Different River

”You can never step in the same river twice.” –Heraclitus

February 13, 2008

Only 40% of doctors and nurses wash their hands?

Filed under: — Different River @ 10:50 am

From the AP, via David Williams’ Health Business Blog:

Turns out installing alcohol-based handwashing gel dispensers in hospitals and encouraging staff to use them isn’t enough to prevent infections. … The issue was studied at a hospital in Nebraska, where gel use doubled but infection rates didn’t budge. It’s not surprising to learn that one tactic isn’t sufficient to control infections. Still, whenever I read about the poor record of hospital safety and quality it makes me mad. From the Associated Press:

More gel dispensers were put in the units, and usage rose from 37 percent to 68 percent in one unit and from 38 percent to 69 percent in the other. Compliance for hand washing of any kind in most hospitals is estimated to be about 40 percent, according to experts, although some hospitals do better.

Can you imagine a 40 percent compliance rate in any other business besides health care?

  • Pilots going through their pre-flight checklists completely 40 percent of the time?
  • Accountants calculating profit and loss correctly 40 percent of the time?
  • Hamburger flippers putting all the ingredients on a Whopper 40 percent of the time?

No way. We shouldn’t tolerate it in health care either.

(Boldface added.)

“Don’t treat the old and unhealthy”

Filed under: — Different River @ 10:43 am

News from the (British) National Health Service (NHS), which is the UK’s universal health care system:

Don’t treat the old and unhealthy, say doctors

By Laura Donnelly, Health Correspondent
Last Updated: 2:09am GMT 28/01/2008

Doctors are calling for NHS treatment to be withheld from patients who are too old or who lead unhealthy lives.

Smokers, heavy drinkers, the obese and the elderly should be barred from receiving some operations, according to doctors, with most saying the health service cannot afford to provide free care to everyone.

Fertility treatment and “social” abortions are also on the list of procedures that many doctors say should not be funded by the state.

The findings of a survey conducted by Doctor magazine sparked a fierce row last night, with the British Medical Association and campaign groups describing the recommendations from family and hospital doctors as “out­rageous” and “disgraceful”.

About one in 10 hospitals already deny some surgery to obese patients and smokers, with restrictions most common in hospitals battling debt.

Managers defend the policies because of the higher risk of complications on the operating table for unfit patients. But critics believe that patients are being denied care simply to save money.

Nice to see that in a universal health care system, everyone has equal access to care, and no one is denied care just so the insurance companies can save money.

I’d like to see the presidential candidates comment on this!

December 12, 2006

Stem Cells from Live Babies in Ukraine

Filed under: — Different River @ 2:12 pm

As predicted, now researchers are reportedly using stem cells not (just) from embryos, but from born-alive infants killed for their stem cells. This according to the BBC, which (understatement alert!) is not exactly a right-wing news source. (Boldface in the original.)

Ukraine babies in stem cell probe

By Matthew Hill
BBC Health Correspondent
Tuesday, 12 December 2006, 09:34 GMT

Healthy new-born babies may have been killed in Ukraine to feed a flourishing international trade in stem cells, evidence obtained by the BBC suggests.

Disturbing video footage of post-mortem examinations on dismembered tiny bodies raises serious questions about what happened to them.

Ukraine has become the self-styled stem cell capital of the world.

There is a trade in stem cells from aborted foetuses, amid unproven claims they can help fight many diseases.

But now there are claims that stem cells are also being harvested from live babies.

Wall of silence

The BBC has spoken to mothers from the city of Kharkiv who say they gave birth to healthy babies, only to have them taken by maternity staff.

In 2003 the authorities agreed to exhume around 30 bodies of foetuses and full-term babies from a cemetery used by maternity hospital number six.

One campaigner was allowed into the autopsy to gather video evidence. She has given that footage to the BBC and Council of Europe.

In its report, the Council describes a general culture of trafficking of children snatched at birth, and a wall of silence from hospital staff upwards over their fate.

The pictures show organs, including brains, have been stripped – and some bodies dismembered.

A senior British forensic pathologist says he is very concerned to see bodies in pieces – as that is not standard post-mortem practice.

It could possibly be a result of harvesting stem cells from bone marrow.

Hospital number six denies the allegations.

July 24, 2006

A Cure for Alzheimer’s Disease?

Filed under: — Different River @ 10:36 pm

I’m checking around to see if anyone I know can verify if this is for real. (Translation: I sent an e-mail to one guy I know who used to do research in this field.) If you have any insights or information, please chime in by posting a comment.

This is from the Herald-Sun of Melbourne, Australia:

New hope for Alzheimer’s cure

By Robyn Riley, July 23, 2006

In a world first, Melbourne scientists have developed a once-a-day pill that they claim may cure Alzheimer’s disease. Human trials of the drug start next month.

The drug — called PBT2 — was developed by a team from the Mental Health Research Institute of Victoria in collaboration with Melbourne-based Prana Biotechnology.

“It is a major breakthrough and very much a Melbourne discovery,” said Prof George Fink, the director of the Mental Health Research Institute.

“Though much depends on the next phase of human clinical trials . . . early results indicate this drug offers hope to people with Alzheimer’s disease,” he said.

The revolutionary drug stops the buildup of a protein called amyloid.

Many scientists accept amyloid is a major cause of Alzheimer’s as the protein is thought to cause the brain to “rust”.

Prof Fink said the drug could significantly prevent Alzheimer’s developing or delay the on-set of the brain disease for many years.

Early clinical testing has confirmed the drug is fast-acting. Levels of amyloid dropped by 60 per cent within 24 hours of a single dose.

It found also that PBT2 suppresses the impairment of memory function.

More human studies begin in Sweden next month and Australians will join a major international trial of the drug next year.

Alzheimer’s is a progressive and fatal brain disease. It is the major form of dementia, a disease that affects one in four Australians over the age of 60.

Prof Fink said the institute was optimistic about the results of clinical trials and said the drug could be on the market within four years.

(Hat tip: Slashdot)

The “John Stossel question” is, how many people will suffer, die, or go beyond the point of help in those four years it takes to get the drug through regulatory hurdles? I’m not saying I’d take the drug on the say-so of a newspaper article, but that seems and awfully long time to test a drug for a disease that can be fatal or completely debilitating within four years, or even less. Especially when you consider that the drug has already passed Phase I clinical trials — that is, it has already been found to be safe.

So if it’s not likely to hurt people, and no other effective treatments are available, what is the problem with making the drug available now, to patients willing to take it without the Phase II trials showing whether it works or not?

May 31, 2006

Saved by a Defibrillator Salesman

Filed under: — Different River @ 12:13 am

Thanks to a reader for alerting me to this story, which is almost too good to be true:

ST. PETERS, Mo. — A driver who suffered a heart attack and crashed into a guardrail was saved by a defibrillator salesman and two nurses who happened to be passing by.

The salesman, Steve Earle, was transporting an automated external defibrillator, a device used to shock the heart into a normal rhythm.

This article has some more details, if less dramatic wording:

Four people stopped to help her. Two of them were registered nurses. A third was Steve Earle, who makes a living selling automatic external defibrillators, the devices used to shock a patient’s heart into a regular rhythm.

It was kind of crazy luck that it was me with the device and two nurses that were three of the first four on the scene,” Earle said.

Earle grabbed the defibrillator he uses for demonstrations and rushed to help. Meanwhile another motorist used a trailer hitch to break out the rear passenger window of Holt’s car, unlocked the front passenger door and dragged her to the pavement.

The two nurses – Mary Blome and a woman identified only as Laurie – started cardiopulmonary resuscitation, but Holt wasn’t breathing. Earle and one of the nurses hooked Holt up to the defibrillator and delivered a shock. Holt got a pulse back, and St. Charles County paramedics rushed the woman to the hospital.

She underwent surgery Tuesday to have an automatic internal cardiac defibrillator implanted and is expected to fully recover.

She’s got one built-in now, so she doesn’t have to depend on another defibrillator salesman to happen by if she ever has another heart attack. There’s gratitude for you! ;-)

Seriously, though — it’s really good to have one of these things around if you can swing it. It is probably worth having if you run an establishment with large numbers of people — or to have at home if you are have enough of risk of a heart attack, but not enough to get the built-in version. Amazingly, you can buy these things on Amazon.com — here’s a home model, another home model (with free carrying case!), and another model, I guess for when you’re not home. They start at $1,135, which I’m sure is a tenth or a hundredth of what the hospital versions cost a few years ago.

Marty Limpert, spokesman for the St. Charles County Ambulance District, said Tuesday he hopes the $1,400 devices will become as common at places of business as fire extinguishers.

And oh yes — get a fire exthinguisher, too. They’re a heckuva lot cheaper, and they can save your life, too. I have one for the kitchen, one for the room with the fireplace, and one for the car. If I could convince Different Wife, I’d have one for the van, too….

May 23, 2006

Canada Kills

Filed under: — Different River @ 6:32 pm

David E. Williams writes on the Health Care Business Blog:

A friend in Canada felt so sick that when she went to the hospital on Thursday she told the staff that she felt even worse than she had immediately after her two surgeries. They sent her home with instructions to follow up next Tuesday (tomorrow). By Saturday she felt even worse. Ambulance dispatch told a friend who called to expect an ambulance in 3 hours –the timing based on the perceived severity of the symptoms. The friend took her to the ER instead, where she was promptly taken into the ICU. But it was too late; she is in a coma and will almost certainly succumb to pneumococcal meningitis.

She died the next day.

She died because by Canadian standards, she was not sick enough to deserve a place in the hospital.

And lots of people here in the U.S. want us to adopt the Canadian system.

By the way, they are supposed to transplant her kidneys and liver. Someone is going to get some sort of brownie points for acquiring those organs. Would I be too cynical if I said the incentives to save a patient’s life are reduced when one benefits from that patient’s death?

May 18, 2006

Yes, I’m Still Alive

Filed under: — Different River @ 1:42 am

Not one, but two readers have written to ask what happened to me. The answer is: I’m OK, and I’m (unfortunately) not on vacation.

I’m just very busy at work. New Medicare payment rules are out for the next rate year, and we are busy calculating how much les our clients will be paid. So they can complain to their Congresspeople, I imagine. This is what replaces “marketing” when an industry is paid by the government for half its output.

I do have lots to say, though — as soon as I can find time to type it all in.

Unfortunately, I’m not a professional blogger. The ads below the blogroll on the right don’t even cover the costs — which fortunately are quite low. Of course, if anyone would like to “sponsor” a full day of blogging by replacing a day’s salary while I take a day of “leave without pay” I’m sure we can work something out. Heh. ;-)

March 29, 2006

Biased Health Care Advice

Filed under: — Different River @ 2:39 pm

The Health Care Business Blog quotes MedPage Today:

Men trying to decide how to have their localized prostate cancer treated may get incomplete or biased advice from both physicians and patient-education materials, a review of the literature suggested.

For example, urologists nearly universally indicate that surgery is the optimal treatment strategy, and radiation oncologists similarly indicate that radiation therapy is optimal, said Scott D. Ramsey, M.D., Ph.D., of the Fred Hutchinson Cancer Research Center here, and colleagues.

This should not be a surpirse. If your only tool is a hammer, every problem looks like a nail.

These doctors are not necessaily recommending their own treatment to feather their own nests; they are just recommending what they know. It is human nature to look at a problem and see how you can solve it, rather than how it is best solved. Plus, it’s natural caution not to recommend things with which one is less familiar.

The lesson is that patients have to take an active role in determining their own medical treatment. Your doctor is your partner in this, not your commanding officer. Before taking drastic treatment, ask the doctor to justify his/her recommendation, find out about other options and ask politely why they aren’t appropriate (maybe they are and the doctor just didn’t think of them; I’ve had this happen), and above all, use your brain.

It doesn’t hurt to have some basic knowlege of statistics, and to be able to read those inserts that come with your prescription drugs.

February 3, 2006

Paul Krugman and VA Health Care

Filed under: — Different River @ 4:46 pm

Several blogging economists seem to have made a cottage industry debunking the New York Times columns of (formerly-respected?) economist Paul Krugman. Now, I guess it’s my turn. Krugman writes:

I know about a health care system that has been highly successful in containing costs, yet provides excellent care. And the story of this system’s success provides a helpful corrective to anti-government ideology. For the government doesn’t just pay the bills in this system — it runs the hospitals and clinics… our very own Veterans Health Administration, whose success story is one of the best-kept secrets in the American policy debate. … This high level of quality (which is also verified by objective measures of performance) was achieved without big budget increases. In fact, the veterans’ system has managed to avoid much of the huge cost surge that has plagued the rest of U.S. medicine.

The secret of its success is the fact that it’s a universal, integrated system.

Now the first paragraph has a grain of truth to it, but that last sentence is pure grandstanding. And what comes next is completely false:

Because it covers all veterans, the system doesn’t need to employ legions of administrative staff to check patients’ coverage and demand payment from their insurance companies.

This is completely false. It does not cover all veterans, and it does have “legions [pun intended?] of administrative staff to check patients’ coverage.” They have an entire web site devoted just to eligibility which states, in part “All Veterans are Potentially Eligible” (emphasis mine). There is an eight-level system of “priority” detailed here. It has categories like, “Veterans with service-connected disabilities rated 30% or 40% disabling” (priority 2) and “Veterans who agree to pay specified copay with income and/or net worth above VA Income Threshold and income below the Geographic Means Test Threshold” (priority 7 — which has FOUR “subpriorities,” only two of which are
currently in use).

Does Paul Krugman really believe they can determine eligibility under such complete rules with fewer administrative staff than it takes another health system just to look at someone’s ID card and take down their policy number?

In fact, the real “secret of its success” is the fact that, unlike other government health care systems, they get to pick their patients, and can limit the number of patients based on their budget. Contrary to popular belief — and Krugman’s statment — not every military veteran is in the VA system — the VA sets those eligibility requirements in order to make sure that the number of patients they have is limited to what thay can fit within their budget. In fact, only a minority of former military personnel are in the VA system.

Now, to be fair, Krugman does say one thing that is true and perhaps not so well-known:

Because it’s integrated, providing all forms of medical care, it has been able to take the lead in electronic record-keeping and other innovations that reduce costs, ensure effective treatment and help prevent medical errors.

They really do have a truly state-of-the art record-keeping system, and they actually do use it to save money. For example, if they get a deal on some drug (say, Nexium), they can switch nearly everyone on therapeutic equivalents (say, Protonix) within 90 days. All they do is send a message to every doctor who prescribed Protonix, given them a list of patients to whom they’ve prescribed it, and ask for approval to switch them to Nexium. It’s not mandatory, since everyone knows that two “therapeutic equivalents” are not really equivalent for ALL patients — but they say that about 95% of the patients switch.

Krugman also quotes someone who knows something true:

Moreover, the V.H.A., as Phillip Longman put it in The Washington Monthly, “has nearly a lifetime relationship with its patients.” As a result, it “actually has an incentive to invest in prevention and more effective disease management. When it does so, it isn’t just saving money for somebody else. It’s maximizing its own resources. … In short, it can do what the rest of the health care sector can’t seem to, which is to pursue quality systematically without threatening its own financial viability.”

In the private sector, the “churn” of people in and out of health insurance companies
makes it so that if an insurance company spends on preventative care, by the time the patient is around long enough to avoid a disease as a result, they are quite likely to be insured with another company. So you have a muted version of the classic “tragedy of the
commons” — you pay for preventative care, and some other company benefits from lower costs.

Think about it: If it weren’t for the “churn,” health insurance companies wouldn’t just cover preventative care — they’d require it. And they’d probably even require (say) blood tests to make sure you’re taking your preventive drugs (like blood pressure medicine). (Assuming preventative care is actually cost-effective, of course.)

(Hat tip: Tyler Cowen and Brad DeLong and Arnold Kling.)

December 29, 2005

Government Micromanagement

I find it quite curious and fascinating (in a morbid sort of way) that the same side of the political aisle that is so eager to “get the government out of the bedroom” when it comes to things like abortion and homosexuality, is so eager to set up a government-run and government-paid-for health care system, which will put government into not only your bedroom, but your kitchen, living room, and anywhere else you go.

As Coyote Blog puts it, it’s a “Health Care Care Trojan Horse“:

I get email and comments from time to time that my language deriding government’s intervention into every aspect of our lives is overblown and exaggerated. My answer: Oh yeah, well how about this:

Mike Huckabee, the Governor of Arkansas, now requires annual fat reports. These are sent to the parents of every single child aged between 5 and 17; a response, he says, to “an absolutely epidemic issue that we could not ignore” in the 1,139 schools for which he is responsible.

As I have argued many times in the past, a large part of the blame for these initiatives is public funding of health care. Beyond the efficiency and choice arguments, I have tried to point out that publicly funded health care is a Trojan horse for a number of truly intrusive nanny-state government controls of our lives.

When health care is paid for by public funds, politicians only need to argue that some behavior affects health, and therefore increases the state’s health care costs, to justify regulating the crap out of that behavior. Already, states have essentially nationalized the cigarette industry based on this argument.

And later he writes:

The logic is that by paying for your health care, the government can argue it has a financial interest in your not eating fatty foods, not smoking, wearing a bike helmet, exercising, etc, decisions that would otherwise only affect the individual themself.

For those who often accuse me of exaggerated paranoia when it comes to government intervention, check out this from the UK:

People who are grossly overweight, who smoke heavily or drink excessively could be denied surgery or drugs following a decision by a Government agency yesterday. The National Institute for Health and Clinical Excellence (Nice) which advises on the clinical and cost effectiveness of treatments for the NHS, said that in some cases the “self-inflicted” nature of an illness should be taken into account.

Sorry, but I told you so. What’s next? Is an unwanted pregnancy “self-inflicted”? How about an STD from unprotected sex?

Well, there’s a way to get the Left’s attention…

December 21, 2005

“Botax” update

Filed under: — Different River @ 7:55 pm

Almost a year ago, I posted a story about how some states were considering taxing Botox injections and other cosmetic procedures.

My point at the time was that taxing something like that is not really a very good way to generate tax revenue, since anyone who can afford to get Botox can also afford not to get Botox. It’s similar to the case in 1990 when Congress imposed a 10% tax on luxury yachts — and instead of raising money, they caused unemployment, when yacht sales dropped 90% and yacht-building workers were laid off.

Now, the Sacramento Bee is reporting that doctors and “patient advocates” in California are raising another issue:

More than three dozen consumers, businesses and health groups sent that message to the [California] Board of Equalization this month after the state agency raised the idea of a sales tax on the popular wrinkle treatment.

In letters to the Sacramento-based board, Californians argued that medicines like Botox should never be taxed because such a move might open the door to taxes on other drugs and even medical procedures.

“Even a healthy individual like me can see the problems inherent in looking to medicines as a way to raise sales tax revenue,” wrote Kimberly Jenkins, a Woodland resident who said she is against a Botox tax.

“There’s no guarantee that a person whose election depends on getting the budget under control is going to make sound decisions about what medicines to tax,” added Jenkins.

(And how, exactly, is that different from taxes on anything else? ;-) )

That request came after state tax auditors started asking dermatologists why they hadn’t charged sales tax on Botox treatments for cosmetic purposes since 2002, the year the substance was approved by the Food and Drug Administration for cosmetic treatments.

Doctors argued that prescription medicines were exempt from sales tax, but auditors pointed to state regulations specifying that the exemption applies only if medicines are used to treat “disease,” not to erase wrinkles for cosmetic purposes.

A lobbyist for the physicians raised concerns about tax auditors peering at confidential patient files, asking what expertise the auditors had to decide which treatment was cosmetic and which was medical.

“I don’t believe legislators are better able than doctors to decide which prescription medicines are necessary,” Villarreal wrote. “We Californians are already paying very high taxes, and certainly some of the most expensive health care costs in the country.”

(If that last argument is right, what business do legislators have telling us which medicines are legal? How do they know that, say, Vioxx is too dangerous but Celebrex isn’t? What, because they created an FDA run by doctors and scientists? Well, they also created a Board of Equalization which, in theory, can hire whatever experts they want.)

Sales of the drug have exploded and have come close to hitting $1 billion a year since the FDA authorized its use for cosmetic treatments three years ago. While that could make a nice tax revenue generator for the Golden State, it also could affect sales of the product.

(A rare correct use of economics in a news story! Though it would have been nice to explain it so people without a college course in economics would know why it could affect sales of the product. I bet a lot of this reporter’s colleagues don’t know!)

November 25, 2005

Will the FDA kill Brian White?

Filed under: — Different River @ 2:54 pm

Brian White, of Fairfax, Virginia, is hoping to survive long enough for the FDA to allow him to be treated. Here’s an excerpt of the story in The Fairfax Times:

Battling a rare disease

By Frank Mustac

His breathing is shallow and deliberate, but, despite a constant struggle to fill his lungs, Brian White is determined to keep up with his young sons playing at the basketball hoop outside his home in Fairfax’s Kings Park West neighborhood.

But with each breath White takes, the slender-framed 42-year-old husband and father of two is even more determined to stay healthy long enough to receive a yet-unavailable but promising new treatment for the rare neuromuscular disorder he has.

In 2002, after two and a half years of misdiagnoses, White was finally diagnosed correctly at Johns Hopkins in Baltimore with Pompe disease, a disorder that affects only about 5,000 people in the United States.

Pompe is caused by a deficiency of an enzyme responsible for breaking down glycogen, a form of sugar stored in the muscle cells throughout the body. This buildup inside cells causes muscle fibers to expand and leak, leading to muscle weakness that becomes more severe over time and can often be fatal.

Now, along with his job as a regulatory expert for a gas pipeline company, White has kept busy as a vocal advocate, despite the sound of his voice, doing all he can as a patient to help win approval by the Food and Drug Administration for a new enzyme replacement therapy for the treatment of Pompe.

Developed by Genzyme, a Massachusetts-based company, the firm earlier this year submitted an application to the FDA for both the adult and infant therapies, White said. A response from the FDA is expected sometime next year.

What is the reason for the delay here? Every day the FDA delays action, Bryan White and 5,000 other people are one day closer to being so sick they can’t be treated. No doubt many of these people will die, untreated, waiting for FDA approval.

This is not like people who die waiting for organ transplants, or people who die waiting for a treatment to be invented. These people are dying waiting for a signature on a piece of paper.

Why is this? In 1962, Congress passed the Kefauver-Harris Amendments, which changed the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any drug that had not been determined by the FDA to be “safe and effective.” The law didn’t say how the FDA was to determine that, so the FDA prescribed a long, complex, and expensive process that companies must go through before the FDA approved their drugs. Prior to 1962, the requirement was the that the FDA find the drug “safe” — and furthermore, the FDA has 180 days to act on a drug application, after which, if it was not unsafe, it could be sold. The 1962 amendments removed the 180-day limit, added the “effective” requirement, and set the stage for thousands of people to die while the FDA spends years processing each new drug application. The FDA’s own history of itself calls this, “a milestone advance in medical history.”

One can only ask what kind of a “milestone” this is when applied to a treatment for a fatal disease for which no other treatment is available. What is “effective”? Without treatment, the patient dies. There is no treatment other than the one current candidate. How could any treatment be less effective than this? If the treatment saves 5% of the patients, is that “effective”? Surely not, by the FDA’s standards — nor anyone else’s. But if the alternative is to save 0% of the patients by having no treatment available, should the FDA stand in the way?

And what about safety? Again, without treatment, the patient dies. What treatment could be less safe than that? Perhaps they will die faster — but this is the sort of thing that can be ruled out fairly easily in animal tests, and anyway the safety hurdle is not what holds up most drug applications; it’s the efficacy requirement. Indeed, the Genzyme treatment has already passed the FDA’s initial safety hurdle, since recruiting for clinical trials is already underway.

If the FDA were operating under the pre-1962 rules, Brian White and many of the 5,000 other people with Pompe disease would be receiving treatment, rather than fighting to be among the few included in clinical trials.

But they can’t do that; they’ve been forced to become lobbyists:

Back in September, White and four other Pompe patients he met through Internet support groups and on Web sites containing detailed information about the disease, spoke with FDA officials to convey the severity of the ailment from a patient perspective. He also appeared in a recently completed video of Pompe patient testimonials.

White said he hopes the FDA will convene a patient advisory committee during the approval process and that members of Congress will use whatever influence they have with the agency to win approval.

As time goes on, White said his advocacy work has become more important, primarily because of his concern for others with Pompe in worse shape than him.

“Just that hope of a better chance is something we’d all jump on,” he said.

Just the hope of a better chance — a hope that, under current regulations, depends on the whims of members of Congress to use “whatever influence they have” with an overloaded agency. And all they are being asked to do is remove a barrier to treatment that they themselves — both Congress and that agency — have erected.

I’m sure most of the FDA’s employees are hard-working scientists, doctors, and bureaucrats who do the best they can with what they’ve got. But these are human beings we’re talking about. In addition to processing millions of pages of material for every new drug application, they have their own lives to live — they have to get their oil changed, mow their lawn, drive their kids’ carpools, take out the garbage, and do all sorts of other things that will not be the impacted in the least if some patient they never heard of dies because some piece of paper is sitting on their desks.

The problem is the fact that Congress and some bureaucrats decided a long time ago that people ought to die if those papers are still on those desks.

November 24, 2005

Will the FDA pull a drug that kills women?

Filed under: — Different River @ 5:34 pm

Not if NOW or Planned Parenthood has its way.

It seems that Mifeprex (the “abortion pill” also known as “RU-486″ and “mifepristone”) has been killing women. No, not just the fetal women (and men) it was designed to kill, but the women who take it. As the New York Times reports (emphasis added):

[F]our women in this country who died after taking an abortion pill suffered from a rare and highly lethal bacterial infection, a finding that is leading to new scrutiny of the drug’s safety.

Since all four deaths occurred in California, an unusual clustering, the Food and Drug Administration quietly tested to see if abortion pills distributed in California were somehow contaminated. They were not.

Stumped, officials from the F.D.A. and the federal Centers for Disease Control and Prevention have decided to convene a scientific meeting early next year to discuss this medical mystery, according to two drug agency officials who spoke on the condition of anonymity because of the sensitivity of the topic.

Among other issues, the experts hope to explore whether the abortion pill, called Mifeprex or RU-486, somehow makes patients vulnerable to an infection with Clostridium sordellii, the lethal bacteria. If so, they will explore how such an infection “could be more easily diagnosed and even prevented,” one official said.

Monty Patterson, whose daughter Holly died on Sept. 17, 2003, less than a month after her 18th birthday, said he believed that Mifeprex inhibits the immune system, making women more vulnerable to bacteria.

Mr. Patterson’s campaign against Mifeprex helped persuade the family of at least one other woman who died to have tissue samples tested for the presence of the rare bacteria, he said.

“I believe this drug should be taken off the market,” Mr. Patterson said.

For now, there is no indication that the F.D.A. is considering restricting access to the drug. Indeed, it has advised doctors against giving antibiotics as a precaution to prevent the rare infections since antibiotic therapy carries its own risks.

Mifeprex has been used in more than 500,000 medical abortions in the United States since its approval in September 2000. The risks of death from infection after using the pill are similar to the risks after surgical abortion or childbirth, said Dr. Steven Galson, director of the F.D.A.’s center for drugs.

Warnings about the drug’s possible link with Clostridium sordellii were placed on Mifeprex’s label in July, and the drug agency without announcement updated this information on its Web site on Nov. 4 after it discovered that all of the deaths involved the lethal bacteria.

Ms. Patterson died seven days after taking Mifeprex. She lived in Livermore, Calif.

On Dec. 29, 2003, Vivian Tran, 22, of Costa Mesa, Calif., died six days after taking Mifeprex.

On Jan. 14, 2004, Chanelle Bryant, 22, of Pasadena, Calif., died six days after taking Mifeprex. And on May 24, 2005, Oriane Shevin, 34, of Los Angeles died five days after taking Mifeprex.

In each case, Clostridium sordellii infected the women’s uteruses, flourished and then entered their bloodstreams. The bacterium can cause nausea, vomiting, diarrhea and weakness but may not induce fever, so victims often fail to realize how sick they are until it is too late and succumb to toxic shock. Antibiotics are often ineffective once an infection has flourished because even in death, the bacteria release toxins.

The families of Ms. Patterson, Ms. Tran and Ms. Bryant have all filed suit against Danco, claiming the company failed to warn patients of the drug’s dangers.

A woman who died in Canada after taking Mifeprex during clinical testing in 2001 also suffered from a Clostridium sordellii infection. …

Wendy Wright, executive vice president of Concerned Women for America, a conservative group, said that the latest news about deaths involving Mifeprex proved that the drug was unsafe. Ms. Wright also speculated that more women were dying after using the drug but that their deaths were going unreported.

“I’m pleased that the F.D.A. is taking a serious look at this,” she said, “and hope that they will no longer allow this drug to be available to cause the deaths of more women.”

Dr. Scott J. Spear, chairman of the national medical committee of the Planned Parenthood Federation of America, the nation’s largest provider of abortions, said there was no evidence that the vaginal administration of misoprostol increased the risks of bacterial infections.

No, four dead women is “no evidence” when a political drug is involved. It only took three deaths to get Vioxx off the market, and that was a drug given to millions more people, mostly older people who have a greater risk of death than 18- to 22-year-old women, even in the absense of any drug. And there is no known mechanism by which Vioxx can cause death either.

One might ask, if there’s a problem with Mifeprex, why didn’t the FDA find it in testing? The reason is, Mifeprex was exempted from the usual standards the FDA uses to approve drugs. First, on his third day in office, President Clinton issued an executive order directing the Secretary of Health and Human Services to allow the importation of the drug for personal use, and to “promptly” “promote” the manufacture of the drug in the United States:

I direct that you immediately take steps to rescind Import Alert
66-47 [which barred the importation of unapproved RU-486].

In addition, I direct that you promptly assess initiatives by which the Department of Health and Human Services can promote the testing, licensing, and manufacturing in the United States of RU-486 or other antiprogestins.

Of course, we all “know” it was pure coincidence that the FDA gave its preliminary approval (subject to resolving labelling issues) in September 1996, during a presidential campaign, and final approval in September 2000, during the next presidential campaign.

You might think that the National Organization for Women might be interested in investigating the safety of this drug that kills only women. But you would be wrong — they are focusing their FDA-lobbying efforts on preventing women from exercising their right to control their own bodies. (See my previous post on that topic.)

October 17, 2005

Abrogating Patents?

Filed under: — Different River @ 5:14 pm

Some people (including, but not limited to, Stephen Gordon and Andrew Sullivan) have suggested that the U.S. government abrogate the patent on the antiviral drug Tamiflu to produce enough doses to be ready in case there is an outbreak of avian flu.

This is a very bad idea — not because of the practical limits of Tamflu, but mainly because (a) the U.S. government does not exactly have a drug facgtor lying around ready to make the stuff, and (b) this would basically guarantee that no company would bother inventing drugs for any infectious disease again. After all, why bother making something if the government is just going to come and take it whenever enough people need it to make it profitable?

This doesn’t mean there aren’t things the government can do. I don’t have time for a full-length post on this right now, but Tyler Cowen has a number of suggestions for things to do, all of which are good if it’s physically possible for Roche to produce a huge amount of Tamiflu in a short period of time. (Note for the record: Most of the comments on that post are seriously wrong-headed.)

Looking long-term, one of the problems with this is that flu vaccines take about 4 months to produce (they are grown in eggs), in a process that’s been around for a long time, probably since before the FDA started regulating vaccine production methods. I’ve read that there’s a faster method, but the FDA is taking forever to act on the application for approval (I’ll try to find a link later this week).

There is also the vaccine liability issue — basically, if you make a vaccine and the all 300 million people in the U.S. are vaccinated, and any of them get sick with anything in the near future, it’s your fault. (This is why the flu vaccine has a warning about Guillain-Barre Syndrome — in 1976 there was a massive vaccination against a flu epidemic and a few people got Guillain-Barre Syndrome afterwards. It was the about the same number of people that get it every year, but this time there was a flu vaccine, so they all sued.)

I’ll try to post more on this later, but now I’m going offline for a couple of days for the star of Sukkot — and I have huge stack of work waiting for me when I get back. See you Thursday!

(Thanks toThe Glittering Eye for the pointer!)

July 21, 2005

Lester Crawford confirmed as FDA Commissioner

Filed under: — Different River @ 5:57 pm

The Senate has confirmed the President’s nomination of Lester Crawford, D.V.M., Ph.D. to be the new FDA Commissioner. Dr. Crawford has been acting commissioner since March 2004, when then-commissioner Mark McClellan, M.D., Ph.D. was appointed Administrator of Centers for Medicare and Medicaid Services (CMS).

Dr. Crawford is known as a food safety expert; he is also a veterinarian with a Ph.D. in pharmacology. Dr. McClellan is a respected health economist; he is a physician with a Ph.D. in economics. I doubt somehow that this will put to rest accusations that the Bush administration is a bunch of uneducated idiots, but it should.

(Trivia: Mark McClellan is a brother of White House spokesman Scott McClellan, and both are sons of Texas Comptroller Carole Keeton Strayhorn, who was also the first woman mayor of Austin and is now running for governor. There’s a fascinating story about her here.)

June 28, 2005

Doctor for Starvation

Filed under: — Different River @ 4:54 pm

Earlier I posted the story of Marjorie Nighbert, who was starved and dehydrated by court order (like Terri Schiavo), but in Nighbert’s case she was conscious, ambulatory, and begging for food — and had to be restrained to her bed to enforce the court and prevent her from raiding other patients’ food trays.

Recently that post has started to attract comments — specifically, comments from a practicing neurologist who says he sees this sort of thing happen “on a regular basis.” And, he strongly implies that he sees this as right and appropriate.

If you think these are isolated, extreme cases, go read those comments.

(I’m disabling comment on this post. If you have something to add, please add it to the comments on the earlier post.)

Now, there’s an excuse!

Filed under: — Different River @ 2:46 pm

If you’re overweight and looking for an excuse not to go to the trouble of losing weight, you can’t do better than this: An article in the journal PLoS Medicine finds that overweight people who intentionally lose weight have a higher mortality rate than overweight people who just stay overweight. In fact, those who lose weight even have a higher mortality rate than those who gain weight! (Although those with stable weight have the lowest mortality rate.)

The study surveys Finnish twins in 1975, and asked overweight people if they “intended” to lose weight. Their weight was re-checked in 1981, and their mortality was followed until 1999. To summarize the results:

Mortality Hazard Ratios
Lost Weight Stable Weight Gained Weight
Intended to Lose Weight 1.87 0.84 0.93
Did not intend to Lose Weight 1.17 1.00 1.58

In other words, an overweight person who intends to lose weight, and succeeds in doing so, is 87% more likely to die than an overweight person who makes no effort to lose weight, and in fact maintains a stable weight. However, an overweight person who intends to lose weight and fails to do so is slightly less likely to die than someone who never intends to lose weight in the first place. Those who have no intention of losing weight but do so anyway are have a slightly higher risk of mortality, but not nearly as much as those who lost weight on purpose. Those who have no intention of losing weight and in fact gain weight have a substantially higher risk — but still less than those who lost weight on purpose. In short, if this study is right, the worst thing for an overweight person to do is to try to lose weight and succeed; the best thing to do is to try to lose weight and fail. Not trying at all is somewhere in between.

Not only is this the best possible result for those who like excuses (“Doctor, I’m trying to lose weight, but I’m not succeeding and that’s good!”), it also flies in the face of most previous work in the field, which of course shows that losing weight (or at least, not being overweight) is good. The article is by actual scientists and appears in a peer-reviewed journal, so it cannot be dismissed out of hand. However, given the weight of the evidence (sorry for the pun!) on the other side of the question, it can’t be accepted uncritically, either.

I can think of several possible reasons why the authors might have found the results they did that would still leave the conventional wisdom mostly intact:

  • Perhaps those who are losing weight on purpose are doing dangerous things to accomplish the loss. For example, not all diets are safe, even if they are successful. (Three doctors told me that if the only way I could lose weight was to use the Adkins diet, I was better off staying fat.) Also, some people may exercise beyond their body’s capabilities in an effort to lose weight.
  • The study counted as overweight anyone with a body mass index (BMI) greater than 25. This is a fairly loose standard; while many experts say 25 is the “ideal” BMI, few would label as “overweight” someone with a BMI of 25.1. Yet, this study appears to do so. Furthermore, there is some evidence that the longevity-maximizing BMI is actually more like 26.5, rather than 25. In this study, less than 10% had a BMI greater than 30 (i.e., were “obese”), and in fact those included had a median BMI of 26.7 — and “losing weight” was defined as reducing BMI by at least 1. So for about half the people in the sample, losing weight meant moving away from the longevity-maximizing BMI — so we would actually expect an increase in mortality. So perhaps it’s not that losing weight is bad for people who are actually overweight — rather, the people in the sample weren’t overweight enough to benefit from weight loss, and many of those who lost weighted actually dropped below their ideal weight.
  • The statistical model they used controlled for sex, age, current smoking in 1981, hypertension, physical activity, life satisfaction, work status, and income. Patients with previous heart attacks, diagnosed angina, or diabetes as of 1981 were excluded. However, the model did not control for family history of these conditions, nor did it exclude people with these conditions. It is quite possible that family history of heart attacks and diabetes — both of which are correlated with obesity — could both increase the probability of death by 1999, and cause people to want to lose weight. In other words, patients in the study know their family history, and if it contains heart attacks or diabetes, they know they are at higher risk of death. They also know — or at least, believe — that the risk of these diseases can be reduced by losing weight. So they report an “intention” to lose weight. Among those who report an intention to lose weight, those with a family history of obesity-related diseases are more motivated to succeed, and thus over-represented among those who both intend to lose weight and actually do so. However, weight is only one factor in those diseases; even after losing weight they still have a higher risk of those diseases — and thus early death — than people without that family history (even if their risk is less than what it was when they were overweight). The study then finds that people who intend to lose weight and succeed have a higher risk of mortality. But it’s not that the weight loss is causing the mortality, it’s precisely the opposite: The higher risk of mortality is known to the patients in advance, and thus causes the weight loss. (This is what econometricians call “reverse causation;” in fact, a brief Google search confirms that this has occurred previously in research on weight loss.) The weight loss may reduce the risk of mortality, but if so it does not reduce it enough to bring it down to the level of the general population.
  • Participants were asked once — in 1975 — whether they “intended” to lose weight (and if so, how). The determination as to whether they had done so was made in 1981, when they were not asked whether they had carried out their intentions. Lots of things can change in six years. As an extreme example, someone who got cancer in 1978 (say) may have lost a lot of weight from the disease by 1981, and be more likely to die by 1999. Perhaps such a person, knowing about cancer risk, reported an intention to lose weight in 1975, but failed to do so — until getting cancer three years later. This is of course a purely hypothetical example — and purely speculative. The point I’m trying to make is that the data may be insufficient to draw conclusions about the link between weight loss and mortality.
  • Another possibility is that they just got a weird draw from a random distribution. If you look at enough studies, this is bound to happen. Analogy: If you flip 10 coins, it’s very unlikely that you’ll get 10 heads, or even 9 — but it is certainly possible. If you flip 10 coins once, there’s only a 1.07% chance that you get 9 or more heads. But if 500 people flip 10 coins each, there’s a 99.54% change that somebody gets 9 or more heads. It’s like that with these studies, too. Assume that the conventional wisdom is right — that weight loss actually does reduce mortality. Even if that’s true, it’s still random in individual cases — even if weight loss reduces mortality on average, some people are going to lose weight and die early anyway, and some people are going to stay fat and live a long time anyway. Not as many, but some. Now, if you do a study on weight loss and mortality, it’s like flipping coins — it’s very likely you are going to find data consistent with the theory. But if 500 people do studies like that, somebody is going to find data inconsistent with the theory. But if it’s just one or a few studies, that doesn’t mean the theory is wrong — any more than one person flipping 9 out of 10 heads means that the “theory” of coin-flipping produces a 50% chance of heads.

The complete article is here. There is also a synopsis, a “patient summary,” and a note on “perspectives” which raises some other issues with the study, none of which I think are as serious as the issues raised above. Personally, I think the most likely culprit is reverse causation.

Grand Rounds XL is up

Filed under: — Different River @ 12:00 am

Grand Rounds XL is up, hosted at the Health Business Blog — an interesting blog which I’ve just discovered, and will no doubt be reading regularly and quoting from.

June 23, 2005

Begging for Food, Starved by Court Order

Filed under: — Different River @ 8:00 pm

In the wake of the Terri Schiavo case and the recent autopsy report, it’s worth noting that Terri Schiavo’s state of consciousness was legally irrelevant to whether she could be starved to death or not. In 1995, Marjorie Nighbert was starved/dehydrated to death on the strength of a power of attorney, even though she was able to speak and literally begging for food.
As Wesley J. Smith wrote,

The worst of these cases of which I am aware is the tragic dehydration of Marjorie Nighbert. Marjorie was a successful businesswoman until a stroke left her disabled. She was unable to swallow safely, but not terminally ill. She was moved from Alabama to a nursing home in Florida where she would receive rehabilitation to help her relearn how to chew and swallow without danger of aspiration. A feeding tube was inserted to ensure that she was properly nourished during her recovery.

Marjorie had once told her brother Maynard that she didn’t want a feeding tube if she were terminally ill. Despite the fact that she was not dying, Maynard believed that she had meant that she would rather die by dehydration than live the rest of her life using a feeding tube. Accordingly, he ordered all of Marjorie’s nourishment stopped.

As she was slowly dehydrating to death, Marjorie began to beg the staff for food and water. Distraught nurses and staff members, not knowing what else to do, surreptitiously snuck her small amounts. One staffer — who was later fired for the deed — blew the whistle, leading to a hurried court investigation and a temporary restraining order requiring that Marjorie receive nourishment.

Circuit Court Judge Jere Tolton appointed attorney William F. Stone to represent Marjorie and gave him twenty-four hours to determine whether she was competent to rescind the general power of attorney she had given to Maynard before her stroke. After the rushed investigation, Stone was forced to report that Marjorie was not competent at that time. (She had, after all, been intentionally malnourished for several weeks.) Stone particularly noted that he had been unable to determine whether she had been competent at the time the dehydration commenced.

With Stone’s report in hand, Judge Tolton ruled that the dehydration should be completed! Before an appalled Stone could appeal, Marjorie died on April 6, 1995.

Indeed, the Washington Post reported on January 5, 1997,

Marjorie Nighbert, a 76-year-old Florida woman, was hospitalized in 1996 after a stroke. Before her hospital admission, she signed an advance directive that no “heroic measures” should be employed to save her life. On the basis of that directive and at the request of her family, the hospital denied Nighbert’s requests for food and water, according to reports in the Northwest Florida Daily News. A hurriedly convened hospital ethics committee ruled that she was “not medically competent to ask for such a treatment.” Until her death more than 10 days later, Nighbert was restrained in her bed to prevent her from raiding other patients’ food trays.

The legal theory on which Terri Schiavo was put to death was identical to that used for Marjorie Nighbert — not legally competent, and once said she wouldn’t want tubes.

June 15, 2005

New Treatment for Stroke

Filed under: — Different River @ 3:35 pm

Here’s something which looks to me like unalloyed good news. AstraZeneca has a drug called Cerovive in Phase III clinical trials which seems to have great promise for treating ischemic stroke. (An “ischemic stroke” is cause by a blood clot in the brain which cust off the flow of blood to a part of the brain, thus depriving it of oxygen. This is as opposed to a “hemorrhagic stroke,” in which a blood vessel in the brain ruptures, damaging the brain by internal bleeding. About 85% of strokes are ischemic.)

Right now, the best treatment for ischemic stroke is a drug called tPA, which can break up the blood clot and stop further damage. There are two drawbacks with tPA: First, to be effective it has to be given within 3 hours of the stroke. Second, while it’s great for ischemic strokes, it can make a hemorrhagic stroke worse by inhibiting the clotting necessary to stop the internal bleeding. This means doctors have 3 hours from the time of the stroke — which means even less time from the time the patient arrives in the emergency room — to both figure out that it’s a stroke and what type of a stroke it is, and administer the tPA.

It turns out, however, that much of the damage is cause not by the oxygen deprivation directly,

But much of the damage happens when brain cells, starved of oxygen, start churning out compounds that can actually be toxic.

If all goes well, Cerovive will be able to stop this type of damage. Furthermore, it seems to be effective up to six hours after a stroke, rather than three — and better yet, it seems to be as safe as a placebo. If my understanding of all this is correct, this means that Cerovive could be administered as soon as a patient shows up with stroke-like symptoms, since it wouldn’t do any damage if it turned out to be a non-ischemic stroke or something other than a stroke.

This all started in one lab over twenty years ago:

he work that led to Cerovive began almost twenty years ago, in the lab of Robert Floyd, a chemist at the Oklahoma Medical Research Foundation. Floyd discovered a compound that seemed to limit the damage from ischemic strokes in lab animals. But the medicine had a potential for toxicity, and he spent years refining it before founding a company called Centaur. Rights to the drug were eventually purchased by Renovis.

Matthew Herper of Forbes reports that doctors are enthusiastic:

Doctors with no financial relationship to the drug’s makers say the news is a welcome surprise, as no other drug has ever shown a statistically significant benefit in preventing such injuries. Says Steven Rudolph, director of the Stroke Center at Maimonides Medical Center in New York: “Everything has been negative until now.”

“I’m surprised and encouraged,” says Marc Fisher, a professor of neurology at the University of Massachusetts Medical School. “I didn’t think it was going to be positive. This is really a good thing for the acute stroke field because it’s clearly a safe drug, and it’s a step forward for providing additional therapy.”

“It’s a very exciting time in stroke now,” says Maimonides’ Rudolph. “Stroke is not being viewed by the medical community as something hopeless. It’s an area of active innovation, and it’s an area of progress. That’s very exciting for us.”

Of course, this being Forbes, he also points out that a lot of money could be made from this:

Shares in Renovis, which licensed the drug to Astra and will receive royalties should it reach the market, shot up 86% to $12.64 on the news, giving the little company a market value of $312 million. Astra shares rose slightly in mid-day trading. The results must be confirmed in a second big trial, which is already ongoing, but doctors and the companies are cautiously optimistic. Cerovive could produce $1 billion in annual sales once it wins Food and Drug Administration approval.

Then again, it’s not like they aren’t doing anything for the money. Renovis claims on its web site:

The annual cost of stroke-related care in the United States exceeds $51 billion. More than two million strokes occur each year in the world’s major industrialized countries, about 700,000 of which occur in the United States.

So, this is a drug that could help millions of people avoid or reduce the brain damage caused by stroke, saving their lives, avoiding or reducing their disabilities, and saving everybody money while doing it.

What was that again about the evil, profit-hungy drug companies? ;-)

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