If People Don’t Bother to Perform Their Own Double-Blind Studies Before Taking Drugs, They Deserve to Die!
In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.
Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.
But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.
“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.
The heart risks from Avandia first became public in May 2007, with a study from a cardiologist at the Cleveland Clinic who used data the company was forced by a lawsuit to post on its own Web site. In the ensuing months, GlaxoSmithKline officials conceded that they had known of the drug’s potential heart attack risks since at least 2005.
But the latest documents demonstrate that the company had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public. In one document, the company sought to quantify the lost sales that would result if Avandia’s cardiovascular safety risk “intensifies.” The cost: $600 million from 2002 to 2004 alone, the document stated.
Some combination of deregulation and tort reform should solve this problem!
And with their profits from dead people, they spent 700 million on ultra shady Sirtris. But let’s not focus on the past, we need to look forward!
So risk assessment has degenerated to assessing the effect of a potentially deadly drug (Avandia) on the bottom line or assessing the risk to the bottom line of inadequate safety in drilling an oil well (BP). Notice the philosophy, a reluctance to spend money up front to improve drug or well safety (an expense, much like taxes, etc…see J. Boehner), rather, it is calculated as a risk to profit down the road. They have no interest in mitigating the effects of their products or actions. They attempt to mitigate the effect of bad outcomes on their profit.
Even if they somehow rationalized the ethical question (eg, thinking it was a great drug despite the deaths), even just cynically they must have known this cover-up was building a liability time bomb.
It’s always the coverup that kills you. Just ask Nixon.
Yeah but they just have to keep it down until their options vest and then who cares?
I think this case, as well as BP, Goldman-Sachs, & AGI, do indeed make a compelling case for tort reform. Specifically they underline the need to remove all caps on punitive damages that can be levied against corporations and to make chief executives personally liable for damages done by their companies.
Mudge, that’s my point: they aren’t rationally calculating costs, unless they expect to collect big salaries and bonuses as individuals but be gone (or immune) when the company has to pay the piper.
Warren, I’m sure you’re right.
I’ve got mine, fnck the public, pretty well covers it, don’t you think?
The market will correct this situation. Sales will drop as SmithKline Beecham’s customers die.
But, but, but we have to pay higher prices for our drugs than the rest of the world pays because the prices we pay funds the R&D required to bring us the miracle drugs! Or something to that effect. The upshot, though, is SmithKline can still sell Avandia, though you would have to wonder what doctor would actually prescribe a drug that could lead to a malpractice claim from a patient who had a heart attack after taking the drug.
Except that most of the actual research is done at universities and funded by the federal government. The drug companies spend far more on advertising than on research.
We’ve got to keep big government and its’ red tape from interfering with drug companies’ innovation. They wouldn’t sell it if it wasn’t safe!
Right. And also too we want to see those walrus protection plans for the gulf, and its ok if you don’t really wanna’ clean those meat-grinding machines. Writing a new plan for pelicans, and buying some of that antiseptic cleaner, costs money, you know.
OK, everybody’s being humorously cynical. Ha, Ha, I get it.
But which “regulations” we’re all laughing about being obviously missing are going to solve this problem? I’m being serious here. I mean really — stop laughing for ten seconds and do something honest.
You have two competing motives: (1) drugs that help people, and (2) drugs that make money. Given that (3) drugs take significant money to develop, how do you balance the priorities?
Discuss.
Oh, please. Pharmaceutical company profits are huge and rising. The lame excuse that they have to charge an arm and both legs for their products because of research costs is also just that, an excuse. Most of the basic biomedical research is done by universities on federal grants, with the drug companies only doing a small amount of it. In fact they spend twice as much on advertising as on research.
What is needed is not new regulations, and no one here has suggested that, but rather enforcement and oversight of the existing ones.
What portion of their surging profits and focus on advertising over R&D is directly related to the manner in which drugs get approved by the FDA?
Basically all drugs come out with a standard perception of excellent quality, and that stamp of quality is dependent upon huge investment in advertising and lobbying.
If you eliminated the approval process of the FDA, and even assumed that no private consumer agencies popped up to verify the efficacies and quality of these medications, you would see an enormous increase in R&D and quality investments. As it stands now, SmithKline will pay a hefty fine and move on simply because they are a major player and have already invested in the lobbying and other overhead costs and can continue gaining that stellar quality rating that all medications come out with. Very few pharmaceutical consumers will go to their doctor or pharmacist and say “This was made by SmithKline? I don’t trust it.”
In our alternative scenario, SmithKline is discovered knowingly distributing dangerous medicine, they suffer greatly, as there is perception of quality directly tied to SmithKline, and all of their medications will suffer.
I’m not saying that deregulation is the answer, but a great deal of the distortions regulation puts on risk accounting are downplayed.
Fine; but let’s also acknowledge that equally important are market realities surrounding the pharmaceutical industry, national structures for the purchase and distribution of pharmaceuticals, and the administration of regulatory structures, and the actual effects of regulation from a market pressure perspective.
The idea that people will hold GSK responsible through market pressures for lethal products is a sick joke. Partly because the patent structure ensures corporations hold a 20-year monopoly on new drugs, partly because the idea of a perfectly informed consumer populace is laughable. We can’t even get everyone to agree on AGW and evolution, what chance do people have against an advertising-reliant media and a highly funded free-speech protected propaganda campaign by the companies profiting from misinformation?
Sure, we need to figure out ways that we can improve the safety of drugs. But let’s not ignore several other possibilities in reforming the drug approval process. What about international cooperation and joint trials in drug testing to speed approval, and provide independent corroboration between agencies? That might help make the FDA less of a target for lobbyists, especially if they have to ork with nations that have stricter campaign finance laws. How about existential threats from regulation, as opposed to a slap on the wrist, when it comes to suppressing evidence of potentially fatal side-effects in clinical trials? Then there’s also the issue of bulk purchase negotiation in lowering drug costs in single-payer nations, as opposed to the US, where the government is prohibited by law from bulk-bargaining for government issue pharmaceuticals.
Partly because the patent structure ensures corporations hold a 20-year monopoly on new drugs
You mean the government regulation that guarantees pharmaceuticals price protections and inflated profits?
I say we deregulate.
partly because the idea of a perfectly informed consumer populace is laughable
“Perfectly informed” is a laughable and unnecessary criteria to meet.
You can deride deregulation due to a lack of “perfectly informed” consumers when I deride regulation for a lack of “perfectly benevolent” or “perfectly capable” regulators.
The question is whether systematic information asymmetry is causing people to underestimate risks.
We can’t even get everyone to agree on AGW and evolution, what chance do people have against an advertising-reliant media and a highly funded free-speech protected propaganda campaign by the companies profiting from misinformation?
What good is regulation in solving this? Lobbying investment has long been a far more lucrative investment than spreading misinformation. Why try to convince everyone that you are reputable, when all you have to do is convince government (or more accurately, exploit the regulatory framework to make it look like you have convinced government)?
What about international cooperation and joint trials in drug testing to speed approval, and provide independent corroboration between agencies? That might help make the FDA less of a target for lobbyists, especially if they have to ork with nations that have stricter campaign finance laws.
Any nation that ties their pharmaceutical approval system to our own is beyond insane.
How about existential threats from regulation, as opposed to a slap on the wrist, when it comes to suppressing evidence of potentially fatal side-effects in clinical trials?
You mean government regulation of torts? I say deregulate.
Then there’s also the issue of bulk purchase negotiation in lowering drug costs in single-payer nations, as opposed to the US, where the government is prohibited by law from bulk-bargaining for government issue pharmaceuticals.
You mean how government steps into the market, buys half of the pharmaceuticals sold in the nation at exorbitant prices thereby driving all pharmaceutical prices up?
Guess what my solution would be.
Well, I guess when all you have is a hammer, everything starts to look like a watermelon.
Or the alternative that more approximates the nature of the voter and government:
When everything is watermelons, what is there to do but swing your hammer?
I thought that my point that the issues you list are caused by regulation would imply a need for deregulation was well made.
The problem is not so much that there’s a magic regulation missing, more an illustration of why existing regulations need sharper teeth.
I think we need to start looking at regulations in the context of market forces, and realize that if the fines for bad behaviour fail to outweigh the profits possible through that bad behaviour, that there will still be market pressure to make the immoral choices. Deliberately suppressing data like this should carry existential consequences (such as terminating access to NIH resources), and may need to be coupled with some form of insurance to hedge against bad research bets.
That still leaves the possibility of corporate looters sacrificing corporate health for massive short-term executive compensation, but that seems to be more within the realm of tax policy than regulation per se.
Sure, yes, in this case torts rather than stronger regulation is probably the solution. But you act as if people who oppose string regulation also oppose “tort reform,” whereas in practice there’s almost always a bait and switch where people want to make it much more difficult to sue and then oppose the regulations that are supposed to replace torts as well.
I have absolutely no idea how opinions of that nature gain any traction, but yes that is generally the way it goes in practice.
You have to show that the current regulatory scheme actually helps the situation before you give it sharper teeth.
Can you show me that sharper teeth will cut towards balance and fairness, or will sharper teeth just end up being a more powerful tool for the political arms of large health care providers?
You can mock the idea of treating a market that can result in this sort of thing with very limited regulation and looking for torts to work it out, but I am wondering what exactly existing regulators were lacking in this situation?
This is an extremely important question, as when you commit to regulation like this, you commit to a market where consumers are not exactly demanding of quality and efficacy, as they simply assume that all products will be good.
If you want to regulate the market, you have to do it right, as people will be generally defenseless, as there will be no alternative manners for people to gain adequate information on the products they buy.
Therefore, if we know that existing regulation has failed, we need to make sure we know that regulation can actually be improved, or we risk just continuing the problem or making it worse, as there can be some extremely nasty information asymmetries where regulators fail.
I personally say that, in general, regulators act as absolutely horrible consumer advocates, as the transaction costs of actually approaching regulators with issues related to consumer safety and rights will consistently lead to regulators siding on behalf of large industry players until after the problem has become extremely visible.
So ultimately, there are effective ways in which torts and private consumer agency would combat against such scenarios, but when you institute or maintain regulation, you undercut them. They cease to function as people no longer account for the costs of making sure they are getting a good product.
So when the market puts out a bad product, instead of flippantly dismissing those calling for deregulation, you had better make sure you can actually get regulators in position to actually get things right. And I don’t think we can do that.
Ask your doctor if Fordpintolene is right for you!
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