HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Friday, February 29, 2008

Accuracy of Gender Test Kits and the Ethics of Sex Selection

This past weekend, the LA Times ran an article discussing at-home gender test kits and their high error rate.  Karen Kaplan reports,

Amid the tumult of the delivery room, Rohit and Geeta Jain were calm about one thing: Their new baby was sure to be a boy.  Six months earlier, the Jains had spent more than $300 for a test that screened a minute quantity of Geeta's blood for traces of male DNA. The testing company said it was 95% accurate in determining the sex of a baby, even as early as the eighth week of pregnancy.  After six hours in the delivery room, Rohit gaped as his wife gave birth to a daughter.  "There's only two choices -- either it's a boy or a girl," said Rohit, 35, a computer scientist in the Vancouver, Canada, suburb of Surrey. "I couldn't fathom how it could be wrong."  Like scores of other expectant parents, the Jains had stumbled into a corner of the booming genomics industry and discovered that the claims of some genetic entrepreneurs have gone beyond what science can provide.

The tests are loosely based on legitimate scientific research, much of which has been funded by the

National Institutes of Health

, among others. But often, the companies' claims of accuracy have not been backed up by independent laboratory analysis. Thousands of consumers have bought tests -- and analysts say the number will only grow as entrepreneurs find more ways to market the mysteries of the human genome.  The Federal Trade Commission, which protects consumers from false and misleading advertising, has warned buyers to be skeptical of at-home genetic tests, which are now unregulated.

William Saletan at Slate.com has some thoughts about these tests, sex selection, and the LA Times article.  He focuses on the rationale for these tests and the fact that the LA Times article barely blinks about the sex selection that occurs and instead concentrates on the error rate.  He writes,

Today, however, prenatal sex tests have come down in price to $300 or less, cheap enough to sell directly to would-be parents. And instead of waiting the "10 to 16 weeks needed for traditional medical tests, such as ultrasound," you can now find out at just five to seven weeks whether you're carrying a boy or a girl. That's early enough to get the most basic surgical abortion or, possibly, a chemical abortion instead.

Kaplan's reporting shows how the abortion option looms behind these tests. The Jains considered abortion but decided against it. Another woman "wanted a girl so badly that she and her husband spent $25,000 on in-vitro fertilization so that doctors could select female embryos to implant in her womb." The woman took a test at 10 weeks to make sure she wasn't carrying a male fetus. A third woman who got a bogus result from her test says "there are women out there who experience really big disappointment. They really want to give their husbands the little boy they want, or a little girl, and they will abort based on these results."

One company tells Kaplan it has sold 3,500 prenatal test kits. How many thousands more have been sold by other companies? How many of those tests have led to abortions? Nobody knows. And that's the point: Because the test is taken at home, nobody but the couple has to know that the subsequent abortion is for sex selection.

But abortion isn't the focus of the article. The focus of the article is that these tests often err. The very idea of elective prenatal sex-testing used to be controversial, especially in light of rampant sex-selective abortion in Asia. Now these tests are being bought, used, and reported just like any other prenatal test. The couples who use them are described just as sympathetically. The problem isn't that they're screening their offspring for sex. The problem is that in doing so they're being thwarted by flawed technology and exaggerated marketing.

If you blame the Times for this loss of dismay, you're missing the larger trend. The article exists because the underlying stigma has already decayed. Scores of women are suing over erroneous sex tests. The Jains are unashamed to tell their story and put their names on it. So are the other women quoted in the article. As technology makes it possible to break the sex-selection taboo privately and inexpensively, the practice spreads, and we get used to it. The question of whether to restrict it becomes, as with other prenatal tests, a mere question of consumer protection.

February 29, 2008 | Permalink | Comments (0) | TrackBack (0)

The Return of Managed Care

On Wednesday, the Boston Globe ran an editorial by two physicians arguing that the State of Massachusetts, facing a budget deficit in its subsidy for universal health insurance, needs to revisit managed care.  Drs. Joseph L. Dorsey and Donald M. Berwick, write  

The closest you can come to heresy in today's healthcare policy debate is to suggest that managed care can help and that capitation is the best way to pay for it. No presidential candidate even whispers the terms. What a shame.

Massachusetts faces a $147-million shortfall this fiscal year in its subsidy for the universal insurance coverage that it courageously mandated two years ago. That raises a question: What system of payment will best support innovations that can make care less expensive and better at the same time? The easier solution - make care less expensive and worse at the same time - is neither necessary nor worthy of us.

The answer to the question is that healthcare should be managed in the same way, and for the same reasons, that school systems and air traffic are managed. Managed healthcare was a great idea when it first emerged, before the term got hijacked by insurance companies that claimed to manage care but in many cases only managed money. . . .

The financing system that allowed all that to happen is today as dirty a word as managed care, namely "capitation." That means bundled, prospective payment to an organization for the care of a defined population. In the case of HCHP, that population was our patients, enrolled through their employment-based health insurance, Medicare, or Medicaid. Our job was not to produce transactions. It was to take care of people, and that is what we did. Capitation gave us the flexibility to use our budget with creativity limited only by our imaginations and habits.

The innovations that managed care and capitation made possible were good for almost everyone. For example, with extended hours of service, off-hours telephonic access, and outreach, HCHP's population had a rate of emergency department visits less than half the statewide average. Thousands of people avoided needless hospital visits; they got more appropriate, less expensive, better coordinated care in office settings. Of course, our care systems were far from perfect, but our extensive investments in quality measurement enabled us to identify defects, and capitation gave us the resources to act swiftly and prudently to fix them. . . .

So, America, we have a question. Would you like to think again about managed care and its financing mechanism, capitation? Details matter - a strong focus on patient satisfaction, compensation and incentives, sound leadership, transparent and sophisticated measurement and information - but done right, managed care works. We lived it. Maybe, properly defined and designed, these may not be dirty words after all.

February 29, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 28, 2008

Consequences of Failure to Vaccinate

Well, what do you know - if you don't vaccinate children, they get sick and sometimes they die.  Firedoglake's Phoenix Woman provides an update on the increasing number of children suffering from  preventable childhood diseases as a result of a lack of vaccination.  She writes,

Remember measles? Mumps? All the childhood diseases you thought were vanquished forever -- in the developed world, at least? Guess what -- they're making a comeback.

San Diego is in the midst of an outbreak of measles.  (The child in this picture is one of the victims.)  Mumps has been hitting the UK hard since 2005 -- a British soccer team  recently had a player diagnosed with it -- and strains of the UK mumps made their way to Iowa in 2006 and Canada last year.  Measles, once rare in Britain, has also made a comeback in recent years.

Why is all of this happening?   Because a growing number of parents, particularly in Britain and California, are falling under the spell of the anti-vaccination cultists who claim, in spite of repeated debunkings and no actual evidence in their favor, that vaccines are icky and cause autism -- claims opposed by legitimate autism experts

The anti-vaccination promoters, who got their start in the UK in 1998 on the strength of a study that was later debunked six ways from sundown, had started out by blaming only vaccines containing mercury compounds for the alleged "autism epidemic" that in reality is far more likely to be the result of changes in how autism is diagnosed.  But since most of those types of vaccines haven't been used in years and autism hasn't declined as a result, they're now attacking all vaccines. Parents who fall for this don't get their kids vaccinated -- which leaves them easy prey for all the diseases we thought were just bad memories.

None of the child victims in the San Diego measles outbreak were vaccinated.  In fact, two of them attended a charter school with the highest rate of non-vaccination of any campus in San Diego.

Ironies abound in the anti-vax movement. The anti-vaccinators claim that vaccination is done solely for profit -- yet Andrew Wakefield, the researcher whose original flawed 1998 study had its conclusions retracted and denied by ten of his fellow twelve collaborators, started his study in August of 1996 after Richard Barr, a lawyer for a group of parents of autistic children, hired him to do so, and helped get him £55,000 (around $90,000 back then) from the UK's Legal Aid Board -- a serious breach of ethics that Wakefield neglected to mention to The Lancet's editors, who would have never published the study had they known about this ethical conflict. . . .   

UPDATE:  Great minds think alike!  Orac over at Respectful Insolence in the ScienceBlogs complex has this to say today:

In case you haven't heard it enough on this blog and elsewhere: Antivaccination lunacy has consquences. In the UK, measles cases have jumped to a record high:

The number of measles cases in England and Wales jumped more than 30% last year to the highest level since records began in 1995. The Health Protection Agency (HPA) recorded 971 cases during the year - up from 740 in 2006. . . .

As I've pointed out before, this is the true legacy of Andrew Wakefield: Falling vaccination rates, misery and suffering due to the return of vaccine-preventable diseases, and at least one dead child. Ten years later, the effects of his pseudoscience and lack of ethics continue to reverberate in the U.K. The same could happen here in the U.S. if the mercury militia has its way.

February 28, 2008 | Permalink | Comments (1) | TrackBack (0)

Wednesday, February 27, 2008

Organ Transplants, Doctors and Criminal Prosecutions

The New York Times reports on a surgeon accused of speeding up an individual's death to procure his organs. 

On a winter night in 2006, a disabled and brain damaged man named Ruben Navarro was wheeled into an operating room at a hospital here. By most accounts, Mr. Navarro, 25, was near death, and doctors hoped that he might sustain other lives by donating his kidneys and liver.

But what happened to Mr. Navarro quickly went from the potentially life-saving to what law enforcement officials say was criminal. In what transplant experts believe is the first such case in the country, prosecutors have charged the surgeon, Dr. Hootan C. Roozrokh, with prescribing excessive and improper doses of drugs, apparently in an attempt to hasten Mr. Navarro’s death to retrieve his organs sooner.

A preliminary hearing begins here on Wednesday, with Dr. Roozrokh facing three felony counts relating to Mr. Navarro’s treatment as a donor. At the heart of the case is whether Dr. Roozrokh, who studied at a transplant fellowship program at the Stanford University School of Medicine, was pursuing organs at any cost or had become entangled in a web of misunderstanding about a lesser-used harvesting technique known as “donation after cardiac death.”

Dr. Roozrokh has pleaded not guilty, and his lawyer said the charges were the result of overzealous prosecutors. But the case has sent a shudder through the tight-knit field of transplant surgeons — if convicted on all counts, Dr. Roozrokh could face eight years in prison — while also worrying donation advocacy groups that organ donors could be frightened away. . . .

Transplanting organs from patients whose hearts have stopped, or cardiac-death donations, began to go out of vogue in the late 1960s and early ’70s after medical advances like life support and subsequent changes in the legal definition of death made donations from those declared brain dead more efficient. But health officials have encouraged cardiac-death donations in recent years.  There were 670 cardiac-death donations through the first nine months of 2007, the most in any year this decade, according to the United Network for Organ Sharing, which oversees organ allocation. Over the same period, there were 12,553 brain-dead donations, according to the network.

In brain-death donations, the donor is legally dead, but machines keep the organs viable by machines. In cardiac-death donations, after the patient’s ventilator is removed, the heart slows. Once it stops, brain function ceases. Most donor protocols call for a five-minute delay before the patient is declared dead. Transplant teams are not allowed in the room of the potential donor before that. . . .

Several days after Mr. Navarro was hospitalized at the Sierra Vista Regional Medical Center here, a decision was made to remove his ventilator. According to the criminal complaint, Dr. Roozrokh ordered excessive doses of morphine and Ativan, an anti-anxiety medicine, both of which are used to comfort dying patients. In the most shocking accusation, the complaint said Dr. Roozrokh introduced Betadine, a topical antiseptic, into Mr. Navarro’s system; Betadine, the complaint said, is “a harmful substance that may cause death if ingested.”   Mr. Navarro died about eight hours later of what the coroner ruled was natural causes. In the end, however, because his death was not more immediate, his organs had deteriorated too much to be usable for transplant. . . .

Ms. Navarro, a machinist from Oxnard, Calif., who is on disability, said she did not have enough money to stay another night near her son. She said that shortly after leaving the hospital, she received a call from the California Transplant Donor Network, a nonprofit organization. On a tape recording made by the network, Ms. Navarro agreed to donate her son’s organs, saying she did not want him “to suffer too long.”

Late on Feb. 3, a transplant team including Dr. Roozrokh arrived at the hospital.b  According to a police interview with Jennifer Endsley, a nurse, the transplant team, including Dr. Roozrokh, stayed in the room during the removal of the ventilator and gave orders for medication, something that would violate donation protocol. Ms. Endsley, who stayed to watch because she had never participated in this type of procedure, also told the police that Dr. Roozrokh asked an intensive care nurse to administer more “candy” — meaning drugs — after Mr. Navarro did not die immediately after his ventilator was removed. . . .

Several months after the incident, federal health officials cited the hospital for a series of lapses, including failing to grant temporary clinical privileges to Dr. Roozrokh, who was under contract with the donor network. Last February, the United Network for Organ Sharing reprimanded the California Transplant Donor Network for breaking “established protocol” in the case. The donor network declined to comment. . . .

February 27, 2008 | Permalink | Comments (1) | TrackBack (0)

Update on Anti-Depressants

The Huffington Post has several articles on why the press is getting it wrong about the results of the PLOS study discussing placebos and anti-depressants.  One author, Gary Marcus writes about the terrible media coverage (oops!) and states,

Dashing by Google News before bed, I noticed that the usually careful Washington Post had ran a headline saying, "Only Severely Depressed Benefit From Antidepressants: Study", which I, can only imagine, will lead hundreds, if not thousands of people to get off their anti-depressants -- and probably for the wrong reasons. Time Magazine, meanwhile, has reported that "Antidepressants hardly help."

Both stories report on a study that was just published in the well-respected journal PLoS Medicine. But neither shows anything like what the headlines suggest.

Which -- and this is the part that gets me -- would be obvious not only to anyone who read the original study (which is available online for free), but also to anyone who even bothered to carefully read the news stories.  Does the Washington Post article actually show that only the severely depressed benefit from antidepressants? Noooo. Does the Time Magazine article actually show that antidepressants hardly help? Noooo. Does the PLos Medicine study show either of these things? Noooo.

Let's consider first The Washington Post's headline -- "only the severely depressed benefit from antidepressants". Um, hello? Does the study really show that? Four paragraphs into the Time study, we find the truth (from a reporter who was far more careful than the person who crafted her headline), "The researchers behind this new paper did find that SSRI drugs [like Prozac and Zoloft - GFM] have a statistically significant impact for most groups of patients."

That's right, most groups of patients.

The effect is, to be sure small, for many people scarcely more than a placebo. But most people were in fact helped, at least a little. As a much more thoughtful blog on the Wall Street Journal put it, "for many patients, placebos work pretty well indeed."

The Time headline -- "antidepressants hardly help" -- is even more misleading than the Post's. It might be argued that antidepressants are only of mild help for people who are only mildly depressed (with less room for improvement). But the current study, because of its sheer scope. provides some of the strongest evidence to date that on average (individual mileage may vary), antidepressants are a great deal of help to those most severaly depressed --- and somewhere in between for those with intermediate levels of depression. All of which is pretty clear if you pause for a minute and look at this graph of the results.

The real story here is not that the antidepressants are ineffective, but that the magnitude of their effect is (roughly) proportional to the magnitude of the depression; if you're happy, there's no point in taking them, but the more depressed someone is, the more the medications may help. Isn't that true of most medicines? . . . .

Another commentator , Maia Szalavitz remarks,

A new meta-analysis of research on modern antidepressants -- some of it unpublished by the drug companies -- suggests that the drugs have little advantage over placebos.

Why then do so many people consider drugs like Prozac to be miracle drugs for depression -- many putting up with serious sexual side effects in order to take them? Are they simply being duped by a placebo effect or avoiding withdrawal symptoms? And how could drugs which are little different from placebo also produce suicidal or even homicidal thoughts in some patients?

The answer reveals a key flaw of randomized clinical trials and meta-analyses: when you are looking at aggregated data, huge individual differences can be washed out. For example, let's imagine a drug that causes people with one genetic variation to have a profound positive effect -- but causes those with another to get dramatically worse and has little effect on everyone else.

A clinical trial could easily find that this drug has no advantage over placebo, depending on the proportion of people with each gene in the study. Another study of the same drug might find it to be a blockbuster -- while another found it dangerous. Same drug, different populations. . . . .

This doesn't mean that we don't need randomized clinical trials or meta-analyses: RCT's are the gold standard of evidence-based medicine with good reason. But it does mean that until we can better understand how genetic variation affects drug response, we will continue to have these boring debates about Prozac: Angel or Devil.

Especially in a context where the media often refuse to explain how ideological biases affect people's positions on these medications and conveys the story as a clash between two conflicting views of the world. Both sides are right -- but only about the response of particular people to particular drugs. This is why it can be true both that 80% of depressed people can find a medication that works and that clinical trials don't find these drugs much better than placebo when looking at the general population of depressed people.

February 27, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 26, 2008

Just for Fun - Be Your Own Jackson Pollack

You may already be aware of this nifty website but if not, you should pay a visit to JacksonPollack.org and then start moving and clicking your mouse - viola - you end up with a lovely painting in the Jackson Pollack style.  My son (age 4) really likes it and so do I (age - no comment).  It is fun, relaxing, and perhaps you can make a few extra dollars on the side when you visit an art auction house.  Thanks again to Americablog for the link.

February 26, 2008 | Permalink | Comments (0) | TrackBack (0)

Prozac Doesn't Work . . . .

The Guardian UK today reports on studies demonstrating that Prozac doesn't work, or put another way, it works just as well as a placebo.    --- writing for the Guardian reports,

Prozac, the bestselling antidepressant taken by 40 million people worldwide, does not work and nor do similar drugs in the same class, according to a major review released today.

The study examined all available data on the drugs, including results from clinical trials that the manufacturers chose not to publish at the time. The trials compared the effect on patients taking the drugs with those given a placebo or sugar pill.  When all the data was pulled together, it appeared that patients had improved - but those on placebo improved just as much as those on the drugs.

The only exception is in the most severely depressed patients, according to the authors - Prof Irving Kirsch from the department of psychology at Hull University and colleagues in the US and Canada. But that is probably because the placebo stopped working so well, they say, rather than the drugs having worked better.

"Given these results, there seems little reason to prescribe antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed," says Kirsch. "This study raises serious issues that need to be addressed surrounding drug licensing and how drug trial data is reported."

The paper, published today in the journal PLoS (Public Library of Science) Medicine, is likely to have a significant impact on the prescribing of the drugs. The National Institute for Health and Clinical Excellence (Nice) already recommends that counselling should be tried before doctors prescribe antidepressants. Kirsch, who was one of the consultants for the guidelines, says the new analysis "would suggest that the prescription of antidepressant medications might be restricted even more".

The review breaks new ground because Kirsch and his colleagues have obtained for the first time what they believe is a full set of trial data for four antidepressants.  They requested the full data under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

The pattern they saw from the trial results of fluoxetine (Prozac), paroxetine (Seroxat), venlafaxine (Effexor) and nefazodone (Serzone) was consistent. "Using complete data sets (including unpublished data) and a substantially larger data set of this type than has been previously reported, we find the overall effect of new-generation antidepressant medication is below recommended criteria for clinical significance," they write.

Eli Lilly was defiant last night. "Extensive scientific and medical experience has demonstrated that fluoxetine is an effective antidepressant," it said in a statement. "Since its discovery in 1972, fluoxetine has become one of the world's most-studied medicines. Lilly is proud of the difference fluoxetine has made to millions of people living with depression."

A spokesman for GlaxoSmithKline, which makes Seroxat, said the authors had failed to acknowledge the "very positive" benefits of the treatment and their conclusions were "at odds with what has been seen in actual clinical practice".  He added: "This analysis has only examined a small subset of the total data available while regulatory bodies around the world have conducted extensive reviews and evaluations of all the data available, and this one study should not be used to cause unnecessary alarm and concern for patients."

Perhaps, as the article notes, this study will cause some revisions to our drug approval process.  Withholding data that doesn't support your drug claims seems to undermine the entire process.  Thanks to Americablog for the link.  UPDATE:  Ezra Klein has further thoughts on this study and he sends us to Kevin Drum for further thoughts.

February 26, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, February 25, 2008

Nine Million Dollars!

Last week, the L.A. Times reported on an arbitration victory for a women in California against her health insurance company which had cut off her coverage in the middle of her chemotherapy treatment for breast cancer.  The cancellation appears to be related to a policy that rewarded insurance administrators based on the number of policies they canceled.  Needless to say, the cancellation and the reason that allegedly drove it, did not sit well with the Judge.   The LA Times' Lisa Girion states,

One of California's largest for-profit insurers stopped a controversial practice of canceling sick policyholders Friday after a judge ordered Health Net Inc. to pay more than $9 million to a breast cancer patient it dropped in the middle of chemotherapy.

Calling Woodland Hills-based Health Net's actions "egregious," Judge Sam Cianchetti, a retired Los Angeles County Superior Court judge, ruled that the company broke state laws and acted in bad faith.

"Health Net was primarily concerned with and considered its own financial interests and gave little, if any, consideration and concern for the interests of the insured," Cianchetti wrote in a 21-page ruling. (The LA Times has a link to the pdf version of the full decision) . . . .

The majority of the award -- $8.4 million -- was punitive damages, which are designed to teach the defendant a lesson. Such awards are highly unusual in private arbitration, the forum chosen by insurers and other companies to settle disputes. 

Health Net's lawyers had argued that Bates' suffering was minimal, a position that infuriated the judge.

The case was heard by a private judge, rather than a jury, because Health Net required Bates to agree to binding arbitration, a practice common among insurers.

"That's the point," said Carl Tobias, a law professor at the University of Richmond in Virginia. "Those kind of agreements that mandate arbitration tend to favor the bigger party or the interest with more economic clout."

The size of the award will require other insurers to take notice, he said.  "It sounds like he was just outraged," Tobias said of the judge. "He is sending a message."

Here is HealthNet's statement on its future policy adjustments as a result of this arbitration decision.   By the way, just in case you were concerned about the future viability of  HealthNet, it posted four quarter earnings that reflect a 46% increase from last year.

February 25, 2008 | Permalink | Comments (0) | TrackBack (0)

National Women's Law Center: Women and Health Reform

National Women's Law Center has been blogging on women and health reform and posts weekly on a topic in this series.  This week's topic concerns primary care physicians and provides some helpful background on why primary care is so important.  The blogger states,

Folks who have health insurance coverage often wonder about the need for health care reform – and “what’s in it for them.” I would say that my recent experience in trying to find a primary care physician answers the question:  plenty.

When I came to work at the National Women’s Law Center last summer, my change in health benefit plans meant that I needed to find new doctors. I had good health insurance coverage so I thought I was okay – until I tried to find a primary care physician (and believe me, I was prepared!).  I had a list of eight doctors who were recommended by trusted sources and I began to make calls. With each call, my dismay grew. I found that of the eight doctors on my list, three were not taking any new patients at all, two were not taking patients with insurance (self-pay patients only), and the final three had an average three month (!) wait for an appointment. 

After this experience, I was not at all surprised to read this new report that documents a decline in the number of U.S. primary care doctors. The report acknowledges that primary care professionals are undervalued in our health system, despite ample evidence that primary care patients (when compared to other patients) are more likely to receive preventive services, better manage their chronic illnesses and report satisfaction with their care. What’s more, primary care is generally more cost-effective than care provided through specialists or in hospital settings.

February 25, 2008 | Permalink | Comments (0) | TrackBack (0)