History > 2008 > USA > Health (III)

Counting Birthdays

The Short End of the Longer Life

April 27, 2008
The New York Times
By KEVIN SACK

THROUGHOUT the 20th century, it was an American birthright that each generation would live longer than the last. Year after year, almost without exception, the anticipated life span of the average American rose inexorably, to 78 years in 2005 from 61 years in 1933, when comprehensive data first became available.

But new research shows that those reassuring nationwide gains mask a darker and more complex reality. A pair of reports out this month affirm that the rising tide of American health is not lifting all boats, and that there are widening gaps in life expectancy based on the interwoven variables of income, race, sex, education and geography.

The new research adds weight to the political construct popularized by former Senator John Edwards of North Carolina, that there are two Americas (if not more), measured not only by wealth but also by health, and that the poles are growing farther apart.

The most startling evidence came last week in a government-sponsored study by Harvard researchers who found that life expectancy actually declined in a substantial number of counties from 1983 to 1999, particularly for women. Most of the counties with declines are in the Deep South, along the Mississippi River, and in Appalachia, as well as in the southern Plains and Texas.

The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.

“Some people are actually sinking,” said Majid Ezzati, one of the report’s authors. “The line of excuse that we can live with inequality as long as no one is getting worse is just no longer there.”

The researchers found statistically significant declines for women in 180 of the 3,141 counties in the United States and in 11 counties for men. In an additional 783 counties for women and 48 for men, there were declines that did not reach the threshold of statistical significance.

Of particular concern is that the gap in life expectancy between top and bottom counties expanded by two years for men and by about 10 months for women. In the worst-performing counties, all in southwestern Virginia, the drop in life expectancy over the 16-year period was nearly six years for women and two and a half years for men. In the counties showing the greatest improvement, many in the desert West, life expectancy rose nearly five years for women, and nearly seven years for men.

The first of the two reports, released two weeks ago by the Congressional Budget Office, declared that the life expectancy gap is growing between rich and poor and between those with the highest and lowest educational attainment, even as it is narrowing between men and women and between blacks and whites.

Pointing to the effects of smoking, obesity and chronic disease, the budget analysts wrote that “in recent decades, socioeconomic status has become an even more important indicator of life expectancy, whether measured at birth or at age 65.” Among the implications, they wrote, is that Social Security payroll taxes will become less progressive as the wealthy increase their longevity advantage over the poor.

Peter R. Orszag, the budget office’s director, said that the decline in life expectancy among some Americans was “remarkable in an advanced industrial nation” and that he believed the growing gap related to income inequality. “We’ve had sluggish income growth at the bottom and rapid income growth at the top for the last three decades,” he said.

Mr. Edwards said in an interview that the new findings on disparities demonstrate both the reach and consequences of income inequality. “The wealth and income disparity effectively infiltrates all parts of people’s lives,” he said.

What remains to be determined by the increasingly dynamic field of research into health disparities is precisely how income interacts with factors like race, gender and education to give some people better odds of living longer.

Taken to their extreme, the numbers can be striking: a 2006 study found that Native American men in southwestern South Dakota could expect to live to 58, while Asian women in Bergen County in New Jersey had a life expectancy of 91.

For some groups at some times, disparities can widen and shrink because of societal changes (like fluctuating homicide rates) and medical developments (like the emergence of H.I.V., or the discovery of drugs to treat it). But the causes of more lasting trends may not always be obvious, and some research suggests that income alone cannot explain away many differences.

For example, a 2006 study found that low-income whites in the northern Plains could expect to live four years longer than low-income whites in Appalachia and the Mississippi Valley. Other research indicates that health insurance status, which can relate directly to income, may not be a significant determinant of longevity.

And yet, this month’s Harvard study showed that counties with declining or stagnant life expectancy were poorer than those with improving numbers. Recent cancer studies have found that the uninsured are more likely to fail to get a diagnosis until late stages of the disease. Research also shows that many of the behaviors that drive mortality — unhealthy diet, smoking, poor management of chronic disease — are more common among low-income Americans.

“We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship,” said Sam B. Harper, an epidemiologist at McGill University who has studied the issue.

Dr. Ezzati, of the Harvard School of Public Health, asked: “How much of this is pure material well being, the ability to purchase high-quality food, the ability to have a particular lifestyle? And how much of it is the impact of income on risk behaviors like alcohol and tobacco and stress mechanisms that are more psychosocial? There’s a series of debates around that that are unresolved.”

As for a prescription, Dr. Ezzati and his colleagues are realists. In a 2006 study, they concluded that “because policies aimed at reducing fundamental socioeconomic inequalities are currently practically absent in the U.S.,” life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries.

Dr. Ezzati noted that few industrialized countries have had declines of comparable duration. “This is a very unusual pattern,” he said, “and the question we’re starting to ask is, ‘Is the fact that the bottom 20 percent is not getting better, and may be worse off, going to drive the health of the whole country?’ ”

The Short End of the Longer Life, NYT, 27.4.2008,
http://www.nytimes.com/2008/04/27/weekinreview/27sack.html

A Jump in Doctor Visits and Deaths

in Flu Season

April 18, 2008
The New York Times
By DENISE GRADY

The current flu season has been more severe than the last three, with more doctor visits and more deaths from flu and pneumonia, federal health officials are reporting.

The season peaked in February, when flulike illnesses accounted for 5.9 percent of doctor visits. Over all, doctor visits for these illnesses were higher than normal for 13 consecutive weeks.

The death rate related to flu and pneumonia was also higher than usual for 13 consecutive weeks; at the worst point, in March, the illnesses were listed as underlying or contributing causes of death in 9.1 percent of deaths. Any rate over 6.9 percent is considered unusually high.

The deaths included 65 children under 18. The youngest was a month old, and the median age was 4.5 years. In each of the three previous flu seasons, 46 to 74 children died.

The statistics were published online on Thursday by the Centers for Disease Control and Prevention.

The main reason for the increased severity this season is that a more virulent type of virus, called A(H3N2), has predominated, said Dr. Dan Jernigan, deputy director of the influenza division at the disease centers. There are many A(H3N2) variants, and this particular one was first identified in Brisbane, Australia, in 2007.

The virus caught vaccine makers off guard. Though the current vaccine does contain an A(H3N2) strain related to the Brisbane variant, it is not exactly the same, making the vaccine less effective than it might have been.

A study found that the vaccine reduced people’s risk of contracting any type of influenza A by 58 percent. But when vaccine strains are well matched to viruses, they can cut the risk by 70 percent to 90 percent in healthy adults. Generally, the vaccines do not work as well in the elderly or in small children.

Normally, if 100 people who are not vaccinated are exposed to the flu, 10 will get sick. But if 100 who are vaccinated are exposed, and the vaccine is 70 percent effective, then only 3 will get sick.

Flu vaccines generally contain three types of virus, and this year’s vaccine has a second mismatch as well: it is completely inactive against the kind of influenza B virus that has been circulating this year.

Dr. Jernigan said mismatches could occur because vaccine makers must decide which strains to include by February, many months before the flu season begins, so that they can make the vaccine in time for autumn. Sometimes, he said, “a virus will emerge that was not even available at the time the decision had to be made.”

The vaccine for the next flu season has been formulated; it will contain three completely different strains from the ones used this year.

Articles published Thursday in two scientific journals, Science and Nature, discussed the evolution and spread of influenza A viruses. Researchers have long believed that new flu viruses originated each year in Asia, and the Science article provided evidence that the theory was correct. Its authors analyzed 13,000 flu virus samples from around the world and traced them to East and Southeast Asia.

Many scientists had believed southern China was the main source of flu viruses, but the new study suggests they come from other parts of Asia as well. The viruses reach Europe and North America six to nine months later and then after a few more months arrive in South America, where they die out.

The disease centers estimates that every year 5 percent to 20 percent of the United States population gets the flu, and that more than 200,000 people are hospitalized because of flu complications and about 36,000 die.

    A Jump in Doctor Visits and Deaths in Flu Season, NYT, 18.4.2008, http://www.nytimes.com/2008/04/18/health/research/18flu.html?hp

Mind

Who Are We? Coming of Age on Antidepressants

April 15, 2008
The New York Times
By RICHARD A. FRIEDMAN, M.D.

“I’ve grown up on medication,” my patient Julie told me recently. “I don’t have a sense of who I really am without it.”

At 31, she had been on one antidepressant or another nearly continuously since she was 14. There was little question that she had very serious depression and had survived several suicide attempts. In fact, she credited the medication with saving her life.

But now she was raising an equally fundamental question: how the drugs might have affected her psychological development and core identity.

It was not an issue I had seriously considered before. Most of my patients, who are adults, developed their psychiatric problems after they had a pretty clear idea of who they were as individuals. During treatment, most of them could tell me whether they were back to their normal baseline.

Julie could certainly remember what depression felt like, but she could not recall feeling well except during her long treatment with antidepressant medications. And since she had not grown up before getting depressed, she could not gauge the hypothetical effects of antidepressants on her emotional and psychological development.

Her experience is far from unique. Since their emergence in the late 1980s, serotonin reuptake inhibitors like Prozac and Zoloft have become some of the most widely prescribed drugs in the world, for depressed teenagers as well as adults. Because depression is often a chronic, recurring illness, there are certain to be many young people, like Julie, who are coming of age on these newer antidepressants.

We know a lot about the course of untreated depression, probably more than we do about very long-term antidepressant use in this population. We know, for example, that depression in young people is a very serious problem; suicide is the third-leading cause of death in adolescents, not to mention the untold suffering and impaired functioning this disease exacts.

By contrast, the risk of antidepressant treatment is small. A 2004 review by the Food and Drug Administration, analyzing clinical trials of the drugs, did show an elevated risk of suicidal thinking and nonlethal suicide attempts in young people taking antidepressants — 3.5 percent, compared with 1.7 percent of those taking a placebo. But since the lifetime risk of actual suicide in depressed people ranges from 2.2 to 12 percent, risk from treatment is dwarfed by the risks of the disease itself.

Still, what do we know about the effects of, say, 15 to 20 years of antidepressant drug treatment that begins in adolescence or childhood? Not enough.

The reason has to do with the way drugs are tested and approved. To get F.D.A. approval, a drug has to beat a placebo in two randomized clinical trials that typically involve a few hundred subjects who are treated for relatively short periods, usually 4 to 12 weeks.

So drugs are approved based on short-term studies for what turns out to be long-term — often lifelong — use in the world of clinical practice. The longest maintenance study to date of one of the newer antidepressants, Effexor, lasted only two years and showed the drug to be superior to a placebo in preventing relapses of depression.

What do I say to a depressed patient who is doing well after five years on such a drug but can’t stop without a depressive relapse and who wants reassurance that the drug has no long-term adverse effects?

I usually say that we have no evidence that the drug poses a risk with long-term use; and since the risk of untreated depression is much greater than the hypothetical risk of the drug, it makes sense to stay on it.

This large gap in our clinical knowledge is compounded by the public’s growing and well-founded skepticism about research sponsored by drug makers. A study in the January 2008 issue of The New England Journal of Medicine, involving 74 clinical trials with 12 antidepressants, found that 97 percent of positive studies were published, versus 12 percent of negative studies.

Clearly, physicians and the public need much better data on the safety and efficacy of drugs after they hit the market, which at present consists mainly of anecdotes and case reports.

Congress recently reauthorized the Prescription Drug User Fee Act, which will expand the F.D.A.’s post-marketing drug surveillance, though I think it did not go far enough in mandating the use of powerful epidemiological strategies to monitor drugs over the long term.

Beyond these concerns, there are other important issues to consider in long-term use of antidepressants, especially in young people. One patient, a woman in her mid-20s, told me that she felt pressured by her boyfriend to have sex more often than she wanted. “I’ve always had a low sex drive,” she said.

For the past eight years she had been taking Zoloft, which like all the antidepressants in its class is known to lower libido and to interfere with sexual performance. She had understandably mistaken the side effect of the drug for her “normal” sexual desire and was shocked when I explained it: “And I thought it was just me!”

This just underscores how tricky it can be to use psychotropic drugs during adolescence — when the brain is still developing, when one’s identity is still work in progress.

The drugs save lives, and we often have no choice but to use them — even if we have questions about their long-term use. But the questions are big ones, and we owe it to our patients to try to answer them.
 

Richard A. Friedman is a professor of psychiatry at Weill Cornell Medical College.

    Who Are We? Coming of Age on Antidepressants, NYT, 15.4.2008, http://www.nytimes.com/2008/04/15/health/15mind.html

Editorial

When Drug Costs Soar Beyond Reach

April 15, 2008
The New York Times
 

It doesn’t take a health policy expert to recognize that something has gone terribly wrong when patients have to pay thousands of dollars a month for drugs that they need to maintain their health — and possibly save their lives. Congress needs to determine why this is happening and what can be done about it.

The plight of patients who have recently been hit with a huge increase in their insurance co-payments for high-priced prescription drugs was laid out in The Times on Monday by Gina Kolata. Instead of paying a modest $10 to $30 co-payment, as is usually the case for cheaper drugs, patients who need especially costly medicines are being forced to pay 20 percent to 33 percent of the bill (up to an annual maximum) for drugs that can cost tens of thousands of dollars, or even hundreds of thousands of dollars, a year.

These drugs — what insurers call Tier 4 medicines — are used to treat such serious illnesses as multiple sclerosis, hemophilia, certain cancers and rheumatoid arthritis. And since there are usually no cheaper alternatives, patients must either pay or do without, unless they can get their medicines through some charitable plan.

There is little doubt that the so-called tiered formularies, in which co-payments rise along with the cost of the drugs, are a sensible approach for encouraging consumers to use the cheapest drug suitable for their condition. But the system seems to break down when it moves to Tier 4 drugs where co-payments can be huge and suitable alternatives don’t exist.

The insurers say that forcing patients to pay more for unusually high-priced drugs allows them to keep down the premiums charged to everyone else. That turns the ordinary notion of insurance on its head. Instead of spreading the risks and costs across a wide pool of people to protect a smaller number of very sick patients from financial ruin, insurers are gouging the sickest patients to keep premiums down for healthier people.

The health insurance system is so complex that it is hard to parse the blame for this injustice. The drug companies, especially the biotechnology companies, are at the root of the problem; they often charge exorbitant prices for monopoly drugs that were developed with heavy government assistance. Washington needs to rein them in by encouraging generic competition for biological drugs and allowing government programs to negotiate lower prices.

Employers, including the federal government, also bear responsibility. They have been pressing to reduce their prescription drug expenditures, and all health care expenditures, by shifting more of the burden to patients. One patient who had been paying only $20 for a month’s supply of a multiple sclerosis drug was shocked when the charge rose to $325 per month. (It has since been suspended.) Another patient found that his co-payment for a newly prescribed leukemia drug would exceed $4,000 for a 90-day supply, so he has deferred buying it.

If patients do without medicines or put off taking them, the likely result will be sicker patients, and higher costs, down the road.

What is not clear is whether insurers are primarily reacting to pressure from employers or are exploiting the situation to increase their profits. Congress needs to probe hard to find out how many patients are facing enormous drug bills and how best to protect them from medical and financial disaster.

    When Drug Costs Soar Beyond Reach, NYT, 15.4.2008, http://www.nytimes.com/2008/04/15/opinion/15tues1.html

Co-Payments Go Way Up for Drugs With High Prices

April 14, 2008
The New York Times
By GINA KOLATA

Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.

With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.

The system means that the burden of expensive health care can now affect insured people, too.

No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without.

Insurers say the new system keeps everyone’s premiums down at a time when some of the most innovative and promising new treatments for conditions like cancer and rheumatoid arthritis and multiple sclerosis can cost $100,000 and more a year.

But the result is that patients may have to spend more for a drug than they pay for their mortgages, more, in some cases, than their monthly incomes.

The system, often called Tier 4, began in earnest with Medicare drug plans and spread rapidly. It is now incorporated into 86 percent of those plans. Some have even higher co-payments for certain drugs, a Tier 5.

Now Tier 4 is also showing up in insurance that people buy on their own or acquire through employers, said Dan Mendelson of Avalere Health, a research organization in Washington. It is the fastest-growing segment in private insurance, Mr. Mendelson said. Five years ago it was virtually nonexistent in private plans, he said. Now 10 percent of them have Tier 4 drug categories.

Private insurers began offering Tier 4 plans in response to employers who were looking for ways to keep costs down, said Karen Ignagni, president of America’s Health Insurance Plans, which represents most of the nation’s health insurers. When people who need Tier 4 drugs pay more for them, other subscribers in the plan pay less for their coverage.

But the new system sticks seriously ill people with huge bills, said James Robinson, a health economist at the University of California, Berkeley. “It is very unfortunate social policy,” Dr. Robinson said. “The more the sick person pays, the less the healthy person pays.”

Traditionally, the idea of insurance was to spread the costs of paying for the sick.

“This is an erosion of the traditional concept of insurance,” Mr. Mendelson said. “Those beneficiaries who bear the burden of illness are also bearing the burden of cost.”

And often, patients say, they had no idea that they would be faced with such a situation.

It happened to Robin Steinwand, 53, who has multiple sclerosis.

In January, shortly after Ms. Steinwand renewed her insurance policy with Kaiser Permanente, she went to refill her prescription for Copaxone. She had been insured with Kaiser for 17 years through her husband, a federal employee, and had had no complaints about the coverage.

She had been taking Copaxone since multiple sclerosis was diagnosed in 2000, buying 30 days’ worth of the pills at a time. And even though the drug costs $1,900 a month, Kaiser required only a $20 co-payment.

Not this time. When Ms. Steinwand went to pick up her prescription at a pharmacy near her home in Silver Spring, Md., the pharmacist handed her a bill for $325.

There must be a mistake, Ms. Steinwand said. So the pharmacist checked with her supervisor. The new price was correct. Kaiser’s policy had changed. Now Kaiser was charging 25 percent of the cost of the drug up to a maximum of $325 per prescription. Her annual cost would be $3,900 and unless her insurance changed or the drug dropped in price, it would go on for the rest of her life.

“I charged it, then got into my car and burst into tears,” Ms. Steinwand said.

She needed the drug, she said, because it can slow the course of her disease. And she knew she would just have to pay for it, but it would not be easy.

“It’s a tough economic time for everyone,” she said. “My son will start college in a year and a half. We are asking ourselves, can we afford a vacation? Can we continue to save for retirement and college?”

Although Kaiser advised patients of the new plan in its brochure that it sent out in the open enrollment period late last year, Ms. Steinwand did not notice it. And private insurers, Mr. Mendelson said, can legally change their coverage to one in which some drugs are Tier 4 with no advance notice.

Medicare drug plans have to notify patients but, Mr. Mendelson said, “that doesn’t mean the person will hear about it.” He added, “You don’t read all your mail.”

Some patients said they had no idea whether their plan changed or whether it always had a Tier 4. The new system came as a surprise when they found out that they needed an expensive drug.

That’s what happened to Robert W. Banning of Arlington, Va., when his doctor prescribed Sprycel for his chronic myelogenous leukemia. The drug can block the growth of cancer cells, extending lives. It is a tablet to be taken twice a day — no need for chemotherapy infusions.

Mr. Banning, 81, a retired owner of car dealerships, thought he had good insurance through AARP. But Sprycel, which he will have to take for the rest of his life, costs more than $13,500 for a 90-day supply, and Mr. Banning soon discovered that the AARP plan required him to pay more than $4,000.

Mr. Banning and his son, Robert Banning Jr., have accepted the situation. “We’re not trying to make anybody the heavy,” the father said.

So far, they have not purchased the drug. But if they do, they know that the expense would go on and on, his son said. “Somehow or other, myself and my family will do whatever it takes. You don’t put your parent on a scale.”

But Ms. Steinwand was not so sanguine. She immediately asked Kaiser why it had changed its plan.

The answer came in a letter from the federal Office of Personnel Management, which negotiates with health insurers in the plan her husband has as a federal employee. Kaiser classifies drugs like Copaxone as specialty drugs. They, the letter said, “are high-cost drugs used to treat relatively few people suffering from complex conditions like anemia, cancer, hemophilia, multiple sclerosis, rheumatoid arthritis and human growth hormone deficiency.”

And Kaiser, the agency added, had made a convincing argument that charging a percentage of the cost of these drugs “helped lower the rates for federal employees.”

Ms. Steinwand can change plans at the end of the year, choosing one that allows her to pay $20 for the Copaxone, but she worries about whether that will help. “I am a little nervous,” she said. “Will the next company follow suit next year?”

But it turns out that she won’t have to worry, at least for the rest of this year.

A Kaiser spokeswoman, Sandra R. Gregg, said on Friday that Kaiser had decided to suspend the change for the program involving federal employees in the mid-Atlantic region while it reviewed the new policy. The suspension will last for the rest of the year, she said. Ms. Steinwand and others who paid the new price for their drugs will be repaid the difference between the new price and the old co-payment.

Ms. Gregg explained that Kaiser had been discussing the new pricing plan with the Office of Personnel Management over the previous few days because patients had been raising questions about it. That led to the decision to suspend the changed pricing system.

“Letters will go out next week,” Ms. Gregg said.

But some with the new plans say they have no way out.

Julie Bass, who lives near Orlando, Fla., has metastatic breast cancer, lives on Social Security disability payments, and because she is disabled, is covered by insurance through a Medicare H.M.O. Ms. Bass, 52, said she had no alternatives to her H.M.O. She said she could not afford a regular Medicare plan, which has co-payments of 20 percent for such things as emergency care, outpatient surgery and scans. That left her with a choice of two Medicare H.M.O’s that operate in her region. But of the two H.M.O’s, her doctors accept only Wellcare.

Now, she said, one drug her doctor may prescribe to control her cancer is Tykerb. But her insurer, Wellcare, classifies it as Tier 4, and she knows she cannot afford it.

Wellcare declined to say what Tykerb might cost, but its list price according to a standard source, Red Book, is $3,480 for 150 tablets, which may last a patient 21 days. Wellcare requires patients to pay a third of the cost of its Tier 4 drugs.

“For everybody in my position with metastatic breast cancer, there are times when you are stable and can go off treatment,” Ms. Bass said. “But if we are progressing, we have to be on treatment, or we will die.”

“People’s eyes need to be opened,” she said. “They need to understand that these drugs are very costly, and there are a lot of people out there who are struggling with these costs.”

    Co-Payments Go Way Up for Drugs With High Prices, NYT, 14.4.2008, http://www.nytimes.com/2008/04/14/us/14drug.html?hp

Drug Makers Near an Old Goal: A Legal Shield

April 6, 2008
The New York Times
By GARDINER HARRIS and ALEX BERENSON

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the food and drug agency received reports of at least 50 deaths associated with the drug.

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

Gloria Vanderham, a Johnson & Johnson spokeswoman, said the company acted responsibly.

“We have regularly disclosed data to the F.D.A., the medical community and the public in a timely manner,” Ms. Vanderham said. “Ortho Evra is a safe and effective birth control option for women when used according to the labeling.”

But Janet Abaray, a plaintiff’s lawyer from Cincinnati, said that Johnson & Johnson took advantage of an agency overwhelmed by its many responsibilities.

“Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” Ms. Abaray said.

A series of independent assessments have concluded that the agency is poorly organized, scientifically deficient and short of money. In February, its commissioner, Andrew C. von Eschenbach, acknowledged that the agency faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.”

The F.D.A. does not test experimental medicines but relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. “These are scientists, not cops,” said David Vladeck, a professor at Georgetown Law School.

Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.

“We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.”

For years, top officials at the agency acknowledged that lawsuits could aid the agency’s oversight of safety issues. In the last decade, suits over Zyprexa, the withdrawn pain pill Vioxx, the withdrawn diabetes medicine Rezulin, the withdrawn heartburn medicine Propulsid and several antidepressants have shown that companies played down the risks of their medicines and failed to disclose clinical trials to the public even as they have aggressively marketed their drugs.

But now, the agency says a proliferation of lawsuits could lead to an overlapping patchwork of rules that would burden companies and might discourage patients from taking useful medicines.

The Ortho case, however, suggests that Johnson & Johnson, like other drug makers, is not always quick to tell the F.D.A. about potential problems with its medicines.

In 1996, the company told the agency it planned to develop the Ortho Evra patch in part because it would be likely to expose women to less estrogen than pills. The company suggested that the body would not break down hormones delivered via the patch as readily as the pill, so lower doses could be used to achieve contraception. And unlike the pill, which must be taken daily, the patch is changed weekly.

High doses of estrogen are known to raise the risk for blood clots that can cause heart attacks and strokes.

But a crucial trial completed in 1999 showed that the patch delivered 30 to 38 micrograms of estrogen into the bloodstream each day, according to company documents.

Because up to half of the estrogen in pills is lost in the digestive tract before it reaches the blood, the study suggested that the patch delivered an amount of estrogen that could be as high as a pill containing 76 micrograms of estrogen. In 1988, the F.D.A. banned birth control pills with more than 50 micrograms of estrogen.

But the study’s author, Dr. Larry Abrams, who has since retired from Johnson & Johnson, decided to apply a “correction factor” to the results of the 1999 trial, according to documents. He claimed that the patch actually delivered about 40 percent less estrogen than the trial results showed — about 20 micrograms a day.

Dr. Abrams made the change, according to his deposition, to adjust for the different ways the body metabolizes hormones from pills and patches. This adjustment was never part of the study protocol, a plan filed with the F.D.A..

“The judgment was made by the pharmacokeneticists at the time that in doing the calculation, it was probably appropriate to make that correction,” Bob Tucker, a lawyer representing Johnson & Johnson, said in an interview Thursday. “Later on when people looked at it in a different time frame, they concluded that probably the correction shouldn’t be applied.” The company mentioned its decision to use the “correction factor” only once in a 435-page report filed with the F.D.A., and then only in a complex mathematical formula. When the study was published in 2002, there was no reference to the alteration.

Mr. Tucker said that the F.D.A. was aware of the “correction factor.”

Clinical trials conducted before the patch was approved raised other red flags, as patients complained of breast soreness and nausea. “The side effects seem related” to high estrogen doses, one company scientist wrote in an e-mail message.

Two other studies, one conducted in 1999 and another in 2003, confirmed that the patch released more estrogen than the pill. Still, Johnson & Johnson delayed reporting those results to the food and drug agency, according to documents that have been made public in lawsuits.

After the patch was approved, the company marketed it as releasing 20 micrograms of estrogen to the blood every 24 hours, a figure it now acknowledges was inaccurate. It also acknowledges that the patch releases more estrogen than the pill but says that the estrogen released under the two methods cannot be directly compared.

The New York Times provided the drug agency with a copy of a court brief and asked whether agency medical reviewers were aware of the “correction factor.”

Rita Chappelle, an F.D.A. spokeswoman, replied, “At present, we are reviewing the allegations and cannot comment further at this time.”

Prescriptions for the patch grew rapidly after its introduction, reaching more than 900,000 by March 2004, according to data from Wolters Kluwer, a company that tracks prescription trends. But as the use of the patch rose, so did reports of side effects.

By 2004, after the death of Zakiya Kennedy, an 18-year-old college freshman in New York, food and drug officials had become concerned.

In November 2005, the agency announced that it had placed a warning that the patch “exposes women to higher levels of estrogen than most birth control pills.”

Since then, an epidemiological study has shown that women on the patch can have as much as double the risk of blood clots than those taking pills. And prescriptions for the patch have fallen 80 percent.

Still, lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the F.D.A. approved the patch and its label.

“F.D.A. is responsible for making those decisions,” said John Winter, a lawyer for the company.

Judge David A. Katz of Federal District Court for the Northern District of Ohio is expected to rule soon on whether any of the lawsuits against Johnson & Johnson can go forward.

In the fall, the Supreme Court will hear a separate pre-emption case involving Wyeth, another drug company. Chris Seeger, a plaintiffs’ lawyer who has about 125 Ortho Evra cases, said he expected the court to rule in Wyeth’s favor.

“Our lawsuits are the ultimate check against the mistake made by the government, or fraud made by the companies against the government, or just an underfunded bureaucracy stretched thin,” he said.
 

Janet Roberts contributed reporting.

    Drug Makers Near an Old Goal: A Legal Shield, NYT, 6.4.2008, http://www.nytimes.com/2008/04/06/washington/06patch.html?hp

In Massachusetts, Universal Coverage Strains Care

April 5, 2008
The New York Times
By KEVIN SACK

Correction Appended

AMHERST, Mass. — Once they discover that she is Dr. Kate, the supplicants line up to approach at dinner parties and ballet recitals. Surely, they suggest to Dr. Katherine J. Atkinson, a family physician here, she might find a way to move them up her lengthy waiting list for new patients.

Those fortunate enough to make it soon learn they face another long wait: Dr. Atkinson’s next opening for a physical is not until early May — of 2009.

In pockets of the United States, rural and urban, a confluence of market and medical forces has been widening the gap between the supply of primary care physicians and the demand for their services. Modest pay, medical school debt, an aging population and the prevalence of chronic disease have each played a role.

Now in Massachusetts, in an unintended consequence of universal coverage, the imbalance is being exacerbated by the state’s new law requiring residents to have health insurance.

Since last year, when the landmark law took effect, about 340,000 of Massachusetts’ estimated 600,000 uninsured have gained coverage. Many are now searching for doctors and scheduling appointments for long-deferred care.

Here in western Massachusetts, Dr. Atkinson’s bustling 3,000-patient practice, which was closed to new patients for several years, has taken on 50 newcomers since she hired a part-time nurse practitioner in November. About a third were newly insured, Dr. Atkinson said. Just north of here in Athol, the doctors at North Quabbin Family Physicians are now seeing four to six new patients a day, up from one or two a year ago.

Dr. Patricia A. Sereno, state president of the American Academy of Family Physicians, said an influx of the newly insured to her practice in Malden, just north of Boston, had stretched her daily caseload to as many as 22 to 25 patients, from 18 to 20 a year ago. To fit them in, Dr. Sereno limits the number of 45-minute physicals she schedules each day, thereby doubling the wait for an exam to three months.

“It’s a recipe for disaster,” Dr. Sereno said. “It’s great that people have access to health care, but now we’ve got to find a way to give them access to preventive services. The point of this legislation was not to get people episodic care.”

Whether there is a national shortage of primary care providers is a matter of considerable debate. Some researchers contend the United States has too many doctors, driving overutilization of the system.

But there is little dispute that the general practice of medicine is under strain at a time when there is bipartisan consensus that better prevention and chronic disease management would not only improve health but also help control costs. With its population aging, the country will need 40 percent more primary care doctors by 2020, according to the American College of Physicians, which represents 125,000 internists, and the 94,000-member American Academy of Family Physicians. Community health centers, bolstered by increases in federal financing during the Bush years, are having particular difficulty finding doctors.

“I think it’s pretty serious,” said Dr. David C. Dale, president of the American College of Physicians and former dean of the University of Washington’s medical school. “Maybe we’re at the front of the wave, but there are several factors making it harder for the average American, particularly older Americans, to have a good personal physician.”

Studies show that the number of medical school graduates in the United States entering family medicine training programs, or residencies, has dropped by 50 percent since 1997. A decadelong decline gave way this year to a slight increase in numbers, perhaps because demand is driving up salaries.

There have been slight increases in the number of doctors training in internal medicine, which focuses on the nonsurgical treatment of adults. But the share of those residents who then establish a general practice has plummeted, to 24 percent in 2006 from 54 percent in 1998, according to the American College of Physicians.

The Government Accountability Office reported to Congress in February that the per capita supply of primary care physicians actually grew by 12 percent from 1995 to 2005, at more than double the rate for specialists. But the report also revealed deep shifts in the composition of primary care providers.

While fewer American-trained doctors are pursuing primary care, they are being replaced in droves by foreign medical school graduates and osteopathic doctors. There also has been rapid growth in the ranks of physician assistants and nurse practitioners.

A. Bruce Steinwald, the accountability office’s director of health care, concluded there was not a current nationwide shortage. But Mr. Steinwald urged the overhaul of a fee-for-service reimbursement system that he said undervalued primary care while rewarding expensive procedure-based medicine. His report noted that the Medicare reimbursement for a half-hour primary care visit in Boston is $103.42; for a colonoscopy requiring roughly the same time, a gastroenterologist would receive $449.44.

Numerous studies, in this country and others, have shown that primary care improves health and saves money by encouraging prevention and early diagnosis of chronic conditions like high blood pressure and diabetes. Presidential candidates in both parties stress its importance.

Here in Massachusetts, legislative leaders have proposed bills to forgive medical school debt for those willing to practice primary care in underserved areas; a similar law, worth $15.6 million, passed in New York this week. Massachusetts also recently authorized the opening of clinics in drug stores, hoping to relieve the pressure.

“It is a fundamental truth — which we are learning the hard way in Massachusetts — that comprehensive health care reform cannot work without appropriate access to primary care physicians and providers,” Dr. Bruce Auerbach, the president-elect of the Massachusetts Medical Society, told Congress in February.

Jon M. Kingsdale, executive director of the agency that oversees the Massachusetts initiative, said he had not heard of major problems, but acknowledged “the prospect of a severe shortage” as newly insured patients seek care in doctors’ offices rather than emergency rooms.

Given the presence of four medical schools and Boston’s dense medical infrastructure, it might seem difficult to argue that Massachusetts has too few doctors. The state ranks well above the national average in the per capita supply of all doctors and of primary care physicians.

But those measures do not necessarily translate into adequate access, particularly in remote areas. Annual work force studies by the medical society have found statewide shortages of primary care doctors in each of the last two years.

The share who accept new patients has dropped, to barely half in the case of internists, and the average wait by a new patient for an appointment with an internist rose to 52 days in 2007 from 33 days in 2006. In westernmost Berkshire County, newly insured patients are being referred 25 miles away, said Charles E. Joffe-Halpern, director of an agency that enrolls the uninsured.

The situation may worsen as large numbers of general practitioners retire over the next decade. The incoming pool of doctors is predominantly female, and many are balancing child-rearing with part-time work. The supply is further stretched by the emergence of hospitalists — primary care physicians who practice solely in hospitals, where they can earn more and work regular hours. President Bush has proposed eliminating $48 million in federal support for primary care training programs.

Clinic administrators in western Massachusetts report extreme difficulty in recruiting primary care doctors. Dr. Timothy Soule-Regine, a co-owner of the North Quabbin practice, said it had taken at least two years and as long as five to recruit new physicians.

At the University of Massachusetts Medical School in Worcester, no more than 4 of the 28 internal medicine residents in each class are choosing primary care, down from half a decade ago, said Dr. Richard M. Forster, the program’s director. In Springfield, only one of 16 third-year residents at Baystate Medical Center, which trains physicians from Tufts University, plans to pursue primary care, said Jane Albert, a hospital spokeswoman.

The need to pay off medical school debt, which averages $120,000 at public schools and $160,000 at private schools, is cited as a major reason that graduates gravitate to higher-paying specialties and hospitalist jobs.

Primary care doctors typically fall at the bottom of the medical income scale, with average salaries in the range of $160,000 to $175,000 (compared with $410,000 for orthopedic surgeons and $380,000 for radiologists). In rural Massachusetts, where reimbursement rates are relatively low, some physicians are earning as little as $70,000 after 20 years of practice.

Officials with several large health systems said their primary care practices often lose money, but generate revenue for their companies by referring patients to profit centers like surgery and laboratories.

Dr. Atkinson, 45, said she paid herself a salary of $110,000 last year. Her insurance reimbursements often do not cover her costs, she said.

“I calculated that every time I have a Medicaid patient, it’s like handing them a $20 bill when they leave,” she said. “I never went into medicine to get rich, but I never expected to feel as disrespected as I feel. Where is the incentive for a practice like ours?”

This article has been revised to reflect the following correction:

Correction: April 9, 2008

An article on Saturday about a shortage of primary care physicians in Massachusetts misstated a word in a quotation by Katherine J. Atkinson, a doctor who said that her insurance reimbursements often do not cover her costs. She said, “I calculated that every time I have a Medicaid patient, it’s like handing them a $20 bill when they leave;” she did not say “Medicare” patient.

In Massachusetts, Universal Coverage Strains Care, NYT, 5.4.2008, http://www.nytimes.com/2008/04/05/us/05doctors.html