Merck May Resume Sales of Painkiller, Official Says (Vioxx) -- NYT

[Sgent]

WASHINGTON, Feb. 17 - A top Merck research official suggested to a federal drug advisory panel on Thursday that the company might soon decide to start reselling the painkiller Vioxx in the United States, despite risks it may pose to the heart.

The official, Dr. Peter Kim, Merck's research chief, said that if the panel decided that Celebrex and Bextra, drugs similar to Vioxx, also hurt the heart, "then that would be important to us to take that into consideration with regard to Vioxx."

<snip>

The news was a remarkable disclosure in an already landmark hearing. Panel members have been sifting through studies trying to weigh the risks and benefits of Vioxx, Celebrex and Bextra. None of the drugs cure pain any better than older medicines. They were developed with the hope that they would cause fewer ulcers than older medicines, but Merck withdrew Vioxx in September after a study showed that the drug doubled the risks of heart attack and stroke.

Since then, more studies have shown similar risks for Celebrex and Bextra. The agency called the committee together to tell it what to do. According to much of the testimony, the committee will probably suggest that the drugs stay on the market, with tough warnings about risks.

<snip>

NY Times Article

[bpilgrim]

1. they don't need no stink'n regulations...

their boyz in the WH and CONGRESS got their BACKS!

peace

[MisterP]

2. remember, Chimpy won't let you sue if mumsie turned into a pile

of ash due to this pill or that--it'll "prevent people from getting treatment they need"
monsters, all of them; it's like a slumlord getting all tearful when accosted, saying he was so NICE in providing a home for all those poor people

[Indiana_Dem]

3. Yup! Now that the class action lawsuits are null and void! nt

[Dr Ron]

4. Might not be bad

The problem with Vioxx and similar drugs is that the manufacturers hid evidence of their side effects. This prevented us from making reasonable decisions about their use, balancing risks and benefits.

While we now know that the risks are greater than the drug companies initially admitted to, these drugs also do have benefits. Many people receiving them should no longer receive them with current knowlege of their cardiac risks. However, there are people with severe arthritis who cannot tolerate NSAID's for whom the risks might be worth taking for improved quality of life with control of arthritis.

Keeping them on the market with warnings about risks actually may be the right decision.

[Liberty Belle]

5. My uncle had no cardiac risk factors. His life is ruined from Vioxx.

This drug killed HUNDREDS, not just a handful of cardiac patients.

It's extremely dangerous and ought to be banned. There are far safer arthritis remedies. I just wrote an article on this. Glucosamine, acupuncture, and several herbs can all alleviate arthritis. I interviewed a researcher on a national trial of arthritis treatments, both pharmaceutical and other. He is a big believer in "other."

[davepc]

7. And some people experience a world of difference using it

and dont die.

People should be allowed to make informed decisions as to what to put into their own bodies. Their bodies, their choice.

The trick is keep Merc or the FDA or whomever covering up or discounting side effects.

The tragedy isint that the drug is aviable, its that people didn't know the full story.

[SOS]

11. Vioxx is no more effective

than ibuprofen for arthritis pain. Here is some info from FDA researcher Dr. David Graham:

“For the past 20 years, I have worked at the FDA as a post-marketing drug safety researcher,” Graham told a group of about 65, including drug safety activists, some FDA colleagues, and members of his family gathered to witness the awards ceremony. “Education I received at the Johns Hopkins School of Medicine taught me to act in the best interests of my patients, regardless of personal cost or inconvenience. My religious faith taught me to preserve their lives to the best of my ability and to do nothing to intentionally injure or harm them."

At that hearing, Graham estimated that between 88,000 and 139,000 people in the United States had suffered heart attacks or stroke as result of taking Vioxx and that as many as 40 percent of those, or about 55,000, died as a result."

[Dr Ron]

12. Not being more effective is not the point

Many people can tolerate Vioxx but cannot tolerate Ibuprofen. There is no question that Vioxx was over used. Even before we had the evidence of side effects, I believed Vioxx was over used. There was no reason to use Vioxx in someone who could tolerate Ibuprofen.

[SOS]

22. But there are other pain meds

ibuprofen, aspirin, acetaminophen, naproxen plus the opiate derivatives.
You can also take concentrated turmeric for Cox 2 inhibition.
The pharmacos were more interested in money than superior pain relief, imo.

[Dr Ron]

25. Other meds aren't replacements for Cox II inhibitors

Cox II inhibitors still offer an alternative your choices don't provide for people who cannot tolerate aspirn and NSAID's (including ibuprofen and naproxen from your list). In inflammatory arthritis, a Cox II inhibitor will provide more benefit than narcotics and more than acetaminophen. Besides, even acetaminophen (Tylenol) isn't without side effects. People who use it mutliple times a day for control of arthritis are at increased risk of liver failure.

The pharmaceutical companies were definately more interested in money, and behaved dishonestly. That doesn't mean that there still isn't a use for the drug, provided accurate information on risks is available for consideration.

[Liberty Belle]

13. Exactly. It's one thing to allow a risky drug if no safer option exists,

But Vioxx provides a serious risk of death or heart attacks without offering any greater improvement to patients than many other, much safer alternatives. 55,000 deaths is not a small risk--it's an unacceptably enormous risk!

[davepc]

21. Thats great, it should still be a decision made by a patient and doctor

NOT a fiat decision by the FDA. The problem is that Merc *LIED* about the risks. Patients and doctors can't make good informed choices without all the necessary information.

The problem is not that Vioxx was aviable.

Vioxx helps some people. They should not be denied the ability to use it because it causes risks in others.

It should be a patients decision.

[Dr Ron]

8. Have you ever treated arthritis patients?

These measures might help in cases of run of the mill osteoarthritis (although even that is far from certain). There are many people who are severely crippled from various forms of inflamatory arthritis who require medications of this type. If they are not able to tolerate NSAID's, then COX II inhibitors are worth considering (providing there is adequate consideration of risks and benefits).

While there is evidence of cardiac risk which now affects prescribing decisions, it is also likely that many who are claiming problems from Vioxx are incorrect. For example, a few weeks ago I had a patient try to blame Vioxx for her stroke. She regularly skips her blood pressure and diabetes medications, resulting in neither being controlled. This is far more likely to be the reason for her stroke than having used Vioxx short term.

I don't know if your uncle had cardiac risk factors. I see people every day who have serious cardiac risk factors but are in total denial of this, and I'm sure their families believe they have no cardiac risk factors. As cardiac risk factors are frequently assympotmatic problems, it is easy to deny their existence.

There is also a good chance your uncle was on Vioxx when it shouldn't have been used--this is probably the case in the majority of cases wehre it was used. This does not mean there are situations where the benefits do outweigh the risk.

[Liberty Belle]

14. I'm not a doctor, just a medical writer.

I've interviewed many nationally prominent experts on arthritis, including MDs, government health officials, and researchers involved in alternative treatments. I have severe joint pain myself and treat it successfully with a variety of alternative therapies, which work much better than the Celebrex I used to use.

My uncle had no diagnosed health problems except a backache when he went on Vioxx. He'd recently had a physical and was found to have no cardiovascular problems. He's now so weak he can't get out of a chair and suffers severe orthostatic hypertension and fainting spells. His doctors and pharmacist suspect Vioxx caused this, but have offered no remedy. If you have any suggestions to help him, I would welcome any recommendations.

[Dr Ron]

17. Can't say about your uncle

Without seeing your uncle I can't say what is going on or what to do for him. A clearer etiology needs to be diagnosed. Saying VIoxx caused it doesn't mean much. Even if Vioxx is the cause, there still needs to be a more definitive diagnosis as to what is going on.

Alternative therapies work for some, but far more, especially with inflamatory arthritis, respond far better to NSAID's and COX II inhibitors than alternative therapies and should have this option.

[rockedthevoteinMA]

24. wasn't it something like 25,000? and that was a low number. n/t

[alittlelark]

6. Of Course They Will....

They need to boost their shareholder profits,:evilfrown:

[leesa]

9. A little payola here...a little payola there....what problem??

[central scrutinizer]

10. nice end run, Bushco

if you can't get the tort reform (read: repeal) your cronies want, just absolve them by saying the drug is not dangerous.

[Dr Ron]

18. Two different issues

Allowing Vioxx on the market should not absolve them from liability for problems people have had when they kept the side effects secret. No body is saying the drugs don't have side effects--just that there are people for whom the benefits out weight the risks.

[LiberallyInclined]

15. who's gonna take it?

morans?

[Horse with no Name]

19. The Docs in Iraq have been complaining

about it being pulled. They wanna give it to the troops--within two days of making that statement--guess what? Vioxx is coming back.
Guess if they are giving them XTC--then they can give them Vioxx too.
This regime makes me sick.

[LiberallyInclined]

20. like i said...and have said...and will say again-

IMHO- anybody that would choose to serve in uniform under this mis-administration is a grade-A, certifiable MORAN!

[daleo]

16. Would most average people really understand the risk involved?

It is a tough issue, I have a brother that used one of these Cox 2 inhibitors for arthritis, and it seemed to help him. He said he might prefer to run some risk for the benefits that he perceived. Still, communicating risk is very tricky (the book "Calculated Risks" by Gerd Gigerenzer is a good treatment), and it is hard to say if tough warnings would really compensate for the legal right to market a drug with such known high risk side effects.

[Sgent]

23. According to the research I've seen

Vioxx is about on par with smoking for risk of Cardivascular problems.

The real issue (and reason people may use it) is that for some, the Cox-II are the only effective medication. For many others, they may not be able to take NSAIDS due to gastro-intestinial bleeding.

Like all medications, Vioxx had problems. When doctors and patients weren't aware of it, it was terrible; however, somethimes cost benefit analysis has to be done. To this day, Lithium is still frequently perscribed for bipolar disorder and depression. Although by no means a benign drug, it still has many uses.

[Dr Ron]

26. Many risky drugs used

Agree re considering risks vs. benefits. The problem is that every drug used in arthritis is risky.

As you mentioned, NSAID's can cause GI bleeds, and may also have cardiac side effects. Tylenol doesn't provide the same control of inflamation, and increases the risk of liver damage. Steroids have multiple effects which shorten life span when used. Methtrexate can casuse life threatening anemias and liver damage, among its many side effects. Plaquenil can also cause serious anemias, visual problems, and many other side effects.

It all comes down to weighing risk versus benefits, which can only be done when all the data is available.