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Bartelby
11-29-2011, 08:13 AM
Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled.

Agent Orynge
11-29-2011, 08:44 AM
Go on...

10char

mikeler
11-29-2011, 09:02 AM
Perhaps the thread title of Beware of Vioxx would be more appropriate? Who is Graham? Links please.

r2473
11-29-2011, 09:30 AM
Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled.

Just playing with the numbers:

140,000 heart attacks and strokes
55,000 deaths
XXXXXX permanately disabled (many more than 55,000).

So I have to assume that not all Vioxx deaths and permanent disabilities were accompanied with heart attacks and strokes?

Otherwise your numbers don't make much sense.

ollinger
11-29-2011, 09:49 AM
Vioxx pretty clearly had cardiac risks and there are better drugs available, though the numbers presented by the OP are a little misleading as it's believed Vioxx also prevented deaths from GI bleeding that would have occurred if people had been using Naprosen or Aspirin in its place. GI events are at least 3 times more common than cardiac events on these meds, and a third of those GI events are serious, sometimes fatal. So some of those on Vioxx might have died from the GI events that may have occured had they instead been on Naprosen or Aspirin, but which were rare when using the Vioxx. This data on GI issues was presented to the Senate Committee when Graham presented his findings. Graham noted that his figures on heart attack and stroke were estimates.

LuckyR
11-29-2011, 09:52 AM
Graham’s data indicate that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, and many more were permanently disabled.

Are you familiar with the concept of risks and benefits?

Agent Orynge
11-29-2011, 11:05 AM
The real question is how do I defend myself against a man armed with a banana?

Bartelby
11-30-2011, 08:58 PM
They did take it off the market and now regret ever putting it on the market, so the risks were too great for the putative benefits.



Are you familiar with the concept of risks and benefits?

Bartelby
11-30-2011, 09:06 PM
Evidence that using Vioxx doubled a patient’s risk of suffering a heart attack or stroke —based on a review of 1.4 million patients’ records— was about to be published in Lancet by David Graham, MD, an FDA investigator. The FDA director’s office, devoted valet of Big PhRMA, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.

LuckyR
12-01-2011, 12:11 PM
They did take it off the market and now regret ever putting it on the market, so the risks were too great for the putative benefits.

I don't dispute your comment above since it is much more informative than your OP.

Limpinhitter
12-04-2011, 04:20 PM
Are you familiar with the concept of risks and benefits?

I am! And my question to you is, who decides if you are going to take that risk?

Limpinhitter
12-04-2011, 04:23 PM
They did take it off the market and now regret ever putting it on the market, so the risks were too great for the putative benefits.

Actully, Pfizer is quite happy they put it on the market. The FDA let them keep it on the market long enough to make a big fat profit before it was "voluntarily" withdrawn.

ollinger
12-04-2011, 04:53 PM
^^^ no, Pfizer is glad they put Neurontin on the market. They had to pay something like an 800 million dollar fine for falsified pain relief data, but the drug was grossing something like 3 to 5 billion a year. Vioxx was sold by Merck, not Pfizer.

Fifth Set
12-04-2011, 05:25 PM
...The FDA director’s office, devoted valet of Big PhRMA...

I was wondering what the real point of this thread was. Perhaps this little gem is the hint that it may not necessarily go in a rational direction.

Bartelby
12-04-2011, 05:34 PM
... rhetoric would be the simpler explanation.

Talker
12-04-2011, 05:57 PM
The way I see it is Pharma suppresses the bad studies then gets approval.

Eventually people will die or be harmed, the information can also be leaked out.

The drug is then pulled off the market and the pharma company pays a fine but ends up making a lot of money still.

The end result is the company gets money but it costs people their lives or some type of injury and the company already knew this would happen beforehand.
No one goes to jail.

This looks like business as usual and because the government does little to stop it people are not outraged.

We are lambs just following the governments lead, even as those around us die.
Sad state of affairs.

Fifth Set
12-05-2011, 06:09 AM
The way I see it is Pharma suppresses the bad studies then gets approval.

Eventually people will die or be harmed, the information can also be leaked out.

The drug is then pulled off the market and the pharma company pays a fine but ends up making a lot of money still.

The end result is the company gets money but it costs people their lives or some type of injury and the company already knew this would happen beforehand.
No one goes to jail.

This looks like business as usual and because the government does little to stop it people are not outraged.

We are lambs just following the governments lead, even as those around us die.
Sad state of affairs.

Wow, you have a pretty warped view of how medicine gets delivered in the U.S.

Do your kids get immunizations that spares them the measles, pertussis, etc.? Thank big pharma.

Do you care about anyone who has survived cancer, HIV or any other deadly disease? Thank big pharma.

Bartelby
12-05-2011, 06:20 AM
There's no doubt Wall Street banks sell dud investments for a billion and then take a hundred million dollar fine, and know in advance they walk away with a profit. In fact, a judge just threw out one such deal as not in the interests of justice.

Talker
12-05-2011, 06:29 AM
Wow, you have a pretty warped view of how medicine gets delivered in the U.S.

Do your kids get immunizations that spares them the measles, pertussis, etc.? Thank big pharma.

Do you care about anyone who has survived cancer, HIV or any other deadly disease? Thank big pharma.

You missed my point badly. :oh well:

Limpinhitter
12-05-2011, 05:51 PM
^^^ no, Pfizer is glad they put Neurontin on the market. They had to pay something like an 800 million dollar fine for falsified pain relief data, but the drug was grossing something like 3 to 5 billion a year. Vioxx was sold by Merck, not Pfizer.

You're right, it was Merck.

But, my understanding is that the fine against Pfizer was for marketing neurontin for "off label" use (a use other than what the FDA approved it for). A doc has the discretion to prescribe a drug off label. But, a drug company can't market it off label. And the size of the fine was basically a palm greasing to Pfizer. They made out like bandits, thanks to their friends at the FDA.

Limpinhitter
12-05-2011, 05:57 PM
The way I see it is Pharma suppresses the bad studies then gets approval.

Eventually people will die or be harmed, the information can also be leaked out.

The drug is then pulled off the market and the pharma company pays a fine but ends up making a lot of money still.

The end result is the company gets money but it costs people their lives or some type of injury and the company already knew this would happen beforehand.
No one goes to jail.

This looks like business as usual and because the government does little to stop it people are not outraged.

We are lambs just following the governments lead, even as those around us die.
Sad state of affairs.

Here's what I wrote in another thread in another section.



* * *

The FDA SHOULD regulate the drug industry. But, it doesn't. Rather, it pimps for the drug industry by protecting it from competition and from taking responsibility for the deaths and serious injuries caused by the drug industries products. The question is, how did this happen to the FDA?

The corruption of the state and federal administrative agencies began with the Ronald Reagan deregulation movement. This movement was, and continues to be, a multi-focal attack. Regulatory agencies are created by statute and are authorized and mandated to promulgate regulations necessary protect public health, safety and welfare from the abuses of industry. One point of attack is to legislatively minimize the regulatory authority of such agencies. Another is to corrupt the agencies by creating what has come to be called "captive agencies." Ronald Reagan started that trend by nominating industry executives and lawyers, whose loyalty is to their industry and their company, to head up these agencies and to hire personnel also loyal to the industry. The FDA is only one example of many such captive agencies. Rather than fulfilling its mandate to protect public health, safety and welfare, the FDA protects the drug industry from competition, and from taking responsibility for the deaths and serious injuries caused by its products.

So, the reason that the FDA can't competently regulate the nutritional supplement industry is because it will only do what is in the interest of protecting the drug industry, not the interest of protecting public health, safety and welfare. What is in the interest of the drug industry? The same as any industry, the elimination of competition. The drug industry wants control of that market and there is NOTHING it won't try to do to get it, including the use of its private police, the FDA, to aid it in that effort. To be clear, there are many fine, dedicated, lifelong science based employees at the FDA and other agencies. They just don't have the authority to take any final agency action. The nominated pimps with conflicts of interest and their hand picked corrupt minions are the ones who make those decision.

Limpinhitter
12-05-2011, 05:58 PM
Wow, you have a pretty warped view of how medicine gets delivered in the U.S.

Do your kids get immunizations that spares them the measles, pertussis, etc.? Thank big pharma.

Do you care about anyone who has survived cancer, HIV or any other deadly disease? Thank big pharma.

Actually, I suspect you have a pretty warped view about how medicine gets delivered in the U.S.

Fifth Set
12-06-2011, 09:52 AM
Here's what I wrote in another thread in another section.

Kind of a bizarre manifesto, to be honest.

The nutritional supplements reference especially came out of nowhere. You aren't one of those colloidal silver hawkers, are you?

http://4.bp.blogspot.com/__sm1kmNiWAo/THbYP_McPhI/AAAAAAAADXQ/wg_CxqGZl3o/s400/argyria.jpg

Talker
12-06-2011, 11:32 AM
I found this article about Vioxx, nothing new for some but others may find it interesting.

Merck—Too Big to Prosecute?

December 6, 2011

There is a surprising reason why the government won’t go after drug companies for serious crimes.


It is because government programs like Medicare, Medicaid, and the Veterans Administration would then be barred from doing business with them!


In 1999 the FDA approved Vioxx, a drug created by Merck and Co. to treat arthritis. Vioxx was pulled off the market in 2004 because evidence showed it greatly increased the risk of heart attack in the 25 million Americans who had taken the drug. Some 50,000 patients sued, and 27,000 of the plaintiffs received $4.85 billion in settlement of their claims.


Last week the Department of Justice announced that Merck has agreed to pay a $321 million criminal fine and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce. Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. Those payments will settle civil claims that its marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed.


Please note that these settlements are for rather minor infractions—not for deliberately concealing the danger of a killing drug from patients, the medical community, and their investors. Despite the serious consequences of Merck’s actions, the government won’t prosecute them for any serious charges—because, if they did and won, it would mean they would have to stop doing business with Merck in the future! Federal law makes it illegal for Medicare and Medicaid to do business with “an excluded or debarred entity resulting from serious criminal charges.”


This means that when a company becomes too deeply enmeshed in the government’s business, these companies simply become too big to prosecute!


Paying fines without serious criminal charges does not appear to be enough of a deterrent. A new report from the consumer group Public Citizen shows that the pharmaceutical industry now leads all other industries in fraud against the federal government—and that includes the defense industry! Big Pharma led the pack in the total amount of fraud payments for actions against the federal government under the False Claims Act. Four companies (GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough) accounted for more than half (53 percent or $10.5 billion) of all financial penalties imposed over the past two decades.


In 2006, Dr. David Graham, associate director of the FDA’s Office of Drug Safety and a courageous whistleblower, said in an interview, “The FDA is responsible for 140,000 heart attacks and 60,000 dead Americans. That’s as many people as were killed in the Vietnam War. Yet the FDA points the finger at me and says, ‘Well, this guy’s a rat, you can’t trust him,’ but nobody is calling them to account. Congress isn’t calling them to account. For the American people, it’s dropped off the radar screen. They should be screaming because this can happen again.”


If a supplement killed 60,000 Americans, what do you think the reaction would be? It would be pulled from the shelves, the FDA would outlaw it, and the media would be screaming about the dangers of supplements. Vioxx does the same thing, and the FDA gives Merck a slap on the wrist and gets a financial settlement.


As Public Citizen told NPR, “The current system of prosecution and recovery isn’t working, because companies can take even the biggest settlements in stride. What’s needed is more criminal prosecution—and the prospect of jail time for Pharma executives.”


ANH-USA is not trying to put anybody in jail. But if we pass laws, they should apply to everyone, including members of Congress and big companies, whether on Wall Street or in the drug industry. Crony capitalist arrangements between government and special interests should never be allowed to create a special category of “too big to prosecute.”

El Diablo
12-06-2011, 11:43 AM
At the time of the fine against Pfizer in 2004, the company had already gotten approval to market for neuralgia pain two years earlier. So the false research data that led to that approval was one of the reasons the company was fined.

Fifth Set
12-06-2011, 01:14 PM
I found this article about Vioxx, nothing new for some but others may find it interesting.

Alliance for Natural Health. Hmmm....

You supplement folks are funny. Full of skepticism and cynicism about the government and big pharma. No such critical thinking when it comes to the pushers of Zicam and Super Silver.

Take two of these and call me in the morning.

http://martianchronicles.files.wordpress.com/2010/06/denialism.jpg

http://www.amazon.com/Denialism-Irrational-Thinking-Scientific-Threatens/dp/1594202303

dlk
12-06-2011, 01:20 PM
The real question is how do I defend myself against a man armed with a banana?

That no doubt is more important than if COX II Inhibitors increase clot formation:)

I'm no phamacological researcher (but have a friend who retired from Eli Lilly), but I'll bet the diagnosis of osteoarthritis has a roughly 40-50% greater chance of CAD.

I'm just impressed with all the folks who can read through so many studies and trials in order to understand the medications that are currently on the market and why:shock:

Limpinhitter
12-06-2011, 06:59 PM
Kind of a bizarre manifesto, to be honest.

The nutritional supplements reference especially came out of nowhere. You aren't one of those colloidal silver hawkers, are you?

* * *

I did explain that it was something I wrote in another thread in another forum area. You're going to have to employ some critical thinking skills and pick out the issues and comments that are germaine to this thread, if you have any critical thinking skills to employ.

Limpinhitter
12-06-2011, 07:02 PM
Alliance for Natural Health. Hmmm....

You supplement folks are funny. Full of skepticism and cynicism about the government and big pharma. No such critical thinking when it comes to the pushers of Zicam and Super Silver.

Take two of these and call me in the morning.

* * *

You're beginning to smell like a drug rep! The canned pajoratives are a dead givaway!

Limpinhitter
12-06-2011, 07:10 PM
That no doubt is more important than if COX II Inhibitors increase clot formation:)

I'm no phamacological researcher (but have a friend who retired from Eli Lilly), but I'll bet the diagnosis of osteoarthritis has a roughly 40-50% greater chance of CAD.

I'm just impressed with all the folks who can read through so many studies and trials in order to understand the medications that are currently on the market and why:shock:

My advice to anyone who will listen to me is that: (1) medical doctors are not qualified to prescribe drugs, they don't know how they work, or what the risks are, they don't read the package inserts, they get virtually all of their information about the drugs they prescribe from commissioned drug salesmen who have a finanical interest in bribing doctors to sell their brand, and the few that do actually read package inserts, don't have enough respect for their patients to share the information they have in order to obtain their patients' informed consent before prescribing a drug, and (2) You have to be an informed medical consumer. Do not allow a doctor to make any medical decisions for you. Further, if you have not read and taken the time to understand the package insert of a drug that a doctor has prescribed for you, then just don't take it. The risk of taking a drug outweighs the risk of not taking it almost every time.

Talker
12-06-2011, 07:30 PM
Alliance for Natural Health. Hmmm....

You supplement folks are funny. Full of skepticism and cynicism about the government and big pharma. No such critical thinking when it comes to the pushers of Zicam and Super Silver.

Take two of these and call me in the morning.

http://martianchronicles.files.wordpress.com/2010/06/denialism.jpg

http://www.amazon.com/Denialism-Irrational-Thinking-Scientific-Threatens/dp/1594202303

I'm trying to upgrade your knowledge base.

Because I posted it doesn't mean I agree in whole, it's just information.

What do you see wrong or right with it?

Fifth Set
12-06-2011, 07:50 PM
My advice to anyone who will listen to me is that...the risk of taking a drug outweighs the risk of not taking it almost every time.

Thankfully, most people are not listening to you. If they were, U.S. life expectancy would still be about 45!

dlk
12-06-2011, 08:42 PM
My advice to anyone who will listen to me is that: (1) medical doctors are not qualified to prescribe drugs, they don't know how they work, or what the risks are, they don't read the package inserts, they get virtually all of their information about the drugs they prescribe from commissioned drug salesmen who have a finanical interest in bribing doctors to sell their brand, and the few that do actually read package inserts, don't have enough respect for their patients to share the information they have in order to obtain their patients' informed consent before prescribing a drug, and (2) You have to be an informed medical consumer. Do not allow a doctor to make any medical decisions for you. Further, if you have not read and taken the time to understand the package insert of a drug that a doctor has prescribed for you, then just don't take it. The risk of taking a drug outweighs the risk of not taking it almost every time.

Fortunately for me, I 've seen more than enough physicians who can and do presrcible the right dose, at the right time, at right quantitiy, for the right reasons. I may not want them changing my oil, but they're okay on my tennis team, except when their own. Limphitter, I like to know your background, where you can believe in such statements like "taking a drug outweighs the risk of not taking it almost every time."

Your heart has stopped & I throw a Zoll defibrillator on your lifeless body, the EKG suggests Torsades, the Mag I'm gonna give you can only help (99%) of the time . Is this the "almost every time" occaision?

Limpinhitter
12-07-2011, 10:48 AM
I'm trying to upgrade your knowledge base.

Because I posted it doesn't mean I agree in whole, it's just information.

What do you see wrong or right with it?

The silence is deafening isn't it!

Limpinhitter
12-07-2011, 10:50 AM
Thankfully, most people are not listening to you. If they were, U.S. life expectancy would still be about 45!

You're a drug rep! Not only do you know nothing about nutrition, you know nothing about the dangers and limitations of allopathic medicine. Why would you? You're a trained parrot. Wait, that would make you a medical doctor!

Limpinhitter
12-07-2011, 10:59 AM
Fortunately for me, I 've seen more than enough physicians who can and do presrcible the right dose, at the right time, at right quantitiy, for the right reasons. I may not want them changing my oil, but they're okay on my tennis team, except when their own. Limphitter, I like to know your background, where you can believe in such statements like "taking a drug outweighs the risk of not taking it almost every time."

Your heart has stopped & I throw a Zoll defibrillator on your lifeless body, the EKG suggests Torsades, the Mag I'm gonna give you can only help (99%) of the time . Is this the "almost every time" occaision?

You're not thinking clearly. Torsedes de Pointes is a lethal condition justifying drastic intervention. So what? On its own, your example is inapposite to the discussion! Are you aware that there are FDA approved drugs that can induce tdp? Do you know which ones they are? Do you think your doctors know? Are you aware that in the U.S. medical care, as a whole, is the third leading cause of death, behind only heart attacks (both congestive and arrhythmic), and cancer?

dlk
12-07-2011, 11:02 AM
You're not thinking clearly. Torsedes de Pointes is a lethal condition justifying drastic intervention. So what? On its own, your example is inapposite to the discussion! Are you aware that there are FDA approved drugs that can induce tdp? Do you know which ones they are? Do you think your doctors know? Are you aware that in the U.S. medical care, as a whole, is the third leading cause of death, behind only heart attacks (both congestive and arrhythmic), and cancer?

Whew, somebody's a little bitter and smarter than everyone else:shock:

Fifth Set
12-07-2011, 12:21 PM
You're a drug rep! Not only do you know nothing about nutrition, you know nothing about the dangers and limitations of allopathic medicine. Why would you? You're a trained parrot. Wait, that would make you a medical doctor!

I don't take being called a medical doctor as an insult - more twilight zone stuff.

If this thread is going to go somewhere more interesting than your name calling, I will actually give you the floor to take it there with this question.

Since we can only assume that you are an advocate of either homeopathy or spiritual healing, can you provide links to professionally conducted clinical studies providing the efficacy of any of these offerings? This should be easy since you apparently consider them to be superior to those of conventional medicine.

chrischris
12-07-2011, 12:47 PM
Ask Theo Colburn.

dlk
12-07-2011, 12:56 PM
Ask Theo Colburn.

Or Ian C. Read:)

Limpinhitter
12-07-2011, 04:05 PM
I don't take being called a medical doctor as an insult - more twilight zone stuff.

If this thread is going to go somewhere more interesting than your name calling, I will actually give you the floor to take it there with this question.

Since we can only assume that you are an advocate of either homeopathy or spiritual healing, can you provide links to professionally conducted clinical studies providing the efficacy of any of these offerings? This should be easy since you apparently consider them to be superior to those of conventional medicine.

This thread has gone somewhere interesting. An uninformed, misinformed, malinformed, drug rep, who makes a living bribing doctors to switch their patients to his brand of unsafe and largely ineffective drugs, is trying to defend the diabolical, criminal industry that he makes his living off of.

Homeopathy and spiritual healing kill far fewer Americans than allopathic medical practitioners.

Avles
12-07-2011, 09:08 PM
I have no problem with "allopathic" medicine, and I think Limpinhitter is being very hyperbolic here.

On the other hand... in a drawer in my kitchen is one of those rubber things that you use to get a grip on the lid of a jar so you can open it. I'm not sure where it came from-- I think my girlfriend picked it up somewhere, maybe secondhand.

Stamped on this jar opener are the words "VIOXX (rofecoxib)." I guess this is because people with arthritis have trouble opening jars.

I see no reason that a jar opener with "Vioxx" on it should ever have existed, and when I look at that jar opener it's hard not to think that there are some serious ethical issues in the pharmaceutical industry.

dlk
12-07-2011, 09:37 PM
I have no problem with "allopathic" medicine, and I think Limpinhitter is being very hyperbolic here.

On the other hand... in a drawer in my kitchen is one of those rubber things that you use to get a grip on the lid of a jar so you can open it. I'm not sure where it came from-- I think my girlfriend picked it up somewhere, maybe secondhand.

Stamped on this jar opener are the words "VIOXX (rofecoxib)." I guess this is because people with arthritis have trouble opening jars.

I see no reason that a jar opener with "Vioxx" on it should ever have existed, and when I look at that jar opener it's hard not to think that there are some serious ethical issues in the pharmaceutical industry.

I followed you clearly until your last sentence. Please explain the issue you have with the marketing to people who need assistive OT devices. How does looking at the jar stir memories of "serious ethical issue?''

El Diablo
12-08-2011, 05:37 AM
^^ I also wonder about this. Tennis players festoon their clothes with ads for any manner of products irrelevant to what they do, but a jar opener aimed at advertising pain relief to people who might have trouble opening jars is unethical? As for drug reps, Pharma changed its own rules some years ago (not so much because they're great guys, but to show the government they could act on their own, and head off government action) and the reps now do almost nothing that isn't for an educational/informational purpose. Dinners and trips must have an educational purpose, and always do in my experience, though that wasn't always the case some years ago. I don't think it's always perfect, but is there an industry more closely regulated in this respect? Are people in other industries never sent on junkets by reps who are trying to sell something?

Bartelby
12-08-2011, 05:40 AM
They use education elsewhere as a tool for marketing as well and the difference between pharmaceutical goods and others is that they are not a simple consumption good like coca-cola.

El Diablo
12-08-2011, 05:47 AM
Oh. Thanks for clarifying. I imagine that's why Coca Cola doesn't conduct educational seminars on the pharmacology of caffeine for supermarket purchasing reps. Coca Cola markets by saying "Coke is It!" and drug manufacturers market by providing some rather good educational opportunities. Myself and two colleagues were taken to dinner a few years ago with the former head of NIMH; it was tremendously helpful in terms of information, and he in no way was pimping for the host's product. I've been to a number of meetings where the speaker, usually someone of some gravitas, has essentially denigrated the product made by the host. People who haven't been to these meetings really have no clue what goes on at them.

Bartelby
12-08-2011, 05:53 AM
Yes, well, one could argue being on the inside has advantages, but some see disadvantages.

I've seen and heard documentaries about the subject and have heard people defend and others criticise the system.

Drugs are massively costly both to governments and to people so they should only be prescribed on the basis of independent professional advice unsullied by commercial considerations.

El Diablo
12-08-2011, 06:45 AM
1) most of the drugs I prescribe are paid for by commercial insurers or, more and more recently, the patients themselves. That there is marketing directed towards both the patient and myself is consistent with how the rest of the economy functions.
2) the government spends money on everything from F-22 fighters to cars to pens to ground coffee to toilets to....well, pretty much every sort of product. Should we prohibit marketing for exactly one type of product because you don't happen to like the industry? Seems a bit arbitrary.

Avles
12-08-2011, 07:14 AM
Why is the jar opener ethically worrisome?

Because the product in question was a new and not-yet thoroughly tested prescription drug with potentially deadly side effects.

And because pharma manufacturers defend direct-to-consumer marketing by claiming that their ads are educational, but there's nothing educational about slapping your product's name on a jar opener (or a pen, or an umbrella, or any other piece of swag-- I'm sure you've seen plenty of examples) and hoping that it sticks in someone's head.

The whole "ask your doctor if [OUR NEW DRUG] is right for you" phenomenon makes me pretty uneasy. Here's a Vioxx ad which was apparently aired in 2004 (so right before the drug was pulled): http://www.youtube.com/watch?v=Lel03EKzqsg

Do you really feel like that ad was fine? I don't.

Bartelby
12-08-2011, 07:30 AM
I don't need a commercial insurer to buy a coke and if one cost thousands of dollars I wouldn't buy one.

I don't need a commercial to make me desire a drug in the same way that one might want me buy a coke.

Government is always involved in the drug industry, in america it happens indirectly so it benefits the companies and not people.



1) most of the drugs I prescribe are paid for by commercial insurers or, more and more recently, the patients themselves. That there is marketing directed towards both the patient and myself is consistent with how the rest of the economy functions.
2) the government spends money on everything from F-22 fighters to cars to pens to ground coffee to toilets to....well, pretty much every sort of product. Should we prohibit marketing for exactly one type of product because you don't happen to like the industry? Seems a bit arbitrary.

El Diablo
12-08-2011, 07:34 AM
The ad you cite has more to do with the product than "Coke is It! or "The most interesting man in the world," or most ads for that matter. As annoying as direct-to-consumer drug ads can be for doctors, I see no ethical issue there. Why shouldn't the end-point consumer be part of the process, or ask me about medications? Drug ads may feature sunny images, but they generally do deal with the product itself for more than ads for other products do. As for the jar opener, at what point does it become OK to advertise? Ford Pintos were being advertised for years before we learned they explode if you back into something. Drug manufacturers go through a particular process of testing and evaluation before they are released. Perhaps more should be done, but allowing advertising once a drug has been approved seems reasonable.

Bartelby
12-08-2011, 07:42 AM
The reality is that the retailer of the drug is the doctor, that's why the companies always want to get to the doctor.

I don't need a doctor to buy a coke or a Pinto.

A doctor is supposed to exercise his skills solely for the benefit of the patient.

A company telling him to prescribe and a patient telling him to prescribe puts unnecessary commercial pressure on his judgement.

Nostradamus
12-08-2011, 08:00 AM
The reality is that the retailer of the drug is the doctor, that's why the companies always want to get to the doctor.

I don't need a doctor to buy a coke or a Pinto.

A doctor is supposed to exercise his skills solely for the benefit of the patient.

A company telling him to prescribe and a patient telling him to prescribe puts unnecessary commercial pressure on his judgement.

Fact: FDA recently passed a regulation that makes it much more difficult for the drug companies to promote their product to the physicians. Perks and kickbacks and favors are no longer allowed. No free lunches, no paid seminars, no all expense paid vacations and no more free gifts to the physicians from the drug company reps.

Fact: Doctors are human beings. and they do get tempted to use more of the certain product if they keep getting free money and gifts from that company for using more of that medication. but no ethical physician will knowingly prescribe or give samples of a medication that could harm the patient. but a physician could prescribe the medication if they don't have all the facts.
Such as when vioxx first came out, physicians didn't know that it could have harmful cardiovascular side effects so they used it alot. but after new findings came out, they stopped using it. that is ethical thing to do.

also a silly CNN reporter said, when the drug comes into the market, FDA should make sure the drug is safe and understand all the harmful side effects. Stupid statement. There is no way to know all the possible harmful side effects of the medication at the time FDA approves it. Sometimes we find out about certain bad side effects as the public uses it more and as the time goes on and we gain more and more experience with the medication.

Limpinhitter
12-08-2011, 08:34 AM
Fact: The latest from the FDA's Medwatch function. While reading, remember that vitamin D is a dangerous drug that can only be safely used under the supervision of a trained medical doctor.

************************************************

Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events
AUDIENCE: Cardiology, Pharmacy, Hematology

ISSUE: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282820.htm

Limpinhitter
12-08-2011, 08:37 AM
Fact: FDA recently passed a regulation that makes it much more difficult for the drug companies to promote their product to the physicians. Perks and kickbacks and favors are no longer allowed. No free lunches, no paid seminars, no all expense paid vacations and no more free gifts to the physicians from the drug company reps.

Fact: Doctors are human beings. and they do get tempted to use more of the certain product if they keep getting free money and gifts from that company for using more of that medication. but no ethical physician will knowingly prescribe or give samples of a medication that could harm the patient. but a physician could prescribe the medication if they don't have all the facts.
Such as when vioxx first came out, physicians didn't know that it could have harmful cardiovascular side effects so they used it alot. but after new findings came out, they stopped using it. that is ethical thing to do.

also a silly CNN reporter said, when the drug comes into the market, FDA should make sure the drug is safe and understand all the harmful side effects. Stupid statement. There is no way to know all the possible harmful side effects of the medication at the time FDA approves it. Sometimes we find out about certain bad side effects as the public uses it more and as the time goes on and we gain more and more experience with the medication.

But, what % of the public do you think understand that when they take a newly approved drug, that what they are really doing is volunteering to be guinnea pigs in the service of drug corporation profits?

Fact: NONE!

Avles
12-08-2011, 08:45 AM
The ad you cite has more to do with the product than "Coke is It! or "The most interesting man in the world," or most ads for that matter. As annoying as direct-to-consumer drug ads can be for doctors, I see no ethical issue there.


Evidently the drug companies do see one, at least to the extent that they persist with the idea that their marketing is a form of "education." Why not drop the euphemisms? Dos Equis doesn't pretend that it's "educating" the consumer about beer.


Drug ads may feature sunny images, but they generally do deal with the product itself for more than ads for other products do. As for the jar opener, at what point does it become OK to advertise?

Maybe at the point where a product is considered innocuous enough that you don't need a doctor's written permission to acquire it? Just a thought.

Bartelby
12-08-2011, 08:55 AM
The company always knew the problems with the drug, but yet they sold it to physicians and the public and only withdrew it after public revelations concerning these undisclosed problems.



Fact: FDA recently passed a regulation that makes it much more difficult for the drug companies to promote their product to the physicians. Perks and kickbacks and favors are no longer allowed. No free lunches, no paid seminars, no all expense paid vacations and no more free gifts to the physicians from the drug company reps.

Fact: Doctors are human beings. and they do get tempted to use more of the certain product if they keep getting free money and gifts from that company for using more of that medication. but no ethical physician will knowingly prescribe or give samples of a medication that could harm the patient. but a physician could prescribe the medication if they don't have all the facts.
Such as when vioxx first came out, physicians didn't know that it could have harmful cardiovascular side effects so they used it alot. but after new findings came out, they stopped using it. that is ethical thing to do.

also a silly CNN reporter said, when the drug comes into the market, FDA should make sure the drug is safe and understand all the harmful side effects. Stupid statement. There is no way to know all the possible harmful side effects of the medication at the time FDA approves it. Sometimes we find out about certain bad side effects as the public uses it more and as the time goes on and we gain more and more experience with the medication.

ollinger
12-08-2011, 12:42 PM
When subjects are chosen for clinical trials, they're chosen within a certain age range (usually 18-65) and they're chosen so as to be free of other medical conditions and, for the most part, to be on no other medications. Once a drug is approved for release, it's then taken by people of all ages (certainly over 65, often under eighteen) who happen to be on other medications and have other medical illnesses. This is why side effects, interactions, and other problems that weren't seen prior to release then become apparent. It would be essentially impossible to test drugs for all these variables before release, so complete safety information will never be known until a drug's been on the market for awhile. FDA has a pretty good mechanism in place for reporting problems after a drug has been released. (This is one of the responsibilities of those drug sales reps, and they're intensely dilligent about it in my experience.) Merck was certainly negligent in withholding information for several years, but there's no adequate safeguard against that short of a huge expansion of FDA to handle the information that now goes to the manufacturers, unlikely in the current budgetary climate. FDA is usually very willing to pull the plug on a drug (read up on lovastatin and breast cancer, among many recent examples) IF it can get the data.

Talker
12-08-2011, 01:00 PM
When subjects are chosen for clinical trials, they're chosen within a certain age range (usually 18-65) and they're chosen so as to be free of other medical conditions and, for the most part, to be on no other medications. Once a drug is approved for release, it's then taken by people of all ages (certainly over 65, often under eighteen) who happen to be on other medications and have other medical illnesses. This is why side effects, interactions, and other problems that weren't seen prior to release then become apparent. It would be essentially impossible to test drugs for all these variables before release, so complete safety information will never be known until a drug's been on the market for awhile. FDA has a pretty good mechanism in place for reporting problems after a drug has been released. (This is one of the responsibilities of those drug sales reps, and they're intensely dilligent about it in my experience.) Merck was certainly negligent in withholding information for several years, but there's no adequate safeguard against that short of a huge expansion of FDA to handle the information that now goes to the manufacturers, unlikely in the current budgetary climate. FDA is usually very willing to pull the plug on a drug (read up on lovastatin and breast cancer, among many recent examples) IF it can get the data.

They can prosecute those who are found to hide information leading to additional deaths.
This would be a definite deterrant I suppose.
I posted some of the reasons they won't above.

In summary:
Please note that these settlements are for rather minor infractions—not for deliberately concealing the danger of a killing drug from patients, the medical community, and their investors. Despite the serious consequences of Merck’s actions, the government won’t prosecute them for any serious charges—because, if they did and won, it would mean they would have to stop doing business with Merck in the future! Federal law makes it illegal for Medicare and Medicaid to do business with “an excluded or debarred entity resulting from serious criminal charges.”

Limpinhitter
12-08-2011, 02:42 PM
When subjects are chosen for clinical trials, they're chosen within a certain age range (usually 18-65) and they're chosen so as to be free of other medical conditions and, for the most part, to be on no other medications. Once a drug is approved for release, it's then taken by people of all ages (certainly over 65, often under eighteen) who happen to be on other medications and have other medical illnesses. This is why side effects, interactions, and other problems that weren't seen prior to release then become apparent. It would be essentially impossible to test drugs for all these variables before release, so complete safety information will never be known until a drug's been on the market for awhile. FDA has a pretty good mechanism in place for reporting problems after a drug has been released. (This is one of the responsibilities of those drug sales reps, and they're intensely dilligent about it in my experience.) Merck was certainly negligent in withholding information for several years, but there's no adequate safeguard against that short of a huge expansion of FDA to handle the information that now goes to the manufacturers, unlikely in the current budgetary climate. FDA is usually very willing to pull the plug on a drug (read up on lovastatin and breast cancer, among many recent examples) IF it can get the data.

It's called the Medwatch system. FDA estimates that from 1-10% of all adverse drug events are reported to Medwatch. Not very much cause for confidence, IMO.