Hollywood Sees Corruption in Pharma, and Suddenly Scientists are the Bad Guys

that will rival their own, more expensive brand-namemedications. For example, Bristol-Myers Squibb paid a $2.1 million fine as well a $125 million shareholder settlement over the company’s failed attempt to negotiate a favorable drug patent settlement with the generic manufacturer Apotex. While not currently illegal, the Federal Trade Commission is trying to curb this egregious practice and has estimated it would save consumers some $3.5 billion annually.

Off-Label Drug Marketing. This is the practice of marketing drugs for uses they were not approved for by the FDA. This happens so often, it is clearly considered a cost of doing business in the industry. Recent settlements with the government include Pfizer ($2.3 billion dollar fine), Eli Lilly ($1.4 billion), Cephalon ($425 million), and Otsuka ($4 million). Part of what Pfizer paid ($1.19 billion) constituted the largest criminal fine in U.S. history.

Corrupt CEOs. This is certainly not exclusive to the pharma industry, but where do they find these guys? In the past few years, we’ve seen CEOs canned amid accusations of insider trading (ex-ImClone CEO Sam Waksal), sexual harassment and income tax fraud (ex-Astra CEO Lars Bildman), generating bogus data (ex-Sequenom CEO Harry Stylli), and wire fraud (ex-InterMune CEO W. Scott Harkonen), for distributing a press release that falsely portrayed clinical trial results.

Ghostwritten Science Articles. These are papers that are written for scientific journals by drug company employees, not the independent academics who were listed as authors. They are generally crafted to show the company’s drugs in a positive light, and are supposed to carry weight because of the credibility of the named authors. This apparently widespread—and deceptive—practice has led scientific journals to respond with (what else?) “ghostbusting.”

Fake Medical Journals. In was revealed this year that in 2003 Merck paid Elsevier, the publisher of many peer-reviewed scientific journals, to print several issues of The Australasian Journal of Bone and Joint Medicine, which was not peer reviewed and was not a legitimate medical journal. This was simply an advertising vehicle for Merck in the disguise of a real publication. Hooking up with a legitimate publisher of biologic journals helped to sell the illusion.

Serious Prescription Drug Pollution. Drug levels in treated wastewater from a plant where Indian drug companies dump their residues were 150 times higher than the highest level detected in the US. Be thankful you don’t have to drink this stuff. This problem is hardly unique to India. In the US, antibiotics, anti-convulsants, sex hormones and other pharmaceuticals have been found in the drinking supplies of at least 41 million Americans.

Raising Drug Prices. In 2009, pharma companies have raised drug prices an average of about 9% at a time when the Consumer Price Index—a common measure of price inflation in many consumer goods—has fallen 1.3%. This was the highest increase in drug prices in years.

Attempting to Fix Company Mistakes Via Legislation. The Medicines Company mistakenly filed some patent extension paperwork one day later than it should have. The mistake will cost the company four years of patent protection on its drug bivalirudin (Angiomax), and potentially hundreds of millions of dollars in revenue. To fix this, the company has spent millions of dollars on lobbyists

Author: Stewart Lyman

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides advice to biotechnology and pharmaceutical companies as well as academic researchers and venture capital firms. Previously, he spent 14 years as a scientist at Immunex prior to its acquisition by Amgen.