Let no one say the studies in JAMA are funded by hidden drug company money. The funding is right out in the open.
"Effects of Continuing or Stopping Alendronate After 5 Years of Treatment," in the December 27, 2006 issue of JAMA was funded by Merck who manufactures alendronate, a bisphosphonate, under the patent name Fosamax.
Not only was the study "supported by contracts with Merck and Co" according to JAMA, it "was designed jointly by the non-Merck investigators and Merck employees" and written "with editorial input from Merck throughout the process."
Want further transparency? "The final version of the manuscript was approved 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 companies including Eli Lilly, Pfizer, Roche, SmithGlaxoKline, Wyeth, Novartis, Procter & Gamble and of course Merck.
And the three Merck authors disclosed they "potentially own stock and/or stock options"--as if working for Merck weren't enough of a conflict of interest.
Dr. Cathleen S. Colon-Emeric who wrote an accompanying editorial, "Ten Vs Five Years of Bisphosphonate Treatment for Postmenopausal Osteoporosis," and discloses she has received money from Novartis, even appears on an "Understanding Osteoporosis" Novartis web page.
It's a good thing editor in chief Dr. Catherine DeAngelis has cleaned things 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 mid 'nineties 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 so patients wouldn't have to go too far to be told they had osteopenia which they all had--a term that also appeared when bisphosphonates did, meaning low bone mass or low rate of drug sign up depending on whom you ask.
But there were a few wrinkles in the bone-anza.
Soon after Merck launched Fosamax, it was slapped with an FDA warning that its advertising was misleading and in violation of the Federal Food, Drug and Cosmetic Act.
"The headline on page two, 'Menopause is the single most important cause of osteoporosis' is false," wrote Anne M. Reb, Regulatory Review Officer in a July 2, 1997 letter, "because although menopause is a factor contributing to the development of osteoporosis, menopause alone does not cause osteoporosis. Further the headline [Are You One of 20 Million Women With Osteoporosis?] is misleading because it overstates the population eligible for therapy with Fosamax by implying that all women 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 another pill called Vioxx.
Doctors were also having doubts.
"Many people believe that these drugs are 'bone builders,' but the evidence shows they are actually bone hardeners," wrote Dr. Susan M. Ott in the Annals of Internal Medicine in 2004 pointing out that they depress "the bone resorption rate as well as the bone formation rate" and "bones could become brittle with long-term accumulation."
Big pharma should rebuild it's public image.Recent survey shows only about 9% of Americans trust them,this is the same as the tobacco companies.
Hey,they have an estimated 90,000 drug reps in the USA promoting to doctors.
Eli Lilly has a rich humanitarian history,but if you do a blog search of "Eli Lilly and "zyprexa (their blockbuster) keywords you will find much negative blogging.
Some of it is from claimants of their Zyprexa settlement like myself who are still awaiting promised resolution.
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Danny Haszard Eli Lilly customer www.zyprexa-victims.com
by
Danny Haszard (2 articles, 0 quicklinks, 0 diaries, 53 comments)
on Sunday, January 7, 2007 at 4:22:17 AM
It will be interesting to read the responses you receive from the Fosamax article. It is interesting that Merck is just now coming out with this information when Fosamax is coming off patent. It will also be a kick in the pants to Merck if Teva decides to back off jumpting into the market. I doubt they will in light of the billions to be made selling this stuff. Oh, and note that good docs will not give this drug to women with osteopenia and will suggest the best option is vitamin D, calcium and exercise. Further, note that the test of choice is bone densitometry to establish a baseline guide to determine the need for any bisphosphonate. The problem is that the followup tests are useless as most prescribers tell you that if the scan shows "worse", they say imagine how bad it would be without Fosamax. If it's the same, they say it's working. Same thing if it shows improvement. Finally, ask yourself if this stuff stays in the bones for 10 yrs, what is it doing? Just my thoughts.
Lowell
by
Lowell Finson (0 articles, 0 quicklinks, 0 diaries, 1 comments)
on Monday, January 8, 2007 at 9:38:42 AM
2 comments
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