The Basics: The Asterisk on Cancer Deaths

October 21, 2007 on 2:59 am | In Uncategorized | Comments Off

There was good news about cancer last week, a report that death rates in the United States have begun falling by 2.1 percent a year, nearly twice the rate of previous declines.

But the same report, by the American Cancer Society and other groups, also said certain cancers seem to be becoming more common — not hugely so, but noticeable. Among those increasing in men and women are myeloma and cancers of the thyroid and kidney. In women, melanoma and cancers of the bladder have increased; in men so have cancers of the liver and esophagus.

Why? Experts point to a mixed bag of facts, theories and educated guesses. One overarching culprit may be America’s level of obesity, which has been linked to increased risk of several types of cancer, including tumors of the kidney, liver and esophagus.

But there are much stronger risk factors for liver cancer. The major ones are the viruses that cause hepatitis B and C. In some people, those infections turn chronic and gradually lead to tumors. A vaccine that can prevent hepatitis B is used routinely in the United States. But not every country uses it, and liver cancer here may be rising in part because of cases among immigrants.

Hepatitis C is more of a homegrown problem. There is no vaccine, and infections surged in the 1960s and 1970s among drug users who shared needles. The virus then spread into the blood supply and may have infected tens of thousands of transfusion recipients before a test was developed to screen donated blood. Liver cancer is still turning up in people infected decades ago.

When it comes to thyroid cancer, researchers do not know whether the incidence of the disease is actually increasing, or simply being diagnosed more often because of improved tests. But it is a cause for concern. Increases in kidney cancer can probably be traced mostly to increased detection. As for melanoma, the increases probably come from both better detection and a real rise in cases due to sun exposure, researchers said.

Smoking raises the risk of bladder cancer. Rates in women may be rising because they started smoking, and quitting, later than men did, said Elizabeth Ward, director of cancer surveillance for the American Cancer Society.

There has been a similar trend with lung cancer. But over all, men have much higher rates of bladder cancer, possibly due to higher smoking rates and chemical exposures on the job.

Trends in myeloma, a bone marrow cancer, have researchers puzzled.

“It could be improvements in diagnosis,” Dr. Ward said. “It bears looking into, though, because it is more common in blacks than whites, and I don’t think we have a huge amount of knowledge about risk factors.”

Baltimore Journal: The Smoking Scourge Among Urban Blacks

October 21, 2007 on 1:59 am | In Uncategorized | Comments Off

BALTIMORE, Oct. 15 — Outside subway stops and bars in parts of this blighted city, slouching hustlers mutter “loosies, loosies” to passers-by, offering quick transactions, 50 cents a stick or three for a dollar.

Their illegal, if rarely prosecuted vocation: selling loose Newport cigarettes to those who do not have $4.50 to buy a pack.

In small corner markets, customers sometimes use code words like “bubble gum” or “napkins” to receive individual cigarettes wrapped in a napkin. Or they buy a flavored Black and Mild, the latest smoking craze here, from an opened five-pack.

Out-of-package sales are common in the poor areas of many cities, an adaptation to meager, erratic incomes and rising cigarette taxes. But researchers say they are just one facet of a high smoking rate among low-income urban blacks.

Even as antismoking campaigns have sharply reduced tobacco use in society at large, smoking has remained far more common among the poor of all races.

Still, officials here said they were surprised when a recent study suggested that more than half of poor, black young adults smoke cigarettes — almost always menthol, almost always Newports.

In the latest twist, the study also found that nearly one in four of them also smoke candy-flavored cigarillos, often inhaling despite the danger posed by higher tar and nicotine levels.

Alarmed by the findings, the city’s health commissioner, Dr. Joshua Sharfstein, on Monday convened health experts, community leaders and high school students to discuss the spreading use of Black and Milds, plastic-tipped cigarillos that come in flavors like wine, cream and apple and are often seen in hip-hop videos and the HBO series “The Wire,” which is set in Baltimore.

Jamila Wilson, 17, said at the meeting that she had started smoking Black and Milds at 15 and now smoked several a day, inhaling.

“If you smoke the wine flavor, it gives you a buzz, ” Jamila said, adding that if she goes too long without, “I get light-headed.”

Amid violence and drug problems, smoking may seem a comparatively harmless vice. “But if you take a step back,” Dr. Sharfstein said, “it’s the smoking that will end up killing a lot of these kids, maybe not next week but well ahead of their time.”

In a stepped-up antismoking campaign, Baltimore officials are offering free nicotine patches or gum and are considering stronger measures to control sales of loosies, which are easily available to youngsters.

“The whole issue here is that the social norms haven’t changed the way they have in most of society,” said Frances Stillman of the Johns Hopkins School of Public Health, co-author of the study of smoking habits among Baltimore’s poor, which was published in August in the American Journal of Public Health. “Everybody smokes, and everybody thinks it’s O.K.”

In this latest study, researchers interviewed 160 blacks ages 18 to 24 who were enrolled in job training. In the group, 60 percent smoked cigarettes and 24 percent had recently smoked cigarillos.

A survey of 1,021 low-income blacks in Detroit, published in 2005 in the American Journal of Preventive Medicine, found that 59 percent of men and 41 percent of women smoked, a finding that “shocked everybody,” said the chief author, Jorge Delva of the University of Michigan School of Social Work.

It has long been known that smoking rates are higher among the poor and least educated of all races, but Mr. Delva and other experts said the rates recently found among inner city blacks were surprisingly high, possibly indicating that they were undercounted in broad standard surveys.

For a mix of cultural reasons as well as targeted marketing, menthol cigarettes are particularly favored by blacks: 75 percent of blacks nationwide smoke them, compared with less than 30 percent of whites.

In the 1960s, Kools dominated the market. But Newports, with a lower menthol level that many say feels smoother, and backed by marketing including the green “Newport Pleasure!” posters in nearly every deli and gas station here, have taken a strong lead in many cities.

“All my friends smoke, and they all smoke Newports,” said Collin Mazick, 24, a resident of northeast Baltimore who is studying to become a geriatric nursing assistant.

In recent years, the promotion budgets of major cigarette companies have been disproportionately devoted to menthols, said Gregory N. Connolly, director of tobacco control research at the Harvard School of Public Health. “It appears the industry is targeting the most vulnerable groups through advertising and manipulation of menthol levels,” Mr. Connolly said.

In an e-mailed response to questions, the Lorillard Tobacco Company, maker of Newports, said its marketing was directed at “all adult smokers,” although 51 percent of Newport buyers are blacks.

In Montebello, a tough section of northeast Baltimore, Newports are shared, sometimes for cash by people trying to recoup the cost of a pack.

“Everybody here smokes who can afford it,” said Eddie Johnson, 54, who broke a heroin addiction during a recent jail stay and is now training to be a drug counselor. Mr. Johnson said he smoked 10 to 20 cigarettes a day.

Scientists have not found that menthol cigarettes per se are more dangerous, but they say that menthol may make it easier to start smoking and harder to quit, and that it intensifies the effect of nicotine.

A resident of the Montebello alleys, Antonio Stokes, 39, who was vague about how he made money, agreed. Of the Newport he bummed off a friend the other evening, he said: “It’s worse than crack. They should have a detox center for these things, too.”

F.D.A. Panel Urges Ban on Medicine for Child Colds

October 20, 2007 on 3:22 pm | In Uncategorized | Comments Off

SILVER SPRING, Md., Oct. 19 — A Food and Drug Administration advisory panel voted Friday to ban popular over-the-counter cold products intended for children under the age of 6.

The panel found there was no proof that the medicines eased cold symptoms in children, while there are rare reports that they have caused serious harm.

If put into practice, the ban could transform pharmacy shelves and change the way parents cope with the most common illness in young children. The vote comes a week after major manufacturers agreed to withdraw more than a dozen cold products labeled for use in infants and babies.

But manufacturers said they would fight the new recommendations.

“We believe these products will remain on the market,” said Linda Suydam, president of the Consumer Healthcare Products Association, a trade group.

A forced withdrawal might take years to carry out, top drug agency officials said.

“We need to go back and review all these recommendations that we heard today and decide what the path forward might be,” Dr. John Jenkins, director of the office of new drugs at the agency, said after the meeting.

If the agency decides to adopt the committee’s recommendation, it must undertake a rule-making process that can “take anywhere from one to many years,” Dr. Jenkins said.

While the panel voted, 21 to 1, to ban over-the-counter pediatric cold products for use in children under 2, its vote to ban them for 2- to 5-year-olds was 13 to 9. The F.D.A. usually follows the advice of its expert panels, but the closer the vote, the more likely the agency is to ignore it.

Dr. Joshua Sharfstein, Baltimore’s commissioner of health and a co-author of a petition that led to the F.D.A. review of the safety of the medicines, said drug makers and the agency should agree to a quick end to the marketing of cold medicines for children under 6.

“After the advisory committee’s clear vote, there is no justification for formulations of these products geared at toddlers or depicting small children,” Dr. Sharfstein said.

Whatever the outcome in the marketplace, the panel’s advice for parents was clear. They should not use over-the-counter cold medicines in young children.

Dr. Jenkins’s own advice to parents was less forceful. “Parents as always should carefully follow directions,” he said. “They should pay close attention to ingredients to make sure they don’t use the same ingredients from multiple products.”

The products under review include such common brand names as PediaCare, Robitussin and Triaminic, which are made, respectively by Johnson & Johnson, Wyeth and Novartis. Some of these products are directly marketed for toddlers and other children under 6.

Ms. Suydam told the panel that pediatric cold medicines were safe and effective, that many of the problems associated with the medicines came from unintentional overdoses and that an educational campaign could resolve most problems.

The panel largely rejected these arguments, voting overwhelmingly that there is no evidence that over-the-counter pediatric cold medicines have any effect on symptoms and that more studies must be done. Still, nine panel members voted against an outright ban in children ages 2 to 5, arguing that doctors and parents need something for ill children, even if it has no proven effect.

Amy J. Celento-Stamateris, a patient’s representative on the panel from Nutley, N. J., said she was worried that a ban would lead parents to give their children products intended for adults, increasing the risks of overdoses.

“I’m not going to name names among my acquaintances,” Ms. Celento-Stamateris said. “But people do use these medications to make their children get some sleep.”

But most panel members said that if the drugs had not proven to be effective in young children, they should not be available.

“Products for children under 2 were withdrawn from the market, and the world didn’t come to an end,” said Sean P. Hennessy, a panel member from the University of Pennsylvania School of Medicine. “Us saying that they should still be used in the absence of efficacy data knowing that they cause risks would be irresponsible.”

There are about 800 pediatric cold products sold in the United States that use one or more of 39 different drugs. Parents spend around $500 million every year buying nearly 95 million boxes containing 3.8 billion doses of medicine.

The panel voted, 15 to 7, to allow the continued marketing of medicines intended for children 6 and older. It voted unanimously to require standard measuring devices across products to cut down on accidental overdoses.

“You can take a cup from one item and place it on a totally different drug without the family recognizing it,” said Michael R. Cohen, a panel member and president of the Institute for Safe Medication Practices in Huntington Valley, Pa.

The panel also voted that no product should be allowed to market itself as “doctor recommended,” a common pitch that many panelists called misleading.

The American College of Chest Physicians recommends that these products not be used in children. Dr. David I. Bromberg, a district vice president for the American Academy of Pediatrics, told the panel that his organization believed that the product labels should warn parents that they were ineffective and, in rare instances, dangerous in children under 6.

“The current labeling of these products is therefore inaccurate, inadequate and dangerous,” Dr. Bromberg said.

Pediatric cold medicines were approved in the early 1970s despite almost no evidence that they worked because regulators assumed then that drugs that worked in adults would also be helpful in children. Since then, researchers have learned that adults and children can react to medicines very differently.

Ms. Suydam said manufacturers would immediately begin studies of the medicines, nearly all of which lost patent protection decades ago. Any money that companies spend on studying unpatented drugs also benefits competitors that spend nothing.

Daniel A. Mannello of Largo, Fla., told the committee that the pediatrician for his son, Dennis, suggested that he be given Dimetapp as an infant and that the medicine caused scarring in the boy’s brain that has led to chronic seizures. Dennis, now 9, is facing brain surgery to relieve the debilitating condition. Dimetapp has since been reformulated.

“Please do the right thing and remove these drugs from the shelves immediately,” Mr. Mannello said.

Dr. Geoffrey L. Rosenthal, a panel member who works at the Pediatric and Congenital Heart Center at the Cleveland Clinic Children’s Hospital, said pediatric cold medicines could be particularly dangerous for children with unrecognized congenital heart problems.

“In my pediatric cardiology practice, we uniformly suggest that patients avoid these medications,” Dr. Rosenthal said.

Health Plan Used by U.S. Is Debated as a Model

October 20, 2007 on 6:56 am | In Uncategorized | Comments Off

It makes for a compelling stump speech. And the leading Democratic candidates for president are all saying pretty much the same thing: adapt the health care program that covers Congress and offer it to the 47 million Americans currently without insurance.

“The American people should have access to the same array of health care choices and benefits as the senators and representatives they elect,” Senator Hillary Rodham Clinton said as she introduced her health care plan last month.

Mrs. Clinton’s main rivals for the Democratic nomination, Senator Barack Obama and former Senator John Edwards, have made similar proposals to expand the Federal Employees Health Benefits Program.

The program gives members of Congress, along with about four million other active and retired government workers, a wide array of private insurance offerings with fairly generous benefits. But if this would be health care reform, it is reform with a small “r,” according to many nonpartisan experts.

While health policy experts acknowledge that the federal employees’ program could be a workable way to reach some of the uninsured, they also say there is nothing about it that would help address what they see as an underlying reason for the growing numbers of uninsured: the nation’s runaway medical costs. And without major changes, they say, the model would be sharply limited in achieving the goal of universal coverage for all Americans.

“It would be a very expensive system that would not necessarily be on the cutting edge,” said Peter V. Lee, the chief executive of the Pacific Business Group on Health, a California group of employers that offer insurance to their workers.

“You don’t control costs by being big,” Mr. Lee said. True health reform is not a matter of simply covering more people, he said. Instead, it would require more fundamental changes in how care is delivered, he said, like making sure every diabetic gets the appropriate treatment.

To begin with, not everyone makes the $165,000 a year or so that members of Congress do. In fact, at least 100,000 federal workers — at least 5 percent of the active work force — do not have health insurance. In many cases, according to the union that represents the workers, they consider even the cheapest options within the federal plan unaffordable. The lowest-priced family coverage offered by Blue Cross, for example, costs the employee about $2,400 a year.

And despite the program’s federal imprimatur, the government currently plays only a limited role, preferring to let commercial insurers take the lead. Under an expansion of the program, the government’s main contribution might be the billions of dollars in subsidies necessary to pay for additional coverage.

“This is a private-based solution, with all of its foibles,” said Jonathan Gruber, a professor of economics at Massachusetts Institute of Technology who is advising various Democrats about the federal program as a possible model. It would probably have higher administrative costs and pose more of a risk of private insurers trying to enroll only the healthiest people, Mr. Gruber said, than if the government were to provide the insurance directly.

But a market-based solution is much more palatable politically than a government-run program, he said. Any government-run program proposed by a Democratic presidential candidate might be quickly tarred by conservatives as “socialized medicine.”

Still, for all its limitations, policy experts say, using a model like the federal employees system would probably give many people better and more affordable insurance than they could find on their own. While many individuals currently cannot get coverage because of their medical status, under the Democrats’ proposals insurers would not be allowed to turn anyone down.

“It’s a good option for the individual, the self-employed and small business,” said Karen Davis, the president of the Commonwealth Fund, a nonprofit group in New York that specializes in health care policy issues. Individuals and small businesses would benefit from the creation of large insurance pools in which the risks of paying for expensive medical care could be spread over a large population of both the sick and the healthy, she said.

Under the program, the government negotiates with insurers to offer its employees a wide range of health plans. While there is no set benefits package, the government has the final say over whether the coverage is adequate and priced fairly. In most cases, the insurers are limited in how much profit they can make under the program; anything above those amounts is put in reserves used to keep average premium increases lower than they would otherwise be.

As with a big employer like General Electric or Intel, the government relies on Blue Cross and other brand-name insurers to handle claims and determine how much to pay hospitals and doctors.

And the officials running the federal program emphasize that theirs is not a government-run plan like Medicare, in which the government is the main buyer of health care and can effect broad changes in public health.

“We want to behave like another employer — that’s by design,” said Nancy H. Kichak, associate director at the United States Office of Personnel Management, which oversees the program. “We’re not in the public health arena.” The program is as innovative as those typically offered by corporations, she said.

Neera Tanden, the policy director for Mrs. Clinton’s campaign, acknowledges that adapting the federal employees’ program would not be a cure-all for the nation’s health care system. She stressed that the proposal was only one of several aimed at overhauling health care. Others, she said, included offering people younger than 65 a Medicare-like option in addition to private insurance plans. Mrs. Clinton’s plan would also require insurers to cover more preventive medical care.

The idea of using the federal plan as a model for the larger population is hardly new, having been floated periodically for well over a decade by politicians from both parties.

While the Democrats have latched onto it this season, what they describe is not much different from what Mitt Romney championed when he was the Republican governor of Massachusetts. That state now oversees an insurance exchange of offerings from private insurers meant to give individuals affordable coverage.

Mr. Romney, now a Republican presidential candidate, has said he does not favor the same federal approach the Democratic candidates are proposing. He prefers to let the states experiment with different ways of expanding coverage, Mr. Romney has said, because the states have different needs.

To achieve universal coverage, both Mrs. Clinton and Mr. Edwards would borrow from the Massachusetts model by making it mandatory for each person to have health insurance and then providing government subsidies to ensure that everyone can afford it. Affordability is already a challenge for some federal employees, who pay about a quarter of the cost of their coverage and sometimes much more. And in at least one case, for a Vermont plan offered by MVP Health Care, a regional insurer in Schenectady, N.Y., the employee premium is $12,400 a year for family coverage.

Timothy Byrnes, a union local president with the Army Corps of Engineers in Buffalo, says the premium deducted from his paycheck in 2008 will nearly double from two years ago. He will now pay about $360 a month — more than $4,200 a year — for family coverage from Univera Healthcare, an insurer in Buffalo.

Not all his union local’s members can afford coverage, Mr. Byrnes said, recalling that one member told him, “ ‘I’m making choices between medicine and gas.’ ”

In order to make insurance affordable to a greater number of the 47 million who currently have none, experts say, the coverage might have to be much more limited than even the most basic federal employees option, and be designed to protect mainly against catastrophically high doctor or hospital bills.

“You don’t want to take them from nothing to a Cadillac,” said Professor Gruber, who noted that affordability was a vital component of the Massachusetts plan, which he helped develop. The lowest-priced options in that state are as much as one-third cheaper than what is currently available through the federal employees’ program, he said.

To make the federal employee system work on a national scale, the government would almost certainly have to tweak it significantly.

One major concern would be preventing any federal program from becoming a dumping ground for states and corporate employers intent on getting the oldest and sickest people off their insurance rolls. Such protection might require changing the existing rules, which now let insurers refuse to cover certain people, like those with pre-existing heart conditions.

And expanding the federal program to cover about six times the number enrolled in it now — currently about eight million, including dependents — would probably require setting up a new federal administrative apparatus.

After all the adjustments, the end result is likely to be something very different from the current program for members of Congress and other federal workers, according to Mark Merlis, a health policy consultant who has analyzed the program. Because the expanded program would play such a big role in the insurance market, it would probably become less flexible and require greater regulation than it does now, he said.

“What you would have is not the Federal Employees Health Benefits Program,” Mr. Merlis said.

Mothers Split Over a Ban on Children’s Cold Medicine

October 20, 2007 on 6:42 am | In Uncategorized | Comments Off

Mothers reacted yesterday with confusion, irritation and some touches of defiance as a Food and Drug Administration advisory panel voted for a ban on cold medicines for young children.

“I’d say I’m upset,” said Jennifer Lenn, a graphic designer with two sons, 5 and 2. “They were handy. They helped me a lot. The doctors tell you to steam the kids, use a humidifier, put them near a hot shower. But those just don’t work the way the medicines do.”

At the same time, Ms. Lenn said, she will not consider dosing her children, even though she had given her younger boy the infant versions with no ill effects.

“I’ll follow the rules,” she said. “I’d be too worried not to.”

Joanna Frank, a real-estate developer in Brooklyn with a 6-year-old son and a 4-year-old daughter, felt differently.

“Oh, I’ll probably ignore it,” Ms. Frank said, speaking over the cacophony of a four-children-in-a-brownstone play date that sounded more like New Year’s Eve on Times Square. “It’s miserable if they can’t sleep. So I’m afraid I’d use it, regardless. But sparingly. And if they were babies, I’d hesitate.”

Ms. Frank said that she had discussed the proposed ban with two other mothers over lunch at her office and that “we were kind of mad at the F.D.A.”

The medicines have been in use for a long time, she noted, “so why do they always come out with this stuff years after?”

On urbanbaby.com, a Web site for new parents that appears to attract mothers with more disposable income and throwaway lines than disposable diapers, the discussion flew back and forth between the desperate and the facetious.

“Now what do I do in the middle of the night when they need that stuff???” one mother wrote.

The most judicious response advised: “Disaggregate the symptoms. Like folks did before there were multi-symptom cold medicines: vaporizer for stuffy nose, pain reliever for fever.”

A second, terser, landed two minutes later saying, “Stock up now.”

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