Currently viewing the tag: "Merck"

The Fosamax mistrial, and other options in osteoporosis medication

Earlier this month, a closely-watched trial over the osteoporosis drug Fosamax ended in mistrial, to the frustration of nearly everyone involved. The trial was marked by great tension, with a deadlocked jury, reports of threats of physical violence, and a judge-ordered cooling-down period.

What could cause such intense drama? Well, this was just one of approximately 900 state and federal cases pending against Fosamax, alleging that that medication causes osteonecrosis of the jaw (the death of jawbone tissue). In large part, the tension in the Manhattan courtroom was that this trial “the first” was supposed to be an indicator of how these hundreds of similar cases might proceed. The other major factor is that it is notoriously difficult to “prove” drug-related injuries, and this difficulty was definitely shown in the frustration and tension among jury members.

Millions of women have taken Fosamax (alendronate), a Merck drug that was approved in 1995 to treat osteoporosis associated with menopause, and in 1997 to prevent osteoporosis itself. Until the recent introduction of some competing medications, it was one of the most popular drugs in the U.S. It is still prescribed millions of times per year to women suffering from bone loss.

In short, Merck’s defense on this topic is that there is no definitive evidence that Fosamax causes the death of jaw tissue, while plaintiffs and their lawyers insist that Merck overpromoted Fosamax without warning doctors about the potential for jaw injury. Obviously, no conclusions were reached.

Of course, this is of great interest to women who may have taken, or are considering taking, Fosamax. Only your doctor can decide what is the right choice for you, but we thought we would enumerate the other medications available for treating osteoporosis for those doing research on Fosamax alternatives. One very important thing to be aware of it is that Fosamax is not the only osteoporosis drug in this class (the bisphosphonates), which all have a similar mode of action. Fosamax is being talked about most in the media, but all are associated with some amount of risk of damaging the jaw.

If you do choose to take a bisphophonate, know these facts:

  • A high proportion of jaw injuries occur following high-dose intravenous administration, so that is a particularly risky way to take the medication.
  • As many as 60% of the cases are preceded by a dental surgical procedure involving the jaw. In short, women who are expecting major dental work should consider delaying treatment with Fosamax, Boniva, Actonel or similar drugs until after their dental surgery.

Here are the main alternatives on the market for Fosamax:

  1. Actonel (risedronate) is a bisphosphonate manufactured and marketed by Procter & Gamble and Sanofi-Aventis. It belongs to the same family of drugs as Fosamax, and may be associated with the same jaw side effects.
  2. Boniva (ibandronate) is also a bisphosphonate, manufactured and marketed by GlaxoSmithKline and Roche Laboratories. It is a competitor to Fosamax, and may also affect the jaw tissue.
  3. Evista (raloxifene) is NOT a bisphosphonate , but rather an oral selective estrogen receptor modulator from Eli Lilly and Company that affects bones through estrogen. Evista may be an interesting alternative for women concerned about their jaw health or planning oral surgery.

Also this month, The Wall Street Journal published an article called “From the Osteoporosis Front, Updates on Potential New Drugs“. These are the up-and-comers in clinical trials and going before the FDA. The story covers the latest news about Wyeth’s Viviant, Pfizer’s Fablyn, Amgen’s denosumab, and other upcoming treatments for osteoporosis.

If you are interested in following the Fosamax case that ended in a mistrial, it is expected to be re-tried in the spring. The name of the case is “In re Fosamax Products Liability Litigation, U.S. District Court, Southern District of New York (Manhattan), No. 06-1789.”

Oh what fun it is to cover Big Pharma. First we get the Wall Street Journal crediting Peter Rost and BrandweekNRX for breaking an insider trading scandal at Schering-Plough.

Then we get Merck and Schering-Plough pulling their popular “two sources of cholesterol” commercials from television because Vytorin apparently does not reduce the buildup of fatty plaque as claimed.

As Media Orchard puts it, there are

Two Ways to Get Egg on Your Face

1. You can crack one open.
2. You can be Merck CEO Richard Clark.

Two ways to get egg on your face, starring Merck CEO Richard Clark

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From the Daily Dog:

The state and city of New York filed suit this week against Merck, claiming the drugmaker concealed the risks of the withdrawn arthritis treatment Vioxx. The lawsuit seeks damages, penalties and restitution for “tens of millions of taxpayer dollars wrongfully spent on Vioxx prescriptions,” the office of New York State Attorney General Andrew Cuomo said in a statement… “Merck’s irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars,” Cuomo said…

The Attorney General’s office said this is the first case to be brought under New York’s recently-enacted False Claims Act, which allows the state to seek damages for the amount spent in Medicaid and EPIC healthcare programs to pay for drugs prescribed under false pretenses … Between 1999 and 2004 Medicaid and EPIC spent over $100 million on Vioxx prescriptions in New York State, the Attorney General’s office said, referring to the New York State Medical Assistance Program and the Elderly Pharmaceutical Insurance Coverage plan.

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Remember the little problem with Vioxx? As a result, Vioxx still has more than 13,800 lawsuits on the docket. Over the last two years, only four trials have been held, but Judge Carol Higbee is looking to pick up the pace — from glacier slow to snail-in-winter slow. Higbee’s goal, according to Pharmalot, is to “ease the logjam”. But Pharmalot points out:

With so many lawsuits, it’s entirely possible that many of the Vioxx plaintiffs will never see their day in court, or collect if they do win, because Merck is appealing every outcome that doesn’t go its way. For this reason, Wall Street believes Merck’s Vioxx liability is $5 billion, not the $25 billion or more that many once estimated.

Lesson for Big Pharma: Sometimes it’s better for your product to suck a lot, rather than just a little. (Especially for your lawyers.)

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