Aletho News

ΑΛΗΘΩΣ

Big Pharma Still Tries to Push Dangerous Drug Class

By Martha Rosenberg | CounterPunch | February 16, 2018

Bisphosphonate bone drugs are among the most harmful and misrepresented drug classes still on the market. But that has not stopped Pharma-funded medical associations like the American Society of Bone and Mineral Research, the National Osteoporosis Foundation and the National Bone Health Alliance from periodically wringing their hands over low sales. [1]

This week the New York Times repeats the industry lament. “Currently, many people at risk of a fracture — and often their doctors — are failing to properly weigh the benefits of treating fragile bones against the very rare but widely publicized hazards of bone-preserving drugs, experts say,” it writes. Hip fractures among women 65 and older on Medicare are rising says the piece and Medicare reimbursements for bone density tests are falling. “Doctors who did them in private offices could no longer afford to [do them] which limited patient access and diagnosis and treatment of serious bone loss,” says a doctor quoted in the article which sounds like a Pharma plea for tax-payer funding.

But here is the back story.

The first bisphosphonate bone drug approved for osteoporosis, Merck’s Fosamax, received only a six month review before FDA approval. When its esophageal side effects were revealed, the FDA tried to unapprove it but Merck got the FDA to settle for a warning label that told patients to sit upright for an hour after taking the drug. Six months after Fosamax was approved, there were 1,213 reports of adverse effects including 32 patients hospitalized for esophageal harm. One woman who took Fosamax but remained upright for only thirty minutes was admitted to the hospital with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine (NEJM).

Soon bisphosphonates (which include Boniva, Actonel and Zometa) were shown to weaken not strengthen bones by suppressing the body’s bone-remodeling action. Yes bone loss is stopped but since the bone is not renewed, it becomes brittle, ossified and prone to fracture. More than a decade ago, articles in the NEJM, the Annals of Internal Medicine, the Journal of Clinical Endocrinology & Metabolism, Journal of Orthopaedic Trauma and Injury warned of the paradoxical drug results. One-half of doctors at a 2010 American Academy of Orthopaedic Surgeons annual meeting presentation said they’d personally seen patients with bisphosphonate-compromised bone. “There is actually bone death occurring,” said Phuli Cohan, MD on CBS about a woman who’d been on Fosamax for years.

By 2003, dentists and oral surgeons found that after simple office dental work, the jawbone tissue of patients taking bisphosphonates would sometimes not heal but become necrotic and die. They had received no warnings though Merck knew about the jawbone effects from animal studies since 1977.

“Up to this point, this rare clinical scenario was seen only at our centers in patients who had received radiation therapy and accounted for 1 or 2 cases per year,” said the authors of an article titled “Osteonecrosis of the Jaws Associated with the Use of Bisphosphonates: A Review of 63 Cases,” published in the Journal of Oral and Maxillofacial Surgery.

Despite reports of ulcerative esophagitis, bone degradation, fractures and jawbone death Merck aggressively promoted Fosamax. It hired researcher Jeremy Allen to plant bone scan machines in medical offices across the country to drive sales and to push through the Bone Mass Measurement Act which made bone scans Medicare reimbursable paid by you and me. Hopefully that is changing.

Blaming hip fractures on not enough people taking bisphosphonates is not a new tactic for Pharma. It blamed increasing suicides on not enough people taking antidepressants (even when as much as a fourth of the population takes antidepressants). Get ready for Pharma to blame obesity on not enough people taking prescription obesity drugs. The ruse is even more dishonest because many popular drugs people are taking like GERD medications really do thin bones. First do no harm.

Notes.

[1] According to the British Medical Journal, the National Osteoporosis Foundation is funded by Bayer Healthcare, Lane Laboratories, Mission Pharmacal, Novartis, Pharmavite, Pfizer, Roche, Warner Chilcott and Eli Lilly. The American Society for Bone and Mineral Research is funded by Pfizer and Eli Lilly. The National Bone Health Alliance is a public- private partnership that is an offshoot of the National Osteoporosis Foundation.

Martha Rosenberg is an investigative health reporter. She is the author of  Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The Public Health (Prometheus).

February 16, 2018 Posted by | Deception, Science and Pseudo-Science | , , , , | Leave a comment

After First Drug Injures Patients Shameless Drug Company Pursues Follow-up Drug

By Martha Rosenberg | Dissident Voice | October 22nd, 2012

The year 1999 was a good one for the drug company Merck. In its 64 page annual report, it predicted that the arthritis medicine Vioxx (“Our Biggest, Fastest, and Best Launch Ever!”) would also prevent Alzheimer’s disease and colon cancer. It announced it was seeking approval to market the asthma drug Singulair to two-year-olds. And it forecast that 40 million women would take its new osteoporosis drug, Fosamax, as Merck continued to “help educate both doctors and patients” about the bone disease.

It turned out Merck spoke too soon. Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long-term users; Singulair now carries FDA warnings about “neuropsychiatric events” and Fosamax is suspected of doubling the risk of esophageal cancer, causing bone fractures instead of preventing them and causing heart problems, intractable pain and jawbone death. Oops!

There’s plenty of ka-ching in selling “strong bones” products for the same reason there was plenty of ka-ching in selling “hormone replacement” products: one-half the population is female, and no one wants to look old. Of course, “avoiding hot flashes” really means “still looking hot” in hormone marketing terminology, and “avoiding fractures” really means “still looking hot” in bone product marketing lingo. That’s why attractive women like Meredith Vieira from the Today show and former Charlie’s Angel Cheryl Ladd and actress Sally Field push bone drugs, just as model Lauren Hutton pushed hormone replacement therapy.

To cash in on Fosamax, the first in the bisphosphonate bone drug class, Merck decided to market the dangers of osteoporosis “far beyond ailing old ladies.” It hired researcher Jeremy Allen to whip up fears of “osteopenia,” the risk of osteoporosis, as a health epidemic to sell bone drugs and planted bone scan machines in medical offices across the country, says National Public Radio. Allen created the faux “Bone Measurement Institute” which also maneuvered Medicare reimbursement for the scans. By 1999, there were 10,000 bone scan machines in medical offices, said the Associated Press, when there had been only 750 before Fosamax.

Like its trouble-laden drug Vioxx, Merck’s Fosamax flew out of the FDA. It received only a six month review before its 1995 FDA approval. (The government also helped its promotion with the HHS secretary herself, Donna Shalala, participating in a 1998 rally kicking off free bone density screenings to be offered in 100 cities.)

But the wheels soon came flying off the bone drug. Patients experienced esophageal “irritation”  and the warning to stay upright for one full hour after taking Fosamax, eating or drinking nothing was added after approval. One woman who took Fosamax but remained upright for only 30 minutes, not 60, had to be admitted to the Mayo Clinic with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine.

Next, dentists and oral surgeons discovered after simple tooth extractions and other in-office dental work, the jawbone tissue of patients on bisphosphonates would sometimes not heal but become necrotic and die — a condition called osteonecrosis of the jaw(ONJ), The necrotic condition did not take long to manifest “even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients” — wrote a dental journal, but it somehow slipped through Fosamax’s two, three-year clinical trials on which its FDA approval was based. Doctors, dentists, and pharmacists were enraged at what looked like deliberate obfuscation by Merck.

And there were second, third and fourth opinions about Fosamax! According to an FDA epidemiologist writing in New England Journal of Medicine in 2009 there were 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and 27 incidences of cancer in Europe and Japan and six deaths.

Next reports in medical journals linked bisphosphonates to the risk of developing atrial fibrillation, or a chronically irregular heartbeat and to severe bone, joint or muscle pain. “In the most serious cases, the pain was so severe that patients could not continue their normal activities,” wrote the FDA in a press release. “Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.” Clearly, the FDA was trying hard to avoid the word irreversible.

Finally, in a development that suggests tremendous medical ineptitude if not duplicity, bisphosphonates were found to sometimes cause the very fractures they were supposed to prevent. The thigh bones of patients on bisphosphonates have “simply snapped while they were walking or standing,” after “weeks or months of unexplained aching,” reported the New York Times in an article called “Drugs to Build Bones May Weaken Them.”

It should be embarrassing to the medical establishment that a prominent drug company and the FDA “discovered” severe side effects after years of patient use and that bone scans are still merchandised though they are of no value to 90 percent of women, according to the New England Journal of Medicine. It should be further embarrassing that Merck was allowed to make $3 billion a year off a drug that many say would not have been approved had clinical trials lasted longer. Its patent expired in 2008.

Now Merck is about to launch a new drug for osteoporosis called odanacatib which has already intrigued the money men on Wall Street. “Odanacatib may be a viable alternative for patients who need continued therapy and who want benefits beyond what they received from bisphosphonates,” a senior Merck research executive told Reuters without a hint of irony.

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

Related articles

October 22, 2012 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , , , , , | Leave a comment