Medical Papers By Ghostwriters Pushed Hormone Therapy 289
krou writes "The New York Times reports on newly released court documents that show how pharmaceutical company Wyeth paid a medical communications firm to use ghost writers in drafting and publishing 26 papers between 1998 and 2005 backing the usage of hormone replacement therapy in women. The articles appeared in 18 journals, such as The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology. The papers 'emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia,' and the apparent 'medical consensus benefited Wyeth ... as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.' The apparent consensus crumbled after a federal study in 2002 'found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke.'"
Re:Here come the Lawyers (Score:3, Interesting)
Agreed. I think say, fining them two hundred times their gross worth and imprisoning their board of directors and corporate officers until every penny has been paid off ought to do the trick.
Re:Protecting investment ... (Score:3, Interesting)
But the law should, and should make the *criminal* and *civil* penalties so utterly destructive to any business that they don't dare do it. I'm talking life imprisonment, seizure of assets, massive awards for those injured, and so forth. I mean, basically make such behavior a recipe for extinction of the company, utter destruction of share value, imprisonment of researchers who colluded, seizures of every asset of every member of the board, every officer of the company, and so forth.
Re:Here come the Lawyers (Score:4, Interesting)
What... would be the point? (Score:5, Interesting)
Except that nobody is really being held accountable, unless you're talking about SERIOUS jail time for the officers and forfeiture of profit + interest (at credit card rate no less.) Let's be honest here, the worse that can be expected is that FDA will slap some fine on the companies, and the companies will just happily pass the cost onto its paying customers (you and I.) There is NO ACCOUNTABILITY.
Re:Wyeth isn't alone (Score:5, Interesting)
No, the reason they dropped the pens / pencils / paper AND the cruises to the Bahamas AND the free golf AND the fancy dinners wasn't cost. The costs were cheap compared to the benefits they wrought. They stopped them because of the noise and bad press (and the belated 'ethics' whitepaper by the AMA and other trade groups).
The ghost writing and the funding of spurious research is / was one step removed from this in the public's eye. Now the heat is one here and big Pharma will paper over this issue and continue some other way of pushing their agenda. Look to lobbying for the next big push. If you take away an individual doctor's role in deciding which drug or treatment to prescribe and bump it up to a committee or better yet, a legislator, then you can pay a K Street firm a couple of times per year and not worry about having an army of drug reps running around.
Big Pharma has it's strategy mapped out for any possible occasion. They're smart, cunning and have been playing this game for a long time. Resistance is futile....
Re:Here come the Lawyers (Score:5, Interesting)
That's true, but journals' reputations still do depend on a perception that the studies they publish are generally high-quality and honest. So I could see a case for these journals suing Wyeth for the damage to their reputations that these papers have caused.
Re:Here come the Lawyers (Score:2, Interesting)
That's true, but journals' reputations still do depend on a perception that the studies they publish are generally high-quality and honest. So I could see a case for these journals suing Wyeth for the damage to their reputations that these papers have caused.
Science just does not work that way. You don't establish reputation of your journal in court. It's too late now.
Re:Here come the Lawyers (Score:5, Interesting)
Defrauded. Falsified. Lied. But what does that even mean anymore?
The reality is our society is so mired in exaggeration, misrepresentations, doublespeak, non-denial denials, irrelevant conclusions, marketing lies, cover your ass language and general bullshit that we, as a culture, have probably lost the ability or even the inclination to discriminate truth and lies.
And by discriminate, I don't mean being able to tell one from the other. I mean we have actually lost much of our capacity to actually care whether anyone is telling the truth or lying to us. Truthfulness is no longer rewarded. Indeed it is often punished. Falsehood is conversely rarely, if at all punished and is most often rewarded. This is the culture we live in, so why should people recognize any intrinsic ethic in telling the truth or unethical in lying? Even organizations that are supposed to deal in disclosing the truth are widely recognized and accepted to be mostly peddling lies.
Did Wyeth actually lie? Do you think you would be able to "prove" in a court of law that a single thing they paid to have printed was in fact a lie, rather than a simple massaging of data or a case of being liberal with the truth. The latter won't be enough to secure a conviction as well the Wyeth layers know. And besides, who care if people lie anyway.
Companies don't have honor or morals or ethics. If they break their word, even on a signed contract, no one is going to come after them. There's not going to be a permanent black mark on their reputations. With the world the size it is, the same holds true for people as well. Sure, some of us might get indignant about it all, but most people will never even hear about it, and most of those that do will forget about it by the next morning.
This is the society we, as democracies, have chosen for ourselves. The fruits of our decision should come as no surprise to anyone.
Re:Perhaps now people will isten? (Score:2, Interesting)
Your money? In a fee-for-service scheme, the more treatments my doctor gives me, the more she gets paid. Fortunately, my own physician is a person of high moral character; and an office visit with a family practitioner doesn't get the sort of payments from an insurance company that drug therapies or surgeries do.
As this incident proves, "science" and "medicine" are often far apart.
My physical therapist took my money for months, and did me less good than my acupuncturist. As an Asian Bodywork therapist [earthtouchshiatsu.com] I use some of the same techniques as acupuncturists, and my clients pay me and come back and refer their friends, because my treatments do some good. And I even have some science to back that up [earthtouchshiatsu.com].
Placebo effect? Perhaps. It plays a role in any treatment, including surgery [google.com]. My mom used the placebo effect to help relieve people's suffering when she was a nurse, she got paid for that. If someone can put on a little show that gets my brain to release endorphins and stop the pain, I don't see a problem with paying for that performance, whether it's a nurse's "beside manner" or a shaman's ritual.
(Hey, I just found yet another case where a surgical technique was found no more effective than a placebo surgery [discovermagazine.com]. That makes 5. I have yet to find a trial where a surgical intervention was compared to a sham in a blinded trail and proved superior.)
Re:Here come the Lawyers (Score:3, Interesting)
Surely the doctors who put their names on the papers are the ones who should both be sued and also have their reputations for research completely trashed.
+1, and don't forget the plain economic stupidity (Score:3, Interesting)
I wish there was more study and awareness of the economic idiocy and need for regulation to resolve it, too.
In the UK, the NHS (national health service) cannot afford to treat everyone with certain life-saving drugs because those drugs are too expensive, so they don't, or do so only for a few people.
The drug companies lobby the NHS to include those drugs, and the NHS refuses because the money is better spent on cheaper treatments for more people. Some newspapers and some people side with the drug companies.
Those drug companies justify high prices due to the cost of research, trials and so on, and the patents enable them to maintain the prices.
To be fair, the cost of research etc. is high, and investing in the next drug is needed.
The stupid, awful paradox though, is that if the NHS enforced a lower price, by having the power to override company patents and threaten to make them generically (but only if the company does not agree to sell them at that price itself), then the companies involved could be guaranteed a higher profit for helping more people, while reducing the cost of treatment and care to the NHS.
[All prices in UK pounds - Slashdot does not handle the £ sign properly.]
It's quite simple: Let X be the cost of R&D to the company. Let HP be the high price per person, say 20,000, that the company chooses currently. Let's say 10,000 people choose to use the drug privately. (Revenue = 200 million). Let's say the company believes that strategy makes it's R&D sustainable for future developments. Let's say the marginal cost of production is HP/200 = 100 - after all they say it's dominated by the cost of R&D. (Production cost = 1 million, leaving 199 million for R&D and profits).
Clearly if the NHS agrees to take 1,000,000 person's worth of the drug while enforcing a far lower price of LP = HP/100 = 299 (very affordable per person), then the company will make exactly the same profit, and that's not counting the benefit of scaling up production.
If the NFS takes 1,000,000 person's worth while enforcing a price of 498 (still very affordable compared with 20,000), the company will make guaranteed at least twice the profit, at the same time as helping 100 times as many people.
(* - It's "at least twice" because it's between two and infinity times the profit, depending on the cost of R&D which is somewhere between zero and 199 million, established earlier).
Now will someone explain to me why helping 100 times as many people, while making more profit and/or doing more research, doing more business, with guaranteed long-term business, getting a better reputation and becoming more well known, and yes the individual reps, executives and shareholders can all reap rewards... Why is this something the drug companies negotiate against??!
Simple greed cannot explain it, because everyone in the company stands to benefit personally in the scenario where drugs are cheaper and given to more people, if done properly.
I believe the scenario we're currently seeing is not a result of "evil" corporations and/or individuals in them, nor a result of rational collective greed, but instead is a result of systemic idiocy...
Re:I am a physician (Score:3, Interesting)
Where does that leave the HMOs from the USA?
I don't practice in the USA so it wouldn't be appropriate for me to make a detailed post about that. However I know a lot of professionals who have quit for just that reason - they don't enjoy being told how to practice medicine by an accountant.
From my perspective, working in a country that has both a mandatory (ie, it gets docked from your paycheck every month) health care system BUT ALSO offers private medicine for those rich enough to afford to skip the waiting lists, working for the government can't be much different than an HMO. Which is why I no longer work for the government.
All the drugs are generics - which isn't too bad except that every year or so they have new biddings to fill their purchasing contracts for the following year, and usually switch labs. Now a pharmacologist will talk a lot of BS about the area under the curve and "bioequivalence", but the truth is that even the same drug in the same dose from a different lab will have different rates of absorption, etc. So every year or so all the chronic patients become uncompensated, but all "administration" sees is that they saved $50k or so on their purchase of Atenolol... job well done. Who cares if all the medical beds are full of hypertensives who were taking their medication as usual and suddenly started having hypertensive crises.
The problem is that medicine is no longer practiced by doctors. We just follow the guidelines established by HMO's or pen pushers (give that patient a CT scan and we'll make next week hell for you if you can't think of a cheaper exam that would have been just as good), try to avoid the shark infested pools of lawyers swimming on the other side of the ledge just waiting for a chance to SETTLE (read: free money), and just do what everyone else does.
And yet in most countries it is a CRIME to practice medicine without a license. How did we let this happen? It's a WORLDWIDE phenomenon.
I've taken a cue from my own mother (Score:4, Interesting)
Who had these drugs pushed at her with a great deal of pressure to take them. She finally said, "I'm almost seventy, for chrissake. I'm SUPPOSED to be old. She also clued me in as to how these drugs are harvested or manufactured or whatever you would call it. They're extracted from the urine of pregnant mares. In order to do that, the horses are made pregnant. Then they are confined to their stalls, 24/7, so that the urine can be collected. They're never allowed outside, never allowed even to move around in the stalls--just made to stand there without a break for their rather lengthy gestation terms. When the foals are born, they are taken away from the mothers immediately and are often slaughtered. That kind of confinement would be torture for any animal--it is doubly so for a horse which needs to be able to move about and use its legs.
A few wrinkles in the fullness of time were much preferable to her, and so they will be to me.
Re:I am a physician (Score:2, Interesting)
Say what you will about our patent system, but 85% of medical research in the world is funded by the United States, and the vast majority of that is funded by the private sector. Pharmaceutical companies spend disproportionately large amounts of their budgets on research compared to other industries or to the government.
Quite frankly, all the countries with "socialized medicine" are not paying their fair share for medical research. We should be encouraging our friends abroad to contribute their fair share, rather than looking for ways to reduce our spending on medical research.
Of course, all this assumes that you have the goal of continuing to increase the quality of health care available worldwide through more medical research. If you wish to slow the advance of medical technology, then sabotaging our current system may be the way to go.
Re:Wyeth isn't alone (Score:2, Interesting)
Then it becomes like artificial sweeteners, where you have a mountain of evidence stating that it is safe (from the corporations, or people funded by the industry)
As for the oldest of artificial sweeteners (Saccharin), there is actually mountains of evidence that it is safe. The "evidence" which shows it to be unsafe was originally sponsored by sugar growers (direct competition). In fact, research clearly shows sugar to be far, far, far, far, far more dangerous, bringing horrible disease to every culture to which it is introduced and yet law required a cancer warning on the product which is actually far safer.