Abstract
The appointment of Dr. Bernard Prigent, vice-president and medical director of Pfizer Canada, to the Governing Council of the Canadian Institutes of Health Research, outraged many Canadian health researchers. Pfizer has been a “habitual offender,” persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. Since 2002 the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards. The $2.3-billion settlement in September 2009 – a month before Dr. Prigent’s appointment – set a new record for both criminal fines and total penalties. A link with Pfizer might well advance the commercialization of Canadian research – unhindered by law or morality. Is that now the only mandate, Dr. Beaudet?
Résumé
La nomination du Dr Bernard Prigent, vice-président et directeur médical de Pfizer Canada, au conseil d’administration des Instituts de recherche en santé du Canada a indigné plusieurs chercheurs du milieu de la santé au Canada. Pfizer est un ≪ récidiviste ≫, souvent impliqué dans des pratiques commerciales illégales ou malhonnêtes, offrant des pots-de-vin aux médecins et discréditant les résultats d’essais jugés indésirables. Depuis 2002, le montant total des condamnations, des amendes administratives et des amendes prononcées par des jurys, imposées à la firme et à ses filiales, est évalué à 3 milliards de dollars. L’amende de 2,3 milliards de dollars, prononcée en septembre 2009, a établi un record tant pour les amendes au criminel que pour l’ensemble des sanctions pénales. Les liens avec Pfizer peuvent sans doute faire progresser la commercialisation de la recherche au Canada – sans les entraves de la loi ou de la morale. Est-ce donc là votre unique mandat, Docteur Beaudet?
On January 15 of this year, US federal prosecutors in Boston filed a complaint against Johnson & Johnson (J&J) and related companies, alleging violations of the federal False Claims Act and related legislation (Associated Press 2010).1 Allegedly, from 1999 through 2004, J&J made payments to Omnicare to induce increased prescribing of Risperdal to patients in nursing homes. Risperdal is J&J’s brand of risperidone, a drug used in the treatment of schizophrenia.
The inducement was somewhat indirect. Omnicare is a pharmaceutical services provider, the largest in North America, that contracts with nursing homes and other facilities to provide drugs prescribed by patients’ physicians. Omnicare’s pharmacists dispense these drugs; they also provide oversight of patients’ drug use and health condition. According to the complaint, Omnicare pharmacists review patients’ charts at least monthly and make prescribing recommendations that physicians follow more than 80% of the time.
The ultimate objective of all prescription drug marketing is to determine what is written on the prescription pad. In this case, the chain of influence ran from drug company to dispensing contractor to pharmacist to physician. Over the period alleged, J&J sales through Omnicare rose from $100 million to $280 million. Risperdal made up more than one-third of these sales.
Omnicare’s website stresses the company’s mission to promote the health of seniors.
Omnicare: The Prescription for Positive Outcomes
Omnicare is the nation’s leading provider of pharmaceutical care for seniors. Each day, our pharmacists serve more than 1.4 million residents of skilled nursing, assisted living, and other healthcare facilities in 47 states and Canada. While doing this, we capture a tremendous amount of data. Omnicare combines this data with its proprietary outcomes algorithm technology, based on best practices in geriatric medicine, to identify and help treat diseases in the elderly.
We do all this, and much more, with one goal in mind: to help ensure the health of seniors in a cost-effective manner. (Omnicare 2010)
This noble language might suggest that Omnicare is “an eleemosynary outfit.”2 Not so. It is a strictly for-profit corporation (OCR-N on the NYSE) like Johnson & Johnson (JNJ-N), with the mission – the one for which its executives are paid – of providing “enhanced shareholder value” – i.e., profit for its shareholders. For the hard-eyed men and women of Wall Street, the rest is just public relations fluff. Payments from J&J to Omnicare to encourage pharmacists to promote the prescribing of Risperdal were a win–win strategy for both corporations.
For patients, perhaps not so much. Atypical antipsychotic drugs such as risperi-done can have some quite nasty side effects; in particular, the US Food and Drug Administration requires manufacturers to include special labelling warning of an increased risk of death related to psychosis and behavioural problems in elderly patients with dementia.
Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving. … Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy. (US Attorney Carmen Ortiz, quoted in Associated Press 2010).
In addition to the risks to patients, the other side of the coin of corporate gain was the cost to public and private payers. But these interests, like those of patients, were not represented when J&J implemented a strategy of, in effect, purchasing Omnicare’s nursing home pharmacists to act as an extension of its own sales force.
The charges against J&J have not been proven in court, nor are they likely to be. Corporations prefer not to go to trial; rather, they negotiate a settlement that will permit them to continue denying wrong-doing while paying to make the charges go away. (Such settlements may, however, include a formal guilty plea on one or more criminal charges.) Omnicare, as it happens, settled related charges last November for a payment of $98 million to the United States and state governments (Associated Press 2010); with that case settled, J&J will probably choose the same option. The only real issue in dispute will be the size of the penalties.
The amount of money involved in this case is in fact very small potatoes. J&J will probably pay a couple of hundred million in fines and civil penalties. The stakes were somewhat higher last September, when Pfizer and related companies settled a number of charges for a total of $2.3 billion (O’Reilly and Capaccio 2009). This settlement set a new record for a criminal fine – $1.2 billion – plus civil penalties of $1 billion. Subsidiary Pharmacia & Upjohn pleaded guilty to one count of a felony, misbranding of a pharmaceutical, and was assessed a forfeiture of $100 million.
A number of fraudulent marketing practices were involved for a number of different Pfizer or subsidiary products. The criminal charges focused on the illegal promotion of several Pfizer brands – Bextra (valdecoxib, a pain medication, since removed from the market), Geodon (ziprasidone HCl, an atypical antipsychotic), Zyvox (linezolid, an antibiotic) and Lyrica (pregabalin, a seizure medication). These were promoted for “off-label” use, i.e., for uses other than those approved by the FDA.3 But there were also kickbacks to physicians and the use of unverified and misleading marketing materials to promote the prescribing of several other Pfizer brands, including Viagra (sildenafil) and Lipitor (atorvastatin).
This was by no means Pfizer’s first offence. In 2007, Pfizer subsidiary Pharmacia & Upjohn paid $34 million and pleaded guilty to paying kickbacks for formulary placement of its drugs and entered into a Deferred Prosecution Agreement for off-label distribution of Genotropin, its brand for the human growth hormone somatropin (US Department of Health & Human Services and US Department of Justice n.d.).
In 2004, Pfizer subsidiary Warner–Lambert pleaded guilty and paid more than $430 million to resolve criminal charges and civil liability arising from its fraudulent marketing practices with respect to Neurontin, its brand for the drug gabapentin. Originally developed for the treatment of epilepsy, Neurontin was illegally promoted off-label for the treatment of various forms of neurological pain, and in particular for migraine.
In 2002, Pfizer and its subsidiaries Warner–Lambert and Parke–Davis paid $49 million to resolve civil claims that it had failed to report best prices for its drug Lipitor as is required under the Medicaid Drug Rebate Statute.
As this is being written, gabapentin is back in the news. The CBC (2010) reports that
Pfizer has been ordered to pay $142 million US in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin. A federal jury in Boston ruled Thursday that Pfizer fraudulently marketed the drug and promoted it for unapproved uses.4
This case demonstrates one reason why drug companies often prefer
