Corporate America Needs Protection — From Itself

Corporate America needs protection from trial lawyers!?

So goes the tort reform mantra. Trial lawyers are victimizing corporations; which is causing job loss; which is ruining the economy; which is leading to higher prices; which is causing Wall Street uncertainty; which is leading to all around chaos.

I have worked for Corporate America and I have worked for lawyers. All the lawyer jokes aside, I am happy to no longer be working in the moral ambiguity of Corporate America.

Let’s take today’s Corporate citizenship example. Pfizer, Inc.

Recently, Pfizer agreed to pay fines of a record amount, $2.3 billion, for hiding off-label drug marketing practices. That would be the practice of selling drugs for uses that the FDA has not approved them for or, in some cases, uses that the FDA has specifically prohibited. Now, Pfizer investors are suing Pfizer saying that the Corporate Pharma “promised” it would stop its off-label marketing practices, but $2.3 billion later proves otherwise.

Also, just unsealed yesterday, is a complaint filed against Pfizer for the marketing of its drug, “Vfend” (voriconazole); an antifungal medication approved for the treatment of invasive aspergillosis and candidemia. Pfizer requested FDA approval to market the drug as “empiric therapy” as well. Empiric therapy is the medical practice of initiating treatment before an actual diagnosis can be made based upon laboratory or other objective studies. Antibiotics and some antifungals are often prescribed, quite correctly, by physicians based only upon their judgment of a patient’s symptoms. Pfizer wanted the ability to market Vfend on this broad basis so that physicians would prescribe it more often and, thus, increase Pfizer’s profits proportionally.

The FDA refused to allow Pfizer to market Vfend as an empiric therapy. So, what did Pfizer do? You guessed it, they marketed Vfend for broad use anyway. Why would a corporation specifically violate FDA regulation?

Vfend was approved for the limited use of treating diagnosed fungal infections in 2002. Certainly, the fact that Pfizer made $825 million in 2010; $798 million in 2009; and $743 million in 2008 off the drug may have played into their decision. Also, Vfend was designed to replace an antifungal, Diflucan, for which Pfizer was losing its US patent. Diflucan had been generating annual sales for Pfizer averaging $1.1 billion per year – an amount they stood to lose if they could not replace Diflucan with a substitute.

The current lawsuit brought by the US government was the result of company “whistleblowers”; former employees of Pfizer who have provided information to the US government suggesting that Pfizer’s off-label marketing resulted in much higher sales and this resulted in a fraud upon Medicare and Medicaid.

Sour grapes from some disgruntled employees? Let’s take a look at those employees; both of whom reportedly resigned from Pfizer:

Catherine Brown was Senior Marketing Manager at Pfizer and had been employed by them from 1996 to 2005. She holds multiple degrees in science and business and she was, in fact, “Representative of the Year” in 1998. She resigned from Pfizer in 2005

Bernard Vezeau was a Senior Product Manager on the “Vfend Marketing Team”. Mr. Vezeau went to West Point, was a Captain in the US Army and held a Master’s degree in Business Administration. He worked for Pfizer between 1989 and 1992; and was rehired by them in 2003.

The complaint brought by the US government gives insight into what allegedly occurred. Apparently, Pfizer was using a study, “the 608 Study” to substantiate its claims that Vfend was effective in treating broad categories of fungal infections. Notably, Pfizer claimed that Vfend was effective in treating a very aggressive and potentially lethal fungal pathogen, C. glabrata. The problem explained in the complaint in detail is that the 608 study results were, first, of a small patient population and, second, the results were substantially manipulated by Pfizer in an effort to cause the study to demonstrate an effectiveness in treating broad categories of fungal infection when it, in fact, was not effective.

While Pfizer marketed Vfend as having an “extended spectrum” and recommending physicians use Vfend “at the earliest clinical suspicion of a fungal infection”, respected medical journals condemned these assertions. The New England Journal reviewers stated that the 608 study “significantly obfuscate the presentation of results” and found the study “a bit deceptive”. The Lancet published comments by a noted and respected expert in fungal infections as finding the results of the 608 study to be “most perplexing” and seeming “seriously flawed”. In English, they did not believe Pfizer’s study and, if the allegations prove to be true, these experts had good reason.

What did Brown and Vezeau do wrong? Well, from Pfizer’s perspective, they insisted on clarification of the study results and asked for substantiation for claims that Vfend was effective in treating broad categories of fungal infections, most notable a life threatening fungal like, C. glabrata. Pfizer’s medical director, Dr. Dr. Schlamm, allegedly complained that Mr. Vezeau, was asking too many questions about the 608 study.

Now, Pfizer stands accused, yet again, of marketing drugs for uses NOT approved by the FDA. In addition, they are accused of manipulating scientific studies and opinion – for what? To maximize profits.

So, ask yourself: who needs protection from whom?