Fosamax Joins Vioxx and Vytorin in Merck’s Lethal Trifecta

1999 was a good year for Merck.

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Of course Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long term users, Singular is suspected of causing suicide and Fosamax is tightly linked to osteonecrosis,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.

And that’s not counting Congressional inquiries into alleged Vytorin deceptions!

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.

“Crystalline material similar to ground alendronate tablets has been found in patients with erosive esophagitis, and persistent mucosal abnormalities have been noted in some of these patients, suggesting a potential for carcinogenic effects,” wrote Diane Wysowski of the FDA’s division of drug risk assessment.

In fact, there have been 23 reports of Fosamax-associated esophageal cancer in the US and eight deaths writes Wysowski. Europe and Japan have had 27 cases of esophageal cancer associated with Fosamax and similar drugs with six deaths.

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 didn’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 for mere testing? Merck may have had to pay $4.85 billion in 2007 to settle with 140,000 Vioxx victims–but it still made a profit on Vioxx. (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 after approval.

In fact the FDA threatened to revoke its act-in-haste approval over the emerging esophageal 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 to 3.6 million.

But in addition to questions about osteonecrosis, esophagitis, irregular heartbeat and other side effects–there were questions about Fosamax’ very action as a “bone strengthening” drug.

Was Fosamax’s anti-bone remodeling action that was supposed to stop or prevent osteoporosis actually making the bone more brittle and fracture prone because it was not “turned over”?

“We report atypical skeletal fragility in three subjects after long-term, combined anti-remodeling therapy,” began a study in the Aug. 2008 Journal of Clinical Endocrinology & Metabolism.

“An Emerging Pattern Of Subtrochanteric Stress Fractures: A Long-Term Complication Of Alendronate Therapy?” was the title of another in the Feb. 2008 Injury.

“Low-Energy Femoral Shaft Fractures Associated With Alendronate Use,” was the title of another in the 2008 May-June Journal of Orthopedic Trauma.

Yes, Fosamax emerged as a drug with dangerous side effects whose primary action may not even work! And might even cause what it is supposed to treat.

Or, as the old joke goes: bad food and such small portions.

There are even questions about the “large number of giant hypernucleated, detached osteoclasts” Fosamax creates–when its bone building “works”–also in the Jan.1 New England Journal of Medicine.

As with Vioxx, suspicious journal articles surfaced that “sell” Fosamax like “Loss Of Treatment Benefit Due To Low Compliance With Bisphosphonate Therapy”–get it?–and “Consequences Of Poor Compliance With Bisphosphonates.”

Posters like “Underuse of Osteoporosis Treatment in Postmenopausal Women,” authored by an “employee of Merck & Co”–hello?–were presented.

Merck-funded doctors blamed ONJ on cancer and “bad oral hygiene.”

And, since the damaging Jan. 1 revelations about jaw bone death and cancer, one Merck-associated physician, Dr. Nicholas Shaheen, director of the University of North Carolina Health Care’s Center for Esophageal Diseases, is urging people to stay on Fosamax because its “cancer risk doesn’t outweigh” its benefits.

“If the bisphosphonate gets hung up above the narrowing, it can irritate or burn the tissue around where it gets hung up,” he said. “That’s because the pill never went down into the stomach where it is very well tolerated,” he told MyNC.com.

But Merck’s audacious marketing which includes threatening medical schools according to Tom Nesi in the 2008 book Poison Pills, doesn’t matter anymore.

Fosamax’s patent ran out in February 2008 and Merck got its money’s worth.

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her latest book is Big Food, Big Pharma, Big Lies (2023). Her first book was Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health. She can be reached at: martharosenberg@sbcglobal.net. Read other articles by Martha.

10 comments on this article so far ...

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  1. The Angry Peasant said on January 19th, 2009 at 2:26pm #

    Yet another example of the sheer evil behind the American medical industry. Not only do we get almost no health care or medicine, but what we do get will probably kill us faster than the actual disease we have. All so a few terrible people can turn that profit! And our beneficent government keeps looking the other way or even lending a big hand to the pharmaceutical companies. The FDA is practically employed by companies llike Merck now. Great checks and balances there. Jesus, it’s terrifying to be an American. I think that’s the terror we should be waging war on. Revolution!

  2. Stunned2bme said on January 19th, 2009 at 2:44pm #

    Just great! Finding out my both my family physician and ob/gyn have been cheerleaders for this poison makes me distrust any advice thay would give. Now the question becomes how to find a physician who isn’t in the pocket of the pharmaceutical industry. All suggestions greatly appreciated.

  3. frank said on January 19th, 2009 at 3:38pm #

    I’m sorry, what is the average life expectancy in the US these days? Must have nothing to do with the pharmaceutical industry, I guess…
    Morons

  4. The Angry Peasant said on January 19th, 2009 at 5:20pm #

    The average life expectancy? About 70. Like most of the industrialized world. Whoopee. If it were 108, I might be impressed. And it certainly isn’t from the drug companies. But never you mind, Frank, just keep praising the pharmaceutical companies and their bottom lines.

  5. frank said on January 19th, 2009 at 6:20pm #

    “Most of the industrialized world” had ready access to pharmaceuticals, peasant. There are aspects of this industry that I don’t happen to agree with, like direct-to-consumer advertising (mainly because the average American seems incapable of understanding that there never has been, nor ever will be a 100% safe drug), but I am convinced that few endeavours are as beneficial to the world in general. Are mistakes made? Yes, of course. But drug discovery is only as good as the science upon which it was based, and Lord knows that’s often flawed to begin with. I also hate it when people like you dismiss clinical studies performed by the industry out-of-hand with no idea what goes into one. How many other industries must supply years of consumer data before being allowed to market their product?

  6. The Angry Peasant said on January 19th, 2009 at 7:14pm #

    That’s just my point. The FDA now sits comfortably in the back pocket of the pharmaceutical industry, and allow drug after drug to be passed with a fraction of the research and testing that by law is supposed to go into them. This is happening with many drugs all the time to quicken the pace to market. The drug companies have powerful lobbies and influence, and the FDA looks the other way when many of these under-researched drugs hit the market prematurely. Hence the Vioxx fiasco and others. This is the systemic problem I’m talking about. Of course I’m not anti-medicine. I’m anti- medicine-as-a-quick-money-maker, with no regard for public health.

  7. S. WOLF said on January 20th, 2009 at 4:24pm #

    SOMETHING IS VERY WRONG WHEN COMPLEX DRUGS ARE ALLOWED TO BE MARKETED TO THE LAYMAN!

  8. David said on January 21st, 2009 at 9:53am #

    Let me suggest a solution to this problem, perhaps one that has broad applicability.

    Lobby your representatives to remove the corporate liability umbrella laws that allow executives and board members to escape civil and criminal penalties for the actions of their companies.

    Don’t forget to set aside a few bucks for larger prisons.

  9. Bill Vioxxophobia said on January 25th, 2009 at 1:33pm #

    As a former Vioxx patient who took the “wonder drug” for 18 months, I’ve had countless visual migraines, several “atypical hemoplagic migraines,” and a few TIAs. Because I didn’t know what a TIA was, I didn’t go to a doctor or to an ER when the first one occurred. Thus, I could not qualify for the legal case against Merck.

    My PCP was a cheerleader for Vioxx as was Dorothy Hamil (the ethically challenged Olympic skater). Fortunately, my rheumatologist insisted that I get off Vioxx. I’ve kept physically active, but I have had to take protonix, verapamil, aggrenox, and cyproheptadine to counter Vioxx’s effects. Of course, my HMO and I pick up the costs for Vioxx’s mistakes. The HMO can pass the costs onto its subscribers. If the subscriber is a company, it can deduct the cost from income. Somehow, Merck gets off. I’m shocked, utterly shocked. 😉

  10. Dr Radius said on February 1st, 2009 at 3:11pm #

    @ The Angry Peasant

    “FDA now sits comfortably in the back pocket of the pharmaceutical industry” where have you been in 2008? Two new products were approved in the EU yet were rejected by the FDA over safety concerns last year. The drugs are Bridion/Sugammadex and Cordaptive/ER niacin & laropiprant.; and the data used in their approval in the EU is the same as what was shown to the FDA.

    Bridion is the first new drug for anesthesiologists in over 20 years. It was engineered from the ground up to reverse some of the effects of the temporary paralysis that is induced during general surgery by anesthesiologists. This product would have actually saved money for many hospitals in the US as they would be able to get patients recovering from general surgery to wake up an move faster. Its also better for patients as they could receive less toxic neuromuscular block agents to start with.

    Cordaptive took a newer compound and added it to Niacin which boosts HDL; this was done to avoid the horrible flushing that comes for many patients who take Rx Niacin products today cannot handle the side effects and stop taking the product. For older high risk women HDL is as important as LDL in preventing a stroke or heart attack.

    Both products were very important in the US as we lead in general surgery and have a higher risk of cardio issues than the rest of the world. Yet this bought off FDA you speak off rejected both of these drugs in the worlds neediest and largest market for these medical needs; against the the will of both third party advisory committees and many patient and physician groups.

    I am not saying the FDA is wrong or right; however they had enormous pressure and reasons to approve these drugs for the safety and health of the American public and they rejected them (where is this powerful pharma hand you speak of, surely it could easily get them to switch thier minds). Meanwhile both products do well in the EU countries have not yet shown any safety issues in general use. Time will tell if the FDA was wise or not.

    As you seem to be a member of the ‘Tin Foil Hat Crowd’ Cordaptive is a Merck product and Bridion a Schering-Plough product. I thought Merck
    practically employed the FDA. What happened?

    You clearly have no idea what a proper clinical study is; and whats involved in getting a drug approved in the US. So let me help out…

    Imagine GM must test its products for 5-8 years with test drivers to make sure their cars are safe and effective, needing to prove beyond a shadow of a doubt how this new car is better (or at least as good as) all the other cars in its class today, and than after at least five years and tens of millions of dollars in development they can submit it to the govt. for approval. They have less than a 50% chance of getting approved at all and until this federal government division (with no elected officials) approve the car it cannot be sold or marketed in this country.

    Don’t forget after about 5-6 years this new fictional GM car is approved all of its plans and design specs are available for free to anyone who would like to make a copy. New companies that can prove they can make a good copy of the car; simply copy the plans and manufacture a similar product, undercutting the cost of the originator as much as they want. Car dealers get to substitute these knockoff cars as they wish; with little if any communication to the person buying the car. Of course foreign countries get the plans and copy the new GM car 2 months after it first comes out (not feeling that patent protection matters) and gives the car to its own people for nearly nothing, and also occasionally they sell knockoffs to US citizens on the Internet.

    Unsafe and defective cars kill more people in a year than all of the possible and as of yet clinically unproven deaths resulting in the use of the drugs you mentioned in the last 10 years. You have zero perspective.

    Do you think we would even have a GM to bail out if they had this sort of restriction in the automotive world Angry Peasant, if they did I think your new 2009 Chevy Yukon would look a lot like a 1981 Olds Caprice and cost about $149,999

    We live in the most conservative health regulated environment in the world; yes the FDA has made mistakes; yes the occasional pharma product has been released with issues; but overall we have one of the safest track records of any industry you choose to name in this country.

    Go move to a socialist country with govt. supplied healthcare if you don’t like the USA. Just hope you don’t have a heart attack or need a new knee and the wait weeks or months for a procedure to help you.

    However you should look at the bright side Angry Peasant; if you live in the EU you can benefit from two products that the FDA said were not safe enough for you to take as an American citizen, that are also made by American companies.