HealthLawProf Blog

F.D.A. Reviewing Deaths in Anemia Drug Study

The New York Times reports that federal health officials, on September 26, said that they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson anemia drug in a German study of stroke patients.  The New York Times writes,

Sixteen percent of patients who were treated with the drug, Eprex, had died three months after the study began, compared with 9 percent who were given a placebo, the Food and Drug Administration said in a statement.

The study was testing whether Eprex could improve brain function in stroke patients, an unapproved use of the drug.

The 522 patients were given relatively high doses of Eprex for three days or a placebo. Most were not anemic, the drug agency said.

Eprex is known generically as epoetin alfa. Johnson & Johnson also sells epoetin alfa under the name Procrit. Amgen sells a version under the name Epogen.

The blockbuster drugs are part of a class called erythropoiesis-stimulating agents, or ESAs, which are approved for treating patients with kidney disease and cancer.

The safety of ESAs came under scrutiny in recent years after other studies found tumor growth or shorter survival for some patients given high doses.

The drug agency ordered strong new warnings on the medicines in July.

The agency said Friday that it was aware of other trials testing the potential neurological effects of epoetin alfa.

The higher death rate in the German study “suggests the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials,” the agency said.

Johnson & Johnson reported last week that early data showed Eprex patients in the German study died more frequently than placebo patients, and said it was doing additional analyses to better understand the findings. The company alerted the drug agency to the findings, a Johnson & Johnson spokesman, Mark Wolfe, said Friday.

The study was initiated by the researcher, Mr. Wolfe said. Johnson & Johnson provided financing and supplies of the drug but was not involved in the trial’s design or conduct, he said.

China’s Milk Scandal Now Seen as Risk in Europe

The New York Times reports that European Union regulators, on September 25, ordered rigorous testing of imports containing at least 15 percent milk powder after concluding that food containing tainted milk powder from China may well be circulating in Europe and putting children at risk.  Elisabeth Rosenthal writes,

The action, announced by the European Food Safety Authority and the European Commission, significantly expands the potential geographic reach of a milk adulteration scandal in China to now include a range of foods sold around the world. The Europeans said cookies, toffees and chocolates were the major concerns.

The World Health Organization and the Unicef also expressed concern on Thursday about the Chinese milk contamination and the implications for other foods. In the United States, some consumer groups called on the Food and Drug Administration to restrict imports of foods that may contain suspected dairy ingredients from China.

In China, milk products contaminated with the industrial chemical melamine have sickened more than 50,000 young children in recent weeks and created a spiraling government scandal.

While it is illegal to import dairy products and baby formula from China into the European Union, European nations can and do import many processed foods containing milk powder as an ingredient that are manufactured outside of Europe. Such products could contain milk powder from China.

In 2007, the European Union imported from China about 19,500 tons of confectionary products, including pastries, cake and cookies, and about 1,250 tons of chocolate and other prepared foods containing cocoa.

“Children who consume both biscuits and chocolate could potentially exceed the T.D.I. by up to more than three times,” the European Food Safety Authority said Thursday, referring to the tolerable daily intake of melamine that the agency regards as safe. Levels above that could result in kidney stones, Ian Palombi, a spokesman for the agency, said in a telephone interview.

In Brussels, the European Commission was trying to assess the extent of the risk. “The problem is with the composite food products, which can be imported, even if they contain milk powder from China,” said Nina Papadoulaki, a spokeswoman for the commission. She said the Commission did not know how many companies sell snacks in Europe that were manufactured in China or included ingredients from China.

She said that member states and food companies in the European Union had been asked to test products for melamine in the past 10 days and so far had not detected a problem, although the testing was continuing.

In the United States, some consumer groups called for stricter regulation as well.

“It is now clear that China has exported dairy products like powdered milk and milk protein products around the globe and we know that some of them came to the United States,” said Wenonah Hauter, executive director of Food and Water Watch. “It is time for the F.D.A. to take this issue seriously and stop the import of dairy products from China until this situation is under control.”

The United States has imported two million pounds of a milk protein called casein this year, along with other powdered milk proteins that are used as ingredients in many processed foods, according to figures from the United States Department of Agriculture. This includes 293,000 pounds that were imported in July. The Food and Drug Administration did not immediately return calls for comment on Thursday.

Melamine is a chemical used in plastic manufacturing that can be added to foods to artificially increase their protein content in testing. Its presence was detected in pet foods originating from China last year.

Even if present in foods in Europe, milk powder contaminated with melamine is not likely to cause the kind of public health disaster that is occurring among Chinese infants. In China, babies drank contaminated milk powder as their sole source of nutrition for weeks if not months, and a handful have died.

Because the harm caused by melamine is related to someone’s weight, it is far less harmful to older children and not likely to be dangerous for adults. Also, for children and adults in Europe, melamine-contaminated milk powder is one small component of a broader diet. The toxic effects of melamine are cumulative, creating kidney stones that can in severe cases lead to kidney failure. Still, children who eat very large quantities of sweets could be at risk.

This week, a number of countries and companies that had previously removed Chinese dairy products from supermarket shelves have started removing snack foods containing milk powder as well. On Thursday, members of the Philippine Association of Supermarkets removed Chinese food products with milk ingredients.

In an increasingly globalized food economy, manufacturers use raw ingredients from all over the world, often making it difficult to track the origins.

For example, Kraft Foods, the maker of Oreo cookies, recently moved one of its large cookie factories from Australia to China. But Claire Regan, a spokeswoman for the company, said that most of the products Kraft made in China were distributed within China, although a limited number were exported. Most do not contain milk products from China, she said, and, when they do, the levels of such ingredients are very low. The Oreo product line does not contain milk ingredients from China, Ms. Regan said.

Goal of CDC Vaccine Program Sets Record: 86% of Americans Told to Get Flu Shot

The Washington Post reports that the CDC is targeting 86% of the population for flu vaccination, a record setting number of people, with a similar record breaking number of flu vaccines made available this fall.  David Brown writes,

A record-setting amount of influenza vaccine is available this fall for a record-setting number of people being advised to get it.

That was the message yesterday from officials at the Centers for Disease Control and Prevention and several private organizations, who convened in Washington to urge Americans to get flu shots.

The number of people targeted for flu vaccination has grown steadily in recent years and now constitutes 86 percent of the population.

For the first time, the federal government is recommending this year that children 5 to 18 years old get vaccinated, along with the previously targeted group of 6 months to 5 years. That will add about 30 million children to the number advised to get the shots.

CDC recommends that children ages 6 months to 8 years get two flu shots a month apart, because a single shot may not be enough to fully protect them.

Over the last decade, flu seasons have been marred sporadically by shortages or excesses of vaccine and, in the case of last year, relatively poor protection against the strains of influenza causing illness.

None of those problems is anticipated this year, said Julie Louise Gerberding, CDC's director.

"I have a smile on my face this year because we are looking at a wonderful supply of flu vaccine," she said at news conference at the National Press Club.

Manufacturers will make about 145 million doses. While the number of people targeted is substantially higher -- 261 million -- not everyone will choose to or be able to get vaccinated.

The targeted groups also include pregnant women, people 50 and older; younger adults with chronic illnesses such as diabetes and asthma; health-care workers; people in contact with children younger than 6 months; and people in contact with those who are at high risk of flu's complications, such as those with AIDS.

The vaccine consists of three killed flu viruses -- two from the influenza A family and one from influenza B. The components are dropped and replaced by updated ones each year as influenza viruses circulating the world evolve. This season, all three of the components are new, an unusual event.

Last year, the vaccine was poorly matched to the strains of flu virus in circulation. It was 58 percent effective in preventing infection with influenza A strains and did not protect against infection by influenza B at all. Its overall effectiveness was 44 percent -- about half what it is when the vaccine is well matched to the season's viruses.

Continue reading "Goal of CDC Vaccine Program Sets Record: 86% of Americans Told to Get Flu Shot"

Aid Plan Aims to Help Poor Farmers Reach Markets

The Washington Post reports that The Bill and Melinda Gate Foundation has created the Purchase for Progress Program that will transform rural agriculture in undernourished parts of Africa and Latin America by helping small farmers sell their surplus crops at competitive prices.  Philip Rucker writes,

In an ambitious move to combat the global food crisis, the Bill and Melinda Gates Foundation on Wednesday unveiled an experimental public-private initiative that could transform rural agriculture in undernourished parts of Africa and Latin America by helping small farmers sell their surplus crops at competitive prices.

Rather than only delivering food to hungry nations, this partnership between the world's richest philanthropy and the U.N. World Food Program promises to help build a sustainable farming infrastructure across the developing world.

The Purchase for Progress program will give poor farmers, many of them women with little or no access to commercial markets, a chance to move beyond subsistence living with opportunities to sell their milk, grains, produce and other products to reliable buyers. During a five-year pilot period, it hopes to increase the incomes of 350,000 farmers in 21 countries and give them a path out of poverty.

"This is not your grandmother's food aid," said Josette Sheeran, executive director of the World Food Program. "This is a revolution in food aid, where food aid becomes a productive investment that not only feeds today but produces solutions for tomorrow."

Funded largely by the Gates Foundation, the program is part of the foundation's broader $900 million investment in agricultural development, with many of its efforts made in concert with foreign states and public institutions. The initiative is the latest example of how software giant Bill Gates, who stepped down this summer from Microsoft, is committing his time and fortune to trying to create a results-oriented brand of philanthropy focused on taking risks to achieve lasting impact.

Announcing the Purchase for Progress program here flanked by the presidents of three African nations, Gates said he hopes the effort linking poor farmers to commercial markets will be successful enough that it becomes "self-sustaining," no longer needing private funding.

"It transforms the way that small holders are able to get to market, whether it's helping them with guaranteed purchase, helping them with their storage, understanding crop quality," Gates said. "It will increase the supply of food, and it will increase the well-being of these farmers."

Purchase for Progress is one of several public-private hunger initiatives expected to be announced this week in New York, as world leaders converge at the U.N. General Assembly to draw attention to the Millennium Development Goals, a series of benchmarks aimed at slashing the poverty levels in the world's poorest countries by 2015.

Former president Bill Clinton will announce at his philanthropy conference on Thursday that Yum! Brands, the parent company of such fast-food chains as KFC, Pizza Hut and Taco Bell, is donating $80 million over five years to purchase 200 million meals for school-age children.

This is part of a five-year campaign by the restaurant behemoth to provide hunger relief to the poorest people in the United States and worldwide. The company's 35,000 restaurants in 111 countries are pledging to donate $200 million worth of prepared foods to community soup kitchens and food banks, Yum! Brands chief executive David Novak said.

"We're inspired by the fact that there are so many kids out there who die because they can't eat," Novak said. "It's a huge problem and has only gotten worse, so it's even more timely that we commit."

The company will roll out a marketing campaign Thursday in its restaurants to persuade its customers to donate toward anti-hunger causes, and pop star Mariah Carey is releasing a single with sale proceeds going toward the cause.

Hunger around the world is so chronic, scholars say, that it far outstrips the financial resources committed to fight it. The number of hungry people worldwide has ballooned over the past year to 923 million and threatens to grow further, Sheeran said.

The problem is growing against the backdrop of a food price shock that is roiling world markets and igniting street riots. Over the past three years, world food prices were estimated to have surged by 80 percent, outpacing the 78 percent jump during the Soviet grain emergency of 1972-75.

"There's a need for a much larger international response," said Jeffrey D. Sachs, an economist and founder of the Millennium Promise Alliance, an anti-poverty nonprofit organization. "The Gates Foundation is playing an important role in helping people become aware of this, but in this case no single action is going to be decisive."

The Purchase for Progress program, to be administered by the U.N. World Food Program, is being funded by $66 million from the Gates Foundation, $9.1 million from the Howard G. Buffett Foundation and $750,000 from the Belgian government. Program planners said that if the pilot program is successful, it will be expanded.

The presidents of Rwanda, Tanzania and Uganda and the first lady of Guatemala hailed the initiative as a catalyst to help poor farmers in their countries who are cut off from markets, roads, transportation and storage for their surplus crops.

"This will go a long way in building the capacities of the farmers," said Rwandan President Paul Kagame.

About 1.1 billion people live on $1 a day or less, and more than seven in 10 people around the world depend on work in agriculture for food and income, said Rajiv Shah, agricultural development director of the Gates Foundation.

"In order to help farmers and small farmers in part move out of poverty, you need to help them improve productivity," Shah said. "But you also need to improve access to markets and create the financial and commercial incentives so that farmers are rewarded for their additional efforts."

In a preliminary test of the program last year in Uganda, poor farmers achieved dramatic results, Shah said.

Buffett, an environmentalist and businessman whose father, investor Warren Buffett, has pledged much of his fortune to the Gates Foundation, said the program provides "a critical link" to existing efforts to boost crop production.

"Agriculture development is the most effective way to combat poverty and pull these people in these populations up into a higher level of food security," Buffett said. "It's important to realize that we can all work on the production of the supply side, but without something to pull that through to the market, we'll never be successful in our efforts."

Medicare Officials Advise Seniors to Shop Around

The Washington Post reports that federal health officials encouraged Medicare participants on Thursday to shop around for their prescription drug coverage next year because it could include significant price increases or changes regarding which drugs the plans will cover.  Kevin Freking writes,

Overall, the landscape for prescription drug coverage won't look dramatically different next year. The typical beneficiary will still have dozens upon dozens of plans to choose from, but most people will see an increase in their monthly premiums if they stay with the same insurer.

For those enrolled in the 10 most popular drug plans, the cost increases will range from 8 percent to as much as 64 percent, according to an analysis by Avalere Health, a consulting firm.

The monthly premium for the most popular Medicare Part D plan, the AARP Medicare Rx Preferred Plan, will increase 15 percent, from $32 to $37. The next most popular plans come from Humana Inc. The premium for the standard Humana plan will go up 60 percent, from about $25 to $40, while the premium for the enhanced Humana plan will go up from about $23 to $38.

Still, the vast majority of participants will have access to prescription drug coverage for the same amount or for less than they're paying now. They will, however, have to do some searching to find those offerings, said Kerry Weems, acting administrator for the Centers for Medicare and Medicaid Services.

"The engine behind Part D is choice and competition," Weems said.

The nation's 44 million Medicare beneficiaries can choose a drug plan only, or they can choose to get all of their health benefits through a Medicare Advantage plan. The drug-only plans offering standard coverage will rise from $27 to $32 next year, on average. Meanwhile, Medicare Advantage plans will rise from $18 to $21 on average, CMS officials said. The federal government provides much larger subsidies for the latter option. Also, the poor are eligible for drug coverage with no monthly premiums.

Medicare participants can begin enrolling in drug coverage for next year from Nov. 15 through Dec. 31.

Federal Health Official to Step Down

The New York Times reports that Dr. Elias A. Zerhouni, director of the National Institutes of Health, who shook up the agency when he barred scientists from consulting for drugmakers, announced that he would leave at the end of October.  Gardiner Harris writes,

During his six-year tenure, Dr. Zerhouni pushed scientists to focus more on patient care and less on basic research, and he forced the agency’s independent institutes to cooperate on common projects. But he also faced a stagnant budget that has curtailed research around the country and demoralized scientists.

In a conference call with reporters, Dr. Zerhouni said he planned to write about his time at the health agencies before accepting another job.

“I know there’s speculation that I’m going back to Johns Hopkins,” Dr. Zerhouni said. “That’s not been decided by me at all. I want to finish here, take a few weeks, maybe write a bit and evaluate what I want to do next.”

One of the few prominent Arab-Americans in the Bush administration, Dr. Zerhouni is an Algerian immigrant who came to this country more than 30 years ago with $369 in his pocket and became a multimillionaire after inventing numerous devices as a radiologist at Johns Hopkins University.

Dr. James Thrall, chairman of the radiology department at Massachusetts General Hospital, said that Dr. Zerhouni got the health institutes to focus “on the big problems, big issues and big opportunities.”

“Uniquely among all the recent people to hold that position, he got the battleship to turn in a different direction,” Dr. Thrall said of Dr. Zerhouni.

The most controversial part of Dr. Zerhouni’s tenure was a years-long Congressional investigation of agency scientists who mixed their government research positions with private consulting deals. Dr. Zerhouni decided in 2005 to ban agency scientists from consulting for drug and device companies.

The ban was unpopular among many agency scientists, who said it would make recruiting top scientists difficult. But in the wake of continuing Congressional investigations, a growing number of medical schools and medical groups are now cracking down on the outside consulting relationships of their faculty and staff members.

“I took decisions early relative to conflict of interests that are frankly now proving to be the right ones,” Dr. Zerhouni said.

Dr. Zerhouni said his tenure at the health institutes could be split into three periods. His first two years, he said, were a “euphoric phase” because the agency’s budget was growing rapidly. The second two years were difficult. Besides the conflict of interest controversy, the agency’s stagnant budget during this time forced him to explain “why it was harder getting grants.” His final two years involved “institutionalizing many of the reforms I had been advocating” and hiring many of the agency’s present leaders.

Dr. Ezekiel J. Emanuel, chairman of the agency’s department of clinical bioethics, had criticized Dr. Zerhouni’s handling of the conflict-of-interest scandal but said Wednesday that Dr. Zerhouni “has been a victim of very difficult circumstances that he didn’t create.” Dr. Emanuel praised Dr. Zerhouni’s clinical research initiative.

Dr. Zerhouni was chosen after President Bush announced strict limits on federal financing of stem-cell research, and the White House made clear that Dr. Zerhouni was expected to support this policy. But in 2004 and 2005, Dr. Zerhouni told Congress that the president’s policy was hindering scientific progress.

That he maintained the support of the White House despite this public disagreement is noteworthy. By contrast, Dr. Richard Carmona, whose appointment as surgeon general was announced on the same day as Dr. Zerhouni’s, was forced from his job in 2006 and later told a Congressional panel that he had been muzzled and his initiatives suppressed.

Dr. Zerhouni said he decided to leave the agency before the election “so there is a clear sense that whoever wins the election, N.I.H. has to be a clear priority in their mind.”

Raynard S. Kington, deputy director of N.I.H., is expected to serve as the agency’s interim director for the remainder of the Bush administration.

Congress Approves Mental Health Bill

The Washington Post reports that Congress approved legislation yesterday that would require private insurers to provide the same level of benefits for mental illness as they do for physical maladies, a change lauded by advocates as a great shift in the nation's understanding of mental health.  Lyndsey Layton writes,

"We've always had a stigma, sort of like mental illness is a character flaw," said Rep. Patrick J. Kennedy (D-R.I.), who has struggled with drug and alcohol addiction and co-sponsored the House version with Rep. Jim Ramstad (R-Minn.), a recovering alcoholic. "But now science has moved forward, and we can see the complexities in the brain that lead to eating disorders, compulsive disorders. All these connections are being made, the science is just becoming so firm. And it destroys the myth that this stuff is a choice."

The measure has received strong bipartisan support in the House and Senate and has the backing of business, insurance companies, health advocates, the medical community and the White House. But its passage into law was not ensured last night.

The remaining obstacle appeared to be ironing out differences in how to pay the cost to the federal government -- estimated at $3.4 billion over 10 years, in the form of forgone tax revenue. Lawmakers also needed to resolve whether the final bill should be a standalone measure or part of a larger package of legislation.

The House approved the language in a standalone bill, while the Senate wrapped it into a $150 billion package of popular tax cuts, including a one-year patch for the alternative minimum tax, and extensions of expiring tax provisions including tuition credits and state and local sales tax deductions (for states that do not have an income tax), as well as research and development tax credits.

It is unclear whether a joint agreement can be reached in the few days remaining before Congress recesses.

"The Senate has devolved to the point where almost nothing is moving now," one senior Senate staff member said. "The issue is whether this gets caught up in the bigger inertia of the Senate."

Lobbyists for health care and industry and Hill staff members say now is the best moment for the bill to be passed.

"We've come so very, very far," said Andrew Sperling, legislative affairs director for the National Alliance on Mental Illness. "We are in a whole world of trouble if we don't get this done. We just can't pick up the pieces and start where we left off this year if it doesn't pass."

Federal law now allows insurers to set higher co-payments or stricter limits on mental health benefits than they do for medical or surgical coverage.

"You go in there with a broken arm, you have a $200 deductible and your insurance kicks in," Kennedy said. "You have depression, schizophrenia, substance abuse, and you find out you have a $2,000 deductible, you've got limitations on your treatment and all kinds of co-pay."

Typical annual limits include 30 visits to a doctor or 30 days of hospital care for treatment of a mental disorder. Under the legislation passed yesterday, those limits would no longer be allowed if the insurer had no limits on treatment for medical conditions such as cancer, heart disease and diabetes. Small businesses with fewer than 50 employees would be exempt.

Currently, 42 states require insurance companies to cover mental and physical illnesses equally, as does the federal employees' health benefit program. But 82 million people work for employers who self-insure, which means they are exempt from state parity laws. An additional 31 million are in other plans that do not have to offer equal coverage.

The legislation is the culmination of more than a decade of lobbying by mental health advocates and several members of Congress.

Studies Show Strain of Medical Bills

The New York Times reports on a study that underscores the need for the government to address the growing unaffordability of health care as many people are leaving medical bills unpaid.  Reed Abelson writes,

Even as Washington and Wall Street debate the best way to avert an economic meltdown, increasing numbers of Americans are struggling with another financial crisis: the growing burden of unpaid medical bills.

Two studies released Wednesday morning provide further evidence of the toll health care is increasingly placing on working families, even for those who have health insurance. And as employees are paying more medical expenses out of their own pockets, they are having a harder time coming up with the money.

The studies, by the Kaiser Family Foundation and the Center for Studying Health System Change, were completed earlier this year before the financial markets reached their current state of crisis. But policy analysts say the findings underscore the mounting additional strain that medical care is placing on working Americans.

“The problems people are having paying for health care and health insurance are a central dimension of the economic and pocketbook concerns right now,” said Drew E. Altman, the president of the Kaiser Family Foundation, a nonprofit health research group that conducts an annual survey of employer medical benefits.

The studies, policy analysts say, underscore the need for the government to address the growing unaffordability of care, despite the distraction — and cost to taxpayers — of a proposed $700 billion bailout of the financial sector.

“This makes clear the cost of doing nothing is high and growing,” said Len Nichols, a health economist at the New America Foundation, a nonpartisan policy group in Washington that advocates universal medical coverage.

While policy analysts acknowledge that finding any new money to expand coverage may prove difficult, some also say the terms of the debate may be changing as policy makers and the public rethink their positions on the need for regulation and the role of the government in industry — including the health care system.

“We can now imagine a government takeover that we could not imagine before,” Mr. Nichols said.

Although inflation in insurance premiums has moderated in recent years, the Kaiser survey found employees were continuing to spend more in medical costs, including their share of yearly insurance premiums. Employees are paying an average of $3,354 in premiums for family coverage, more than double the amount they paid in 1999. The total cost for family coverage now averages $12,680 a year, up 5 percent from 2007.

And as people are paying more, they are finding the higher expense less affordable. In the study by the nonpartisan Center for Studying Health System Change, based on its national survey of households, nearly one of every five families had problems paying medical bills last year. More than half of these families said they borrowed money to pay these expenses, and nearly 20 percent of those having difficulty said they contemplated declaring personal bankruptcy as a result of their medical bills.

The study estimates that 57 million Americans live in families struggling with medical bills, and 43 million of those have insurance coverage. “It’s hitting both the insured and the uninsured, and it’s hitting middle-class families,” said Karen Davis, the president of the Commonwealth Fund, a nonprofit research organization that financed the study.

Because they are already in debt over their medical care, some families start forgoing treatments, even for serious or chronic conditions, Ms. Davis said. By deciding not to fill a prescription for high blood pressure medication or failing to go to the doctor for diabetes, they are at risk of incurring more serious and costly problems that can land them in the emergency room.

“It’s a serious health problem and it’s a serious economic problem,” she said.

As the nation has moved toward greater cost-sharing of medical expenses, “what we’re seeing is families are not in a position to shoulder that financial risk,” Ms. Davis said.

While large employers remain a strong and generous source of coverage, the Kaiser study pointed to the widening divide between employees working for big companies and those at companies with less than 200 employees.

Virtually all large employers offered coverage, but only 62 percent of small companies did. People working for big companies were also paying less — about $3,000 a year for family coverage — compared with $4,100 for those in small companies.

Faced with the choice of dropping coverage altogether, many small companies have opted for health plans that ask employees to pay much more in the form of deductibles and out-of-pocket expenses. One in three workers in small businesses has annual deductibles of $1,000 or more, in contrast to one in five in the previous year’s survey.

“We still strongly believe health care is an economic issue for small business, not only to the owners but to their employees; they are both paying for it,” said Amanda Austin, a lobbyist for the National Federation of Independent Business, a Washington group that represents small employers.

FDA Cracks Down on Eye Wash and Skin Cream

The Washington Post reports that federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks.  The Washington Post writes,

The eye wash, known as a balanced salt solution, is used to keep the eyes moist during surgery. Two companies, Alcon Laboratories and Akorn, Inc. have versions that are officially approved by the Food and Drug Administration, and are not affected, the FDA said in a public notice.

But three other firms are selling similar types of eye wash without federal validation of their safety and effectiveness, said Deborah Autor, who directs the FDA's unapproved drugs initiative. They are B. Braun, Baxter, and Hospira, she said.

The skin cream contains an enzyme called papain, derived from the tropical papaya plant. It is used for treating skin ulcers from diabetes and other causes. Although such products have been used for more than 100 years, the FDA said there are no approved versions on the market. About a dozen companies market such creams in a lucrative business worth about $50 million a year.

The agency said it has received more than 300 reports of serious reactions to the eye wash, and about 40 reports on the papaya creams, including some that said the ointment was of no help to patients and others describing life-threatening allergic reactions.

Companies making the unapproved products must file for FDA approval, or cease production by Nov. 24. Violators face FDA seizures and other legal action.

Unapproved drugs, many of which pre-date federal regulation, are a continuing problem for the FDA. The agency estimates that about 2 percent of all prescriptions written each year are for unapproved drugs, or about 72 million scripts.

Study Finds Major Shift in Abortion Demographics

The Washington Post reports on a study highlighting the shift in proportions of women getting abortions.  The study found that the proportion of all abortions performed for white women has decreased, while the proportion for Hispanic and African American women has increased.  Rob Stein writes,

The face of women who have abortions has shifted significantly in the past 30 years, with relatively fewer white childless teenagers and more mothers of color in their 20s and 30s opting to terminate their pregnancies, according to a report being released today.

In the first comprehensive analysis since 1974 of demographic characteristics of women who have abortions, researchers found that the overall drop in the abortion rate has been marked by a dramatic shift, declining more among white women and teenagers than among black and Hispanic and older women.

"There's been a real change in the picture of women who get abortions," said Rachel Jones, a senior research associate at the Guttmacher Institute, a private nonprofit reproductive health research organization considered to be one of the most authoritative sources on abortion trends. "This is the first time anyone has looked at this in a comprehensive way."

Jones and her colleagues analyzed annual data collected by the federal Centers for Disease Control and Prevention and by periodic surveys that Guttmacher has conducted of abortion providers between 1974 and 2004.

The analysis confirmed previous reports that the abortion rate fell to the lowest level since 1974, dropping 33 percent from a peak of 29 abortions per 1,000 women ages 15 to 44 in 1980 to 20 per 1,000 in 2004.

During that period, the proportion of abortions obtained by women younger than 20 dropped steadily, falling from 33 percent in 1974 to 17 percent in 2004. For those younger than 18, it fell from 15 percent of all abortions in 1974 to 6 percent in 2004. At the same time, the proportion of abortions obtained by women in their 20s increased from 50 percent to 57 percent, and the share done for women age 30 and older rose from 18 percent to 27 percent.

Although abortion rates have declined among all racial and ethnic groups, large disparities persist, with Hispanic and black women having the procedure at rates three to five times the rate of white women.

In 2004, there were 10.5 abortions per 1,000 white women ages 15 to 44, compared with 28 per 1,000 Hispanic women of that age and 50 per 1,000 black women. That translates into approximately 1 percent of white women having an abortion in 2004, compared with 3 percent of Hispanic women and 5 percent of black women. Jones attributed that to the focus on reducing teenage pregnancy and on increasing contraceptive use.

"We've made the most important progress in reducing teen pregnancy and abortion rate, [rather] than reducing unintended pregnancy in older women," Jones said.

The proportion of all abortions performed for white women decreased from 45 percent in 1994 to 34 percent in 2004, while the proportion for Hispanics increased from 16 percent to 22 percent and the proportion for black women rose from 35 percent to 37 percent.

"We know from other research that having lower income makes a woman more likely to get an abortion. Women of color tend to be lower-income, and so in turn when confronted with an unintended pregnancy are more likely to have an abortion," Jones said.

The proportion of all abortions performed for women who already had a child increased from 46 percent in 1974 to 60 percent in 2004, reflecting the trend of women who cannot afford to have another child turning to abortion, Jones said.

The findings indicate "we need to figure out efforts to reduce unintended pregnancy, not only among teenagers but among all women, and in particularly women of color," she said. "A lot of policymakers are stuck 30 years back when most women getting abortions are teenagers and college students, and that isn't so much the case these days."

Others said the findings underscore the need to increase access to contraception for poor women.

"Birth control is the best way to prevent unwanted pregnancies," said Laurie Rubiner, vice president for public policy at the Planned Parenthood Federation of America. "Unfortunately there's a large number of uninsured people in this country, and if you are uninsured you are less likely to have access to affordable health care, including affordable birth control."

Michael J. New, an assistant professor of political science at the University of Alabama who works with the Family Research Council, attributed the drop in teenage pregnancies to a combination of factors, including increased contraceptive use, more teenagers delaying sex and state laws requiring parental consent.

"The states with the most active pro-life laws have seen the biggest abortion declines," he said.

EPA Unlikely to Limit Perchlorate in Tap Water

The Washington Post reports that the Environmental Protection Agency, under pressure from the White House and the Pentagon, is set to rule as early as today that it will not set a drinking-water safety standard for perchlorate, a component of rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children across the nation.  Juliet Eilperin writes,

According to a near-final document obtained by The Washington Post, the EPA's "preliminary regulatory determination" -- which was extensively edited by White House officials -- marks the final step in a six-year-old battle between career EPA scientists who advocate regulating the chemical and White House and Pentagon officials who oppose it. The document estimates that up to 16.6 million Americans are exposed to perchlorate at a level many scientists consider unsafe; independent researchers, using federal and state data, put the number at 20 million to 40 million.

Some perchlorate occurs naturally, but most perchlorate contamination in U.S. drinking water stems from improper disposal by rocket test sites, military bases and chemical plants. A nationwide cleanup could cost hundreds of millions, if not billions, of dollars, and several defense contractors have threatened to sue the Defense Department to help pay for it if one is required.

The new EPA proposal -- which assumes the maximum allowable perchlorate contamination level is 15 times what the EPA had suggested in 2002 -- was heavily edited by officials of the White House Office of Management and Budget. They eliminated key passages and asked the EPA to use a new computer modeling approach to calculate the chemical's risks.

Under a process the OMB initiated in 2004, federal agencies with an interest in chemicals such as perchlorate, such as the Defense Department, have opportunities to weigh in on the EPA's regulatory decisions before they become final: The Government Accountability Office reported this spring that the Pentagon had pressured the EPA for several years not to regulate perchlorate.

"They have distorted the science to such an extent that they can justify not regulating" the chemical, said Robert Zoeller, a University of Massachusetts professor who specializes in thyroid hormone and brain development and has a copy of the EPA proposal. "Infants and children will continue to be damaged, and that damage is significant."

Zoeller said scientific studies have shown that a small reduction in thyroid function in infants can translate into a loss of IQ and an increase in behavioral and perception problems. "It's absolutely irreversible," he said. "Even small changes in thyroid functions early on have impacts on functioning through high school and even into people's 20s."

A reference to those studies in the EPA's proposal was deleted by OMB officials.

The document states that establishing a drinking-water standard for perchlorate "would not present a 'meaningful opportunity for health risk reduction for persons served by public water systems,' " but it also reveals that many Americans will be exposed to the compound at levels higher than recommended if nothing is done to remove it. Perchlorate impedes the functioning of the thyroid gland, which produces hormones that foster mental and physical development and control metabolism. The notice indicates that the agency plans to finalize its decision by Dec. 1.

The EPA's assistant administrator for water, Benjamin H. Grumbles, said in a statement yesterday, "Science, not the politics of fear in an election year, will drive our final decision."

"Until then, final numbers and strategies are mere speculation," Grumbles added. "We know perchlorate in drinking water presents some degree of risk and we're committed to working with states and scientists to ensure public health is protected and meaningful opportunities for reducing risk are fully considered."

The Senate Environment and Public Works Committee, chaired by Barbara Boxer (D-Calif.), has endorsed legislation requiring the EPA to set a standard for the chemical and to monitor perchlorate in tap water. Yesterday, Boxer lambasted the agency for refusing to establish a federal exposure standard.

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Consumer Ads for Medical Devices Subject of Senate Panel

The New York Times reports that some lawmakers and medical groups are calling for restrictions on advertisements for medical devices like artificial knees and heart stents, claiming they mislead patients.  Barry Meier writes,

As makers of medical devices like artificial knees and heart stents increasingly pitch their products directly to consumers, some lawmakers, medical groups and others are calling for restrictions on such advertisements, claiming they mislead patients.

The amount of medical device advertising directed to consumers on television or over the Internet — an estimated $193 million last year — represents just a small fraction of the volume of consumer advertising for prescription drugs, according to TNS Media Intelligence, a consulting firm.

But some experts maintain that the advertising of a medical device can have more of an impact on a patient’s well-being than a drug, because devices often require surgery to implant and may remain inside the body for years.

“The results are irreversible because you are kind of stuck with a device,” said Dr. Kevin J. Bozic, a professor of orthopedics at the University of California, San Francisco.

On Wednesday, the Senate Special Committee on Aging plans to hold a hearing about direct-to-consumer promotions of medical devices. Dr. Bozic, who was an author of a recent medical journal article critical of consumer advertising, is among those scheduled to testify.

In a statement, the committee’s chairman, Herb Kohl, Democrat of Wisconsin, said he was holding the hearing because he thought that the Food and Drug Administration might have to increase its scrutiny of medical device promotions, much as it had done for pharmaceutical advertisements.

“The medical device industry is just beginning to get into the game,” Mr. Kohl said.

David Nexon, a senior official at the Advanced Medical Technology Association, a trade group in Washington that represents medical device makers, said the organization thought that current F.D.A. rules governing direct-to-consumer advertising were adequate.

He added that while an advertisement might stimulate a patient to ask a doctor about a device, the process of receiving one involves a discussion of its benefits and risks.

“You may take a pill because it doesn’t involve very much,” Mr. Nexon said. “But you don’t undergo surgery unless you think you have a serious need for it.”

In 2007, spending by medical device makers on direct-to-consumer advertising was nearly double the amount in 2005, according to data provided to the Congressional Research Service by TNS.

Over the last three years, a variety of device makers have started ad campaigns. Stryker, for instance, has run ads for a ceramic replacement hip, a device that some patients have since complained squeaks loudly enough to be heard while they walk.

Another orthopedics maker, Zimmer Holdings, has advertised a replacement knee created for women, and Medtronic, a maker of heart devices, has run consumer promotions about heart defibrillators.

At the hearing on Wednesday, an official of Consumers Union, the publisher of Consumer Reports magazine, is expected to testify that current rules requiring consumer drug advertisements to provide balance between a medication’s benefits and risks should be extended to cover medical devices.

Institutionalized Medicaid Recipients Sue Florida

The Washington Post reports on a class action lawsuit against Florida by institutionalized Floridians claiming the state is illegally forcing them to live in nursing homes when they should be able to choose where they live.  They argue that nursing homes have successfully pressured politicians to make qualifying for community care more difficult.  Matt Sedensky writes,

Charles Todd Lee spent a lifetime going backstage at concerts, following politicians on the campaign trail and capturing iconic shots of everyone from Martin Luther King Jr. to Mick Jagger to Mickey Mantle. Today, he enjoys such freedom only in his dreams.

The 67-year-old photographer has been confined to a nursing home for five years, the victim of a stroke that paralyzed his left side. And he's angry.

"Most of the people come here to die, so you want to die," he said. "It is a prison. I can't escape it."

Lee is among the Medicaid recipients across Florida challenging the nightmare of the old and disabled: to be forced from comfort and familiarity into a nursing home.

They say the state is illegally forcing them to live in nursing homes when they should be able to live where they choose. Advocates charge that nursing homes, afraid of losing money, have successfully pressured politicians to make qualifying for community care more difficult. They have filed a federal lawsuit seeking class-action status on behalf of nearly 8,500 institutionalized Floridians.

Whether the litigation gets Lee and others moved out of nursing homes remains to be seen. But at the very least, it has illuminated the frustration experienced by older people or those with disabilities who say they're shuttled into nursing homes when they are healthy enough to live at home, with relatives, or in other less institutional settings.

"There are very, very, very few people who cannot be cared for outside in the community," said Stephen Gold, a Philadelphia disability lawyer who, along with AARP attorneys and others, is representing the group. "Why should the state give a damn whether you put the money in the left pocket of the nursing home or the right pocket of the community?"

Americans who qualify for Medicaid and get sick or disabled enough to require substantial care typically have little problem gaining admission to a nursing home. But obtaining Medicaid-supported services at home, such as visits from an aide, is substantially harder and often involves a long waiting list, even though it may cost the government less.

Advocates for the elderly and disabled had hoped a 1999 Supreme Court case would change that. The Olmstead decision, as it is known, involved two Georgia women, both Medicaid beneficiaries with mental retardation who wanted community-based services, but were refused and were treated in institutions.

The high court ruled unjustified isolation of the disabled in institutions amounted to discrimination under the Americans with Disabilities Act. It said states must provide community services if patients want them, if they can be accommodated and if it's appropriate. Medicaid is the state-federal partnership that provides health coverage and nursing home care to the poor.

"There's a lot of concern that the nursing home industry is very powerful in many states and has made sure that a lot of Medicaid dollars go to institutional care as opposed to home and community-based care," said Toby Edelman, an attorney at the Center for Medicare Advocacy.

States have been putting more money into community services, but not nearly enough to meet the demand of people who would rather stay at home than go to a facility. Nationally, state Medicaid payments for long-term community care have skyrocketed since the Olmstead decision, from $17.4 billion in 1999 to $42.8 billion last year, though spending on nursing homes and other institutions is still substantially higher.

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Study Finds Few Pain Doctors Face Criminal Prosecutions

The New York Times reports on a new study that shows doctors are rarely criminally prosecuted or sanctioned in connection with prescribing narcotic painkillers.  Barry Meier writes,

The study, published this month in the journal Pain Medicine, found that 725 doctors, or about 0.1 percent of practicing physicians, had been prosecuted or sanctioned by state medical boards between 1998 and 2006 on charges arising from illegally or improperly prescribing narcotics. Of that group, 25 doctors specialized in pain treatment.

“The widely publicized chilling effect of physician prosecution on physicians concerned with legal scrutiny over prescribing opioids appears disproportionate to the relatively few cases,” the study reported.

The study was undertaken by the Center for Practical Bioethics in Kansas City, Mo., the Federation of State Medical Boards and the National Association of State Attorneys General.

The study’s authors acknowledged that their review, while extensive, did not account for prosecutions against doctors brought by state and local law enforcement officials.

Also, one of the report’s authors, Dr. Scott M. Fishman, a pain specialist, said that the “chilling effect” on doctors involved not just legal cases but also visits from law enforcement agencies like the Drug Enforcement Administration.

“One has to temper the interpretation of the data with all the other phenomenon of how physicians perceive the heat of regulators,” said Dr. Fishman, a professor at the University of California, Davis. “Most of us have had visits from the D.E.A., and I can tell you that it can be a scary thing.”

The question of how doctors perceive their legal vulnerabilities when prescribing narcotics has consequences because studies have long suggested that doctors, fearful of drawing legal scrutiny, may not adequately treat patients.

In recent years, the issue has become amplified because of several highly publicized prosecutions of doctors accused of selling narcotics like OxyContin, Percocet and Vicodin, or recklessly prescribing them. Some news accounts about those cases have also contended that they were part of a broader, national crackdown against doctors who treat pain patients.

Myra Christopher, the president of the Center of Practical Bioethics, a group that supports improved patient pain care, said the purpose of the study was to “discern the facts from the folklore.”

Robert T. Libby, the author of “The Criminalization of Medicine: America’s War on Doctors” (Praeger Publishers, 2007), said he believed that the study was seriously flawed and that pain doctors were subject to repeated harassment.

“They want to say this is not real,” said Mr. Libby, who is a professor of political science at the University of North Florida in Jacksonville. “They are minimizing it.”

Dr. Fishman said that the study, despite his reservations about how broadly it could be interpreted, was not advocating any point of view.

“We looked at what was happening, and that is what we found,” he said.