Biovail Pleads Guilty

As reported by by Fortune (via

The big Canadian drug company [Biovail Pharmaceuticals] agreed Friday to plead guilty to U.S. kickback and conspiracy charges. The decision, which closes out a federal investigation of the company's unusual actions in support of a 2003 drug launch, means Biovail (BVF) and a New Jersey-based subsidiary will pay a $24.6 million fine to avoid a court case that could have cost them future business with federal agencies.

The marketing program in question - Proving Cardizem LA through Clinical Experience, or PLACE - aimed to build physician awareness of Biovail's 2003 launch of a crucial product, the long-acting formulation of heart drug Cardizem. Skeptical hedge funds and research outfits charged that by paying doctors up to $1,000 for prescribing the drug for up to 15 patients, Biovail's program amounted to little more than bribery.

Note that, as reported by Bloomberg, the payments were meant to be for "research,"

Biovail's plan [was] to offer them $1,000 to write 15 prescriptions for Cardizem LA, then complete a report on each patient.

However, as Fortune's article noted,

Biovail, the U.S. attorney's office wrote in its press statement Friday, 'did not design or implement the PLACE program in a way calculated to provide new or meaningful scientific data about whether Cardizem L.A. worked better than other available drugs.' It added in settling charges against the company that the payments to doctors exceeded the 'reasonable fair market value' of the physicians' services.

Add this to our collection of grossly unethical financial interactions between health care organizations (in this case, a pharmaceutical company) and physicians. In this case, payments apparently meant to serve as inducements for physicians to prescribe a drug were prettied-up as research support.

Pharmaceutical, biotechnology, and device companies now spend vast amounts on payments to physicians. These include payments for "consulting," "honoraria" for speaking, "royalties" for use of intellectual property, and funding for "research." Rarely do the companies or physicians involved disclose the amounts paid, or what the physicians did in return for these payments. One can only wonder how many other such payments are really for physicians' prescribing particular products, or helping to market these products. Only full disclosure of all payments made to physicians, other than fees for clinical services, could put such concerns to rest.

I would implore my fellow physicians who take payments for "consulting," "honoraria," "royalties," and "research" support to fully disclose these patients, their amounts, and what the physicians have done for them. If such disclosures might seem embarrassing, then the affected physicians should consider whether they should be taking such payments at all. Similarly, the organizations making such payments ought to fully disclose the people getting them, the amounts, and the reasons for the payments. Again, if such disclosures seem embarrassing, then the companies should consider whether they should be making such payments at all.

Physicians rightly often complain the they are being deprofessionalized. Being professional involves subscribing to and upholding a clear code of ethics. A major element of physicians' ethical codes is putting the interests of individual patients first. Taking payments to prescribe particular products, rather than prescribing for individual patients those drugs which are most likely to help, and least likely to hurt those patients, appears to violate this prime ethical directive. Physicians deprofessionalize themselves when they take payments or gifts in return for prescribing specific products. If we do not want to be deprofessionalized, we must not take actions that deprofessionalize ourselves.

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