How Pfizer And The US Gov't Set Up A Fake Subsidiary To Take The Brunt Of Lawsuit Over Falsely Marketed Drugs
from the don't-you-feel-healthy-now dept
The pharmaceutical industry is a huge mess, which has little, if anything, to do with making people healthy. The way the system is currently designed, if it's more profitable for a pharmaceutical company to put you at greater risk, it will do so. And sometimes the US gov't will help them brush it under the rug. Reader Bill Pickett points us to a recent investigative report concerning the big, high-publicity lawsuit the US gov't filed against Pfizer, after the company blatantly went against FDA approvals and marketed a drug for all sorts of alternative uses, which the FDA had specifically noted could be dangerous and could put people at greater risk.The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain. Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.Where the story gets scary is in what happened when all this came out. Federal officials announced a criminal case over this, but they didn't actually sue Pfizer directly. Instead, they sued a (not kidding) subsidiary of a subsidiary of a subsidiary of a subsidiary of Pfizer, which was basically set up just take the brunt of this lawsuit:
But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.
A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe....
Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.
Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.... But an internal marketing plan called for training physicians "to serve as public relations spokespeople."
According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.But it was only that last one, Pharmacia & Upjohn Co. Inc., that was sued -- and the report also notes that this company just happened to be set up the same day that Pfizer and federal officials worked out a deal for it to plead guilty -- even though it, as an entity, hadn't done anything.
Why did they do this? Well, if Pfizer itself had been found guilty then it would be barred from Medicare and Medicaid, and prosecutors figured it would effectively close down Pfizer -- and Pfizer was deemed "too big to fail" like that. Why? I have no idea. If the company really did have to close down, it seems likely that others would have picked up the company's various products -- and perhaps done so without putting people's lives at risk.
Really, the problem here is the way the entire system is set up. The FDA requires expensive and involved clinical trials. This is very good, because we want to make sure that any drugs actually do what they're supposed to do, and don't have serious side effects or cause even worse problems. But, the system is currently set up so that the pharmaceutical company itself is in charge of paying for and running those clinical trials, which creates two very problematic situations. First, it gives the company all sorts of incentives to fudge the results or to pretend the results said something different than they really did (see the example above, or Merck with Vioxx) and second, it contributes to the "expense" that a drugmaker can claim comes from developing a new drug, which is part of why it demands patent rights. But if you break out the costs of the clinical trials, the marketing-hidden-ad-development-costs, and the amount of research that's actually funded by gov't grants -- you find that pharmaceutical firms really aren't spending nearly as much as they claim. A big part of the issue is the clinical trials, and that's leading to all sorts of questionable behavior. In the past, some have suggested that such trials should be conducted by the gov't, rather than by the pharma companies themselves. While I'm not sure that's the answer, it's pretty clear that the existing system is not working, if our end goal is to make people healthier.
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Individual responsibility.
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Re: Individual responsibility.
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Re: Re: Individual responsibility.
how about this
find the CEO
have him test all the damn drugs
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Re: Individual responsibility.
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Re: Re: Individual responsibility.
If the primary purpose of big pharma is not to make people WELL, but instead to endlessly sell them symptom suppressing product. Why do we need them at all? For thousands of years the Chinese medical system has taken a different view about the role of medicine, (not entitled to payment unless the patient is cured) and now you think they should Americanize it because the American health care system is better???
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Re: Re: Re: Individual responsibility.
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Re: Re: Individual responsibility.
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I've always wondered...
When everything is "too big to fail", the whole system fails.
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Re: I've always wondered...
When everything is "too big to fail", the whole system fails.
Indeed. "Too big to fail" = already a fail.
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Cronyism
Mike, I agree the system is the problem, but how do you get around the fact that the drug co will have to pay for the trials? Whether it's a 3rd party or the gov running them, it's still open to corruption.
IMO, the FDA should be optional. If you want to spend the billion dollars and 10 years for the FDA label, by all means, go right ahead. But if you don't, then you can sell your product without the label. Let the market decide if the FDA label is necessary on all products.
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Re: Cronyism
Agreed. I seriously doubt whether the remedies we (the regular people) have for malfeasance by drug manufacturers would even be affected one bit. Whether the drug is FDA approved or not is irrelevant when someone is actually injured or killed by negligent drug design or manufacturing.
People make the argument that you *need testing and validation of drugs, and I tend to agree. Where I tend to disagree is when it is asserted that it must be through government action alone that people can be protected.
I feel drug testing would be better off in the hands of a not-for-profit, democratically monitored (as in, without the intervention of a central governmental power) entity run by rotating leadership drawn from private, independent medical professionals. Its charter, guidance and procedures completely "open-source".
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Too bad the FDA is paid off anyways
There's not a dang bit of good that comes from the FDA. Most of the people on the FDA's panels have been, are currently, or have a vested interest in the companies they support. Look at Monsanto for example.
Monsanto's genetically modified corn grains are proven by lab studies to cause cancer and a slew of other problems in Mice and Rats. Yet it's good enough to be given as feed to animals and humans alike? Any meat you eat from grocery stores has been grown through corn fed animals. And any of you think that there's no issue with that?
Hello rise in cancer, birth defects, hormone problems, diabetes, and a long list of other issues!!!! When will people wake up that the FDA has been bought by the greedy companies making the harmful foods we eat and the drugs we're SUPPOSED to use!?
Look at the statistics people... have we gotten healthier or sicker???
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Re: Too bad the FDA is paid off anyways
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Just one more...
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Regulating a healthy market?
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Re: Regulating a healthy market?
The "to big to fail" premise is false, as is the notion that morality of any sort is derived from the economic system. Unregulated capitalism conducted by moral people is moral. Regulated capitalism when regulated by immoral people is immoral.
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Re: Re: Regulating a healthy market?
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Re: Re: Re: Regulating a healthy market?
No company would do that in a free market because if they did then they would get a bad reputation and nobody would buy their products. And that's why there should be no government regulation in a capitalist system.
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Re: Re: Re: Re: Regulating a healthy market?
No system can work when corrupt people are permitted to be in power; there is no set of checks and balances, or limits, or laws, which can stop evil people from being evil.
Until someone figures out how to prove intent (say, with a mind reading device), nobody is going to be able to stop this mess for good, and the price will continue to be paid in the blood of innocents.
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Re: Re: Re: Re: Re: Regulating a healthy market?
If you mean political power, then what you are asking is for free market distortions.
"than your competition, then you can buy out the media and lie"
No, the media can only be bought out because there is a government sanctioned lack of competition on media outlets. Otherwise, it can't be, if the media is broken in a free market people will know and they will build new media and communicate to each other through the new media, new media that won't simply be bought out because doing so would simply create new media and customers won't go to broken media. But as it stands the government prevents new media from being created by granting monopolies.
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Re: Re: Re: Re: Re: Regulating a healthy market?
the assumption is that this regulation, created by the government, is better able to determine what's in my best interest than me. I take offense to this notion, I will seek honest media and will go to great lengths to ensure the quality of what I get in a free market, so long as the broken government (which has no legitimacy) does not get in my way, which it currently tries to.
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Re: Regulating a healthy market?
While it is not in a company's best interest to cause harm to its customers (customers can't buy from you if they're dead), some companies don't do what's in their best interest. When that happens and they cause harm to a customer, the courts are there as a medium for redressing those grievances.
There is no such thing as too big to fail. That's a BS title assigned by government for some political purpose. Any company that grows to a given size has done so because they're leveraging their competitive advantages and are selling products people want to buy. There is no need to break up those companies as there is sufficient competition in the marketplace. In fact, breaking them up would make the system worse as you are removing the economies of scale the large company could employ to keep costs down.
Your issue is not with capitalism but with government involvement in preventing the proper penalty from being assessed to the offending party. Those are separate issues.
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Re: Re: Regulating a healthy market?
Like when the buyer and the seller both benefit from the sale of a slave? Of course the slave doesn't count because he had no say in "the deal".
When that happens and they cause harm to a customer, the courts are there as a medium for redressing those grievances.
Wait a minute. Now you're getting the government involved? I thought "the market" was supposed to be self correcting and able to enforce moral behavior all by itself. What are you, some kind of socialist or something?
Your issue is not with capitalism but with government involvement in preventing the proper penalty from being assessed to the offending party. Those are separate issues.
What is "the proper penalty"? Should that be determined by the government or the market? Or should the government really just be up to the highest bidder? I think you're confused as to whether you're really a capitalist or a socialist.
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Re: Re: Re: Regulating a healthy market?
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Re: Re: Regulating a healthy market?
You are right, I don't think that the proper penalty was served in this case. I think the huge fine Pfizer received will do quite a bit to restructure them but I fully believe that instead of trusting them to restructure themselves that they should have received the "corporate death penalty" and had the restructuring forced onto the market through either breaking them up or denying the medicare/aid contract. I don't trust companies to change themselves - they just don't seem to be capable of doing it most of the time - I think that for the health of the market itself it would have been better to cut them up into pieces and then hung those pieces out in the public square to terrify the next generation of companies that would have grown to replace them. To me, that would have effectively addressed what I see as the structural issues.
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FDA approved Drugs (what a joke)
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Re: FDA approved Drugs (what a joke)
Welcome to my world. Get ready to enjoy being called a nutcase conspiracy theorist.
But before you recoil, take a peek into how aspartame was pushed through by the FDA once Donald Rumsfeld, former CEO of Searl, went to Washington. It's such a fun story....
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Re: Re: FDA approved Drugs (what a joke)
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Re: Re: Re: FDA approved Drugs (what a joke)
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I blame the judges
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So sue them, let them fail, pick up the pieces, and everyone wins (except for the suits at the top that caused all this).
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the real question
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Re: the real question
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I'd think that if (for instance) the marketing costs were higher than the actual science, it would be nice bullet point to illustrate that the system needs to change.
That the cost of R&D isn't actual research, but is actually primarily licensing and marketing and such really screams for reform.
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Re:
A good book on the subject:
http://books.google.com/books?id=SKr5BDAmiMoC&lpg=PA86&ots=eO-JOtt54C&dq=myt h%20of%20the%20%24800%20pill&pg=PP1#v=onepage&q&f=false
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Typo
should be 'they sued'
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Re: Typo
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make people sick
Seriously though, are you saying that the current review process for new drugs is some guy reading a report on research conducted by the company making said drug, saying "yah this looks good" and stamping it 'approved'? Thats incredible. Doesn't the FDA do more checking into food products like beef and chicken than what they apparently do for new drugs?
also, how can you create a company in one day? does this mean they hired a guy and put him in charge just so they could sue the company and fire him?
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make people sick
Seriously though, are you saying that the current review process for new drugs is some guy reading a report on research conducted by the company making said drug, saying "yah this looks good" and stamping it 'approved'? Thats incredible. Doesn't the FDA do more checking into food products like beef and chicken than what they apparently do for new drugs?
also, how can you create a company in one day? does this mean they hired a guy and put him in charge just so they could sue the company and fire him?
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"Ask your doctor" ... I am so sick of hearing that crap.
Maybe there is a TLA for that too.
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So you want to pull Lipitor from Medicare and Medicaid? Don't think that will happen. It will go generic soon.
Is the drug industry perfect? Of course not but don't believe for a second that our health isn't better than it was 10-20-50-200 years ago. That facts just don't support it.
Want to really improve health in the US? Ban smoking, tax fat people at higher rates. That would do more to improve our health than anything else that you can even imagine. Good luck on that too.
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Re:
Doubtful that would do anything other than create another war on something that does not go well.
You think the state of health care is better than ten years ago, is there any data to support that? (not pharma data) Certainly there are many more three letter acronyms than ten years ago, maybe that is a measure of progress.
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Re:
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Murderers only kill one (or a few) person(s); a bad law maker can kill millions.
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The two things that would improve Americas health is stop smoking and lose weight. Those are facts, if you don't like them, well, that is too bad.
As for the health improving? One pretty good indicator of that is life expectancy. The fact is, life expectancy is better today than it was 10 years ago, 20 years ago, ect. You hear about cancer more today, but that may in fact be because people are living longer. Fewer people die younger in life only to be hit with cancer in their older years. I can guarentee that dmentia will be going up in the future because more and more people will live longer lives. How about AIDs? People live longer and longer with AIDs. I remember when that was the final word, be told you had that and you were dead. I know Magic Johnson is still walking around, something must have changed.
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Pharma off label
could you please send me the source for the info on the subsidiary that was set up to take the hit for the criminal fine (for marketing Bextra off-label)?
I'm investigating another off-label promotion - BIG TIME promotion -- of another of Pharmaci Upjohn's drugs. I knew about the charges for BEXTRA but didn't know about this further scam.
Also I am trying to find out if Pharmacia has any connection to manufacturers of Flumazenil, which are all Chinese, as far as I can tell. Do you know if Pharmacia has any Chinese subsidiaries or other connections to Chinese companies?
By the way, with the king of propaganda now on board (Monsanto - agent orange, Roundup ["safe as table salt], terminator seeds and bovine growth hormone), Pharmacia will be getting all kinds of tips on how to deceive the public.
If you want to get a detailed, documented account of how FDA waived conflicts of interest between assessment committee members and Upjohn regarding Halcion, then read John Abraham and Julie Sheppard's paper on this - Univ of Sussex, School of Social Sciences.
There is NO excuse for not putting company members in JAIL for these activities. People taking their dangerous drug kept on the market through corruption have rec'd DEATH sentences for crimes they've committed due to prescription drug intoxication. I'm referring to Halcion -- known for its deadly effects, kept on the market after banning in the UK, it's now being HEAVILY promoted off-label as a dental sedative -- AT DOSES DOUBLY EXCEEDING THE MRD -- AND EVEN HIGHER.
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