepsiCo Inc. and Wendy's International, which sell food products; Wal-Mart Stores Inc., which includes pharmacies; and Embrex, an agriculture biotechnology company where Dr. Crawford was once a board member.

The value of the sales varied from $1,001 to $100,000, according to the form.

Embrex, Kimberly-Clark, Pepsico and Wendy's are not on a form listing the Crawfords' 2003 holdings, although that form states that the Crawfords sold shares that year in Wendy's and Sysco valued at $1,001 to $15,000.

Dr. Crawford was quoted by Forbes.com last month as saying that he had sold all of his interest in Embrex before he went to work for the F.D.A.

[bm]

Target's Pharmacy Conscience Issues

Majikthise has a post discussing the recent Target decision to support a Missouri pharmacist's actions in refusing to fill a prescription for emergency contraception. Apparently Target believes that its actions are supported by the Civil Rights Act of 1964.  Several commentators have debunked such a use of the CRA and its religious accommodation provision, here, here and here.  [bm]

Walmart and the ADA: A Misunderstanding

The New York Times ran this article yesterday discussing Walmart's new efforts to cut health care costs.  An internal memo from the company reveals,

In the memorandum, M. Susan Chambers, Wal-Mart's executive vice president for benefits, also recommends reducing 401(k) contributions and wooing younger, and presumably healthier, workers by offering education benefits. The memo voices concern that workers with seven years' seniority earn more than workers with one year's seniority, but are no more productive.

To discourage unhealthy job applicants, Ms. Chambers suggests that Wal-Mart arrange for "all jobs to include some physical activity (e.g., all cashiers do some cart-gathering)."
. . . . .

The memo noted that Wal-Mart workers "are getting sicker than the national population, particularly in obesity-related diseases," including diabetes and coronary artery disease. The memo said Wal-Mart workers tended to overuse emergency rooms and underuse prescriptions and doctor visits, perhaps from previous experience with Medicaid.

The memo noted, "The least healthy, least productive associates are more satisfied with their benefits than other segments and are interested in longer careers with Wal-Mart."

The memo proposed incorporating physical activity in all jobs and promoting health savings accounts. Such accounts are financed with pretax dollars and allow workers to divert their contributions into retirement savings if they are not all spent on health care. Health experts say these accounts will be more attractive to younger, healthier workers.

"It will be far easier to attract and retain a healthier work force than it will be to change behavior in an existing one," the memo said. "These moves would also dissuade unhealthy people from coming to work at Wal-Mart."

Thanks to Labor Blog for this update.  [bm]

Post Doctoral Fellowship

Post-doctoral Fellowship Position in Public Health Law

The Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and the Center for Law and the Public’s Health at Johns Hopkins and Georgetown Universities are seeking qualified candidates for a one-year post-doctoral fellowship position in public health law. The candidate will work full-time with a collaborative team of faculty, fellows, and students at the Johns Hopkins Bloomberg School of Public Health and Georgetown University Law Center pursuant to a multi-year project that the Center is engaged through funding of the Health Resources Services Agency (HRSA) and other potential projects.  For more information about the HRSA project, please see the Center’s website at: http://www.publichealthlaw.net/Research/Affprojects.htm

Candidates must have their J.D. degree from an accredited law school, and should have exceptional academic credentials (preferably including scholarly or applied practice publications) and strong research interests, knowledge, course work, or experience in public health law, ethics, and policy. Candidates who also have a M.P.H. degree from an accredited school of public health or a public health background may be preferred.

Applications must be received by November 15, 2005, and should include: (1) a cover letter that states the candidate’s research interests and experience in public health law; (2) current resume; (3) writing sample[s] that are written solely by the candidate; and (4) at least two professional references.  Some candidates may also be asked to provide official academic transcripts or other data.  Applicants must be prepared to begin on or about January 1, 2006.  Salary and benefits through the Johns Hopkins Bloomberg School of Public Health will be based on federal guidelines for post-doctoral fellow positions.

For further information or to apply, please email or call:

James G. Hodge, Jr., J.D., LL.M., Executive Director, Center for Law and the Public’s Health, Johns Hopkins Bloomberg School of Public Health, Hampton House, Room 588,  624 North Broadway, Baltimore, MD  21205-1996   (410) 955-7624  [email protected]

Patented Genes

A recent report demonstrates that nearly 1/5 of all human genes have been patented.  From National Geographic,

A new study shows that 20 percent of human genes have been patented in the United States, primarily by private firms and universities.

The study, which is reported this week in the journal Science, is the first time that a detailed map has been created to match patents to specific physical locations on the human genome.

Researchers can patent genes because they are potentially valuable research tools, useful in diagnostic tests or to discover and produce new drugs.

"It might come as a surprise to many people that in the U.S. patent system human DNA is treated like other natural chemical products," said Fiona Murray, a business and science professor at the Massachusetts Institute of Technology in Cambridge, and a co-author of the study.

"An isolated DNA sequence can be patented in the same manner that a new medicine, purified from a plant, could be patented if an inventor identifies a [new] application."

[bm]

Susan Wood: Why I Resigned From the FDA

Do you remember Susan F. Wood, Ph.D?  She was the assistant commissioner for women's health and director of the Office of Women's Health at the Food and Drug Administration from November 2000 to August 2005, when she resigned in protest over the FDA's decision to indefinitely defer a decision whether to approve nonprescription sales of the emergency contraceptive Plan B to women 17 years of age and older.  She has an opinion piece (free access) in the current New England Journal of Medicine in which she explains the reasons for her resignation.  Here' a quote:

If the FDA is to continue to fulfill its important role in public health, both in the United States and internationally, its professional scientific and clinical staff must maintain its independence and thus its scientific credibility. In compromising these values and ignoring the expertise within the agency, the FDA's leadership has compromised the health of women and families.

The article doesn't come out and say, in so many words, that the agency bowed to political pressure, but it is damning in the way it details the mysterious and unprecedented departures from agency practice represented by the Plan B decision. 

The GAO is apparently prepared to be more explicit about the way science was trumped by politics at the FDA.  According to the Kaiser Family Foundation's "Daily Women's Health Policy Report," the GAO is circulating a draft report that says the decision on Plan B was" made with uncharacteristic involvement from leading agency officials and might have been decided several months prior to its formal announcement."  The Washington Post reports that a final version of the GAO report is due out at the end of this month.  [tm]

Update on Bird Flu

Here is a great update from DailyKos on the bird flu and the latest preparations.  [bm]

Stem Cell Debate Pushed Back

The New York Times reports that no review of the current ban on federal funding for stem cell research will occur this year.  According to the Times,

A Senate debate over whether to ease federal restrictions on stem cell research will be put off until next year, an influential senator seeking to relax the rules said Friday.

The lawmaker, Senator Arlen Specter, Republican of Pennsylvania and chairman of a subcommittee that oversees spending on health issues, said the majority leader, Senator Bill Frist of Tennessee, had agreed to make consideration of a measure governing stem cell research a priority when Congress reconvenes in 2006.

That pledge led Mr. Specter to drop his threat to use a health spending bill to try to lift the ban on federal financing of stem cell research involving destruction of human embryos.

"It would be a logical spot to remove it," Mr. Specter said of his previous plan, "but it would cause a multifaceted controversy" at a time when the Senate has an abundance of other issues to deal with.

Mr. Specter and some fellow Republicans including Senator Orrin G. Hatch of Utah had joined Senate Democrats in pushing for a vote before the end of this year despite opposition from other Republican lawmakers, the Bush administration and conservative activists. They had believed that they gained new momentum when Mr. Frist, a physician, broke with the administration in July and endorsed the concept of legislation passed by the House that would allow government financing of research on embryos that are in frozen storage at fertility clinics and due otherwise to be discarded.

But on Friday, Mr. Specter bowed to the crush of events that have crowded the Senate agenda with spending legislation, bills related to Hurricane Katrina and a second Supreme Court nomination. He said the stem cell measure would get fuller attention next year.

[bm]

When Health Insurance Is Not a Safeguard

That's the title of a good article in today's New York Times, the latest in a series on how the health care system is experienced from the patient's perspective.  This one looks at the phenomenon of medical bankruptcies, focusing on the experience of an Indiana couple with pretty good health insurance coverage and a child with a medical mystery.  [tm]