USA > Histoire > 2006 > Santé (I)

Like many places for alternative medicine, the Trinity Family Health Clinic in Lynnwood, Wash., also has a spiritual bent.

Kevin P. Casey for The New York Times        February 3, 2006

When Trust in Doctors Erodes, Other Treatments Fill the Void        NYT        3.2.2006
http://www.nytimes.com/2006/02/03/health/03patient.html?_r=1&oref=slogin

Study: Canadians healthier than Americans

Posted 5/30/2006 7:37 PM ET
USA Today

ATLANTA (AP) — You can add Canadians to the list of foreigners who are healthier than Americans. Americans are 42% more likely than Canadians to have diabetes, 32% more likely to have high blood pressure, and 12% more likely to have arthritis, Harvard Medical School researchers found. That is according to a survey in which American and Canadian adults were asked over the telephone about their health.

The study comes less than a month after other researchers reported that middle-aged, white Americans are much sicker than their counterparts in England.

"We're really falling behind other nations," said Dr. Steffie Woolhandler, a co-author of the Canadian study.

Canada's national health insurance program is at least part of the reason for the differences found in the study, Woolhandler said. Universal coverage makes it easier for more Canadians to get disease-preventing health services, she said.

James Smith, a RAND Corp. researcher who co-authored the American-English study, disagreed. His research found that England's national health insurance program did not explain the difference in disease rates, because even Americans with insurance were in worse health.

"To me, that's unlikely," he said of the idea that universal coverage explains international differences.

Woolhandler said her findings were different in at least one important respect: In the Canadian study, insured Americans and Canadians had about the same rates of disease. It was the uninsured Americans who made the overall U.S. figures worse, she said.

The study, released Tuesday, is being published in the American Journal of Public Health. It is based on a telephone survey of about 3,500 Canadians and 5,200 U.S. residents in 2002-03. Those surveyed were 18 or older.

The results are based on what those surveyed said about their health. In contrast, the researchers in the American-English study surveyed participants and also examined people and conducted laboratory tests on them.

The new study found that 6.7% of Americans and 4.7% of Canadians reported having diabetes; 18.3% and 13.9%, respectively, reported having high blood pressure; and 17.9% and 16.0% said they had arthritis. The Americans also reported more heart disease and major depression, but those difference were too small to be statistically significant.

About 21% of Americans said they were obese, compared with 15% of Canadians. And about 13.5% of the Americans admitted to a sedentary lifestyle, vs. 6.5% of Canadians. However, more Canadians were smokers — 19%, compared with about 17% of Americans.

About 42% of the Americans rated their quality of health care as excellent, while 39% of Canadians did.

Also, 92% of American women said they had a Pap test within the last five years, while 83% of Canadian women had. But Canadians have lower death rates from cervical cancer. "It's a little hard to interpret," Woolhandler said.

One more plus for the Americans: Fewer than 1% said they were unable to get needed care because of long waits, compared with 3.5% of Canadians.

However, about 80% of Americans had a regular doctor, while 85% of Canadians did. And nearly twice as many Americans said there were medicines they needed but couldn't afford (9.9% vs. 5.1%).

    Study: Canadians healthier than Americans, UT, 30.5.2006, http://www.usatoday.com/news/health/2006-05-30-canadians-health_x.htm

Doctors Struggle to Treat Mysterious and Unbearable Pain

May 30, 2006
The New York Times
By KATHLEEN McGRORY

It was supposed to be a typical ballet class. Cynthia Toussaint, then a senior dance major at the University of California, Irvine, engaged in her usual stretching routine: she raised her left leg to the barre and slowly bent her upper body down to her right knee.

For a moment, she delighted in the long stretch. But as she returned to an upright position, she felt a sudden pop in her hamstring. "It felt like a guitar string had been plucked and it had broken," said Ms. Toussaint, who is now 45.

An intense burning sensation followed; it felt as if her leg had been doused in gasoline and set on fire, she said. The next day, the college athletics trainer determined that she had pulled her hamstring. But even years later, the pain would not subside. It migrated to her other leg, leaving her bedridden for nearly a decade, and overtook her vocal cords, leaving her temporarily mute.

All the while, doctors puzzled over and even doubted her mysterious condition.

Ms. Toussaint now knows that she is among an estimated one million Americans living with complex regional pain syndrome, a nerve disorder formerly known as reflex sympathetic dystrophy syndrome. For patients with the disorder, a trauma as mild as a fractured wrist or a twisted ankle can cause the nerves to misfire, so much so that intense pain messages are constantly sent to the brain.

For the past 150 years, so little was known about complex regional pain syndrome that it was often diagnosed as psychosomatic. But doctors now believe that the condition complicates 1 of every 1,200 traumatic injuries. And desperate patients are turning to new, often unproven, drugs and treatments. "It is still quite a mysterious condition," said Dr. Scott M. Fishman, a pain management specialist at the University of California, Davis, and the author of "The War on Pain."

"It raises doubts in the eyes of doctors and the people that are looking for hard lab evidence or good imaging confirmation," Dr. Fishman said. "With this condition, we simply don't have that."

Baffling as it may be, the syndrome is not new to the medical literature. It was first documented by Dr. S. Weir Mitchell, a Civil War surgeon. But few physicians are familiar with it; the average patient sees 8 to 10 doctors before a diagnosis is made, according to a recent survey by American RSDHope, a support organization.

Pain is the hallmark of the condition, which outranks cancer as the most painful disease on the McGill Pain Index. For some, the sensation remains in one place, most commonly one of the extremities. For others, it spreads throughout the body, making even a light touch or minor changes in temperature agonizing.

For Ms. Toussaint, as for many other patients, the pain was life altering. When she tore her hamstring, she was on the verge of completing her bachelor's degree. She was also being considered for a part on the television series "Fame." But the injury left her in debilitating pain. She could no longer stand on her own or leave her house; riding in a car on the bumpy California roads was torture.

Ms. Toussaint dropped out of school and fell into a deep depression, she said. It took 13 1/2 years for her disorder to be diagnosed. Dozens of doctors told her it was "all in her head"; one even suggested she suffered from stage fright.

Without clear clues as to what induces the syndrome or who is particularly susceptible, doctors say that treating it is a challenge. Sympathetic nerve blocks can reduce the pain, and doctors say the relief often lasts longer than the anesthetic.

More than two dozen drugs are also being used to treat the pain. But none of the medications, which range from acetaminophen and ibuprofen to morphine and methadone, have been approved by the Food and Drug Administration for this use.

"The myth is that this condition isn't treatable, but the truth is that it responds to the same kinds of treatments that have been found effective for other neuropathic pain," said Dr. Anne Louise Oaklander, director of the nerve injury unit at Massachusetts General Hospital and an associate professor of neurology at Harvard.

Dr. Russell K. Portenoy, chairman of the department of pain medicine and palliative care at Beth Israel Medical Center in New York, added that treatment was "a trial and error" process.

Doctors tend to use the drugs that are most commonly prescribed for other conditions before the drugs that are less commonly used," he said. "But in many cases, doctors need to perform sequential trials to find out which drug or combination of drugs helps the most."

Dr. Portenoy said he is a consultant for drug companies but not on work related to the syndrome or its treatment.

Another treatment is to implant an electrical stimulator near the base of the spinal cord or the injured limb. The device sends low-level electrical signals to the spinal cord or to specific nerves and blocks pain signals from reaching the brain.

Dr. Robert J. Schwartzman of the Drexel University College of Medicine in Philadelphia is skeptical of the electrical stimulators. Although he first began implanting them in patients in 1986, he no longer does. "Long term," he said, "stimulators don't work. From what I've seen, they wear out and then they stop working."

Dr. Schwartzman treats the condition with ketamine, an anesthetic that blocks one of the body's pain receptors. In most cases, this five-day inpatient therapy reduced the pain significantly for three to six months, he said.

In addition, a 10-day outpatient procedure — more than 1,200 people are on a waiting list for it — is being tested in a controlled experiment. Although the trial has been approved by the F.D.A., it is awaiting approval by Drexel's institutional review board.

Dr. Schwartzman has also sent the most extreme cases — the 30 patients who were found to be intractable to all other treatments — to Germany for five days of prolonged ketamine anesthesia, enough to put them into a coma.

Ten patients were completely relieved of their pain, Dr. Schwartzman said, noting that the treatment has not been approved in the United States.

Some doctors have strong concerns about the ketamine treatments. Dr. Oaklander, for one, believes there is not enough research to support its effectiveness, especially in light of the risks.

Either way, said Ms. Toussaint, who has not had the therapy herself, "It says a lot about this disease that we are willing to be put in comas." New research is also helping doctors understand the pain syndrome. In early 2006, a team at Massachusetts General was the first to identify organic nerve injuries in a large group of people with the disorder. The research, published in February in the journal Pain, confirmed that the syndrome was not psychosomatic, said Dr. Oaklander, who led the study.

This progress is promising for Ms. Toussaint. Since her illness was diagnosed in 1995, medications have reduced her pain, enabling her to stand and speak again. She and her partner, John Garrett, now manage For Grace, a nonprofit organization dedicated to increasing awareness of complex regional pain syndrome. Ms. Toussaint is also running for the California State Assembly on a health-based platform.

"People see me and they recognize me as the ballerina, but they don't remember the name of my disease," she said recently, "but that's all about to change."

    Doctors Struggle to Treat Mysterious and Unbearable Pain, NYT, 30.5.2006, http://www.nytimes.com/2006/05/30/health/30pain.html

Drive for Vote on Abortion Accelerates

May 27, 2006
The New York Times
By MONICA DAVEY

Advocates of abortion rights were planning a final push this weekend for signatures to a petition that could send South Dakota's ban on abortion, which was intended as a direct legal challenge to the 1973 Supreme Court decision that established a constitutional right to abortion, to a statewide vote in November.

The advocates had intended to file the signatures — more than 16,000 are required to bring a law passed by the state legislature to the voters — several weeks from now, the deadline under their interpretation of a state law providing for such referendums.

But they said on Friday that they had heard talk from supporters of the ban about a possible legal challenge to the referendum, based on how quickly the petitions needed to be filed. As a result, the advocates said, they have decided to take the signatures to Pierre, the state capital, on Tuesday to avoid any debate over timing.

State Representative Roger Hunt, the chief sponsor of the legislation, which outlaws all abortions except when the pregnant woman's life is in jeopardy, said that he and others who supported the law had never raised a question about the filing deadline and had no intention of stirring up a legal fight over that issue.

"I don't know where this thing came from," Mr. Hunt said on Friday. "Actually, I think it's a smoke screen. The pro-abortion people have raised it, I think, in order to generate some more interest in signing their petition. The signatures have been slacking off, and they did this to beat the bushes."

Abortion rights advocates, however, said that signatures had swept in at a rapid pace. Sarah Stoesz, the president of Planned Parenthood Minnesota, North Dakota and South Dakota, said 1,100 volunteers had gathered signatures in every county in the state since the ban was signed into law in March. Ms. Stoesz predicted that opponents would gather close to 35,000 signatures, more than twice the number required, after this weekend's effort.

If enough signatures are filed, the law, which was to go into effect July 1, will be put on hold until after the November election.

"After we file, the real battle begins," Ms. Stoesz said. "We anticipate that the right wing of the country will consolidate around this election and will put enormous resources into upholding this ban."

Mr. Hunt, meanwhile, said that he certainly intended to fight for the ban in the months ahead. "Of course I'm going to be speaking out," he said. "I'm a firm believer in this."

    Drive for Vote on Abortion Accelerates, NYT, 27.5.2006, http://www.nytimes.com/2006/05/27/us/27abortion.html

Vermont signs ambitious health-insurance law

Thu May 25, 2006 8:16 PM ET
Reuters
By Darren M. Allen

MONTPELIER, Vermont (Reuters) - Vermont's governor signed a bill on Thursday that would make the state the second in the nation with near-universal health-care insurance by extending coverage to as much as 96 percent of its residents by 2010.

The law comes a month after neighboring Massachusetts passed the nation's first near-universal health-care reform plan, which aims to provide insurance to about 95 percent of the state's half-million uninsured residents by 2009.

Both plans reflect state efforts to tackle growing concerns over health care with 46 million Americans uninsured, traditional employer-based coverage shrinking and the cost of insurance premiums steadily rising.

Vermont's legislation, signed by Gov. James Douglas at a ceremony at the state's second-largest hospital, aims to reduce the ranks of uninsured -- about 10 percent of the state's 620,000 residents -- while also streamlining care given to those with coverage.

A new subsidized health-care plan called Catamount Health will be offered by insurance companies and paid for in part with a hike in the state's cigarette tax and a fee on employers who do not offer health insurance to their workers.

It will provide coverage similar to that offered to state employees, taking nearly 25,000 people off the rolls of the uninsured, backers of the legislation say.

"This is potentially a national model," said Kenneth Thorpe, an Emory University professor and health-care consultant who helped create Vermont's reforms.

Massachusetts' plan has also been touted as a possible national model by requiring all residents to obtain health insurance by July 1, 2007, or face possible tax penalties.

The Massachusetts plan will provide insurance to the lowest-earning residents by offering low- or no-cost plans, with premiums and co-payments paid entirely by the state.

In Vermont, insurers can begin offering the new plan from July 1, 2007, but some benefits will be phased-in sooner.

Douglas, a Republican, had up to a month ago threatened the Democrat-controlled Legislature with a veto if they rejected his demand that the plan be run by private insurers.

"This law preserves the private sector role in providing insurance, it preserves economic security of our state and it makes a strong commitment toward wellness and the management of chronic diseases," he said.

The reforms follow a two-year debate in the state Legislature and call for streamlined record keeping, free immunizations, and greater access to preventive care.

    Vermont signs ambitious health-insurance law, R, 25.5.2006, http://today.reuters.com/news/newsArticle.aspx?type=domesticNews&storyID=2006-05-26T001458Z_01_N25196970_RTRUKOC_0_US-VERMONT.xml

Study: Obesity rises faster in poor teens

Posted 5/23/2006 8:11 PM ET
USA Today

CHICAGO (AP) — Older American teenagers living in poverty have grown fatter at a higher rate than their peers, according to research that seems to underscore the unequal burden of obesity on the nation's poor.

"Today the percentage of adolescents age 15-17 who are overweight is about 50% higher in poor as compared to non-poor families, a difference that has emerged recently," said Johns Hopkins' sociologist Richard Miech, the study's lead author.

Obesity rates among all teens climbed substantially during the study, which covered 30 years. But the great divide according to income occurred most notably among the 15- to 17-year-old age group.

That led one outside expert to challenge the findings. Rand Corp. economist Roland Sturm said it seems implausible that younger teens would differ so much from older teens. Even if they do, he said, "It seems a rather secondary issue compared to the general trend in weight gain across all youth."

Miech argued that older teens generally have more autonomy to buy what they want and to determine their own activity levels, which he said might explain the results. And Sturm and other experts said the study's underlying message about obesity and poverty is sound.

The study appears in Wednesday's Journal of the American Medical Association. It is based on data from 10,800 youngsters ages 12 to 17 who participated in four nationally representative health surveys conducted from 1971 to 2004.

The researchers determined poverty levels using family income and the U.S. Census Bureau's poverty threshold.

In the early 1970s, about 4% of poor youngsters ages 15 to 17 were severely overweight, compared with about 5% of teens who weren't poor. By the early 2000s, those rates jumped to 23% of the poor and 14% of other kids, the researchers said.

The results contrast with recent research suggesting that while the poor are most likely to be overweight, obesity rates among U.S. adults have climbed fastest in recent decades among those with annual salaries over $60,000.

Miech said both could be right because eating and exercise habits are different for adults and adolescents.

Over the past decade, the percentage of calories from sweetened drinks has grown by more than 20% among kids in the 15-17 age group — an increase concentrated among the poor, he said.

"We also find that physical inactivity increases with age in adolescence, as well as the probability of skipping breakfast," said Miech. "Both these factors are more likely to be found among the poor and are also associated with overweight."

Economic differences have been linked to other health problems too, including AIDS, cardiovascular disease and some cancers. The disproportionate rates emerge as wealthier people seek medical care and make lifestyle changes, while the poor do not, said Barry Popkin, a nutrition scientist at the University of North Carolina at Chapel Hill.

The study shows that this trend "is emerging in late adolescence and just building into adulthood," Popkin said.

The results also show the need for healthful resources in low-income neighborhoods, said Dr. Rebecca Unger, a Chicago pediatrician who works with a group seeking to lower obesity rates among Chicago children.

Adam Drewnowski, a University of Washington researcher, said the disparity will persist unless the underlying problem, poverty, is also addressed.

"The campaign against obesity and the struggle against poverty are, in fact, one and the same," he said. "...Healthier diets cost more," he said, and access to physical activity "depends on how much money you've got."

    Study: Obesity rises faster in poor teens, UT, 23.5.2006, http://www.usatoday.com/news/health/2006-05-23-obesity-teens_x.htm

Why the Data Diverge on the Dangers of Vioxx

May 22, 2006
The New York Times
By ANDREW POLLACK and REED ABELSON

Eighteen months.

Ever since Merck pulled its arthritis painkiller Vioxx off the market in September 2004 on evidence that it could cause strokes or heart attacks, the company and its lawyers have stood by the premise that it was dangerous only to patients who took it for at least 18 months.

So it was news last week when prominent medical experts said that new data from Merck indicated that Vioxx's risks started to emerge after only four months of use. The controversy is the latest illustration of how widely open to interpretation and potential corporate pressure the results of clinical trials can be — even when reported in a leading medical journal.

Critics say it is now clear that the previous data analysis was done in a way that minimized the risks of the drug. Some also say that Merck and its academic collaborators should have known about that four-month threshold and made the earlier risks clearer in a medical journal article in March 2005.

It was the first scientific report of the clinical trial results that had prompted the company to withdraw the drug. That article, in The New England Journal of Medicine, concluded: "The increased relative risk became apparent after 18 months of treatment."

The conclusion "makes the drug look a lot safer than it was," Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, said last week after reviewing the new data. "If you wanted to construct a legal defense that says nothing happens for 18 months, this is how you would cut the data."

Merck said the new data, seeming to show an earlier risk from Vioxx, had not yet been compiled in early 2005. But the company argues that even now that the fuller data were available, the numbers do not show a danger from Vioxx before 18 months.

The outside academic scientists who were the authors on the 2005 paper with Merck scientists said they had not seen the new information until recently and would meet this week to evaluate it. But they, too, defend the original article, saying it accurately represents the trial's findings at the time.

The new data were certain to be seized upon by lawyers representing former Vioxx users, who have filed more than 11,500 lawsuits against Merck. Doctors say the new data also suggest a somewhat greater risk for people who took Vioxx, although some said that by now, presumably more than a year and a half since anyone has taken the drug, the risks of future problems are small.

One thing that seems certain in the latest controversy is that the measurable risks posed by Vioxx depend on whose strokes and heart attacks were counted, and when.

The clinical trial at issue, called Approve, studied 2,600 people, half of whom took Vioxx and half a placebo for three years. The trial was designed to see if Vioxx could prevent precancerous colon polyps, but after concern rose about the heart risks of Vioxx, the trial was also used to study cardiac risk.

The results showed that Vioxx users had twice the risk of a heart attack, stroke, other blood clot or death from a cardiac cause than those who took a placebo. It was when Merck learned the preliminary results of that trial in September 2004 that it withdrew Vioxx from the market worldwide and the paper on the results was prepared. The New England Journal of Medicine published the results online in February 2005 and in print the next month.

The article, to illustrate its conclusion that risk did not arise before at least 18 months, used a type of graph known as a Kaplan-Meier curve to plot the cumulative number of heart attacks or other cardiac "events" that occur over time.

For 18 months the line for the Vioxx users and the one for the placebo users essentially coincide, like two runners neck and neck in a race. After 18 months, the Vioxx line rises at a much faster rate than the placebo line as the users of the drug began having heart attacks and strokes at a greater rate than the placebo group.

But as it turns out, the data used in that chart included heart attacks and other events that occurred only while a patient was taking the drug or for up to 14 days after they stopped. That point was noted in the paper, but only in passing.

The new data Merck submitted to the Food and Drug Administration earlier this month include what happened to the patients for a longer period after they stopped taking the drug. And in this presentation, the Kaplan-Meier chart — the one critics have seized upon — shows those lines starting to separate at around four months and remaining separate thereafter, although they do diverge more widely at the 18-month point.

The reason for the difference is that more patients taking Vioxx dropped out of the trial earlier than patients taking a placebo. And many of the patients who stopped taking Vioxx before the three-year study period was over did so because they had hypertension or other problems that could raise the risk of a heart attack. And so, critics say, the 14-day cutoff could miss heart attacks in these people.

"People may drop out because they had chest pain and then weeks later they had a heart attack," said Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University. Merck says it was simply adhering to the study's original design, and that the more recent chart reflects data that were not available to analyze in early 2005. It said, and some outside experts agreed, that a 14-day cutoff is frequently used in clinical trials. Indeed, they said, measuring what happens to patients long after they have stopped using a drug could minimize the measured effects of the drug.

In any case, the company says, the difference between the two charts is not significant. In the old analysis, 22 people taking Vioxx and 20 taking a placebo had a heart attack or other event by the 18th month. The new data, which includes heart attacks after the 14-day cutoff, shows 26 events in the Vioxx group and 21 in the placebo group in the first 18 months.

"We don't feel that these data change our assessment that over the first 18 months there is not a difference in risk between Vioxx and placebo," Dr. Ned S. Braunstein, senior director of Merck Research Labs, said in an interview during the weekend.

The use of the 14-day cutoff was also criticized by some members of an advisory panel to the F.D.A., including Dr. Nissen of the Cleveland Clinic, at a meeting on Vioxx in February 2005. But the academic scientists defend the paper and say there was no undue influence.

"The product did not represent any pressure from Merck or skewed interpretation of the data," said Dr. Robert S. Bresalier of the University of Texas M. D. Anderson Cancer Center, the lead author for the paper.

Dr. Gregory D. Curfman, the executive editor of The New England Journal of Medicine, said editors there would study the new information, but said he could not comment further until then. A spokeswoman for the journal, Karen Pedersen, said that could take several weeks.

The journal has already accused Merck of deliberately omitting information about three heart attacks from a paper in 2000 reporting the results of a previous Vioxx clinical trial. Omitting the information made the drug look less dangerous, they said.

Even before publication of the article in March 2005, there was significant debate over exactly how much emphasis should be placed on the difference in risk for patients who took the drug for less than 18 months and those who had taken it longer.

One of the investigators seems to have voiced some qualms, according to an e-mail message that first surfaced as part of the Vioxx litigation, and the reviewers of the original manuscript also voiced some unease over this finding and concern about the possibility that Merck had too much influence over the conclusions. Those reviewers were anonymous.

In an e-mail message sent to his co-authors as the manuscript was being written, Dr. Marvin A. Konstam, a cardiologist at Tufts-New England Medical Center, wrote that the authors were "going out on a limb by emphasizing the 18-month issue," saying they needed to make sure they properly underscored the main finding of the study — the cardiovascular risk of the drug. Dr. Konstam, when contacted Friday, declined to comment.

Some of the outside reviewers of the article before it was published did raise concerns about the overall validity of the 18-month threshold as it was presented in the original draft.

"The 'hand' of the study sponsor seems too evident throughout the manuscript, which is written consistently in a fashion designed to support the company's public positions," said one reviewer. Another argued that the paper "aggressively promotes the safety of up to 18 months of use of rofecoxib. This goes beyond the data of the study." Rofecoxib is Vioxx's chemical name.

At the time, Merck was already the target of Vioxx-related plaintiffs' lawsuits. In the cases that have gone to trial, the company has consistently said there was no danger from Vioxx at less than 18 months' use.

So far, though, in the three of the five cases that Merck has lost in court — with juries awarding verdicts of more than $10 million each time — jurors have seemed to look more at the specifics of each patient's case than whether the drug had been take for at least 18 months.

In The New England Journal of Medicine's response to the original manuscript, the editor, Dr. Curfman, asked the authors to remove the assertion "that increased risk was observed only after 18 months." Nevertheless, the 18-month finding was published as part of the article's main results.

But Merck and the researchers continue to insist that the 18-month finding was a legitimate conclusion, based on the data that were analyzed. In commenting on this early draft, the reviewers were not aware of the statistical analysis that had been performed to reach the conclusion, said Dr. John A. Baron, a professor at the Dartmouth medical school who was one of the authors.

The researchers say they did not play down the risk of taking Vioxx, and they say they never made the claim that people taking the drug for a shorter period of time were not at any risk.

The reviewers' comments were the result of the decision to submit a preliminary draft for review as well as the typical peer-review process, said Dr. Bresalier, the paper's lead author.

While he acknowledged that Merck was involved in reviewing the manuscript, he said the paper's authors responded to all the comments raised by the editor and the reviewers and that the final draft reflected changes made to address their concerns. "The end product was a good final product," he said.

"If The New England Journal didn't think this was an appropriate and satisfactory product, they didn't have to publish it," Dr. Bresalier said.

While Dr. Bresalier and the other outside authors reached insisted that they felt comfortable with how the risks were eventually portrayed, he said the 18-month finding was not seen as critical by the researchers, even if it had been "up-played" by Merck and its lawyers.

"Of course they want to minimize their liability," he said.

    Why the Data Diverge on the Dangers of Vioxx, NYT, 22.5.2006, http://www.nytimes.com/2006/05/22/business/22drug.html

Thanks to birth control pills and other hormonal contraceptives, Stephanie Sardinha, 22,
hasn't had a mentrual period since she was 17.

By Joel Page, AP        UT        21.5.2006

   With new mindset, new contraceptives, menstruation becomes optional        UT        21.5.2006
http://www.usatoday.com/news/health/2006-05-21-stoppingperiods_x.htm

With new mindset, new contraceptives, menstruation becomes optional

Updated 5/21/2006 7:27 PM ET
USA Today

TRENTON, N.J. (AP) — For young women with a world of choices, even that monthly curse, the menstrual period, is optional.
Thanks to birth control pills and other hormonal contraceptives, a growing number of women are taking the path chosen by 22-year-old Stephanie Sardinha.

She hasn't had a period since she was 17.

"It's really one of the best things I've ever done," she says.

A college student and retail worker in Lisbon Falls, Maine, Sardinha uses Nuvaring, a vaginal contraceptive ring.

After the hormones run out in three weeks, she replaces the ring right away instead of following instructions to leave the ring out for a week to allow bleeding. She says it has been great for her marriage, preventing monthly crankiness and improving her sex life.

"I would never go back," said Sardinha, who got the idea from her aunt, a nurse practitioner.

Using the pill or other contraceptives to block periods is becoming more popular, particularly among young women and those entering menopause, doctors say.

"I have a ton of young girls in college who are doing this," says Mindy Wiser-Estin, a gynecologist in Little Silver, N.J., who did it herself for years. "There's no reason you need a period."

Such medical jury-rigging soon will be unnecessary. Already, the Seasonale birth control pill limits periods to four a year. The first continuous-use birth control pill, Lybrel, likely will soon be on the U.S. market and drug companies are lining up other ways to limit or eliminate the period.

Most doctors say they don't think suppressing menstruation is riskier than regular long-term birth control use, and one survey found a majority have prescribed contraception to prevent periods. Women have been using the pill for nearly half a century without significant problems, but some doctors want more research on long-term use.

The new methods should be popular. A non-scientific Web survey for the Association of Reproductive Health Professionals found at least two-thirds of respondents are bothered by fatigue, heavy bleeding, "really bad cramps" and even anger. Nearly half said they would like to have no period at all or decide when to have one.

For some women, periods can cause debilitating pain and more serious problems.

Two recent national surveys found about 1 in 5 women have used oral contraceptives to stop or skip their period.

"If you're choosing contraception, then there's not a lot of point to having periods," says Leslie Miller, a University of Washington-Seattle researcher and associate professor of obstetrics and gynecology whose website, noperiod.com, explains the option.

She points out women on hormonal contraception don't have real periods anyway, just withdrawal bleeding during the break from the hormone progestin.

According to Miller, modern women endure up to nine times more periods than their great-grandmothers, who began menstruating later, married young and naturally suppressed periods for years while they were pregnant or breast-feeding. Today's women may have about 450 periods.

Still, surveys also show most women consider monthly periods normal. Small wonder: Girls learn early on that menstruation is a sign of fertility and femininity, making its onset an eagerly awaited rite of passage.

The period is "way over-romanticized," says Linda Gordon, a New York University professor specializing in women's history and the history of sexuality.

"It doesn't take long for women to go from being excited about having a period to feeling it's a pain in the neck," said Gordon, author of The Moral Property of Women: A History of Birth Control Politics in America.

She says caution is needed because there's not enough data on long-term consequences of using hormones continuously. Gordon notes menopausal women for years were told that hormone drugs would keep them young — until research uncovered unexpected risks.

"People should proceed very cautiously," she says.

Today's birth control pills contain far less estrogen and progestin than those two generations ago, but still increase the risk of heart attack, stroke and blood clots. The pill should not be used by women who have had those conditions, unexplained vaginal bleeding or certain cancers, or if they are smokers over 35.

But there are benefits from taking oral contraceptives too, such as a lower risk of ovarian and endometrial cancer, osteoporosis and pelvic inflammatory disease. And forgoing periods means no premenstrual syndrome and a lower risk of anemia and migraines, says Sheldon Segal, co-author of Is Menstruation Obsolete? Segal has been involved in research for several contraceptives.

Almost since the first pill arrived in 1960, women have manipulated birth control to skip periods for events such as a wedding, vacation or sports competition.

Female doctors and nurses were among the first to block menstruation long-term to suit their schedules, said Susan Wysocki, head of the National Association of Nurse Practitioners in Women's Health.

"They were then more comfortable recommending it to their patients," said Wysocki, who uses a vaginal ring to prevent menstruation.

The idea gained momentum after Barr Pharmaceuticals launched Seasonale in November 2003. It's a standard birth control pill taken for 12 weeks, with a break for withdrawal bleeding every three months. Amid wide acceptance by doctors, sales shot up 62% last year, to $110 million.

Publicity for Seasonale made women wonder, if just four periods a year are OK, why have any at all?

Users of Pfizer Inc.'s Depo-Provera, a progestin-only contraceptive shot lasting three months, usually are period-free after a year or two. There's now a generic version, but the drug can thin bones.

And many women have been getting extra prescriptions so they could continuously stay on birth control pills, the Ortho Evra patch or the vaginal ring, rather than bleeding every fourth week. That schedule was set by the original birth control designers to mimic normal menstrual cycles. But the extra prescriptions have led to insurance company hassles.

"What Seasonale did is get rid of that nuisance," says Peter McGovern of University of Medicine and Dentistry of New Jersey.

New extended-cycle contraceptives will do the same. Wyeth is hoping by late June to get Food and Drug Administration approval to sell Lybrel, its low-dose, continuous birth control pill; approval also is pending in Canada and Europe.

Also in June, FDA should decide whether to approve Implanon, a single-rod, three-year contraceptive implanted in the upper arm that maker Organon USA has been selling it in Europe for a decade.

Berlex Inc. is developing its own birth control pill for menstrual suppression.

Barr, aiming to be a leader in extended contraception, last November bought the maker of ParaGard, an intrauterine device that blocks periods in some women. Barr's new product Seasonique, a successor to Seasonale, likely will get federal approval at week's end.

Patricia Sulak, who researches extended contraception at Texas A&M College of Medicine, applauds this new trend. The doses in standard pills are now so low, she said, that having seven days off them raises the risk of pregnancy.

"This redesign is way overdue," she says. "It's going to be the demise of 21-7."

    With new mindset, new contraceptives, menstruation becomes optional, UT, 21.5.2006, http://www.usatoday.com/news/health/2006-05-21-stoppingperiods_x.htm

Unease on Industry's Role in Hypertension Debate

May 20, 2006
The New York Times
By STEPHANIE SAUL

Three pharmaceutical companies donated $700,000 to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure.

The same three companies — Merck, Novartis and Sankyo — also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs.

The seven dinners at Ruth's Chris Steak Houses around the country are just one example of why the small medical society, the American Society of Hypertension, has been in the midst of a dispute over the influence of drug industry money.

"This is about the monetarization of medicine," Dr. Michael H. Alderman, a past president of the organization, said in a recent interview.

The dinners promoting a new definition of high blood pressure illustrate connections — among the pharmaceutical industry, academic physicians and societies that formulate opinion — that can ultimately affect patient treatment. And the dispute within the society reflects a growing unease that industry money is influencing scientific discourse in medical societies and elsewhere.

At a recent speech before another society, the American College of Cardiology, its new president, Dr. Steven E. Nissen of the Cleveland Clinic, suggested that the medical profession had become addicted to industry money just as the nation was addicted to foreign oil.

After months of controversy within the American Society of Hypertension that included accusations of industry influence, the society's president, Dr. Thomas D. Giles, said yesterday that the group's leadership would be required to disclose more details about the money they receive from industry.

Dr. Giles said the organization had always maintained a firewall between its activities and industry funding. "We don't take money that has strings attached to it," Dr. Giles said, emphasizing that its industry grants are not earmarked for any specific purpose.

The added disclosure had been sought by a board member, Jean E. Sealey, a biochemist and a longtime blood pressure researcher affiliated with Weill Medical College of Cornell University, who was among those also involved in a leadership struggle within the organization.

Dr. Alderman, a professor of medicine and epidemiology at the Albert Einstein College of Medicine in the Bronx, is one of several doctors who withdrew from a group formed by the society to write the new blood pressure definition.

He complained that the definition was derived from a hodgepodge of opinions not supported by hard science, and also questioned whether the society of 1,600 could insulate itself from the drug company donations it used to operate.

Controlling blood pressure has long been a mainstay of the pharmaceutical industry. About 65 million Americans have high blood pressure under the current definition and they help fuel a $17 billion annual market in drugs for hypertension. But another 59 million people are on the borderline, and many doctors believe the new definition of hypertension could make drugs a standard treatment for many of them, drastically expanding the potential drug market.

Dr. Giles of Louisiana State University's medical school in New Orleans was the driving force behind the new definition. The work of the group that developed it was financed by $75,000 in unrestricted drug industry grants from Merck, Novartis and Sankyo, according to Susan Rood, a spokeswoman for the Society of Hypertension. Ms. Rood also confirmed that the dinners were financed by $700,000 in grants, also unrestricted, from the same companies. The new definition that resulted was written by some of the leading experts in blood pressure medicine.

Pre-hypertension has been considered a blood pressure reading of 120/80 to 139/89, according to guidelines developed by a National Institutes of Health panel, which first identified the pre-hypertension category in 2003. Currently, pre-hypertension is generally not treated with drugs.

The new definition proposes assigning some of the people with pre-hypertension to a new category called Stage 1 hypertension. Hypertension is currently defined as blood pressure readings of 140/90 and above.

Dr. Giles estimated that the proposed definition would move half of those whose blood pressure readings are currently considered pre-hypertension to the Stage 1 hypertension category.

That determination would be based not just on their blood pressure readings, but also on other risk factors.

The proposed definition makes no specific treatment recommendations. But some specialists who have read the proposed definition say it is a short step from labeling someone with high blood pressure to prescribing pills. And they predict that if the new definition is embraced, it will expand the use of medications.

Dr. Curt D. Furberg, a professor of public health science at Wake Forest University, who was among those who withdrew from the writing group, citing concerns that its work was not evidence-based, said, "The industry wants to sell drugs and to as many people as possible."

But Dr. Giles said it was possible that the use of medication could actually contract under the new definition, with some doctors recommending lifestyle modifications rather than medication. And he said industry money or influence did not play a role in the proposed definition, which he said reflected a concern that too many people with diagnoses of pre-hypertension ended up having strokes.

"I will tell you that if you've ever sat there and watched patients in the prime of life get a stroke or a heart attack, it's heart-wrenching," Dr. Giles said last week.

The recommendations by Dr. Giles and his group are considered influential in the evolving thinking over what constitutes high blood pressure. In addition, the discussion about whose blood pressure should be treated is also being driven by a new study that concluded that a drug called Atacand by AstraZeneca could reduce the risk that people with pre-hypertension will develop hypertension.

Treating pre-hypertension was among the topics at a meeting this week of the society at the New York Hilton. The meeting ends today.

The debate is in some ways similar to questions about changing thresholds for defining high cholesterol, diabetes and obesity — areas where accusations have been leveled in the past that the pharmaceutical industry has tried to exert influence.

"All of this has got the ring of seeming to be of great benefit to the pharmaceutical industry without clear evidence that it's going to be the same benefit to the public," Dr. Alderman said recently

In statements, spokeswomen for Merck and Novartis confirmed that their companies had helped finance the society's work, but said that they had no influence over the outcome of the new definition or the content of the dinner briefings held last fall in seven cities.

Sankyo did not return calls seeking comment.

Of the seven doctors who wrote the proposed new definition, six have said that they served as consultants and speakers for pharmaceutical companies that make blood pressure medications. The seventh is a consultant and stockholder in a company that markets a diagnostic method to measure damage to blood vessels.

Such industry affiliations are not unusual among prominent doctors at academic research centers. And for years, the American Society of Hypertension, known as ASH, has operated with industry support.

But some members of ASH have become vocal critics of the influence wielded by the drug industry, including the person who was next in line to become the society's president, Dr. Sealey, who has been embroiled in a longstanding dispute with the organization's current leadership over that and other issues.

"The truth of the matter is that we have many members who are leaders in our society who are making well into the six figures from their pharmaceutical-company-supported activities," Dr. Sealey, a research biochemist and physiologist, said in an interview two weeks ago.

But many members of the society have taken umbrage at suggestions that their work for drug makers affects their scientific independence.

"There are those who accuse us of being nothing more than shills of industry; a lot of us take pretty great offense at that," said Dr. Joseph L. Izzo, a professor of medicine at the University of Buffalo who was part of the group that developed the new definition. "We've basically devoted our careers to researching this disease and how to treat it."

Dr. Sealey's assertions had fueled dissension within the society and were among the reasons that a vote to block her presidency had been expected at yesterday's business meeting of the society.

Instead, an agreement was forged under which Dr. Sealey gave up her term as president and, according to written statements circulated among those attending the meeting, the organization's leadership agreed that its board would soon submit detailed financial disclosure forms, which Dr. Giles said had been in development for more than a year.

Dr. Giles said those disclosures would go beyond the affiliations that were currently disclosed and would require leaders of the group to state how much they received, in broad categories.

    Unease on Industry's Role in Hypertension Debate, NYT, 20.5.2006, http://www.nytimes.com/2006/05/20/business/20hyper.html?hp&ex=1148184000&en=a98fc2622f7af4de&ei=5094&partner=homepage

For a Kennedy, Fighting the Stigma of Mental Illness Becomes Personal

May 15, 2006
The New York Times
By SHERYL GAY STOLBERG

WASHINGTON, May 14 — Patrick J. Kennedy was keeping an uncomfortable secret.

Representative Kennedy, scion of America's most loved and hated Democratic clan, has been a passionate advocate for ending the stigma of mental illness; he told voters years ago of his treatment for depression and cocaine abuse. But when he slipped off to the Mayo Clinic last December to get help for addiction to prescription painkillers, he had trouble overcoming that stigma himself.

When he crashed his Mustang convertible into a Capitol barricade in the middle of the night earlier this month, Mr. Kennedy, of Rhode Island, was thrust into a clash between personal privacy and political beliefs. Hours before he told the world he was checking himself back into the Mayo Clinic, he wrestled with going public.

"He consistently talked about being in the spotlight and not being able to just say, 'I'm struggling, I have issues,' " said Jack McConnell, a good friend who counseled Mr. Kennedy that morning, May 5. "One of the things he weighed was whether doing this would take the weight off his shoulders that he always felt when he was out in public."

In the mix of blessing and burden that invariably accompanies life as a Kennedy, the congressman has perhaps had more burden than most. At 38, the youngest child of Senator Edward M. Kennedy, Democrat of Massachusetts, and his first wife, Joan, is a success in his own right. But the skinny kid with the red hair and freckles is a man now, and after years of having his foibles turn up in the gossip sheets, he is at a turning point both political and personal.

"This is a test," said one of his mentors, Senator Jack Reed, Democrat of Rhode Island. "I think he has set a standard for himself of dealing forthrightly."

That forthrightness only goes so far; while in treatment, Mr. Kennedy declined an interview. He has attributed the accident to confusion caused by two medicines, Ambien, a sleep aid, and Phenergan, for gastric distress. Medical experts say his explanation for the accident is plausible, though the Capitol Police, who complained that their supervisors barred sobriety testing, said they suspected that Mr. Kennedy had been drinking. He said he had not.

Some people close to the congressman, including his father, who has lunch with his son every Thursday, said they saw nothing amiss before the accident.

"Certainly this last Christmastime we talked about it, whether he ought to try and take a reading about where his whole health stood," Senator Kennedy said. "He made a judgment to get help at that time, and he came back and was very upbeat and positive. Now he understands that this is a continuing process."

Representative Kennedy sometimes seems ill suited to the legacy of Camelot. He is reserved, and his syntax sometimes gets mangled.

There is a tentativeness about him, "a bit of awkwardness," said Representative Jim Langevin, Democrat of Rhode Island. Mr. Kennedy's biographer, Darrell M. West, a political scientist at Brown, said some people called him "the un-Kennedy."

Still, he has traded on the Kennedy mystique, using his celebrity to start his career. His celebrity did not hurt, either, when he got into various scrapes, like the time he shoved a Los Angeles airport security guard or when the Coast Guard retrieved a woman who said the two had argued while drinking on his yacht.

Mr. Kennedy's advisers say he now views these incidents, as well as his addiction and bouts of binge drinking, through the prism of his bipolar disorder, a type of depression marked by extreme highs and lows. But some wonder whether this latest incident must be his last.

"I don't think anybody realized until now how serious his problems were," said M. Charles Bakst, a longtime political columnist for The Providence Journal. "Now it all makes sense, and you realize that this kid is on the brink. And I think if it happens again, you are going to see people say, not necessarily angrily or bitterly, but sadly, maybe, that public life isn't for him."

From the moment Patrick Joseph Kennedy was born, on July 14, 1967, his was a public life. In his Capitol Hill office, Mr. Kennedy keeps a framed copy of The Cape Cod Times's coverage of his christening, with the headline "Patrick's First Bow Draws 1,200."

He was a frail child. While his cousins played touch football at the family estate in Hyannis Port, Mass., Patrick's severe asthma sidelined him. His mother struggled with alcohol dependence, and his father was often away.

"He was never the guy who hung out with the captain of the football team," said his cousin, Anthony Shriver. "He was always the guy who hung out with the guy nobody wanted to hang out with."

Those life experiences seem to have shaped him. Like many of his relatives, he is an advocate for the disenfranchised. But as Mr. Bakst said, "He seems to feel it personally."

He was interested in politics early on, and he was a frequent presence on the campaign plane during his father's 1980 run for the Democratic nomination for president.

His parents split right after that race. Later, at prep school, Patrick sought treatment for cocaine abuse. As a student at Providence College in 1988, he underwent surgery to remove a tumor from his spine. The operation left him with lingering back pain that, he has said, prompted his use of narcotics.

He was recovering in the hospital when he decided to make his first electoral bid, for the Rhode Island Legislature against an entrenched Democratic incumbent. Kennedy money poured in, and pundits knew it was over when Mr. Kennedy cleverly stationed famous relatives at polling places and had photographers offer to take Polaroid pictures of voters with them.

Mr. Kennedy entered the statehouse as a maverick and left six years later a member of the establishment. He won his first House race in 1994. Joshua Seftel, a documentary filmmaker who chronicled the race, said, "You could see a sadness in Patrick."

In the House, Mr. Kennedy caught the attention of the Democratic minority leader, Representative Richard A. Gephardt, who persuaded him to become chairman of the Democratic Congressional Campaign Committee in 2000. It was a grueling year of fund-raising and travel, marked by both the Los Angeles airport and Coast Guard episodes.

It was also the year he disclosed, in an appearance with Tipper Gore, his bipolar disorder. The announcement was unplanned, but House members were not shocked.

After the 2000 elections, Mr. Kennedy was rewarded with a coveted seat on the House Appropriations Committee. He considered running for the Senate, but decided against it. And he has made mental health his signature issue.

"He found an altitude he was comfortable flying at," said Erik Smith, who was Mr. Kennedy's spokesman at the campaign committee.

That is how it appeared, from a distance at least, until 2:45 a.m. May 4, when Mr. Kennedy crashed his car. In the lone interview he has given, to The Providence Journal, Mr. Kennedy said he was at home with a female friend when he woke up and thought he needed to go to the Capitol to vote. She tried unsuccessfully to dissuade him, he said.

Mr. Kennedy's immediate future is unclear. Senator Kennedy could not say when his son's treatment would be over, and the congressman may be greeted with as much scrutiny as sympathy on his return.

But his cousin Mr. Shriver, who said he had watched "countless members of my family" overcome addiction, was optimistic.

"Once he gets this current challenge under control, watch out," Mr. Shriver said. "He'll just knock the socks off of everybody."

    For a Kennedy, Fighting the Stigma of Mental Illness Becomes Personal, NYT, 15.5.2006, http://www.nytimes.com/2006/05/15/washington/15kennedy.html



 

Amy Carlsen of Fargo, N.D., waits in a hallway to enter surgery with her twin girls in Rochester, Minn.

By Ann Arbor Miller, AP

  5-month-old girls in ICU after separation        UT        14.5.2006
http://www.usatoday.com/news/health/2006-05-13-conjoined-twins_x.htm

 

5-month-old girls in ICU after separation

Updated 5/14/2006 12:11 AM ET
USA Today

MINNEAPOLIS (AP) — Abbigail and Isabelle Carlsen remained in intensive care under sedation Saturday, one day after doctors spent nearly seven hours in surgery separating the conjoined twins.

The 5-month-old girls were breathing with the assistance of ventilators "after an uneventful night," according to a statement released by the Mayo Clinic in Rochester, Minn.

The sisters, who spent their first months with their noses just inches apart, were recovering in separate beds.

"We've had our prayers answered up to now," the girls' parents, Amy and Jesse Carlsen, wrote in a message posted Saturday on the family's Web journal. "And we will continue to pray for a perfect recovery."

When the girls were born Nov. 29 to the Fargo, N.D., couple, they were joined at the diaphragm, pancreas and liver, and shared a common bile duct and part of an intestine.

A 70-member Mayo Clinic team has cared for the twins since Feb. 24. About 30 people took part in the operation, with specialists rotating in and out of the operating room. The separation, which took nearly seven hours, was like one major surgery after another.

After the procedure began, doctors confirmed the girls had two separate hearts. Medical imaging done in the weeks before the surgery showed Isabelle's heart was tipped into her sister's body and would have to be moved.

Mayo spokesman Lee Aase said Isabelle's blood pressure remained stable as her heart was maneuvered into her own chest cavity.

Doctors also removed both of the girls' gall bladders during the procedure, so the drainage systems in the organs could be rerouted, Aase said.

He said that after the girls' livers were separated, the medical team applauded, having completed one of the more complicated parts of the operation because of the way the organs were fused and because the circulatory structures inside the livers needed to be divided correctly.

Isabelle retained the common bile duct, and doctors constructed a biliary structure for Abbigail. The length of their intestines was a concern, too, but doctors found enough and divided it evenly between the girls.

Doctors had estimated there was a 90% to 95% chance that both girls would survive.

"The girls did great," said Randall Flick, the lead anesthesiologist. "The credit goes to them. I think they are tough little girls."

    5-month-old girls in ICU after separation, UT, 14.5.2006, http://www.usatoday.com/news/health/2006-05-13-conjoined-twins_x.htm

Attention Shoppers: Low Prices on Shots in Clinic

May 14, 2006
The New York Times
By MILT FREUDENHEIM

Everyday low prices on strep-throat exams.

That is the basic idea behind a retail approach to routine medical care now catching on among consumers and entrepreneurs. At Wal-Mart, CVS and other chain stores, walk-in health clinics are springing up as an antidote to the expense and inconvenience of full-service doctors' offices or the high-cost and impersonal last resort of emergency rooms.

For a $30 flu shot, a $45 treatment for an ear infection or other routine services from a posted price list, patients can visit nurse practitioners in independently operated clinics set up within the stores — whose own pharmacies can fill prescriptions.

"It was a lot easier to know you can just drive up the block to a clinic, rather than spend time in the pediatrician's waiting room," said Liz Lyons, who recently took her 9-year-old son to have a sore throat swabbed in a clinic at a CVS drugstore in Bethesda, Md.

She made a $10 co-payment, with her husband's insurance picking up the rest of the $59 tab.

About 100 of these clinics, which typically lease space from the host stores, are now operating around the nation. Hundreds more are in the works, bankrolled by a range of competing entrepreneurs who include Stephen M. Case, the former AOL chairman; Richard L. Scott, who once ran the nation's largest hospital chain; and Michael Howe, a former chief executive of the Arby's restaurants group.

Despite their diverse backgrounds, those executives and others share a concept of "consumer-directed health care" — a marketing and political term that usually means higher out-of-pocket medical costs — as a mass-market opportunity. Even some family physicians say the clinics may have their place in the array of American medical offerings.

And most insurers so far are welcoming retail clinics as a way to save money. The uninsured, meanwhile, typically find the clinics more affordable than most alternatives — including the for-profit storefront clinics that have long offered a full range of physician-provided medical services to a walk-in clientele.

Uwe E. Reinhardt, a professor of economics and public affairs at Princeton University, said that the store chains, with their reputations on the line, would insist that the clinics maintain high standards and low error rates. "Primary care is a neglected field in the United States, lagging other economically advanced countries," he said. "The clinics can teach the rest of our health system how primary care could be done and brought to the public."

Whether a fad or the beginning of a fundamental shift, the retail clinic trend comes in response to an erosion in employer-sponsored insurance benefits that is forcing people to pay more or all of their own health costs. It is also a reaction to the growing perception that conventional medical service for routine and preventive care has become too costly and inefficient.

" Starbucks has 10,000 locations; health care is certainly more important," said Mr. Case, who made his name and fortune on the Internet but is now betting that his chain of RediClinics at Wal-Mart, Walgreens and other retailers can be the next big thing.

Mr. Case says his epiphany came a few years ago when he took his young daughter to an emergency room on a Sunday for an ear infection. "We waited four hours and they just weren't able to see us," he recalled. "This is crazy: a society in which everything is convenient other than what people care most about, which is taking care of their health."

Mr. Case's company, Revolution Health Group, has 11 RediClinics now running, including one at a Duane Reade pharmacy on West 50th Street in Manhattan. He plans to open 90 others in various retail chains by the end of this year, and 500 within three years.

Other executives bringing their names and money to the field include Hal Rosenbluth, who sold a travel business to American Express and is now behind a clinic chain called Take Care Health Systems. It has clinics in 16 stores, and Mr. Rosenbluth has raised $77 million with an eye toward expanding to 1,400 in the next few years.

Another in the game is Dr. Glen D. Nelson, a Minneapolis surgeon and investor whose company, MinuteClinic, has branches in 73 stores.

"The clinic concept is a microcosm of what you could do to the whole system to improve it and make it more consumer friendly and economical," Dr. Nelson said.

The licensed nurse practitioners who run most of the clinics typically have advanced training and referral arrangements with local doctors for cases beyond the clinics' scope. When Ms. Lyons recently took her son, Daniel, to the MinuteClinic at the CVS in Bethesda, the nurse practitioner on duty was Trish Hughes, who performed a quick swab test to check for a streptococcal bacterial infection. In less than three minutes, that preliminary test came up negative; the swab was retained for further testing.

Ms. Lyons said she was pleased with the clinic experience. "I will be back," she said.

For Beth Brauning, 54, a self-employed house cleaner who is uninsured, the prices at a clinic in a CVS near Columbus, Ohio, were a big attraction. The nurse practitioner took her blood pressure and wrote two allergy prescriptions she needed.

The bill was $49 — "probably half what my doctor would have charged me," Ms. Brauning said. "It was such a good experience for me. You go to an emergency room, it's $300 to walk in the door."

Having someone in the store writing prescriptions could be a boon for pharmacy chains. "Pharmacy is 70 percent of our business," said Jim Maritan, a CVS vice president for strategy and business development. "It is a great experience having a nurse practitioner clinic on site."

But some doctors say the clinic-pharmacy relationship could create conflicts of interest. "We want to make sure that the patient is protected," said Dr. Joseph P. Annis, an anesthesiologist in Austin, Tex., who is the chairman of an American Medical Association council that studied the clinics for a report due out later this month.

Dr. Anne B. Francis, a pediatrician in Rochester, said it was important for children to have a physician who gets to know the family and keeps a complete health record that can help point to underlying causes of some ailments. "All earaches are not ear infections," she said.

Although some physicians are fearful of losing business to the clinics, others say that the clinics may fill a need. Larry S. Fields, a family doctor in Ashland, Ky., who is president of the American Academy of Family Physicians, said that if the clinics "stick to this limited scope, they may have a small role in providing acute health care to people who are mildly ill, when their only other alternative at the time might be an emergency room."

With no need for expensive medical equipment or office space, the clinics tend to be cheap to operate — particularly since the nurse practitioners are paid $30 to $45 an hour, compared with the $65 or much more an hour that a primary care doctor can command. A store clinic can be profitable with 25 patients over a 12-hour day, clinic executives said.

A clinic company with somewhat grander ambitions is Solantic. Its clinics are staffed by doctors and provide a wider range of services that include X-rays at $90 apiece (or two for $150).

For routine services, Solantic's prices may be slightly higher than at other clinics — $55 or more for a Solantic doctor visit compared with $45 to be seen by a nurse practitioner at a rival's clinic. But having doctors on staff "dramatically increases the number of services we can provide to a patient," said Richard L. Scott, the chairman of Solantic, which is based in Jacksonville, Fla.

Mr. Scott built Columbia- HCA Healthcare into the nation's largest hospital chain. But in the late 1990's, the company faced an array of charges that it had defrauded the government, charged private insurers for unnecessary tests and improperly paid kickbacks to referring doctors. The board forced Mr. Scott out, and the company paid billions of dollars in fines and penalties; Mr. Scott was never charged with wrongdoing. "I always wanted to create a clinic business when I was in the hospital business," Mr. Scott said.

Glenn Habern, Wal-Mart's senior vice president for business development, said that Solantic and three of its rivals would be among the clinic companies leasing space in about 60 of Wal-Mart's 1,300 "superstores" by the end of this year.

"It's still a test for us," Mr. Habern said. "If customers like it we may open more. So far, we've not seen any reason not to do so." But a big Wal-Mart competitor, Target, has evidently seen drawbacks.

At the end of this month Target plans to close the 11 MinuteClinics in stores in Maryland and Minnesota; the company would not explain why. "Target will begin remodeling to open new health clinics in these stores in fall 2006," the company said in an e-mail message.

Dr. Nelson, at MinuteClinic, said in an interview before the breakup with Target was disclosed that "the pharmacy business is a small percentage of the Target footprint."

"Target also is very disciplined," he added. "They like to have things totally designed and controlled to their own specifications. They struggled with whether they want somebody else talking to their clients."

    Attention Shoppers: Low Prices on Shots in Clinic, NYT, 14.5.2006, http://www.nytimes.com/2006/05/14/business/14clinic.html?hp&ex=1147665600&en=3bd56c45080282c1&ei=5094&partner=homepage

Bush defends prescription drug program

Tue May 9, 2006 5:44 PM ET
Reuters
By Caren Bohan

SUN CITY CENTER, Florida (Reuters) - President George W. Bush urged older Americans on Tuesday to sign up for the government's prescription drug program before a May 15 deadline and disputed complaints that the plan is too complex.

"This is a good deal for American seniors," Bush said at the Kings Point retirement community near Tampa, Florida. The visit was part of two-and-a-half day tour to promote the program in the state, a favorite retirement spot.

The program, offered to the 42 million people in the Medicare health program, began on January 1. More than 30 million are receiving drug coverage. Of those, 8.1 million have signed up voluntarily for the new program and the rest transferred from other programs or have coverage through former jobs.

Most others who are eligible must sign up within six days or face a penalty.

Democrats have called for an extension of the deadline, faulting Bush and his Republican allies for creating a plan that is too confusing for many to navigate. But Bush has rejected calls for a deadline change.

Bush has also taken heat from some Republicans over the drug plan's estimated cost of $724 billion over 10 years.

Rep. Robert Wexler, a Florida Democrat, called the program a failure and said Republicans had allowed pharmaceutical and insurance companies too much sway in its design.

"Instead of more empty rhetoric from the president and Republicans in Congress, we must fix this disastrous drug plan and extend the enrollment deadline to protect America's seniors," Wexler said.

The program relies on private insurers and health plans to deliver benefits. One difficulty for potential users has been choosing among the dozens of plans offered.

The administration has set up hotlines and enlisted the help of community groups to help sign people up.

EARLY PROBLEMS

Bush has acknowledged problems early on in the process when helplines were jammed and some poorer people had trouble shifting from other government programs. But the administration has said it has ironed out many snafus and Bush said the array of choices would benefit users in the long run.

"The reason why we felt it was necessary to provide choices is because we want the system to meet the needs of the consumer. The more choices you have, the more likely it is you'd be able to find a program that suits your specific need," Bush added.

The president is crisscrossing the state to tout the program and was joined by his brother Jeb, Florida's governor. He plans another Medicare event on Wednesday in Orlando.

In Coconut Creek on the east coast, Bush met with older adults enrolling in the program and said it would offer "significant savings." He also said the May 15 deadline did not apply for low-income people who qualified for extra help.

When he worked to push the legislation creating the drug program through Congress in 2003, Bush hoped it would gain favor for Republicans among older voters.

But Democrats believe that the problems with the plan's troubles may instead boost their bid to wrest dominance from Republicans in November's congressional election.

Bush's record-low approval rating, which fell to 31 percent in the latest Gallup poll, is a broader problem for Republicans that Democrats hope to use to their advantage.

(Additional reporting by Tabassum Zakaria)

    Bush defends prescription drug program, R, 9.5.2006, http://today.reuters.com/news/newsArticle.aspx?type=politicsNews&storyID=2006-05-09T214446Z_01_N09317367_RTRUKOC_0_US-BUSH-MEDICARE.xml

Bottlers Agree to a School Ban on Sweet Drinks

May 4, 2006
The New York Times
By MARIAN BURROS and MELANIE WARNER

The country's top three soft-drink companies announced yesterday that beginning this fall they would start removing sweetened drinks like Coke, Pepsi and iced teas from school cafeterias and vending machines in response to the growing threat of lawsuits and state legislation.

Under an agreement between beverage makers and health advocates, students in elementary school would be served only bottled water, low-fat and nonfat milk, and 100 percent fruit juice in servings no bigger than eight ounces. Serving sizes would increase to 10 ounces in middle school. In high school, low-calorie juice drinks, sports drinks and diet sodas would be permitted; serving sizes would be limited to 12 ounces.

The agreement, which includes parochial and private schools contracts, is voluntary, and the beverage industry said its school sales would not be affected because it expected to replace sugary drinks with other ones.

"This is a voluntary policy, but I think schools will want to follow it," said Susan K. Neely, president of the American Beverage Association.

Still, about 35 million public school children would be affected by the agreement, which would apply to extended school functions like band practice but would not apply to events likely to be attended by parents, like evening plays or interscholastic sports. An additional 15 million students attend schools that operate under stricter regulations, where the guidelines would not apply.

Last week, for example, Connecticut banned all sodas, including diet drinks and sports drinks like Gatorade, in its schools; New York City schools permit only low-fat milk, water and 100 percent fruit juice — which is sold under an exclusive contract with Snapple.

Contracts between schools and bottlers would be updated under the deal, and changes would not go into effect before the next school year.

The agreement was brokered by the Alliance for a Healthier Generation, a collaboration between the William J. Clinton Foundation and the American Heart Association. It is similar to an arrangement that the industry had been negotiating with a coalition of lawyers and the Center for Science in the Public Interest, an advocacy group, that had threatened to sue if an agreement could not be reached. The terms were accepted by the three biggest soft-drink companies, Coca-Cola, PepsiCo Inc. and Cadbury Schweppes (whose products include Dr Pepper and Snapple), which together control more than 90 percent of school sales.

At a news conference at his office in Harlem, Mr. Clinton called the beverage industry "courageous" for agreeing to switch to lower-calorie drinks. Mr. Clinton, who has made obesity a major issue of his postpresidency agenda, was joined by Gov. Mike Huckabee of Arkansas, a vocal proponent of fitness.

Later in the day, Mr. Clinton said it was more than the threat of lawsuits that spurred the agreement.

"We've been talking to them for months and months, and they may have liked the way we were working with them, not just singling them out," he said in a telephone interview. "I'm glad we did it without litigation and could accelerate the process."

It will take three years for the agreement to be put fully into effect. The industry has agreed at the end of each school year starting in 2007 to disclose the progress toward fulfilling the agreement. The new standards are expected to be in place in 75 percent of schools by the summer of 2008 and all by 2009. The success of the program depends on schools' willingness to amend existing contracts, industry representatives said.

The majority of school contracts with Pepsi Bottling Group, Pepsi's largest bottler, for instance, are for three to five years, said its spokeswoman, Kelly McAndrew, who said Pepsi would encourage schools to renegotiate their contracts.

"We're doing our part to communicate this new policy," she said.

Mirroring overall beverage consumption in the United States, bottled water and sports drinks have become increasingly popular in schools in recent years. But in a survey released in August, the American Beverage Association said 45 percent of all school vending sales were sweetened soda.

While the soft-drink industry was negotiating the deal, it was discussing a similar accord with the Center for Science in the Public Interest and a group of lawyers who had successfully sued tobacco companies.

Richard A. Daynard, associate dean at Northeastern University School of Law, a tobacco-lawsuit veteran, called the agreement "the first major victory for the obesity-litigation strategy."

"This would not have happened but for the threat of litigation," Professor Daynard said.

Beverage-industry officials acknowledged discussions with the lawyers but would not comment further.

Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, applauded the agreement, but said, , "I'd like to get rid of the Gatorades and diet soft drinks completely."

Nutritionists and parent groups have pressured schools and the beverage industry for some time to restrict sales. Several states, including California, and some local school districts have banned soft-drink sales, and other states are considering similar crackdowns. In response, the beverage association last year announced a policy that would have cut back on the sale of certain soft drinks in schools. But critics said the plan was unenforceable.

Gary Ruskin, executive director of Commercial Alert, a nonprofit public-health group, said the new agreement might prove to have the same problem. Mr. Ruskin criticized it, too, because it did not address soft-drink advertising in schools and did not stop bottlers from advertising on Channel One, which is shown to seven million schoolchildren a day.

Mr. Clinton said there remained "an enormous amount to be done" about childhood obesity.

"You can't single out one cause of this problem," he said. "But if an 8-year-old child took in 45 less calories per day, by the time he reached high school, he would weight 20 pounds less than he would have weighed otherwise.."

    Bottlers Agree to a School Ban on Sweet Drinks, NYT, 4.5.2006, http://www.nytimes.com/2006/05/04/health/04soda.html?hp&ex=1146801600&en=d6a3567a85c3250b&ei=5094&partner=homepage

Doctors Object to Gathering of Drug Data

May 4, 2006
The New York Times
By STEPHANIE SAUL

Although virtually unknown to consumers, the information has long been considered the most potent weapon in pharmaceutical sales — computerized dossiers showing which physicians are prescribing what drugs. Armed with such data, a drug sales representative can pressure a doctor to write more prescriptions for a name-brand medicine or fewer orders for a competitor's drug.

But now a rebellion is under way by some doctors, who consider the data-gathering an intrusion that feeds overzealous sales practices among the nation's estimated 90,000 drug company representatives. Public officials are also weighing in. A vote on a state bill to clamp down on the practice is scheduled for today in New Hampshire, and similar bills have been introduced in other states, including Arizona and West Virginia.

To appease the doctors and try to stave off the state restrictions, the American Medical Association will soon give individual physicians the choice of declaring their prescription records off limits to drug sales representatives. The new measure is viewed as a self-policing move that the drug industry and the A.M.A., which has lucrative contracts with data-mining companies, hope will keep states from banning sales of prescription data altogether.

If the A.M.A effort succeeds, "legislators will turn their attention elsewhere, and the industry can hang on to one of its most valuable data sources," according to an article this week in the industry trade magazine Pharmaceutical Executive, which was co-written by an A.M.A. official and an executive with the leading vendor of prescription data. Even many critics concede that patients' privacy is apparently not an issue, because the tracking systems identify only the prescribing doctors, not patients. But many doctors find the use of the data by sales representatives an intrusion into the way they practice medicine.

"These doctors were outraged that people came into their office and talked to them about how many times they prescribed a particular drug," said Dr. John C. Lewin, the chief executive of the state medical association in California, one of the states where complaints about the current system arose.

The California group is beginning its own program under which doctors who do not opt out under the A.M.A. system will get comparisons of their prescribing patterns in 17 classes of drugs from the data companies, said Dr. Lewin, who added that the program was being started as a pilot effort that he hoped would be extended statewide.

Among the doctors who raised an early complaint about the system was Dr. Brad Drexler, an obstetrician in Healdsburg, Calif., who said he was surprised four years ago when pharmaceutical representatives began thanking him for writing prescriptions — the first time he realized that the drug representatives had information he assumed was private.

"I think it adds to the potential that physicians could be targeted one way or another for perks," said Dr. Drexler, alluding to the practice by drug companies of deciding which doctors to reward with the gifts, meals and other perks that sales representatives have dangled over the years, or to gauge which physicians might be worthy of signing up as paid speakers or consultants.

"It's the most powerful tool a drug rep has, for sure," said Jamie Reidy, a former drug salesman who was fired last year by Eli Lilly & Company after writing "Hard Sell," a humorous exposé of the pharmaceutical industry. Mr. Reidy said the pharmaceutical representatives received updated prescription data every two weeks. The information also sometimes characterizes each physician's prescribing patterns, Mr. Reidy said.

For example, "early prescribers" — also known among drug representatives as "cowboys," according to Mr. Reidy — are those doctors who start prescribing a drug as soon as it comes to market. If you are a drug sales representative, "you go to see that doctor in the first week," Mr. Reidy said.

Although the drug representatives are told not to share the prescribing details with doctors, some nonetheless have confronted doctors with the data. A representative might become frustrated, for example, if after providing numerous lunches to a doctor's staff, the data show that the doctor is not writing prescriptions for the company's drug.

"It just creates a weird atmosphere," Mr. Reidy said.

State Representative Cindy Rosenwald of New Hampshire, lead sponsor of her state's bill, said she was motivated partly by high Medicaid drug costs, which she said she believed had been driven up by the pharmaceutical industry's success in coaxing doctors to prescribe expensive brand-name drugs.

"To me this is a money issue," Ms. Rosenwald said. "When I look at our state's budget, the fastest-growing part of the Medicaid program here in New Hampshire is for prescription drugs. It's an enormous cost for a small state like New Hampshire."

Ms. Rosenwald's legislation has been adopted by the New Hampshire House and is tentatively set for a Senate vote this afternoon.

She said she did not believe the A.M.A.'s self-policing measure would provide enough protection, partly because even if doctors specify that their prescription records not be available to drug sales representatives, the information would still be sold to drug companies for other marketing and research purposes. The drug companies, she said, would be on their honor not to share the data with their sales staffs. A Gallup Poll commissioned by the A.M.A. in 2004 found that two-thirds of doctors surveyed were opposed to the release of such data to pharmaceutical representatives, and that 77 percent felt that an opt-out program would alleviate concerns about the release of data. Nearly a quarter of the doctors were not even aware that the pharmaceutical industry had access to such information.

That same year, the American College of Physicians requested that the A.M.A. prohibit the release or sale of doctors' prescribing information. The college represents internists and related medical subspecialties, while the A.M.A. is a broader trade group whose members include all doctors, including surgeons.

Dr. Dean Abramson, an Iowa physician, is among the doctors who plan to opt out under the new A.M.A. process, which will involve a sign-up registry that goes into use on July 1. His opposition began nearly a decade ago, he recalled, when a representative from TAP Pharmaceutical Products let slip during a sales call that Dr. Abramson wrote more prescriptions for Prevacid, a treatment for acid reflux, than any other doctor in the state.

"I was pretty surprised that they kept that data, and I was not happy at all," Dr. Abramson said. "I said, 'Why is that data even kept?' She didn't really give me an answer."

Since then, Dr. Abramson has become something of an activist against the lunches and gifts that the pharmaceutical industry dispenses to doctors. His gastroenterology group in Cedar Rapids, Iowa, accepts neither, he said.

The leading compiler and vendor of prescription data is IMS Health, a publicly traded company based in Fairfield, Conn., that had revenue last year of $1.75 billion. IMS and its competitors gather the data through contracts with retail pharmacy chains and companies that manage drug plans for insurers, then sell it to pharmaceutical companies.

IMS and its competitors — the main ones are Verispan, Dendrite International and a Dutch company, Wolters Kluwer — also pay the A.M.A. for access to its repository of information on approximately one million doctors who are graduates of American medical schools, as well as foreign medical school graduates licensed in the United States.

The A.M.A., which calls this repository Masterfile, begins collecting the information when a doctor enters medical school. Over doctors' careers, additional material includes information on their board certifications, types of practice and disciplinary records. The Masterfile information is among data that companies like IMS use in developing physician profiles.

In an interview, IMS officials said they believed that state efforts to curtail their activities were misguided. "Limiting the access to our data will not stop pharmaceutical marketing," said Robert J. Hunkler, whose job with the company includes serving as a liaison with the medical profession. Mr. Hunkler also says that the data his company collects is valuable for medical research and is sometimes shared free with researchers.

Mr. Hunkler was a co-author of the Pharmaceutical Executive article describing the new A.M.A. program. The other writer was Robert A. Musacchio, the A.M.A.'s senior vice president for publishing and business services. While Mr. Musacchio declined to disclose the exact value of its Masterfile contracts with the four main data companies, he said that the organization made $40 million a year selling information, which also includes mailing lists and a service through which hospitals can check the credentials of doctors. Mr. Musacchio said that doctors had always been able to put a "no contact" status on their Masterfile record, meaning their name would not be licensed for marketing by mail, telephone or fax.

The A.M.A.'s new registry, administered partly through a Web site, will enable doctors listed in its Masterfile to indicate that they do not want their prescribing data shared with pharmaceutical sales representatives. The decision will remain in force for three years.

And yet, even those doctors' prescription information will still be collected and transmitted to drug companies, whose other uses of the data include tallying bonuses paid to pharmaceutical representatives, which are based on sales. "What we've always stressed is that physicians have rights and they can always tell pharmaceutical representatives that they don't want to be called upon," said Mr. Musacchio. But he said the organization had always made clear to the pharmaceutical industry that its representatives should never "badger or embarrass or harass" physicians.

"They sometimes try to get their point across a little too strongly," he said.

    Doctors Object to Gathering of Drug Data, NUT, 4.5.2006, http://www.nytimes.com/2006/05/04/business/04prescribe.html?hp&ex=1146801600&en=346cd8831aba4c5d&ei=5094&partner=homepage

More working Americans go without health-care coverage

Posted 4/26/2006 9:08 AM ET
USA Today

NEW YORK (AP) — The percentage of working-age Americans with moderate to middle incomes who lacked health insurance for at least part of the year rose to 41% in 2005, a dramatic increase from the 28% in 2001 without coverage, a study released on Wednesday found.

Moreover, more than half of the uninsured adults said they were having problems paying their medical bills or had incurred debt to cover their expenses, according to a report by the Commonwealth Fund, a private health care policy foundation. The study of 4,350 adults also found that people without insurance were more likely to forgo recommended health screenings such as mammograms than those with coverage, and were less likely to have a regular doctor than their insured counterparts.

The report paints a bleak health care picture for the uninsured. "It represents an explosion of the insurance crisis into those with moderate incomes," said Sara Collins, a senior program officer at the Commonwealth Fund.

Collins said the study also illustrates how more employers are dropping coverage or are offering plans that are just too expensive for many people.

About 45.8 million Americans did not have health insurance in 2004, according to the U.S. Census Bureau.

The percentage of individuals earning less than $20,000 a year without insurance rose to 53%, up from 49% in 2001. Overall, the percentage of people without insurance rose to 28% in 2005 from 24% in 2001.

The study also found that 59% of uninsured with chronic conditions such as asthma or diabetes either skipped a dose of their medicine or went without it because it was too expensive.

One-third of those in that group visited an emergency room or stayed in a hospital overnight or did both, compared to 15% of their insured counterparts.

Collins said those statistics are significant because giving up medicines typically leads to more expensive health problems later. Treating people in expensive settings such emergency rooms places a financial burden on the health care system.

"People not being able to take care of themselves should send out a big red flag," said Collins.

HCA hoisted a red flag on Tuesday, when the the nation's largest for-profit hospital operator said its earnings fell 8.5% in the first quarter after a 13% increase in uninsured admissions cut into revenue gains. The company said its provision for "doubtful accounts" rose to $852 million from $683 million a year earlier.

The Commonwealth Fund's study was bolstered by analysis of government data funded and released by the Robert Wood Johnson Foundation, a private organization that provides health care grants.

That study found that cost prevented 41.1% of uninsured adults from seeing a doctor, compared to 9.2% of individuals with coverage.

Meanwhile, 51% of women without health insurance haven't had a mammogram in two years, compared to 22.8% of women with insurance.

And 76.3% of uninsured men between the ages of 40 to 64 haven't had the PSA test, which detects prostate cancer, in two years. That compares to 52.2% of their insured counterparts.

Researchers at the University of Minnesota School of Public Health used data from the U.S. Centers for Disease Control and Prevention to reach the study's conclusion.

    More working Americans go without health-care coverage, UT, 26.4.2006, http://www.usatoday.com/money/industries/insurance/2006-04-26-uninsured-workers_x.htm

Calif. judge backs $3 billion stem-cell effort

Fri Apr 21, 2006 10:51 PM ET
Reuters

SAN FRANCISCO (Reuters) - A California judge on Friday opened the way for the state to begin funding $3 billion of stem-cell research, ruling the controversial voter-approved California Institute for Regenerative Medicine is constitutional.

But opponents can still appeal the decision.

California has been at the center of the stem-cell debate since voters in 2004 approved using state funds for research. The debate pits groups that morally oppose using fertilized human eggs for study against others who see stem cells as key to curing many diseases such as Alzheimer's and diabetes.

Alameda County Judge Bonnie Sabraw held that the institute, approved by state voters in November 2004, is a legitimate state agency that can issue debt.

"This will enable the stem cell agency to carry out critically important research in the most exciting area of biomedical research," Dr. Phillip Pizzo, dean of the Stanford School of Medicine said in a statement.

Opponents had challenged the constitutionality of the institute, effectively freezing its efforts to issue up to $300 million in debt annually.

"We have a victory across the board on every issue presented," Robert Klein, the institute's chairman, said on a conference call.

The suit was filed in April 2005 by a group of defendants that now includes the California Family Bioethics Council, a project of the California Family Council which opposes abortion and gay marriage, and the National Tax Limitation Foundation.

President Bush in August 2001 restricted federal funding of embryonic stem cell research to existing batches of the cells, w