Rationing is Not a 4-Letter Word

Finally a mainstream article (in the NY Times, no less) redefines the misunderstood notion of rationing and healthcare reform.

David Leonhardt's timely and important article deconstructs (I love that word; here's one definition of it: textual analysis that can reveal hidden ideological assumptions) rationing. Here is a definition of rationing: the controlled distribution of resources and scarce goods or services.

Most Americans do not feel they get sufficient time and attention from their medical providers. They find the prices of drugs (or even their fractional co-payments) too high. They do not get enough information on wellness and prevention. Hello. Those problems are the result of an unacknowledged system of rationing. And the current rationing system works to prevent doctors conversing together about your medical problems, to prevent doctors reviewing your old medical records, to prevent doctors educating you about wellness. That is because the current system rations those services by failing to pay for them.

Oh, and by the way--don't you dare come down with an illness that cannot be successfully treated with a drug or operation, because other forms of treatment are highly rationed in the current system.

Most Americans put up with long waits for care, too-short visits, too many tests and not enough face time, because they have been led to believe they have the best healthcare system in the world. If best is costliest, with the most varied and numerous medical devices, procedures, and specialists, then we do have the best system. But if best is measured by outcomes, then we aren't doing very well.

What we really need is rational rationing. Not decided by medicare bureaucrats or by default, but by the stakeholders. We have got to get the price of healthcare down, and that will take rationing. Let's do it in ways that enhance health, longevity and safety. (I could name hundreds of ways to save that would yield better results.) Hello.

Anyway, Leonhardt makes these points so much better than I can. Read his short piece. Uwe Reinhardt discusses the misunderstood concept of healthcare rationing in another excellent article.

Barriers to an Improved and more Cost-Effective Medical System

Health care per capita in the United States costs at least double nearly every other country on earth. Yet our longevity, infant mortality, and other health indices lag behind the rest of the industrial world. What's not to change about such a system? Think of it: we do the same tests and radiology studies as other countries, use the same drugs, and I get paid about the same (as a primary care doctor) as if I lived in western Europe, Canada or Australia. But healthcare costs twice as much over here, because we do more or different things than we need to do for patients, our drugs cost more, our equipment costs more, and there is an enormous amount of "fat" everywhere you squeeze the system.

Egregious financial conflicts of interest can be found under every stone you care to turn up in the healthcare garden.

Profit margins have been reliably above 10% per year for most healthcare companies. No wonder members of Congress and the administration have invested in them. However, those investments are anchors, preventing the US from turning around the ship of state when it comes to healthcare. Shouldn't our legislators recuse themselves from a role in healthcare policy reform while hamstrung by personal investments?

We administer more in the US. A lot of the administration is not designed to reduce procedures or cut costs. Instead, it redirects resources. For example, insurer A contracts with Pharmacy Benefits Manager (PBM) B to supply medications to its customers. Drug manufacturers or wholesalers make deals with the PBM to sell only certain drugs, and to shift prescribed drugs to others in the same class. This is done through the mechanism of the Formulary, a fancy name for limiting the selection of available drugs. But every year the formulary (or pricing pattern of available drugs) changes, so patients (and hospitals) have to frequently change the drugs they have available, or pay through the nose. This is one of many wasteful situations in healthcare, in which the beneficiary of the change (the PBM) shifts the costs of the change onto consumers, hospitals and pharmacies. It is a shell game.

Here is another example of crazy healthcare economics. I see a patient on referral. Another doctor thought I had some expertise to offer this patient. I do a complete evaluation, and give the patient and referring doctor my advice. I bill the patient's insurance company, which decides how much it wants to pay me for the service. I never know what I will receive, how long it will take to arrive, and I frequently receive nothing. I can write letters, make phone calls, and sometimes some money will arrive late, but it is entirely unpredictable. Can you name any other industry in which the price that will be paid for a service (if any) is kept a secret by the payer until after the service is rendered, and often bears little relationship to the time spent or complexity of the service?

Since billing rules are constantly changing (another version of the shell game) billing cannot be done cost-effectively in a small office, for you cannot keep up with the changing regulations and software needed.

The unpredictable payment system led many doctors to sell their practices and take a salary, swapping autonomy for income stability. (I gave away my practice in 2002, and was mighty glad to relinquish captivity to an incomprehensible system of reimbursement.)

There has been a revolving door at FDA for employees or consultants to drug and device manufacturers, who become regulators for awhile. Maybe that is why the rules for scrutinizing new medical devices have been so weak. Attorney Daniel Troy was the top attorney and enfant terrible at FDA, appointed by Bush to gut public health protections. He is infamous for creating the legal doctrine of "preemption": if FDA approved it, no state courts can hear challenges to the safety or efficacy of the product. Now he has returned to the pharma industry as senior VP at Glaxo.

Let's talk pricing. Competition controls prices, right? But FDA approval gives manufacturers a license to steal, since no one else can sell your drug while it is on patent, and no one can tell the manufacturer how to price it. Is the drug used for cancer, a heart attack or stroke? Then it is worth thousands of dollars a dose. (You heard me right. Thousands. No wonder the drug companies focus on drugs for the final year of life.) Because most patients are shielded from the full cost by insurers, there is no outcry. Those not shielded may go bankrupt trying to pay.

Need I go on? An army of hardworking, well-intentioned health professionals puts a good face on a heathcare industry replete with dirt. And given the nutty payment system, healthcare institutions are practically forced to steal from Peter (i.e., overcharge) to pay Paul, a very unsatisfactory situation that currently is a requirement for hospitals (and healthcare professionals like me) to stay in business.

Our nation is desperate for an accounting of where the healthcare dollars are going; for accountability for quality outcomes; and to develop a system in which excellent health indices, broad preventive services, and enhanced provider communications occur -- one for which we can all be proud, and healthier!

The Cost Conundrum: What a Texas town can teach us about health care

Atul Gawande is a marvelous writer, as well as a surgeon. In an article in today's New Yorker, Gawande proves himself to be in the first rank of health care pundits, as well. His extraordinary article is a joy to read, but also extremely important. For example, it identifies and explores the reasons a negative correlation between healthcare costs and quality of care exists.

"Two economists working at Dartmouth, Katherine Baicker and Amitabh Chandra, found that the more money Medicare spent per person in a given state the lower that state’s quality ranking tended to be. In fact, the four states with the highest levels of spending—Louisiana, Texas, California, and Florida—were near the bottom of the national rankings on the quality of patient care."

Gawande travelled to McAllen, Texas, to investigate why per capita healthcare costs (paid by medicare) were higher there than almost anywhere else in the country. Many theories that might explain this were examined, but eventually had to be rejected. Finally, it became clear that in McAllen, many of the doctors had learned how to game the system for maximal financial benefit. The medical culture had evolved to one in which "financial considerations drove the decisions doctors made for patients."

McAllen's patients got an overabundance of illness care. However, preventive care was lacking, and people were no healthier than in markets where health care costs were 50% less. "So here, along the banks of the Rio Grande, in the Square Dance Capital of the World, a medical community came to treat patients the way subprime-mortgage lenders treated home buyers: as profit centers."

Things were McAllen's mirror image at the Mayo Clinic in Rochester, Minnesota. "Among the things that stand out from that visit was how much time the doctors spent with patients," Atul noted. Yet costs were among the nation's lowest at Mayo. Mayo doctors were salaried, and primarily focused on improving the quality of care.

“When doctors put their heads together in a room, when they share expertise, you get more thinking and less testing,” Denis Cortese, Mayo's CEO, told Atul.

Colorado had an interesting model. "Grand Junction’s medical community was not following anyone else’s recipe. But, like Mayo, it created what Elliott Fisher, of Dartmouth, calls an accountable-care organization. The leading doctors and the hospital system adopted measures to blunt harmful financial incentives, and they took collective responsibility for improving the sum total of patient care."

"When you look across the spectrum from Grand Junction to McAllen—and the almost threefold difference in the costs of care—you come to realize that we are witnessing a battle for the soul of American medicine."

Gawande questions whether the doctor--any doctor-- "is set up to meet the needs of the patient, first and foremost, or to maximize revenue. There is no insurance system that will make the two aims match perfectly. But having a system that does so much to misalign them has proved disastrous. . . Every incentive in the system is an invitation to go the way McAllen has gone. "

Gawande concludes, "As America struggles to extend health-care coverage while curbing health-care costs, we face a decision that is more important than whether we have a public-insurance option, more important than whether we will have a single-payer system in the long run or a mixture of public and private insurance, as we do now. The decision is whether we are going to reward the leaders who are trying to build a new generation of Mayos and Grand Junctions. If we don’t, McAllen won’t be an outlier. It will be our future."

How am I to treat patients with H1N1 flu? How am I to protect them from the treatment?

The 2009 "Swine flu" A (H1N1) outbreak has been recognized for the past six weeks. It has been studied intensively, we are told, and a number of Americans have died from the disorder, although less than 1% of those diagnosed with this specific virus. It apparently is a bit more contagious than the usual flu, but may cause the same or fewer deaths than usual flu. However, since we have no good data on the number of Americans who die from flu every year, it is very hard to say how this swine flu compares to others in virulence.

CDC has told medical practitioners from the beginning to use Tamiflu or Relenza (the generic names of these drugs are oseltamvir and zanamivir) for treatment, or for prophylaxis of exposed persons. An Emergency Use Authorization has been issued for these drugs, which allowed them to be released from the Strategic National Stockpile for distribution to states and localities, to be used outside the labeled indications, and to somehow avoid GMP (Good Manufacturing Practices) standards if necessary.

However, although CDC has repeatedly told doctors to use the antivirals above, what it has failed to tell us, even once, even on its frequently updated website, is how effective we can expect these drugs to be. Nor has CDC gone into much detail about safety, particularly when the drug is being used on very young children, off-label.

Since safety and efficacy are the only two facts one needs to know about any drug (apart from the fidelity of the manufacturing and distribution processes) these are two very big omissions.

Furthermore, I want to know what clinical syndromes patients are developing that occur in those who become critically ill, so that I can treat those aspects of the illness in the best possible manner. Are seriously ill patients developing a secondary, bacterial pneumonia, sepsis or Adult Respiratory Distress Syndrome (ARDS)? Do they benefit from mechanical ventilation, steroids or antibiotics? This could be life-saving information, yet it is not being disseminated and I could not find anything related to it on the CDC website.

If that is not bad enough, you may be interested to learn that the government has invoked the Public Readiness and Emergency Preparedness Act (PREP Act), which makes it almost impossible to sue the manufacturer (as well as the government) for injuries you sustain from use of Tamiflu and Relenza. How is that, you may ask: there has been no media coverage of this. But you can confirm it on CDC's website and in the Federal Register of October 10, 2008. Here is how it works.

Guess what? Tamiflu and Relenza were given the benefit of the PREP Act in 2008, by Secretary Leavitt, before there was any swine flu pandemic. The Center for Infectious Disease Research & Policy at the University of Minnesota had this to say last December:

... A recent declaration by HHS Secretary Mike Leavitt provides that state and local governments will be immune to liability related to the use of oseltamivir and zanamivir only to the extent the drugs are obtained by voluntary means, not confiscation. The Public Readiness and Emergency Preparedness (PREP Act) gives the HHS secretary the authority to do that, the document states.

For a good primer on PREPA, the Congressional Research Service has written a valuable report.
If use you Tamiflu or Relenza and develop a serious adverse reaction, you will be on your own. The manufacturer, distributors and the government program planners involved in the decision to invoke the PREP Act, were all given near-total immunity for liability by the Act. The Declaration (and immunity shield) will remain in effect through the end of 2015.

The Anthrax Vaccine: A Dilemma for Homeland Security/LtCol Tom Rempfer

This article, from the journal Homeland Security Affairs, recaps the history of the anthrax vaccine program and explores how the anthrax letters attack might be related to it.

Past problems with the Department of Defense anthrax vaccine currently impact
national emergency response plans approved by the Department of Homeland
Security and Department of Health and Human Services. Following the 2001 anthrax letter attacks, those departments diverged from long established protocols advocating limited use of the old anthrax vaccine, also known as BioThrax®. The Executive departments procured mass quantities of the product for the Strategic National Stockpile as a prophylaxis for citizens under emergency contingencies.
The departments share oversight responsibilities for the emergency stockpile’s
composition of vaccines and drugs based on Presidential Directives. (1) Yet a
review of past oversight efforts reveals regulatory problems, ethical controversies and dubious threat assessments underlying use of the vaccine. Based on the historic controversy, and studies suggesting the majority of U.S. service members continue to object to the vaccine’s use, (2) the government should resurvey the vaccine’s suitability for American citizens. A thorough review may find that widespread use of a known antiquated product of disputed safety and efficacy in treating a non- communicable threat provides an imprudent illusion of protection for our citizens.

This article explores the Department of Defense’s experience with the anthrax vaccine, and the troubling possibility that the 2001 anthrax letter attacks were a deliberate and successful effort to sustain a program that federal investigators determined was on the verge of failing. . .

.

U.S. funded anthrax vaccine trials on IDF soldiers/ Haaretz

According to an article by Yossi Melman, the US spent $200 million dollars for Israel to develop and produce an anthrax vaccine, and test it on Israeli soldiers during the 1990s.

When the US military was testing plenty of other experimental vaccines on American soldiers during the 1990s (I know of at least half a dozen) what might have led them to test this one offshore? What did the military know about the anthrax vaccine? And when did they know it?

It seems they knew it before the mass mandatory inoculation program began in 1998, but went ahead anyway. That program was initially slated to vaccinate every soldier, but after many vaccine refusals and production problems, vaccinations were limited to those soldiers deploying to Asia.

This story is getting a lot more interesting...

CDC's anthrax vaccine safety studies defunded/ Science online

from Science: Michael McNeil's portfolio of flawed anthrax vaccine safety studies at CDC is going away. Drum roll, please.

This is a good thing, since the studies were basically a boondoggle lacking a scientific foundation. Even Army vaccine scientists, as well as this blog's owner, published criticisms of the laughable methodologies used by the CDC group in its first published study. That study purported to show no increase in cases of optic neuropathy following anthrax vaccine, by using idiosyncratic study methods that enhanced bias.

The Institute of Medicine was asked to review this study portfolio back in 2001. Here are some comments (verbatim) from their interim report in January 2002:

• CDC's plan appears to include useful components that have not to date been integrated into a whole or comprehensive plan.
• No matter how meritorious the parts, however, the apparent lack of overall planning and coordination of the whole is a deficit that should be remedied.
• The CDC either has not developed, or has not communicated, a comprehensive plan for the CDC's role in anthrax vaccine safety and efficacy research.

The final report of the IOM was ignored by CDC, which continued on with projects that IOM had found to lack merit and recommended ending.

This group also worked on the CDC anthrax vaccine trial, a 42 month study designed to look at long-term adverse vaccine reactions. What did they do instead? After the study had been completed, they published a paper discussing data from only the first 7 months of the study. This allowed CDC to hide long-term adverse reactions, and get the vaccine approved for civilians last October, potentially leading to large profits for the vaccine maker: Bioport aka Emergent Biosolutions. Qui Bono? Not the first responders who were slated for vaccination, since they were barred from seeking compensation if they got sick from either the manufacturer or government officials. Coincidentally, what barred them was an Emergency Declaration from HHS' Secretary Leavitt...conveniently issued the same month CDC published its paper and approved the vaccine for civilian first responders.

If CDC is serious about getting back on track with transparency, accurate information and quality research that will enhance public health, the anthrax vaccine safety group needed to go. Bravo to those at CDC who chose this program to cut.

FBI Anthrax Investigation Under Scientific Review/ Science online

Brief article by Yudhijit Bhattacharjee:

A long-awaited review of the scientific evidence relating to the investigation
of the 2001 anthrax letter attacks is finally getting off the ground. The study,
to be conducted by the National Academies, will check the validity of the
scientific techniques used by the Federal Bureau of Investigation in solving the
case. What the study will not do, as spelled out in the academies’ official
description of the study, is issue a verdict on whether U.S. Army researcher
Bruce Ivins was indeed guilty of the crime, as concluded by FBI officials. . .

Research Advisory Committee on GW Illness Chairman explains how Institute of Medicine was Made to Perform Studies Whose Conclusions Were Predetermined

Jim Binns, chairman of VA's Research Advisory Committee on GW Veterans' Illnesses since its inception, authored a detailed memo, with supporting documents, to show how Congress' statutory charge to the IOM was changed to exclude animal studies and raise the bar for granting presumptive disabilities to ill Gulf War veterans.

Jim deserves enormous thanks for his tireless pursuit of fairness for ill veterans, and his methodical discussion of how a series of mostly useless IOM reports came to be produced.

Army Nearly Done With Probe of Fort Detrick Lab/ Wash Post

No Signs of Criminal Misconduct Found Yet in Disappearance of Virus, Official Says

This rather inconsequential article (lacking context) says Fort Detrick is still working on its inventory...going on 3 months now? Not surprisingly, the Army hasn't found anything to be concerned about, according to Fort Detrick's PR person. The article implies that much of the base's research remains on hold.

Despite fines and sanctions at other research institutes for safety lapses, I have never heard of a single research center that basically shut down for weeks or months pending a review. That back story--what it took to shut the place down, and whether it relates to the anthrax letters--could be extremely interesting.

The 2008 Naval Environmental Health Center Study by Dr. Margaret Ryan et al. on anthrax vaccination during pregnancy: a critique and historical review

Comments on: Ryan, MAK, et al. Birth Defects among Infants Born to Women Who Received Anthrax Vaccine in Pregnancy. American Journal of Epidemiology; July 2008.

Meryl Nass, MD

April 20, 2009

Dr. Margaret AK Ryan reports that of the 95,595 military women who delivered babies between 1998 and 2004, anthrax vaccine (one dose or more) was given to 3,465 military women during their first trimester of pregnancy. Dr. Ryan, a physician epidemiologist and Navy Commander, has studied these women for the past eight years, and published results in 2008.

The Original Study Led to Major Policy Changes

Dr. Ryan presented results of a subset of this group (those vaccinated 1998 through mid 2001) in late 2001 and early 2002. Shortly after her presentation to FDA, in January 2002 FDA changed the pregnancy warning on the anthrax vaccine label to category D from C, indicating that data showed the vaccine was associated with birth defects, and should not be given to women during pregnancy. The Assistant Secretary of Defense for Health Affairs, Dr. William Winkenwerder, also responded to Dr. Ryan's findings. He sent memos to all the military services, directing that special efforts should be made to avoid giving the vaccine during pregnancy, including the use of pregnancy tests if appropriate.

[He was reacting to the increased rate of birth defects, but also to the relatively high rate of first trimester vaccinations. Before 2002, military medical professionals tended to vaccinate women who thought they might be pregnant but had no proof. Fortunately, that changed after Dr. Ryan's 2001 preliminary report. A much smaller number of women with first trimester pregnancies have been vaccinated since.]

Her 1998-2001 study data were shared with the Institute of Medicine Committee to Assess the Safety and Efficacy of Anthrax Vaccine and with the Armed Forces Epidemiology Board, as well as FDA. When initially presented, the study compared first trimester-vaccinated women to women who had been vaccinated at any other time. The data showed a reportedly small increase in birth defects in offspring of first trimester-vaccinated women, yet the increase was statistically significant. For some reason, these data were never published, despite the effect they had on both vaccination policy for military women, and changing the pregnancy warning on the vaccine label.

Expanding the Dataset but Reducing Statistical Significance

Subsequently, Dr. Ryan et al. added to the original data collection, extending the period of births through 2004. In 2008, Dr. Ryan published these data, discussing the original comparison between first trimester-vaccinated mothers and mothers vaccinated at another time, but the published paper also compared these births to births in mothers never vaccinated against anthrax.

This expanded dataset yielded a smaller difference in birth defect rates in offspring between first trimester-vaccinated women and those vaccinated at any other time, which was only statistically significant when offspring of first trimester-vaccinated women were compared with offspring of those never vaccinated.

In February 2002 it was reported (in the CDC’s Morbidity and Mortality Weekly Report: MMWR 127 vol 51 No. 6: Notice to Readers: Status of US Department of Defense preliminary evaluation of the association of anthrax vaccination and congenital anomalies) that investigators were conducting a systematic evaluation of original (paper) medical records of women who received anthrax vaccine to determine how well the electronic medical data agreed with the (paper) medical records.

In 2008, Dr. Ryan described significant problems with the electronic data that she used. Her published paper states that only “a subset of women whose data were archived after they left military service” had their hard-copy data compared with the electronic database. Hardcopy records were reviewed for 11,271 of the 95,595 women who gave birth during the study period, and “were more likely from women who gave birth earlier in the observation period and left military service soon after” and “did not represent a random sample.”

Of the 11,271 women whose paper records were reviewed, 1,318 had anthrax vaccinations recorded on paper. Of these 1,318, only 1,158 had anthrax vaccination recorded electronically. “When compared with those of [paper] medical records, the specificity of electronic data was 97.5%, and the sensitivity was 61.5% for correctly identifying [anthrax] vaccine recipients.” This means very few women whose paper records showed they did not get the vaccine were identified electronically as having received it, but that many who did receive it, according to their paper medical records, failed to have the vaccinations recorded electronically.

Could it be that the poorer sensitivity (ability to correctly identify those who received the vaccine) of the electronic database contributed to the drop in birth defect rates in offspring of those vaccinated women added to the database later? Given the demonstrated low sensitivity of the electronic record for identifying vaccinations, it is very likely that some of the women who had infants with birth defects failed to have their vaccinations accurately recorded in the electronic database. Since electronic records supplied more of the study data for women vaccinated later compared to earlier, relatively more late-vaccinated women would be expected to be incorrectly placed in the unvaccinated group. This could dilute the measured adverse vaccine effect in infants born later, compared with the data used in Ryan’s earlier assessment.

In other words, the greater use of the more accurate paper records, for those vaccinated earlier, would be expected to result in more accurate vaccination ascertainment for mothers of infants with birth defects who were born earlier.

Merging data from both paper and electronic records, despite low sensitivity for identifying anthrax vaccinations in the electronic records, is a major problem with this study. It may have led to loss of statistical significance for some comparisons despite a larger number of subjects in the later study.

Biologic Plausibility of Vaccine-Induced Birth Defects

Dr. Ryan stated that, “there is little information available to support biologic plausibility of anthrax vaccine as being teratogenic.” The CDC’s Morbidity and Mortality Weekly report, cited earlier, reported that, “although the Food and Drug Administration-licensed vaccine has not been suspected to be a hazard to reproductive health, no studies of animals or pregnant women have been conducted.” Shouldn’t studies in pregnant animals have been required prior to mandatory use of the vaccine in the young female military population? Then again, if no animal studies had been conducted, it was easy to say there was no information linking the vaccine to birth defects.

The anthrax vaccine contains formaldehyde, aluminum, benzethonium, 3 anthrax toxins that are known to exert profound biologic effects, and an array of uncharacterized substances derived from anthrax fermentation. Why is it implausible to think that injecting this mix might contribute to birth defects?

Dose-Response Relationship

Is there a dose-response effect from anthrax vaccine on the rate of birth defects, as might be expected if the vaccine were truly causing such problems? Ryan et al. state that “infants exposed to two or more maternal anthrax vaccine doses in the first trimester did not have a significantly increased risk of birth defects,” implying that there was no dose-response relationship.

But a positive dose-response relationship did exist. Infants exposed to two or more vaccine doses in the first trimester had an adjusted rate of birth defects 1.19 times higher than infants of mothers vaccinated at another time. But a smaller number of infants received 2 or more vaccinations prior to detecting a pregnancy, rather than just one, so this increased rate did not achieve statistical significance. More infants of multiply-vaccinated first trimester mothers would have been needed to achieve statistical significance.

Birth Defect Rates

In the US overall, 3.0% of infants are born with a significant birth defect. However, in military women vaccinated outside the first trimester, 4.2% of offspring had at least one major birth defect. In never-vaccinated women, 4.03% of offspring had a birth defect. In those vaccinated during the first trimester, 4.7% had at least one major birth defect.

When 4.7% is compared to 4.2%, the increase in the birth defect rate is only 12%. But consider the vaccine's makeup. Anthrax vaccine uses the aluminum adjuvant Alhydrogel to create a depot effect, slowly releasing vaccine antigen over some months following an injection. So women vaccinated prior to the first trimester could still be exposing their fetus to the vaccine. That is why they should not have been included in the control group: at least, those vaccinated in the year prior to conception should not have been used as controls.

Ryan’s data support the hypothesis of pre-pregnancy vaccination contributing to birth defects. In women vaccinated during the first trimester, the birth defect rate in offspring was 4.68%. In offspring of women vaccinated prior to pregnancy, the birth defect rate in offspring was 4.56%: nearly as high. In those vaccinated after pregnancy, the birth defect rate in offspring was only 3.85%.

By including pre-pregnancy vaccinations in the original control group, the effect of the vaccine on birth defect rates was diluted.

Now compare birth defect rates of infants born to women given anthrax vaccine during their first trimester with all infants born in the United States. When you compare 4.7% to 3.0% (the rate of major birth defects diagnosed in the first year for all infants) the unadjusted increase in the birth defect rate is 57%. This suggests that the increase in birth defects attributable to anthrax vaccine could be quite considerable. (However, these numbers have not been adjusted to take account of other possible differences between the two populations. On the other hand, military populations are considered healthier, on average, than their civilian counterparts, so the comparison is probably fair.)

Conclusions

In the 2008 paper’s conclusions, Dr. Ryan et al. note that additional research should be done, and make the excellent suggestion to perform active follow-up, such as that being performed by the Smallpox Vaccine in Pregnancy Registry. Ryan et al. also point out that potential adverse effects of vaccinations given pre-conception should be assessed.

But the sentence immediately following this recommendation states incorrectly that, “these analyses found no evidence that prepregnancy maternal anthrax vaccination is associated with an increased risk for birth defects.” Maybe the relationship was not significant, but the rate was considerably higher than for offspring of military women never vaccinated, of military women vaccinated postpregnancy, and for offspring of American women overall.

Ryan’s final sentence makes this reasonable point: “… women with no known exposure to inhalation anthrax should continue to avoid anthrax vaccination during pregnancy.”Overall, the data presented by Ryan et al. give cause for concern, and should provide the impetus to further study the issue of anthrax vaccine and birth defects. Most importantly, these data tell us that the military’s electronic database has serious flaws, and requires enhanced data entry and ongoing testing to assess the validity of the information it contains.

For future study of the effects of anthrax vaccine in pregnancy, paper records should be used. Furthermore, women receiving pre-pregnancy vaccinations, who were shown to have high rates of infants with birth defects, cannot be used as the control group in a scientifically valid study. Finally, an understanding of how and why birth defects rates in the offspring of military women exceed civilian rates must be sought.

Redesigning Healthcare: Don't Miss This Reinhardt Gem!

Uwe Reinhardt, Princeton's healthcare economist who has previously been featured in this blog, has posted a very interesting article to his NY Times blog. In it, he dissects the various roles of the healthcare system, using the German model to explain how some roles can be performed by government and others by private health insurance companies. In the German system, everyone (90%) is covered, all workers and their employers contribute, and social goals are attained, at a cost less than half that in the US. Germans can choose from 200 different health insurance funds to get their health needs met.

Reinhardt has also started talking about one of the (cultural) elephants in the healthcare room. Must it take someone who hails from outside the US to explain to us our cultural biases? One recalls the success of DeToqueville in a similar arena.

Reinhardt spits it out: prevailing views of what our rights should be, vis a vis health care costs and entitlements, is inherently contradictory:

They [health plans in Germany, Netherlands, Switzerland] all rely on purely private, nonprofit or for-profit insurers that are goaded by tight regulation to work toward socially desired ends. And they do so at average per-capita health-care costs far below those of the United States — costs in Germany and the Netherlands are less than half of those here. . .

In Europe, as in Canada, that social ethic [guiding the payment for and provision of healthcare] is based on the principle of social solidarity. It means that health care should be financed by individuals on the basis of their ability to pay, but should be available to all who need it on roughly equal terms. The regulations imposed on health care in these countries are rooted in this overarching principle.

First, these countries all mandate the individual to be insured for a basic package of health care benefits.

Many Americans oppose such a mandate as an infringement of their personal rights, all the while believing that they have a perfect right to highly expensive, critically needed health care, even when they cannot pay for it. This immature, asocial mentality is rare in the rest of the world.

Read the full article, browse his other posts, and be grateful that a few pundits like Reinhardt are pointing to sensible solutions to the health care morass choking our nation.

One step could dramatically improve hospital care and patient safety

Information has many ways of falling through the cracks in hospitals and medical practices.

The wrong test may be mistakenly ordered by the doctor. The ward secretary may order the wrong test. The lab may perform the wrong test, or rarely perform it on the wrong person. The result may not be available until after the patient leaves the hospital, and then gets lost in cyberspace; or it reaches the chart after the doctor has dictated the discharge summary and is never seen.

Usually more than one doctor takes care of each patient, but each may not be aware of everything the other has done, or which tests were ordered and are still pending.

A simple fix would be to require that all electronic medical records systems must be linked to the laboratory and radiology departments, and must be able to generate a list of all tests ordered; their results; and those tests whose results are still pending. At the end of a hospitalization, each doctor would have to sign off on the list, to ensure all tests had been considered.

We currently have a hodge-podge of hundreds of proprietary EMR systems that do not communicate with each other throughout the US, and the system I use does not have this capability.

Electronic medical records are a wonderful idea in theory. In practice, they are fraught with difficulties and potentially may be accessed or "hacked" by unauthorized individuals, making a mockery of patient confidentiality. The problem of confidentiality is central to getting a working EMR system in place throughout the nation, through which doctors and patients can communicate; yet it requires cybersecurity resources beyond the financial resources of hospitals and medical practices in the private sector. This is why the development and maintenance of such a system must be federalized.

MK Shai calls for anthrax vaccine experiment probe

from YNet:

Kadima Knesset Member and former Israeli Defense Force spokesman Nachman Shai on Friday said either a state commission of inquiry or a parliamentary commission of inquiry should be set up to look into the anthrax vaccine experiments conducted on IDF soldiers. MK Shai said, "The fact that the experiment was hidden from the public and the examinees is a moral issue of the highest degree".

More on the Israeli anthrax vaccine experiment on soldiers

From the Jerusalem Post

From the AP

Excerpts from today's Ha'aretz:

Dr. Reuven Porat, who chaired the medical committee, told Haaretz the panel had not been presented with any official documentation that shows the decision to develop, test and produce the vaccine had been authorized by the government. Similarly, there was no authorization presented from the defense minister, who is charged with responsibility for the Institute for Biological Research, and not from the IDF, and there was no proof the chief of staff was consulted about or agreed to the project...

In its report the panel is highly critical of the "secrecy" imposed by the managers of the experiment and ask "whether the secrecy was necessary because the experiment was to be hidden from the Israeli public."

The medical panel noted: "Selecting soldiers as the population for the experiment prevented achieving the declared aim of the experiment, which was to examine its safety and effectiveness in broad use among the general civilian public, the elderly, women, children and sick patients," the committee wrote.

From YNet come these excerpts:

Israel has admitted to developing a vaccine against anthrax, fearing it might be used as a bio-weapon by enemy nations against civilians, and tested it on IDF soldiers. "Once we face a substantial threat, we would be able to vaccinate all citizens, ranging from babies to the elderly, and protect them against the virus," a senior defense source told Ynet. (But the report indicates Israel already had a large enough stock of vaccine for its population prior to beginning this trial--Nass) From PressTV: Some of the soldiers, who say that the experiment has had life-threatening side effects for them are now filing a lawsuit against the Israeli Army, Haaretz reported... Israeli Physicians for Human Rights have also filed a lawsuit against the army over the experiments.

Medical panel: Anthrax experiments on IDF soldiers were unjustified

Another fascinating article on the Israeli anthrax vaccine experiments by Yossi Melman in Haaretz. Excerpts follow. It seems no one in Israel would take any responsibility for the experiment, which is being laid at the feet of (assassinated) former Prime Minister Itzhak Rabin -- but no documentary evidence was given to the Israeli Medical Association committee invesetigating the experiment to support the putative association with Rabin.

In the US, I have been unable to learn who has been behind approval of the anthrax vaccine for mass use, when there exists no experimental evidence for human efficacy, the safety profile is awful, and the need has never been demonstrated.

Following a three-month legal battle in Israel's High Court of Justice, the report was finally approved for publication Wednesday...

The experiments were carried out in light of what was then defined as the "strategic threat of a surprise biological attack facing Israel. However, the report said that it was not clear who the decision makers were who determined the vaccine's necessity...

The Chairman of the medical committee, Dr. Reuven Porat, told Haaretz that the panel was not presented with any official evidence indicating that either the government, the defense minister of the IDF chief of staff had authorized the development, testing, or production of the vaccine...

The report insinuates that it was improper motivation that prompted the launch of the experiments, but it does not specify what these motivations were, saying that the panel "could not make out the true inspiration behind them..."

The report reveals that even while the experiment was taking place Israel already had a stock of vaccines, a fact which further raised the concern that the experiment wasn't necessary; that it was carried out as a result of external pressure. "An accelerated effort to produce large quantities of the vaccine was underway a year prior to the experiment, and by the time the experiments were launched, Israel had enough vaccines to cover the civilian concerns," the report said...

Israel and the IDF accepted the principles of the Helsinki Accords, declaring many times that they meet their standards. In reality, however, the report states that "the military Helsinki committee failed to fulfill its duties in 'Omer 2' in every one of the points examined by the report."

"No scientific justification was found for the experiment, scientific background was lacking, the experiment's design and execution did not suit its goals, and no result would have justified those goals. Also, conventional guidelines were not followed, risks and possible side effects were not thoroughly investigated, and a follow-up mechanism to keep track of participating soldiers was not set up....."

Preventing Bioterrorism (Op/Ed by Rep. Rush Holt)

Preventing bioterrorism:

Thursday, March 12, 2009
BY RUSH HOLT
Last year, the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism -- itself an outgrowth of the 9/11 Commission and its recommendations -- issued its report. It used alarming language to prod our government to act. It affirmed something that was demonstrated with the deadly anthrax attacks: Terrorists will likely use WMD attacks on America that feature biological weapons. The question now is: Have we implemented "lessons learned" from these attacks that took place in the fall of 2001, which caused such havoc here in New Jersey and across the nation?

I agree with the commission's assertion that "only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity." To that end, the commission made a number of recommendations for improving biosecurity here at home, including the more thorough and persistent monitoring of personnel working at high-containment laboratories (i.e., those who work with dangerous pathogens) and the designation of a single federal agency for tracking the number of such labs in the United States.

I support those and other measures, but I do not believe Congress and the incoming administration can craft an effective biosecurity program for our country unless and until we take the time to investigate thoroughly the only major (and still unsolved, according to many) bioterror attack on our country to date.
Last week, I reintroduced the Anthrax Attacks Investigation Act, to examine and to report on how the attacks occurred and how we can best prevent similar episodes in the future.

Readers may wonder why the commission did not address the 2001 anthrax attacks in detail in its report. The answer is that examining those attacks was not an explicit mandate of the WMD Commission. This is in contrast to the 9/11 Commission, which was specifically charged with looking at how the Sept. 11, 2001 attacks happened, why the federal government failed to prevent the attacks, and what remedial measures are necessary to prevent a similar catastrophe in the future.

A thorough investigation into the federal government's response to the first modern bioterror attack on our soil is absolutely essential if we are to ensure that we have learned the right lessons from that episode to implement countermeasures and changes in policy that are directly tied to those "lessons learned" -- something that The Times of Trenton repeatedly has pointed out in its frequent coverage of this tragedy.

While many of the WMD Commission's recommendations for improving biosecurity look sound on the surface, none of their specific action proposals are based on a detailed examination of how the 2001 anthrax attacks occurred. More than seven years after the attacks, many critical questions remain unanswered. Chief among them is why the Federal Bureau of Investigation's (FBI) "Amerithrax" investigation focused for so long on the wrong suspect.

The FBI's performance in the wake of the attacks has left me and many other Americans wondering whether the Bureau is truly equipped to handle bioterrorism. Deterring such attacks in the future depends in part on at least the expectation of swift and certain detection and punishment.

Neither happened in the case of the 2001 anthrax attacks. We need to know why the first attack succeeded and why the perpetrator or perpetrators escaped justice.

Just as the 9/11 Commission looked not only at the attacks of that morning, but also at recommended changes in the structure of government agencies, screening methods and even congressional oversight, so should an anthrax commission look at the specific crime, but also at measures for prevention, detection and investigation of any future bioterrorism.

An anthrax attack investigation would help address these kinds of policy questions in a level of detail that the WMD Commission could not.

Rep. Rush Holt, D-Hopewell Township, is chairman of the House Select Intelligence Oversight Panel.

FBI Press Release details the meaning of the ASM presentations in Baltimore last week--with comments

For Immediate Release
March 6, 2009

Washington D.C.
FBI National Press Office
(202) 324-3691

FBI Responds to Science Issues in Anthrax Case

FBI Laboratory Director D. Christian Hassell, PhD issued the following statement:

During a recent American Society for Microbiology Biodefense (ASMBD) meeting in Baltimore , Maryland , questions were raised regarding two scientific analyses conducted during the course of the anthrax investigation. While this information is not new, it is important for the FBI to clarify the science since these findings continue to be misinterpreted by various media outlets.

The first item involves the elemental analysis of the anthrax spores that was conducted by Dr. Joseph Michael, a materials scientist at Sandia National Laboratories. At the conference, Dr. Michael presented analyses of three anthrax letters (Leahy, Daschle, and New York Post). He concluded that the anthrax powder in the three letters shared a chemical fingerprint but did not match the chemical fingerprint of spores in Ivins’ flask. Spores from the letters showed a distinct chemical signature that included silicon, oxygen, iron, tin, and other elements. Spores from Ivins’ RMR-1029 flask did not contain those elements in quantities that matched the letter spores. This is not unusual considering that Ivins’ RMR-1029 preparation had been submerged in water and other chemicals since 1997 and was a mixture of 34 different spore preparations. The letter spores were dried spores, produced from two separate growth preparations as indicated by differences in the New York and Washington, D.C. mailings. Although the chemical fingerprint of the spores is interesting, given the variability involved in the growth process, it was not relevant to the investigation.

It is important to note that the genetic profile of the spores from the letters and the spores from Ivins’ RMR-1029 flask was identical. Ivins’ RMR-1029 spore preparation had the same combination of anthrax mutations found in the letters. Only eight of the anthrax samples collected during the course of the investigation matched the genetic profile in the letter material and all were linked back to RMR-1029. This conclusion was the most significant and relevant scientific finding in the case.

By analogy, if one were to grow a corn stalk from a specific corn seed, the trace chemical fingerprint of the stalk might differ from that of the seed due to different compositions—for example iron—in the respective fertilizers used to grow each; however, the genetic profile of the seed and the stalk would be identical.

The second item involves isotopic analysis of the mailed anthrax. Media reports indicated that FBI scientists had concluded in 2004 that out of many domestic and foreign water samples analyzed only water from near Fort Detrick, Maryland, where Dr. Ivins worked, had the same isotopic signature as the water used to grow the mailed anthrax. This statement is incorrect. While water isotopic analysis was researched, the FBI concluded that there were too many confounding variables to precisely match bacteria that were grown using different materials and recipes. This technique was not relevant to the investigation.

While we have full confidence in our scientific approach, an additional independent review will provide further validation and thus benefit the larger scientific community. Consideration of an outside review began before any public disclosure of the scientific aspects of the investigation. This follows our approach throughout the investigation: to bring in external scientists to review and provide advise on our methodologies.

Nass comments: Even if everything stated above is accurate, the FBI has yet to prove that Ivins himself, not just his flask, provided the parent spores for the anthrax letters.

-- How did the FBI "rule out" as perpetrators over 100 other people who had access to spores from Ivins' flask?

-- How did the FBI ascertain that all of the secondary spore collections, derived from the flask, were 100% secure and could not have been surreptitiously obtained by others?

-- How was the FBI sure that no one else received spores from Fort Detrick, given that Fort Detrick's inventory problems were serious enough for there to have been a temporary "stand-down" of research just last month? Also consider that Ivins' flask was in a separate building from his lab, to which others had access, for over a year.

Since a thorough, complete accounting of its six year long, resource-intensive investigation has yet to be provided by the FBI, the following questions (raised by Representative Rush Holt on October 16, 2008) are additionally relevant:

"Are any of the FBI’s scientific findings inconsistent with the FBI’s conclusions?

Are there any scientific tests that the FBI has not done that might refute their conclusions?

Did the FBI follow all accepted evidence-gathering, chain of possession, and scientific analytical methods? Is it possible that any failure to do so could have affected the FBI’s conclusions?

Is it scientifically possible to exclude multiple actors or accessories?"

It is now 7 months since FBI announced the case was closed. During that time, FBI has released many pieces of (selected) evidence. The latest release, at a special ASM meeting convened for the purpose, was designed to make the scientific case.

The FBI charade has failed. The most basic questions remain unanswered.

Israeli Ministries take 'full responsibility' for anthrax vaccine trials

Article in THE JERUSALEM POST
Mar. 4, 2009
Yaakov Lappin

The Defense Ministry, Health Ministry and IDF said they took "full responsibility" for all side effects suffered by participants in a test of an anthrax vaccine, in a joint statement issued Wednesday.

The statement will be submitted to the High Court next week as a reply to petitions submitted by two IDF soldiers who took part in the trial and suffered negative aftereffects.

The petitioners raised questions about the way the vaccine trial was conducted, and are claiming the monitoring of volunteers and subsequent care provided to them was inadequate.

The vaccine trial, code-named Omer 2, took place between 1998 and 2006, and sought volunteers from elite IDF units. Following the test, a number of participants complained of breathing problems and skin conditions.

A quarter of participants were given an American version of the vaccine, while 75 percent were injected with the Israeli vaccine, which had not been previously tested. Members of both groups suffered side effects.

According to the statement, which was released by the Defense Ministry, 716 soldiers took part in the trial, and 11 later required medical treatment.

"Volunteers were given a detailed explanation about the vaccination, the study, and potential side effects. They were given a sheet to study and sign," the statement said.

"All of the soldiers who requested medical care received it," it added.

The Defense Ministry went on to describe Omer 2 as a project with "strategic importance for the State of Israel," adding, "Thanks to Omer 2, Israel has a medical response for the general public against a most severe threat. We thank the volunteers and appreciate their willingness to take part in this important trial, and their contribution to the general security of residents of Israel."

The vaccine is as safe as the anti-anthrax vaccine developed by the US, the Defense Ministry said.

Academic experts and oversight committees within the IDF closely monitored the vaccine trial, the statement added.

Remembering the anthrax attack

Glenn Greenwald's March 4, 2009 Salon article on Representative Rush Holt's bill and the ramifications of the anthrax attack is a must-read. Great links. Here is an excerpt:

The ultimate establishment organ, The Washington Post Editorial Page, issued numerous editorials expressing serious doubts about the FBI's case against Ivins and called for an independent investigation. The New York Times Editorial Page echoed those views. Even The Wall St. Journal Editorial Page, citing the FBI's "so long and so many missteps," argued that "independent parties need to review all the evidence, especially the scientific forensics" and concluded that "this is an opportunity for Congress to conduct legitimate oversight."
In the wake of the FBI's accusations against Ivins, the science journal Nature flatly declared in its editorial headline -- "Case Not Closed" -- and demanded an independent investigation into the FBI's case. After the FBI publicly disclosed some of its evidence against Ivins, The New York Times reported "growing doubts from scientists about the strength of the government's case." The Baltimore Sun detailed that "scientists and legal experts criticized the strength of the case and cast doubt on whether it could have succeeded." Dr. Alan Pearson, Director of the Biological and Chemical Weapons Control Program at the Center for Arms Control and Non-Proliferation -- representative of numerous experts in the field -- expressed many of those scientific doubts and demanded a full investigation.
There may be legitimate grounds for doubting whether an independent, 9/11-type Commission of the type Holt proposes is the ideal tribunal to conduct a real investigation, but it is clearly the best of all the realistic options. The only other plausible alternative -- an investigation by Congress itself -- is far inferior, as anyone who has observed any so-called "Congressional investigation" over the last decade should immediately recognize (here, as but one example, is the account I wrote about a House hearing last September attempting -- with cringe-inducing ineptitude and total futility -- to "grill" FBI Director Robert Mueller about the FBI's case against Ivins). How effective an independent investigative Commission like this will be will depend on the details of its structure -- its subpoena powers, punishments for defiance, and the independence of its members. That Rush Holt will play a key role, if not the key role, in overseeing its creation is a reassuring feature that the bill he introduced can be actually productive.

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

For Immediate Release Contact: Zach Goldberg March 3, 2009
202-225-5801

HOLT INTRODUCES ANTHRAX COMMISSION LEGISLATION

Bill Would Create 9/11 Commission-Style Panel to Investigate Anthrax Attacks and Government Response

(Washington, D.C.) – Rep. Rush Holt (NJ-12) today introduced the Anthrax Attacks Investigation Act of 2009 (HR 1248), legislation that would establish a Congressional commission to investigate the 2001 anthrax attacks and the federal government’s response to and investigation of the attacks. The bipartisan commission would make recommendations to the President and Congress on how the country can best prevent and respond to any future bioterrorism attack. The attacks evidently originated from a postal box in Holt’s Central New Jersey congressional district, disrupting the lives and livelihoods of many of his constituents. Holt has consistently raised questions about the federal investigation into the attacks.

“All of us – but especially the families of the victims of the anthrax attacks – deserve credible answers about how the attacks happened and whether the case really is closed,” Holt said. “The Commission, like the 9/11 Commission, would do that, and it would help American families know that the government is better prepared to protect them and their children from future bioterrorism attacks.”

Under Holt’s legislation, the commission would be comprised of no more than six members from the same political party. The commission would hold public hearings, except in situations where classified information would be discussed. The commission would have to consult the National Academies of Sciences for recommendations on scientific staff to serve on the Commission. The Commission’s final report would be due 18 months after the Commission begins operations.

“Myriad questions remain about the anthrax attacks and the government’s bungled response to the attacks,” Holt said. “One of the most effective oversight mechanisms we can employ to get answers to those questions is a 9/11 style Commission.”

Examining Other Healthcare Models

Healthcare is highly valued by our society, yet it seems that many of our pundits and politicians are willing to create a new healthcare system from whole cloth. In other words, let's consider this or that experiment, and the winner will be the compromise melange that gets passed by Congress. (Definition of melange: a collection containing a variety of miscellaneous things.)

Well, we already experimented with the theory that government was the problem, tossing strict regulation (of banks, mortgage providers, stockbrokers, the food and drug industries, and military procurement, to name a few) in the wastebin, and where did it get us? Do we really want our healthcare system to be crafted by a bunch of horse-traders, and laden with pork?

I, for one, don't think we have the time or money for another major social experiment. I think it is time to put the available information to work to craft a system that we know will meet our needs, before we put it into place.

So far, there has been deafening silence on the subject of healthcare systems in the rest of the world, and what is wrong and right with them. Yet these models can tell us so much about how different programs are likely to work. We should be examining the other systems under a microscope right now, as the administration and Congress begin taking positions.

Thankfully, blogger Tim Foley at Change.org has begun this conversation, describing how a low-cost, high tech, high drug use system has led to enviable life expectancy and infant mortality rates in Japan. Enjoy his enlightening piece.

NY Times "Postscript" to Scott Shane's article on Ivins of Jan 4, 2009

A two-paragraph article in today's NY Times, sans byline, appears to end discussion of the so-called "chemical signature" said to identify the source of water used to grow the anthrax letter spores:

On Tuesday at an American Society for Microbiology conference in Baltimore, an F.B.I. scientist, Jason D. Bannan, said the water research ultimately was inconclusive about where the anthrax was grown. An F.B.I. spokeswoman, Ann Todd, said on Wednesday that the bureau “stands by the statements” of Dr. Bannan.

It is a postscript to Scott Shane's major article on Bruce Ivins dated January 4, 2009, which reported that a "chemical signature" of the water in which spores were grown pointed to Fort Detrick, Md.

Revealed: Scientific evidence for the 2001 anthrax attacks

from an article by Debora MacKenzie, who has been knowledgeably reporting on anthrax and bioterrorism at the New Scientist for more than a decade:

. . . Next the team developed highly sensitive tests to screen all 1072 samples for four of the mutations. Eight samples had all four. One came from a flask labelled RMR-1029 that Ivins was responsible for at USAMRIID. The other seven came from cultures taken from that flask, only one of which was not located at USAMRIID. So while these findings show the attack spores came from one of these cultures, the FBI has gone further in concluding the attack came directly from the RMR-1029 flask.

Another question is how the attacker turned the water-based slurry of spores in the flask to the fine, dry powder in the letters. . .

How to Heal the Ailing FDA

Six spot-on suggestions from Steve Nissen, MD to the Obama administration.

Anthrax investigation still yielding findings: Chemical composition of spores doesn't match suspect flask.

Nature article by Roberta Kwok discusses the American Society for Microbiology's Biodefense and Emerging Diseases Research Meeting in Baltimore, Maryland on February 24, 2009. Excerpt:

Joseph Michael, a materials scientist at Sandia National Laboratories in Albuquerque, New Mexico, presented analyses of three letters sent to the New York Post and to the offices of Senators Tom Daschle and Patrick Leahy. Spores from two of those show a distinct chemical signature that includes silicon, oxygen, iron, and tin; the third letter had silicon, oxygen, iron and possibly also tin, says Michael. Bacteria from Ivins' RMR-1029 flask did not contain any of those four elements. . .

NICE on Mars

Merrill Goozner discusses a BMJ article by Nigel Hawke about Britain's National Institute for Health and Clinical Excellence, and how it might help those of us in the less-regulated medical world to get useful information on pharmaceuticals. Excerpts:

The global pharmaceutical industry considers Great Britain's National Institute for Health and Clinical Excellence (NICE) about as welcome as salmonella-tainted peanut butter at a Super Bowl party.

NICE has used independent researchers to compare the effectiveness of new drugs (especially cancer drugs) to what's already available. It then proceeds to establish their value by measuring how much they extend life and wellbeing (the dreaded cost-effectiveness analysis, also independently derived). Finally, the agency provides the information to England's National Health Service, which uses it to determine what services it can provide through its limited budget.

Great Britain also has longer life expectancy, lower infant mortality and health care costs about 60 percent of what we pay in the U.S.

NICE may export its model for profit to -- oh, double the horror -- the U.S. "It's clear that what we do and how we do it is of interest to healthcare systems around the world, regardless of how they are funded," NICE chief executive Andrew Dillon told BMJ.