Doctors aim to loosen anemia drug limits
Fri, 31 Aug 2007 20:46:46 GMTBy MATTHEW PERRONE, AP Business Writer
WASHINGTON - Cancer doctors seek to loosen federal restrictions on anemia drugs that carry potentially deadly side effects, saying the tight payment guidelines for treatments made by Amgen and Johnson and Johnson are ultimately bad for patients.
The American Society of Clinical Oncology says guidelines issued last month by the Medicare program interfere with physicians' ability to treat patients with the blood disorder anemia, which causes weakness and shortness of breath.
The rules state that doctors will only be reimbursed if they use low levels of the drugs, which the government believes could reduce the risks of death and heart trauma that emerged earlier this year.
Physicians use Amgen's Aranesp and Johnson and Johnson's Procrit to raise patients' red blood cell levels.
"Some of our members are being forced to turn away patients who received these drugs under the old rules, but can't under the new rules," said Dr. Joseph Bailes, the group's chief of government relations.
The society sent a letter to the Centers for Medicare and Medicaid Services Thursday, asking them to suspend the payment policy. The agency, which provides health care to 80 million Americans, reimburses doctors for administering anemia drugs, which are usually injected at doctors' offices.
Safety concerns about anemia treatments have pummeled Amgen's stock price this year, contributing to a 24 percent decline since March. Earlier this month the Thousand Oaks-based, Calif. company said it would lay off 2,600 employees to offset weak sales of Aranesp, which fell 10 percent in the last quarter.
Aranesp was the company's best-selling drug last year with $4.1 billion in sales, or nearly a third of total revenue.
Johnson & Johnson recorded $3.2 billion in Procrit sales last year, though the company is less dependent on the drug because of its size and diversification.
Medicare changed the drugs' reimbursement guidelines after federal health regulators added warnings to their labels in March, cautioning that using too much can increase risk of blood clots, heart attack and death.
Doctors can only be reimbursed under the new policy if they keep a patient's hemoglobin level, a measure of red blood cells, at or below 10 grams per deciliter. Under the old policy doctors could raise hemoglobin levels up to 12 grams per deciliter.
In its letter to the government, the society argues there is no scientific evidence that the reduced dosing policy is safer for patients. The group also points out that the current labeling approved by the Food and Drug Administration says the drugs are safe up to the higher 12 gram per deciliter threshold.
While FDA is considering revising that labeling, a panel of outside advisers in May recommended against lowering the drugs' dosing regimens. FDA does not have to follow the panel's advise, though it usually does.
The society, which represents about 25,000 physicians, argues CMS should wait until FDA wraps up its review before making new guidelines permanent.
Medicare officials did not immediately return calls seeking comment for this story. The agency generally does not revise rules after they are put in place, though it continues to take public comments.
The American Society of Hematology, which represents blood disease specialists, said Friday it would submit a similar request to Medicare next week.
Shares of Amgen Inc. fell 8 cents to $50 Friday. Johnson & Johnson shares rose 19 cents to $61.79.
More may be offered lung cancer surgery
Fri, 31 Aug 2007 17:31:57 GMTBy MARILYNN MARCHIONE, AP Medical Writer
Thousands more lung cancer patients each year could be offered surgery or other aggressive therapy under a new system that classifies many tumors as more treatable than in the past.
It is the first big overhaul of a decades-old method used to predict survival and help determine whether a lung cancer patient will have surgery, chemotherapy or be treated at all.
The new guidance is to be presented at a conference of lung cancer specialists in Seoul, South Korea, that starts Saturday. It is expected to be adopted by policy-making groups in the next year.
Lung cancer is the world's top cancer killer, claiming 1.3 million lives each year. In the United States, 213,380 new cases and 160,390 deaths from the disease are expected this year.
Nearly 60 percent of people die within one year of diagnosis, and nearly 75 percent die within two years, American Cancer Society statistics show.
In treating it, doctors use a formula called tumor staging. It is based on a tumor's size, how far it has spread and other factors to predict a patient's survival odds and to guide treatment.
The current system was developed from about 5,000 tumor samples from University of Texas M.D. Anderson Cancer Center in Houston decades ago — before improved scanning technology was available to evaluate a cancer's spread.
The new plan is based on 100,000 tumor samples from around the world including Asia, where lung cancer rates are projected to climb because of trends in smoking, unhealthy lifestyles and aging populations.
It keeps four broad groupings but sorts people more precisely based on refined understanding of tumor characteristics.
The result: "There will clearly be shifting of patients from categories not operable to operable" — as many as 10,000 a year in the United States, said Dr. David Johnson, a lung cancer specialist at Vanderbilt University in Nashville, Tenn. He reviewed the plan, which was partly published in a medical journal recently.
The stage of the tumor at diagnosis is the best predictor of survival. Only 20 percent of cases are diagnosed in Stages 1 or 2, when tumors are small and confined to a lung, Johnson said. About 30 percent to 40 percent are found in Stage 4, after they have widely spread. The rest are in the middle.
Five-year survival rates are 47 percent for Stage 1 and 26 percent for Stage 2, but only 8 percent for Stage 3, and 2 percent for Stage 4, according to the American College of Surgeons.
Most lung cancers are the type called "non-small cell," which is covered by the new staging system. The system was developed by the International Association for the Study of Lung Cancer, a group of lung cancer specialists from around the world.
Dr. Peter Goldstraw, a surgeon at the Royal Brompton Hospital in London, led the project, and Canadian scientists independently validated the recommended changes by comparing survival across geographic regions.
Among the changes: creating more sub-stages for tumor size, reassigning some large tumors to a more advanced stage, reclassifying tumors that have spread into the fluid surrounding the lung, and recognizing that spread to certain lymph nodes is more dangerous than its spread to others.
"By changing some of these groupings, some patients will get moved to an earlier stage of disease for which we tend to be more aggressive" in treatment, said Dr. Joan Schiller, a lung cancer specialist at the University of Texas Southwestern Medical Center in Dallas.
"Before, a patient may have only been offered chemotherapy. They may now be offered chemotherapy and radiation," or more intense radiation, she said.
Conversely, some people thought to have earlier-stage tumors now will be grouped with those whose tumors have widely spread, and discouraged from undergoing therapies that have little chance of helping them.
"In some cases, patients were getting inappropriately aggressive treatment," Schiller said.
Some people with very small tumors may get away with less therapy — taking out just a segment of lung instead of an entire lobe, said Dr. Stephen Swisher, a chest surgeon at M.D. Anderson.
The impact of the changes in Europe and Japan is unclear because doctors in those countries tend to remove whole lungs rather than lobes to treat lung cancer, Johnson noted.
Doctors hope that ultimately survival will improve, but that won't happen "unless we get patients into the right hands" and they get correct treatment, Johnson said.
Revising the staging system also will do little good if doctors don't do the right tests to properly stage a tumor, said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.
Staging for lung and other types of cancer should become even more precise in the near future as biomarkers and gene tests are developed to better sort patients, he added.
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On the Net:
American Cancer Society: http://www.cancer.org
National Cancer Institute: http://www.cancer.gov/cancertopics/types/lung
Cancer staging explanation: http://tinyurl.com/2np8um
N.Zealand eyes labels to fight obesity
Fri, 31 Aug 2007 09:45:22 GMTWELLINGTON, New Zealand - The government should impose "traffic light" labeling to warn consumers about obesity-causing food and drink products if New Zealand companies won't do it voluntarily, a parliamentary committee said Friday.
After a 10-month inquiry, a majority of lawmakers on Parliament's health select committee recommended a system of red, yellow and green labels to indicate the levels of fat, salt and sugar in products. The committee also recommended guidelines for food-related advertising.
More than half of New Zealand's 4 million people are either overweight or obese, including more than 30 percent of children, according to Health Ministry figures.
The red label — to be used for food such as cakes, pies and chocolates — would warn that the products should only be consumed occasionally. Yellow-labeled foods such as pizza should be eaten "sometimes," while green-labeled products such as low-fat yogurt could be eaten daily.
The committee warned that obesity threatened to overwhelm the health system.
"Tackling the obesity epidemic in New Zealand is imperative," the committee said. "Comprehensive, coordinated action by the government is needed."
The committee also wants targets set for advertising, marketing and promotion of food and drink, saying there needs to be the threat of regulation if voluntary measures don't work.
It recommended a ban on television advertising of "energy dense" food before 8:30 p.m. each night — when younger people are supposed to stop watching.
The Obesity Action Coalition said simply appealing to the food, drink and advertising industries to help fight obesity would not work.
"The time for asking the industry nicely is over," coalition director Leigh Sturgiss said. "We need a ban on the marketing of unhealthy food and drinks to children."
Spinach recall sparks oversight calls
Fri, 31 Aug 2007 07:50:01 GMTBy GARANCE BURKE, Associated Press Writer
FRESNO, Calif. - Consumer advocates and some lawmakers say that a Salinas Valley company's recall of spinach because of a salmonella scare shows that the federal government must do more to protect the nation's food supply, but industry officials call it proof that their voluntary regulations are working.
Metz Fresh, a King City-based grower and shipper, recalled 8,000 cartons of fresh spinach Wednesday after salmonella was found during a routine test of spinach it was processing for shipment. More than 90 percent of the possibly contaminated cartons never reached stores, company spokesman Greg Larson said.
California's leafy greens industry adopted the voluntary regulations last year after a fatal E. coli outbreak, but advocates said a national, mandatory inspection and testing program overseen by the U.S. Food and Drug Administration is needed.
"Eight thousand cartons left the plant for distribution in the U.S. That's 8,000 too many," said Jean Halloran, a food safety expert with Consumers Union. "At this point, we are relying on the leafy green industry to police itself."
Some growers said Metz Fresh's ability to catch the bacteria showed that the new testing regimes are working. No illnesses have been reported from eating spinach linked to the company.
"I think the test of the industry is how we react to these types of situations," said grower Joseph Pezzini, who heads the board that administers the new produce safety rules. "No one was harmed by the product and that's important."
Larsen said the recalled spinach, which was picked Aug. 22, had tested negative in earlier field and production tests. Metz Fresh began telling stores and restaurants on Aug. 24 not to sell or serve the lettuce after a first round of tests came up positive.
"The first thing we are looking at right now is making sure this product, as much as possible, is under our control," he said. "The next step is to back up and take a hard look at how this happened."
Metz Fresh has complied with the California Leafy Green Products Handler Marketing Agreement, a set of voluntary food safety rules drafted after last year's E. coli outbreak in fresh spinach killed three people and sickened 200. By joining the program, participants also agree to have their fields and plants checked for compliance.
In two separate plant and field visits earlier this month, California auditors found no signs of danger at Metz Fresh, said Scott Horsfall, who oversees the industry-sponsored program.
"I'm not trying to put a pretty face on it, but the overall system is working very well," Horsfall said. "Consumers can have a high degree of confidence in this product, notwithstanding this recent problem."
But some legislators said the latest recall showed the FDA had yet to improve a patchwork produce safety system critics believe is vastly understaffed and poorly monitored.
"This in no way should be seen as a success story," said state Sen. Dean Florez, who chairs a committee on food-borne illnesses. He said that Metz Fresh should have caught the salmonella before any of its spinach reached consumers, and that he has written the state's agriculture secretary demanding answers about "this breakdown in California's food safety system."
U.S. Sen. Tom Harkin, D-Iowa, is crafting legislation that would set up national food safety practices for growing and processing fresh produce that run the highest risk of causing food-borne illnesses.
"This is a food safety concern for consumers who wonder if it is OK to serve this produce to their families, and it is an agricultural concern for growers who face another blow to sales of their product," said Harkin, who chairs the Senate Committee on Agriculture, Nutrition and Forestry. "It is long overdue for the FDA to exercise more oversight of food safety practices."
FDA and state public health officials said Thursday they were investigating the company's records, tests and products.
The recall covers 10- and 16-ounce bags, as well as 4-pound cartons and cartons that contain four, 2.5-pound bags, with the following tracking codes: 12208114, 12208214 and 12208314.
The California Department of Public Health and the Food And Drug Administration are investigating the Metz Fresh processing facility in King City.
Salmonella sickens about 40,000 people a year in the U.S. and kills about 600.
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On the Net:
Metz Fresh LLC: http://www.metzfresh.com/
Chic postcode less obesity study
Wed, 29 Aug 2007 22:04:03 GMTWASHINGTON - People who live in chic neighborhoods with high property values are less likely to be obese than those who live in under-privileged areas, a study published Wednesday showed.
Researchers at the University of Washington broke new ground by grouping data gathered from 8,803 respondents by postcode.
Seventy-four postcodes in King County, in Washington state, were included in the study, which found that for every 100,000-dollar increase in the average house price, &;zip code area obesity&; fell by two percent.
Obesity rates reached 30 percent in the most deprived areas but were only around five percent in the most affluent postcodes, the study, which used property values as a proxy measure of a neighbourhood's socio-economic status, showed.
Earlier studies, using data gathered across a broader geographical spread, showed narrower disparities.
Data gathered across King County showed that the obesity rate among blacks was 10 percentage points higher than for whites, and that people with low annual incomes had a 20 percent obesity rate, compared with a 15 percent rate for those who earned more than 50,000 dollars.
&;Obesity is an economic issue,&; Adam Drewnowski, director of the university's center for obesity research and leader of the study, said in a statement.
&;Our research shows that geography, social class and economic standing all play huge roles in the obesity problem,&; Drewnowski said.
&;Some of the most disadvantaged areas -- those hardest hit by low income, low education and low property values -- are also the ones most affected by the obesity epidemic.&;
A report published earlier this week showed that obesity continued to creep upward in the United States last year, with two-thirds of adults and some 25 million children obese or overweight.
Poorer southern states were particularly affected by the epidemic, said the report by the Trust for America's Health.
