From Reuters:
“GAITHERSBURG, Md. - Merck & Co. Inc.’s withdrawn arthritis drug Vioxx is safe enough to rejoin Pfizer’s rival pain relievers Celebrex and Bextra on the U.S. market, an advisory panel said after concluding that all three medicines posed some level of heart risk.
The 17-15 vote on Vioxx’s safety to go to market electrified Merck shares…”
It was a stunning turnaround for Vioxx, which was withdrawn in September by Merck after a study showed the drug doubled heart attack and stroke risk compared with a placebo in patients who took it for at least 18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.
____________________________________________
There you have it! When 17 out of 32 experts stand up and say that a drug is probably helpful enough to offset the doubled risk of heart attack, what else do you need to hear?
Arthritis sufferers need choice, and if on of those choices is an expensive and still-proprietary drug that has a habit of taking away all your pain in a really permanent way, well, that’s what “choice” is all about.
What was Merck supposed to do? Sit back and await another study, the clock ticking all the while, bringing closer the day when seniors might be able to buy generic Vioxx? Would that be fair? As this panel has emphatically declared - a tiny majority of experts feel, after very quick study, that the drug is more or less not going to cause people to die at a rate that is worse than the suffering they’d feel if the drug was banned. Get it? The comfort of the many outweighs the existence of the few, to coin a phrase.
Anyway, it’s about personal responsibility. If grandpa wants to live, he may just have to lay off the Vioxx. If he’d rather ease the pain… well, that’s his choice. Nobody’s forcing these drugs on him. Only advertising ‘em during his favorite programs.
Cynics are bound to compare this quick result to the administration’s 4 year failure to allow drug importation from Canada because of “safety concerns.” They’re bound to point out that all these “safety issues” have a spooky way of resolving themselves in a manner than positively affects drug companies’ bottom lines. These were the same types of knee-jerk liberal cynics who kept saying that Iraq didn’t have weapons of mass destruction, and look who turned out to be right on that one - they just had free elections!
Game and match. We’ll be right back, after an extremely vague drug commercial featuring aging people running through sundrenched meadows as sentimental-yet-energetic music plays in the background. They they are, on their tandem bikes and golf carts, smiling and laughing in golden light, waving as they pass by, freed of the ill-effects of… something. You don’t need to know what the drug does - don’t they look happy? Lookit ‘em there, riding over the horizon! Pain-free and going full-speed…
…to a better place.
Fanny Roborat
37 comments
Mike Z
February 19, 2005 at 2:31 pm
1Even if you feel perfectly fine, you should still ask your doctor if Celebrioxadil is right for you. And don’t take no for an answer.
Jerry
February 19, 2005 at 2:47 pm
2“There’s a bright golden haze on the meadows…”
And why shouldn’t Vioxx be allowed to compete in the free market of American capitalism? OK, sure, it has an unfortunate “side effect” that they have known about for years and don’t mention, even in the literature available to prescribing physicians, but what the hey?!
For instance, I offer a fine medicinal that cures just about everything, “Dr. Jerry’s Rattler-in-a-Box.” Now, ocassionally, one of my customers gets what we call a “bite,” and “dies.” But should I be hurt financially by this perfectly predictable consequence of using my fine, natural product? I think not!!
Tiffany
February 19, 2005 at 3:41 pm
3I, too, have been nauseated by the FDA’s interest in preserving bottom lines instead of the health of Americans. Unfortunately, as one of the millions of uninsured Americans, all I can do is sit back and “choose” between paying for intensely expensive drugs or I can simply pray for the generic versions that may or may not become available in a timely fashion.
I agree with Jerry’s “Rattler-in-a-box” comment…..heaven knows that companies shouldn’t be required to come up with well-tested and “safe” medications when it’s just so easy to rush a miracle drug to market.
Jerry
February 19, 2005 at 4:08 pm
4So, have you noticed that the time spent in commercials for pointless drugs on TV that outline the adverse reactions and pre-existing conditions that should preclude the use of the advertised drug is usually longer than the the part that extolls the benefits of the drug?
Don’t be fooled. When they say, “People with liver, kidney, or heart problems, hypertension, cancerous or pre-cancerous diagnoses, water-retention,” or any of the multitude of other conditions that are listed (oh, so, quickly, and in text that can’t be read on most TVs) they mean, “Our product either exacerbates or can cause such conditions, and will fuck you over royally even if you don’t have these pre-existing conditions.”
Oh, and, yeah, (Thanks, Mike Z) “Go demand your doctor give you this med, even if you don’t know what it is for.” Those commercials drive me nuts, the ones that don’t even say what the med is for!
Emmarie
February 19, 2005 at 5:35 pm
5Since we’re speaking of the FDA:
does anybody know of an article or other respectable publication that gives a good overview of the drug approval process in general? I’m supposed to be writing a paper about the FDA and need that info to get started.
hedera
February 19, 2005 at 5:58 pm
6Speaking as an osteoarthritis sufferer (knees): I asked my doctor a couple of years ago if the COX-2 inhibitors were really any better than the generic I was taking, and he said they don’t really do much better and they’re a whole lot more expensive. We jointly decided to stick with what we’re using. Of course, I have Kaiser Permanente, which a lot of people think isn’t very good medicine; but right now the exchange looks pretty prescient.
In any case the best thing you can do for arthritis is exercise like hell, but of course the drug companies don’t get anything from THAT…
P.W. Fenton
February 19, 2005 at 6:59 pm
7Oh… how I agree with you on this one. The advertising of prescription drugs.. WHICH MUST BE PRESCRIBED BY A PHYSICIAN… must be outlawed. Physicians, the people who can prescribe drugs, represent a fraction of a percent of us… so why is TV pounding US every day with suggestions for what our doctors should be prescribing for us? It’s criminal.
Harold
February 19, 2005 at 7:01 pm
8C’mon, Adam. 17 out of 32. Haven’t you learned how to recognize overwhelming support? In politics that’s way more than a mandate!
chrisanthemama
February 19, 2005 at 7:39 pm
9In any rational universe, marijuana would be legal and Vioxx a controlled substance along with morphine and cocaine.
Mary Kay
February 19, 2005 at 8:01 pm
10I thought the prescription drug ads were bad enough. But now the implant manufacturers are marketing total knee replacements to the general public, using the same nonsensical approach Adam describes. “Ask your doctor today if a total knee replacement is right for you.” Oh, puhlease! What’s next? “Feeling sluggush today? Ask your doctor if a pacemaker is right for you.”
Beth
February 19, 2005 at 8:33 pm
11Adam, perhaps the real beauty of this plan hasn’t hit you yet. Not only will it permit our beloved Older Americans to enjoy an active, pain-free existence, it could also solve our looming social security crisis.
In any rational universe, marijuana would be legal
In some parts of this universe it already is. In Canada, for instance, people can legally use marijuana for a number of conditions, including … (wait for it) …. arthritis.
Lynne
February 19, 2005 at 11:18 pm
12Kids, come one now, don’t you know that the reason we pay more for our prescriptions is R/D?
Not advertising or taking physicians out to dinner, basketball games, baseball games, lunch, breakfast, conferences, golf outings, giving them computers, pens, pads, CEU’s?
And those silly HIPPA laws were not created because drug reps were trolling through patient’s charts. Nice to know that Gerta from Glaxo know knows about your little problem with the herpes.
Isn’t it a beautiful country that my mother is breaking the law every time she fills her prescriptions at a Canadian pharmacy at about half the price she would pay here? She makes too much to qualify for the drug card but not enough to pay double for her drugs.
Ah, I’m ready to stroll through a meadow and do some tai chi.
I have to be serious for just a moment, though.
I hate that woman in the Levitra ad.
sorry. Couldn’t help myself.
Murray
February 20, 2005 at 9:24 am
13Speaking of an old couple riding a tandem.
OK here goes.
No advertising of prescription drugs.
Get rid of the stupid prescription drug law that gives our 500 billion to big Pharma
Do as Canada does and deal directly with Big Pharma for the best deal (because we are bigger then Canada we should be able to hammer out a better deal).
Any drug that shows problems after the initial tests must be re-evaluated immediately.
Now that said;
Every drug has side effects or dangers. If aspirin were introduced today it might not make it out because it thins blood and can lead to internal bleeding. Most drugs lead to liver damage. If you know what the problems are you can make a decision for yourself as to the benefit-risk potential of each drug.
Yesterday my wife and I heard a radio commentator say “Do you want to tie your shoe or die?” A flip question but my wife who has Rheumatoid Arthritis (the one that exercise doesn’t help and leaves people in wheel chairs) answered “If you can’t tie your shoes, you would probably want to die” She knows. She is on a half dozen very powerful (chemotherapy) drugs including Celebrex. She assumes that her life will be shortened by taking the drugs, but it has brought her life back to normal. After years of non use we have gotten back on our tandem and she has been able to enjoy life again.
She is convinced that without the drugs she would be crippled to the point of not being able to work, drive, or even walk. She knows that her life would be a world of pain. All of her joints would hurt all of the time. Massive doses of ibuprophen wouldn’t make a dent on it.
We are glad that the choice is hers to make. A good, productive but possibly shortened life versus living longer crippled in agonizing pain? Not that hard a choice.
Matt
February 20, 2005 at 10:13 am
14Thanks Murray for perspective. But there is one other thing that you left out: they knew and didn’t tell. That’s criminal. And it makes it difficult to say you have a choice if you don’t know.
Peace & Blessings to you and health to your wife.
Murray
February 20, 2005 at 2:06 pm
15Matt,
Knowing and not telling should be TREATED as the criminal action it is. Not company fines, but jail terms for the guilty.
Auros
February 20, 2005 at 4:03 pm
16Oh, I dunno. I really don’t care whether people like Ken Lay, and whatever bureaucrats are responsible for concealing medical data about Vioxx (or tobacco, for that matter) go to jail, as long as we make sure that every cent of profit that came to them through such action is confiscated, and then some. Let them live out their lives in penury, the way they expected the rest of us to.
tess
February 20, 2005 at 4:20 pm
17It’s all about marketshare, people! Don’t you know anything about how our great democracy works? If there good companies don’t keep making new products that you will go out and buy, they lose marketshare! It’s all about the market, people! THE MARKET! THE MARKET! THE MARKET!
Sorry, taking a course in “Special Topics in Bioengineering Technology” right now, and it’s really “management.” It’s starting to bother me, especially whenever I read through my book and it mentions Netscape as an example of a great “technology-based company.”
tim
February 20, 2005 at 4:59 pm
18OK, that’s it, I give up. I heard on Weekend Edition Sunday this morning that in a hypothetical presidential race between George Washington and George W. Bush, that Republicans would vote overwhelmingly for Bush. Washington obviously has a lot to account for regarding that swift boat ride he took across the Delaware River. How dare he catch those Hessians drunk and sleeping! Sounds like a war crime to me.
I can’t think of anything more to say on the topic. I’m blaming the Lipitor. I was fine until I started freebasing it.
Bryan
February 20, 2005 at 9:04 pm
19They actually had a doctor testify that Cox2 inhibitors were necessary for the “War on Terra”. Apparently a lot of our “volunteers” in the Guard and Reserves have chronic pain problems.
All drugs have side effects, but the problem is advertising drugs to patients and not informing people of the possible side effects. Speed talking through a list is not informing.
If people have to choose the lesser of two evils, they at least get the choice. When the choice is made for them, the system is broken.
David
February 20, 2005 at 10:22 pm
20As a person who is alive only because of the discovery of sulfa drugs and the fact that the doctor who was dealing with my infant bronchial pneumonia knew about them, said to my mother that I was going to die, and although he had never used them (it was 1942), sulfa drugs might save me, although he could not say for sure. My mother did what any rational person would do, and as a consequence I am alive to write this post excoriating pharma.
My mother, I might add, also in the main found the behavior of the drug industry self-serving and reprehensible, but she never lost sight of the decent folk doing worthwhile things even in the context of what we’ve come to know and loathe the greed-heads for.
It’s the ruthless pursuit of maximum profit, utterly akin to the ruthless pursuit of the world’s resources, that has made what ought to be a saintly enterprise into something all too often more diabolical than noble. Greed is clearly more powerful than morality in great business enterprises.
Germaine to this is an article de Lorean wrote about his experience with General Motors. The upshot was that a corporate exec who, if he were your neighbor and your house were on fire, would risk his life to save you, could turn around and participate in a corporate decision he knew would likely result in several thousand deaths.
Corporations simply do not regulate their own conduct in accord with any overrriding moral compass. The general public, through our system of government, either demands laws setting certain standards for entire industries, or we remain in this wilderness of ruthless corporate amorality.
Damn, I wish I had some quip to offer - the humor really does help.
Regarding the Republicans who rank Bush above Washington, at least now you have irrefutable proof that they are congenital idiots who are likely deliriously happy in their incredible ignorance. There’s a chance that a portion of them don’t know for sure who Washington was. They sure as hell don’t know anything about him beyond his name. But hey, Bush rocks!
hedera
February 20, 2005 at 10:58 pm
21Murray, my sympathies to you and your wife in a tough situation. I also have RA (in my hands only for now, controlled for now by much lighter drugs); but my sister has one of the small number of autoimmune diseases even worse than RA, and has made the calculated choice to trade longevity for mobility. So far it has worked, mostly, although we almost lost her last summer.
I agree with you that the choice is what matters, and that without all the necessary knowledge, the choice is impossible. And to withhold the information necessary to the choice is immoral.
Linkmeister
February 21, 2005 at 2:33 am
22Emmarie, try this page at the FDA itself. It’s 10 years old, but it’s still relatively accurate in terms of process.
keith
February 21, 2005 at 10:00 am
23Off topic, but I just wanted to thank Adam for the subtle reference to the conservative marketing machine on WWDTM, when he corrected Peter’s use of the phrase “private accounts” for Social Security to “personal accounts”.
It’s important the media use the phrases the GOP has focus-group tested to sell their policies, which like prescription drugs, tend to have disastorous side-effects. “Private accounts” sounds like the government giving money to brokers on Wall Street. “Personal accounts” sounds like the government giving money to me (It’s my money anyway, right?)
It’s the same way the “estate tax” (something rich people have to worry about) became the “death tax” (something categorically unfair that everybody has to worry about), and “global warming” (something scary that evokes the image of the devil himself basking on a flaming lounge chair on the charred desert plain which was once the bed of lake Michigan) became “climate change” (something we casually do every time we adjust the thermostat).
I’d just love to hear a reporter one day call a Republican on the carpet when he/she uses the term “death tax” and say, “Now, when you say ‘death tax’ do you mean the estate tax that only effects estates worth over $1.5 million dollars?” I’ve never heard it, but then again that would take the kind of “Fair and Balanced” journalist I just don’t find on NPR.
Jerry
February 21, 2005 at 3:38 pm
24A quick personal gripe: Drugs do not have “side effects!” They have a range of effects, one of which is considered to be beneficial, some of which may be inconsequential, and some of which are detrimental and in some cases irreversable. “Side effect” is classic weasel-wording.
J. Deighton
February 21, 2005 at 4:13 pm
25Off topic, but I just heard about Hunter S Thompson. I can personally say that he has had more of an impact on my morality and humor than Arthur Miller and Johnny Carson combined. Damn, I’m gonna miss just knowing he was there.
David
February 21, 2005 at 6:17 pm
26Hunter S. Thompson had more impact, period - very, very liberating impact. My reaction: “Goddammit, Hunter, why’d ja do it?” followed by, “Goddammit, Hunter, I know you had the right to.” Clearly one of the rights our political and religious institutions have the greatest difficulty allowing. And so Jack Kevorkian languishes in jail. Makes me so proud.
J. Deighton
February 21, 2005 at 6:47 pm
27Couldn’t agree with you more David, just mentioning the two aspects that came up as topics of conversation in the comments section here before.
Murray
February 21, 2005 at 6:51 pm
28hedera,
Autoimmune diseases do run in families. My wife’s sister has Graves Disease (thyroid) and it appears that her mother died of an autoimmune disease of the liver. (Johns Hopkins couldn’t find anything either in diagnosis or autopsy, but they were looking for liver not autoimmune problems).
Our sympathies are with you and your sister (we just got done with a bike ride and are feeling fine). Thank Lobster that the drugs work so well and that her insurance protects us from the immense cost.
Matt
February 21, 2005 at 7:54 pm
29Auros, I do want to see them all in jail. I want them all to suffer like the penny-ante pot dealers who go in for a short stint and come out hardened beyond what the street could ever do. I want them to see first-hand what our prison system is like–just like Martha (who by the way is starting to work for prison reform, go figure). Call me bitter, vindictive, and petty. Oh yeah, also take all their money.
Mike Z
February 22, 2005 at 3:26 am
30Regarding side effects: Maybe this is just a semantic issue, but the drugs we’re talking about were manufactured for a specific purpose, so any effects they have other than that purpose can legitimately be called side-effects.
Matt
February 22, 2005 at 11:17 am
31I agree with Mike Z. There is an intended effect, and all others are side effects. Finasteridine shrinks swollen prostates, but had a side effect of growing hair on balding scalps. In a lower dose, it’s now sold as Propecia.
Side effects are somewhat prone to definition, as coumadin may thin your blood to prevent clots, but may cause bleeding as well.
By the way, I agree with Murray. Get rid of advertising to the public. Until we complain, the drug companies will continue to foist these expensive alternatives on the consumer when less expensive and perfectly acceptable alternatives exist.
Steve
February 22, 2005 at 12:27 pm
32Okay, so it doubles the risk of heart attack. Heart attacks are a bad thing, certainly. But so is living with pain so bad you can’t walk or even function normally. I know. I’m looking at having my knees replaced in a couple of years if things continue as they are.
The one bit of missing information is what the actual risk is. Is it significant? If the probabilty of a heart attack in the control group is 0.000000001 (I’m obviously making up these numbers) and, hence, if doubled is 0.000000002, then the risk may be acceptable.
I’m by no means a fan or an apologist for Big Pharma but without complete information I find it hard to make a judgement as to whether this is a good decision or not.
Clearly this is where informed consent comes into play in the doctor-patient relationship.
bri
February 22, 2005 at 3:34 pm
33Did I miss something here?
Class action lawsuits are a thing of the past now and Vioxx comes back. Coincidence?
bri
Murray
February 22, 2005 at 8:46 pm
34Here’s another thing to chew on.
If my wife didn’t take Celebrex (and a bunch of other drugs) she couldn’t ride on the tandem. We spent 5 hours this weekend riding at an aerobic level, (we do better when the temperature is ABOVE freezing). This exercise, more or less, makes her immune from heart problems. It’s possible only because she can take the drugs that could leave her more susceptible to heart (and liver) problems.
tess
February 23, 2005 at 2:49 am
35testing, testing . . .
tess
February 23, 2005 at 2:50 am
36Okay, that was just odd. I tried posting on the lastest post, and I kept getting an error spat back at me about needing to correct something in my post. Anyone having problems?
Jerry
February 23, 2005 at 4:05 pm
37“It’s the ruthless pursuit of maximum profit, utterly akin to the ruthless pursuit of the world’s resources, that has made what ought to be a saintly enterprise into something all too often more diabolical than noble. Greed is clearly more powerful than morality in great business enterprises.” David
Yes, of course! And it is the selling of anti-biotics in vast quanitities for use in sub-clinical doses in feed lots, the prescriptions (often, also, for sub-clinical doses) by MDs when their patients “demand” something for the flu, and the failure of personal responsibility to use anti-biotics as prescribed, all leading to the selection for drug-immune strains of deadly organisms that has kicked a benevolent Lobster in the teeth (oral palps?)when it granted us a great boon.
Also: the issue is informed consent! If my doctoer tells me (based on information that is accurate and reflects valid studies, ones that would be publishable in the refereed literature) that I can live a a significantly improved and active life, but I risk a 100% increased risk of heart problems, which are defined, then I can make my choice. Just like I think I ought to be able to choose to smoke marijuana if I want to.
I think the whole problem is the failure of the megapharms to be candid about what they know, and responsible for knowing what they should know about their products.