Bone Loss and the Drug Fosamax

I hope and pray the day will come when we can once again return to the wisdom of Hippocrates who said, "Let your food be your medicine and your medicine be your food."

The following is an article exposing the conflict of interest between JAMA's study of Fosamax funded by the very company making the drug - Merck - and the long term health risks uncovered.

If you want healthy bones then you have to make healthy blood. And if you want healthy blood then you must eat and drink green foods.

Once we understand that our bones our a product of our blood then we will understand how to prevent bone loss.Bone loss is also the result of the body in preservation mode protecting the delicate pH balance of the blood and tissue from an over-acidic lifestyle and diet.

The key pH Miracle Secret to healthy bones is in the blood and maintaining the alkaline design of our body.Not part of our healthy alkaline community? Join us now at: www.phmiracleliving.com

Health

JAMA's Fosamax study funded by Merck

By Martha Rosenberg

Online Journal Contributing Writer

Jan 9, 2007

Let no one say the studies in JAMA are funded by hidden drug companymoney. The funding is right out in the open."Effects of Continuing or Stopping Alendronate After 5 Years ofTreatment," in the December 27, 2006, issue of JAMA was funded by Merck that manufactures alendronate, a bisphosphonate, under the patent nameFosamax.

Not only was the study "supported by contracts with Merck and Co.,"according to JAMA, it "was designed jointly by the non-Merckinvestigators and Merck employees" and written "with editorial inputfrom Merck throughout the process."

Want further transparency? "The final version of the manuscript wasapproved by all coauthors, including Merck authors," says JAMA.

The study's 11 non-Merck authors disclosed 40 research grants,consultancies and other financial relationships with drug companiesincluding Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth, Novartis, Procter & Gamble and, of course, Merck.

And the three Merck authors disclosed they "potentially own stock and/orstock options" -- as if working for Merck weren't enough of a conflictof interest.

Dr. Cathleen S. Colon-Emeric who wrote an accompanying editorial, "TenVs Five Years of Bisphosphonate Treatment for PostmenopausalOsteoporosis," and discloses she has received money from Novartis, evenappears on an "Understanding Osteoporosis" Novartis web page.It's a good thing Editor in Chief Dr. Catherine DeAngelis has cleanedthings up since the scandals about JAMA authors taking undisclosed drug company money earlier in 2006.

Of course the osteoporosis market is big -- the malady "grew" from half a million to 3.6 million when bisphosphonates were introduced in the mid1990s, says the Associated Press with tongue firmly in cheek -- and Fosamax is Merck's second biggest performer.

Merck even presciently went into the bone density measuring equipment business, says Maryann Napoli of the Center for Medical Consumers, sopatients wouldn't have to go too far to be told they had osteopenia(which they all had) -- a term that also appeared when bisphosphonatesdid, meaning low bone mass or low rate of drug sign up, depending onwhom you ask.

But there were a few wrinkles in the bone-anza.Soon after Merck launched Fosamax, it was slapped with an FDA warningthat its advertising was misleading and in violation of the FederalFood, Drug and Cosmetic Act."

The headline on page two, 'Menopause is the single most important causeof osteoporosis' is false," wrote Anne M. Reb, regulatory reviewofficer, in a July 2, 1997 letter, "because although menopause is a factor contributing to the development of osteoporosis, menopause alonedoes not cause osteoporosis. Further the headline [Are You One of 20Million Women With Osteoporosis?] is misleading because it overstates the population eligible for therapy with Fosamax by implying that allwomen develop osteoporosis at menopause."

Two years later Merck was again cited for misleading advertising, this

time for failing to include risk information about Fosamax and anotherpill called Vioxx, used for the treatment of osteoarthritis.

Doctors were also having doubts.

"Many people believe that these drugs are 'bone builders,' but theevidence shows they are actually bone hardeners," wrote Dr. Susan M. Ottin the Annals of Internal Medicine in 2004, pointing out that theydepress "the bone resorption rate as well as the bone formation rate"and "bones could become brittle with long-term accumulation."

Indeed, problems from lack of bone formation is exactly what a study inthe March 2005 issue of the Journal of Clinical Endocrinology &Metabolism (Severely suppressed bone turnover: a potential complicationof alendronate therapy) found.

"We report on nine patients who sustained spontaneous nonspinalfractures while on alendronate therapy, six of whom displayed eitherdelayed or absent fracture healing for 3 months to 2 years duringtherapy," wrote the authors.

"Our findings raise the possibility that severe suppression of boneturnover may develop during long-term alendronate therapy, resulting inincreased susceptibility to, and delayed healing of, nonspinalfractures."

And there were patients themselves.

"I still suspect I have been permanently (or hopefully semi-permanently) altered by Fosamax," wrote one woman on the web site Ask a Patient whereover 450 rate the drug.

"It is as though my ligaments becamecrystallized, without elasticity."

"After six years of taking Fosamax, I slipped in ice in my driveway andbroke my femur (thigh bone). Two years later, still taking Fosamax, Ifell in the snow and my other femur snapped before I hit the ground,"wrote another woman.

"My condition is basically the same as rickets," wrote a third aftergoing off Fosamax.

And there was more bad news.

Merck's attempt to bill a once a week version of Fosamax as a new drug protected by a new patent -- yeah, right -- until 2018 was denied by the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., afteryears of litigation. Generics maker Teva Pharmaceutical Industries is now nipping at Merck's heels and ready to begin marketing alendronatenext year.

In its self-funded study, "Effects of Continuing or Stopping AlendronateAfter 5 Years of Treatment," -- did JAMA charge ad rates? -- Merckconcludes the residual effects of Fosamax in women who have taken thedrug for five years will last indefinitely. (Just what many feared.)

What else will last indefinitely is the effect of Merck's shameless and deceptive marketing.

Martha Rosenberg is a Staff Cartoonist at the Evanston Roundtable. Herwork has appeared in the Chicago Tribune, LA Times, San Francisco Chronicle, Boston Globe, Providence Journal. Arizona Republic, NewOrleans Times-Picayune and other newspapers. She can be reached at:mrosenberg@evmark.org <mailto:mrosenberg@evmark.org> .

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