HealthLawProf Blog

Canadian Drugs

CNN and the New York Times are reporting that the Canadians are apparently tired of providing U.S. citizens with discount drugs.  According to CNN,

Canada cannot be the drugstore for the United States," Health Minister Ujjal Dosanjh told reporters at a news conference.

With the cost of prescription medicine rising in the United States, many people, including some senior citizens on fixed incomes, have traveled to Canada to buy medications. The Canadian government controls prices charged by drug companies.

"In light of potential American legislation legalizing the bulk import of Canadian prescription and other medications, our priority must be the health and safety of all Canadians and the strength of our health care system," he said.

"We must be proactive in making sure that the supply of affordable prescription medications remains stable and sufficient to meet the needs of Canadians," he said.

I was wondering when this might happen.  I figured that drug companies would not happily continue to supply Canada with sufficient drugs for not only their citizens but also our citizens for very long.  Larry Lessig has an additional thought-provoking and information article about this topic in Wired magazine. 

Thanks to Neil Wehenmen (new UC College of Law student) for this post.  [bm]

Tom Cruise Update

Here is a follow-up to our June 25 posting.  As you will recall, actor Tom Cruise appeared on the June 24 "Today" show to plug his new movie, "War of the Worlds."  Host Matt Lauer later asked the actor about his recent criticism of actress Brooke Shields, who has publicly described taking the antidepressant medication Paxil to treat her postpartum depression.

Mr. Cruise, who ascribes to Scientologist beliefs, responded with a tirade of criticism for psychiatry and pharmacologic treatment. After calling the psychiatry a "pseudoscience," Mr. Cruise stated, "There is no such thing as a chemical imbalance ... These drugs are very dangerous. They're mind-altering, antipsychotic drugs."

The American Psychiatric Association, an organization of nearly 36,000 mental health physicians (full disclosure: I’m a member), has responded by calling Mr. Cruise's behavior "irresponsible." A June 27 statement issued by APA President Dr. Steven Sharfstein criticizes Mr. Cruise for using "his movie publicity tour to promote his own ideological views and deter people with mental illness from getting the care they need. ... Rigorous, published, peer-reviewed research clearly demonstrates that treatment works. It is unfortunate that in the face of this remarkable scientific and clinical progress that a small number of individuals and groups persist in questioning its legitimacy."

You can read a transcript of the Today show interview with Mr. Cruise at:

http://www.msnbc.msn.com/id/8343367/

(His comments about psychiatry appear in the second half of the interview.)

You can find the American Psychiatric Association's response at:

http://www.psychiatry-mps.org/documents/pressreleasetomcruise_000.pdf

This excellent post is from Douglas Mossman, Professor and Director of the Division of Forensic Psychiatry, Wright State University School of Medicine, an adjunct professor at the University of Dayton School of Law, and, much to my great benefit,  a current visiting professor at the University of Cincinnati College of Law, and administrative director of the Weaver Institute for Law and Psychiatry.  Dr. Mossman's e-mail is:  douglas.mossman@wright.edu.  His webpage is available here.

Scrushy Not Guilty

I won't even try to explain this story.  It is unbelievable!  CNN reports that Richard Scrushy, former CEO of HealthSouth has been found not guilty of all charges.  Their website states,

Scrushy was the first chief executive charged with violating the 2002 Sarbanes-Oxley Act, a corporate reform measure passed after a wave of corporate scandals that followed the collapse of Enron. Five former chief financial officers testified against him.

A federal jury in Alabama began deliberating about six weeks ago and appeared deadlocked until last week, when U.S. District Judge Karon Bowdre replaced one juror on the 12-member panel.

As the verdict was read in the early afternoon, defense lawyers were crying while the prosecutors sat stone-faced, according to an eyewitness who was in the courtroom. Scrushy hugged his wife and his pastor.

Speaking to reporters outside the federal courthouse in Birmingham, Scrushy lashed out at prosecutors.

The 52-year-old founder and ex-CEO of HealthSouth faced 36 counts, including fraud, money laundering, and conspiracy charges. Prosecutors accused Scrushy of masterminding the fraud in order to inflate the company's stock price and to finance a lavish lifestyle consisting of real estate, luxury cars, and diamond jewelry.

Scrushy did not take the stand in his own defense, but his lawyers argued at trial that other former HealthSouth executives committed the fraud without Scrushy's knowledge. Other executives faced with similar charges, including former WorldCom CEO Bernard Ebbers, have used the same defense and were convicted.

Thanks to Jim Tomaszewski for the article.  [bm]

Update"  Here is the New York Times story on the not guilty verdict as well as a story on the jury pool.  Also, law.com has an article about future SEC civil sanctions.

Supreme Court Accepts Abortion Protest Case

Yesterday, the Supreme Court granted cert. in Scheidler v. Now & Operation Rescue v. Now Certiorari granted: 06/28/05 Nos. 04-1244 & 04-1352 (Consolidated) Courts below: 396 F.3d 807 (7th Cir. 2005) Full text:

http://caselaw.lp.findlaw.com/data2/circs/7th/993076pv4.pdf

.  The issue in the case involves whether Violation of the Acts or Threats of Violence Language in the Hobbs Act May Serve as Independent Predicate Grounds for Injunctive Relief?

Here is a summary of the case from the Willamette Law Onlinet: 

The National Organization for Women (NOW) and two health clinics that perform abortions filed a class action law suit against Joseph Scheidler, Pro-Life Action Network, and other individuals and organizations that oppose abortions (Anti-abortion Groups). NOW alleged that the Anti-abortion groups engaged in conduct in violation of the Hobbs Act. A jury in the United States District Court for the Northern District of Illinois (District Court) found that the Anti-abortion groups had committed numerous violations of both state and federal extortion law, and also had committed four acts or threats of violence to persons or property. The United States Supreme Court (the Court) granted limited certiorari to address whether the Anti-abortion groups had committed extortion within the meaning of the Hobbs Act and whether NOW, as private litigants, could obtain injunctive relief under RICO. However, the Court did not ultimately reach the question of availability of private injunctive relief under RICO because it held that the Anti-abortion groups did not commit extortion. On remand to the United States Court of Appeals for the Seventh Circuit (Court of Appeals), NOW argued that they had not petitioned for a writ of certiorari on the four acts involving violence, and therefore it remained to be decided whether these acts could serve as a predicate for injunctive relief. The Court of Appeals remanded the matter to District Court. [Summarized by Kianna B. Bradley.]

[bm]

Teaching Public Health Law in the Standard-Issue Survey Course

For a variety of reasons, I have decided to add a public-health component to my health law survey course this fall.  One reason is that it provides a nice counterpart to the relentlessly individualistic informed-consent and right-to-die stuff.  (My decision to put "right to die" back into the survey course, after having relegated it for years to my 3-hour bioethics course, is a story for another time.)  Another reason is to provide an antidote to the students' general confusion over "the police power" in our system of dual federalism.  And a third reason is that federal, state, and local preparations for bioterror have made it imperative that health lawyers acquire at least a passing acquaintance with the tools of the public health agencies.  In some ways, the Raich case (medical marijuana) and the upcoming Gonzales v. Oregon (assisted suicide) have crystalized my thinking about the interrelationship of the traditional state role in defining the scope of medical practice, self-determination and autonomy, the regulation of end-of-life medical choices, and the respective public-health roles of federal and state actors.  I am looking forward to ending the course this fall with Raich and Oregon, and part of the set-up for all of this will be some public-health law basics at the beginning of the semester. 

Health law casebooks have made it easy do this, by providing judiciously edited sections on public health law.  As memory serves (I am writing this in San Diego, 1000 miles from my books in Dallas), at least the casebooks by Furrow et al. (West), Hall et al. (Aspen), and Areen et al. (Foundation) -- and possibly others -- have been revised in recent years to include some public-health law materials.

A great resource, to which I recur with pleasure and profit on a regular basis, are the public-health law pages on the CDC's website.  Their weekly newletter is e-mailed for free every Wednesday, and they've put up a lot of archival material that is worth visiting, especially the "26 readings in public health law" and 15 presentations on a variety of current public-health law topics.  [tm]

Flu Wiki

To help keep everyone up-to-date on the Bird Flu, please check out the new Flu Wiki.  A description from the creators follows:

Here is their description of this new Wiki:

A Wiki is a form of collaborative software that allows anyone to edit (change) any page on the site using a standard web browser like Explorer, Firefox or Safari.The purpose of the Flu Wiki is to help local communities prepare for and perhaps cope with a possible influenza pandemic. This is a task previously ceded to local, state and national governmental public health agencies. Communications technology has now become sufficiently available to allow a new form of collaborative problem-solving that harvests the rich fund of knowledge and experience that exists among those connected via the internet, allowing more talent to participate.

What the Flu Wiki is not:

It is not:

• a news filter

• a discussion board

• a place to promote commercial products

• a soap box

• a place to advance pet theories

There is nothing wrong with these things. Many of us have blogs that do some or all of them. The wiki is not a replacement or competition for any existing blog or site. We hope existing sites will continue to grow, flourish and generally continue to carry out the important functions they have already done so well.

What we hope the wiki will be:

• a reliable source of information, as neutral as possible, about important facts useful for a public health approach to pandemic influenza

• a venue for anticipating the vast range of problems that may arise if a pandemic does occur

• a venue for thinking about implementable solutions to foreseeable problems

No one, in any health department or government agency, knows all the things needed to cope with an influenza pandemic. But it is likely someone knows something about some aspect of each of them and if we can pool and share our knowledge we can advance preparation for and the ability to cope with events. This is not meant to be a substitute for planning, preparation and implementation by civil authorities, but a parallel effort that complements, supports and extends those efforts.

The open nature of the wiki format has shown itself able to develop surprisingly effective and sophisticated products, as in the Wikipedia. Whether it will work to fashion new solutions to a complex public health problem remains to be seen. This is in the nature of a grand experiment. We hope you will join us in it.

The initial offerings are small and illustrative, in keeping with the limited resources of those of us who are turning the keys in the ignition for the first time. While we will continue to administer and maintain the Wiki, we are turning the wheel over to the community, to take it where the road leads us. There is a bit of a learning curve to driving this rig. We hope you will find the instructions sufficient to get started. You'll soon be learning on your own. There is a "sandbox" page you can use to play with if you wish.

Regularly updated content will be forthcoming in the days and weeks to come, both by us and by you. That's what wikis arefor.

Melanie Mattson (Just a Bump in the Beltway), DemFromCT (The Next Hurrah), Revere (Effect Measure).

[bm]

New Bird Flu Warning

Forget terrorism, according to the Independent (UK), bird flu is as a big a threat if not bigger than international terrorism in Britain.  The article reports,

Bird flu is now as much of a danger to Britain as terrorism, ministers have been told by the Government's official emergency body.

Top officials from the Civil Contingency Secretariat (CCS), part of the Cabinet Office, told a cabinet subcommittee last week that a flu pandemic - which it believes could kill 700,000 Britons - is now one of the most serious threats facing the country.

Plans are being made to close schools and cancel sporting fixtures in an attempt to limit the spread of the virus, and official advice on how to try to avoid being infected will be ready for publication this summer.

Cobra, Britain's emergency committee, will co-ordinate attempts to fight the virus. But the Government accepts that, if the flu reaches Britain, there is no hope of stopping an epidemic, and that the only hope is to mitigate its effects.

The top-level warning comes as alarming evidence emerges from Asia that the virus, which has killed more than half of those known to have caught it, is spreading. Patchy reports from China and Vietnam suggest that the disease is affecting larger clusters of people, raising concern that it is mutating into a highly infectious strain that will sweep through the world. The World Health Organisation has warned that "the world is now in the gravest possible danger of a pandemic", while the Food and Agriculture Organisation calls it a "sword of Damocles" hanging over the globe.

For more information on the Bird Flu, please see Effect Measure, an excellent public health blog, which provides updated information as well as interesting commentary on this potential pandemic.  Indeed, they have formed a Flu Wiki to help keep everyone up-to-date with the latest information.  [bm]

FDA and Politics

The FDA has been under attack by a number of forces recently, and perhaps in some respect deservedly so given the problems with some drugs that won FDA approval and have now been pulled from the store shelves as well as allegations of politics infecting their decisions on drug safety.  Matthew Holt at Health Care blog has a nice post on some of the FDA's current problems.  He writes,

The FDA has barely had a full time official commissioner since the start of the Bush Administration. Mark McClellan was officially head for a brief while in 2003, but he barely had time to look embarrassed on 60 Minutes when asked why Canadian drugs weren't safe enough for Americans before he nipped off to the rather more rarefied atmosphere of CMS -- where he's much better suited.

Meanwhile before, after (and basically during) McClellan's time at FDA, the acting commissioner has been Lester Crawford. Some cynics have noticed that there are a few clouds over Crawford. He was involved in some pretty close to the wind activities when he was in charge of Food Safety (ironically this weekend, there's more suspicion about the Administration covering up a second case of Mad Cow).  But more recently there's been much fuss over both his personal affairs (i.e. was he or wasn't he abusing his power to forward the career of a female colleague with whom he was having a close relationship) and, much more importantly, about his being behind the non-approval of Barr Labs' Plan B emergency contraceptive.

Robert Steeves has written convincingly on Why Plan B went down. Essentially Crawford overruled a scientific committee which voted overwhelmingly that Plan B (an emergency morning-after contraceptive) was safe and effective.  So it won't go on the market. Of course, any time you hear anything to do with "safety" in reproductive health care in this country, your ears should prick up. There are allegations that information was withheld from the Senate Panel investigating this. Whether that's true or not, David Hager the physician who apparently has Crawford's ear and was a one of the few dissenters on the panel, appears to be a certifiable loon. Yup, he attributes all his research skills and influence to God and is not shy about telling the world about it.  However, his ex-wife is not shy about telling the rest of the world about Hager's at the least inhumane and at most criminal treatment of her -- including paying her (at first) and then forcing her into types of sex that many on the Christian right probably think of as against God's law and should be banned (although they all probably indulge in private...OK that's my last direct slam on the Fundamentalists in this piece).

At any rate, it's good to know that the future of contraception in this country is in such stable and rational hands. And overall of course the whole thing is a payback from Crawford to the Christian right for supporting his appointment.

The whole article is an interesting read with some helpful links.  [bm]

A Short History of Vaccines and Immunizations

There's a nice piece in the May/June issue of Health Affairs by Alexandra Minna Stern and Howard Markel entitled, "The History Of Vaccines And Immunization: Familiar Patterns, New Challenges."  The authors' thesis:

Human beings have benefited from vaccines for more than two centuries. Yet the pathway to effective vaccines has been neither neat nor direct. This paper explores the history of vaccines and immunization, beginning with Edward Jenner’s creation of the world’s first vaccine for smallpox in the 1790s. We then demonstrate that many of the issues salient in Jenner’s era—such as the need for secure funding mechanisms, streamlined manufacturing and safety concerns, and deep-seated public fears of inoculating agents—have frequently reappeared and have often dominated vaccine policies. We suggest that historical awareness can help inform viable long-term solutions to contemporary problems with vaccine research, production, and supply.

[tm]

Cost of Health Insurance

MyDD, a liberal blog, has an undate on how expensive health insurance has become for the American family.  [bm]

Medicaid Reform

Today's New York Times has an article discussing potential reforms for the Medicaid program, which has been growing and growing in cost.  One popular set of ideas is to remove from Medicaid those who are "poor" so that they qualify for Medicaid as a means to pay for long term care.   The article states,

Congress is holding hearings. The governors have a plan. The Bush administration has named a commission. Insurance companies have weighed in, and so have lawyers and the AARP.

The idea is to restrain the explosive growth in the taxpayers' contribution to the cost of long-term care for middle-class Americans in frail old age by making it harder to qualify for government benefits and shifting costs to individuals and private insurers.

Lawmakers, health policy experts and stakeholders in the long-term-care industry are rushing forward with proposals to remove from the Medicaid rolls people who are not poor by standard definitions, but who rather have exhausted a lifetime of resources or used legal strategies to give their money away.

There is plenty of argument about which proposals are best, but the broad consensus is that none, alone or in combination, will do much to cut government spending or provide older Americans an affordable and ethical way to pay for long-term care. And the need for a solution is critical; Medicaid, a government program created for the poor, is straining to cover two-thirds of the nation's 1.6 million nursing home residents, many of them real estate rich but cash poor.

How to care for our elderly who need long term care is a problem that this country has avoid dealing with for quite some time.  I am a little worried about shifting people out of Medicaid  - nursing homes are expensive.  However, I also agree that having people game the system to qualify for Medicaid doesn't seem to be helpful either.  The article mentions that long term care insurance has taken off and as a person with aging parents, I can tell you that one reason may be the extremely high cost.  [bm]

Orthopedic Surgeons Pushing For Better Data Reporting On Medical Devices

According to Barry Meier of the New York Times, doctors get less information about products that are implanted in bodies than consumers get on the safety and performance of cars.   A group of orthopedic surgeons has suggested that the government create a database that shows how competing products performed by adding additional information to the claim form. The data base would also serve as an early warning system to show when a device is repeatedly failing.  The government pays hundreds of millions a year on hip and knee replacements for Medicare patients.   The problem is in part a consequence of manufacturers not regularly disclosing why products are failing, no systemic reporting of how many implanted devices break down while in use, and regulators and manufacturers not disclosing the the data they do gather.    The FDA requires makers of defibrillators and pacemakers to report detailed performance annually, but it does not make those reports public.   

Dr. Steve Phurrough, a Medicare official, says that "this would require an overhaul of Medicare forms and computer software. "  Also, because data comparing competing products are not necessary for payment, Congress does not allow CMS to collect them.

Dr. Robert Haralson, a top official of the American Academy of Orthopaedic Surgeons says that they have "little information on which one of these devices perform better than others."   Dr. Robert Hauser, a cardiologist at Abbott Northwestern Hospital in Minneapolis, voluntarily maintains a database in which several hospitals report problems with pacemakers and defibrillators. 

Currently, doctors and hospitals do not routinely include in their records the make or model of a device used in a procedure as they do for drugs.  This makes it almost impossible to track over time how long a product lasts or what kind of flaws develop over time.  Instead doctors rely on product performance reviews issued by manufacturers who report the "survival rate" of a device, which is not an accurate tell of how well the device functions.  Some physicians argue that if manufacturers were required to publicly disclose more collected safety data, the industry would be forced to produce better products and improve safety.  Thanks to Lindly Bain for her assistance in preparing this post.  [tm]

Milk from Cloned Animals - Yummy!

The Financial Times reports on a new item that will appear shortly on your grocery shelves - milk and food from cloned animals - I can hardly wait.  According to the Financial Times,

Meat and milk from cloned farm animals is about to be declared safe for human consumption by the US Food and Drug Administration, one of the world's most powerful regulatory bodies.

A favourable risk assessment from the FDA is expected to start the commercial exploitation of cloning to improve livestock quality around the world.

FDA officials told the BIO 2005 biotech industry conference they had completed a four-year assessment process and concluded that cloned animals and their progeny would be as safe to eat as conventionally bred animals. They also found that cloning was acceptable from the viewpoint of animal welfare.

Scientists said the first pork and beef from cloned animals could reach the market next year. John Matheson, senior regulatory scientist at the FDA, said uncertainty in the US government about the ethics of animal cloning had delayed publication of the assessment.

I think that vegetarianism looks more and more attractive.  [bm]

Childhood Vaccines and Mercury

Today's New York Times has a detailed front-page article discussing the controversy over childhood vaccines and autism/mercury concerns.   The article details the difficulty that public health officials have in convincing parents that there is no scientific link between vaccines and autism.   The Times reports,

Public health officials like Ms. Ehresmann, who herself has a son with autism, have been trying for years to convince parents like Ms. Rupp that there is no link between thimerosal - a mercury-containing preservative once used routinely in vaccines - and autism.

They have failed.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Institute of Medicine, the World Health Organization and the American Academy of Pediatrics have all largely dismissed the notion that thimerosal causes or contributes to autism. Five major studies have found no link.

Yet despite all evidence to the contrary, the number of parents who blame thimerosal for their children's autism has only increased. And in recent months, these parents have used their numbers, their passion and their organizing skills to become a potent national force. The issue has become one of the most fractious and divisive in pediatric medicine.

"This is like nothing I've ever seen before," Dr. Melinda Wharton, deputy director of the National Immunization Program, told a gathering of immunization officials in Washington in March. "It's an era where it appears that science isn't enough."

The Times also contains an article discussing some of the newer therapies that parents try with their children with autism; and the fact that experts have rejected many of them.  According to the article,

Practitioners are using nutritional supplements, sauna baths and powerful "detoxification" drugs to treat autism in the belief that it is caused by thimerosal, a vaccine preservative that contains mercury. But health experts say such therapies are not effective and can be harmful.

   

Dr. Susan Swedo of the National Institutes of Mental Health said the use of drugs to remove metals from the body, called chelation, could cause liver and kidney damage and other problems. . . . .
            

One of the first to advocate treating autism with chelation and other therapies was Dr. Stephen Edelson of Atlanta.

Dr. Edelson said in an interview that he stopped practicing medicine last year after the state medical board censured him for abusing prescription drugs and parents filed lawsuits contending that their children had regressed under his care.

Dr. Edelson said he placed children in 160-degree saunas as part of their treatment. Some children fought to get out of the sauna and kicked out its window, an assistant said in a sworn statement.

The doctor said he also used chelation and prescribed 60 to 70 supplements a day, causing some children to vomit. Children had so much blood taken for tests - often 20 vials in a sitting - that one child passed out, a parent claimed in a lawsuit.

But many parents are desperate. Dr. Jim Laidler, an anesthesiologist in Portland, Ore., said that after he learned that his two sons had autism, "if someone had e-mailed me that powdered rhino horn worked, I would have gone off on safari."

[bm]

Tom Cruise and Pscyhiatry: Not a Fan

The New York Times has a brief article about the Today' show host Matt Lauer's interview with Tom Cruise and Mr. Cruise's attack on pharmaceutical cures for mental disabilities and his rather negative view of psychiatry in general.  Here are some choice excerpts from the show, curtesy of the Detriot Free Press,

Cruise also told Lauer he didn't understand the effects of prescribing the drug Ritalin when the host asked Cruise about Brooke Shields, whom Cruise previously slammed for promoting medication and psychiatry to deal with postpartum depression.

 

Cruise's tone grew fiercer -- Cruise accused Lauer of being glib -- and when Lauer mentioned how psychiatry helped Shields, Cruise declared: "I've never agreed with psychiatry, ever. Before I was a Scientologist I never agreed, and when I became a Scientologist, I never agreed. ... All it does is mask the problem."

 

Cruise also insisted, "There is no such thing as a chemical unbalance," and that through "vitamins and exercise" a person's problems can be cured. "Drugs are not the answer," said Cruise. "I think there's a better quality of life."

I am not a psychiatrist but perhaps someone could use some counseling . . . . [bm]

Doctors Linked to Torture

In an article released early by the New England Journal of Medicine (will be available July 7th in hardcopy, now available on-line), Dr. Gregg Bloche, a physician and law professor at Georgetown University Law Center and Jonathan Mark, a London Barrister, who is currently a Greenwall fellow  in bioethics at Georgetown University Law Center and the Bloomberg School of Public Health, provide evidence that doctors and nurses are being required to provide health information to military and CIA interrogators.   Their article states,

Mounting evidence from many sources, including Pentagon dsocuments, idnciates that military interrogators at Guantanamo Bay have used aggressive counter-resistance measurs in systematic fashion to pressure detainees to cooperate.  These measures have reportedly inculded sleep deprivation, prolonged isolation, painful body posistion, feigned suffocation, and beatings.  . . .  The International Commitee of the Red Cross and others charge that such tacitics constitute cruel and inhuman treatment, even torture.

To what extent did interrogators draw on detainees' health information in designing and purusing such approaches?  The Pentagon has persistently denied this practice. . . .

But this claim, our inquiry has determined, is sharply at odds with orders given to military medical personnel - and with actual practice at Guantanamo.  Health information has been routinely available to behavioral science consultants and others who are responsible for crafting and carrying out interrogation strategies.  Through early 2003 (and possibly later), interrogators themselves had access to medical records.  And since later 2002, psychiatrists and psychologists have been part of a strategy that employs extreme stress, combined with behavior-shaping rewards, to extract actionable intelligence from resistant captives.

In response to the article, the Toronto Star provides commentators who question the use of medical records for such purposes.  The Star states,

Using medical records to devise interrogation protocols crosses an ethical line, said Peter Singer, director of the University of Toronto's Joint Centre for Bioethics."The goal for the physician is to care for the sick, not to aid an interrogation," he said. "Patients are patients and prisoners are prisoners and mixing those two things on the part of physicians who work in prisons is actually quite dangerous. Physicians are there for the benefit of patients and if they are seen to be there for some other purpose, it really blurs what they're doing."

An Amnesty International Canada spokesman said the report gives serious pause to anyone who is following what happens at Guantanamo. "This reinforces the necessity for a full, independent commission of inquiry into the detentions. What is going on and what rules are being violated," John Tackaberry said from Ottawa. "The American government needs to accept its responsibility to expose what is actually happening and show the world they are following standards that are acceptable in terms of international law," he said.

This article follows up on an excellent presentation that Gregg Bloche and Jonathan Marks made at the annual meeting of the American Society of Law, Medicine and Ethics.  This article, and the others that follow it, should hopefully help generate some greater discussion about  how we are treating our prisoners abroad and bring about much needed change in policies.  [bm]

More Bads Act by Merck

An Associated Press piece details some new wrongdoing by Merck with respect to its Vioxx drug.  According to the article,

That document, a communication between Merck researchers and the company's patent department, stated that the way Vioxx works to reduce pain might also increase cardiovascular problems. They suggested a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk.

Merck removed Vioxx from the market last September after a later study showed it doubled patients' risk of heart attacks and strokes. Thousand of wrongful death and injury lawsuits have been filed against Merck based on claims that the company hid Vioxx's risks. Analysts estimate the company's liability could reach as high as $18 billion. The first trial is set to begin next month in Angleton, Texas.

The document is potentially among the most damaging to emerge since the drug's sales were suspended because it calls into question the bedrock Merck defense that company officials were convinced of the drug's safety. The desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks.

"The document suggests a level of concern about the drug. The fact that they wanted to patent a different product raises questions — it says something," said Anthony Sebok, a professor at Brooklyn Law School. "Should they have been open about concerns? The failure to be honest is what gets companies (in product liability cases) in trouble."

A copy of the document was provided to The Associated Press on the condition that its source not be identified. A lawyer for Merck declined to discuss the specifics of the document, contending that it was a privileged internal company discussion.

Well, it doesn't look good for Merck right now . . . [bm]

Proposed Bill Will Require Parental Notification Before Giving Contraception to Minors

Rep. Tod Akin (R.- Miss.) has introduced legislation - the Parents Right to Know Act - in the House that would require federally funded health clinics to notify the parents of any minors seeking contraception at least five days before dispensing the contraception.  The law would not require parental consent.   

According to CNS News. com, Coburn argues that "this bill does nothing but put parents back in charge of their adolescent daughters. . . . In almost every area of our children's lives strict parental notification standards and laws are in place."  He says "this bill will encourage parents to get a second medical opinion and make them more aware of what is happening to their kids."  Akin has said that it is "inconceivable that children could walk into a federally funded family planning clinic and be administered a potentially life threatening birth control medication without their parents' knowledge." 

Opponents of these bills say requiring parental notification could discourage young women from seeking reproductive health care and put them at risk for unplanned pregnancy or sexually transmitted diseases.    Nancy Keenan, President of NARAL Pro-Choice America says that "Senator Coburn ["Dr. Tom" Coburn, R-Okla.], Senator Santorum and the other anti-birth control zealots behind this bill are determined to impose their values on others, even if it means more unintended pregnancies and an increased need for abortions.  They know their opinions are unpopular with Americans, so they are trying to endanger the health of young people to score points with the radical right."  This legislation would affect about 4,400 health clinics that provide reproductive health services to about five million low income and uninsured women.   

For further analysis see National Family Planning & Reproductive Health Association's article.  Thanks to Lindley Bain for her help with this post. [tm]

Childhood Vaccines: An Update

I recently received an e-mail from Professor Ross Silverman (happily tenured) at the Southernn Illinois University School of Medicine.  He had written an article earlier concerning the debate over the safety of childhood vaccines and statutory exemptions in the Annals of Health Law.  The piece is entilted, "No More Kidding Around:  Restructuring Non-Medical Childhood Immunization Exemptions to Protect Public Health." (Hein Online)  He will be working to update to that piece as new data has become available.  For our purposes, right now, however, he has reviewed the Robert Kennedy article in Salon.com, which I had referred to earlier on June 20th.  He has this to say: 

On the Rolling Stone/Salon piece: to put it mildly, it's a bunch of unbalanced bunk. It may be prettily packaged in a conspiracy theory cloak, but the claims are either inaccurate, incomplete (he does a lot of quote cherrypicking), or have been widely refuted by mountains of sound research.

He refers to several links that provide some more detailed de-bunking of the Kennedy article. 

http://majikthise.typepad.com/majikthise_/2005/06/thimerosal_corr.html
http://oracknows.blogspot.com/2005/06/saloncom-flushes-its-credibility-down.html
http://skeptico.blogs.com/skeptico/2005/06/robert_f_kenned.html

Professor Silverman also adds, "But unfortunately, it appears that the Kennedy name is going to get this far more publicity than those who refute his assertions can ever hope to achieve."

I must admit, I am a little worried that parents will stop having their children vaccinated, especially since the story will appear on the ABC News and get even more publicity.  Thanks to Professor Silverman for his research in this area and for sharing his knowledge with us on this article.  [bm]

Greenhouses - The New Trend in Nursing Homes

National Pubic Radio ran an interesting series of stories over the past two days about some new nursing home arrangments that seem to be working well for the elders who live in them.  The new arrangements involve having elder residents live in a house, affording them personalized care while at the same time providing them with a more family-friendly living space.  Unfortunately, it is not clear that those in the nursing home industry will be willing to make the change due to the fact that Medicaid budgets are not the most stable (to say the least).  [bm]

FDA's Approval Not Enough For Some African Countries

Four African countries - Nigeria, Uganda, Ethiopia and Tanzania - are refusing to allow delivery of generic AIDS drugs that the US Food and Drug Administration has approved.  According to the Boston Globe, these countries have told South African generic drug maker Aspen Pharmacare that "its FDA approval for antiretroviral drugs have no standing in their regulatory review of medicine, and that they have long required a study of the drug's safety and quality from the WHO. " The effect of this is a delay of delivery of the lower cost medicine to patients. 

Many US, UN, and African officials are now asking the WHO to immediately approve the FDA-tested drugs and Dr. Kim, WHO's head of HIV/AIDS program, says he will approve the drugs quickly.  He adds that the Africans' reliance on WHO standards "shows the importance of our process, and the strength of our relationship with the countries."

This conflict stems from the lack of coordination between parallel US and UN drug regulators, which makes it difficult for the US to rapidly increase treatment in regions hardest hit by the AIDS/HIV virus.  Last year US officials said they would buy generic AIDS drugs for Africa as long as those medicines met the same safety standards established for sale in America.    They said WHO standards would not ensure the same quality standard, and the US rejected an option to send US scientists to Geneva to assist the WHO.  US officials argue that confusion over safety and quality of certain generic medicines caused by the WHO in its approval and disapproval process has caused several African countries to switch treatment regimens. 

Paul Zeits, head of the Global AIDS Alliance, criticizes the US, arguing that if US officials had "started a regulatory system that everyone could have agreed to more than a year ago, we would have been much farther along...[the US] has created the controversy." 

Establishing a parallel review system between WHO and the US global AIDS program has proven to be difficult.  Dr. Mark Dybul, deputy coordinator of US global AIDS program says that "we've been blamed by quite a few people about delaying procurement of drugs by going through a stringent regulator before we make the drugs available.  And now we have the premier stringent regulatory agency in the world..or one of them..find that the drugs meet all the requirements, and then we have the inability to use the drugs."  Dr. James Makumbi, chairman of the National Drug Authority in Uganda defends their position by saying that "asking for WHO approval is partly historical and because of our membership in the organization...This is how we've been doing things for time immemorial.  We don't ask for FDA approval.  I think this is basically a problem with the FDA interacting with the WHO, because the WHO can always endorse the US regulator's review." 

The FDA tentatively approved two generic versions of a major AIDS drug on Monday.   According to the AP, the two tentative approval applications for neviraprine tablets go to two companies in India, Ranbaxy Laboratories Limited and Aurobindo Pharma LImited in Hyderabad.   The drugs can be used by relief organizations outside the United States funded by the US AIDS relief plan.  Last year some criticized the administration for refusing to purchase drugs that hadn't been reviewed by the FDA, and in effect, were bolstering the sales of US drug makers at the expense of AIDS patients in the developing world. 

Thanks to Lindley Bain for her work on this post.  [tm]

Potential Problems with Stem Cells

National Public Radio's Morning Edition ran a story this morning concerning some new and potentially troubling developments in human embryonic stem cells.  The story summary states,

Scientists have uncovered problems that may limit the usefulness of human embryonic stem cells. After several months of growing in a lab, the cells exhibit genetic abnormalities. Scientists will have to address that issue before stem cells can be used to treat disease.

For the full story, click here.  [bm]

JAMA - Call for Papers on Women's Health

For those of you working on research on a health topic pertaining to women, you may be interested to know that the Journal of the American Medical Association is sponsoring a women's health issue March 2006 and has issued a call for papers.  More information is available here.  [bm]

Anesthesiologists Pay Less for Med Mal Insurance

An article in today's Wall Street Journal (paid subscription required) has a provocative thesis:

Anesthesiologists pay less for malpractice insurance today, in constant dollars, than they did 20 years ago. That's mainly because some anesthesiologists chose a path many doctors in other specialties did not. Rather than pushing for laws that would protect them against patient lawsuits, these anesthesiologists focused on improving patient safety. Their theory: Less harm to patients would mean fewer lawsuits. . . .

Over the past two decades, anesthesiologists have advocated the use of devices that alert doctors to potentially fatal problems in the operating room. They have helped develop computerized mannequins that simulate real-life surgical crises. And they have pressed for procedures that protect unconscious patients from potential carbon-monoxide poisoning.

All this has helped save lives. Over the past two decades, patient deaths due to anesthesia have declined to one death per 200,000 to 300,000 cases from one for every 5,000 cases, according to studies compiled by the Institute of Medicine, an arm of the National Academies, a leading scientific advisory body.

Malpractice payments involving the nation's 30,000 anesthesiologists are down, too, and anesthesiologists typically pay some of the smallest malpractice premiums around. That's a huge change from when they were considered among the riskiest doctors to insure. Nationwide, the average annual premium for anesthesiologists is less than $21,000, according to a survey by the American Society of Anesthesiologists. An obstetrician might pay 10 times that amount, Medical Liability Monitor, an industry newsletter, reports.

Imagine that.  Tort law works.  [tm]

American Medical Association Annual Meeting

There appears to be much discussion at the AMA annual meeting this week in Chicago concerning prescription drugs.  Yesterday, the AMA approved a measure supporting  legislative initiatives in a number of states that require pharmacies to fill legally valid prescriptions.  The AMA is having some greater difficulty agreeing on prescription drug advertising.  According to the Chicago Tribune,

The American Medical Association on Tuesday is expected to authorize a comprehensive study examining whether advertising drugs directly to consumers leads to additional costs, unneeded prescriptions or other negative side effects.

The AMA's 543-member policymaking body had been expected to put forth a policy on drug advertising, but lively testimony Sunday at this week's AMA meeting in Chicago prompted a committee of the AMA to defer a vote and refer the issue for more study.

AMA officials said the referral to the board keeps the issue alive until a future meeting but allows for more scientific input and research about legal remedies that could be used to rein in drug ads.

The AMA's discussion of drug ads has been so heated that Illinois Gov. Rod Blagojevich entered the fray Monday, sending a letter to the AMA urging it to support a ban amid rising drug costs and increased concerns over drug safety that have arisen from large pharmaceutical ad campaigns.

AMA support of drug ad regulation would fuel action by Congress or the Food and Drug Administration to curtail drug ads, many observers believe.

Several delegations within the AMA want the national doctors group to take a concrete stand that pushes for more regulation, but there has been enough opposition expressed to prompt at least a deferral.

Some doctors said the industry is already curtailing ads, while other doctors, such as psychiatrists, say ads for antidepressants have helped get patients into their offices who would not otherwise come in for treatment.

[bm]

Tobacco Trial Update - Judge Urges Settlement

With the Department of Justice investigating the government's handling of the racketeering case against the tobacco industry, Judge Kessler is now urging settlement.  According to the Washington Post,

The judge presiding over the government's troubled racketeering case against the tobacco industry summoned cigarette companies' chief executives, their lawyers and Justice Department attorneys for a closed-door meeting yesterday and urged both sides to settle the case.

U.S. District Judge Gladys Kessler explained in a court order late in the day that she closed the meeting to the public because she considered it "a routine, informal discussion with the parties urging them, once again, to consider the advantages of settling the case rather than the risks of litigating it." . . . .

Kessler's urging that the parties settle comes as the government's civil racketeering suit is in political turmoil and viewed with suspicion by anti-tobacco advocates. The government had claimed that America's six largest tobacco companies engaged in a 50-year conspiracy to conceal the dangers of smoking from the public -- and should have to pay to help 45 million Americans quit smoking.

But the Justice Department stunned activists during closing arguments June 7 when it announced it would seek $10 billion for smoking-cessation programs instead of the $130 billion that government lawyers previously argued was needed. Since then, news reports have said that senior political appointees at the Justice Department pressured career department lawyers to reduce penalties and soften the testimony of government witnesses.

Yesterday's meeting was the first opportunity for Kessler to meet with the parties since the eight-month trial ended June 9 and the allegations of political interference were reported. If the parties do not settle, Kessler will decide whether the industry engaged in a fraudulent conspiracy and what penalties, if any, it should face.

[bm]

Bull and Bear Markets for Law Professors

From LawProfBlogMaster Paul Caron:

My friend and former colleague Sara K. Stadler (Emory) has posted a wonderful essay, The Bulls and Bears of Law Teaching (forthcoming in Washington & Lee Law Review), on SSRN.  Here is the abstract:

This Essay provides readers with a unique perspective on the world of law teaching:  Employing a quirky methodology, Professor Stadler predicts which subjects are likely to be most (and least) in demand among faculties looking to hire new professors in future - rating those subjects, like so many stocks, from "strong buy" to "weak buy" to "weak sell" to "strong sell." To generate the data on which her methodology is based, Professor Stadler catalogued, by subject, almost every Article, Book Review, Booknote, Comment, Essay, Note, Recent Case, Recent Publication, and Recent Statute published in the Harvard Law Review between and including the years 1946 and 2003. In the end, she found an interesting (and, she thinks, predictive) relationship between the subjects on which faculty choose to write and the subjects on which students choose to write.

Larry Solum says "I love this essay!" -- and I agree.  After all, Sara rates tax as one of her "strong buys".  [I guess I'd add the same comment, because health is rated a "strong buy," as well.]

Strong Buy	Weak Buy	Weak Sell	Strong Sell
Bankruptcy	ADR	Civ Prof/Evid	Admin.
Education	1st Amendment	Contracts	Antitrust
Energy	IP	Corporations	Commercial
Family-Gender	Int’l & Comp	Crim Law/Pro	Con Law
Health	Int’l Trade	Election	Environmental
Labor & Emp	Law and...	Legal History	Jurisprudence
Tax	Media	Property	Admiralty/T&E
		Torts	Cyberlaw

[tm]

Childhood Vaccines

Salon.com (available with subscription or by viewing brief ad) has an interesting article by Robert F. Kennedy, Jr. concerning the use of thimerosal in a variety of childhood vaccines. He alleges that a study revealed that mercury in childhood vaccines may have caused autism in thousands of children.  This piece concerns a highly charged controversy and one with many different viewpoints as to what might cause autism (which seems to be a very popular diagnosis right now).  In addition, the piece deals with allegations that Congress was ready to immunize the pharmaceutical manufacturers from liability surrounding their vaccines and their relationship to childhood illnesses..  Salon also has several other articles on the same topic - discussing the parent perspective as well as some of the science. 

Associate Professor Steve P. Calandrillo at the University of Washington has an excellent article in the  University of Michigan Journal of Law Reform entitled, "Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?," which addresses the controversy from a somewhat different standpoint, noting the many holes in the scientific evidence proving a link between the vaccines and autism.  Full cite for the article is:  37 U. Mich. J.L Ref. 353 (2004).  [bm]

Update:  ABC news will be running an interview with Robert Kennedy Jr. in which he will discuss some of his allegations against the pharmaceutical companies.  No word on when exactly the interview will air.

Prison Reform for Drug Users

Maternal and Child Health has an interesting article on why increased rehab services, as opposed to long prison, are not available for those who suffer from alchol and drug dependance.  The answer relates partially to the the prison guard lobbying.  The post reads,

Alex  at Marginal Revolution argues that it in California, at least, one reason that users go to prison instead of getting drug treatment is lobbying by prison guard unions. The guards apparently view drug treatment as competition.

The prison guard unions typically have monopolies and do lobby for tougher sentences.  The California Correctional Peace Officers Association, for example, has spent millions shamelessly creating a front of victim’s rights groups who campaign against drug rehabilitation programs instead of jail, revising the three strikes law, and reducing sentences.

[bm]

Life At A Hospice

The Washington Post has a moving story about life at the hospice where Terri Schiavo died.  I must admit that I didn't think too much about the toll the whole episode would take on those who worked at the hospice.  They are truly remarkable people.  [bm]

Male and Female Brains

This article discusses some interesting research on the differences between the male and female brain and what those differences may mean.   It is an interesting read and the Witelson seems to be quite the fascinating researcher with quite a large collection of human brains.  According to the article,

Witelson is convinced that gender shapes the anatomy of male and female brains in separate but equal ways beginning at birth.

On average, she said, the brains of women and men are neither better nor worse, but they are measurably different.

Men's brains, for instance, are typically bigger — but on the whole, no smarter.

"What is astonishing to me," Witelson said, "is that it is so obvious that there are sex differences in the brain and these are likely to be translated into some cognitive differences, because the brain helps us think and feel and move and act.

"Yet there is a large segment of the population that wants to pretend this is not true."

No one knows how these neural differences between the sexes translate into thought and behavior — whether they might influence the way men and women perceive reality, process information, form judgments and behave socially.

But even at this relatively early stage in exploration of the brain's microanatomy, battle lines between scientists, equal rights activists and educators have formed.

Some activists fear that research like Witelson's could be used to justify discrimination based on gender differences, just as ill-conceived notions of human genetics once influenced laws codifying racial stereotypes about blacks, Asians and Jews.

Thanks to Heather Lutz for bringing this article to my attention.  [bm]

More Attention Should Be Paid to Ethics and Infectious Diseases

Michael Selgelid of the University of Sydney has published the paper "Ethics and Infectious Disease" in which he claims that "bioethics suffers from a misdistribution of research resources" and that "the general topic of infectious disease has received relatively little attention from the discipline of bioethics in comparison with things like abortion, euthanasia, genetics, cloning, stem cell research, and so on."  He argues that infectious diseases deserves more attention due to historical and potential future consequences of infectious diseases such as the Black Death, small pox, AIDS, and SARS.  Possible ethical questions having to do with infected person infecting the rest of the population could involve infringing on basic human rights and liberties by surveillance, isolation, and quarantine.   Another ethical consideration is balancing the "utilitarian aim of promoting public health" and the "libertarian aims of protecting privacy and freedom of movement."   He also points out that the poor face, especially in third-world countires, suffer from infectious disease disproportionately.  I appreciate research assistant Lindley Bain's help with this post. [tm]

[LB]

Clinton & Frist Introduce Bipartisan IT Bill

To speed up IT utilization in healthcare, Senators Bill Frist and Hillary Clinton have introduced a bill (summary) that would establish legal safe harbors allowing hospitals and other organizations to extend their IT systems and allow data to be easily exchanged over a secure network.  According to Health Care IT News, the exceptions to federal Stark and anti-kickback laws would allow healthcare providers to share IT tools as long as they are used to exchange health information, as well as create standard quality measures to better assess the value of federal programs.  Modernhealthcare.com reports that the bill will provide $625 million over five years for regional and local healthcare information technology projects.   Supporters of the bill include AFL-CIO, U.S. Chamber of Commerce, Ford Motor Co., General Motors Corp, American Medical Group Association, the Healthcare Information and Management Systems Society, and the Joint Acreditation of Healthcare Organizations.  One aim of the bill is to legislatively codify the Office of the National Coordinator for Health Information Technology in HHS.   A permanent IT standards work group made up of representatives from federal agencies and the private sector and chaired by the coordinator would adopt recommendations as standards for the federal government and voluntary data standards for the private sector.    See the analysis of the bill.   Clinton and Frist have said that IT's use in healthcare will eliminate inefficiency, reduce costs, and improve care.    This is one of several healthcare IT bills introduced in the Senate in the past week or so.  Thanks to law student research assistant Lindley Bain for her help on this post.  [tm]

Pediatric Research Rules Allegedly Violated

DHHS' Office of Human Research Protection (OHRP) has concluded that "some AIDS drug experiments [at Columbia University Medical Center/New York Presbyterian Hospital] involving foster children violated federal rules designed to ensure vulnerable youths were protected from the risks of medical research," according to this morning's Washington Post.  (Our earlier posts on this subject were on May 4 and May 24.)

The article continues:

The government cited Columbia Presbyterian in a letter dated May 23 with violating rules in at least four AIDS studies involving foster children, including:

• Failing to "obtain sufficient information regarding the selection of wards of the state and foster children as research subjects."
• Failing to "obtain sufficient information regarding the process for obtaining permission of parents or guardians for wards of the state or foster children."
• Failing to have enough information to ensure the selection of patients for the studies was "equitable" . . . .

[An AP news story on May 4] prompted a congressional hearing, at which experts testified that the standards for enrolling foster children in medical experiments varied widely across the country. Some lawmakers complained that the foster kids had fewer protections than prisoners.

The OHRP's determination letter is here.  [tm]

Tobacco Settlement Update

Thursday's New York Times reports that politics may have been involved in the recent reduction in penalty against the tobacco companies from $130 billion to $10 billion.  The article states,

At the close of a major trial that dozens of Justice Department lawyers spent more than five years preparing, the department stunned a federal courtroom last week by reducing the penalties sought against the industry, from $130 billion to $10 billion, over accusations of fraud and racketeering.

The decision generated protests from health advocates and Democratic lawmakers, who accused the Bush administration of political motives, and it prompted an internal departmental inquiry. But details of the behind-the-scenes debate over the issue had remained a mystery.

The department has vigorously defended the decision, denying political motives and saying the $10 billion reflected an effort to arrive at a figure that would comply with an adverse decision from an appellate court this year that some officials said sharply limited the types of sanctions the department could seek. The department did not dispute the authenticity of the memorandum but declined to make Mr. McCallum or other lawyers available to discuss it.

A spokesman for the department, Kevin Madden, said political considerations were never factored into the decision to reduce the penalty.

"This was a decision that was made on the merits of the case and that strictly followed the law," Mr. Madden said.

In light of the appellate court ruling, he said, "a decision was made by the department that the best argument for the government to make was one that would preserve credibility in the government's case with the trial judge, would result in a favorable decision from the trial judge and would result in a trial court decision sustainable upon appeal."

The newly disclosed documents make clear that the decision was made after weeks of tumult in the department and accusations from lawyers on the tobacco team that Mr. McCallum and other political appointees had effectively undermined their case. Mr. McCallum, No. 3 at the department, is a close friend of President Bush from their days as Skull & Bones members at Yale, and he was also a partner at an Atlanta law firm, Alston & Bird, that has done legal work for R.J. Reynolds Tobacco, part of Reynolds American, a defendant in the case.

[bm]

Cruise Ships and the Disabled

SCOTUSblog has some further thoughts about the Supreme Court's recent decisions in Spector v. Norwegian Cruise Lines; a case involving the application of Title III of the ADA to foreign cruise ships.   

Also, during the January Annual Meeting of the Association of American Law Schools, the maritime law section will be discussing this case in more detail.  Here is a brief line-up of the speakers and a brief description of their talks:

        "Civil Rights on a Cruise ~ Spector v. Norwegian Cruise Lines" 
        Saturday, January 7, 2006, at 3:30 to 5:15 p.m.
        Hilton New Orleans Riverside, 2 Poydras at the Mississippi River.

        Speakers

        Jack Beermann (BU) on problems of civil rights litigation in this context
        Dean Mary Crossley (Pittsburgh) on special problems of ADA litigation
        Curtis Bradley (Duke) on extraterritorial application of U.S. civil rights law
        Sarah Cleveland (Texas) on international norms of civil and human rights
        Dean Symeon Symeonides (Willamette) on the choice of law problem in Spector

        Program Summary
        "Civil Rights on a Cruise ~ Spector v. Norwegian Cruise Lines"