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RE: Neurontin Mfr. Pfizer

Posted by Dorothy on 5/13/04 at 23:29 (150557)

From Washington Post May 13, 2004


washingtonpost.com
Fraud Sold Drug, Pfizer Admits

By Caroline E. Mayer
Washington Post Staff Writer
Friday, May 14, 2004; Page E01

Pfizer Inc., the world's largest pharmaceutical firm, agreed yesterday to pay more than $430 million to settle criminal and civil charges that one of its divisions fraudulently marketed a popular drug, Neurontin, for unapproved uses.

The company pleaded guilty to charges that its Warner-Lambert division engaged in a widespread, coordinated effort -- offering kickbacks, one-sided education classes and free trips to the Olympics and to Florida -- to encourage doctors to prescribe Neurontin for uses not approved by the Food and Drug Administration.

First approved by the FDA in 1993, Neurontin became a major drug, with $2.2 billion of sales in the United States last year; worldwide sales were $2.7 billion, about 6 percent of Pfizer's total revenue of $45.2 billion. Law enforcement officials said yesterday a month's prescription costs about $200 and that about 90 percent of the prescriptions are for unapproved uses.

The FDA has approved Neurontin only to treat epilepsy and shingles, but Warner-Lambert promoted it to treat a variety of psychiatric ailments (including bipolar disorder and attention deficit disorder), back pain, migraines and amyotrophic lateral sclerosis (Lou Gehrig's disease), the Justice Department said yesterday.

'This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision making, thereby putting patients at risk,' U.S. Attorney Michael J. Sullivan of Massachusetts said in a written statement. Also participating in the settlement were the 50 state attorneys general.

Pfizer, in a written statement, said that by settling, it would no longer have the expense and uncertainty associated with the allegations. In January, the company announced a pretax charge of $427 million in connection with the investigations. Pfizer stock closed yesterday at $35.40 a share, down 31 cents.

The Pfizer statement said the underlying allegations in the case originated in 1996, before it acquired Warner-Lambert in 2002 and 'the allegations and conduct pertain solely to Warner-Lambert practices.'

The case is part of a government crackdown on the pharmaceutical and health care industry.

'Increasing pharmaceutical prices are a huge issue for federal and state government, insurance companies and consumers, so governmental entities are looking at actions that have caused drains on state and federal budgets and added greatly to the increased cost of health care for Americans,' said Vermont Attorney General William H. Sorrell, who took a leading role in the settlement on behalf of the states.

In previous cases, Sorrell said, the government went after drugmakers who were paying off companies to keep generic drugs off the market, making misstatements to federal authorities to prolong their patent protections and engaging in kickbacks or illegal pricing schemes.

Pfizer agreed to pay a criminal fine of $240 million and $190 million in civil fines to be divided among the states and federal government. It is the second-largest criminal fine ever imposed in a health care fraud prosecution.

The largest, $290 million, was assessed in 2001, on TAP Pharmaceuticals, a venture of Abbott Laboratories Inc. and Takeda Chemical Industries Ltd., which was charged with using kickbacks, travel and free goods and services to illegally market its prostate cancer drug, Lupron.

In the Neurontin case, law enforcement officials said, Warner-Lambert promoted the drug even when scientific studies showed it wasn't effective and made false or misleading statements regarding its efficacy and FDA approval. The company also paid doctors to allow sales representatives to accompany them while they saw patients, with the salesmen offering advice that was 'biased toward the use of Neurontin,' the Justice Department said.

Warner-Lambert also paid doctors to attend 'consultants' meetings' that included expensive dinners, tickets to the 1996 Olympic Games in Atlanta and one-sided presentations about using Neurontin for uses other than those approved by the FDA. The company also used 'medical liaisons' who represented themselves -- 'often falsely,' the Justice Department said -- as scientific experts to promote Neurontin's unauthorized use.

It was through one such liaison, David Franklin, that Warner-Lambert's activities first became known. Under the settlement, he will receive more than $24 million under the law that permits whistle-blowers to share the proceeds in successful lawsuits against corporate wrongdoing.

Also under the settlement, a $28 million fund will be set up for the states to sponsor a program to provide doctors and consumers with fair and balanced information about drugs. Although small compared with the marketing budgets of drug companies, 'it's a lot more than nothing,' Sorrell said.

2004 The Washington Post Company

Re: RE: Neurontin Mfr. Pfizer

Kathy G on 5/14/04 at 08:49 (150568)

What's ironic is that Pfizer bought the problem when they purchased Warner Lambert. They were the ones who were incorrectly pushing the off-label uses. Not the brightest move that Pfizer ever made!

I still think it's stupid since so many people have had success with the Neurontin helping them with nerve problems and bi-polar disorder.

Several years ago, it was discovered that a allergy nasal spray containing cromolyn (excuse the spelling) would also help people with allergic symptoms affecting their eyes. Opthamologists were writing prescriptions for people to use one spray in each nostril four times a day but were telling patients to put two drops in each eye. A couple of years later the preparation came out for use in the eyes. Those with eye problems would have had to suffer for two more years and that just seems stupid.

As for the perks the docs were getting, I'm glad those have ended. I resented the fact that the money I was paying for drugs was going toward doctors and their families getting all-expense paid vacations to Hawaii and Disney!

Re: RE: Neurontin Mfr. Pfizer

Ed Davis, DPM on 5/14/04 at 11:05 (150580)

Dorothy and Kathy:
I realize that I am opening a 'bag of worms' here, but ultimately those settlement dollars come out of your pockets and mine. The action is absurd in that everyone im health care knows and has known for years that Neurontin is used to treat chronic pain more than epilepsy. The FDA is maintaining an expensive charade. Not to mention, what ever happened to 'freedom of speech?' They are basically charging the drug company with talking too much about things they SHOULD be able to talk about.
Ed

Re: RE: Neurontin Mfr. Pfizer

BrianG on 5/14/04 at 11:55 (150583)

It's probably a good idea that the owners of the high power ESWT machines (in the US) decided not to advertise that their machines could cure tennis elbow. I remember there was some talk on this message board about this last year.

Regards,
BrianG

Re: RE: Neurontin Mfr. Pfizer

Ed Davis, DPM on 5/14/04 at 12:00 (150585)

Brian:
True. Although providers have a lot more latitude than manufacturers. I still cannot fathom that we live in country where the flow of health care information is so tightly controlled by a government agency. I am not pro-manufacturer but am very much for allowing the free flow of information provided that information is not intentionally made innacurate or there is no obvious intent to mislead. The US has become the most restrictive country with regards to this is the 'free world.'
Ed

Re: RE: Neurontin Mfr. Pfizer

Kathy G on 5/14/04 at 15:44 (150599)

You know, Ed, there are those rare occasions when you and I agree and this is one of them!:o

I think that the FDA is out of control. Why are so many drugs approved in Europe years before they're approved in the US? Because the drug companies know they can stick it to the American public to pay for the R&D for the drugs they're working on.

To talk of changes would lead to a political discussion and you know how I feel about that but I did want you to know that I think you're entirely right on this. While I believe that that the US, as the richest nation on earth, should, from a humanitarian point of view, bear the majority of the cost for R&D, it's gotten way out of hand. That's where my bleeding heart liberalism gets in the way and why no further discussion should take place but I just had to point out that we agree! :D

Re: RE: Neurontin Mfr. Pfizer

Ed Davis, DPM on 5/14/04 at 19:21 (150604)

Kathy:
This is an issue that transcends any political philosophies. Any political system can develop a dysfunctional bureaucracy and that is what I feel we have in the FDA. I tend to look north to Canada in such matters as they seem to have a reasonable balance between protecting the public and not restricting access to needed devices and drugs.

Another thing to consider is that this is not completely a philosophical discussion as I feel that bureaucarcies can be used as a 'tool' to limit competition and raise prices. A prime example of that is an ESWT company convincing the FDA that ESWT should be a class 3 device (necessary for sustenance of human life) and that the 'bar' for approval of new machines (ie. machines of competitors) need be raised so high that most manufacturers just won't bother introducing their technology to the United States.

PS. We probably agree on more things than you realize -- it just that that stuff has not made it to the discussion boards. :)
Ed

Re: RE: Neurontin Mfr. Pfizer

john h on 5/15/04 at 10:27 (150635)

Ed you are very correct when you say in the final analysis these lawsuits and cost come from the consumers. It comes down in the form of higher prices as do all the legal cost to defend themselves. I suspect at least 25% of our Doctors charges are a result of liability insurance.

Re: RE: Neurontin Mfr. Pfizer

john h on 5/15/04 at 10:30 (150636)

Most of you probably realize Senator Edwards who ran for the Presidency made his fortune in the tobacco law suits. The lawyers are now gearing up to go after the manufactures of alchol using the same tactics they used with tobacco.

Re: RE: Neurontin Mfr. Pfizer

Dr. Z on 5/15/04 at 13:23 (150642)

John,

That use to be true. I think that the increase costs come from the greed for increase profit from the insurance company and severe mis-managment within the insurance company. Doctors fees are fixed and coming down with regard to insurance payments, but premiums are increasing We need to remove the private insurance company from the equation and switch to a medicare type progam.

Re: RE: Neurontin Mfr. Pfizer

Ed Davis, DPM on 5/17/04 at 10:22 (150694)

Dr. Z:
I see MSA's as a better answer because they place the PATIENT in the drivers seat. MSA's combined with catastrophic medical coverage places medical care back where it belongs -- a relationship between doctor and patient.
Ed