HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, June 25, 2005

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]

June 25, 2005 | Permalink | TrackBack (0)

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]


June 25, 2005 | Permalink | TrackBack (0)

Friday, June 24, 2005

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]

June 24, 2005 | Permalink | TrackBack (0)

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]

June 24, 2005 | Permalink | TrackBack (0)

Thursday, June 23, 2005

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]

June 23, 2005 | Permalink | TrackBack (0)

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]

June 23, 2005 | Permalink | TrackBack (0)

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]

June 23, 2005 | Permalink | TrackBack (0)

Wednesday, June 22, 2005

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]

June 22, 2005 | Permalink | TrackBack (0)

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]

June 22, 2005 | Permalink | TrackBack (0)

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]

June 22, 2005 | Permalink | TrackBack (0)

Tuesday, June 21, 2005

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]

June 21, 2005 | Permalink | TrackBack (0)

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]

June 21, 2005 | Permalink | TrackBack (0)

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]

June 21, 2005 | Permalink | TrackBack (0)

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]

June 21, 2005 | Permalink | TrackBack (0)

Monday, June 20, 2005

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.

June 20, 2005 | Permalink | TrackBack (0)

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]

June 20, 2005 | Permalink | TrackBack (0)

Sunday, June 19, 2005

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]

June 19, 2005 | Permalink | TrackBack (0)