53-year-old Dr. Peter Gleason was arrested last March for promoting Xyrem for medical purposes other than those approved by the US government.
When this news hit headlines in the US, many felt that the long overdue exposure of murky financial relationships between doctors and pharmaceutical companies would finally happen.
Dr. Gleason has admitted to earning over $100,000 last year from Jazz Pharmaceuticals through conducting seminars, delivering speeches, and visiting fellow doctors in their offices to promote the narcolepsy drug Xyrem. However what makes Dr Gleason's case so peculiar is that he had been promoting Xyrem as a drug to be prescribed for depression and as a pain reliever.
In January a group of prominent American doctors had issued a sweeping call for reform in the medical profession saying that "doctors shouldn't accept drug samples, junkets or even ballpoint pens from drug or medical-device companies."
According to Dr. Gleason, who is now free on bail and continues to practice medicine, he is not guilty of conspiracy and that t he was charged only after his refusal to help the government build a case against the drug's maker, Jazz Pharmaceuticals which seem to be a sequence of events that court documents seem to support.
On his part Dr. Gleason freely acknowledges he advocated Xyrem as a treatment for many conditions, including depression and fibromyalgia in meetings with other doctors. He claimed to believe everything he said about the drug and that his right to express his views are protected by both F.D.A. rules and the First Amendment.
An assistant F.B.I. director was reported as comparing Dr. Gleason to a "carnival snake-oil salesman."
According to according to Harvey A. Silverglate, a lawyer in Boston who specializes in civil liberties cases Dr. Gleason has been trapped in the complex rules that cover what doctors and drug manufacturers are allowed to say about prescription drugs. He said, 'What they are doing is criminalizing conduct that is not clearly criminal.'
It is no secret that the same practices are observed in many parts of the world with severe and far-reaching consequences. Its primary effect is on the price of just about every drug in the market. The retail price is based on the wholesale price. The wholesale price is known to be the production cost plus operating cost plus markup. Production costs involve the actual expenses in the manufacture of drugs, such as research, development and testing. The operating costs involve the costs iinvolved in marketing the products which could involve expenses of drug companies in wining and dining doctors, sending them on local and foreign trips, and showering them with gifts, all declared to be a part of marketing expenses.
These doctors are the ones who instruct the patients on what kind of medicine they need and why. In other words they are the direct link between consumers and the drug companies. So they are pampered and these costs are passed on to the public.
Matters are complicated further because F.D.A. rules allow doctors to prescribe federally approved drugs for any purpose, although it is not indicated on the medicine's label. However drug companies are constrained in what they can say about their medicines. Companies can only promote drugs for their federally approved purposes or the so-called "on label" use.
Since "off label" promotion by drug companies has been declared illegal several drug makers have paid large fines to settle federal criminal cases over off-label prescriptions.
For instance Pfizer paid $430 million in 2004 to settle allegations that it had promoted Neurontin, an anti-epilepsy medicine, for pain and bipolar disorder.
In spite of the F.D.A.'s constraints on drug makers the companies are allowed to hire independent doctors to talk to other physicians about their medicines. In addition companies can sponsor "continuing medical education" sessions, that could range from lunches to weeklong conferences, during which specialist doctors tell other physicians about the latest developments in their fields including off-label uses for drugs already on the market. These promotions usually reward doctors to the tune of $3,000 or more a day from the companies.
By this process the F.D.A. rules allow drug makers to reward or pay independent doctors to discuss medicines in ways that might be illegal for the companies themselves. Guidelines by doctors' groups also give physicians wide latitude to talk about off-label use beyond federal rules.v In fact it is doubtful that a doctor would keep on prescribing a certain drug if the company that manufactures it is less than generous with its rewards and incentives.
Therefore caught in the stranglehold of the drug companies and the doctors they pamper, health comes with too high a price tag.