HealthLawProf Blog

Some at FDA Oppose Rules Against Suing Drugmakers

The Washington Post reports that congressional investigators said Wednesday that top scientists and career employees at the FDA opposed agency regulations that weaken consumers' ability to sue drugmakers.  The Washington Post writes,

At issue is language in a drug labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called preemption.

Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry A. Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.

"Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted John Jenkins, a doctor who oversees the FDA's new drug reviews, as saying. "We know that such an assumption is false."

Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.

In a case to be argued before the Supreme Court on Monday, a Vermont woman sued Wyeth after she lost her right arm below the elbow following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, prompting gangrene to set in. Diana Levine argued that the company had a duty to warn consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million.

Wyeth appealed, saying it was protected from such suits. It argued that a state court cannot overrule the FDA's judgment on label warnings.

FDA scientists had weighed the risks and benefits of Phenergan, used to treat nausea and allergies, when it approved the prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.

Nobelist Sees US Accepting Universal Health Care

The Washington Post reports that Nobel Prize-winning economist Paul Krugman believes universal health care may soon become an accepted feature of American life.  The Washington Post writes,

In an interview with the Bulletin of the World Health Organization, the Princeton University professor says the U.S. has retirement and social security systems that are "in some ways more comprehensive" than many European countries.

He says Americans would find universal health care inconceivable to live without once they see the benefits of a good plan.

In the interview published Friday, Krugman said he was optimistic because he feels there's growing consensus on what is needed, unlike in 1993 when the Clinton administration tried to draft an agreement.

Some 45 million Americans lack health care.

Obama Jumps on McCain Adviser's Health Remarks

The Washington Post reports that Sen. Barack Obama's presidential campaign claimed Tuesday that comments by a top adviser to John McCain reinforced Obama's contention that millions would be worse off if they lose employer-sponsored health coverage and end up buying it themselves.  Kevin Freking writes,

McCain wants to change the current income tax treatment of health insurance, treating payments toward health insurance as taxable wages. In exchange, individuals would get a $2,500 tax credit and families would get a $5,000 credit when buying health coverage.

Some health analysts say the Republican's plan would erode employer-based health insurance coverage by encouraging younger, healthier workers to shop around and find a better deal directly from an insurer in the individual market. And, if those workers dropped employer coverage, some companies would eliminate coverage entirely because of the costs associated with insuring older or less healthy employees.

Douglas Holtz-Eakin, a domestic policy adviser for McCain, attempted to assure that such a scenario would not occur, but gave Obama an opening.

"Why would they leave?" Holtz-Eakin said in a story published by CNNMoney.com "What they are getting from their employer is way better than what they could get with the credit."

Obama's campaign quickly seized on the comment. In remarks prepared for delivery Tuesday in Harrisonburg, Va., Obama described Holtz-Eakin's comments as a "stunning bit of straight talk, an October surprise from his top economic adviser."

"(Holtz-Eakin) said that the health insurance people currently get from their employer is and I quote 'way better' than the health care they would get if John McCain becomes president," Obama said. "Now this is the point I've been making since Sen. McCain unveiled his plan. It took until the last seven days of this election for his campaign to finally admit the truth. But hey, better late than never."

Holtz-Eakin said he was trying to say that the individual health insurance market can be improved and that McCain has offered proposals to make it better, but that the changes McCain seeks won't weaken employer-sponsored health coverage.

"The question I answered was: 'Will the young and healthy leave their generous employer-sponsored coverage as the Obama campaign claims?' My response was that, obviously, if they had better coverage, they would not change. The Obama campaign deliberately took the quote out of context. This continues their disgraceful campaign," Holtz-Eakin said.

Obama campaign officials noted that an independent analysis by the Tax Policy Center projects that McCain's plan would cause about 21 million people to buy coverage in the individual market over the next 10 years, but that 20 million would have lost or refused coverage through their employer. The Tax Policy Center is a joint project of the Urban Institute and the Brookings Institution, two think tanks.

"It's a bad deal to push people into the individual market because people pay more for less," said Neera Tanden, Obama's domestic policy director. "So what was astonishing is that Doug Holtz-Eakin basically agreed with Sen. Obama that the individual market is a worse deal."

FDA's Stance on Bisphenol A is Questioned

The Los Angeles Times reports that an independent panel of scientific advisors said the FDA's conclusion that bisphenol A is safe for use in food containers is badly flawed because the agency did not consider all the data.  The Los Angeles Times writes,

The chemical, known as bisphenol A, is used to make plastic for food packaging, baby bottles and other consumer and medical goods. Environmental groups want to ban BPA in products for infants because of concerns that it can interfere with their development. But the FDA recently said there was no harm from the low doses of BPA that babies, children and most adults get by eating foods from containers made with the chemical.

Asked by the FDA to review that conclusion, a panel of outside advisors delivered what amounted to a scientific rebuke.

"The margins of safety defined by FDA as 'adequate' are, in fact, inadequate," the report said. The advisors found that the FDA had not considered all available, credible scientific evidence, and urged the agency to essentially go back to the lab.

The report came as a surprise to environmentalists and supporters in Congress. Citing some advisors' ties to industry, critics had initially questioned the panel's objectivity.

The report will be discussed at a meeting of the FDA's science board Friday, but what it will mean for consumers was not immediately clear.

Consumers can reduce their exposure by avoiding plastic containers imprinted with the recycling number 7. Many of these contain BPA.

How Obama would Change Health Care

The Washington Post reports on Sen. Barack Obama's health care reform proposals.  Amy Goldstein writes,

On the ninth floor of an office building just off the Boston Common, a group called Health Care for All runs a help line that, not long ago, got 40 calls a month. Today, the calls each month have swelled to 3,000, as people throughout Massachusetts phone in for guidance in navigating a state experiment in health reform that is the most ambitious in the country -- and a test of Sen. Barack Obama's vision for reshaping health care nationwide.

Kate Bicego, the help line's manager, slipped on her headset one recent afternoon as a call came in from Travis Lynn, a 26-year-old from Jamaica Plain with asthma and a part-time job at an old movie theater. He wanted to renew his enrollment in Commonwealth Care, government insurance that Massachusetts now offers adults who cannot get coverage through their work or afford it themselves. After a few questions, Bicego told him: "So, it sounds like you will still be eligible . . . premium-free, with vision, dental and medical."

Lynn is one of 439,000 people here who have gained insurance since Massachusetts embarked two years ago on a path to near-universal coverage. More than half of them are paying toward it; the rest, like Lynn, get it free. How close Massachusetts can come to its goal -- and what obstacles it encounters -- is significant, because its strategies resemble much of the approach to health care that Obama has said he would pursue if elected president next week.

Obama says he would keep the familiar arrangement in which most Americans get health insurance through their jobs, as Massachusetts is doing. Yet he also favors profound -- and controversial -- changes that Massachusetts also is putting in place: Expanding government insurance programs and subsidies. Requiring employers to offer their workers coverage or face penalties if they do not. Forbidding insurance companies to reject anyone or charging more if they are sick. Creating a national health insurance exchange to help people to find and compare private insurance policies on their own.

In the most significant departure from the Democratic nominee's thinking, Massachusetts has imposed a mandate that requires most adults to carry health insurance -- and fines them if they refuse.

In the 31 months since the experiment here began, the share of working-age people without health insurance has plunged -- from 13 percent to 7 percent by one estimate -- more sharply and quickly than anyone expected, leaving Massachusetts with the lowest uninsured rate in the country. But the unexpected number of people also has translated into higher-than-expected costs. Massachusetts has been forced twice to scrounge for extra money, totaling more than $250 million this year and last, from state funds and other places.

There have been more unintended consequences. The large number of people who have gotten insurance and are suddenly looking for care has aggravated a shortage of family physicians and other primary-care doctors. A reshuffling of federal and state money, to help pay for the extra insurance, has pulled funds away from some hospitals and clinics that have long been havens for poor patients.

Hard as it was to enact Chapter 58, as the health-care law here is known, the work of putting the plan into practice is proving even more rigorous, according to state officials, business leaders, health-care providers and community activists. The law left unanswered polarizing questions, including who should be eligible for subsidies, what benefits must be included and whether some people should be excluded from the mandate.

"It isn't like you come up with a perfect plan and turn it on and see how it works," said Brian Rosman, research director at Health Care for All, the nonprofit that runs the state's largest private health help line. "Washington needs to understand that as well."

"This is all really a journey," said Nancy Turnbull, an associate dean at the Harvard School of Public Health and member of the governing board of the Health Connector, a new agency created out of the law. "Every time we make one of these decisions, we take a leap of faith."

Whether what is unfolding in Massachusetts could be replicated in Washington during an Obama administration is, people here say, an open question. The law that emerged in 2006 from the gold-domed statehouse on Beacon Hill was the product of an unusual alignment of outside forces, motivations of key players, and the local health-care climate.

Massachusetts's lawmakers had been warned that federal health officials would take away $385 million a year in money for poor patients unless the commonwealth found a different way to spend it. And on the streets of Boston, an influential coalition -- community activists, hospitals, doctors, unions and hundreds of religious groups -- had gathered signatures for a popular ballot initiative that, if the legislature did not act, could have rewritten the state constitution to make health care a right.

Continue reading "How Obama would Change Health Care"

How McCain would Change Health Care

The Washington Post reports on Sen. John McCain's health care reform proposals.  Amy Goldstein writes,

When Diane Derichs's husband was retiring from his assembly-line job making fruit bars for ConAgra Foods, the couple invited over an insurance agent to help her find a health plan.

A part-time hairdresser, Derichs, at 58, was too young for the Medicare that her husband, Vernold, could already get. Sitting at their kitchen table in a St. Paul suburb, Derichs told the agent about the back surgery she had once needed for her scoliosis, the bad tendons in her feet, the lupus that causes painful sores on her skin.

Blue Cross Blue Shield, the agent discovered, wouldn't accept her. Nor would Mutual of Omaha. Or any other company he checked. "It's like, whammo, don't get sick," Derichs said. "As soon as I said 'lupus,' it was just like: 'Red flag. Sorry, can't do anything.' "

And so, on the agent's advice, she signed up for the Minnesota Comprehensive Health Association, a last-ditch chance at coverage that the state offers to those the insurance industry does not want.

How well this nonprofit corporation -- and similar ones set up by nearly three dozen other states -- can serve insurance castaways such as Derichs is a test of Sen. John McCain's road map for the nation's health-care system. High-risk pools, as such arrangements are known, are a linchpin of the Republican presidential nominee's thinking about how to make health insurance more plentiful and less expensive.

If McCain is elected president next week, he has said, he would work to remove the tax preference for company health benefits and offer Americans tax credits to put toward any health plan they choose. He wants to let people buy health plans from insurance companies anywhere in the country, preempting state regulations that spell out whom insurance carriers must cover and what kinds of benefits they must provide.

McCain acknowledges that such a free-market climate would inevitably freeze out some people with serious medical problems who are looking for insurance on their own. So he is calling for a guaranteed access plan, a federal effort to share the cost of high-risk pools and dramatically expand their reach -- from fewer than 200,000 Americans in state plans today to perhaps 5 million.

A philosophical difference between the presidential candidates over health insurance comes down to this: Given that relatively few people have extremely expensive medical problems, is it better to require insurance companies to include them with everyone else, as Democrat Barack Obama favors, or to separate them, as McCain prefers, in insurance pools just for them?

Among the high-risk pools in 34 states, Minnesota's is the oldest, largest and, many believe, the most successful. "It just seems to work," said Doug Holtz-Eakin, senior policy adviser to McCain.

Created in a wave of health-care changes here in the late 1970s, the Minnesota Comprehensive Health Association (MCHA) had a membership of 28,000 last year, equaling nearly 7 percent of the state's uninsured population. Small as that share was, it far exceeded any other state's, according to the National Association of State Comprehensive Insurance Plans.

The price of belonging to MCHA is lower than in most states, set one-fifth above the cost of the average individual insurance policy in Minnesota. Like all such programs, MCHA requires a waiting period for new members before it will pay for treatment of medical problems they already had -- but the six-month wait here excludes drugs and is shorter than in some places.

Its finances are strained and getting worse, but less so than in other states. California's high-risk pool is so strapped that it put a limit on enrollment this year and lowered the maximum it would spend on anyone's treatment. Tennessee's pool has had to eliminate low-income subsidies for new members. Florida's pool has not let in anyone since 1991.

Continue reading "How McCain would Change Health Care"

California High-Risk Pool for Medically Uninsurable Helps Fewer Residents

The Los Angeles Times reports that a $75,000 benefit cap, high deductible and costly premiums make the Major Risk Medical Insurance Program unavailable, ineffective or unaffordable for many. Gov. Arnold Schwarzenegger recently vetoed a bill to expand the pool.  Jordan Rau writes,

Dave Dunlap is a Kern County trucker with a failing liver. Like about 600,000 Californians, he is too sick to qualify for private insurance on the open market.

"I'm trying to fight to get a transplant," he said. "Everyone's waiting for me to have a way to pay for it. I can't even get on the donor list until I have a way to pay for it."

California is supposed to have a solution for people like Dunlap. It is one of 35 states that arranges health coverage for people rejected by commercial companies because they have blemished medical histories.

This group -- known as "medically uninsurable" -- accounts for about an eighth of the 5 million Californians who lack health insurance. Most are self-employed, work for companies that don't provide insurance or don't have a job.

But California's publicly subsidized high-risk pool, long one of the least generous in the country, has atrophied over the tenure of Gov. Arnold Schwarzenegger -- even as the governor put the plight of the uninsured at the top of his political agenda.

Rising premiums and limited subsidies have made the Major Risk Medical Insurance Program either unaffordable, unavailable or ineffective for many of those who most need health insurance.

The program now covers about 13,000 Californians -- about 2% of the medically uninsurable.

Enrollment has dropped by almost a third since Schwarzenegger became governor.

Schwarzenegger last month vetoed a measure that would have expanded the 17-year-old pool, overruling the bill's endorsement by the pool's own governing board, most of whom he appointed.

The governor said "the only solution for our healthcare crisis" is a complete overhaul of the state's healthcare system along the lines of his $14.9-billion plan that the Legislature rejected last January as too expensive.

"We supported wholesale health reform, but this is a population that has nowhere else to go, and he's leaving them high and dry," said Elizabeth Landsberg, legislative advocate for the Western Center on Law & Poverty, a Los Angeles nonprofit.

Subscribers pay two-thirds of the pool's cost and the state about one-third. The insurers that voluntarily participate -- primarily Blue Cross of California and Kaiser Permanente -- break even.

Unlike most other states, which finance their programs either directly with tax dollars or with assessments on insurers, California's subsidies have come only from the state's tobacco tax.

Lawmakers have kept annual financing at or below $40 million a year, requiring the pool's administrators to cap its enrollment. As a result, for much of Schwarzenegger's tenure, the pool has had a waiting list of hundreds of people.

This year, Schwarzenegger and legislators provided a one-time allotment of $10 million out of fines against insurers to expand the pool's enrollment to 915 more people, including all those on the waiting list.

Even with that expansion, the pool will assist half the number enrolled at the program's apex in 1999.

One of the major obstacles is the cost of premiums, which the law sets at 125% of commercial insurance rates. More than a third of pool participants who dropped out this year told the pool's administrators that they couldn't afford it anymore. A 55-year-old Los Angeles County resident with one dependent would have to pay $11,240 in premiums and a $450 deductible this year for the cheapest plan.

Anne Walzer, a freelance graphic designer in San Francisco who is insured through the pool, said her premiums amount to 14% of her income. She said that she was diagnosed with the mildest form of multiple sclerosis.

Even though she has no symptoms and her doctor said the chance of serious sickness was minute, Blue Cross told her she was a "lifetime denial," she said.

"I'm healthy," said Walzer, 56, who said she pays $600 a month in premiums. "I hardly ever go to the doctor. I don't feel I belong in the major risk pool."

Continue reading "California High-Risk Pool for Medically Uninsurable Helps Fewer Residents"

Diabetes Drug Costs Soaring, Topping $12.5 Billion Last Year

The Washington Post reports that Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion.  Carla K. Johnson writes,

Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin - an inexpensive generic used reliably for decades - may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said Dr. David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

In one, researchers from University of Chicago and Stanford University looked at which pills and insulin doctors prescribed and total medication costs. Diabetes drug spending rose from $6.7 billion in 2001 to $12.5 billion in 2007, a period when costs dropped for metformin.

More patients got multiple prescriptions as new classes of drugs came on the market. And more patients with diabetes were seeing doctors, increasing from 14 million patients in 2000 to 19 million in 2007.

"There's been a remarkable change in diabetes treatments and remarkable increases in the cost of treatments over the past several years," said study co-author Dr. Caleb Alexander, assistant professor of medicine at the University of Chicago. "We were surprised by the magnitude of the changes and the rapid increase in the cost of diabetes care."

Nearly 24 million Americans, 8 percent of the population, have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.

Current guidelines say doctors should prescribe metformin (about $30 a month) to lower blood sugar in newly diagnosed patients and urge them to eat healthy food and get more exercise. Other drugs can be added later, on top of metformin, to help patients who don't meet blood sugar goals. The updated guidelines don't include Avandia, which costs about $225 a month.

Dr. Susan Spratt, an endocrinologist at Duke University Medical Center, said she prescribes whatever it takes to lower her patients' future risk of blindness and amputations. That can mean coupling more costly drugs with metformin to hit blood sugar goals.

Continue reading "Diabetes Drug Costs Soaring, Top $12B last year"

Fresh Hopes and Concerns As Fetal DNA Tests Advance

The Washington Post reports that doctors have started using powerful new DNA tests to screen fetuses for a wider range of genetic abnormalities, spotting more problem pregnancies early but stirring fears that the results will increase abortions as well as confuse and needlessly alarm many couples.  Rob Stein writes,

The tests, which use "gene chips" to detect much subtler chromosomal variations than standard prenatal testing can, have also triggered complaints that they mark another step toward a society that seeks to weed out aberrations in the quest for the perfect child.

Proponents argue that the tests allow couples to harness the latest molecular technology to target the most devastating genetic syndromes, alleviating their worries in some cases and in others identifying abnormalities soon enough to terminate the pregnancy or prepare to care for an afflicted baby.

But critics say the tests have not been thoroughly validated and threaten to produce a flood of murky, misleading results that will subject emotionally vulnerable couples to unnecessary anxiety, perhaps prompting some to abort healthy pregnancies.

Some worry that the technique could be used to hunt for the rapidly growing list of genetic markers that merely signal an increased risk for cancer, diabetes, mental illness, obesity, addiction and other conditions later in life. Someday, similar tests could perhaps even vet fetuses for traits associated with beauty, personality or intelligence.

"It's a classic Pandora's box," said Leslie G. Biesecker of the federal government's National Human Genome Research Institute. "Like any powerful technology, it solves some problems while at the same time creating new ones. How you use a powerful technology decides whether it's good or bad."

The testing is being introduced at a time when there is already intense debate about wider screening for Down syndrome, which is detected by examining fetal DNA obtained through amniocentesis or chorionic villus sampling.

Called comparative genomic hybridization, the new tests use "microarrays" or gene chips to search for dozens of less common, often more severe syndromes caused by subtle deletions or additions of genetic material that standard genetic analysis misses.

"We can interrogate the fetal genome to identify smaller pieces of DNA that are either added or subtracted, and many of these can cause disease," said Ronald J. Wapner of Columbia University, who is leading a $3.3 million federally funded study that is starting to evaluate the technology in 4,000 pregnancies.

Many experts say doctors should wait for the outcome of that study and possibly others before offering the testing widely. But two labs in the study -- Baylor College of Medicine in Houston and Signature Genomic Laboratories of Spokane, Wash. -- are already publicly promoting the service, and a third at Emory University in Atlanta has quietly started doing the tests.

"I believe it's ready for prime time," said Arthur L. Beaudet, who chairs Baylor's Department of Molecular and Human Genetics. "For people who want the best possible prenatal diagnosis and want the maximum information, this is the best option."

The tests, which cost about $1,600 and are not yet covered by insurance, can detect about 150 known genetic disorders that can cause physical deformities, mental retardation and a host of health and behavioral problems, he said.

Continue reading "Fresh Hopes and Concerns As Fetal DNA Tests Advance"

AIDS Treatment Should Start Sooner, Study Finds

The Washington Post reports that a large new study could change the care of hundreds of thousands of Americans, suggesting that people who have the AIDS virus should start drug treatments sooner than current guidelines recommend.  Marilynn Marchione writes,

The study found that delaying treatment until a patient's immune system is badly damaged nearly doubles the risk of dying in the next few years compared to patients whose treatment started earlier.

Doctors have thought it would be better to spare patients the side effects of AIDS drugs as long as possible.

"The data are rather compelling that the risk of death appears to be higher if you wait than if you treat," said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which helped pay for the study.

If the results prompt doctors to change practice _ as Fauci and other AIDS specialists predict _ several hundred thousand Americans who are not taking AIDS drugs now would be advised to start.

The study was reported Sunday at an infectious diseases conference in Washington.

About 56,300 Americans are newly infected with HIV each year. The virus ravages T-cells _ "helper cells" of the immune system that fight off germs. Once that happens, people can fall prey to a host of diseases that prove fatal.

Powerful drug combinations available since the mid-1990s have transformed HIV infection into a manageable chronic condition rather than the death sentence it once was. But they can cause heart and cholesterol problems, diarrhea, nausea and other side effects. They also must be taken faithfully or resistance develops and the drugs stop working.

That is why guidelines by the government and the International AIDS Society recommend that patients who are not yet having AIDS symptoms delay starting on the drugs until their T-cell counts fall below 350 per cubic millimeter of blood (healthy people have more than 800).

"There was this thinking, maybe the drugs were worse than the disease. If you could wait as long as you possibly could wait, you would have fewer side effects," said Dr. Robert Schooley, infectious diseases chief at the University of California, San Diego.

The new study is the largest to look at whether that advice is sound. Researchers led by Dr. Mari Kitahata of the University of Washington in Seattle pooled information on 8,374 people in the United States and Canada with T-cell counts of 351 to 500 from 1996 to 2006.

About 30 percent started taking AIDS drugs right away; the rest waited until their T-cell counts fell below 350, as guidelines recommend.

"We found a 70 percent improvement in survival for patients who initiated therapy between 350 and 500" compared to those who waited, Kitahata said.

Two other recent studies found that people who start taking AIDS drugs while their T-cell count is above 350 have a better chance of getting their count back to normal than those who start later. Another key study found that briefly interrupting treatment to give patients "drug holidays" puts them at grave risk.

"These studies have all shown the same thing _ that we were starting too late" and need to keep treatment going once it starts, said Schooley. He helped write the AIDS society guidelines and consults for several companies that make AIDS drugs.

The bigger problem is that as many as a third of people diagnosed with HIV only discover they are infected after their T-cell counts already have fallen below 350 and they have serious complications.

"People are still being tested and identified way too late," and the new study shows how important it is to test and find people sooner, said Dr. Daniel Kuritzkes, an AIDS specialist at Brigham and Women's Hospital in Boston.

Newer drug combinations that have come out in recent years have fewer side effects. Also, some require only a pill or two a day, making adherence less of an issue.

These advances and the new study justify a fresh look at the guidelines, Fauci said. He predicted that doctors would not wait for them to change to start treating patients sooner.

The new study's findings do not apply to HIV patients who also have hepatitis, kidney damage or other medical problems, or who are pregnant - doctors have long advised that these people start treatment as soon as they are diagnosed.

A Plan to Improve Health Care and Limit Costs

The New York Times provides an interview with Scott Serota, President and CEO of the Blue Cross and Blue Shield Association, about the association's newly adopted four-point initiative aimed at containing health care costs and improving care.  Elizabth Olson writes,

The issue of health care costs usually comes up for discussion right after the economy as costs for businesses and consumers continue to climb. The Blue Cross Blue Shield Association insures 102 million Americans — one in three people — and has networks that include 90 percent of the nation’s providers and 80 percent of its hospitals.

The association’s board just adopted a four-point initiative aimed at containing health care costs and improving care. The goals range from eradicating hospital infections to pushing for health care coverage for everyone. From Chicago, Scott Serota, the association’s president and chief executive, recently discussed the new goals:

Q. What was the impetus for adopting a new plan of action, and why now?

A. Much of what is discussed in virtually all forums as health care reform is really health care financing reform. We really have not gotten sufficient national attention on the real underlying issue, which is that the entire health care delivery system needs to be modified. We, the Blues, feel we should try to drive toward a vision for the health care delivery system which we can move collectively forward with our partners.

Q. One of your goals is to cut the prevalence of diabetes in half. Why did you select that?

A. There are 57 million Americans today who are prediabetic. The cost of treating it is $116 billion annually. We treat it pretty well, but there are tangible things we can do in the areas of obesity, weight management, nutrition, fitness and health risk assessment to reduce the incidence of diabetes. We can cut that 57 million number in half and make a dramatic impact not only in the delivery system costs but in people’s lives.

Q. Your second point is more affordable health care. How do you translate that sweeping goal into something concrete when costs are steadily mounting for both businesses and individuals?

A. We’re not saying the cost of health care will go down. It won’t. Our goal is that health care costs rise no faster than any other goods and services. The essential fundamental to getting there is improving the underlying system because 30 percent of care rendered today, according to some studies, is unnecessary, redundant and, in some cases, even harmful. We need to get waste out of the system. That means $700 billion in a $2.4 trillion system.

Q. When you say waste, what do you mean?

A. I’m talking about a whole battery of things like duplicative testing such as two M.R.I.’s instead of one or hospital-acquired infections. The cornerstone of how we get at this is creating a comparative effectiveness institute to study what treatments really work best for a given condition — and letting everyone know what works. There is legislation on this pending in Congress.

Q. Medicare just announced it would stop paying hospitals to treat patients harmed by care, like being given an incompatible blood transfusion. One of your goals addressed that — to eradicate so-called “never events” — but is that the cart following the horse?

A. Not paying for them is the end point. If they are no longer getting reimbursed for those costs, institutions will be very aggressive in eliminating those events. There are some Blue plans that are not paying for those events.

Q. Why haven’t more Blue plans limited reimbursement for hospital-caused problems?

A. More will. We’re trying to figure out mechanisms to help them improve their performance. Then we’ll tie reimbursement to performance. These events are a huge problem where we haven’t made a lot of progress over the last 10 years. We have to fix it, then adjust the financing.

Q. An ambitious point you have adopted is to ensure that everyone has health care coverage. What specific steps can Blue Cross Blue Shield take to solve something that has remained so elusive?

A. We believe that every American should have coverage, but 45 million don’t have it. The reasons are not the same, but if coverage is affordable, more people will be able to buy it. We also need to work with people who are eligible for government programs but are not enrolling. And we need to develop new products like high-deductible plans to attract people like the “young invincibles” — who think they will never get sick — and get them in the habit of buying coverage.

Q. Do you support proposals like the one from the Republican presidential candidate John McCain that move away from the employer-based system?

A. It is essential that we continue to support the employer-based system because 162 million Americans today get their coverage through their employer. We should not disrupt this important piece. Employers provide significant financing and they keep us on our toes.

Q. How do you plan to get others in the health care industry to sign on and help achieve your newly adopted goals?

A. Conversations, dialogue and meeting with trade association leaders. These are goals for all of us. We are insuring one-third of all Americans so we need to step out and provide leadership with real actionable steps.

Q. Do you have any near-term — like one-year — benchmarks to measure whether the Blues are making progress in meeting each of the new goals?

A. We will have annual benchmarks that we will put out. We believe that what gets measured is what gets done.

Is Going Public with your DNA too Revealing?

US News discusses an interesting initiative by Harvard professor, George Church, called the Personal Genome Project, which seeks 100,000 volunteers to publish their genomes online in an attempt to advance science.  Although commendable, these volunteers, however, could potentially waive their privacy rights, find it harder to get health insurance, and suffer discrimination.  Nancy Shute writes,

Facebook has nothing on George Church when it comes to sharing sensitive personal details. This Harvard Medical School genetics professor happily posts his family medical history and ailments (narcolepsy, motion sickness) on the Web—and he's telling the world just what's in his DNA. As one of the first 10 people to publish their genomes online, Church hopes to make the point that sharing genes on the Internet can advance science further than the current system, in which DNA databases are protected from public scrutiny and individuals aren't identified.

In the same way that you have amateur astronomers who help track celestial events, we hope to inspire a whole generation of 'amateur geneticists' to mine DNA sequences," Church says. His Personal Genome Project is recruiting 100,000 volunteers who would be willing to tell all for science, and signed up 10 scientists, who presumably know enough to understand the potential risks of doing so, to be the first guinea pigs. Their genetic data was to be released October 20.

The notion is that linking genetic data and extensive personal information—traits such as height, weight, ethnic background, or a fondness for cheeseburgers—will make it easier to advance research on the genetic basis of diseases such as cancer and heart disease, which have so far eluded discovery. To protect privacy, most genetic databases that researchers mine to unearth keys to our individual idiosyncrasies have been stripped of that kind of personal data, or phenotype, and family histories. Another very 21st-century notion is that making the information open to all increases the odds of collaboration and speeds discovery—a scientific Wikipedia.

But genetic oversharing could be dangerous, Church admits. Participants could find it harder to get health insurance or might suffer discrimination if their genes show they're likely to get a serious disease. "Some of them know they're going to get hurt, like astronauts and mountain climbers," Church says. "But if enough of them see a benefit to themselves, their families, and society, then it will keep growing."

Want to peek into your own DNA? More and more companies are eager to help you try. Options include:

GeneTree.com. Ancestry testing that links to genealogical records, combined with a social-networking website. $149 to $199.

AfricanDNA.com. Ancestry testing, with the option of personalized genealogical research. $189 to $1,077.

deCODEme.com. Genetic scan with health risk, ancestry, and sharing. $985.

23andme.com. Genetic scan that calculates health risks and ancestry, and allows sharing with friends and family. $399.

Navigenics.com. Scans genes to assess relative health risks, with access to genetic counselors. $2,500.

Knome.com. Sequence your whole genome—all 3 billion base pairs and 25,000 genes—for $350,000.

Personalgenomes.org. The Personal Genome Project aims to recruit 100,000 people willing to share their genes and medical history with the world. It was to start publishing information on donors on October 20. Cost is expected to run $1,000 to $2,000.

Medical genetic tests are also available online—even paternity tests—but are largely unregulated. U.S. News tested some of the more heavily marketed genetic tests and found their quality and reliability vary wildly—even if you try, as we did, to find out if a beloved dog has a genetic propensity for macular degeneration.