Analysis Deaths from drug reactions up
Tue, 11 Sep 2007 20:01:38 GMTBy LINDSEY TANNER, AP Medical Writer
CHICAGO - Reports of dangerous side effects and deaths from widely used medicines almost tripled between 1998 and 2005, an analysis of U.S. drug data found.
The number of deaths and serious injuries from prescription and over-the-counter drugs climbed from 34,966 to 89,842 during the study of reports to the Food and Drug Administration.
Potent narcotic painkillers including Oxycontin, sold generically as oxycodone, were among 15 drugs most often linked with deaths in the study. Drugs frequently linked with serious nonfatal complications included insulin, the arthritis drugs Vioxx and Remicade, and the antidepressant Paxil.
The report adds to recent criticism of FDA oversight on drug safety, including its handling of serious problems connected with Vioxx, which was removed from the market in 2004.
"This growing toll of serious injury shows that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes," the authors said.
The analysis appears in this week's issue of Archives of Internal Medicine. Its authors are Thomas Moore and Michael Cohen of the Institute for Safe Medication Practices, a nonprofit educational group that analyzes drug safety issues; and Dr. Curt Furberg of Wake Forest University School of Medicine.
They analyzed excerpts of reports on serious side effects received by the FDA between January 1998 and December 2005. A total of 467,809 serious complications were found. Reported deaths nearly tripled, rising from 5,519 to 15,107.
A disproportionate number of complications occurred in elderly patients. Women were more often victims than men, 55.5 percent compared to 45.5 percent. Children were involved in 7.4 percent of the problems.
The FDA issued a statement saying it is aware of the growing number of reported problems and takes them seriously, but the reason for the increase "is not completely known."
"While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase, such as the increase in public attention to drug safety, and use of the Internet to make it easier for the public to submit," Dr. Gerald Dal Pan of the FDA's surveillance and epidemiology office said in the statement.
Sen. Charles Grassley, an Iowa Republican and frequent FDA critic, said the report is another indication that the FDA's review of drugs already on the market "must be rigorous and timely."
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On the Net:
Archives: http://www.archinternmed.com
Tue, 11 Sep 2007 20:16:29 GMT
By LARRY NEUMEISTER, Associated Press Writer
NEW YORK - A judge struck down a New York City rule Tuesday that required fast-food restaurants to post calorie counts on their menus.
U.S. District Judge Richard J. Holwell said he determined the rule conflicted with federal law. Businesses had claimed that their First Amendment rights were violated by the rule, described as the first of its kind in the nation, but Howell said he reached his decision without needing to address those claims.
The city had targeted national fast-food chains by applying the law only to those that served standardized portion sizes and that were already making calorie information available voluntarily as of March 1.
Howell said that conflicted with federal regulations because the rule wasn't mandatory for all restaurants. Federal regulations already advise restaurants how to post the information voluntarily.
The city law office did not immediately comment on how it would respond.
The New York State Restaurant Association had challenged the rule. On the other side, the National League of Cities, the National Association of County & City Health Officials, the International Municipal Lawyers Association and the League of California Cities supported the city, saying the new rule was necessary to fight obesity.
In the last 25 years, obesity rates have doubled among U.S. adults and tripled among children, and rates have increased in every state in the nation, the groups said.
The Centers for Disease Control and Prevention estimated in a 2005 study that approximately 112,000 deaths are associated with obesity each year, making obesity the second leading contributor to premature death, behind tobacco.
In arguments supporting the city's rule, the groups argued that an adverse ruling would undermine pending legislation in state and local legislatures around the country.
Legislation similar to New York City's is under way in 14 states where obesity rates have recently surged — Arizona, California, Connecticut, Hawaii, Illinois, Maine, Massachusetts, Michigan, New Jersey, New Mexico, New York, Pennsylvania, Tennessee and Vermont.
Nutrition labeling legislation has also been introduced in Chicago, Philadelphia and Washington.
New York City's rule took effect in July, but enforcement was suspended pending the outcome of the court fight.
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On the Net:
New York State Restaurant Association: http://www.nysra.org
Centers for Disease Control and Prevention: http://www.cdc.gov
Utah extends pool ban to battle parasite
Tue, 11 Sep 2007 21:06:37 GMTSALT LAKE CITY - After more than 1,300 illnesses, health officials Tuesday extended a ban on toddlers in public swimming pools to try to stop cryptosporidium, a parasite that can cause severe diarrhea.
The ban on kids under 5 and anyone in diapers will remain through Sept. 25 at pools at parks, schools, apartments, hotels and amusement parks.
Since Aug. 28, when restrictions were first announced, cases continue to be reported in "substantial numbers," the Utah Department of Health said.
"Public-health officials have been unable to determine whether the restrictions have been effective in controlling the outbreak," the department said.
Crypto is found in soil, food, water or surfaces that have been contaminated with human or animal feces. Diapers in a swimming pool are a common way to spread it, but they are not the only way.
"If you have a family member who is sick, it's important to practice good hygiene so the illness is not spread from person to person," said Ilene Risk, a manager at the Salt Lake Valley Health Department.
Utah typically sees about 30 cases of crypto a year. So far this year: 1,302.
There have been 492 cases in Salt Lake County and 454 in Utah County, said Rich Lakin, state manager of disease investigation.
At least 39 people have been treated at hospitals, "but we don't know for how long," he said. "Most probably were dehydrated."
Cases have been reported around the state, but not all counties are adopting the pool restrictions.
There is no ban on kids under 5 at pools in Daggett, Duchesne, Uintah, Beaver, Garfield, Iron, Kane and Washington counties, said state health spokesman Tom Hudachko.
Drug may help lung cancer patients
Tue, 11 Sep 2007 16:31:46 GMTBy DAMIAN J. TROISE, AP Business Writer
NEW YORK - ImClone Systems Inc. and Bristol-Myers Squibb Co. claimed Tuesday that the drug Erbitux improved the survival rate of patients with the most common type of lung cancer in a late-stage study. ImClone shares jumped 21 percent.
The drug, already approved to treat colon cancer and head and neck cancer, was given to patients with advanced, non-small cell lung cancer in combination with chemotherapy treatment. The study compared the combination to chemotherapy alone.
The non-small cell type accounts for the overwhelming majority of cases of lung cancer, which is the leading cause of cancer-related death in men and women in the U.S., with 160,000 deaths estimated in 2007.
More detailed results of the study will be presented at a yet-to-be-disclosed medical conference.
Wall Street maintained a positive outlook for the company, with several analysts saying the new late-stage, or Phase III, Erbitux results were unexpected.
Shares of ImClone jumped $7.88 to $45.81 in Tuesday trading and reached a 52-week high of $47.22 earlier in the trading session.
"Phase III Erbitux data in front-line lung cancer are a clear positive," said Morgan Stanley analyst Steven Harr, upgrading the company's stock to "Equal Weight" from "Underweight" in a note to investors. He said the company's earnings could double over the next five years because of the these results.
Still, the drug would face competition from Genentech Inc.'s Avastin, said Citigroup analyst Dr. Yaron Werber.
And in July, ImClone said Erbitux failed a separate late-stage study focusing on lung cancer, in which Erbitux was combined with different chemotherapy drugs. The goal was for approval as an initial treatment for spreading non-small cell lung cancer. The company and Wall Street have since cited the study design for its failure.
"Given recent disappointing data, we do not believe that Erbitux will unseat Genentech's Avastin in this setting," Werber wrote, reaffirming a "Hold" rating, but raising Erbitux sales estimates for 2008 to 2010.
Erbitux is co-promoted in North America with Bristol-Myers.
In August, ImClone named former Johnson & Johnson executive John H. Johnson as its new chief executive. The position had been open since last year, when Carl Icahn won control of the company and became chairman of the board.
Higher gasoline price seen trimming down Americans
Tue, 11 Sep 2007 20:43:18 GMTNEW YORK - Higher U.S. gasoline prices may slim more than just wallets, according to a new study from Washington University in St. Louis.
Entitled &;A Silver Lining? The Connection between Gas Prices and Obesity,&; the study found that an additional $1 per gallon in real gasoline prices would reduce U.S. obesity by 15 percent after five years.
The report, written by Charles Courtemanche for his doctoral dissertation in health economics, found that the 13 percent rise in obesity between 1979 and 2004 can be attributed to falling pump prices.
Gasoline hit a low of less than $1.50 per gallon in 2000 before moving back to a record high of $3.22 in May 2007.
Higher gasoline prices can reduce obesity by leading people to walk or cycle instead of drive and eat leaner at home instead of rich food at restaurants.
Courtemanche said he became interested in the link after rising gasoline prices made him think about eschewing his car for public transport.
&;I was pumping gas one day, thinking with gas prices so high I may have to take the Metro,&; he said, referring to the public transportation system serving the St. Louis area.
Courtemanche said he figured he would get an extra 30 minutes of exercise per day by walking to and from the Metro station.
Obesity, defined as having a body mass index greater than 30, has been considered to factor in as many as 112,000 deaths annually.
U.S. health costs related to obesity are estimated at $117 billion per year as studies sponsored by the U.S. government have linked it with high blood pressure, diabetes, heart disease and stroke.
Cialis boosts sex after spinal cord injuries study
Mon, 10 Sep 2007 20:40:46 GMTCHICAGO - The impotence pill Cialis appears to work even in men with spinal cord injuries, French researchers said on Monday.
Impotence often follows spinal cord injuries. Only about 25 percent of men with such injuries are capable of having sex, Dr. Francois Giuliano and colleagues at the Raymond Poincare Hospital in Garches, France said.
They found that Cialis tripled the number of times the men could have sex.
Their study, funded by Eli Lilly and Co, maker of tadalafil or Cialis, involved 197 men with an average age of 38 in France, Germany, Italy and Spain with spinal cord injuries.
After a one-month waiting period, in which no one got treatment, a questionnaire to assess sexual function found both groups had moderate erectile dysfunction, Giuliano's team reported in the Archives of Neurology.
Then 142 men were assigned to the Cialis group and 44 got a placebo for a 12-week period, taking no more than one pill daily as needed before sexual activity.
After 4 months, men taking Cialis were successful nearly half the time they attempted intercourse, while men in the placebo group succeeded only 16.8 percent of the time.
Cialis and similar drugs work by increasing blood flow to the genitals.
The researchers said the Cialis study achieved success similar to that found in studies of Pfizer Inc.'s Viagra or sildenafil and Glaxosmithkline Plc's Levitra or vardenafil, all of which improved erections in men with impotence after spinal cord injury.
Older Americans dump drugs when payments stop study
Tue, 11 Sep 2007 21:14:45 GMTWASHINGTON - Some elderly Americans simply stop taking their prescribed drugs when insurance plans cease paying for them, U.S. researchers reported on Tuesday.
And when the benefits reset at the beginning of a new year, many fail to resume taking their drugs, the team at the nonprofit Rand Corporation found.
The findings suggest the same may happen when patients enrolled in Medicare's new &;part D&; prescription plan hit gaps in coverage popularly known as the doughnut hole, they said.
&;Prescription use falls significantly as patients reach their benefit caps,&; said Geoffrey Joyce, a health economist who led the study at the research organization.
&;Most of the drugs we studied help prevent long-term complications of chronic disease so there are likely to be adverse health consequences for seniors who hit their caps.&;
Joyce and colleagues studied 60,000 retirees enrolled in a private health plan offered by a large national employer in 2003 to 2005. They had a choice of two drug plans that offered annual drug benefit caps of $1,000 or $2,500 and a third that had no spending limit. Participants had a co-pay in each of the plans.
Between 6 percent to 13 percent of the patients enrolled in drug plans with caps reached their spending limits in each of the years studied, with about half going uncovered for more than 90 days.
They were more likely to forgo prescription drugs than those in plans with no cap, the researchers reported in the journal Health Affairs.
This ranged from 15 percent of people taking cholesterol-lowering drugs to 28 percent of people on heart drugs.
To the surprise of the researchers, few of the patients switched to cheaper generic drugs.
&;Given the importance of these drugs, it's distressing that the resumption rates are not higher,&; said Dana Goldman, director of health economics at Rand.
&;Drug caps are a cost-saving measure, but our findings raise the issue of whether in the long run they may lead to other medical costs such as increased hospitalizations.&;
Lowfat vegetarian diet may stall prostate cancer
Tue, 11 Sep 2007 20:39:52 GMTNEW YORK - Low-fat, plant-based diets may help prevent or slow the progression of prostate cancer, according to a new research review.
A number of studies, though not all, have suggested that eating plenty of fruits and vegetables may help ward off prostate cancer, while &;Western&;-style diets heavy in animal fat and dairy products may increase a man's risk of developing the disease.
In the current study, researchers reviewed 25 previously published studies that examined the effects of plant-based diets on prostate cancer development or progression.
Overall, the evidence suggests that diets high in fiber, fruits and vegetables, and low in meat and dairy, can help battle the disease, they report in the journal Nutrition Reviews.
For example, several studies of men with prostate cancer have linked high saturated fat intake to faster disease progression and a higher risk of death. Saturated fat is found mainly in animal products.
In contrast, some small trials have found that a high-fiber, low-fat vegetarian diet may slow the growth and spread of early-stage prostate tumors. Some other studies have suggested that components of plant-based foods -- like certain antioxidants or soy isoflavones -- might be beneficial.
&;For men diagnosed with prostate cancer, the key to improving the odds of survival is avoiding high-fat fare and instead choosing fruits, vegetables, beans and other cancer-fighting vegetarian foods,&; lead study author Dr. Susan Berkow said in a statement.
Berkow is with George Mason University in Alexandria, Virginia, and serves as a consultant to Physicians Committee for Responsible Medicine, a group that advocates vegetarian and vegan diets.
Berkow and her colleagues speculate that the fiber and other nutrients found in plant-based diets may affect prostate cancer by altering levels of certain hormones that can feed tumor development, including testosterone and insulin.
The balance of fats in a man's diet may also be key, the researchers point out. Some studies have found that omega-3 fatty acids may help stall prostate cancer progression. Omega-3 fats are found largely in oily fish, but also in some vegetable sources, like flaxseeds and canola oil.
SOURCE: Nutrition Reviews, September 2007.
