Saturday, March 27, 2010

What If, God Forbid, Sally Field Broke Her Leg?

[UPDATE: See "Bone-Loss Drugs Linked to Increased Risk of Thigh Fracture - FDA May Act"]

As written in wikipedia, "Break a leg" is a well-known saying in theatre which means "good luck." It is typically said to actors and musicians before they go out onto stage to perform.

I doubt, however, that anyone would say this to Sally Field before filming one of her BONIVA TV commercials. BONIVA, after all, is a drug designed to PREVENT bone fractures in women with postmenopausal osteoporosis.

Actually, the patient information page (on Genentech's site) linked to from the BONIVA Web site says "Boniva helps reverse bone loss in most women who take it, even though they won't be able to see or feel a difference. Boniva may help lower the chances of breaking bones (fractures)."

The part about preventing broken bones, however, is merely conjecture propagated by the marketers of BONIVA. They know that women with osteoporosis are prone to bone fractures and that's what gets them to take the drug.

But does BONIVA and other similar drugs such as Merck's FOSAMAX, Procter & Gamble’s ACTONEL, and Novartis' RECLAST actually INCREASE a woman's chance of breaking a bone?

Where do I get a crazy idea like that? Well, from patients via social media! You know, the crowd that has all that wisdom. In a blog post entitled "Pharma and New York Times are 'Puzzled' by Bone Drug Fractures -- But Patients Aren't," the author cites patient testimonials seen on askapatient.com, a social network site where people can rate the medicines they are taking.

On a scale of 1 to 5 (1=LOW, 5=HIGH), BONIVA gets a score of 1.3 based on 1084 ratings.

Patients also posted stories about how they broke bones while taking BONIVA and similar drugs:
"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."

"I am filling this out because my Mom took Boniva for many years. I now realize her death was in part due to her taking Boniva. She had so many of the side affects listed and I wish I had known while she was alive that they were caused by Boniva, so I could have taken her off of this poison.I suggested that she go on this-I feel so guilty. I hope this report helps others recognize what this drug does to your body. It certainly did not make my mother's bones stronger. She had so much muscle pain all over, but especially her back, broke her pelvis and had fratures in 4 vertebrae while taking Boniva."
The site is a virtual treasure trove of adverse events reported by patients! You can find the BONIVA stories here. Oh, the humanity!

I noted before that relying on the "wisdom of the crowd" to decide which drugs to take was a mistake (see "Crowdsourcing Vs. Science"). So, I don't believe in patient ratings of drugs when you don't even know the N -- the number of people voting, which was the case with the iGuard ratings I criticized.

But 1084 is a pretty impressive N! Also, I might look to the crowd's negative experiences to help inform me of the risks of drugs I am taking or about to take.

Like all Rx drugs, BONIVA has risks. One of them is increase bone brittleness, according to this report cited in the blog post I mentioned above:
"Bisphosphonates preserve and remineralize bone by turning off bone remodeling– creation of new bone–that would normally occur. But as early as 2004, Gordon Strewler, MD in the New England Journal of Medicine and Susan M. Ott, MD in the Annals of Internal Medicine warned the remineralized bones could become brittle and fracture-prone and that the drug may actually cause what it is supposed to prevent."
In a study sponsored by Merck and Novartis, in which 14,000 women were given Fosamax, Reclast or dummy treatments for three to 10 years, these drugs do not "significantly raise the risk of a rare type of fracture near the hip" (see "Study Adds Evidence That Bone Drugs Work, Are Safe").

That conclusion was based on 12 such "rare types of fractures near the hip." Meanwhile, there a total of 284 hip and leg fractures in the study group.

This is reassuring, although the study cannot rule out risk, said Dr. Dennis Black, the study's leader, who consults for makers of osteoporosis treatments. There was a trend toward more of these unusual fractures among bisphosphonate users, but the difference was small enough to have occurred by chance. "There are too few fractures for definitive proof. But what it does show is that these are very, very rare," Black said.

The study was designed to counteract case reports that have tied these drugs to the unusual fractures of the upper thigh bone, just below the hip, that seem to occur without provocation or injury. But I don't think the results warrant the glowing NYT headline "Study Adds Evidence That Bone Drugs Work, Are Safe."

Another problem with the study was it was a "meta-analysis" of several different studies. I think GSK has balked at using such analyses when Dr. Steven Nissen cited the heart risks associated with AVANDIA. Just another example of the drug industry having its cake and eating it too!

Anyway, back to Sally. She's been a spokesperson for BONIVA since 2006. So far, she hasn't broken a leg that I know of and I hope she doesn't break any bones in the future. It would be a devastating event both for her and for BONIVA, which is my focus here.

The problem with celebrity endorsements is that the celebrity may experience a side effect and become disgruntled and turn on the brand (see "Andy Behrman, Now an Anti-BMS Spokesperson, Says 'Ask Your Doctor If Abilify is Wrong for You'").

Sally has been taking BONIVA now for 4 years. Perhaps it is time for GSK to drop her before she becomes a liability. But, I wish her good luck. Break a leg, Sally!

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P.S. Meanwhile, Novartis uses "real" women to tell their Reclast stories.

That's "Rhoda" on the left. "Age 65 • Senior citizens program director • Widowed • Plays a mean game of bridge, bakes the best brownies, knits one, purls one (scarf is a work in progress)" is how the site describes her on the Meet Rhoda page.

Is she a real patient?

10 comments:

  1. The Merck/Novartis published study you mention is a terrific example of the triumph of marketing over medicine.

    For example, this New England Journal of Medicine's article’s own lead author confesses:

    “The study was underpowered for definitive conclusions.”

    Underpowered for definitive conclusions? We might justifiably ask why any medical journal would be stooping to publish an industry-funded, essentially meaningless meta-analysis that the paper’s own authors admit lacks any “definitive” conclusion.

    And yet virtually all media coverage has somehow omitted that little problem - instead, trumpeting like the sensationally inaccurate New York Times headline does: "Study Adds Evidence That Bone Drugs Work, Are Safe".

    The study does no such thing!

    Even more troubling than a journal article that was itself bought and paid for by Big Pharma, is the conflict of interest disclosure list at the bottom of this NEJM article.

    Of the 12 study authors listed in the NEJM article, for example, at least three are full-time employees of Merck or Novartis.

    And every single one of the remaining "researchers" - and I use this word charitably - admit owning equity interests in or receiving cash, travel expenses, or “consulting and lecture fees” from dozens of drug companies -it's like a 'Who’s Who' of the industry.

    Sellers of bisphosphonate drugs may well be in big trouble now with all these pesky medical warnings that bisphosphonates like Fosamax, Actonel or Boniva can make our bones brittle, not stronger. As Dr. Susan Ott describes: "Many people believe that these drugs are ‘bone builders,’ but the evidence shows they are actually bone hardeners.”

    Dr. Ott, by the way, can hardly be dismissed as representing "the wisdom of the crowd" or a mere "patient testimonial".

    Big Pharma can and must do whatever they can to bury the bad news and pump up the good, however they can, including buying a few doctors and a medical journal or two.

    More on this at: "We Never Imagined People Would Think Of Osteopenia As A Disease!" at: http://ethicalnag.org/2010/02/06/osteopenia/

    Regards,
    Carolyn Thomas

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  2. Carolyn,

    Thanks for that very informative comment.

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  3. Could it be that bisphosphonates make bones harder but not necessarily stronger?

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  4. Jeanne1:34 PM

    Hi, John. We have an online support group for women and men who have experienced spontaneous femur fractures and/or stress fractures from taking these meds. The stories are heartrending.

    This so-called "study" is a joke, bought and paid for by Merck and the other manufacturers. Important data was excluded as mentioned above. And, the women took smaller doses than usual and only a fraction of them had been on the medication for longer than 5 years.

    It was expected for Merck to fight back with such tripe. The market for these drugs is more than $4 billion a year.

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  5. Anonymous9:48 PM

    Jeanne,

    How do you the link to the online support group mentioned above? I have looked for such a support group since 2005, when I became affected by recurrent rib fractures caused by bisphosphonates.

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  6. Break a leg; very strange sort of way to wish some one, good luck. I hate drugs, I used to be ill every time having devil pills all around me , then I joined the jym, now free from doctors.

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  7. mary R.3:13 PM

    John,

    Thanks for covering the problems caused by taking bisphosphonates. Nobody should take them, but women get scared into doing it. The more you and others cover this story, the better for all of us.

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  8. Thx for your comment.

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  9. I still believe that pharma companies are trying to accomplish the same goal although you certainly pointed out some excesses in that effort.

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  10. this is a pretty crazy article, so first off thanks for posting it. I can't believe that people taking a medicine that's supposed to do one thing, but ends up doing another. If it's supposed to help strengthen your bones you shouldn't break a bone. To the story about the woman who broke a femur in each leg, I could see one time being an accident, but the second time no. Something should be done.

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