Give Up Blog

Saturday, July 22, 2006

Paying for off-label opinions - crime or merely medical discussion?

I found this interesting NYT article about a Maryland psychiatrist arrested by the feds for promoting off-label use of a prescription drug called Xyrem (aka the illegal drug GHB) while being paid by the manufacturer of the drug $100k a year.

Dr. Gleason, 53, was taken aback because he was arrested, and later charged, for doing something that has become common among doctors: promoting a drug for purposes other than those approved by the federal government.

But prosecutors say that Dr. Gleason went too far. At hundreds of speeches and seminars where he was rewarded with generous fees, Dr. Gleason advised other physicians that a powerful drug for narcolepsy could be prescribed for depression and pain relief. In doing so, he conspired with the drug’s manufacturer to recommend it for potentially dangerous uses, the prosecutors claim.

The case has put the spotlight on the murky financial relationships between drug companies and the physicians they use to promote their medicines. Companies cannot directly advertise drugs for purposes not approved by the Food and Drug Administration. But getting drugs prescribed for unapproved uses can increase a drug's sales, so companies often skirt the rules by sponsoring seminars where doctors are paid to make presentations promoting their drugs, including the "off label" uses.

I tend to think this guy should be jailed. Personally, I don't think doctors should be receiving this kind of money, period. 100k for consulting? Bullshit. That's just bribery.

Despite the F.D.A.'s constraints on drug makers, though, the companies are allowed to hire independent doctors to talk to other physicians about their medicines. Companies can also sponsor "continuing medical education" sessions, ranging from lunches to weeklong conferences, where specialist doctors tell other physicians about the latest developments in their fields - including off-label uses for drugs already on the market. For such speaking engagements, doctors can receive $3,000 or more a day from the companies.

So it's illegal for a company to advertise off-label uses, but the doctors they pay to do the same thing are somehow "independent" and it becomes legal? Based on what this guy was doing, this sounds like a practice that needs to be made fully illegal. Off-label use should still be allowed, but not based on this word-of-mouth BS that's being paid for by drug companies.

The affidavit says that a cooperating witness repeatedly taped Dr. Gleason as he discussed Xyrem, including the Denver talk where he compared Xyrem to table salt and a meeting in November where he said Xyrem was safe for children.

The indictment also charges that Dr. Gleason committed fraud against insurance companies by advising doctors to leave blank an area on the Xyrem prescription form that asked for a disease diagnosis. Dr. Gleason acknowledges that he told doctors not to offer a diagnosis but says he never told them to lie if they were asked for one.

So, he's promoting off-label use of a drug, on the payroll of a the drug company that makes it, while telling doctors the drug is safer than it is and encouraging them to defraud the government to do so. How about some jail time for this guy?

5 Comments:

Daniel Haszard said...

I took zyprexa starting in 1996 the year the FDA approved it, which was ineffective for my condition and gave me diabetes.

Zyprexa is the product name for Olanzapine,it is Lilly's top selling drug.It was approved by the FDA in 1996 ,an 'atypical' antipsychotic a newer class of drugs without the motor side effects of the older Thorazine.Zyprexa has been linked to causing diabetes and pancreatitis.

Zyprexa, which is used for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, accounted for 32% of Eli Lilly's $14.6 billion revenue last year.

Did you know that Lilly made nearly $3 billion last year on diabetic meds, Actos,Humulin and Byetta?

Yes! They sell a drug that can cause diabetes and then turn a profit on the drugs that treat the condition that they may have caused in the first place!

I was prescribed Zyprexa from 1996 until 2000.
In early 2000 i was shocked to have an A1C test result of 13.9 (normal is 4-6) I have no history of diabetes in my family.

All the psychiatrist I've interviewed and the information on line presents zyprexa as a worse offender than the other Atypicals such as seroquel.My doctor has stopped prescribing zyprexa altogether.

The PDR classifies zyprexa as 'severe' for causing weight gain and diabetes and seroquel as 'moderate'.

Of course the 50 year old Thorazine didn't cause diabetes and is many times cheaper but it could cause tardive dyskinesia.

Where Eli Lilly's negligence comes in,is their KNOWING and not informing consumers (black box warning) until the FDA demanded it.

Lilly's incentive not to readily disclose is they had billion$ coming in from state medicaid scripts.
----
Daniel Haszard http://www.zyprexa-victims.com

11:17 AM, July 23, 2006

luxtian said...

CME is needed...the doctors and patients will suffar from this FDA INS company gulag..by first ammendment and best of care!

8:35 AM, July 25, 2006

C. said...

Please visit the following blog to comment on this issue further:

http://gleasondiscussion.blogspot.com/

10:23 PM, July 26, 2006

luxtian said...

CME-continuing medical eduaction, allows the evolution of medicine FDA entrance into the medical world to "usual and custoary" use and finally "best of care" standards used by state regulatory boards as well as attorneys in malpractice cases. As a new FDA Indication Label costs between 20-40 million dollars and the current 'off label' proceedure is leagal, usual and customary, ther is no monetary incentive for a pharm company to obtain a new FDA LABEL> On the other hand there is monetary incentive formanaged care insuance companies to want to only pay for "On Label" uses of medications as this can result in large profits for uncovered medication. The use of FDA Indication as a standard of care actually represents a level of care that is years if not decades old.

8:44 AM, July 27, 2006

Anonymous said...

I am sad to know that the young man who took Zyprexa starting in 1996 got diabetes yet for some of us, the news has been even worse.

My son was killed by Zyprexa in 2002. Many of us fought to get a warning on the label: A warning had already been required in other countries. But both the FDA and Lilly fought the warning for as long as possible. Zyprexa was a cash cow. Finally, way after knowing of the lethal nature of the drug, the FDA required all the atypical antipsychotics to place a warning on the label. They knew Zyprexa was the worst but by not singling it out, it didn't hurt Lilly's bottom line. Now Zyprexa has dropped to "third place" because the truth of its danger and damage is known, at least in this country.

This is a terrible drug yet the FDA has done nothing to restrict or ban its use.

9:31 PM, August 11, 2006