In its 64 page annual report it predicted arthritis medicine Vioxx--Our Biggest, Fastest and Best Launch Ever!--would prevent Alzheimer's disease and colon cancer.
It announced it was seeking approval to market asthma drug Singular to two-year-olds.
And it predicted 40 million women would take its new osteoporosis drug the bisphosphonate Fosamax as it continued to "help educate both physicians and patients" about the bone disease.
Of course Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long term users, Singular is suspected of causing suicide and Fosamax is tightly linked to osteonecrosis, atrial fibrillation, intractable pain and now cancer.
While everyone knew Fosamax (alendronate) and the esophagus didn't mix--patients who don't remain upright for half an hour after taking it risk inflammation, ulcers, bleeding, blockage and sometimes perforation (see: landmine in throat)--no one expected the salvo from the FDA which appeared in the Jan. 1 New England Journal of Medicine.
There have been "reports of 23 patients in the United States receiving a diagnosis of esophageal cancer, with alendronate (Fosamax, Merck) as the suspect drug (in 21 patients) or the concomitant drug (in 2 patients)," wrote Diane Wysowski of the FDA's division of drug risk assessment, leading to eight deaths.
Europe and Japan have had 27 cases of esophageal cancer from Fosamax and similar drugs with six deaths Wysowski wrote.
And while most people knew Fosamax could cause osteonecrosis of the jaw (ONJ or jaw bone death)--dentists and the FDA reported it in 2004 though Merck wouldn't label it until 2005---few expected the definitive study in the Jan.1 Journal of the American Dental Association which said "even short-term oral use of alendronate led to ONJ."
Oops.
Like Vioxx which was launched a month early thanks to its collegial relationship with the FDA, Fosamax was rushed to market in 1995 six months after its application on the basis of two three-year studies.
Why hold up profits testing a drug when it can be "tested" on first users--the public--and make money at the same time? Merck may have paid $4.85 billion in 2007 to settle with 140,000 Vioxx heart attack victims--but it still made a profit. (see: forgiveness vs. permission).
So no one was surprised when Merck had to send a Dear Doctor letter about Fosamax--"Since market introduction some of these [esophageal] side effects have been of greater severity than we observed in our controlled clinical trials, said the letter,"--just months later.
In fact the FDA threatened to revoke its act-in-haste approval over the emerging side effects says Fortune magazine but the head of Merck research at the time, Edward M. Scolnick "wrote to doctors, in his own hand, explaining the causes" and convinced the FDA "to let Merck keep Fosamax on the market, albeit with a warning label that told patients to sit upright for an hour after taking the drug."
Thanks to Merck's osteoporosis "awareness" campaign which included placing of its own bone density measuring machines in doctors offices in the 1990's, the number of people "at risk" for osteoporosis grew from half a million sufferers to 3.6 million.
But in addition to questions about osteonecrosis, esophagitis, an irregular heartbeat and other side effects--there were questions about Fosamax' very action as a "bone strengthening" drug.
What angers me most about this drug is that most women entirely rely on their doctors who prescribe it. And of course the doctors rely on the FDA which approves it. How sad that most women or men don't do a whole lot more exploration on their own re the drugs that are pushed on us. I have been afraid of drug usage for years. Somehow for an "intelligent" nation, I guess we really aren't.
And another gripe of mine - the doctors like to jump on alternative medicine and supplement use. What nerve. Neither by and large has caused so much illness and death as the drugs they push on a gullible society.
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Suzana Megles (66 articles, 0 quicklinks, 21 diaries, 363 comments [43 recommended, 0 rejected]) on Sunday, Jan 4, 2009 at 1:55:10 PM
After I broke my hip and my back became bent I was told I had severe osteoporosis. I was prescribed Fosamax. I was desperate and took it very carefully for a year. That was 4 years ago. After I read so much bad stuff about it I stopped taking it. My dentist was horrified when I told him I had been taking it. Apparently the dangers stay in your body for many years even after stopping taking it. I've been taking Strontuim Citrate and all the vitamins I've read help bones; and staying away from drugs. So far, I'm okay.
Martha Rosenberg wrote a wonderful, extremely informative article.
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EnceladusJ (0 articles, 0 quicklinks, 0 diaries, 18 comments [3 recommended, 0 rejected]) on Sunday, Jan 4, 2009 at 4:47:24 PM
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