FDA Denies Approval of Merck Arthritis Pain Medication

On April 12, the Food and Drug Administration panel reviewing Merck & Co's application to market a new drug, Arcoxia (etoricoxib), recommended disapproving the application by a resounding 20-1 vote.

Does this result demonstrate that our system for testing the safety and efficacy of drugs is effective?

Arcoxia is in the same class of compounds as Vioxx. Remember Vioxx? Merck voluntarily removed Vioxx from the market in 2004 following publicity surrounding a number of deaths blamed on the drug. Merck is now defending itself against lawsuits brought by numerous affected individuals and their families.

In November 2006, Merck published the findings of a large clinical trial which it portrayed as demonstrating Arcoxia to be essentially equivalent to the most frequently prescribed drug for chronic arthritis pain, diclofenac, in effectiveness and in side effects. According to Merck, its drug had fewer gastrointestinal side effects, which it argued should make Arcoxia preferable and worth marketing.

The FDA panel, however, found that the reduced gastrointestinal side effects and its ability to relieve pain were overshadowed by cardiac side effects. Its findings, which are not binding on the FDA, will be considered as the FDA issues its final determination, expected soon.

If the vote were closer to even, rather than overwhelmingly against approval, the costs of the testing and analysis might be worthwhile. Such extensive review may not seem reasonable when it seemed so clear to the FDA's experts that the drug was just too risky to allow on the market.

And what about the thousands of participants in the clinical trials of Arcoxia? Have their contributions been for nothing? Maybe not, since patients will not be subjected to the drug's side effects.

As for Merck, its stock jumped 8% overnight, following the release of the FDA panel's recommendations on April 13. It seems that Merck's Friday the 13th announcement of good first quarter profits far overshadowed Arcoxia's apparent obituary in the minds of investors.

In the meantime, let's see what the FDA's final decision on Arcoxia turns out to be.

~Joe

Update: On April 27, Merck announced that the FDA has rejected Merck's application to market Arcoxia.

Related Topics:

• WebMD Video: Arthritis Drugs Provide the Help Patients Need
• Painkiller Risks Are Not Alike

Technorati Tags: Arcoxia, etoricoxib, Vioxx, Merck, FDA, clinical trials, pain, arthritis, health-and-wellness

Unapproved Drugs for the Terminally Ill?

Marcelo Alves

If federal regulations change - and they are being reviewed by the FDA and the courts this spring - drugs that have not yet been approved for use will be made available to patients.

As the regulations currently stand, a physician can prescribe a drug that shows potential even though it has not received FDA approval if certain conditions are met.

• The patient's condition must be "serious" or "immediately life-threatening."
• Comparable approved and experimental treatment options must not be readily available to the patient for some reason.
• The drug must have some potential to save the patient's life as shown in preliminary, ongoing clinical trials.
• And (and this is the center of the current debate) the FDA must approve the use of the drug in the patient. This is done on a case-by-case basis - for what is known as "compassionate use" or "investigational new drug treatment" use.

It is the requirement for FDA approval that is being questioned.

Patient advocacy groups argue that the terminally ill should hold special status when it comes to experimental compounds that have not been fully tested in clinical trials. For those for whom all existing medications have failed, the opportunity for hope provided by drugs having the potential to prolong life should not be denied.

The pharmaceutical industry and the FDA raise several objections to this argument. First, the FDA approval process relies on sophisticated and relatively long-term science to assure that drugs that reach the market are both safe and effective. Second, the Big Pharma foresees numerous lawsuits against the manufacturers of compounds that prove to be unsafe, perhaps even dangerous. Finally, there are fears that patients will take this "easy route," making fewer individuals available for clinical trials.

Should the safeguards that are now in place to protect the market from drugs with significant life-threatening side effects be jettisoned for the terminally ill who may feel they have no choice but to gamble on a cure or improvement because their dire prognoses warrant the risk?

Perhaps this is not the real question. Perhaps the real question is exactly what value is the FDA's approval contributing to the existing decision-making process? If it is not adding significantly to the effort, then what is the harm in eliminating it?

Even if the FDA approval does not reflect a thorough case-by-case review of risks and benefits, the very fact that the requirements for approval are checked and documented, may be enough to keep the process honest and give terminal patients some legitimate hope.

-Joe

Related Topics:

• Experimental Treatments? Unapproved But Not Always Unavailable
• 12 Answers to Common Questions About Clinical Trials

Technorati Tags: clinical trials, FDA, drug approval, terminal illness