Illegal Drug Marketing Admitted

[dArKeR]

Pfizer Inc. has agreed to plead guilty to charges that Warner-Lambert, the company it acquired four years ago, flouted federal law by promoting non-approved uses for one of its drugs, a source familiar with the deal told The Associated Press.

Under the agreement to be announced Thursday by the U.S. Attorney's office in Boston, Pfizer, the world's largest pharmaceutical company, has agreed to plead guilty to violating the Food and Drug Cosmetic Act and pay an undisclosed amount to settle the case, the source said.

Company officials had previously said they were setting aside at least $400 million for the settlement.

The Wall Street Journal, citing sources familiar with the matter, reported Thursday that Pfizer will pay about $430 million in fines in one of the largest Medicaid-fraud settlements.

http://www.cbsnews.com/stories/2004/05/13/health/main617223.shtml

I wonder why the people harmed by this practice will never see a penny? Why is the Government able to keep the settlement?

[JayS]

1. "Why is the Government able to keep the settlement?"

The government will make sure the money is spent wisely and for the betterment of all. If it went directly to the people, they would only waste it on food and stuff. :)

[Trillo]

5. It's a derived fundraising tactic.

By not having real damages going to anyone but the closed government-corporate loop, prices for products rise and budgets are balanced--only the little people suffer. If you're corporate, just keep the campaign donations flowing.

[SeattleDem]

6. it's reimbursement for Medicaid fraud

the government spent a lot of money for the prescription of a drug that did not work for what Pfizer claimed it worked for.

thus, Medicaid paid for a useless treatment for many patients. They are being reimbursed.

Perhaps an attorney out there could file a class-action lawsuit for those patients who paid out of pocket for inappropriate use of Neurontin.

[mulethree]

10. how much does the government keep?

"Franklin filed his lawsuit under the U.S. False Claims Act, which allows private citizens to sue on behalf of the government and receive a portion of awards in cases where companies are defrauding the government."

Better than nothing, why can't the government be compelled to act once presented with evidence?

[UpInArms]

2. you haven't gotten your memo, have you?

"people" are not "harmed" by corporations, only the "rules" were broken and there are "fines" for such lawless acts - there are no real physical consequences for corporations breaking the rules :crazy:

Therefore, all funds that are received for such "rule breaking" belong to the "rule makers" and those people that were "harmed" just need to "get over it"!

[mulethree]

11. the harmed can still sue for themselves?

1. claim that their doctor was duped into prescribing this to the detriment of the patient?

2. or a rival drug company with approved drugs for those off-purpose treatments could sue that they hurt the sales of the legitimate drugs?

3. ??? citizens group could sue the 'legitimate drug companies' for failing to sue for case#2 on the grounds that by failing to sue they are participating in a 'trust' or conspiracy by drug companies not to sue each other?

[amazona]

3. WAS anyone harmed by this, I wonder

Most drug companies do not bother to jump through all the expensive FDA hoops to get every possible use of a drug "approved."

I had LASIK before it was FDA approved. Best thing I've ever done for myself. I've had drugs prescribed for "off-label" purposes. They worked as well or better than the others.

This is just a scam for the gov't, the attorneys, and the so-called whistleblower to split a LOT of money for a harmless practice. Our doctors need to be able to prescribe off-label drugs, and our drug companies need to be able to tell people what the uses of a drug might be.

I am not a Warner-Lambert or Pfizer shareholder, just someone who can recognize the ridiculous when I see it.

Drug companies do go overboard sometimes with the seminars but I don't see the gov't jumping to educate doctors about the uses for new drugs. If Medicaid only pays for the very limited range of FDA approved uses, that harms and kills people too if their doctors can't describe the drug that is needed, instead of from a more restricted list.

[SeattleDem]

4. yes, people were harmed

I saw the whistleblower interviewed on 60 Minutes or some show like that, and having worked a similar job to what the whistleblower did, I followed this case closely.

Pfizer was aggressively promoting a seizure drug for all sorts of purposes for which there were nearly no supporting data. It was an egregious abuse of the system and abuse of its employees. It was a systematic effort to sell drug without supporting data, and amazingly enough, busy doctors trusted the company reps and pushed the drug doses higher and higher, resulting in patient harm.

[TexasBushwhacker]

8. This is not about off-label prescriptions

As the doctor who originally reported the abuse said:

"I couldn't be more supportive of doctors using drugs for off-label uses. Doctors have to use their best judgment — sound medical judgment — to treat their patients," Franklin told The Associated Press in a recent interview.

"But what this company chose to do was to use that intense desire by doctors for information about drugs and pollute it with false information," he said. "The primary victims here are the patients whose doctors might have made another decision if they had the right information."

This was not marketing FDA approved uses of a new drug. It was marketing uses of the drug that were not approved by the FDA. The doctor can decide to do that on his/her own, and suffer the consequences if the patient has a bad result, but the drug company cannot market the drug for something it was not approved for. The fact that they were marketing an anti-seizure drug for conditions such as headaches is scary. If you take Motrin for headaches and you quit taking it, you get headaches again. If you take Nuerontin for headaches for a while and quit taking it, you get SEIZURES. Anti-seizure drugs should not be MARKETED for other uses unless they've been approved by the FDA for those uses. That's the law that Warner-Lambert broke, and that's the practice that is rampant in the pharmaceutical industry that needs to stop.

[TO Kid]

9. One problem with off-label

The main reason the FDA and pharmaceutical firms are gun-shy about off-label use is not one to trifle with- the deformities caused by thalidomide were all a direct result of off-label prescribing- it was never tested with pregnant patients because it was never marketed as a treatment for morning sickness.

I agree that the cost and effort needed to get additional uses for a drug approved is prohibitive, but that is a problem with the way the regulations are structured. It would be far more sensible to base the FDA approval on safety alone, rather than effectiveness, so that more testing can be done on safety-related issues including risks associated with different uses.

[TexasBushwhacker]

7. This is why Medicaid gets the money, and so does Dr. Franklin

"Franklin filed his lawsuit under the U.S. False Claims Act, which allows private citizens to sue on behalf of the government and receive a portion of awards in cases where companies are defrauding the government."

This is not your typical class action lawsuit where the attorneys on both sides get 90% of the money and the plaintiffs in the "class" get to divy up their small slice of the pie.

The False Claims Act allows private citizens to be watchdogs and whistleblowers on the governments behalf. For example, someone who works for a nuclear power plant knows that there is missing plutonium that is not being reported to the regulatory agencies. Under the False Claims Act, they could file a suit, on the governments behalf. It goes to court and it is discovered that in fact, there IS missing plutonium at this nuclear facility. The facility is fined XXX amount of dollars, which goes to the government, and the government inspectors etc. swoop down on the facility and try to figure out where the hell is the missing plutonium.

In the meantime of course, this employee lost their job and more than likely, their career. They've put themselves at considerable risk. If their claims prove to the false, then of course they get nothing, but if they prove to be true and fines are assessed, they get a small percentage of those fines. In this case, Dr. Franklin got 5.75% of the settlement, of which his attorney gets a considerable amount,I'm sure. But that's okay. They both went out on a limb.

In this case:

"We believe we have exposed an illegal practice in the pharmaceutical industry that caused the Medicaid program to pay tens of millions of dollars for off-label prescriptions that were not eligible for reimbursement under the Medicaid program," said Franklin's attorney, Thomas Greene."