"Laws are like cobwebs, which may catch small flies, but let wasps and hornets break through." - Jonathan Swift
After reading "The Neurontin Legacy -- Marketing through Misinformation and Manipulation" in the January 8, 2009 issue of the New England Journal of Medicine, one may conclude that (1) America's prisons would be put to better use incarcerating drug company executives instead of pot smokers, and (2) society may need a return of public scorn via the pillory for those doctors who are essentially drug-company shills.
Drug-company corruption of American medicine is of course not news. What is news is that such corruption has become so egregious, so transparent, and so embarrassing that the New England Journal of Medicine, perhaps the most influential American medical journal, is now stating that "drastic action is essential to preserve the integrity of medical science and practice and to justify public trust."
Neurontin was approved by the Food and Drug Administration (FDA) in 1993 in doses of up to 1800 mg per day as adjunctive therapy for partial complex seizures. How did U.S. annual sales of Neurontin increase from $98 million in 1995 to nearly $3 billion in 2004? The answer is "off-label" marketing, in which Neurontin manufacturer Parke-Davis (a division of Warner-Lambert purchased by Pfizer in 2000) marketed Neurontin to doctors for uses not approved by the FDA (because doctors can legally prescribe drugs for uses not approved by the FDA).
While aggressive off-label marketing to doctors is standard among drug companies, it is routinely kept quiet. But thanks to a Parke-Davis whistle blower, we have first-hand evidence of off-label marketing -- and how the Neurontin financial bonanza was created.
In 1996, David Franklin, a young biologist, took a sales representative position for Parke-Davis. But shortly after beginning the job, Franklin grew concerned that he was participating in the illegal marketing of Neurontin. Franklin reports that a Parke-Davis executive informed him and his fellow sales reps:
"I want you out there every day selling Neurontin. . . .We all know Neurontin's not growing for adjunctive therapy, besides that's not where the money is. Pain management, now that's money. Monotherapy [for epilepsy], that's money. . . . We can't wait for [physicians] to ask, we need [to] get out there and tell them up front. Dinner programs, CME [continuing medical education] programs, consultantships all work great but don't forget the one-on-one. That's where we need to be, holding their hand and whispering in their ear, Neurontin for pain, Neurontin for monotherapy, Neurontin for bipolar, Neurontin for everything. I don't want to see a single patient coming off Neurontin before they've been up to at least 4800 mg/day. I don't want to hear that safety crap either, have you tried Neurontin, every one of you should take one just to see there is nothing, it's a great drug."
Franklin left Parke-Davis and filed suit (ultimately, United States of America ex rel. David Franklin vs. Pfizer, Inc., and Parke-Davis Division of Warner-Lambert Company) alleging that off-label marketing of Neurontin constituted false claims designed to elicit payments from the federal government. In 2004, Warner-Lambert resolved criminal charges and civil liabilities by agreeing to plead guilty and pay $430 million -- less than 15 percent of the $3 billion the drug company had grossed on Neurontin in 2004.
The current New England Journal of Medicine article concluded that the marketing of Neurontin involved "the systematic use of deception and misinformation to create a biased evidence base and manipulate physicians' beliefs and prescribing behaviors." This is one of many examples:
"In a recently unsealed 318-page analysis of research sponsored by Parke-Davis, epidemiologist Kay Dickersin concluded that available documents demonstrate 'a remarkable assemblage of evidence of reporting biases that amount to outright deception of the biomedical community, and suppression of scientific truth concerning the effectiveness of Neurontin for migraine, bipolar disorders, and pain.' For example, publication was delayed for a report on a multi-center, placebo-controlled study that found no effect of Neurontin on the primary outcome measure for neuropathic pain because 'we [Parke-Davis employees] should take care not to publish anything that damages neurontin's marketing success.'"
Exactly what does it take for drug executives to do jail time?
And let's not kid ourselves about the innocence of doctors. The tactics used by Parke-Davis and other drug companies to manipulate doctors make it clear that too many doctors have been willing participants in the corruption of their profession.
The New England Journal of Medicine discusses some of the practices used by Park-Davis (and commonly used by other drug companies): recruit local physicians who are then trained and paid to serve as speakers in "peer-to-peer selling" programs; financially cultivate renowned professionals, so-called "thought leaders;" financially influence academics with educational grants, research grants, and speaking opportunities worth hundreds of thousands of dollars; create drug "advisory boards" to launder pay offs to "friendly" physicians; provide doctors employed by medical-education companies with "unrestricted educational grants" to produce programs that promote off-label (unapproved) uses of drug; fund doctors' "research" that in fact is designed and commissioned to promote a specific drug; and credit doctors as authors for ghost-written research articles that downplay drug ineffectiveness or lack of safety.
The New England Journal of Medicine is now warning physicians that medicine's corruption by drug companies has threatened public confidence in their profession. If those physicians who are not drug-company shills want to save their profession, they might want to start taking aggressive actions against their colleagues who are on the take. Perhaps it will help motivate clean physicians to be reminded that history shows that any institution -- no matter how large and powerful -- can arrogantly cross those lines leading to its demise.
Bruce E. Levine is a clinical psychologist and author of Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Chelsea Green Publishing, 2007).
I was never informed that the AD could cause permanent movement disorders. I also was never told that I was being given an antipsychotic to treat the drug reaction.
As a result, I now have what appears to be permanent brain damage. All of this because I had situational problems, and because I blindly trusted a doctor.
Never, never again will I do this.
The blatant conflict of interest between corporations and doctors has cost the lives of many, many people and harmed many more. Anyone with two functioning neurons can see the conflict, but because doctors have been deified in our culture we allow them a free hand to harm. We let them feign ignorance. Enough already. They belong in jail, along with the executives.
We should have real scientific data educating us about these medications, ban all off label prescribing and eliminate television and radio advertisements for medications. If we are being experimented upon, we should know about it and be compensated by some of the billions of dollars big pharma rakes in every year.
Regulate big pharma!
The question is whether we as a society reward these people, regulate them or tax them...Is the President of United Healthcare, (and insurance company) worth 5 billion?.. 1.6 billion in options alone and that is not the entire package... The boards of directors who are supposed to be responsible to the shareholders are indemnified so that their loyalty is to the man who writes the checks, that is the CEO who rewards them for rewarding him... Then should we regulate them or tax them... Well with regard to regulation, the systems are not there, not enforced, and avoided... too unsteady and ineffective and easy to be abrogated (they make it work in Germany, but that is Germany). So that leaves us with taxing them at the rates in effect prior to Reagan....It is incredible to me that Paulson, worth hundreds and hundreds of millions did not see this coming, if he did not see the mess coming, that means to me that he is not worth the hundreds and hundreds of millions and just has been successful at gambling and gutting the companies....
I just came looking fo a god topic to discuss, and here sits one of the greatest injustices to fall onto our country's collective position.
The 'Giants' verses the 'Sheep'.
How would the sheep like it if the sheppard worked fo rthe wolves?
The pharmacutical presriptive culture for treating (not curing) disease has lost its luster.
No more snake oils allowed.
Stop allowing the giants free marketing time on our television sets.
Make it illegal to advertise 'ask your doctor'.
Let the Doctor recommend what he or she thinks best suited for the abatement of disease to a well intended patient as oppossed to unending therapy druggings.
Not only have people been harmed in large numbers by a very broken US health care system, equally as damaging is that the public trust in the "former profession" of medicine, the so called "ethical" drug companies (Big PhRMA) and the federal governmental agencies that are charged with protecting our public health has been seriously eroded.
It will take years to rebuild this lost trust. But we MUST begin
Dr. Rick Lippin
Southammpton,Pa
How often do you prescribe drugs off label?
Not trying to flippant but I honestly would rather prescribe a book or a behavioral prescription than a pill
Among my favorite "behavioral Rxs" are exercise, laughing, weeping etc
Dr. Rick Lippin
Southampton,Pa
I live in a European country with a public health care system, and there are all kinds of agreements with drug companies to provide common drugs as generic, at a much lesser cost. Having lived in both the US and Europe, I compare and find that the SAME medication costs up to 10 !!!!! times as much in the US
This I have seen with my own eyes, taking money out of my wallet to pay for these things.
MAFIA of the worst kind is how the US private health care system can be described
As for the cost of drugs in the US, that's easily explained. The US is the only market where drug developers make their money back. It costs close to a billion dollars to get a drug to the market (failed products included). No other country pays for that but the US. Usually over 50% of the income from any one drug are generated in the US while the rest of the world freeloads on the R&D cost. One can argue about the merits of this situation for both the drug developer and the patient here and abroad.
I pay a nominal amount, say 1 euro for a medicine that might cost 10 euros if you just buy it over the counter, outside of the national health system, of which I am a beneficiary.
I dont know about business numbers, but declare : may the whole US health care system be rebuilt inside and out so it works like the European one ! : drug makers make a reasonable profit, both employers and employees are happy with the coverage that we have in exchange for reasonable taxes, and it costs the economy as a whole about 40 - 45% less than the US model, while covering everyone
Daschle should take a trip to Europe before deciding anything, to see what has PROVEN to work. When I look at the Obama website and see all those complicated plans for "improvement" of the system, I say : that is too compliated and slow : scrap it all instead ! take a radical step towards something ( the European model ) that is proven to work
See (among others): Press, Associated. “FDA OK's describing off-label drug uses.” The Boston Globe, January 13, 2009. http://www.boston.com/business/healthcare/articles/2009/01/13/fda_oks_describing_off_label_drug_uses/.
The only possible solution is careful government regulation, but even objective, well-intentioned regulators can be misled. There's just so much money involved that it's hard to trust any research funded by manufacturers. This also goes for medical devices and diagnostic tests.
It will take many years to undo all the harm he has done..
We Need Single Payer Health Care...!
Simple as that...