Friday, February 29, 2008
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.
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.
Thursday, February 28, 2008
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.
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:
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.
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. . . .
Wednesday, February 27, 2008
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. . . .
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.
Tuesday, February 26, 2008
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.
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.
Monday, February 25, 2008
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.
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.
Friday, February 22, 2008
Today, DemFromCt writing at Daily Kos notes that Representative Kagan (D-WI) has introduced new legislation to end discrimination in health care coverage. The author states,
Now, Rep. Kagen has introduced something else to the discussion: legislation that alters the "pre-existing condition" concept.
Our Constitution protects every citizen against discrimination, the result of long and hard-won gains by ordinary people who for decades showed extraordinary courage fighting for change. Applying these fundamental gains to our health care system is the right thing to do, because my patients and my constituents cannot hold their breath any longer.
That's why I've introduced the No Discrimination in Health Insurance Act. This essential legislation will guarantee access to affordable care for every citizen in America by bringing an end to discriminatory practices employed by insurance companies who deny life-saving coverage to millions of Americans solely because of their pre-existing medical conditions.
The grim reality is our Constitution does protect you against discrimination, until you become ill. Well, my legislation puts discrimination where it belongs -- in the past.
More description of the bill directly from Kagen:
The essential elements of this necessary legislation are: (1) No Discrimination due to pre-existing conditions, (2) Open Disclosure of all prices, and (3) Every Citizen is allowed to Pay the Lowest Price available. These ideas must be included in any successful comprehensive health care reform legislation.
At this very early step in the process, I am pleased to have the encouragement and support of many of my freshman colleagues, AFSCME and Families USA. I am looking forward to presenting this bill and these ideas in a Congressional hearing this spring.
Surely, the insurance companies will oppose this. But first, Kagen's bill need to pass Ways and Means and make it out of committee before further action is taken. The bill is HR 5449 and like other health care bills from SCHIP to the Langevin-Shays universal health care bill, it may or may not go anywhere in an election year. Sometimes, these bills are little more than posturing. Chris Shays is the last House R in New England, and the CT-04 Republican survives by talking like a moderate in even-numbered years; Jim Langevin, the Democrat from RI-02, has introduced this bill before though this is the first time Shays has signed on).
DemFromCt has further information on the politics of this bill and how health care reform has definitely made it to the frontburner of many people's legislative agenda.
Thursday, February 21, 2008
The New York Times reports on the Supreme Court's decision in in which the Justices ruled "that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury." The TImes --- reports,
The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval.
In 1996, a balloon catheter burst and severely injured Charles R. Riegel while he was undergoing an angioplasty. Mr. Riegel and his wife, Donna, sued the company in federal court, contending that the catheter had been designed, labeled and manufactured in a way that violated New York state law, and that those defects had caused severe and permanent injuries to Mr. Riegel.
But a federal district court and the United States Court of Appeals for the Second Circuit, in Manhattan, dismissed the Riegels’s suit on the ground that the catheter had been given pre-market approval by the Food and Drug Administration, thus protecting the manufacturer from liability under state law. (The case of Riegel v. Medtronic was tried in federal court because the plaintiffs and defendant were based in different states.)
The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”
But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.
In 1996, when there was a different lineup of justices, the Supreme Court ruled that medical devices approved by the F.D.A. under a different, more expedited process were not shielded from state liability. At the time, the federal government took that position.
But in 2004, the Bush administration reversed the government’s position and began to take the side of manufacturers. In the Medtronic case, the administration argued that there would be “serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits” if juries could second-guess the agency.
Justice Ruth Bader Ginsburg was the lone dissenter on Wednesday, asserting that the majority had adopted an unnecessary “constriction of state authority.” Justice Ginsburg said she did not believe that Congress had intended to bring about “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”
But, will the Supreme Court have the last word on this topic . . . we discover that perhaps not -
“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Representative Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
Senator Edward M. Kennedy of Massachusetts, the chairman of the Senate Health, Education, Labor and Pensions Committee, agreed, saying: “Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court’s decision. Otherwise, F.D.A. approval will become a green light for shoddy practices by manufacturers.”
If I had a better feeling about how the people running our government, I probably wouldn't be upset by this decision but it doesn't appear that everyone is playing on a level field. With all the stories in the news about recalls for tainted products and food, I am a bit concerned about the regulators being influenced too greatly by those they are supposed to be regulating.
Wednesday, February 20, 2008
The Wall Street Journal Health Blog reports on the use of retail health clinics. It states,
The public’s still pretty wary of the retail clinics cropping up in Wal-Marts and drugstores around the country. But there are enough people comfortable with the clinics to fuel their continued spread. At least, that’s the conclusion we drew from reading the results of a survey to be published this week by Deloitte’s Center for Health Solutions, and talking with Paul Keckley, who runs the center.
In an online survey that drew roughly 3,000 responses, about 33% of people didn’t like the idea of retail clinics much at all. On a scale of one to 10, with one being “not at all comfortable” and 10 being “completely comfortable,” this group of doubters put themselves at one, two or three. Only 16%, on the other hand, put themselves at eight, nine or 10.
The clinics are typically staffed by nurse practitioners or physicians assistants. But that’s a big problem for a sizable chunk of the public that’s reluctant to be treated by anyone other than a doctor, even for the sorts of minor complaints (sore throats, flu shots) handled by the clinics, Keckley said.
But the 16% who are comfortable going to the clinics will be enough to keep the business model going, Keckley said. And the number of people who are comfortable going to a retail clinic is likely to grow as the clinics figure out how to make the business work. . . .
That particular detail reminded us of Wal-Mart’s recent re-positioning of the retail clinics in its stores. A few weeks after a company suddenly closed retail clinics it was operating in 23 Wal-Mart stores, Wal-Mart said it would be opening its own brand of retail clinics — and that they’d be affiliated with local hospitals and health systems.
CNN.Com reports on the increase number of cancer deaths in 2005 although the overall death rate from cancer continued to decline. The story states,
U.S. cancer deaths rose by more than 5,000 in 2005, a somewhat disappointing reversal of a two-year downward trend, the American Cancer Society said in a report issued Wednesday.
The group counted 559,312 people who died from cancer.
The cancer death rate among the overall population continued to fall, but only slightly, after a couple of years of more dramatic decline. In 2005, there were just under 184 cancer deaths per 100,000 people, down from nearly 186 the previous year. Experts said it wasn't surprising that the rate would stabilize. The cancer death rate has been dropping since the early 1990s, and early in this decade was declining by about 1 percent a year. The actual number of cancer deaths kept rising, however, because of the growing population. . . .
But now the death rate decline is back to 1 percent. And the 2005 numbers show annual cancer deaths are no longer falling, but are up more than 5,400 since 2004. "The declining rate was no longer great enough to overcome the increase in population," said Elizabeth Ward, a co-author of the cancer society report. Officials with the organization say they don't know why the decline in the death rate eased. . . .
It may be that cancer screenings are not having as big an effect as they were a few years ago, said Dr. Peter Ravdin, a research professor in biostatistics at the University of Texas M.D. Anderson Cancer Center in Houston. One possible example: In 2004, the largest drop in deaths among the major cancers was in colorectal cancer. Experts gave much of the credit to colonoscopy screenings that detect polyps and allow doctors to remove them before they turn cancerous. They also mentioned "the Katie Couric effect" -- a jump in colonoscopy rates after the "Today" show host had the exam on national television in 2000. In the new report, the colorectal cancer death rate decreased by about 3 percent from 2004 to 2005, after plunging 6 percent from 2003 to 2004. . . .
Cancer society officials have also voiced concern that cancer deaths may increase as Americans lose health insurance coverage and get fewer screenings.
The good news is the cancer rate is still declining, and that since the early 1990s is down more than 18 percent for men and more than 10 percent for women. Those reductions translate to more than half a million cancer deaths avoided, according to the cancer society. Experts attribute the success to declines in smoking and to earlier detection and more effective treatment of tumors.
Monday, February 18, 2008
The New York Times reports today on the largest meat recall ever!! I feel safer - my government at work etc. but unfortunately this appears to be a little late - I certainly don't have meat in my freezer from two years ago. It is enough to make me - a true beef-loving person - into a vegetarian. The Times story states,
A California meatpacker accused of animal cruelty is making the largest U.S. meat recall on record -- 143 million lbs, the U.S. Agriculture Department said on Sunday.
Most of the meat, raw and frozen beef products, probably has already been consumed, said USDA officials at a briefing. Some 37 million lbs were bought for school lunches and other federal nutrition programs. USDA said there was only a minor risk of illness from eating the beef. Hallmark/Westland Meat Packing Co voluntarily recalled all of its beef produced since February 1, 2006. USDA said Hallmark violated rules against the slaughter of "downer cattle" -- that is, animals too ill to walk.
"This is the largest beef recall in the history of the United States, unfortunately," said Agriculture Undersecretary Richard Raymond. Based in Chino, California, Hallmark/Westland has been closed since early February. Company officials were not immediately available for comment.
The Humane Society of the United States showed videotapes on January 30 showing workers at the plant using several abusive techniques to make animals stand up and pass a pre-slaughter inspection. These included ramming cattle with forklift blades and using a hose to simulate the feeling of drowning.
The HuffingtonPost Blog has more about the slaughterhouse. Perhaps there could be an updated novel in this . . . . mmmmm
The New York Times reports today on an American Cancer Society study illuminating the disadvantages of being without health insurance - later cancer diagnosis. The Times' Kevin Sack states,
A nationwide study has found that the uninsured and those covered by Medicaid are more likely than those with private insurance to receive a diagnosis of cancer in late stages, often diminishing their chances of survival. The study by researchers with the American Cancer Society also found that blacks had a higher risk of late diagnosis, even after accounting for their disproportionately high rates of being uninsured and underinsured. The study’s authors speculated that the disparity might be caused by a lack of health literacy and an inadequate supply of providers in minority communities. The study is to be published online Monday in The Lancet Oncology.
Previous studies have shown a correlation between insurance status and the stage of diagnosis for particular cancers. The new research is the first to examine a dozen major cancer types and to do so nationally with the most current data. It mined the National Cancer Data Base, which began collecting information about insurance in the late 1990s, to analyze 3.7 million patients who received diagnoses from 1998 to 2004.
The widest disparities were noted in cancers that could be detected early through standard screening or assessment of symptoms, like breast cancer, lung cancer, colon cancer and melanoma. For each, uninsured patients were two to three times more likely to be diagnosed in Stage III or Stage IV rather than Stage I. Smaller disparities were found for non-Hodgkins lymphoma and cancers of the bladder, kidney, prostate, thyroid, uterus, ovary and pancreas.
When comparing blacks to whites, the disparities in late-stage diagnosis were statistically significant for 10 of the 12 cancers. Hispanics also had a higher risk but less so than blacks.
The study’s authors concluded that “individuals without private insurance are not receiving optimum care in terms of cancer screening or timely diagnosis and follow-up with health care providers.” Advanced-stage diagnosis, they wrote, “leads to increased morbidity, decreased quality of life and survival and, often, increased costs.” . . .
“There’s evidence that not having insurance increases suffering,” said Dr. Otis W. Brawley, the American Cancer Society’s chief medical officer.
Not all cancer researchers believe that comprehensive screening and early detection is universally constructive. They argue that with certain cancers, like melanoma and prostate cancer, it can lead to misdiagnosis and overdiagnosis, with doctors identifying and treating tumors that may never cause serious problems. In some of those cases, surgery and drug therapies may actually shorten lives. . . . .
Thursday, February 14, 2008
What terrific timing! The 5th Circuit Court of Appeals overturns the Texas ban on sex toys just in time for Valentine's Day! I am sure that this will make some people's day really special!
Even more fun could be in store for the courts on this privacy issue and how broadly to interpret the Supreme Court's decision in Lawrence v. Texas. Yesterday's Fifth Circuit decision creates a conflict with an Eleventh Circuit decision from last Valentine's Day which upheld Alabama's sex toy ban. For more details, see How Appealing and law.com.
The LA Times reports on the recent investigations of health insurers. Lisa Girion writes,
With medical costs rising, record numbers of people losing their coverage and healthcare at the top of the domestic agenda, health insurers found themselves Wednesday in the cross-hairs of regulators, elected officials and law enforcement in California and across the nation.
New York Atty. Gen. Andrew Cuomo said the nation's largest health insurers have rigged rates they pay for physician visits, leaving patients with higher medical bills. In Los Angeles, City Atty. Rocky Delgadillo has assembled a team of investigators and prosecutors to probe industry practices such as canceling patients' coverage after they get sick. Today he is set to unveil a first-of-its-kind website to solicit information about insurance cancellations and delays and denials of treatment.
The announcements follow a yearlong string of fines and citations against insurers in California. Just last month, amid widening state probes, state Insurance Commissioner Steve Poizner decided to seek as much as $1.3 billion in penalties from Cypress-based PacifiCare as a result of widespread claim problems. . . .
Insurers defend their business practices, saying one of their top goals is to keep health insurance affordable for all. In fact, they say, many of the practices in the spotlight actually are good examples of their value in holding down healthcare costs. "At a time when the costs of medical services soar above inflation every year, health insurance plans' tools and techniques are mitigating the damage done to consumers and employers," said Karen Ignagni, president of America's Health Insurance Plans, a Washington-based trade group, speaking about the Cuomo announcement. . . .
Cuomo alleged in a news conference Wednesday that a company called Ingenix helped its parent, UnitedHealth Group, and other insurers low-ball payments to physicians who provided care to patients outside their healthcare networks. The company sells data to insurers who decide how much they will reimburse patients for out-of-network visits. If insurers pay less, physicians may bill patients for the difference. For example, he said, a market survey showed physicians typically charge $200 for a routine visit. But the insurers, using Ingenix data, claimed to their members that the typical rate was $77. Applying the 80% reimbursement rate, they covered $62, leaving the patient to pay $138 out of pocket.
"Getting insurance companies to keep their promises and cover medical costs can be hard enough as it is," Cuomo said in a news conference. "But when insurers like United create convoluted and dishonest systems for determining the rate of reimbursement, real people get stuck with excessive bills and are less likely to seek the care they need." Cuomo said Ingenix data are used by the nation's five largest insurers, including UnitedHealth, which purchased California's PacifiCare two years ago. Cuomo added that the alleged scheme could affect 70% of Americans with health coverage. His office issued subpoenas for information to several big health insurers, including Health Net Inc., Aetna Inc. and Cigna Corp.
The insurers pledged to cooperate with the investigation. United defended the integrity of Ingenix data, saying it was "rigorously developed, geographically specific, comprehensive and organized using a transparent methodology that is very common in the healthcare industry." . . . .
Insurance trade groups said the use of data to standardize medical reimbursements shows the value insurers bring to healthcare. "It's unfortunate that today's media event ignored these facts and failed to address the appropriateness of charging out-of-network patients $200 for 'simple doctor visits' lasting '15 minutes' -- which equates to a billing rate of at least $800 an hour," said Ignagni of America's Health Insurance Plans. "As medical costs continue to soar, this is the discussion that public policy leaders need to have."
Working for several months, the Los Angeles city attorney's task force is focused on industry practices that affect patients financially as well as medically. The website to be launched today -- www.protectingtheinsured.org "> www.protectingtheinsured.org -- invites patients, physicians and hospitals, as well as current and former insurance employees, to provide information on problems they've had with insurers.
"At a patient's most vulnerable moment, the insurance company won't pay for care or will cancel the policy altogether," Delgadillo said. "Industry schemes to maximize profits at the expense of patients are unfair and unlawful, and must be stopped." . . .
The city attorney could seek restitution for victims -- such as restoration of insurance coverage -- as well as civil penalties and other remedies. The task force was initially focusing on insurers' widely disputed practice of canceling patients with individual policies after they submitted claims for medical care.
Here is some further information on the New York reimbursement suits.
Wednesday, February 13, 2008
Just when you thought it was safe to start taking drugs again (I mean - we will be getting a new President soon and hopefully he or she will want to increase the funding and re-think the staffing for the FDA), we learn that it isn't just the drugs themselves that can be harmful, but the people who fill those drugs can make mistakes - quite a few of mistakes actually. From the Wall Street Journal's Health Blog's Jacob Goldstein,
A Florida roofer died a few years back from a methadone overdose, 36 hours after a pharmacy technician mistakenly typed prescription instructions that said the pills should be taken “as needed.” The instructions were supposed to say four tablets, twice daily.
The roofer’s story lands in today’s USA Today as part of a series the paper is rolling out on pharmacy errors. The pharmacy industry says it’s spent lots of money on high-tech systems to drive the rate of such errors well below 1%. But even a very low rate can mean lots of cases.
An Auburn University pharmacy study in 2003 projected the odds of getting a prescription with a serious, health-threatening error at about 1 in 1,000, USA Today reported yesterday. That could amount to 3.7 million such errors a year, based on 2006 national prescription volume, according to the paper. . . . .
Bonus Pills: Read our post on drug errors that can occur when pharmacy employees or doctors confuse one drug name with another.
Ezra Klein has a great post today on why insurance companies pose a problem for the provision of health care in our country and ways to solve this problem. He writes,
Lets start from a basic proposition: In the current system, insurance companies add negative value, which is to say, they make health care worse, not better. Conservatives often complain that health insurance is not "insurance" in any real sense, it is not protection against unexpected costs, but insulation from largely predictable costs. We know we will need to purchase health care. We contract out with health insurers to smooth those expenditures -- render them predictable and manageable over the course of years, rather than unexpected and crushing in the course of months. That's why we pay insurance premiums so we can one day get chemotherapy, rather than simply paying for chemotherapy.
But "we" here is misleading. Not all of us make this deal with insurers. And among those of us who do make this deal, we make it in different ways, purchasing different levels of insulation, on different time periods. So the insurers, quite naturally, turn their attention to making deals with the most profitable among us, and avoiding deals, or finding ways to break contracts, with the least profitable. They are very innovative in their attempts to do this. But there's nothing good about those attempts. Competition among drug dealers does not aid the neighborhood, and currently, competition among insurers does not aid the ill. Indeed, their inattention to actual care is startling. America, for all its technological advancement, has among the lowest adoption of cost-saving, care-improving, electronic records in the world. That is the fault, in part, of our insurers. . . .
Given those incentives, insurers cannot compete to offer better care, because if they offered better care, all that would happen is they would attract worse deals. Which is why, in the current system, insurers make things worse. Tyler Cowen has a vision for how insurers could, in a more perfect world, compete to our benefit. And I don't necessarily disagree with it. But let's be clear on what's necessary:
- Universality: Insurers cannot compete effectively unless everyone is in the pool. If the healthy can leave, insurers cannot compete to offer better care. They'll have to compete to attract the healthiest, which means offering the lowest costs, which means insuring the fewest sick people. The system has to be universal.
- Community Rating: Insurers cannot be allowed, before offering insurance, to use demographic subslicing to cherrypick the market. That means no more preexisting histories, no complex formulas around age and income and race and region. They offer insurance to anyone who wants it for the exact same price. No exceptions.
- Risk Adjustment: Merely having everyone in the system won't be enough, and nor will forcing insurers to do away with their most delicate cherrypicking tools. Insurers will just become sophisticated at advertising on G4 Tech TV, and in snowboarding magazines, and in urban centers -- in places, in other words, where the young and the healthy gather. So atop the universal system, atop the community rating, you need risk adjustment, which means either that insurers are reimbursed more for taking on sicker patients, or, my preferred method (and the one used in Germany), insurers with particularly healthy pools pay into a central fund that redistributes to insurers with less healthy pools. At the end of the day, it has to be as profitable for an insurer to insure a sick person as a healthy one.
- Information Transparency: It needs to be easy for individuals to compare insurers on plan comprehensiveness, price, outcomes, etc. That means we need a marketplace where folks can go to shop for insurers, and they need to have standardized comparisons, or non-partisan rating authorities, providing information they can use.
- One Market: This is contained in the last point, but there needs to be a singular place, or set of them, where individuals can shop around for insurance. This is hard stuff to find, and harder yet to understand, and real effort needs to go into constructing an easily accessible marketplace that customers can effectively navigate.
There are probably more, but those are the major ones. It's not impossible to imagine a scenario in which insurers actually compete to offer better service, in which the marketplace really does work to the consumer's benefit. That could take a million different forms, from personalized care coordinators to electronic records to online access to your health information to negotiated discounts on gym memberships to a million things I haven't thought of. But none of them happen with any sort of frequency now because insurers operate in a perverse market in which their incentives are to make the system, and our care, worse.
Tuesday, February 12, 2008
The LA Times reports on doctors in California refusing to comply with a request from Blue Cross of California that they provide information on a patient's pre-existing condition. Lisa Girion writes,
The state's largest for-profit health insurer is asking
physicians to look for conditions it can use to cancel their new patients' medical coverage. Blue Cross of California is sending physicians copies of health insurance applications filled out by new patients, along with a letter advising them that the company has a right to drop members who fail to disclose "material medical history," including "pre-existing pregnancies."
Any condition not listed on the application that is discovered to be pre-existing should be reported to Blue Cross immediately," the letters say. The Times obtained a copy of a letter that was aimed at physicians in large medical groups.
The letter wasn't going down well with physicians. "We're outraged that they are asking doctors to violate the sacred trust of patients to rat them out for medical information that patients would expect their doctors to handle with the utmost secrecy and confidentiality," said Dr. Richard Frankenstein, president of the California Medical Assn.
Patients "will stop telling their doctors anything they think might be a problem for their insurance and they don't think matters for their current health situation," he said. "But they didn't go to medical school, and there are all kinds of obscure things that could be very helpful to a doctor."
WellPoint Inc., the Indianapolis-based company that operates Blue Cross of California, said Monday that it was sending out the letters in an effort to hold down costs. "Enrolling an applicant who did not disclose their true condition (and the condition is chronic or acute), will quickly drive increased utilization of services, which drives up costs for all members," WellPoint spokeswoman Shannon Troughton said in an e-mail. . . .
The California Medical Assn. sent a letter to state regulators Friday urging them to order Blue Cross to stop asking doctors for the patient information, saying it was "deeply disturbing, unlawful, and interferes with the physician-patient relationship." . . .
Lynne Randolph, a spokeswoman for the state Department of Managed Health Care, said the agency would review the letter. Blue Cross is fighting a $1-million fine the department imposed in March over alleged systemic problems the agency identified in the way the company rescinds coverage. A spokesman for state Insurance Commissioner Steve Poizner said the Insurance Department had not received any complaints about Blue Cross' letter. But because the medical association had sent a copy of its complaint to the department, the letter is "on our radar now," spokesman Byron Tucker said.
The letter is "extremely troubling on several fronts," Tucker said. "It really obliterates the line between underwriting and medical care. It is the insurer's job to underwrite their policies, not the doctors'. Doctors deliver medical care. Their job is not to underwrite policies for insurers."
, executive director of HealthAccess California, a healthcare advocacy organization, said the letter had put physicians in the "disturbing" position of having to weigh their patients' interests against a directive from the company that, in many cases, pays most of their bills.
"They are playing a game of 'gotcha' where they are trying to use their doctors against their patients' health interests," Wright said. "That's about as ugly as it gets."