Salmonella Recalls Continue to Grow
March 11, 2010
Fox News
By Luke Funk
The number of products being recalled because of Salmonella fears continues to grow. More than 100 products have been recalled so far.
The Food and Drug Administration announced more than a half-dozen recalls just on Wednesday and admits that the recall could continue to grow over the next several weeks.
A so-called “flavor enhancer” supplied by Las Vegas company Basic Food Flavors that is used in thousands of products is being blamed. Tests show it may be contaminated with salmonella.
The product in question is hydrolyzed vegetable protein (HVP). The additive is mixed into foods to give them a meaty flavor. The food industry uses it in soups, cheese, sauces, hot dogs, frozen dinners, snack foods, dips and dressings. The FDA says that the company continued to manufacture and ship HVP even after its own testing found Salmonella in the product.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems, according to the government.
Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.
Some of the recalled food products include some Herrs potato chips, Pringles potato chips, and Quaker snack mix.
In February, a customer of Basic Food Flavors alerted the FDA that it had detected Salmonella in the company’s HVP product.
That led to an FDA inspection at Basic Food Flavors that began on Feb. 12. That inspection led to the FDA’s positive findings of Salmonella in the manufacturing facility.
FDA inspectors also found problems in the company’s manufacturing processes, including a lack of microbial- contamination control. There were also problems with the cleaning and sanitizing procedures of equipment and work areas where food meant for human consumption was processed, as well as plumbing and drainage issues.
The FDA says the chances of a consumer getting sick are small because the foods are generally cooked before they are packaged. To date, there have been no reports of illnesses.
Click here for the full report
Court to Decide if Vaccine Makers can be Sued
March 10, 2010
Google News
By Associated Press
The Supreme Court will decide whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines.
The justices on Monday agreed to hear an appeal from parents in Pittsburgh who want to sue Wyeth over the serious side effects their daughter, six months old at the time, allegedly suffered as a result of the company’s diphtheria, tetanus and pertussis vaccine.
The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled against Robalee and Russell Bruesewitz, saying a 1986 federal law bars their claims.
That law set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.
Wyeth, now owned by Pfizer, Inc., prevailed at the appeals court but also joined in asking the court to hear the case, saying it presents an important and recurring legal issue that should be resolved.
The Obama administration joined the parties in calling for high court review, although the government takes the side of the manufacturers.
Only one state appeals court, the Georgia Supreme Court, has ruled that families can sue in a vaccine case. The vaccine industry has fiercely opposed the Georgia ruling in the case of Marcelo and Carolyn Ferrari. They claim their son suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.
The family has since withdrawn its lawsuit, possibly in an effort to avoid an unfavorable Supreme Court ruling, although the Georgia court’s opinion allowing similar lawsuits remains in force.
The court did not act on the companies’ appeal Monday, but the decision in the other case almost certainly will apply to the Georgia case.
According to the lawsuit, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Now a teenager, Hannah suffers from residual seizure disorder, the suit says.
The vaccine court earlier rejected the family’s claims.
Wyeth lost another high court fight last year over whether federal law barred lawsuits against drug makers. That case, involving a botched injection, asked whether federal law included an implicit prohibition on the lawsuits. The court said it did not.
In this appeal, however, Congress clearly laid out how claims over vaccines were to be made, and the court has repeatedly ruled against plaintiffs when Congress has explicitly sought to bar lawsuits.
Other than the Georgia court, state and federal courts have uniformly invoked a provision of the 1986 federal law, which seems to bar most lawsuits against vaccine makers.
The idea behind the National Childhood Vaccine Injury Act was to ensure a stable supply of childhood vaccines by shielding drug makers from most lawsuits, and setting up a federal vaccine court to handle disputes. The law would serve to block state laws that otherwise would give families the ability to sue the manufacturers.
In recent years, the legal fight has frequently come from families of autistic children claiming that mercury-based thimerosal is linked to autism. Numerous studies have addressed vaccines and autism and found no link, including with the preservative.
Thimerosal has been removed in recent years from standard childhood vaccines, except flu vaccines that are not packaged in single doses.
Last year, special masters appointed by the vaccine court concluded that vaccines aren’t to blame for autism, disappointing thousands of families hoping to win compensation and others who remain convinced of a connection.
But the vaccine court still must rule on additional cases that argue that vaccines with thimerosal are to blame, if the mercury reached and damaged brain cells.
Click here for the full report.
A Drink A Day May Keep the Pounds Away
March 10, 2010
ABC News
By Kristina Fiore
Cheers, ladies! Researchers now say light to moderate drinking may keep women from gaining too much weight.
Normal-weight women who drank 5 to 30 grams of alcohol daily gained less weight and had a lower risk of becoming overweight or obese than either teetotalers or those who drank too much, according to a report in the March 8 Archives of Internal Medicine.
How much is that? A 12-ounce light beer contains about 11 grams of alcohol, while 5 ounces of red wine contains 15 to 16 grams and a 1.5 ounce shot of 80-proof whiskey contains about 14 grams of alcohol.
Despite their findings, Dr. Lu Wang of Brigham and Women’s Hospital in Boston and colleagues cautioned against recommendations for drinking alcohol as a weight control measure.
“Taking into account the potential medical and psychosocial problems related to drinking alcohol,” they wrote, “any recommendation on alcohol use should be made for the individual after carefully evaluating both adverse and beneficial effects of the drinking behavior in broad context.”
Alcohol has a relatively high caloric value and may, in the long run, result in weight gain, some researchers have said. But epidemiological studies haven’t provided consistent evidence of that relationship.
So the researchers conducted an analysis of data from the prospective cohort Women’s Health Study of 19,220 women over age 38 who were disease-free and had a normal body mass index (BMI) at the outset.
They reported their weight and alcohol consumption on a questionnaire at that time, and reported their weight again on eight annual follow-up questionnaires.
The women were followed for an average of 12.9 years. During that time, 41.3 percent of the women became overweight or obese, while 3.8 percent became obese.
Average weight gain was 3.63 kg — about 8 pounds — for those who didn’t drink, compared with 1.55 kg — about 3.5 pounds — for moderate drinkers.
The researchers found an inverse relationship between alcohol consumption and subsequent weight gain. “Weight gain was largest for women who did not consume alcohol and then monotonously decreased with increasing total alcohol intake,” they wrote.
After taking into account many other variables, including nonalcohol caloric intake, physical activity, and other lifestyle factors, the relationship strengthened, with the risk of becoming overweight or obese diminishing as women drank more moderately.
But the risk of weight gain did not decline further once women drank 40 grams of alcohol per day or more.
This is not great news for men, however, the researchers say. That’s because mean and women drink differently: men add alcohol to their daily dietary intake, while female drinkers substitute alcohol for other foods without increasing total calories.
In this study, for instance, women who drank alcohol had lower caloric intake from nonalcohol sources, particularly carbohydrates.
The investigators said there may be gender differences regarding the metabolism of alcohol.
But they cautioned that “complex interrelationships” exist between drinking habits and various lifestyle, clinical, and physiological factors, which may help explain inconsistent findings in studies past.
Click here for the full report.
Obama Seeks to Vilify Health Insurers, Give Them $336 Billion Check
March 10, 2010
ABC News
ABC’s Z. Byron Wolf reports: President Obama and Democrats launched a campaign to vilify insurance companies in the final stretch of their health reform effort.
Republicans, meanwhile, pointed out that those very same insurance companies would get huge checks from the government if health reform is enacted.
“(Health Insurers) will keep on doing this for as long as they can get away with it. This is no secret,” the president said. “They’re telling their investors this – ‘We are in the money. We are going to keep on making big profits even though a lot of folks are going to be put under hardship,’” the President told supporters at a stop in Pennsylvania today.
HHS Secretary Kathleen Sebelius, meanwhile, wrote to insurance company executives demanding that they justify premium hikes.
Neither mentioned that the Senate health reform bill, which is the basis for Democrats’ last best chance at comprehensive reform, would give the insurance companies millions of new customers required by law to buy health insurance. It would also require insurers to cover everyone, regardless of age, gender or pre-existing condition.
To help pay for the new insurance requirements the government would give to people money to buy insurance – $336 billion over the next ten years. That money, ultimately, would have to go to… drum roll… insurance companies.
People without employer-sponsored insurance who make too much money to qualify for Medicaid and less than about $88,000 for a family of four, would get tax credits to help them buy insurance on the open market. But the payment of the tax credits would be made, point out Republican researchers, directly to insurance companies. See page 37 here of the Senate Finance Committee’s exhaustive explanation of the plan:
During the 2008 Presidential campaign, then-Senator Obama criticized a proposal by Sen. John McCain because it would send government help for people to buy insurance directly to insurance companies.
“But The New Tax Credit [For Health Insurance] He’s Proposing? That Wouldn’t Go To You. It Would Go Directly To Your Insurance Company – Not Your Bank Account,” said Obama in October on the Campaign trail.
And yet that’s exactly what Democrats’ proposal would do and why so many would prefer public insurance option to compete with the private market. Supporting the Senate bill will be tough for many liberal Democrats in the House.
To the Republicans’ (and Obama’s on the campaign trail) point about the payments going directly to insurance companies, remember that people with employer-sponsored insurance or current federal medical benefits do not usually get a separate check to buy insurance either. They pay premiums directly to the insurance company and so does their employer. The Senate proposal would create a similar relationship between people who don’t have employer-based insurance and the government.
So why do Insurance companies, if they’re set to receive more than $330 billion in government subsidies to insure people without insurance now oppose the Senate bill?
“Health plans proposed more than a year ago robust insurance market reforms and new consumer protections to guarantee coverage for pre-existing conditions. Much more needs to be done in the current legislation to address the skyrocketing cost of medical care, which is making health care coverage unaffordable for working families and small businesses,” said Robert Zirkelbach, a spokesman from America’s Health Insurance Plans, in a statement today.
He argued that health insurers should not be targeted by the President and their profits are lower by margin than other sectors in the health industry.
“For every dollar spent on health care in America, less than one penny goes towards health plan profits. The focus needs to be on the other 99 cents,” he said.
Click here for the full report.
Court To Hear About Vaccine Side Effects
March 10, 2010
Associated Press
The Supreme Court will decide whether drug makers can be sued by parents who claim their children suffered serious health problems from vaccines.
The justices on Monday agreed to hear an appeal from parents in Pittsburgh who want to sue Wyeth over the serious side effects their daughter, six months old at the time, allegedly suffered as a result of the company’s diphtheria, tetanus and pertussis vaccine.
The 3rd U.S. Circuit Court of Appeals in Philadelphia ruled against Robalee and Russell Bruesewitz, saying a 1986 federal law bars their claims.
That law set up a special vaccine court to handle disputes as part of its aim of insuring a stable vaccine supply by shielding companies from most lawsuits.
Wyeth, now owned by Pfizer, Inc., prevailed at the appeals court but also joined in asking the court to hear the case, saying it presents an important and recurring legal issue that should be resolved.
The Obama administration joined the parties in calling for high court review, although the government takes the side of the manufacturers.
Only one state appeals court, the Georgia Supreme Court, has ruled that families can sue in a vaccine case. The vaccine industry has fiercely opposed the Georgia ruling in the case of Marcelo and Carolyn Ferrari. They claim their son suffered neurological damage after receiving vaccine booster shots made by pharmaceutical companies Wyeth and GlaxoSmithKline that contained the preservative thimerosal.
The family has since withdrawn its lawsuit, possibly in an effort to avoid an unfavorable Supreme Court ruling, although the Georgia court’s opinion allowing similar lawsuits remains in force.
The court did not act on the companies’ appeal Monday, but the decision in the other case almost certainly will apply to the Georgia case.
According to the lawsuit, Hannah Bruesewitz was a healthy infant until she received the vaccine in April 1992. Within hours of getting the DPT shot, the third in a series of five, the baby suffered a series of debilitating seizures. Now a teenager, Hannah suffers from residual seizure disorder, the suit says.
The vaccine court earlier rejected the family’s claims.
Wyeth lost another high court fight last year over whether federal law barred lawsuits against drug makers. That case, involving a botched injection, asked whether federal law included an implicit prohibition on the lawsuits. The court said it did not.
In this appeal, however, Congress clearly laid out how claims over vaccines were to be made, and the court has repeatedly ruled against plaintiffs when Congress has explicitly sought to bar lawsuits.
Other than the Georgia court, state and federal courts have uniformly invoked a provision of the 1986 federal law, which seems to bar most lawsuits against vaccine makers.
The idea behind the National Childhood Vaccine Injury Act was to ensure a stable supply of childhood vaccines by shielding drug makers from most lawsuits, and setting up a federal vaccine court to handle disputes. The law would serve to block state laws that otherwise would give families the ability to sue the manufacturers.
In recent years, the legal fight has frequently come from families of autistic children claiming that mercury-based thimerosal is linked to autism. Numerous studies have addressed vaccines and autism and found no link, including with the preservative.
Thimerosal has been removed in recent years from standard childhood vaccines, except flu vaccines that are not packaged in single doses.
Last year, special masters appointed by the vaccine court concluded that vaccines aren’t to blame for autism, disappointing thousands of families hoping to win compensation and others who remain convinced of a connection.
But the vaccine court still must rule on additional cases that argue that vaccines with thimerosal are to blame, if the mercury reached and damaged brain cells.
The case, to be argued in the fall, is Bruesewitz v. Wyeth, 09-152.
Click here for the full report.
McCain Withdraws Support of Supplement Legislation
March 10, 2010 by JP
Filed under Government, Health
March 10, 2010
Wall Street Journal
NEW YORK (Dow Jones)–Shares of nutritional supplement makers climbed Monday as Sen. John McCain (R., Ariz) withdrew his support for legislation to regulate dietary supplements.
“It looks like it will be an easier world to be in the dietary supplement business,” said Avondale analyst Bret Jordan. “The bill would have significantly tightened regulatory requirements.”
In February, McCain and Sen. Byron Dorgan (D., N.D.) introduced the Dietary Supplement Safety Act of 2010 to give the U.S. Food and Drug Administration more power to oversee the dietary supplement …
Click here for the full report.
Banned But Still Considered Safe?
March 10, 2010
Mercola.com
By Dr. Mercola
A livestock drug banned in 160 nations and responsible for hyperactivity, muscle breakdown and 10 percent mortality in pigs has been approved by the FDA.
The beta agonist ractopamine, a repartitioning agent that increases protein synthesis, was recruited for livestock use when researchers found the drug, used in asthma, made mice more muscular.
Ractopamine is started as the animal nears slaughter.
How does a drug marked, “Not for use in humans. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask” become “safe” in human food? With no washout period?
The drug is banned in Europe, Taiwan and China, and more than 1,700 people have been “poisoned” from eating pigs fed the drug since 1998, but ractopamine is used in 45 percent of U.S. pigs and 30 percent of ration-fed cattle.
Click here for the full report including Dr. Mercola’s comments on the above.
Vitamin D is the Key!
March 10, 2010
Chicago Tribune
By Julie Deardorff
As far as Dr. Joseph Mercola is concerned, vitamin D is the magic bullet we’ve all been looking for. A lack of this wonder nutrient, the controversial natural health advocate said, can set the stage for no fewer than 33 disorders, including autism, cancer, diabetes and infertility.
“Vitamin D appears to reduce your risk of dying from virtually ANY disease,” he wrote on his popular Web site. His recommendation? Get more sun, relax in a tanning bed or try supplements such as “Sunshine Mist,” a vitamin D spray he sells.
Long ignored and feared in high doses, vitamin D is being hailed as the answer to nearly every health issue under the sun. The excitement stems from a flurry of preliminary studies finding links between vitamin D deficiencies and various illnesses, and this summer the federal Institute of Medicine plans to announce revised recommendations regarding dietary intake of vitamin D and calcium that almost certainly will be higher.
Despite the scientific attention being paid to vitamin D, experts caution that claims of wide-ranging health benefits are not yet supported by clinical evidence.
Though D is thought to hold tremendous promise, we’ve been down this garden path before: Hopes for the powers of vitamin E, beta carotene, antioxidant vitamins, selenium and other nutrients collapsed under the weight of rigorous, randomized clinical trials.
“It’s premature to go out and make a big deal out of vitamin D supplementation when we don’t have the evidence,” said endocrinologist Anastassios Pittas, co-director of the Diabetes Center at Tufts University Medical Center in Boston. “We’ve been burned before on nutrition-based interventions,” he said.
Yet already, bread, pasta, orange juice and soy foods are being fortified with vitamin D, and sales of vitamin D supplements grew 116.5 percent, from $108 million to $234 million, from 2007 to 2008, according to Nutrition Business Journal estimates.
The body naturally makes the vitamin when the sun’s ultraviolet rays hit the skin, but fear of health risks and modern lifestyles have limited sun exposure for many.
Mercola, a non-practicing osteopathic physician who owns a clinic in Hoffman Estates, is one of the nutrient’s most public and ardent supporters, with an evangelical style that can grate on the nerves of more cautious physicians.
Unlike most doctors, Mercola recommends universal baseline testing and widespread high-dose supplementation. “I’ve been preaching about this for a long time,” said Mercola, who started his campaign 10 years ago. “Eventually the evidence comes out.”
Mercola said children should get almost six times the amount of vitamin D recommended by the American Academy of Pediatrics, while adults and pregnant women should be receiving 5,000 International Units, or IUs, per day.
Most leading vitamin D researchers recommend no more than 1,000 to 2,000 IUs a day, citing insufficient evidence for higher doses. The federal guidelines, which are widely considered to be woefully inadequate, range from 200 to 600 IUs, depending on age.
“Dr. Mercola popularizes and promotes vitamin D in a very passionate way,” said Dr. Gregory Plotnikoff, a senior consultant at the Center for Healthcare Innovation in Minneapolis who is conducting vitamin D trials. Mercola’s high dosing recommendations “may be correct, but we need supportive data,” he said.
Still, Plotnikoff and other researchers have high hopes for the vitamin, saying it could prove to be the single most cost-effective medical intervention in the U.S. today.
Best known for preventing rickets in children — the reason it is added to milk — vitamin D shines most in the role of absorbing calcium, which we need to form bones. A deficiency of vitamin D can contribute to osteoporosis by reducing calcium absorption.
Unlike vitamin E and others, vitamin D is a potent steroid hormone that has receptors in most, if not all, cells of the body. Mounting evidence suggests the so-called sunshine vitamin may also influence conditions unrelated to the skeleton, including cardiovascular disease, hypertension, diabetes, cancer, autoimmune disorders and mortality, said Dr. Michael Hollick, director of the Vitamin D, Skin and Bone Research Laboratory at Boston University School of Medicine.
“Vitamin D is as important for every cell in the body as thyroid hormone, estrogen and testosterone,” said Plotnikoff. “These hormones turn on and off genes in our DNA. At least 1,000 key genes are under at least partial control by vitamin D. This was never the case for vitamin C, E and others.”
Though observational studies have found a link between low vitamin D levels and an increased risk of disease, such an association doesn’t prove a deficiency caused the problem. Low levels of D could also be a consequence of the illness.
The results of studies can also be skewed by the people participating (vitamin D trial subjects are disproportionately white) or if the research does not account for sunlight exposure or consumption of D in foods. The doses studied are sometimes too low, experts said.
When Pittas and his colleagues systematically reviewed studies on vitamin D’s effect on Type 2 diabetes, hypertension and cardiovascular disease, for example, they found “no clinically significant effects at the dosages given,” according to the research published last week in the Annals of Internal Medicine. They called the vitamin a “promising but unproven” new factor in cardiometabolic disease management.
“There’s a potentially large problem with leaping from observational studies to making decisions about interventions,” said Dr. Ethan Balk, associate director of the Center for Clinical Evidence Synthesis at Tufts Medical Center, a co-author of the Annals study.
“Advocates take the studies and say, ‘If we can move someone’s vitamin D from low to high, the risk would go down.’ While that might be the case, there may be another explanation,” said Balk.
In some ways, it’s much easier to study drugs than nutrients because “everyone starts a pharmaceutical study at the same point, namely … zero,” said Plotnikoff. “In contrast, everyone starts a nutritional study with baseline measurements all over the map. Everyone is given the same dose as if one size fits all. This is a huge mistake.”
Drug effects, meanwhile, tend to be immediate, focused and measureable, while vitamins may have long-term, subtle effects.
Proponents also may oversell the study findings. Mercola’s Web site, for example, recently headlined an item on a new study this way: “Vitamin D fights Crohn’s disease.” But the lead researcher, Dr. John White of the Research Institute of McGill University Health Center in Montreal, said the data came from a lab study that “will have to be borne out in the clinic, which may be tricky.”
“Data is coming, but there’s a good reason to be skeptical — people have been on this bandwagon before,” said White, an endocrinologist. “When it gets into the clinic, it often doesn’t work out quite as well.”
The debate over optimal amounts of vitamin D and how to get it, meanwhile, is ongoing and likely will not be settled by the new National Institutes of Health guidelines.
But one thing is clear: Vitamin D levels are lower than they were 20 years ago. Most Americans, especially those with dark skin, are likely deficient — the result, some say, of widespread campaigns for sunscreen use and sun avoidance, as well as smog and cloud cover, living indoors and rising national trends of inactivity and obesity.
Cardiologist Diane Wallis is one doctor who will continue to test her patients’ vitamin D levels, even though it’s an unproven treatment in her field. “We’re at the threshold,” said Wallis, of Midwest Heart Specialists in Downers Grove, who 10 years ago began seeing female patients with chest pain but no obvious signs of heart trouble. When she tested them, they all had one thing in common: low vitamin D levels. “When I started it we’d just gotten off the whole vitamin E fiasco and people thought I was crazy,” she said. “Anything that had the word ‘vitamin’ led to derision. But no one is making fun of it anymore.”
Click here for the full report.
Government Warning Planned for Baby Slings
March 10, 2010
Google News
By Associated Press
The U.S. government is preparing a safety warning about baby slings — those popular and fashionable infant carriers that parents can sling around their chests to carry their baby.
The concern is that infants can suffocate, and a few have.
Consumer Product Safety Commission Chairman Inez Tenenbaum says her agency is getting ready to issue a general warning to the public, likely to go out this week, about the baby carriers.
She did not single out any specific slings or discuss at least seven reported deaths linked to them.
Safety advocates have cautioned that some slings, where the baby falls into a curved or “C-like” position inside the sling, can lead to suffocation by restricting the baby’s breathing.
Click here for the full report.
Bone Strengthening Drug Linked to Fractures
March 10, 2010
ABC News
By Christine Romo and Lara Salahi
Sandy Potter, 59 of Queens, New York, was jumping rope with neighborhood children when she felt her thigh bone snap.
“I went up in the air and I came straight down to the ground,” Potter said. “The pain was excruciating.”
Potter, who was diagnosed with osteoporosis at age 48, had been taking the popular osteoporosis drug Fosamax for eight years before her femur literally snapped in two.
Fosamax, one in a class of drugs called bisphosphonates, is supposed to make bones stronger. But now there’s mounting evidence that for some women, taking Fosamax or its generic alendronate for more than five years could cause spontaneous fractures.
“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”
Egol said X-rays of some of his patients look more like an injury endured by a car accident than an otherwise minimal fall.
“Over the last 18 months we are seeing this more frequently,” he said.
Sue Heller, 60, of Castle Rock, Colo., had been on Fosamax for almost 10 years. She broke both of her femur bones.
“I’m sure there are a lot of women who have brittle bones right now that maybe are ready to break, and they’re not aware of it,” said Heller. “And my heart aches for them.”
Sales of the popular drug increased when doctors began prescribing it not only to women showing signs of osteoporosis, but also those who were osteopenic, and thus, at risk for the disease. Now some doctors worry that staying on the drug for more than five years can cause some women’s bones to become more brittle.
Weighing the Risks
This is not the first time that many doctors have reported an opposite effect for many people taking the drug. Fosamax has already been linked to severe musculoskeletal pain, as well as to a serious bone-related jaw disease called osteonecrosis.
“In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown,” responded Merck in a written response to the suggested link. “Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines.”
In 2008, the Food and Drug Administration reached out to the pharmaceutical company Merck about the reports of femur fractures. After 16 months, Merck added patients’ reports of femur fractures to the list of possible side effects reported by patients included in the drug’s package insert.
“It took Merck an entire year to respond,” said ABC News senior health and medical editor, Dr. Richard Besser. “Just six words: ‘low energy femoral shaft and subtrochanteric fractures.’”
The FDA has also never made an effort to inform the public or doctors across the country who prescribe bisphosphonates of the possible side effect, said Besser.
Both the FDA and Merck declined ABC News’ request for an interview. The FDA said they are looking into reports of fractures.
“Nothing is more important to Merck than the safety of its medicines,” according to a written statement by Merck to ABC News. A causal relationship between Fosamax and these fractures has not been established, according to Merck.
“The drug companies have to recognize when there is a problem, they have to be up front with the public. If there’s a concern, they have to voice it and at least give everybody a fair chance to look at this carefully,” said Dr. Joseph Lane, orthopedic trauma surgeon at the Hospital for Special Surgery in New York City.
How Much for How Long
Many studies suggest an overall benefit from taking the medication for women who are at risk for osteoperosis. In fact, bisphosphonates can help prevent hip and spine fractures, which for many women may lead to death.
“Normally your bone is constantly being remade,” said Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery in New York City. “These patients don’t remake their bone and they acquire damage, microdamage, the collagen gets altered and we need to rejuvenate the skeleton.”
In 2008, bisphosphonate sales exceeded $3.5 billion according to data from IMS Health. In 2008, over 37 million prescriptions were written for the osteoporosis medications.
While some physicians use bone density scans to help drive their decisions, doctors generally prescribe them to women who are at an increased risk for either osteoporosis or fractures from osteoporosis they already have. A new tool developed by the World Health Organization can determine the risk of having fractures and can help doctors determine which women with osteoporosis should be treated with medications.
Although bisphosphonates are generally recommended for postmenopausal women, research does not indicate how long women should be on the drug. Many doctors now recommend a five-year limit.
“When they are on it for five, six, seven or eight years, they lost their ability to remodel and regenerate their skeleton,” said Lane. “[Some women] are very vulnerable and they will then develop problems of brittle bone.”
Additional time on the medication depends on doctors’ orders, said Besser.
Click here for the full report.
