So Many Authors, Too Many Conflicts of Interest

Back in June, the New England Journal of Medicine published an article about a trial of the promising drug Ibrutinib for patients with relapsed or refractory mantle cell lymphoma – one of the more baffling and hard to treat NHL subtypes.

This article, which outlines a very simple phase II study involving 111 patients, apparently required the work of 31 authors to cobble together – 20 of whom being MDs and four being both MDs and PhDs. Another six had "just" a Ph.D.

The conclusion of this academic tour-de-force?

Ibrutinib shows durable single-agent efficacy in relapsed or refractory mantle-cell lymphoma.

Big money

The money that funded this study came primarily from two sources: Pharmacyclics and Janssen Biotech. In December 2011, these two companies entered into a collaboration for the worldwide development and commercialization of ibrutinib.

Janssen is a part of one of the largest pharmaceutical companies on planet earth, Johnson & Johnson.

Of these 31 authors, 11 of them reported no potential conflicts of interest. The other 20 reported financial relationships with a total of 21 pharmaceutical companies, many of them being among the largest in the world.

These relationships take one of the following forms:

• Consulting fees
• Lecture fees
• Receiving grant money
• Receiving payment for board membership
• Giving "expert advice"
• Being a shareholder
• Being an employee

Sixteen of the 20 have one or more of these financial relationships with either Pharmacyclics, Janssen, or Johnson & Johnson.

Seven of them are employed directly by Pharmacyclics, including the chief medical officer, the vice president of Biometrics, the vice president of research, the vice president of research/biology and the vice president of clinical medicine. They all have strong, vested personal financial interests in seeing ibrutinib reach market.

You can see for yourself at this link to Pharmacyclics' SEC filings.

No doubt

Ibrutinib has been getting lots of hype lately, even though the results of this phase II study are – practically speaking – hardly overwhelming with 21 percent complete response rates and a median response duration of 17.5 months.

Beyond that however, with these kinds of conflicts of interest in place, was there ever any doubt that this study would produce positive results?