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Well, we haven't had a good political discussion for a while (just where IS Harry, anyway? )

There are a couple of interesting articles in Forbes magazine today.

One is regarding the Vioxx liability issue for Merck (which speculation is whether Merck will even survive it). Looking at it from a pure "labor" standpoint, that would be awful. There are hundreds of union members employed there who would suddenly be out of a job! The article ends by saying:

"....This case is sure to cost Merck and its insurers billions in damages and may spread a pall of legal liability over other drug-makers. For patients and Big Pharma alike, the prescription pill business is going to get ugly."

All I can say is "oh, wonderful."

The other article is regarding the FDA and off-label drug use. This one just makes for interesting reading. Anybody else see these?

Deb

Deb,

Here I am....just around the corner

I suppose one could look at both sides of the coin with Merck and Vioxx. Some people may say it serves them right...why didn't they do more proper testing before submitting the drug for FDA approval?

Others may say that any kind of huge lawsuit against a drug company will only have more ramifications down the line on the cost of drugs. The companies may just charge more to cover any possible litigation.

But did anyone notice something missing in this recall?....like the total absence of the FDA!! Usually, it's the FDA who is forcing a drug company to perform a drug recall but in this case it didn't happen. Well, a number of weeks ago, long before Merck announced their recall, Dr. David Graham, one of the FDA's top experts, came forth and expressed a major concern about the safety of Vioxx. Testifying before a Senate committee, Dr. Graham said that his superiors in the FDA applied pressure, intimidation and thinly veiled "threats" against him for coming forth with his concerns about Vioxx. They tried to gag him and cover up the whole matter!!

So much for the FDA protecting us all of the time!

Harry

Hi, Harry!

Unfortunately, it gets even worse than that with Merck!! According to this article in Forbes (mind you - I have no opinion on the validity or accuracy of it), Merck DID have tests that showed a problem. Cardiologists warned them of the potential problem based on Merck's OWN 8,000 person study, but Merck dismissed the result. hmmmmmmm.....interesting.......they even quote a Vanderbilt epidemiologist in this article. He says "We need to investigate why the [safety] signals were ignored."

THEN there were three more studies done that Merck ignored. And then FINALLY, another one of Merck's own studies (originally designed to show Vioxx's benefits), apparently instead, to Merck's surprise and I'm CERTAIN "dismay", confirmed what the cardiologists had warned them of three years earlier, so Merck itself pulled it off the shelf. Here's a good question.......were any of these above studies ever published?

Man, oh man....you can't even blame it on the legal system (litigation) this time, but there is already speculation running rampart about the sharks now coming out of the woodwork ready to file lawsuits on several other drugs. One of them is a drug (Neurontin) used for MS symptoms, BUT it is being attacked judicially ONLY because of Pfizer's mistake in outwardly promoting its off-label uses (which is illegal), i.e. for "unapproved uses". Still, as this article says, the injury lawyers are jumping on the bandwagon, one class action suit already has been filed regarding Neurontin. (Hey, and I'm in law, too!) I sit the fence, of course, because I can usually see both sides. (I'd probably be rotten as a Judge. LOL) In any event, to my knowledge, Neurontin is quite helpful for MS. It would be a shame to see something possibly pulled or jeopardized (and note: there is no indication of that happening!) because of economic downfall instead of bad efficacy of the drug itself. (Still, that was sort of "not smart" on behalf of Pfizer to outright promote non-approved use.) Hey, here's a question I need to legally research to answer: If a drug company goes under, or stops making a drug for reasons other than safety (such as economic), does that negate their patent on their drugs, thereby allowing other manufacturers to pick it up?

Yea..........where WAS the FDA? Well, wait..........how closely does the FDA follow drugs AFTER approval? Are they even expected to? Once approval has been given, I think they are out of the loop at that point. Sort of like someone who marries you.........if you want a divorce later, you need to go see.........gulp...........a lawyer! I haven't read anything about the Senate Committee matter. Maybe because the FDA wanted to stay out of it completely? That's just pure politics going on there, I'd say.

Deb

EDIT: Well, I tried to give the FDA the benefit of the doubt. But Harry is right, one of their responsibilities is to keep watch over the drug and its safety after approval, also.

Here's part of the FDA's response:

"....Did FDA require this action?

No, Merck made this decision independent of input from FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.

FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market. ...."

This Q&A can be found at: http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm

Deb

Ok....next question. And this might hit a hot spot, and I'm not attempting to "insinuate" anything at all, but............

Vioxx is similar to ibuprofen. The problem is with "chronic" use. Isn't ibuprofen (and/or other drugs in the same class, i.e. NSAIDs) given right alongside the MS injectables for relief of side-effects? Isn't that, in effect, encouraging chronic use?

Man.........catch 22. (That's becoming a favorite phrase of mine lately, huh?)

Deb

EDIT: And Wow! That DOES open a HUGE playing field for litigants. Ouch!!!

Deb,

Pfizer not only improperly promoted Neurontin for off label use they told their PhD researcher (who they hired as a sales rep) to deliberately give false information about the drug to the docs. They deserve everything they get from the courts.

And the FDA knew very well weeks before Merck pulled Vioxx that it was trouble.

I think we are starting to see the tip of the iceberg in the dirty world of pharmaceuticals and there is going to be a lot more "dirt" thrown before it's all over.

Harry

Almost two years ago, before I was diagnosed with MS, I was (and still am) dealing with a massive spinal injury for which I was taking CoxII inhibitors, either Vioxx(25mg) or Celebrex (20mg) daily. I work for a Family Doc and she gives me samples of whatever she's prescribed for me, depending upon what we have plenty of. Celebrex and Vioxx worked about the same for me; way better than nothing but still a world of pain.

So when the Merck drug rep came around with a higher dosage of Vioxx(50mg) I got on it. And after 4 days on 50mg Vioxx, I nearly collapsed during physical therapy (which was not strenuous at all), with a massive hypertensive episode, possibly a TIA or mini-stroke. I honestly couldn't afford a head scan, and my B/P (which went up to 220/160!) and grid-like visual symptoms improved quickly with emergency medication. I noticed very slight numbness on the left side of my mouth which didn't go away. We had no idea what had caused the weird hypertensive crisis, but I suspected it was partly from severe pain. I mean, it was over and otherwise I was fine.

Anyway, the next day when I awoke I felt fine until awhile after I took my morning meds, and the same symptoms came back, but faster. Luckily I was already at work by then, so I got treatment even quicker than the day before. We figured out then that it must be from the higher Vioxx dosage, the only change in my morning meds for months. We took me off of all Vioxx permently after that; Celebrex and then Bextra were around and gave me no problems at any dosage so I took that. I still had the facial numbness afterward. (Still do.)

The next week, the Merck rep dropped by and after stocking us up with whatever samples he brought, he mentioned matter-of-factly that there had been "a couple of reports of heart problems" with patients taking 50mg Vioxx. He said that some docs might want to consider withholding the 50 mg dose from "patients who have serious heart disease or really severe hypertension", but that "it's really very safe".

I told him what happened to me, and that I had neither pre-existing condition. he said "hmm" and promptly changed the subject.

Like I said, the facial numbness never went away, but I was mostly OK otherwise. But in the following months I was occassionally experiencing sudden "sinking spells", usually heat-related, like during physical therapy or in a hot car. And all of a sudden, I couldn't tolerate the hot tub at the gym at all, even for 10 seconds. That was a minor bummer because it used to soothe my back a little. I assumed it was a menopause thing. And when I had some cognitive difficulties, I attributed them to severe sleep intolerance due to constant pain. I knew almost nothing about MS then and nothing could have been further from my mind.

Finally, when the cognitive difficulties got more extreme (the day I had to look up the ICD-9 Diagnosis code for "hypercholesterolemia", a code I use 10 times a day), I finally agreed that I needed the MRI of my head, which led to an LP and a definite diagnosis of MS a year ago.

I don't think that Vioxx caused my MS. I But I do suspect that the reaction I had to the Vioxx hit the Fast Forward button on the MS which was undoubtedly already there, benignly. And I do know that my B/P went dangerously high from the Vioxx.

Wow, flora!!

All that was WAY too close for comfort!! I hope you continue to do well, and get better!!

Well, I will say that "trauma" is one of the things that the Boston Cure Project is looking into to try to narrow down possible causal relationships or "triggering" mechanisms of MS. So, .....it could be possible that those series of physiological traumatic events on your body DID trigger something. Who knows?

Are you on any MS disease modifying drugs right now? I hope you don't mind my asking........

Deb

Deb- I certainly don't mind your asking. I'm not currently on any disease modifying drugs at all, but I'll probably get on LDN before long. I have tried and later discontinued first Avonex and then Copaxone. Avonex caused bizarre, totally out-of-the-blue suicidal episodes....exactly once a week. My local reactions to Copaxone just got worse and worse until there were no more injection sites. I first decided to just take a break to see if the tender lumps ever went away, after which time I expected to get back on. But the lumps have stayed for several months, and my MS symptoms are generally much better since I've been off meds, so I'm just managing things non-medically for the foreseeable future.

If I only had a crystal ball......

Hi, flora!

hmmmmmmmmm..........that's really interesting about the injectables (sorry you've had so much trouble in recent months!) I hate to say it, and of course, this is simply a minute sample of MS patients, but it seems that lately, more and more of the people I know who have MS have been doing the same as you........getting off the injectables and actually feeling somewhat better!

Yea, crystal ball is right, huh? Geez, I hate this doggoned disease!

Deb

I'm going to pipe in and remind everyone that we are often complaining on the other side of the fence - that the FDA is being too overprotective and not letting drugs out fast enough.

I'm not endorsing covering up known problems, etc. but we can't have it both ways - complaining when they don't let experimental treatments get used widely and complaining when drugs that have been approved have problems. Of course it's human nature to complain about everything, and I'm a major follower of that philosophy

Hopefully this situation is one of honest mistakes rather than negligence and cover up, but if it isn't I'd say the problem lies in the execution of the process and not necessarily in the general process itself. Me, I'm more for getting more drugs out there for debilitating diseases and allowing people to decide whether to take an informed risk or not.

Yea, me too, Art (getting more drugs out there, AND re-investigating the old ones to see if they might work for other things, and/or reclassifying some usages).

But.....as with everything.....and playing devil's advocate for just a second, whom do/can we trust to give us the best information so we CAN make an informed decision? Sometimes, it's so 50/50 as to flipping a coin being the best option.

Catch 22.

Deb

flora68 wrote:Deb- I certainly don't mind your asking. I'm not currently on any disease modifying drugs at all, but I'll probably get on LDN before long. I have tried and later discontinued first Avonex and then Copaxone. Avonex caused bizarre, totally out-of-the-blue suicidal episodes....exactly once a week. My local reactions to Copaxone just got worse and worse until there were no more injection sites. I first decided to just take a break to see if the tender lumps ever went away, after which time I expected to get back on. But the lumps have stayed for several months, and my MS symptoms are generally much better since I've been off meds, so I'm just managing things non-medically for the foreseeable future.

If I only had a crystal ball......

Deb,

I was on Copaxone for almost two years. I have been off of it for for over eight months now. I have horrible skin damage from the injection sites. I am not over weight, but, now I have big lumps on my legs, big indentions on legs, back of arms, stomache, hips, almost everywhere that I received an injection. If I knew what Copaxone was going to do to me I would have never taken it. I just start LDN last night and am really hoping it will help me. Good luck to you.

Glenda