Friday, July 25, 2008

Selling Prevention

Protecting Bones from Drugs that Protect Bones By MARTHA ROSENBERG

Like gastro-esophageal reflux and bipolar disease, osteopenia began to inflict millions when a drug to treat it came on patent.

Osteopenia or the risk of developing osteoporosis was concocted as a disease at a World Health Organization (WHO) osteoporosis conference in Rome in 1992 sponsored by two drug companies and a drug-company foundation writes Susan Kelleher in the Seattle Times.

Using the bone density measurements or "T scores" of a 30-year-old woman as a standard, the new condition, osteopenia, had "boundaries so broad they include more than half of all women over 50," writes Kelleher. And it didn't hurt that 10,000 bone density measuring machines appeared in doctors' offices by 1999 to detect the new disease--only 750 existed previously--many owned and financed by Merck whose anti bone-thinning drug Fosamax came online in 1995.

No wonder doctor visits for thinning bones increased by five million from 1994 to 2003 according to the Associated Press.

Of course selling "prevention" to at risk patients is a pharma goldmine.

It keep patients on meds for decades through fear, alarmist marketing and after-this-because-of-this reasoning--since a patient doesn't know if she would have gotten the disease anyway.

So even when reports of Fosamax-related jaw problems called osteonecrosis surfaced--1,000 cases have been documented--and even when a study in the Archives of Internal Medicine this year found Fosamax doubled women's risk of irregular heart beat which can cause clots and strokes, few doubted its primary action of protecting women's bones.

But now, like hormone replacement therapy which also exploited women's fear of aging and social marginalization, Fosamax appears to cause the conditions it's supposed to prevent.

Since 2006, articles in the New England Journal of Medicine, Journal of Orthopedic Trauma, Journal of Bone and Joint Surgery, Journal of Clinical Endocrinology & Metabolism, Aging Clinical and Experimental Research, Hong Kong Medical Journal, Geriatrics and Bone have suggested the anti-bone turnover action of bisphosphonate drugs like Fosamax can in some cases cause fractures.

Oops.

Sure bisphosphonates prevent bone loss that is caused by the process of bone turnover or remodeling. But they also fossilize and petrify a bone so it breaks spontaneously and with minimal trauma--like chalk--scientists now say. Nor will it heal properly.

Thighbones of patients on bisphosphonates have "simply snapped while they were walking or standing," reported the New York Times in July following "weeks or months of unexplained aching."

Like other fast-tracked-to-Wall-Street drugs which are effectively "tested" on the first users, adverse reports about bisphosphonates came from patients and practitioners long before the FDA or manufacturers.

Bisphosphonate patients documented excruciating pain from Fosamax since 2001 and GlaxoSmithKline's Boniva since 2006 on askapatient.com, many calling the drugs "poison" and saying they were forced into wheelchairs.

But only in March did the FDA alert healthcare professionals to the, "severe, sometimes incapacitating musculoskeletal pain" bisphosphonate drugs could cause in their patients and caution them to consider whether musculoskeletal pain "might be caused by the drug" not the bone condition.

Not only is the pain bisphosphonate patients report "not in their heads"--imagine 1,257 men on askapatient.com saying their doc dismissed their constant pain and symptomology--it is emblematic of what is really going on.

"There is actually bone death occurring," Dr. Phuli Cohan told Mallika Marshall, MD Medical Reporter for Boston's WBZ-TV News in May. "People don't want to believe that this is happening, but it is a side effect of the medicine," she said.

Dr. David Hunter of the New England Baptist Hospital concurs that bisphosphonates can cause "Dead Bone Syndrome" and patients should have a "drug holiday to allow bone cells to rejuvenate," reports Marshall.

Even drug reps on industry chatroom cafepharma are skeptical about bisphosphonates.

"They over suppress the bone and 'may' cause sub trochanter fractures," wrote one anonymous poster on a thread called "Is Boniva dead" sparked by a rumor that Boniva pitchwoman Sally Fields had fallen and broken a bone. "It's the next hot button."

Nor do bisphosphonates exit the body quickly when patients quit according to a 2006 study in the Journal of the American Medical Association--but remain for years.

(Patients "need not take costly bone-building drugs such as Fosamax for life to reap the medicine's protective benefits," was the News & Observer's upbeat interpretation of the drug's tenacity.)

If bisphosphonates prove to be the next hormone replacement therapy--causing the conditions they were supposed to treat--the osteopenia epidemic will no doubt clear up.

Especially since the patents are running out.
Martha Rosenberg is staff cartoonist on the Evanston Roundtable. She can be reached at mrosenberg@evmark.org

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