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 that 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 1990s, 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, used for the treatment of osteoarthritis.
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."
Indeed, problems from lack of bone formation is exactly what
a study in the March 2005 issue of the Journal of Clinical Endocrinology &
Metabolism (Severely suppressed bone turnover: a potential complication of
alendronate therapy) found.
"We report on nine patients who sustained spontaneous
nonspinal fractures while on alendronate therapy, six of whom displayed either
delayed or absent fracture healing for 3 months to 2 years during
therapy," wrote the authors.
"Our findings raise the possibility that severe
suppression of bone turnover may develop during long-term alendronate therapy,
resulting in increased susceptibility to, and delayed healing of, nonspinal
fractures."
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 where over 450 rate the drug. "It is as though my ligaments
became crystallized, without elasticity."
"After six years of taking Fosamax, I slipped in ice in
my driveway and broke my femur (thigh bone). Two years later, still taking
Fosamax, I fell 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 after going 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., after
years of litigation. Generics maker Teva Pharmaceutical Industries is now
nipping at Merck's heels and ready to begin marketing alendronate next year.
In its self-funded study, "Effects of Continuing or
Stopping Alendronate After 5 Years of Treatment," -- did JAMA charge ad
rates? -- Merck concludes the residual effects of Fosamax in women who have
taken the drug 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. Her work has
appeared in the Chicago Tribune, LA Times, San Francisco Chronicle, Boston
Globe, Providence Journal. Arizona Republic, New Orleans Times-Picayune and
other newspapers. She can be reached at: mrosenberg@evmark.org.