Do Bone Drugs Really Treat Osteoporosis?
If you feel like everyone is warning you about your bones and imminent osteoporosis, you are right. Boniva, an osteoporosis drug which actress Sally Field says helps women "stop losing and start reversing" bone, is one of the top 20 most advertised drugs.
Bone drug Evista was personally promoted by former FDA deputy commissioner for medical and scientific affairs under George W. Bush, Scott Gottlieb.
And "novel" bone drug Prolia, also called a Frankendrug, received a Best New Drug award this month at the 2010 Scrip Awards ceremony.
While most of the world is now aware of the risks of osteoporosis, the problem with the bone drugs is: they may not work and women may not need them.
According to National Public Radio, Merck hired a company to whip up fears of "osteopenia," the risk of getting osteoporosis, to get women to take Fosamax, the first bisphosphonate bone drug launched 15 year ago. The hired guns creating the faux "Bone Measurement Institute," planted bone scan machines in medical offices and pushing the Bone Mass Measurement Act which made scans Medicare-reimbursable. By the end of the 1990s the "disease" of osteopenia had increased seven fold according to the Associated Press.
Even the term osteopenia, created by World Health Organization, was co-opted. It was never meant to be "a disease in itself to be treated," says Dartmouth Medical School professor Anna Tosteson who attended the WHO meeting, and the osteopenia diagnostic criteria were decided arbitrarily because the scientists were tired and wanted to adjourn.
Like Merck's Vioxx, Merck's Fosamax was launched ahead of schedule and its side effects - esophageal erosion, bleeding, inflammation and perforation (why patients have sit or stand for an hour after a dose) - only emerged when the drug was reimbur$able. In fact, Merck was forced to send out Dear Doctor letters months after Fosamax' 1995 approval and the FDA threatened to revoke approval altogether until Merck's head of research at the time, Edward M. Scolnick, convinced it to simply add a warning.
At the same time the clinical picture of bisphosphonates (Roche and GSK's Boniva and Procter & Gamble's Actonel followed) worsened.
It turned out the same mechanism that stops bone loss, suppression of the body's bone remodeling action, can cause bones to become brittle and at risk of breaking because they are not renewed. Since 2006, so many medical journal articles have chronicled spontaneous breaks of thigh and other bones on bisphosphonates, the FDA ordered a fracture warning to appear on the drugs' labels in October. Over a dozen women report their bones breaking while taking bisphosphonates on the drug rating site askapatient.com.
And there are other morbid perks with bisphosphonates.
Dentists and oral surgeons discovered that after simple office procedures patients' jaw bones would not heal but become necrotic and die. Whether Merck hid the jaw bone data, as some dentists claim, or didn't know because only two, three-year Fosamax studies were conducted, many dentists refuse work on bisphosphonate patients and an FDA-mandated jaw bone death warning went on the label. (Some Merck doctors blamed the jaw bone death on "bad oral hygiene.")
Intractable pain and atrial fibrillation, chronically irregular heartbeat, were reported with the bisphosphonates in medical journals and the FDA reported 23 US esophageal cancers and 27 in Europe and Japan in 2008. (Why does FDA put esophageal, fracture and jaw bone warnings on a drug also linked to cancers rather than simply withdraw it?)
But even as the FDA warned about bisphosphonate fractures last month, full page color ads in the New York Times offered women a new bone option: Evista, a Selective Estrogen Receptor Modulator (SERM) similar to the breast cancer drug Tamoxifen.
"You can take Evista at any time of day, with or without food," say the Eli Lilly ads without having to add "unlike SOME drugs we know."
Evista is approved for treatment and prevention of osteoporosis in postmenopausal women and reducing invasive breast cancer risk in other patient groups but it has its own negatives. Researchers at the University of Illinois and University of Southern California link it to ovarian cancer and its label warns about "increased risk of venous thromboembolism and death from stroke." Evista was originally promoted as reducing heart attacks and stroke. Oops.
Of 250 users on askapatient, 130 say they developed debilitating joint pain or muscle cramps on Evista, similar to bisphosphonates (though Evista rates higher than Boniva which is the lowest rated drug of 4,200.)
Many say they developed insomnia, memory loss, hair loss and eye problems - SERMS are linked to cataracts - but most alarming is: patients report losing bone density on a drug designed to preserve bone density.
And there's another macabre option for women's bone health. Amgen's Prolia, a monoclonal antibody derived from genetically engineered mammalian Chinese hamster ovary cells, was approved in June to prevent fractures in people with osteoporosis, two months earlier than expected.
Biologics are more lucrative for pharma than pills and lack generic competition - Amgen's twice yearly Prolia injection costs $1650 per year - but they suppress the immune system's tumor necrosis factor and cause malignancies, infections, tuberculosis and worse. During Prolia trials, 10 volunteers were hospitalized with the skin infection cellulitis and one died. Two monkeys died of protozoal infections on the drug and others developed tooth and jaw abscesses. (Jaw bone death is listed under Prolia's warnings and precautions.)
Immune-suppressing biologic drugs, broadly marketed for "RA," rheumatoid arthritis, which some say is pharma's next push, and to healthy college kids, are also associated with - you guessed it!- bone loss!
Of course no one is suggesting that fractures, especially in the elderly, are not a real problem. But increasingly doctors are looking at solutions other than bone drugs.
"The strongest single risk factor for fracture is falling and not osteoporosis," says a 2008 article in the British Medical Journal called Shifting The Focus in Fracture Prevention From Osteoporosis to Falls. "Despite this fact, few general practitioners will have assessed the risk of falling among their elderly patients or even know how to do it."
"Avoiding drugs that increase the likelihood of falling may be just as important as taking drugs that can make bones stronger," add People's Pharmacy authors Joe and Teresa Graedon, especially sedatives, sleeping pills and anxiety pills.
In fact many everyday pills like diuretics and anticoagulants can cause osteoporosis says an October article in The American Journal of Medicine.
A January British Medical Journal study of 68,500 younger women found calcium and Vitamin D reduced fractures by 50 percent while bisphosphonates exerted no action (unless you count that they "negate the effect" of the two supplements, according to the authors) In fact, Vitamin D and calcium, given with placebo, actually outperformed Prolia in clinical trials.
Researchers are also looking at Vitamin K for osteoporosis protection and the elder plant, often taken to boost the immune system.
And then there's diet.
"There is growing evidence that consumption of a Western diet is a risk factor for osteoporosis through excess acid supply," says an article in the February Proceedings of the Nutrition Society. "Healthy adults consuming such a diet are at risk of chronic low-grade metabolic acidosis, which worsens with age as a result of declining kidney function."
Dean Ornish, Clinical Professor of Medicine at the University of California, San Francisco agrees. "For every gram of excess protein consumed (sulfur amino acid in particular) calcium loss is increased by 1 mg," he writes in a 2005 Journal of the American Dietetic Association. So do recent articles in the Journal of Bone and Mineral Research, Osteoporosis International, nutritionist Nathan Pritikin and probably Michael Pollan.
Yet the USDA pushes high milk, cheese and meat consumption because it helps farmers at the price of food consumers, says last week's New York Times.
In fact long before bone drugs, the government supported "milk mustache" campaign warned teenage girls if they didn't drink milk they could get osteoporosis later in life, in 1993. Not that teens and tweens living with their parents worried about getting old or bone fractures.
A USDA expert panel threw out the bone benefit claims in 2001 but not before the Secretary of Health and Human Services herself, Donna Shalala posed for milk ads in 1998 and kicked off a "milk mobile" tour of 100 cities which offered free bone-density screenings.
The Center for Science in the Public Interest and fellows at the Brookings Institution objected to the government's top health official appearing in corporate advertising, but Shalala insisted that her promotion of the milk industry was to help the public prevent osteoporosis later in life. Today she would have said osteopenia.
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