COX-2 Update: Some Sanity Returns to the Debate
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In case you missed it, late last week an FDA panel recommended the return of Vioxx, Celebrex and other COX-2 inhibitors to the pharmaceutical formulary:
Exactly as it should be. It's not clear whether the COX-2 hysteria was begun, or just catalyzed, by the over-eager personal injury bar. But what is clear is that there will be a lingering fear, probably unwarranted, over these -- by all accounts very effective -- painkillers. And of course these pro-COX-2 developments will not stop the class action juggernaut already set in motion. Stay tuned...
Meanwhile:
The relatively new phenomenon of direct-to-patient advertising opens new questions, and challenges, regarding pharmaceutical -- and physician -- liability. Before "purple pill" and "gotta go" and other "ask your doctor about..." ads began flooding the airwaves and print media, the patient could realistically claim near-total ignorance and, by proxy, immunity from even a hint of comparative fault in cases of serious side effects from pharmaceuticals, or medical malpractice, from the doctor -- "My doctor said take these and I took them..."
But now the compulsion often goes the other way: it's the patient who demands anti-Digger pills or happy-bean-creature pills or who wants the Patrick Stewart cholesterol pill instead of the Dan Reeves cholesterol pill. What responsibility, if any, does the patient now bear if something bad happens? Does "The ad said take these and I took them..." carry the same weight as "My doctor said take these and I took them..."?
As is often the case, the law often has to play catch-up with new fact patterns. So what? Is it true at all that "pharmaceuticals are somehow different," and if so, is it true to such an extent that pre-emptive regulation is warranted (especially regulation from the FDA -- which hardly has a stellar track record these days)?
I don't know. But I do know this: Doctor Cush, quoted above, is exactly right -- the more options we have, the better.
More thoughts at Legal Underground.
The COX-2 Archives:
Will COX-2 Be the Next Asbestos?
COX-2 Update: "Heart Attack for an Ulcer"
COX-2 Update: Other.Shoe.Dropping.
COX-2 Update: "Consumer" Group Calls for Celebrex Ban
It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18 months.
Celebrex and Bextra, which had been under the same cloud of elevated risks of heart problems, also could stay on the market, the panel said. Most members felt all three drugs should have "black box" warnings -- the strongest warnings used for prescription drugs -- explaining their heart risks.
Many urged restrictions if Vioxx is sold again, such as limiting sales to the lowest dose and recommending it be a second choice after patients try another pain reliever.
John Cush, a rheumatologist at Presbyterian Hospital in Dallas, said the risk of heart problems with Vioxx was "still very small" and he wanted "as many options for my patients as possible."
Exactly as it should be. It's not clear whether the COX-2 hysteria was begun, or just catalyzed, by the over-eager personal injury bar. But what is clear is that there will be a lingering fear, probably unwarranted, over these -- by all accounts very effective -- painkillers. And of course these pro-COX-2 developments will not stop the class action juggernaut already set in motion. Stay tuned...
Meanwhile:
Most panelists wanted to forbid drug makers from advertising the COX-2 drugs. The FDA cannot order an advertising ban but will consider asking the manufacturers to do so voluntarily, said Dr. John Jenkins, head of the FDA's Office of New Drugs.
The relatively new phenomenon of direct-to-patient advertising opens new questions, and challenges, regarding pharmaceutical -- and physician -- liability. Before "purple pill" and "gotta go" and other "ask your doctor about..." ads began flooding the airwaves and print media, the patient could realistically claim near-total ignorance and, by proxy, immunity from even a hint of comparative fault in cases of serious side effects from pharmaceuticals, or medical malpractice, from the doctor -- "My doctor said take these and I took them..."
But now the compulsion often goes the other way: it's the patient who demands anti-Digger pills or happy-bean-creature pills or who wants the Patrick Stewart cholesterol pill instead of the Dan Reeves cholesterol pill. What responsibility, if any, does the patient now bear if something bad happens? Does "The ad said take these and I took them..." carry the same weight as "My doctor said take these and I took them..."?
As is often the case, the law often has to play catch-up with new fact patterns. So what? Is it true at all that "pharmaceuticals are somehow different," and if so, is it true to such an extent that pre-emptive regulation is warranted (especially regulation from the FDA -- which hardly has a stellar track record these days)?
I don't know. But I do know this: Doctor Cush, quoted above, is exactly right -- the more options we have, the better.
More thoughts at Legal Underground.
The COX-2 Archives:
Will COX-2 Be the Next Asbestos?
COX-2 Update: "Heart Attack for an Ulcer"
COX-2 Update: Other.Shoe.Dropping.
COX-2 Update: "Consumer" Group Calls for Celebrex Ban
Related Posts (on one page):
- Should Federalism Apply to COX-2 Liability?
- COX-2 Update: Some Sanity Returns to the Debate
Posted by KipEsquire on
22 February 2005
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