Foreign drugs receive little scrutiny
Wed, 31 Oct 2007 21:51:07 GMTBy ANDREW BRIDGES, Associated Press Writer
WASHINGTON - Government inspectors visit the foreign companies that make more and more of the drugs used in the United States just once every eight to 12 years on average, according to congressional investigators.
That's far less oversight than domestic producers face.
Prescription drugs and drug ingredients pour into the United States from an estimated 3,000 foreign companies, though the real number is unknown and could be as high as 6,700, the inspectors said in a memo to members of the House Energy and Commerce subcommittee on oversight and investigations The memo was released Wednesday.
The FDA plans to inspect just 300 of those thousands of firms this year, announcing in advance its intent to do so each time. Of those inspections, most are of plants that make drugs awaiting FDA approval. Just 15 are of the type of periodic assessment meant to ensure a company's products remain safe in the years following FDA approval, though some pre-approval inspections also include some post-approval surveillance.
Federal law requires the roughly 3,300 domestic drug manufacturers to be inspected, often unannounced, once every two years — something the FDA does come close to doing. There is no such legal requirement for foreign makers.
"Given the potential risk from foreign sources, this places an unacceptable risk on the public," said Rep. John Dingell, D-Mich., the committee's chairman.
That discrepancy, along with other issues surrounding the FDA's ability to monitor the safety and purity of imported drugs, will be the subject of a congressional hearing Thursday. Some manufacturers are already crying foul.
"If you're not being inspected, is there really a regulatory scheme at all? Foreign manufacturers are able to not have to worry about inspections and perhaps not follow the rules as they're supposed to — and domestic manufacturers want to play by the rules, have to play by the rules and are inspected to the rules," said Gregory Minchak, a spokesman for the Synthetic Organic Chemical Manufacturers Association, a trade group that has set up a task force to represent U.S. makers of active pharmaceutical ingredients. It estimates foreign manufactures are visited even less frequently, just once every 14 years on average.
An estimated 80 percent of the active pharmaceutical ingredients used to make drugs sold in the U.S. are imported. Among finished drugs, an estimated 40 percent are made abroad.
The FDA's serious problems in its ability to adequately police those imports have been known for years — the FDA itself noted as much in an internal report in 1988, and as did the Government Accountability Office a decade later.
FDA spokeswoman Julie Zawisza said the agency uses a risk-based approach to inspecting both domestic and foreign manufacturers, "with focus on those whose products could pose potential risk to consumers."
But congressional investigators say little over the last two decades has changed, except the FDA now devotes even fewer people and dollars to foreign inspections. The number of employees dedicated to the foreign inspection program is expected to fall to 102 by 2008, down from 149 in 2002. And next year, the program budget should be just shy of $16 million, or less than the $16.7 million spent in 2002, they found.
"They are in an indefensible position from a public health point of view but they have no real choice," said former FDA associate commissioner William Hubbard, citing the budgetary constraints faced by the agency. Hubbard has agitated for more money and inspectors at the agency and is among those expected to testify Thursday. Better technology also is needed, Hubbard said.
Congressional investigators, for example, report that the FDA maintains distinct databases covering imported drugs and their manufacturers. The import data contain largely invoice information and don't reflect how an imported drug was made, processed, packed or distributed.
"FDA has different and incompatible databases for tracking what drugs and drug ingredients are imported into the United States, what companies are certified to import drugs into the United States and which foreign drug producing firms have been inspected by the FDA," said Rep. Bart Stupak, D-Mich., chairman of the subcommittee holding Thursday's hearing.
Stupak said that system leaves the FDA unable to answer even basic questions about the source of foreign drug imports.
McCain clarifies health care plan
Wed, 31 Oct 2007 21:33:04 GMTBy LIZ SIDOTI, Associated Press Writer
WASHINGTON - John McCain clarified an element of his health care plan Wednesday, saying that employers who provide their workers coverage still would get tax breaks.
The Republican presidential candidate said that has been the case since he first announced his proposal three weeks ago, and he apologized for any confusion.
At the time, aides indicated that to help pay for the sweeping reforms, McCain would end a provision in the tax code that allows employers to deduct the cost of health care from their taxable earnings.
But on Wednesday, McCain told a health care forum sponsored by the Kaiser Family Foundation: "There's no reason for us to remove the employer tax incentive. I think that should stay exactly as it is."
Rather, he said his plan calls for getting rid of what he views as the bias toward employer-sponsored insurance by changing the code as it relates to individuals who have employer-sponsored insurance.
Afterward, McCain explained to reporters: "The employer tax deduction stays in place so the employer still has the incentive to provide health insurance to the employee, but the employee now loses the health tax incentive and it is replaced by the refundable tax credit."
He said that was the way his plan always has been, and added: "I'm sorry if there was any misunderstanding."
Under the plan, employees who have employer-provided health insurance would be taxed on the portion of their coverage that their employer pays. Aides say those costs would be offset by providing tax credits of $2,500 to individuals and $5,000 to families. They said low-income and middle-income people would benefit from the changes the most, while people in the top tax bracket and whose employers pay $15,000 or more of their health insurance costs would break even or pay higher taxes.
During the forum, McCain also defended his opposition to Democratic calls for requiring all people to carry insurance and the absence of a proposal for universal coverage in his plan, saying: "I don't think that there should be a mandate for every American to have health insurance."
Asked about his rivals' plans, McCain called those offered by Rudy Giuliani and Mitt Romney not as comprehensive or as oriented toward critical problems as his plan.
Iraq Afghan vets at risk of suicide
Wed, 31 Oct 2007 17:47:36 GMTBy KIMBERLY HEFLING, Associated Press Writer
WASHINGTON - Hundreds of troops have come home from war, left the military and committed suicide.
That is the finding of preliminary Veterans Affairs Department research obtained by The Associated Press that provides the first quantitative look at the suicide toll on today's combat veterans. The ongoing research reveals that at least 283 combat veterans who left the military between the start of the war in Afghanistan on Oct. 7, 2001, and the end of 2005 took their own lives.
The numbers, while not dramatically different from society as a whole, are reminiscent of the increased suicide risk among returning soldiers in the Vietnam era.
Today's homefront suicide tally is running at least double the number of troop suicides in the war zones as thousands of men and women return with disabling injuries and mental health disorders that put them at higher risk.
A total of 147 troops have killed themselves in Iraq and Afghanistan since the wars began, according to the Defense Manpower Data Center, which tracks casualties for the Pentagon.
Add the number of returning veterans and the finding is that at least 430 of the 1.5 million troops who have fought in the two wars have killed themselves over the past six years. And that doesn't include those who committed suicide after their combat tour ended and while still in the military — a number the Pentagon says it doesn't track.
That compares with at least 4,229 U.S. military deaths overall since the wars started — 3,842 in Iraq and 387 in and around Afghanistan.
In response, the VA is ramping up suicide prevention programs.
Research suggests that combat trauma increases the risk of suicide, according to the National Center for Post Traumatic Stress Disorder. Difficulty dealing with failed relationships, financial and legal troubles, and substance abuse also are risk factors among troops, said Cynthia O. Smith, a Pentagon spokeswoman.
Families see the effects first hand.
"None of them come back without being touched a little," said Mary Gallagher, a mother of three whose husband, Marine Gunnery Sgt. James Gallagher, took his own life in 2006 inside their home at Camp Pendleton, Calif.
He was proud of his Iraq service, but she wonders whether he was bothered by the death of his captain in Iraq or an incident in which he helped rescue a soldier who was in a fire and later died. Shortly before his death, her husband was distraught over an assignment change he saw as an insult, she said.
"His death contradicts the very person he was. It's very confusing and difficult to understand," said Gallagher of Lynbrook, N.Y.
The family of another Iraq veteran who committed suicide, Jeffrey Lucey, 23, of Belchertown, Mass., filed suit against the former VA secretary, alleging that bad care at the VA was to blame.
And the family of Joshua Omvig, a 22-year-old Iraq war veteran from Davenport, Iowa, who also committed suicide, successfully pushed Congress to pass a bill that President Bush is expected to sign that requires the VA to improve suicide prevention care.
Suicides in Iraq have occurred since the early days of the wars, but awareness was heightened when the Army said its suicide rate in 2006 rose to 17.3 per 100,000 troops — the highest level in 26 years of record-keeping.
That compares with 9.3 per 100,000 for all military services combined in 2006 and 11.1 per 100,000 for the general U.S. population in 2004, the latest year statistics were available. The Army has said the civilian rate for the same age and gender mix as in the Army is 19 to 20 per 100,000 people.
Just looking at the VA's early numbers, Dr. Ira Katz, the VA's deputy chief patient care service officer for mental health, said there does not appear to be an epidemic of suicides among those who served in Iraq and Afghanistan who left the military.
Katz said post-traumatic stress disorder, depression and problem drinking increase a person's suicide risk by two or three times, but the rate of suicide among those with such conditions "is still very, very low."
He acknowledged, however, that it is too early to know the long-term ramifications for those who served in the wars and said the VA "is very intensely involved in increasing suicide prevention."
"We're not doing it because there's an epidemic in returning veterans, though each death of a returning veteran is a tragedy and it's important to prevent it," Katz said.
The VA and Defense Department have hired more counselors and made other improvements in mental health care, including creation of a veterans suicide prevention hot line.
At the VA's national suicide hot line center based in Canandaigua, N.Y., counselors have taken more than 9,000 calls since July. Some callers are just looking for someone to talk to. Others are concerned family members. Callers who choose to give their names can opt to be met at a local VA center by a suicide prevention counselor; more than 120 callers have been rescued by emergency personnel — some after swallowing pills or with a gun nearby, according to the center.
"It's sad, but I think in the other way it's very exciting because already we've seen really sort of people being able to change their lives around because of the access to resources they've been able to get," said Jan Kemp, who oversees the call center.
Penny Coleman, whose ex-husband committed suicide after returning from Vietnam, said she doesn't buy what she calls the "we didn't expect this" mentality about suicide.
"If you'd chosen to pay attention after Vietnam you would have and should have anticipated it would happen again," said Coleman, who published a book on the subject last year.
One government study of Army veterans from Vietnam found they were more likely to die from suicide than other veterans in the first five years after leaving the military, although the study found the likelihood dissipated over time. There is still heated debate, however, over the total number of suicides by Vietnam veterans; the extent to which it continues even today is unknown.
One major hurdle in stopping suicide is getting people to ask for help. From 20 percent to 50 percent of active duty troops and reservists who returned from war reported psychological problems, relationship problems, depression and symptoms of stress reactions, but most report that they have not sought help, according to a report from a military mental health task force.
"It's only when it becomes painful will someone seek counseling," said Chris Ayres, manager of the combat stress recovery program at the Wounded Warrior Project, a private veterans' assistance group based in Jacksonville, Fla. "That's usually how it happens. Nobody just walks in, because it's the hardest thing for a male, a Marine, a type-A personality figure to just go in there and say, 'Hey, I need some help.'"
While not suicidal, Ayres, 37, a former Marine captain from the Houston area who had the back of his right leg blown off in Iraq, has experienced episodes related to his post-traumatic stress disorder and said he worried about being stigmatized if he got help.
He's since learned to manage through counseling, and he's encouraging other veterans to get help.
Ayres is among 28,000 Americans injured in the war, more than 3,000 seriously.
In a study published earlier this year, researchers at Portland State University in Oregon found veterans were twice as likely to commit suicide as male nonveterans. High gun ownership rates, along with debilitating injuries and mental health disorders, were all risk factors that seemed to put the veterans at greater risk, said Mark Kaplan, one of the researchers.
While veterans from Iraq and Afghanistan were not included in the study, Kaplan said that given the nature of the injuries of the recent wars and the strain of long and repeated deployments, the newer generation of veterans could be at risk for suicide.
Kaplan said primary care physicians should ask patients whether they are veterans, and if the answer is yes, inquire about their mental health.
"This is war unlike other wars and we don't know the long-term implications and the hidden injuries of war," Kaplan said.
Dr. Dan Blazer, a professor of psychiatry at Duke University Medical Center who served this year on the military's mental health task force, said improvements in care will likely help some veterans, but he's concerned about this generation. He said he treats World War II veterans still struggling mentally with their military experience.
"There's still going to be individuals that just totally slip through all of these safety nets that we construct to try to help things in the aftermath," Blazer said.
Suicide, Blazer said, "is a cost of war. It's a big one."
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On the Net: Veterans Affairs Department: http://www.va.gov/
Suicide Prevention Network USA: http://www.spanusa.org/
Wounded Warrior Project: http://www.woundedwarriorproject.org/
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The toll free Veterans Affairs Department suicide hot line number is 1-800-273-TALK .
Vitamin D may not reduce cancer deaths
Wed, 31 Oct 2007 21:51:24 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - A large new study found no sign that vitamin D lowers the overall risk of dying from cancer, injecting a note of caution to the latest vitamin craze. The exception: People with more vitamin D in their blood did have a significantly lower risk of death from colorectal cancer, supporting earlier findings.
Getting enough of the so-called sunshine vitamin — the skin makes it from ultraviolet rays — is vital for strong bones. But vitamin D has made headlines in recent years because of research saying it may be a powerful cancer fighter, sparking a push for people to get more than currently recommended amounts, either through diet or sun exposure.
The first-of-a-kind government study released Tuesday shows the issue is far from settled.
National Cancer Institute researchers analyzed vitamin D levels measured in almost 17,000 people as part of a national study that tracked their health. About a decade after enrolling, 536 of those people had died of cancer. Whether people had low or high vitamin D levels played no role in their risk of dying from cancer in general, they reported Tuesday in the Journal of the National Cancer Institute.
Then the researchers examined different types of cancer. There were just 66 deaths from colorectal cancer. Still, people with high levels of vitamin D appeared 72 percent less likely to die of colorectal cancer than people with the lowest vitamin D levels.
"While vitamin D may well have multiple benefits beyond bone, health professionals and the public should not, in a rush to judgment, assume that vitamin D is a magic bullet and consume high amounts," Johanna Dwyer, a dietary supplement specialist at the National Institutes of Health, cautioned in an accompanying editorial.
Indeed, there are numerous risk factors for colorectal cancer, including obesity and low physical activity, and it's unclear if low vitamin D levels play an independent role or are just a marker for those other risks, she said.
Scientists have been interested in vitamin D's effects for decades, since noticing that cancer rates between similar groups of people were lower in sunny southern latitudes than in northern ones. A handful of studies since then have found people given vitamin D supplements have less risk of developing certain cancers, but much of the evidence is circumstantial.
Experts are cautious because other vitamins and nutrient supplements once widely thought to prevent cancer didn't pan out when put to rigorous testing.
The NCI's study is the first to compare blood levels of vitamin D to cancer mortality, and "it's the best research we have on this topic," said Dr. Len Lichtenfeld of the American Cancer Society.
But a big weakness: It measured vitamin D at just one point in participants' lives, when levels can vary widely with dietary changes and especially the seasons.
Overall, most research "seems to be pointing in the direction that there is a role of vitamin D," Lichtenfeld said. Tuesday's study "puts a note of caution in there that says with all the explosion of information and advocacy on behalf of vitamin D, we need to be cautious. ... We really need some further studies that are well done to answer the question."
Exercise diet improve obese kids39 motor skills
Wed, 31 Oct 2007 20:28:28 GMTBy Amy Norton
NEW YORK - Obese children who lose weight through diet and exercise may become stronger and more agile in the process, a study shows.
German researchers found that a program that focused on physical activity and diet education was able to not just help obese children shed pounds, but to also improve their endurance, strength, balance and coordination.
Their findings point to the importance of exercise in battling childhood obesity, according to the researchers, led by Dr. Ulrike Korsten-Reck of the University of Freiburg.
Childhood obesity is on the rise worldwide and it's thought that a major cause is the demise of physical activity. Fewer children are outdoors riding bikes and playing games, in favor of sitting in front of the TV or computer.
The new study, published in the International Journal of Sports Medicine, evaluated an obesity treatment program that combined regular exercise with nutrition education and psychological counseling.
Korsten-Reck's team followed 49 obese children ages 8 to 12 who participated in the 8-month program. As part of their treatment, the children attended three hour-long exercise classes each week, which involved playing games, swimming, and performing exercises aimed at building their strength, flexibility and coordination.
After 8 months, the researchers found, the children showed an overall improvement in all movement skills tested, including aerobic fitness, balance and coordination.
Improving overweight children's motor skills is important, according to the researchers, because heavy kids often feel too intimidated to participate in sports and other types of exercise. This only exacerbates their weight problems, as well as their self-esteem.
The current findings highlight the benefits of getting overweight children into exercise classes, and encouraging them to be active in their everyday life, Korsten-Reck told Reuters Health.
It's also important for parents to be physically active as well, the researcher noted, so that their children can learn good health habits by example.
SOURCE: International Journal of Sports Medicine, September 2007.
Study estimates 2.4 million with Alzheimer39s in U.S.
Tue, 30 Oct 2007 22:22:15 GMTBy Will Dunham
WASHINGTON - About 10 percent of Americans aged 71 and up, or 2.4 million people, have Alzheimer's disease and 1 million more have some other form of dementia, researchers said on Tuesday, offering figures lower than some widely cited estimates.
The National Institutes of Health, which funded the study, called it the first to gauge U.S. rates of Alzheimer's and other dementia using a nationally representative sample of elderly people.
&;Most studies have been limited to a small region of the country or a few cities within the country, and then have used the findings from local regions to project the estimates of dementia,&; Brenda Plassman of Duke University Medical Center, one of the researchers, said in a telephone interview.
&;Our study has examined people in all regions of the U.S. and then estimated the prevalence,&; Plassman added.
The researchers based their findings on evaluations of 856 people ages 71 and older from 42 states, all of whom were interviewed and evaluated at their homes from 2001 to 2003.
Alzheimer's is difficult to diagnose, with a conclusive diagnosis only possible with a brain biopsy. But there are tests that doctors can perform to give them a good idea.
The researchers assessed each person's cognitive status and symptoms, medications, medical history and family history of memory problems. Brain imaging was also examined. Experts then judged if a person had dementia and, if so, what type.
Alzheimer's disease accounted for about 70 percent of dementia cases among people 71 and older, with vascular dementia the next most common form, the researchers said.
The researchers estimated that 13.9 percent of Americans age 71 and older have some type of dementia, including 9.7 percent suffering from Alzheimer's. That translates to 3.4 million Americans -- one in seven people age 71 and older -- with dementia, including 2.4 million with Alzheimer's.
The researchers said the rate of Alzheimer's rises with age: 2.3 percent of those aged 71 to 79; 18.1 percent of those ages 80 to 89; and 29.7 percent of those ages 90 and up.
The study was published in the journal Neuroepidemiology.
A leading U.S. advocacy group, the Alzheimer's Association, in March reported that there were more than 5 million people in the United States living with the disease. The group said the number included 4.9 million people over the age of 65 and between 200,000 and 500,000 people under age 65 with early onset Alzheimer's disease and other types of dementia.
Other estimates also have been higher than in the new study.
Richard Suzman, director of the Behavioral and Social Research Program at the NIH's National Institute on Aging, said the new estimates are the best to date.
&;It's somewhat lower, yes,&; Suzman said in a telephone interview. &;There are different methodologies around so there is some level of uncertainty.&;
Suzman said regardless of the differences, the number of elderly Americans with Alzheimer's is large. &;But that's not the number to keep your eye on. The real number is what it's going to be in 30 or 40 years because the population of people age 85 and over -- who are at the highest risk for the disease -- is going to quadruple or quintuple,&; he said.
Bill Thies, the Alzheimer's Association vice president for medical and scientific relations, played down the differences between his group's earlier estimates and the new ones, while saying the problem has already reached crisis dimensions.
&;It's in the right range for all the studies,&; Thies said of the new data. &;Do I think any one of the studies has exactly the right number? The answer is no. None of them do.&;
