HealthLawProf Blog

Proposed Bill Would Finalize Sunscreen Labeling Rules

The New York Times reports on the Sunscreen Labeling Protection Act of 2008 proposed Friday [August 1, 2008], which would compel the FDA to make final comprehensive rules on sunscreen.  The new sunscreen rules would require manufacturers to test the efficacy of the products against the sun’s longer-wavelength ultraviolet A rays, which also can damage skin. Sunscreen labels would be required to display both the familiar SPF number and a new rating for UVA protection.  Natasha Singer writes,

Two United States senators on Friday introduced a bill that would compel the Food and Drug Administration to make final comprehensive rules on sunscreen.

Last summer, the agency proposed updated rules that would standardize the labeling on sunscreens, giving consumers more detailed information about their efficacy. But the agency has not made the regulations final, which must happen before they can be implemented.

Senator Christopher J. Dodd, Democrat of Connecticut, said the agency appeared to be moving at a deliberately slow pace for the benefit of sunscreen manufacturers. “The delay is happening for economic reasons,” Senator Dodd said. “The F.D.A. knows better.

“It sounds like an industry reluctant to have a standard set because that may open the doors to insisting upon more accurate labels on certain other products as well.”

The proposed Sunscreen Labeling Protection Act of 2008, sponsored by Senator Dodd and Senator Jack Reed, Democrat of Rhode Island, would give the F.D.A. 180 days to make its own rules final. If the agency fails to do so within 180 days of enactment of the bill, the proposed rules would take effect.

“We hope the mere introduction of the bill will have the desired effect,” Senator Dodd said.

Rita Chappelle, a spokeswoman for the F.D.A., said, “As a federal agency, F.D.A. will continue to work to finalize the sunscreen rule as soon as possible for the American public.”

Since 1978, sunscreens have used the SPF numbering system to rate protection against sunburn caused by the sun’s shorter-wavelength ultraviolet B rays.

The new sunscreen rules would require manufacturers to test the efficacy of the products against the sun’s longer-wavelength ultraviolet A rays, which also can damage skin. Sunscreen labels would be required to display both the familiar SPF number and a new rating for UVA protection.

According to F.D.A. documents, if the agency makes the proposed rule final, manufacturers would then have an implementation period of up to 24 months to comply.

But some sunscreen manufacturers are asking for at least 36 months to test and relabel products.

Manufacturers estimated that the industry would need to put 2,700 products through UVA testing, at a cost of $12,200 per product and $124.2 million industrywide, including relabeling costs, according to collective comments submitted to the agency by two trade groups.

L.A. Law May Keep Homeless in Hospitals

The Wall Street Journal reports on a Los Angeles city ordinance that will cut down on the number of hospitals dropping homeless patients onto skid row by making it a misdemeanor for health facilities to transport patients to places other than their residences without written consent.  Rhonda L. Rundle writes,

Hospitals here have been shamed in recent years by reports some of them dumped homeless patients onto downtown's skid row before they were well enough to care for themselves. Now, hospitals caught in the act will be charged with a crime.

A new city ordinance, believed to be the first of its kind in the nation, makes it a misdemeanor for health facilities to transport a patient to a place other than his or her residence without written consent.

Hospital administrators fear that a conviction could trigger an automatic exclusion from government health programs, a financial blow few hospitals could survive. They also worry about the cost of keeping patients who are healthy enough to be discharged but have no place to go.

Homeless patients have at times received poor treatment by hospitals in other U.S. cities, but the issue has been particularly visible in Los Angeles because of documented reports of patients being dropped off at shelters. The issue achieved national attention after last year's Michael Moore film "Sicko" included video of an elderly woman apparently being dropped off by a taxi on the street while wearing little more than a hospital gown.

"The most important thing is to get culture change in the way that hospitals discharge patients," says a spokesman for Los Angeles City Attorney Rockard J. Delgadillo, whose office is investigating about 50 suspected dumping cases from before June 30, when the law took effect.

The Hospital Association of Southern California says it has asked an attorney to investigate whether the measure violates state law. The association is also seeking clarity from the federal agency that oversees Medicare on the consequences of a conviction.

Several hospitals have admitted failings in their procedures for homeless patients and say they have made changes. They say it has become increasingly difficult to discharge these patients because many refuse to leave.

While the hospitals say they accept their responsibility for the patients' medical care, they say they are being asked to house them after they are treated. The average length of stay for a homeless patient is 4 1/2 days longer than that for others with comparable conditions, says James Lott, executive vice president of the hospital association.

Los Angeles doesn't have enough "recuperative beds," a type of transitional housing for discharged hospital patients who need further medical attention. To help alleviate the shortage, county agencies and private hospitals are financing a pilot project to add 30 beds, bringing the total to 75. Hospitals are also revising procedures for discharge planning, including specialized training for staff members.

A financial crisis in the county's public-health-care system in recent years has led to the closure of many community clinics where homeless people used to go for primary care, so now they are more often going to hospital emergency rooms, Mr. Lott says.

In hospitals, patients have a "nice, warm bed, three meals a day and maybe even a television and people waiting on them. They are literally saying to us, 'I don't want to go. If you discharge me, I will call the L.A. Times,'" says Carol Meyer, director of governmental relations for the Los Angeles County's Department of Health Services.

Thirty to 50 homeless people who no longer have a medical need to be there stay at the county's downtown hospital every night, she says.

Some hospital officials and employees say the new law is being used as an excuse by shelters to deny priority to homeless people after they are well enough to leave the hospital. "When you call a shelter and say, 'We have a patient with no acute-care needs that we would like to send,' all they say is, 'Have them go stand in line at 3 p.m.,'" Ms. Meyer says. Hospitals have little choice but to spend more than an average $1,350 for a homeless person to spend the night, Mr. Lott says.

Last year, one homeless man in his 40s spent several months at Methodist Hospital in Arcadia, Calif., a Los Angeles suburb, after his medical condition had stabilized, says Gloria Nuesch, director of the hospital's care-coordination department. He didn't want to leave, so the hospital kept him until it was able to enroll him in a government-assistance program. Complying with the city's new law is difficult, she says, because about half the hospital's homeless patients won't sign discharge consent forms. "We can't force them," she says.

Methodist Hospital, Hollywood Presbyterian Medical Center and Kaiser Permanente, a managed-care organization, have each reached agreements with Mr. Delgadillo's office over the past year or so to resolve investigations into alleged incidences of patient dumping.

The Rev. Andy Bales, director of Union Rescue Mission, the city's largest homeless shelter, says he is "thrilled" that the new law is working well. The mission can't always accept discharged patients, he adds, because "we can't medically meet their needs." He says he doesn't discuss the new law with homeless guests, but he acknowledges that "these can be difficult patients to deal with."

AIDS Infection Rate in U.S. Higher Than Previously Estimated

The Washington Post reports that the CDC has concluded that there are about 56,300 new HIV infections a year, not the 40,000 figure that has been used for over a decade.  These new numbers do not imply that the epidemic is increasing in the US, but rather showcase more accurate testing methods.  David Brown writes,

Updated federal estimates of the annual number of new HIV infections in the United States, released today, reveal that while the AIDS epidemic here is worse than previously thought, prevention efforts appear to be having some effect.

Even though the number of Americans living with HIV has risen by more than a quarter million people since 1998 -- largely the result of life-extending antiretroviral drugs -- the number of new cases each year has declined slightly over that period. That suggests that a person's likelihood of transmitting the virus to someone else is substantially lower now than it was a decade ago.

The new, if indirect, evidence that prevention programs are paying off was one of the few encouraging findings in an update on the American AIDS epidemic released today by the Centers for Disease Control and Prevention on the eve of the 17th International AIDS Conference, in Mexico City.

"Over 95 percent of people living with HIV are not transmitting to someone else in a given year," said David R. Holtgrave, an expert on AIDS prevention at the Bloomberg School of Public Health at Johns Hopkins University. "What that says is the transmission rate has been kept very low by prevention efforts."

Those include targeting public health messages to high-risk groups, promoting widespread AIDS testing, and getting quick medical care for newly diagnosed cases, which in most cases lowers the person's infectiousness.

The CDC spends about $750 million a year on AIDS prevention. The main finding of its report is that HIV incidence in 2006 -- the latest year for which data are available -- was 56,300 new cases of infection. That is 40 percent higher than the previous government estimate of 40,000, but statistical back calculation suggests that HIV incidence has been unchanged since about 2000.

The more accurate estimate was possible for two reasons. A new testing method lets researchers detect infections that are less than six months old more quickly than before. New federal regulations also are pushing states to collect data on new HIV infections and not just new AIDS diagnoses.

By the time AIDS is diagnosed, the infection has severely damaged the immune system, making the person vulnerable to unusual infections and cancers. This generally occurs eight to 11 years after infection, assuming that there is no treatment with antiretroviral drugs, which can prolong life for many more years.

In December, The Washington Post reported that the CDC was revising HIV incidence upward to 50,000 to 60,000 cases a year. Today's announcement -- and the publication of a paper in the Journal of the American Medical Association -- is the first official acknowledgement of the new, higher estimate.

"These data corroborate what many of us suspected -- that the epidemic is worse than we thought. However, it doesn't seem to be getting worse," said Jennifer Kates, director of HIV policy at the Kaiser Family Foundation in Washington.

The CDC's portrait of the American AIDS epidemic today shows that gay and bisexual men -- especially those who are young or black -- and their female partners are at particular risk.

In 2006, 73 percent of new HIV infections were in men, 53 percent were acquired through homosexual intercourse, and 45 percent were in African Americans. The incidence rate -- the number of infections per 100,000 people -- was seven times higher in blacks and three times higher in Hispanics than in whites. It was highest in people in their 30s, although people younger than 30 accounted for nearly 34 percent of new infections.

The new study also sketches a 30-year picture of how the epidemic has evolved.

Annual incidence peaked in 1985 at 130,000 infections a year, dipped to 49,000 in the early 1990s, rose to 58,000 in 1998 and has now stabilized at about 56,000 a year.

The number of new of HIV cases acquired through drug injection fell by 80 percent over that period through reduced needle sharing by drug users and, in some places, needle-exchange programs. Infections acquired through homosexual sex, which also peaked in the early 1980s, fell to a low in the early 1990s but have risen steadily since then.

The epidemic in the black community is distinctly different from the national epidemic.

From 2001 to 2005, 38 percent of the new diagnoses in African Americans were in women, and 46 percent of new infections overall were from heterosexual contact. Among whites during the same period, 16 percent of new infections were in women, and 16 percent were from heterosexual transmission.

About half of the CDC's HIV prevention budget targets the black community, said Kevin Fenton, who heads those activities at the agency. He said, however, that the rising HIV incidence in gay men, and in young, black gay men especially, is evidence that prevention campaigns have "not reached all those who need it."

Statistics compiled by the Kaiser Family Foundation show that 4 percent of the $23 billion the U.S. government is spending this year on all HIV/AIDS activities (including research, medical care and overseas programs) goes toward prevention.

According to a paper published last year in the American Journal of Preventive Medicine, in inflation-adjusted dollars, the CDC's budget for AIDS prevention in 2006 was only 5 percent higher than it was in 1990.

Mexican Farm Tied to Salmonella Outbreak

The Washington Post reports that the salmonella outbreak initially link to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.  Lawmakers yesterday began the first of two hearings on what went wrong in the investigation.  Annys Shin writes,

A three-month-old salmonella outbreak initially linked to raw tomatoes has been traced to a jalapeño and serrano pepper farm in Mexico.

Investigators discovered the Salmonella saintpaul strain in irrigation water and in serrano pepper samples from the farm, which is in the northeastern state of Nuevo Leon partially bordering Texas. The Food and Drug Administration is now warning consumers not to eat raw serrano peppers, in addition to raw jalapeños.

"We have a smoking gun, it appears," Lonnie King, a director at the Centers for Disease Control, said yesterday.

The discovery of the outbreak strain on a farm does not answer all of the questions confronting investigators. But it will improve their chances of stopping the outbreak, which has sickened more than 1,300 people since April. It also gets them closer to a full explanation of an outbreak that stumped the nation's most experienced disease detectives and drew criticism from tomato growers and Congress about the FDA and CDC's handling of the case.

Lawmakers yesterday began the first of two hearings on what went wrong in the investigation, which was initially focused on tomatoes, and later expanded to include jalapeño and serrano peppers. They had summoned top FDA and CDC officials to testify.

Anyone expecting a grilling was disappointed. Almost as soon as he took his seat in front of the microphone, the FDA's top food safety official, David Acheson, went off script, starting not with his prepared testimony but with news of the Salmonella saintpaul finding in Mexico, information he said he had learned just two hours before the hearing.

The discovery did not let the FDA and the CDC off the hook entirely. Rep. Dennis Cardoza (D-Calif.), who chairs the House subcommittee on horticulture and organic agriculture, asked Acheson to get back to the panel with answers to several questions, including when he first heard CDC officials suspected jalapeño peppers were making people sick.

Investigators did not look into whether jalapeño and serrano peppers could be making people sick until early July when the illness count kept rising despite a nationwide warning against eating raw red plum, Roma and vineless red round tomatoes.

The FDA recently lifted the tomato warning, saying tomatoes now on the market are safe. But by then, tomato growers had incurred more than $100 million in losses.

Investigators have yet to find a contaminated tomato, and many growers assert that tomatoes were never involved. FDA and CDC officials, however, continued to insist that tomatoes and jalapeño peppers could have spread the bacteria if they were contaminated on the same farm or if one cross-contaminated the other somewhere in the distribution chain.

The discovery of Salmonella saintpaul in both jalapeño and serrano peppers partly vindicated proponents of that theory. Acheson told lawmakers yesterday that investigators may still find a packing facility or warehouse where tomatoes and jalapeño and serrano peppers crossed paths.

"We know [the salmonella] was on two [produce items]; it could easily have been on three," Acheson said. "It is certainly plausible that tomatoes were responsible for the early phases of [the outbreak]."

Investigators still have a lot to sort out, starting with the relationships between the farm in Nuevo Leon where the contaminated water and peppers were found and another farm in Tamaulipas that supplied tainted jalapeños to Agricola Zaragoza, a small distributor in Texas. So far the only connection is a packing facility in Nuevo Leon. It bought peppers from both farms and supplied Agricola Zaragoza.

Investigators are figuring out where peppers and tomatoes from the Nuevo Leon farm were shipped to, Acheson said, and awaiting the results of lab tests of samples from the Tamaulipas farm.

It's possible that peppers were contaminated by irrigation water on one farm, then sent to a packing facility where they contaminated other produce.

So far, samples from the packing facility that connects the two farms and the Texas distributor have not contained the outbreak strain, Acheson said. The packing facility handles jalapeño and serrano peppers and tomatoes.

Amgen Told to Reword Drug Label

The New York Times reports that the FDA has ordered Amgen to change the labels for its anemia drugs, which could further restrict their use in treating patients with cancer.  This is the first time the FDA has invoked authority under a 2007 law that empowered it to order changes in a drug's prescribing information.  Andrew Pollack writes,

The Food and Drug Administration has ordered Amgen to change the labels for its flagship anemia drugs in a way that could further restrict their use in treating patients with cancer.

The move, which the F.D.A. announced on Wednesday, represents the first time the agency has invoked authority under a 2007 law that empowered it to order changes in a drug’s prescribing information. Previously, the F.D.A. could only negotiate with a drug’s manufacturer to change the label.

Sales of the drugs, Aranesp and Procrit, have already plummeted in the last year because of studies suggesting that their use to treat the anemia caused by chemotherapy could actually make cancer worse or shorten lives. Procrit is manufactured by Amgen but sold under license by Johnson & Johnson.

Sales of Aranesp, generally considered Amgen’s flagship product, fell 13 percent in the second quarter from a year earlier, to $825 million, the company announced Monday in posting its quarterly results. In the United States alone, sales plunged 26 percent, to $427 million.

Yaron Werber, a biotechnology analyst at Citi Investment Research, estimated that the new label could reduce the use of Aranesp for cancer patients in this country — the drug is also used by people with kidney disease — by an additional 40 percent, further cutting annual sales by about $264 million.

Despite the concerns about the drug, sales of Aranesp and Amgen’s overall financial results were better than Wall Street expected in the second quarter. That, plus the positive result of a clinical trial for a new bone drug, lifted Amgen shares this week. Shares of Amgen rose 2 cents, to $62.30 Wednesday, near their 52-week high.

Amgen said in a statement Wednesday that the new label was consistent with its expectations and that it had already factored the impact of the label change into updated financial guidance it provided to investors on Monday.

Johnson & Johnson said it would cooperate with the F.D.A. in using the new label. Its sales of Procrit and a similar drug, Eprex, dropped 14 percent worldwide in the second quarter, to $652 million, and fell 23 percent in the United States to $346 million. Because the company is larger and more diversified than Amgen, the sales of any one drug tend not to have as large an impact on its financial performance.

The new labels will say that treatment with the drugs should not begin until a patient’s hemoglobin drops to 10 grams per deciliter of blood. And language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter. Hemoglobin is the oxygen-carrying component of blood and is at low levels in people with anemia, causing problems like fatigue. There are no accepted theories yet on why high doses of the anemia drugs seem to make cancer worse.

The new labels also say the drugs should not be used if the chemotherapy is being given to cure patients, rather than to extend their lives. While that would be left to a doctor to judge, it would very likely apply, for instance, to so-called adjuvant therapy, in which chemotherapy is used after a tumor is removed by surgery in hopes of preventing cancer from coming back. When cancer is advanced, chemotherapy is often not considered curative.

However, the new labels will not advise against use of the drugs for all patients with breast cancer or head and neck cancer. An advisory panel to the F.D.A. in March had called for such an advisory, because the drugs’ risks seemed to be stronger for those two types of cancer.

One effect of the label changes could be to make it less likely that Medicare would loosen reimbursement policies for the drugs.

Amgen and many oncologists have been trying to get Medicare to amend a policy in which it will not pay for use of the drugs if hemoglobin is above 10. In their arguments, the company and doctors pointed to the drugs’ labels, which seemed to suggest that the F.D.A. thought that a hemoglobin level of up to 12 was safe.

But now the F.D.A. has also adopted the 10 gram level for initiating cancer therapy, and mention of 12 grams has been removed from the label.

Dr. Richard Pazdur, director of the F.D.A.’s oncology drug office, said that the mention of the level of 12 was confusing people, making them think hemoglobins up to 12 were safe when, in fact, the safety is unknown.

“We felt people interpreted this as an upper safety limit,” he said in an interview Wednesday. He said a hemoglobin level of 8 to 9, just high enough to avoid blood transfusions, was appropriate, though the new labels do not state a specific figure. The labels for the drugs have already been changed a few times since new safety concerns arose early last year. The F.D.A. and Amgen have been negotiating the latest changes since the advisory committee in March recommended further restrictions on use of the drugs.

While the company and the agency agreed on most language, there were some points on which they could not reach agreement, Dr. Pazdur said. That prompted the F.D.A. to invoke its new authority to order the changes, he said.

Amgen had wanted the label to give doctors discretion to initiate therapy before hemoglobin levels dropped to 10 in patients who could not tolerate that degree of anemia. And it wanted mention of the 12 gram upper limit for stopping therapy.

Scientists Create First Personalized Stem Cells in ALS Patients

The Los Angeles Times reports that researchers for the first time are able to reprogram cells from sick patients.  Though hurdles remain, such cells could be used to help screen drugs to treat the crippling disease.  Karen Kaplan writes,

Scientists have created the first personalized stem cells for patients with a genetic disease by rewinding their skin cells to an embryonic state, according to a study published Thursday in the online edition of Science.

The researchers then converted some of those stem cells into the two kinds of brain cells that cause their crippling disease, amyotrophic lateral sclerosis, commonly known as Lou Gehrig's disease.

Stem cell experts said they were delighted -- though not surprised -- to see proof that the reprogramming technique worked on human cells from sick patients.

Previously, human versions of the so-called induced pluripotent stem cells had only been made from skin samples provided by healthy subjects.

"It is quite amazing and an important step that should allow the development of experimental and therapeutic interventions for this disease," said Kathrin Plath, a researcher at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, who was not involved in the study.

The new cells were derived from 3-millimeter patches of skin removed from the arm of an 82-year-old woman and her 89-year-old sister, who share a rare genetic mutation that causes about 2% of ALS cases.

The scientists from Harvard University and Columbia University focused on the rare form of ALS in part to test whether cells from elderly patients could be reprogrammed, said biologist Kevin Eggan of the Harvard Stem Cell Institute.

"This opens the door to being able to make patient-specific stem cell lines from diseases which affect people very late in life, like Parkinson's disease or Alzheimer's disease," said Eggan, the study's senior author.

The team followed a cellular reprogramming recipe pioneered in Japan that has swept through stem cell research labs around the world in the last year. The scientists isolated fibroblast cells from the sisters' skin biopsies and infected them with viruses, prompting the cells to express four dormant genes -- Klf4, Sox2, Oct4 and c-Myc -- that are active during early embryonic development.

The scientists produced eight stable cell lines, and they studied three of them from the 82-year-old woman, whose ALS symptoms were more advanced.

The cells expressed the same markers as embryonic stem cells and were able to grow into all the body's main tissue types.

When the scientists exposed the cells to certain small molecules, the jumbles of tissue began to differentiate into motor neurons, the cells that regulate voluntary muscle movement.

They also found evidence of glial cells, a crucial component of the central nervous system.

ALS is caused by the degeneration of motor neurons, but until now scientists have had no way to take samples from patients and study them in the lab, said Christopher Henderson, a professor of pathology, neurology and neuroscience at Columbia and coauthor of the study. Now he anticipates growing unlimited supplies of motor neurons using the reprogrammed stem cells.

"This is an extremely important resource," said Lucie Bruijn, science director of the ALS Assn. in Calabasas Hills, which was not involved in the study. "It gives you a tool to start screening drugs."

Researchers at Harvard and Columbia are already working to create motor neurons that are genetically matched to healthy people so that they can compare them with the ones derived from ALS patients, Eggan said.

Eventually, the stem cells might be used to create fresh motor neurons that could replace the diseased cells in ALS patients.

But many significant hurdles remain, including finding a way to reprogram the skin cells without relying on viruses or embryonic genes that cause mutations that can lead to cancer.

The research was funded in part by Project A.L.S. and the New York Stem Cell Foundation.

House Votes to Regulate Tobacco as a Drug

The New York Times reports that the House of Representatives has approved legislation giving the FDA power to regulate tobacco products.  Stephanie Saul writes,

Decades after the surgeon general first warned that cigarettes were a health hazard, the House of Representatives overwhelmingly approved legislation on Wednesday that would for the first time give the Food and Drug Administration the power to regulate tobacco products.

Citing the long history of warnings about the dangers of smoking, Representative John D. Dingell, chairman of the Energy and Commerce Committee, said that it was hard to believe that the federal government had not yet regulated the tobacco industry.

“With this legislation, we change this,” said Mr. Dingell, a Michigan Democrat.

The White House has signaled its opposition to the bill. And while the legislation has strong support in the Senate, which could take up the measure this fall, it is not clear whether the bill has a veto-proof majority there.

The show of support in the House, which passed the bill by a vote of 326 to 102, illustrated not only the strength of antismoking sentiment in the country but the benefit of enlisting a powerful ally. The legislation was partly the result of negotiations with Philip Morris USA, the nation’s largest cigarette company, which split with other companies by endorsing it.

Most large public health groups supported the measure — and its passage was applauded by groups including the American Lung Association and the American Heart Association — but some antismoking advocates said the bargain struck with Philip Morris gave too many concessions to the industry.

The bill specifically states that the F.D.A.’s new powers would stop short of the ability to order the elimination of nicotine from tobacco products or place an outright ban on all tobacco products.

But the agency could reduce nicotine to nonaddictive levels if it determined that doing so would benefit public health. The F.D.A. could also require changes in tobacco products, like the reduction or elimination of other harmful ingredients.

The bill bans flavored cigarettes that appeal to young people but exempts menthol from that ban. The exemption raised objections from black antismoking advocates because mentholated cigarettes are frequently chosen by black smokers.

To satisfy the Congressional Black Caucus on that issue, last-minute changes were made in the bill to direct a scientific advisory committee to issue recommendations on menthol in cigarettes within one year.

In a statement, Lorillard Tobacco Company, whose Newport cigarettes are the leading menthol brand, said it opposed the bill but “welcomes the provision in this bill that calls for a scientific review of menthol in cigarettes.”

Lorillard said that scientific studies to date do not support a conclusion that menthol cigarettes are more hazardous or addictive than non-menthol cigarettes.

The amendments also require the F.D.A. to publish an action plan on the advertising and promotion of menthol and other cigarettes to young people, giving priority to minority communities.

The bill was opposed by many Republicans. Many said they objected to expansion of the federal bureaucracy, and complained in particular that the F.D.A. was already unable to fulfill its work overseeing pharmaceuticals and food.

In floor discussion, John A. Boehner, the House minority leader, a smoker, called the legislation a “boneheaded idea.”

“How much is enough?” Mr. Boehner said. “How much government do we need? There’s not a smoker in America that doesn’t understand that smoking isn’t good for you.”

But Henry A. Waxman, the California Democrat who sponsored the bill, responded, “The minority leader said ‘When is enough, enough?’ Well cigarettes, one of the most dangerous products on sale today, are not regulated at all.”

The legislation would finance the F.D.A.’s tobacco supervision primarily through new fees paid by tobacco companies that are earmarked for that purpose.

If the legislation is enacted, consumers would see a wholesale revamping of the warning labels on tobacco products. The small messages currently on cigarette packs warning of the negative health effects would be replaced by graphic images of the physical ravages often caused by cigarettes, such as lung tumors and mouth growths.

The bill will also require cigarette makers to provide detailed disclosure about the type and quantities of ingredients in their products — like ammonia and acetaldehyde — which are believed to work with nicotine to increase the addictiveness of cigarettes and smokeless tobacco. The requirements mean that companies would be required to disclose internal research on the biological effects of those additives.

Cigarette companies could no longer advertise their products as “light” or “ultralight” to convey the notion of less harmful ingredients. Some companies have anticipated those changes by packaging their products so that cigarettes packs are color-coded to denote different blends.

Under the bill, any outdoor advertising of cigarettes, and advertising in publications seen by children, would have to be in black and white, to reduce their visual allure.

House approval of the bill follows years of debate over whether tobacco products should be regulated.

While attempts to place tobacco products under the agency’s jurisdiction date back at least to the 1980s, the impetus for the current bill originates in 1995, when Dr. David A. Kessler, then F.D.A. commissioner, proposed a set of regulations governing tobacco. Dr. Kessler asserted that nicotine was an addictive drug and that tobacco companies deliberately manipulated the nicotine content of their products.

Dr. Kessler had tried to impose regulations on the industry but the Supreme Court overturned them in 2000.

A bill that would have placed tobacco under F.D.A. jurisdiction was passed by the Senate in 2004 but was never approved by the House. The bill that the House approved Wednesday was introduced in both chambers in 2007.

Judge's Ruling Throws Southern California Power Plant Plans into Disarray

The Los Angeles Times reports that a Los Angeles County Superior Court judge ruled Tuesday [July 29, 2008] that thirteen proposed electricity-generating power plants cannot be built without the necessary environmental and health analyses.  Margot Roosevelt writes,

Does Southern California need a dozen or so new gas-fired power plants -- and if it does, can it build them? No one seems to know for sure.

The region's long-term plans to generate electricity to serve a growing population and to replace decades-old dirty plants were thrown into disarray this week, when a Los Angeles County Superior Court judge ruled Tuesday that local authorities had failed to do the necessary environmental and health analyses.

Officials from the South Coast Air Quality Management District, which encompasses Orange County and large swaths of Los Angeles, San Bernardino and Riverside counties, warned of likely "blackouts and brownouts" if the plants are not built.

Many of the plants, such as a 914-megawatt generator sponsored by the small industrial city of Vernon, would be in low-income, crowded areas that have high rates of asthma and other pollution-related diseases. Though they would be outfitted with the latest in pollution-control technology, the gas-fired generators would emit thousands of tons of fine soot particles, which are linked to cancer, heart disease and other illnesses.

The court decision is "a victory for the health of our children," said Lucy Ramos, a Boyle Heights middle-school aide and president of Mothers of East L.A., a group that has been fighting the Vernon plant. "Our community is not a dumping ground."

The proposed plants, which include 11 in the Los Angeles Basin and two in the outlying areas of Desert Hot Springs and Victorville, would be built by private companies, which would sell the power to Southern California Edison and other utilities. But under the federal Clean Air Act, no polluting facilities can be built unless soot and chemicals are reduced elsewhere in the region through a complex system of pollution credits, also known as offsets.

Years ago, the air district set aside what it called Priority Reserve credits so that projects such as hospitals and police stations could be built even if they added to the region's pollution. Last year, the district, lobbied by a host of former politicians, decided to sell the credits to energy companies for $420 million: about half the market value, according to environmentalists' calculations.

Environmental and community groups said Wednesday that they would sue in federal court to nullify such credits.

The decision, meanwhile, left air regulators perplexed at their next move.

"What's the responsible action?" asked Barry Wallerstein, the air district's executive officer. "Should we wait until we have brownouts and blackouts to build new power plants? We need lights in our schools and power for our factories and electricity in our homes."

Wallerstein said the region needs about 2,000 megawatts of new capacity, and that sufficient offsets are unavailable on the open market.

The 32-page decision came in response to a lawsuit filed by the Natural Resources Defense Council, Communities for a Better Environment and other groups. In it, Judge Ann I. Jones told the air district it could not sell offsets to the plants without a fuller analysis under California's Environmental Quality Act. In particular, the judge said, the district needed to analyze exactly how many tons of pollutants, including health-damaging soot and planet-heating greenhouse gases, that each proposed plant would emit.

Wallerstein said the district is unlikely to appeal the ruling. "It will be a question of whether we proceed with a new rule, or whether we throw up our hands and say, someone else should figure this out because it is beyond our control."

If the judge's concerns "are beyond our ability to address, then there will be a permanent moratorium on power plant construction in Southern California."

Environmentalists and many industry experts say that much of the region's demand can be met through conservation and renewable energy.

But no one knows how much could be supplied by wind farms, geothermal energy, solar rooftop facilities or large solar plants, many of which are proposed in fragile desert areas.

Until the 1998 electricity deregulation, the state's Energy Commission was responsible for determining needs. But later, the commission's role was largely reduced to permitting the siting of plants, leaving the market to decide how much and what kind of generation is needed.

Southern California Edison has signed long-term power purchase agreements for 2,556 megawatts of power from new gas-fired generators, including proposed plants in Walnut Creek, Calif., and El Segundo. Spokesman Gil Alexander said Wednesday that the company had not assessed the effect of the judge's decision.

"Obviously we believe new capacity is a critical energy planning issue for the region," he said.

Under California law, private utilities, which produce 11% of their power from renewable sources, must boost their so-called "green" portfolio to 20% by 2010. But a recent plan released by the state Air Resources Board said the amount must increase to a third by 2020 for all utilities, if the state is to meet its goal of reducing greenhouse gases that are causing global warming.

Aides to Gov. Arnold Schwarzenegger are negotiating with legislators to put the 33% requirement into law this year, a measure that could alter plans for many of the new gas-fired plants.

Grassley, Dingell Lead Calls for Overhauling FDA

The Wall Street Journal reports that several of this year's crises like the salmonella outbreak have led some members of Congress to scrutinize the FDA and propose giving it broader powers. Alicia Mundy writes,

Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.

Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa). A series of crises during the past year, including deaths linked to tainted Chinese-made blood thinners and cases of salmonella linked to jalapeño peppers, have given ammunition to the lawmakers, both longtime critics of the FDA.

A House subcommittee led by Mr. Dingell plans a Thursday hearing on the FDA's response to the salmonella outbreak. Mr. Dingell called it a "disaster." Among those hurt were tomato growers, who lost millions of dollars during the month that their products were thought to be the culprit.

Congress isn't likely to enact major changes to the agency this  year because it has only a brief fall session before the November elections, but 2009 may bring the most significant overhaul at the FDA in a generation if Messrs. Dingell and Grassley get their way.

Billy Tauzin, president of the drug industry's lobby, Pharmaceutical Research and Manufacturers of America, said he has warned members about what may lie ahead. "It's an accumulation of things some companies did over the years. Now it's death by a thousand cuts," he said in an interview. "We gotta stop the bleeding."

Controversies over the popular prescription drugs Chantix, an antismoking pill, and cholesterol treatment Vytorin have added to pressure on the FDA, as critics suggest the agency was too lax in pursuing safety or efficacy concerns.

The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

The current FDA commissioner, Andrew von Eschenbach, said the agency is independent of industry influence. In an interview, he said he has been moving to get the agency to act faster on information that a drug may have problems. The heparin crisis demonstrated the challenge to the agency from globalized food and drug supplies, which he described as the biggest issue the FDA faces, but he said the agency's resources are limited.

The pharmaceutical industry is digging in against changes it believes would make it harder to bring innovative drugs to market. Speaking of stricter rules proposed by Mr. Dingell, an industry lobbyist testified this spring: "The FDA currently regulates virtually every stage in the life of a prescription medicine sold in the U.S."

However, drug companies can't afford to appear too aggressive in protecting sales or deflecting stronger safety standards, because that might backfire and prompt embarrassing hearings in Congress.

Leading Democrats would like to see fewer Madison Avenue-style television commercials for prescription drugs. PhRMA earlier this month sent lawyers to meet with staffers for Mr. Dingell's committee and discussed how the industry could preserve its right to advertise medicines directly to consumers. The industry says TV ads help people learn more about diseases and treatments.

To lay the groundwork for their FDA overhaul, Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA. Agency officials have spent hundreds of hours testifying before Congress.

Congressional leaders have directed their frustration at Dr. von Eschenbach, who has led the FDA since December 2006.

After the heparin scandal broke in February, Dr. von Eschenbach at first balked at asking for more money to fund overseas inspections, at one point causing Mr. Dingell to erupt: "You are not the first fellow I've skinned for not doing his job." Finally, on June 9, the commissioner joined the health and human-services secretary in a surprise, night-time news conference. They announced they would formally ask Congress for $275 million for FDA overseas inspections -- for the next fiscal year, ending Sept. 30, 2009.

The move prompted anger from lawmakers who said Dr. von Eschenbach should be seeking the money right away. Sen. Arlen Specter (R., Pa.), usually sympathetic to the agency, called the FDA "a joke." Senate Appropriations Chair Herb Kohl (D., Wis.) privately upbraided Dr. von Eschenbach for undercutting congressional allies, according to Senate staffers.

Mr. Grassley began his campaign to overhaul the FDA in 2004 during an uproar about the agency's slow reaction to potential links between popular antidepressants and teen suicides. Now, he has four staffers and a parade of FDA whistleblowers helping him investigate a plethora of FDA controversies, such as its approval of the antibiotic Ketek. The FDA has cited "serious protocol violations" in clinical trials of Ketek but didn't pursue a criminal case.

Mr. Grassley wants to give safety reviewers complete autonomy from the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials. Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs. An FDA spokeswoman said, "It is not unexpected that at times people will not be unanimous in their views."

Mr. Dingell has a pending bill to add new drug-import registration fees and mandate certification of purity for incoming drug ingredients, among other measures.

"There's a total inability of the FDA to carry out" its mission," said Mr. Dingell, citing the heparin crisis and salmonella outbreak among other issues.

Efforts Against AIDS Among African Americans Criticized

The Washington Post reports that the Black AIDS Institute criticized the federal government yesterday [July 29, 2008] of doing too little to fight AIDS among African Americans in the US.  Bush is scheduled to sign a bill today that will extend the program and authorize the spending of $48 billion for the next five years to twelve countries in Africa, Guyana, Haiti, and Vietnam.  David Brown writes,

A prominent AIDS organization accused the federal government yesterday of doing too little to fight AIDS among black Americans, in whom the size and scope of the epidemic resembles that seen in many African nations.

In a 55-page report, the Black AIDS Institute argued that the disease should be viewed as a threat to the entire black population, and not just specific high-risk groups. Unlike in white Americans -- and in the citizens of most industrialized nations -- HIV in American blacks is increasingly transmitted heterosexually through "networks" where men especially have many sex partners at the same time, the report noted.

The report's authors asserted that the black AIDS epidemic here is being overlooked as the United States is allocating unprecedented resources to fighting the disease in sub-Saharan Africa.

African Americans with HIV -- at least 500,000 -- are more numerous than in seven of the 15 "target countries" in the Bush administration's global AIDS initiative, which has spent about $19 billion overseas in the past five years.

President Bush is scheduled to sign a bill today that will extend the program and authorize the spending of $48 billion for the next five years. The target countries consist of 12 in Africa and three others: Guyana, Haiti and Vietnam.

The report noted that with 39 million people, "black America" would be the 35th most populous country, and the 28th richest, if it were a separate nation. Two percent of adult black Americans are infected, the government estimates, and only four countries outside Africa have a higher HIV prevalence. It would rank 16th in the world in the number of people living with HIV.

The District has the highest prevalence of HIV infection of any American jurisdiction -- 5 percent, or about 1 in every 20 residents. This is nearly as high as the prevalence in Uganda (5.4 percent), which has one of the oldest and most intense epidemics in Africa.

Looked at these ways, the authors wrote, the African American epidemic "would undoubtedly elicit major concern and extensive assistance from the U.S. government."

"The U.S. response to the epidemic in black America stands in sharp contrast to our response to the epidemic overseas," said Phill Wilson, a longtime AIDS activist who is executive director of the Black AIDS Institute.

He added that his purpose in making the comparisons is not to criticize the global program but to urge that more money and attention be directed to the domestic one.

But Kevin A. Fenton, the head of HIV/AIDS prevention at the Centers for Disease Control and Prevention, said the argument that government prevention efforts are not tailored to the black epidemic is mistaken. "CDC prevention efforts have really tried to follow the epidemic," he said.

The proportion of AIDS-prevention funding devoted to the black community has risen as the epidemic has become more concentrated there and now constitutes about $300 million of the $600 million spent each year, Fenton said.

According to the CDC, 1 million to 1.2 million people in the United States are HIV-positive, although that estimate is now five years old. The CDC on Sunday will release more precise estimates of the HIV incidence, or the number of new infections that occur each year. It is believed to be about 50,000. The 2 percent HIV prevalence in adult African Americans exceeds the 1 percent threshold that defines a "generalized" epidemic, rather than one limited to certain subgroups. Two of the striking features of the epidemic in black Americans is the high rate of infection in women and the frequency of heterosexual transmission, both characteristic of Africa.

The CDC estimates that 38 percent of all new infections in African Americans from 2001 to 2005 were in women. Of new infections in black men and women, 46 percent were the result of heterosexual contact. In the District, about 40 percent of new infections are acquired heterosexually, 30 percent from male homosexual contact, and 15 percent from injected drug use.

Among white Americans during the same period, 16 percent of new infections were in women, and 16 percent of new infections in men and women were attributed to heterosexual transmission.

In sub-Saharan Africa, 60 percent of new infections occur in women, and the vast majority of all infections are acquired through heterosexual contact.

"I think there are important parallels between the epidemic in Africa and the epidemic among black people in the United States," said Helene D. Gayle, an epidemiologist who spoke in support of the new report during a teleconference yesterday. "In a lot of places, it is a generalized epidemic."

Once the head of AIDS programs at the CDC, Gayle is now the president of the charity CARE.

The report cited numerous other similarities between the African and African American epidemics. In each, there is HIV prevalence in some rural areas (such as the Mississippi Delta) as high as in cities. Sexual networks in which people have many partners at the same time -- rather than practicing "serial monogamy" with many partners -- is characteristic of both. So are the assertions by many women that they are powerless to negotiate condom use or abstinence.

Also yesterday, the United Nations released its latest synopsis of the global AIDS epidemic, which showed a steady decline in the number of people infected with HIV to 2.7 million last year, from 3 million in 2001. The number of AIDS-related deaths fell from 2.2 million in 2005 to 2 million last year, primarily because of a huge increase in the availability of antiretroviral drug treatment, particularly in Africa.

"We've achieved more in the fight against AIDS in the last two years than in the preceding 20 years," said Peter Piot, executive director of UNAIDS, which published the report. But he cautioned that five people were infected for every two people who gained access to treatment. "The gap between those who are in need of treatment and those who have access to treatment is widening."

New Arthritis Drug Gets Approval Recommendation

The Washington Post reports on the recently approved drug Actemra, a new treatment for rheumatoid arthritis.  Ricardo Alonso-Zaldivar writes,

A government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication.

The Hoffmann-La Roche, Inc. drug is already being used in Japan, and the Food and Drug Administration must now decide whether to give its approval for patients in the United States. Actemra's effectiveness was not in dispute, but some of its side effects raised questions. Nonetheless, the vote was 10-1 in favor of approval, and the agency generally follows the recommendations of its advisors.

While the most common form of arthritis comes from wear and tear on the joints as people age, rheumatoid arthritis is an immune system disorder in which the body turns on itself, attacking the joints. Known as "RA," it affects about 2.5 million Americans and usually strikes in early adulthood or middle age. Women are much more likely to suffer from the condition, which can lead to disability and an early death if untreated.

Actemra works by blocking the effect of a certain protein associated with inflammation. In clinical trials, patients with moderate to severe disease given Actemra showed an easing of symptoms and improvement on lab test results. One trial also showed that Actemra worked in some patients who had not seen improvement with a different type of treatment. In another trial, the drug was shown to help prevent damage to the joints.

But since Actemra acts to suppress the immune system, it can also have serious side effects. These can include severe infections, liver abnormalities and damage to digestive organs.

"It's always good to have new options for treating patients, but with a new drug, you don't know what the side-effect profile is," said Dr. Patience White, chief public health officer at the Arthritis Foundation. "In RA, you have a nearly 100 percent chance of being totally disabled and dying early, and you have a small chance of the side effects we're talking about." The group does not generally take a position on whether a medication should be approved.

The protein that Actemra acts on is known as IL-6 and serves as a chemical messenger between cells. Over-production of IL-6 has been linked to inflammation. Actemra, the only drug to act on this particular protein, blocks the interaction between IL-6 and cells. Actemra is not a chemical, but a type of biologic drug. It is an antibody genetically engineered in the lab.

New biologics are often among the more expensive medications on the market. Other biologic drugs for RA, including Enbrel, Humira and Remicade, act on a different protein related to inflammation. Patients would receive Actemra by intraveneous infusion every four weeks in their doctor's office.

EPA Says Clean-Air Ruling Threatens Health

The Wall Street Journal reports that on Tuesday [July, 29, 2008], the US Court of Appeals for the District of Columbia Circuit struck down the Clean Air Interstate Rule, which sought to reduce smog-forming and soot-producing emissions that contribute to respiratory illnesses by allowing companies that exceed their emissions caps to buy allowances from companies that do not. The EPA had predicted that the rule would prevent about 17,000 premature deaths a year.  Stephen Power and Mark Peters write,

A federal court's decision to strike down the Bush administration's signature clean-air program threatens public health by encouraging companies to slow their pollution-control efforts, a top Environmental Protection Agency official told Congress.

Prospects for a legislative fix are clouded by a dispute between Democrats and Republicans over whether new pollution legislation should cover carbon dioxide, the main global-warming gas.

Separately Tuesday, four Democratic senators asked the Justice Department to investigate whether the EPA's administrator, Stephen Johnson, made false statements to Congress when he testified earlier this year that his 2007 decision to block California from regulating automobile greenhouse-gas emissions was his alone and not directed by the White House.

A White House spokesman accused Democrats of "throwing stones." A spokesman for Mr. Johnson defended the administrator's comments to Congress as being truthful and said Mr. Johnson's overall record was one that promoted "aggressive, health-protective environmental standards."

The matter occupying more senators' attention Tuesday was a decision earlier this month by the U.S. Court of Appeals for the District of Columbia Circuit that struck down the Clean Air Interstate Rule. The regulation, announced in 2005 and covering more than two dozen, mostly Eastern, states, sought to bring about major reductions in smog-forming and soot-producing emissions that contribute to respiratory illnesses by instituting a "cap and trade" system in which companies that exceed their emissions caps can buy allowances from companies that do not. The EPA had predicted that the rule would prevent about 17,000 premature deaths a year.

In response to a court challenge brought by some power companies, the court invalidated the regulation, saying the agency had overstepped its authority.

A Call for a Warning System on Artificial Joints

The New York Times reports that because the US lacks a national database tracking artificial joints, the risk in the US that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases.  Barry Meier writes,

Dr. Lawrence Dorr, a nationally known orthopedic surgeon in Los Angeles, realized last year that something was very wrong with some of his patients.

Months after routine hip replacements, patients who had expected to live without pain were in agony. “The pain was grabbing me around the back,” said Stephen Csengeri, who is 54, and a lawyer from Torrance, Calif.

Dr. Dorr found he had implanted the same metal hip socket in each patient. Several needed surgery again — a replacement for their replacement.

The doctor first told the device’s manufacturer, Zimmer Holdings, last year about his concerns but nothing happened. Then in April, Dr. Dorr, who was a highly paid consultant for Zimmer, sounded an alarm to colleagues in a professional association and soon heard back from doctors with similar experiences.

“I saw one of Zimmer’s engineers at a meeting, and I told her that you should pull this cup because you are crippling patients,” Dr. Dorr said.

Last week, Zimmer announced it was suspending sales of the device, known as the Durom cup, until it trained doctors how best to implant it. The company said a “low” percentage of the 13,000 patients who got the socket would need replacements, but some doctors fear the number could reach into the hundreds.

If those patients lived in other countries where artificial joints were tracked by national databases — including Australia, Britain, Norway and Sweden — many might have been spared that risk. And Zimmer might have suspended sales of the cup months ago.

But the United States lacks such a national database, called a joint registry, that tracks how patients with artificial hips and knees fare. The risk in the United States that a patient will need a replacement procedure because of a flawed product or technique can be double the risk of countries with databases, according to Dr. Henrik Malchau of Massachusetts General Hospital.

Experts say that the United States wastes billions of dollars annually on medical treatments which may not work. But the financial and human consequences are also large when evidence exists but is not collected.

The toll of early device replacement is magnified here because of the sheer number of procedures that take place in the United States. Nearly one million hips and knees were used last year, about half of the world’s total.

“We are No. 1 both as a provider and user of implants,” said Dr. John J. Callaghan, a professor of orthopedics at the University of Iowa. “We should be the leader in the follow-up of them.”

The Food and Drug Administration is charged with monitoring devices like artificial joints. But that system is often overwhelmed by the vast number of products it monitors and because doctors often do not report problems.

Medicare, which pays for about half the hip and knee implants in this country, rebuffed a proposal two years ago from a medical group to support a joint database. It said it was not the agency’s job to gather such data — despite the considerable savings in taxpayer dollars that might come from reducing the number of do-over surgeries.

The use of joint registries has proven beneficial abroad. In Australia, regulators use such data to force manufacturers to justify why poorly performing hips or knees should remain available, and products have been withdrawn as a result. In Sweden several years ago, surgeons alerted by their national registry stopped using a badly flawed hip long before their American counterparts did. A few medical organizations here, like Kaiser Permanente, operate their own registries to good effect and the Hospital for Special Surgery in New York has recently set up a registry.

But for more than a decade, efforts to set up an open national registry in this country have failed. One witness to those events has been Dr. Malchau, who worked for a decade at the Swedish registry. He and other registry advocates have heard all the reasons a registry cannot work here — busy doctors hate paperwork, plaintiffs’ lawyers would mine a database to find cases, general hospitals would be unfairly compared with specialty ones, to name a few.

Drowned out by those complaints is what registries do for patients. “It has been very frustrating,” Dr. Malchau said.

Continue reading "A Call for a Warning System on Artificial Joints"

Doctor and Patient, Now at Odds

The New York Times reports on an alarming study from Johns Hopkins finding that one out of four patients are skeptical of their physicians.  This distrust seems to stem from a system based on impersonal care and declining reimbursements. Tara Parker-Pope writes,

A growing chorus of discontent suggests that the once-revered doctor-patient relationship is on the rocks.

The relationship is the cornerstone of the medical system — nobody can be helped if doctors and patients aren’t getting along. But increasingly, research and anecdotal reports suggest that many patients don’t trust doctors.

About one in four patients feel that their physicians sometimes expose them to unnecessary risk, according to data from a Johns Hopkins study published this year in the journal Medicine. And two recent studies show that whether patients trust a doctor strongly influences whether they take their medication.

The distrust and animosity between doctors and patients has shown up in a variety of places. In bookstores, there is now a genre of “what your doctor won’t tell you” books promising previously withheld information on everything from weight loss to heart disease.

The Internet is bristling with frustrated comments from patients. On The New York Times’s Well blog recently, a reader named Tom echoed the concerns of many about doctors. “I, as patient, say stop acting like you know everything,” he wrote. “Admit it, and we patients may stop distrusting your quick off-the-line, glib diagnosis.”

Doctors say they are not surprised. “It’s been striking to me since I went into practice how unhappy patients are and, frankly, how mistreated patients are,” said Dr. Sandeep Jauhar, director of the heart failure program at Long Island Jewish Medical Center and an occasional contributor to Science Times.

He recounted a conversation he had last week with a patient who had been transferred to his hospital. “I said, ‘So why are you here?’ He said: ‘I have no idea. They just transferred me.’

“Nobody is talking to the patients,” Dr. Jauhar went on. “Everyone is so rushed. I don’t think the doctors are bad people — they are just working in a broken system.”

The reasons for all this frustration are complex. Doctors, facing declining reimbursements and higher costs, have only minutes to spend with each patient. News reports about medical errors and drug industry influence have increased patients’ distrust. And the rise of direct-to-consumer drug advertising and medical Web sites have taught patients to research their own medical issues and made them more skeptical and inquisitive.

“Doctors used to be the only source for information on medical problems and what to do, but now our knowledge is demystified,” said Dr. Robert Lamberts, an internal medicine physician and medical blogger in Augusta, Ga. “When patients come in with preconceived ideas about what we should do, they do get perturbed at us for not listening. I do my best to explain why I do what I do, but some people are not satisfied until we do what they want.”

Others say the problem also stems from a grueling training system that removes doctors from the world patients live in.

“By the time you’re done with your training, you feel, in many ways, that you are as far as you could possibly be from the very people you’ve set out to help,” said Dr. Pauline Chen, most recently a liver transplant surgeon at the University of California, Los Angeles, and the author of “Final Exam: A Surgeon’s Reflections on Mortality” (Knopf, 2007). “We don’t even talk the same language anymore.”

Dr. David H. Newman, an emergency room physician at St. Luke’s-Roosevelt Hospital Center in Manhattan, says there is a disconnect between the way doctors and patients view medicine. Doctors are trained to diagnose disease and treat it, he said, while “patients are interested in being tended to and being listened to and being well.”

Dr. Newman, author of the new book “Hippocrates’ Shadow: Secrets from the House of Medicine” (Scribner), says studies of the placebo effect suggest that Hippocrates was right when he claimed that faith in physicians can help healing. “It adds misery and suffering to any condition to not have a source of care that you trust,” Dr. Newman said.

But these doctors say the situation is not hopeless. Patients who don’t trust their doctor should look for a new one, but they may be able to improve existing relationships by being more open and communicative.

Go to a doctor’s visit with written questions so you don’t forget to ask what’s important to you. If a doctor starts to rush out of the room, stop him or her by saying, “Doctor, I still have some questions.” Patients who are open with their doctors about their feelings and fears will often get the same level of openness in return.

“All of us, the patients and the doctors, ultimately want the same thing,” Dr. Chen said. “But we see ourselves on opposite sides of a divide. There is this sense that we’re facing off with each other and we’re not working together. It’s a tragedy.”

Rapid Rise Seen in Fatal Medication Errors at Home

The Washington Post reports on a study that documents the rise in deaths from abuse of prescription drugs and inattentiveness to taking medications at home such as overdosing, mixing alcohol with medications, and sharing medications.  However, this dramatic increase in deaths may be partly due to better coding location on death certificates. Carla K. Johnson writes,

Deaths from medication mistakes at home, like actor Heath Ledger's accidental overdose, rose dramatically during the past two decades, an analysis of U.S. death certificates finds.

The authors blame soaring home use of prescription painkillers and other potent drugs, which 25 years ago were given mainly inside hospitals.

"The amount of medical supervision is going down and the amount of responsibility put on the patient's shoulders is going up," said lead author David P. Phillips of the University of California, San Diego.

The findings, based on nearly 50 million U.S. death certificates, are published in Monday's Archives of Internal Medicine. Of those, more than 224,000 involved fatal medication errors, including overdoses and mixing prescription drugs with alcohol or street drugs.

Deaths from medication mistakes at home increased from 1,132 deaths in 1983 to 12,426 in 2004. Adjusted for population growth, that amounts to an increase of more than 700 percent during that time.

In contrast, there was only a 5 percent increase in fatal medication errors away from home, including hospitals, and not involving alcohol or street drugs.

Abuse of prescription drugs plays a role, but it's unclear how much. Valid prescriptions taken in error, especially narcotics such as methadone and oxycodone, account for a growing number of deaths, said experts who reviewed the study.

The increases coincided with changing attitudes about painkillers among doctors who now regard pain management as a key to healing. Multiple prescription drugs taken at once _ like the sleeping pills, painkillers and anxiety drugs that killed "Dark Knight" star Ledger _ also play a part, experts said.

"When we see overdoses, we're seeing many more mixed drug overdoses," said Dr. Jeffrey Jentzen, president of the National Association of Medical Examiners and director of autopsies at the University of Michigan in Ann Arbor. Jentzen said autopsies are much more likely to include toxicology tests today than 25 years ago, which would contribute to finding more fatal medication errors as cause of death.

But Phillips said there were no significant increases in other poisonings like suicidal overdoses or homicides, so more testing doesn't explain the huge increase. The analysis excluded suicides, homicides and deaths related to side effects.

The increase was steepest in death rates from mixing medicine with alcohol or street drugs at home; that death rate climbed from 0.04 per 100,000 people in 1983 to 1.29 per 100,000 people in 2004.

Many patients ignore the risk of mixing alcohol with prescriptions, said Cynthia Kuhn of Duke University Medical Center, who was not involved in the study.

"They think, 'Oh, one drink won't hurt.' Then they have three or four," Kuhn said.

The increase in deaths was highest among baby boomers, people in their 40s and 50s.

"We're sort of drug happy," said boomer Dr. J. Lyle Bootman, the University of Arizona's pharmacy dean, who was not involved in the research. "We have this general attitude that drugs can fix everything."

People share prescriptions at an alarming rate, Bootman said. One recent study found 23 percent of people say they have loaned their prescription medicine to someone else and 27 percent say they have borrowed someone else's prescription drugs.

Kenneth Kolosh, a statistics expert at the National Safety Council, praised the study but said improved attention to coding location on death certificates may account, in part, for the huge increases the researchers found.

Phillips countered that home deaths from any cause increased relatively little during the time period, so better coding doesn't explain the change.

Michael R. Cohen, president of the Institute for Safe Medication Practices, said more states should require pharmacists to teach patients about dangerous drugs and insurers should pay pharmacists to do so.

Should Genetic Tests Be Regulated?

Time magazine reports that although a federal advisory committee in April recommended increasing federal regulation of genetic testing and creating a mandatory online registry of all laboratory genetic tests performed, no action has been taken yet.  Sarah Lynch questions whether genetic tests should be regulated in this booming industry.  Lynch writes,

When the human genome was decoded and the achievement breathlessly announced in 2003, a new race was launched: Who would be the first to make this trove of genetic information practically useful — and profitable?

So far, at least 30 direct-to-consumer testing companies have answered the call, analyzing genetic information for curious consumers at anywhere from several hundred to several thousand dollars a pop. (One company charges $350,000 for whole-genome sequencing.) The services range from paternity and ancestry tests to risk assessments for specific diseases, such as breast cancer and Type 2 diabetes. Some tests look for single genes associated with disorders (baldness, in the case of HairDX); others, like 23andMe, one of the industry leaders, use a DNA chip to scan the entire genome in search of single nucleotide polymorphisms, or SNPs — genetic variants that help determine risk for disease or likely traits such as eye color.

Currently this booming direct-to-consumer industry operates with little federal oversight and few industry guidelines. But the popularity of the genetic tests has snared the attention of state and federal regulators. A report released by a federal advisory committee in April recommended increasing federal regulation of the tests and creating a mandatory online registry of all laboratory genetic tests performed, but no action has yet been taken.

Meanwhile, representatives of leading companies, including 23andMe, Navigenics, deCODE Genetics and DNA Direct, have stepped into the void, launching discussions this month in Washington to devise their own voluntary standards, which they expect will promote integrity among their competitors. The companies said they will collaborate with the Personalized Medicine Coalition (PMC), an educational nonprofit, to create the guidelines. They plan to present a draft of the new rules at a PMC conference in December, says Edward Abrahams, PMC's executive director.

The objective is to standardize methods for validating genetic tests and guaranteeing accuracy and quality, says Mari Baker, CEO of California-based Navigenics. For now, all clinical labs, including those that conduct genetic tests, are regulated by the Centers for Medicare and Medicaid Services, which, under the federal Clinical Laboratory Improvement Amendments (CLIA), governs lab-personnel qualifications, quality-control procedures and proficiency testing. But critics argue that the law needs to be updated to include standards for genetic-testing labs. CLIA requires independent evaluations of labs' test-performance proficiency, for example, but genetic-testing labs are exempt from this rule, according to the Genetics and Public Policy Center at Johns Hopkins University.

The industry consortium's voluntary guidelines will also address consumer privacy and transparency and encourage companies to be up-front about the limitations of genetic-risk information, says Baker, who is hoping to model the new guidelines on her company's official standards of practice. She envisions that companies' adherence to the rules will serve as a "Good Housekeeping seal of approval" to help consumers identify the "quality players" in the field.

"This information is new," Baker says. "People need to be able to compare and understand who's doing this the right way. Right now it's too hard to figure that out."

Indeed, even government regulators can hardly figure it out. In June, after receiving complaints from consumers, the California Department of Health sent cease-and-desist letters to 13 companies, including deCODE Genetics, 23andMe and Navigenics, asking them to stop doing business with California customers until they could prove they were complying with state laws. In California, only physicians may order lab tests, and all labs must obtain a state license and meet federal CLIA requirements. Last November, New York State's Department of Health mailed similar letters to 31 companies. (Navigenics and 23andMe have since submitted business plans to New York for approval.) "Our priority is to protect the health and safety of New Yorkers," says Jeffrey Hammond, a spokesman for the department. "Our concerns are about patient safety. These online tests raise the question: What will patients do with this information, and is the information accurate?"

Those questions fuel the debate over whether the information amounts to medical advice. Many doctors say it does. Most companies, including 23andMe, disagree; they say they are simply offering customers genetic information that already belongs to them. If so, how useful is that information? Again, many doctors say it's still far too early to gauge its benefit, because consumers are not capable of interpreting their genetic information or making any meaningful changes in lifestyle or health based on it. In January, Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, co-authored a commentary questioning the tests' value as well as their clinical validity. "We don't think this is ready for common people to use it. Most of the time, it doesn't help you very much, because there isn't much you can do about it," Drazen says. "If they do your test and say you are at a low risk for heart disease, does that mean you should be on a program of sloth and gluttony?"

What's more, the tests don't always offer consistent results. Linda Avey, co-founder of 23andMe, says consumers have received conflicting results from different companies. That can happen for various reasons: not all tests read the same SNPs to calculate the same risk, and not all risks are calculated using the same metric (some results compute the risk of cancer over a lifetime, for example, while others may assess the risk within a 10-year window). "We want to come together as scientists and say, Here's how we should present the information to the consumer," says Avey, who hopes the proposed voluntary industry guidelines will promote consistency among results offered by all companies that read SNPs. "And that way, when they get results back from the different companies, it's more similar."

Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, says establishing industry standards is a step in the right direction but thinks the Federal Government should regulate the industry as well.

"I think that industry or professional standards are really important, and in the absence of clear, coherent state and Federal Government oversight, there is an even more important role that industry guidelines can play," Hudson says. "The [drawback] of industry or professional guidelines is that they are voluntary."

Meanwhile, the U.S. Food and Drug Administration (FDA) has declined to discuss what it may have in store for the genetic-testing industry except to say it's definitely on the regulators' radar. Currently the FDA has chosen not to oversee laboratory-developed tests like these, although it has discretion to do so.

"Of course we are watching this field with great interest," says Dr. Steven Gutman, director of the Office of In Vitro Diagnostics at the FDA.

What Can Genetic Tests Tell You?

Time magazine interviews Linda Avey, co-founder of a genetic-testing company, about some of the misconceptions with the industry and how helpful genetic testing can be for a person.  Time.com writes,

If you'd like to know your lifetime risk of Type 2 diabetes or whence your forebears came, there's probably a Web-based genetic-testing company out there that can tell you. Most of them require just a visit to the website, a credit-card number and your spit sample sent in the mail. But the question is, How helpful is the information you receive? How accurate? The science behind these tests is still so new that some health regulators and medical professionals are questioning their validity and their practical utility. TIME.com's Sarah N. Lynch recently sat down with Linda Avey, co-founder of one of the industry's leaders, 23andMe, based in Mountain View, Calif.

What is the biggest general misconception about your industry right now?

Avey: I think one thing is that people are worried this information could be harmful, and we're really not convinced of that. Like with all new things that come out, we don't always know exactly what the implications are going to be. When the car first came out, for example, it didn't have air bags or seat belts or headrests and all the protections that were built into cars ultimately to make them safer to drive.

What is the biggest misconception among your customers?

Before they sign up, some people make the comment, "Am I going to find out when I'm going to die?" And it's not that black-and-white. There are so many things that go into your overall health and well-being — your environment is a huge part of that. People think [the test results] are going to have more of an impact than they actually do.

So the test, if I get one, won't change my life. How valid are the results?

I think it's really early in the game, and the great thing is that the value of those data is going to grow with time. I think what you learn is a glimpse of what is coming out in the research. A lot of it is looking really great. There are some really solid studies that have been published, so I think you'll start to get an inkling of what your risks might be. It's not 100%, and it might change slightly over time, but you are kind of catching the wave — by getting in now you'll get an early look ... It's really for those people who are the early adopters of a lot of technologies.

If the tests are so new and not fully understood, are they worth the money now? Should consumers wait another five years?

You can ask that of anyone who adopts new technology. It is going to get less expensive with time, and if you are not ready to do it now, then it's best that you wait. Not everybody bought an iPhone when it first came out. If you wait, the prices on the technology do drop.

Have you done your own test?

Oh, yeah. My family and I have all done it. Me, personally, I come from really hearty stock, and we're all a very healthy family. We're really, really lucky that we are so healthy, so for me, it didn't reveal things I didn't already know ... My grandmother is still alive, and she's 99 years old.

There's not much federal oversight right now on the genetic-testing industry. Do you believe there should be?

I do think that it would be good. The good thing is that the FTC — the Federal Trade Commission — has the ability to come down on the companies who are making false claims. I think that is a really good means of watching over what is going on in this phase. Because I think the big problem is that if people are making false claims about what your genetics mean for you and maybe trying to sell you a product based on that — the minute that starts getting ahead of the science and what we really truly understand about genetics, that's where I think the FTC can step in.

Fitter Alzheimer's Patients Had Less Brain Damage

The Washington Post reports on a study that showed less shrinkage in the hippocampus region of Alzheimer's patients' brains with higher fitness scores.  Exercise and physical fitness have been shown to slow age-related brain cell death in healthy older adults.  The Washington Post writes,

Patients in the early stages of Alzheimer's disease who performed better on a treadmill test had less atrophy in the areas of the brain that control memory, according to a study released Sunday.

Magnetic resonance imaging (MRI) showed less shrinkage in the hippocampus region of patients' brains in the Alzheimer's patients with higher fitness scores. In Alzheimer's the hippocampus is one of the first parts of the brain to suffer damage.

Exercise and physical fitness have been shown to slow age-related brain cell death in healthy older adults.

The new study was released at the International Conference on Alzheimer's Disease in Chicago. Researchers at the University of Kansas Medical Center in Kansas City, Kan., studied the connection between cardiorespiratory fitness and regional brain volume in more than 100 people over 60. About half were healthy older adults and half were in the early stages of Alzheimer's.

In a statement, lead researcher Robyn A. Honea said the study suggests "that maintaining cardiorespiratory fitness may positively modify Alzheimer's-related brain atrophy."

But it isn't clear whether exercise helped avoid brain damage or if brain-damaged people had less ability to exercise.

The study was funded by the National Institute on Aging and National Institute on Neurological Disorders and Stroke

Weight Drives the Young to Adult Pills, Data Says

The New York Times reports on the alarming increase of children experiencing problems such as Type 2 diabetes, high blood pressure, high cholesterol, and acid reflux that were unheard of in children two decades ago.  Doctors continue to debate on whether to keep prescribing adult medications to children as a quick fix to lack of exercise and improper diet or because of society and environment.  Stephanie Saul writes,

A growing number of American children are taking drugs for a wide range of chronic conditions related to childhood obesity, according to prescription data from three large organizations.

The numbers, from pharmacy plans Medco Health Solutions, Express Scripts and the marketing data collection company Verispan, indicate that hundreds of thousands of children are taking medication to treat Type 2 diabetes, high blood pressure, high cholesterol and acid reflux — all problems linked to obesity that were practically unheard-of in children two decades ago.

The data, disclosed publicly in recent months or provided at the request of The New York Times, shows that concerns that children will be taking adult medications — heightened recently by a controversial recommendation by a national pediatricians group — are already a reality.

This month, the American Academy of Pediatrics said that more children, as young as 8, should be given cholesterol-lowering drugs. The recommendation was quickly attacked by some experts as a license to put children on grown-up drugs.

While the drugs do help treat the conditions, some doctors fear they are simply a shortcut fix for a problem better addressed by exercise and diet. Even so, some pharmaceutical companies are developing new versions, including flavored ones, of adult medications for children.

While some of the percentage increases in the three analyses are significant, doctors emphasize that prescriptions of these drugs to children still represent less than 1 percent of their sales.

Express Scripts and Medco developed estimates of how many children might be taking such drugs by extrapolating their data — involving a total of more than four million children — across the broader population.

The companies use different assumptions to reach their estimates, but the data suggests that at least several hundred thousand children are on various obesity-related medications.

The greatest increase occurred in drugs for Type 2 diabetes, with Medco’s data showing a 151 percent jump from 2001 to 2007.

Medco’s data, released in May, showed that use of drugs to treat acid reflux problems in children, often aggravated by obesity, increased 137 percent over seven years. Its analysis also showed an 18 percent increase in drugs to treat high blood pressure and a 12 percent increase in cholesterol-lowering medications during the seven-year period.

Express Scripts found a 15 percent increase over three years in drugs to treat cholesterol and other fats in the blood, a category that is primarily statins.

“We were amazed at how quickly the rates of drugs used have climbed,” said Dr. Donna R. Halloran, an assistant professor at St. Louis University who worked on the Express Scripts analysis, presented at a meeting of the American Public Health Association in November.

Verispan data recorded a 13 percent increase in high blood pressure prescriptions in the under 19 age group from 2005 to 2007. Its numbers show, however, a less than 1 percent increase during the period in cholesterol-lowering drugs in children.

Doctors and some financial analysts have said that less pronounced increases in cholesterol drugs compared with some other medications — seen in all three analyses — reflect a wariness by some doctors about using those drugs in children.

Some experts have expressed concern that the increases in many of these obesity-related drugs reflect a systemic failure, with doctors and parents turning to them because they find lifestyle changes too difficult to implement or enforce.

“I think a lot of people in pediatrics, myself included, are struggling with what is the right management to do for these kids,” said Dr. Russell L. Rothman, an assistant professor at Vanderbilt University, who recently surveyed doctors and found wide variations in how children were being treated.

“You see elevated blood pressure, or elevated sugars, or elevated cholesterol and you try exercise and diet and you don’t see any improvement,” Dr. Rothman said. “I worry that some providers and some families are looking for the quick fix, and are going to want to start medication immediately.” Some pediatricians say they have been treating children with statins for several years.

Dr. David Collier, director of a pediatric weight management center at East Carolina University in Greenville, N.C., an area where 45 percent of the children are overweight, is among doctors who support the recent recommendations that statins may be warranted in some children as young as 8. “We have been using statins for two or three years now,” he said.

One of his statin patients, he said, was a 6-year-old girl.

Dr. Collier, who describes his location as “right smack dab in the middle of the stroke belt,” believes that aggressive therapy is needed to prevent a health crisis. “It’s hard to overstate the size of the problem,” he said.

Dr. Francine R. Kaufman remembers a patient, a 13-year-old girl, whose weight had ballooned to 267 pounds. The teenager appeared destined for the same fate as her grandmother, who lost a leg to Type 2 diabetes.

“To control her high blood sugar level, her high blood pressure, and her high cholesterol, this young girl left my office with five medications,” Dr. Kaufman, a pediatric endocrinologist in Los Angeles, told a Senate subcommittee last week during hearings on obesity in children.

The girl stood out as unusual more than 10 years ago, but children with the same array of problems are increasingly seen in the diabetes center where she practices at Children’s Hospital Los Angeles, Dr. Kaufman said.

Diet and exercise are tried first, but “lifestyle is really tough,” Dr. Kaufman said. Some of her patients live in neighborhoods without grocery stores and attend schools that do not offer physical education programs.

“They deserve to be treated,” Dr. Kaufman said. “I think the slant from most of the media is that pediatricians are jumping to put kids on medications. That’s not true at all. Since lifestyle is so difficult, we have no other choice but to go to pharmacotherapy.”

At Camp Pocono Trails, a weight loss camp in Reeders, Pa., that enrolls about 700 children each summer, owner Tony Sparber said that campers are arriving with medications, a pharmacopeia that include statins and diabetes medications.

“You just look at these kids’ medical forms,” Mr. Sparber said. “You see kids with some very high-risk numbers. Cholesterol in the high 200s.”

Experts say that the trend could balloon health care costs. As many as 30 percent of children nationwide are overweight. And children who start such medication often rely on the drugs for a lifetime and are prone to health problems as adults.

Despite a push by the Food and Drug Administration to foster drug studies in children, many experts believe that many clinical studies in children have not been extensive enough. And adult doses are often not correct for children.

The agency publishes a list of drugs for which pediatric versions are needed. So far, the size of the pediatric market is not big enough to make it profitable for companies to make special children’s formulas of drugs for disorders that commonly go along with obesity and high-fat diets. That appears to be changing.

Madeira Therapeutics, based in Leawood, Kan., is formulating a liquid statin for children that will be sold in either grape, cherry or bubblegum flavor, according to the company’s chief executive, Peter R. Joiner.

Madeira became interested in the drug to treat children with a genetic cholesterol condition, familial hypercholesterolemia, which strikes 1 in 500 children regardless of their diet. The recent American Academy of Pediatrics statement adds to the potential market, according to Mr. Joiner.

The company, whose liquid statin may be available by late 2010, is also interested in a liquid oral diabetes medication.

“Because of the obesity epidemic in the United States, we see diabetes as another important area for contribution,” Mr. Joiner said.

A nonprofit group in Cambridge, Mass., the Institute for Pediatric Innovation, is working to encourage the reformulation of medications for children.

Dr. Stephen P. Spielberg, the former dean of Dartmouth Medical School, is leading the effort.

“What we’ve learned over the years is that the way in which the body handles medicines, the half life of a medicine, how it’s metabolized, how it’s excreted by the body, does vary, from babies all the way up to adolescents,” Dr. Spielberg said.

Hypertension medications present a particular challenge in dosing for children. “Even in clinical trials where adult pills were crushed and such, you often can’t even demonstrate that the medication works,” he added.

Medco cautioned that hypertension data can be misleading because some children with attention deficit disorder are treated with hypertension drugs.

The most significant increase in the use of drugs for children has been in oral medication for Type 2 diabetes. And some doctors believe much of those prescriptions were “off-label” use of the drug, metformin, to treat prediabetes, which may affect two million children nationwide.

But some doctors object to the use of metformin for that purpose in children, even though studies have shown it may prevent diabetes in young adults.

“There are no studies like this in children,” said Dr. Tamara S. Hannon, a pediatric endocrinologist at the Children’s Hospital of Pittsburgh.

“The argument may be that we know what happens in adults, so the same should happen in children. It’s been proven untrue in several cases in the history of medicine.”

CDC: ADHD Increasing in Older Kids

Time magazine reports that a government study released July 23, 2008 concludes that the percentage of older children diagnosed with ADHD has been rising by 4% each year. However, these results may not indicate a growing problem with adult concentration, but rather the misuse of ADHD medications as study aides and recreational stimulants.  Mike Stobbe writes,

More older children are being diagnosed with attention deficit hyperactivity disorder while the rate is holding steady for children under 12, according to a government report released Wednesday.

Some experts called the finding surprising, noting that most childhood diagnoses traditionally occur by age 11.

The study didn't investigate why the increase in one age group was so much higher than the other. It found the%age of older children diagnosed with ADHD has been rising by 4% each year.

Some experts say the increase may reflect that doctors are increasingly considering the possibility of ADHD in older kids who have concentration problems — a trend that coincides with the marketing of ADHD medications to teens and adults.

The finding may also reflect the misuse of Ritalin and other ADHD medications in that age group as study aides and recreational stimulants, some experts speculated.

"There are people out there being treated for ADHD that probably don't meet the diagnostic criteria," said Scott Kollins, director of Duke University Medical Center's ADHD Program.

Attention deficit hyperactivity disorder — characterized by impulsiveness, hyperactivity and inability to focus attention — is a behavioral and learning problem that usually appears in children by age 7.

The problem often is identified in school, and most children are diagnosed by age 11. The Centers for Disease Control and Prevention estimates that more than 4.4 million U.S. children have been diagnosed with ADHD by medical professionals.

The new study draws its results from an annual survey of 35,000 to 40,000 U.S. households, in which government researchers go door-to-door to conduct interviews. In households with children, parents are asked if a doctor or health professional had ever told them that their child had ADHD or attention deficit disorder (ADD).

The study's findings cover 1997 through 2006.

In each of those years, nearly 50 million children fell into the 6-to-17 age range, the study estimates. Roughly 4 million of them were given an ADHD or ADD diagnosis, the study estimates.

For children ages 6 through 11, the proportion hovered around 7% during those years. But for children 12 through 17, it rose from just under 7% to nearly 10%. That increase wasn't seen in previous government estimates, said Patricia Pastor, a CDC health statistician and the study's lead author.

It may reflect a growing understanding that a child — especially an older kid — can have ADHD without being disruptively impulsive or hyperactive, said Jeff Epstein, director of the ADHD center at Cincinnati Children's Hospital Medical Center.

Another factor may be that ADHD is sometimes diagnosed when adolescents are being checked for other conditions, such as depression, said Dr. Mohammad Ghaziuddin, director of the University of Michigan's ADHD and autism program.

Meanwhile, the use of ADHD medications has been increasing. According to the CDC, doctor's visits for children under 15 where methylphenidate — also known as Ritalin — was prescribed or given went from 1.9 million in 1993 to 3.2 million in 2005.

The marketing of newer ADHD drugs like Aderall XR and Strattera to adults and older kids is pushing up use, experts said.

"I think the industry does drive a lot of it," said Kollins of Duke, referring to pharmaceutical marketing.