The Health-Care Ego Trip

What's driving the great health debate of 2009 is not a popular clamor for universal insurance. "Many Americans are balking again at the prospect of health care reform," writes pollster Andrew Kohut of the Pew Research Center. A new Wall Street Journal poll found 41 percent of respondents opposed to President Obama's proposals and 39 percent in favor (the rest were undecided). The underlying driver is politicians' psychological quest for glory.

"My colleagues, this is our opportunity to make history," Chairman Max Baucus implored last week as the Senate Finance Committee opened consideration of his bill. Politicians, in their most self-important moments, see themselves as instruments of national destiny. They yearn to be remembered as the architects and agents of great social and economic transformations. They want to be at the signing ceremony; they want a pen.
Ordinary Americans are rightly suspicious of this exercise in collective ego gratification, which has gripped Obama and many of his congressional allies. Even when the goals are worthy -- as they are here -- the temptation to exaggerate, simplify and sugarcoat often proves irresistible. Baucus's promotion of his handiwork is a case in point.
One study "found that every year in America, lack of health coverage leads to 45,000 deaths," he told the committee. "No one should die because they cannot afford health care. This bill would fix that."
There was more. "These reforms would give Americans real savings," Baucus said. The Congressional Budget Office "tells us that the [insurance] rating reforms and exchanges in our proposal would significantly lower premiums in the individual market." As well, the bill wouldn't increase the budget deficit and "starts reducing the deficit within 10 years."

If only all this were irrefutable. But Baucus's claims are shaky. It is questionable whether more insurance would save 45,000 lives a year. Unfortunately, just having insurance doesn't automatically improve people's health. Sometimes more medical care doesn't really help. Sometimes people don't go to doctors when they should or follow instructions (take medicine, alter lifestyles). Indeed, many people don't even sign up for insurance to which they're entitled. An Urban Institute study estimated that 10.9 million people eligible for Medicaid or the Children's Health Insurance Program in 2007 didn't enroll.
The 45,000 figure cited by Baucus is itself an unreliable statistical construct built on many assumptions. It's based on a study of 9,004 people ages 17 to 64 who were examined between 1988 and 1994. By 2000, 351 had died; of these, 60 were uninsured. The crude death rates among the insured (3 percent of whom died) and uninsured (3.3 percent) were within the statistical margin of error. After adjustments for age, income and other factors, the authors concluded that being uninsured raises the risk of death by 40 percent. They then extrapolated this to the entire population by two techniques, one producing an estimate of 35,327 premature deaths and another of 44,789.
This whole elaborate statistical edifice rests on a flimsy factual foundation. The point is not to deny that the uninsured are more vulnerable (they are) or that extra insurance wouldn't help (it would). The point is that estimating how much is extremely difficult. Advocates exaggerate the benefits. Remember: Today's uninsured do receive care.
What about lower insurance premiums? Here's the actual CBO analysis: "Premiums in the new insurance exchanges would tend to be higher than the average premiums in the current-law individual market -- again with other factors held equal -- because the new policies would have to cover pre-existing medical conditions and could not deny coverage to people with high expected costs for health care." The CBO added that it couldn't predict premiums because so many factors might influence them.
It's true, as Baucus says, that the CBO estimated that new taxes and Medicare savings would cover the costs of his original bill. But many Medicare "savings" are probably phony. Congress is likely to reverse them, as in the past. Put in that category about $200 billion in "savings" over 10 years from lower reimbursement rates for doctors (under the "sustainable growth rate" formula). Congress has repeatedly prevented those cuts from occurring. A separate $180 billion in "savings" from lower reimbursement for hospitals and other providers are similarly suspect. Together, these items provide about half the plan's financing.
Americans worried about this legislation may not know its details or may even be misinformed. Still, their skepticism is justified. Grandiose rhetoric obscures unflattering reality. The proposals don't force the major structural changes in the delivery system that might curb uncontrolled health spending, which is the central problem. The bills that Congress is considering might marginally improve Americans' health but would worsen the federal budget outlook and squeeze other public and private spending. Whatever bragging rights result will quickly erode in the face of the health system's continuing problems.

Free Child Vaccinations Saturday

The city of Milwaukee is reminding parents that children will not be allowed in school beginning October 12 if their immunization requirements are not met.

The Milwaukee Health Department is holding two free childhood immunization clinics today at the South Side Health Center at 1639 S. 23rd Street and the Northwest Health Center at 7630 West Mill Road.  The clinics last from 10 a.m. to 2 p.m.

Students and families that are uninsured or under-insured are eligible to receive shots. If possible, parents should bring their child's immunization records with them.  

The Milwaukee Public School System sent home reminder letters this week to parents whose children haven't received their immunizations yet.  State law requires children in Kindergarten through 5th grade to be up-to-date with their shots. 

AIDS vaccine "important step" against disease

An experimental AIDS vaccine made from two older versions has made major progress in finding an effective way to combat the illness, researchers said on Thursday.
But its application may be limited and a commercial vaccine may require more time.
The health minister of Thailand, where the trials were conducted, called the outcome a "very important step for developing an AIDS vaccine." Two U.N. agencies said they gave "new hope" in battling the disease but more work was needed.
At least one researcher suggested the vaccine might not be effective in areas and in instances where AIDS is most prevalent.
The vaccine is a combination of Sanofi-Pasteur's ALVAC canary pox vaccine and the failed HIV vaccine AIDSVAX, made by a San Francisco company called VaxGen and now owned by the nonprofit Global Solutions for Infectious Diseases.
The trial was sponsored by the U.S. army and conducted by the Thai Ministry of Public Health. Officials from the two countries told a news conference in Bangkok the risk of infection had been cut by 31.2 percent among 16,402 volunteers.
"The result of the study is a very important step for developing an AIDS vaccine," Thai health minister Withaya Kaewparadai said. "It's the first time in the world that we have found a vaccine that can prevent HIV infection."
The result puzzled researchers, who said they could not understand why the vaccine combination was working.

TRIAL SUPPORTERS JUBILANT
But it was a triumph for supporters, who went ahead with the giant trial despite criticism it was unethical or a waste of money because the vaccine was widely expected to have no effect.
"Myself, like others, did not think there was a very high chance that this would give any degree of efficacy," said Dr. Anthony Fauci of the U.S. National Institute of Allergy and Infectious Diseases, which helped pay for the study.
"But nonetheless, we went ahead with the trial and it was controversial to go ahead with it."
In Geneva, the World Health Organization and the Joint United Natiopnals Programme on HIV/AIDS said: "The study results, representing a significant scientific advance, are the first demonstration that a vaccine can prevent HIV infection in a general adult population and are of great importance."
The two agencies, in a joint statement, described the efficacy as "modestly productive."
Sanofi shares rose as much as 1.6 percent in early trade in Paris but gave up the gains to fall 0.24 percent to 50.75 euros by 0904 GMT (5:04 a.m. EDT), while the DJ health index was down 0.57 percent. 
"We see no commercial vaccine available for some time yet, but the prospect has finally been raised (after 30 years of trying) that an effective vaccine is possible," said Michael Leacock, an analyst at ABN AMRO research.
More extensive work was needed, he said, before a vaccine could be suitable for regulatory approval.

RESULTS REMAIN INCONCLUSIVE
Muddying the waters of the trial result, people who got the vaccine and who became infected anyway had just as much virus in their blood and just as much damage to their immune systems as HIV patients who went unvaccinated.
That meant the vaccine helped prevent infection but did nothing to affect the virus once it is in the body.
"We had 74 infections in the placebo group and 51 in the vaccine group," Dr. Jerome Kim, a U.S. Army colonel at the Walter Reed Army Institute of Research in Maryland, who helped lead the trial, said by telephone.
"Although the level of protection that we saw was clearly modest, the study is a major scientific advance," Kim said.
"It is the first evidence that the development of a safe and effective vaccine is possible. Although we don't have all the answers now, it does have important implications for the future of HIV vaccine design."
Kim said the vaccine might not work in the people and places where HIV is most common -- in Africa, among men who have sex with men and among injecting drug users.
"The vaccine was tested in Thailand and it is really specific for the strains that are circulating in Thailand now," Kim said.
Both Fauci and Kim noted that the vaccine was formulated specifically to work against two subtypes of the human immunodeficiency virus -- E, which circulates in Thailand and Southeast Asia, and B, common in the United States and Europe.
In a statement, Sanofi-Aventis Chief Executive Chris Viehbacher said that the company would continue its research into HIV in partnership with academics, governments, non-governmental organizations and other vaccine makers.
The volunteers in the trial got six immunizations over six months, four with ALVAC and two with AIDSVAX.
ALVAC is a genetically engineered canarypox virus that has spliced into it synthetic versions of three HIV genes. AIDSVAX is made using two versions of one HIV gene, one from the B subtype and one from the E subtype.
The AIDS virus infects an estimated 33 million people globally and has killed 25 million since it was identified in the 1980s. It affects immune cells called T-cells.
Cocktails of drugs can control the virus but there is no cure. In 2007, Merck & Co ended a trial of its vaccine after it was found not to work, and in 2003, AIDSVAX used alone was found to offer no protection, either.

AIDS Vaccine Experiment Yields Unanticipated Positive Results

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An experiment in Thailand involving 16,000 men and women has demonstrated for the first time a small but measurable protective effect of an AIDS vaccine.

The vaccine, a complicated mixture of six "prime" and "booster" shots, reduced a person's risk of becoming infected by about one-third compared to people getting placebo injections.
The results were barely significant on statistical grounds, perplexing for scientific reasons and unanticipated by most researchers. Nevertheless, the first positive results for an AIDS vaccine after two decades of experimentation was being called a milestone.
"Conceptually, we now know a vaccine is possible," said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, which paid for most of the six-year trial. "Whether the vaccine is going to look anything like this one I don't know. But at least we know it can be done."
The vaccine is not licensed or being produced in large amounts. It is unlikely -- but not impossible -- that any country would consider it effective enough to be used as a public health measure against HIV.
Instead, the chief usefulness of the so-called ALVAC-AIDSVAX vaccine is likely to be what it can teach virologists about what is happening in the immune system when a person is even somewhat protected from HIV.
"We really need to go through the data to see if there are effects here that are potentially useful," said Col. Jerome Kim, a physician involved in the study, which was run by the U.S. Army, the National Institutes of Health, and Thailand's Ministry of Public Health.

He predicted that information gained from the trial after the results are fully analyzed will have "important implications for the design of future HIV vaccines."
Other researchers were less sanguine about the study, but did not want to be quoted by name as being skeptical when only a few details of the results have been released.
"I just think it's too early really," said one, who spoke on condition of anonymity for that reason. "It is in a kind of gray zone, and I think we should really get the data and look at it and see what it all means."
That the vaccine is at least nominally a success comes as a big surprise.
Early in the decade, more than 20 prominent researchers wrote an open letter to the journal Science urging the federal government to cancel the Thai trial because the vaccine was so unpromising. The study cost $105 million, most of it provided by the National Institutes of Health.

One vaccine component (ALVAC) is made by Sanofi Pasteur. The other (AIDSVAX) is made by Global Solutions for Infectious Diseases, formerly known as VaxGen. The vaccine was tailored to the strains of HIV circulating in Southeast Asia. Whether vaccine made from different strains would have the same effect isn't known.
In the study, volunteers in two provinces in central Thailand were randomly assigned to get vaccine or placebo shots. About 40 percent were women, and many were employed in manufacturing and shipping enterprises along Thailand's coast. They were counseled on ways to avoid HIV infection and advised to use condoms.
There were few intravenous drug users and male homosexuals -- groups at unusually high risk for HIV that make up most of the infected population in North America and Europe. In Africa and much of Asia, however, heterosexual intercourse is the most common route of infection.
Of 8,197 people who got vaccine, 51 became infected in the three years after their shots. Of the 8,198 who got placebo injections, 74 became infected.
While that difference -- 23 infections out of more than 16,000 people studied -- is significant, it could have occurred by chance. For example, if further analysis reveals that many of the infections were from IV drug use and that, by chance, there were more drug users in the placebo group of volunteers, the results would be less noteworthy.
Many details of the trial were not released Wednesday afternoon in briefings to reporters. More information will be presented at an AIDS vaccine meeting in Paris later this fall.
As a practical and scientific matter, two questions bedevil AIDS vaccine researchers, who hope this study may help them find answers.

The questions are: Which of the immune system's several defenses do need to be stimulated to keep someone from getting infected? What can be measured in lab experiments that indicates a "candidate" vaccine is doing that job?
Most vaccines contain parts of a virus or bacterium and stimulate the immune system to make antibodies, the dart-like molecules that attack invaders. Preliminary studies of the ALVAC-AIDSVAX vaccine, however, showed it induced very few antibodies. Human trials in 2003 of the AIDSVAX component, which "presents" the immune system with a protein from HIV's outer shell, showed no protection.
The other component, ALVAC, is a disabled bird virus loaded with three HIV genes. It is principally designed not to prevent infection but to stimulate the immune system to fight HIV more successfully after infection through a mechanism called "cell-mediated immunity."
However, in the Thai study infected people who got the vaccine had on average the same "viral load set-point" as people who got the placebo. Viral load set-point is the amount of HIV circulating in the bloodstream after the immune system's initial battle with the virus. It predicts to some extent how long a person is likely to survive.
How a vaccine that induces both a weak antibody response and a poor cell-mediated one can protect some people from HIV infection is the big initial mystery of this study.
"It tells us how much we have to learn about the correlates [indicators] of immunity," Fauci said.
The search for an AIDS vaccine -- famously predicted by Health and Human Services Secretary Margaret Heckler in 1984 to take two years -- has been a long series of disappointments.
The last big human trial, run on four continents in 2007, was stopped early when results not only showed that the vaccine provided no protection but hinted that it might be increasing a person's risk of infection.
A fuller analysis of that study is leading researchers to believe that it was probably differences in the recipients -- specifically, the rates of circumcision -- and not the vaccine that explain the different rates of infection.
That changed thinking is part of the reason some researchers were unwilling to say much of anything about the preliminary results from Thailand.
"The rush to judgment is something we should try to avoid," said John P. Moore, an AIDS researcher at Weill Cornell Medical College in New York. "We shouldn't be drawing radical conclusions based on a few raw numbers."