Thursday, November 15, 2007

Absolutely Smashing Indictment of Big Pharma

Okay, we all know by now that Pharma Giles is the premier site for cutting parody on the pharma industry, bar none. On occasion, he steps away from vicious satire and issues a dead-on, incisive rant. One such rant was recently posted and I think everyone should read it. Teaser follows:
Drugs like Vioxx, Oxycontin and possibly Avandia have all recently been launched onto an unsuspecting public in the quest for billion dollar profits, and have gone on to harm tens of thousands, even though there is evidence to suggest that the companies behind them had a pretty good inkling of the potentially lethal hazards and side-effects from data they chose to selectively ignore during trials.

People have needlessly suffered or died, at best because of complacency and at worst because of corporate greed, and as a result public trust in the pharmaceutical industry has never been lower. And because of public mistrust, the regulatory environment has become so tight that it is now much harder to launch new medicines of any sort – a situation which is a constant cause of whining by the pharma CEOs who are, ironically, ultimately responsible for creating the hostile regulatory climate in the first place!

Pharma industry wonks talk about the “risk/benefit” of new drugs, and yet it seems that these days it’s the public who take the risks and the CEOs and shareholders who get the most benefit.


Executives hide behind the line that they cannot be aware of every little thing that goes on their companies and therefore cannot be responsible for any illegal actions of their underlings. Sorry, guys, but just what do you get paid six, seven or even eight figure "compensation packages" for? By and large, it certainly isn’t for your personalities or good looks, is it?

Howard Udell is certainly now trying to suggest that, well, sure he pleaded guilty, but only because he was the boss and not because he was actually personally responsible for any wrong-doing. Sorry, pal, that may well be true but I think the buck stops with you. If you or your fellow execs weren’t aware of any wrong-doing THEN YOU DAMN WELL SHOULD HAVE BEEN.

Mr. Udell is still employed in his capacity as Chief Counsel for Purdue, Ms. Skolek points out to me.
Slam dunk. I'd also add the atypical antipsychotics into the mix as well. Take a look at recent data regarding their performance in dementia, for example (1, 2). Shockingly poor. And who is accountable when these medications are marketed to bury risks and make false statements regarding a drug's efficacy? Apparently, nobody. Sure, a fine may be levied, but that's just a drop in the bucket. You don't think accountants and lawyers are busy figuring out, as I type, how much money can be lost in lawsuits versus how much can be made from B.S. marketing campaigns that overstate benefits and hide risks? It's all a risk-benefit calculation: How much financial risk do we take by hiding data versus how much can we benefit from aggressively marketing the product?

5 comments:

Pharma Giles said...

I should have included every SSRI ever made in my list of harmful drugs being pimped by the industry for profit. Thanks for pointing that out.

CL Psych said...

I understand your predicament. There are quite a few drugs that would have fit into your description -- you couldn't possibly have included them all!

stevebMD said...

You don't think accountants and lawyers are busy figuring out, as I type, how much money can be lost in lawsuits versus how much can be made from B.S. marketing campaigns that overstate benefits and hide risks?

The sad thing is, it's probably much more insidious than this. I'm sure the accountants, lawyers, and executives have convinced themselves that these drugs have some utility in various off-label indications. And they might. I think some of the overstatement of risks is not so much greed as it is wishful thinking and false hope. Unfortunately, this makes it increasingly difficult to trust that drug companies' claims are backed up by solid data.

Anonymous said...

Some additions to the content of this blog:

In order for a drug to get approved, ultimately, it has to prove itself better only than a placebo, which is a parameter I equate with toddlers.

Secondly, a pharma company can conduct several studies to illustrate this qualification, and some of these studies can show disadvantages of thier new drug. Doesn't matter, as long as the pharma company creates a minimum of two better than placebo studies to get thier drug approved.

To speed things up with the approval process, a pharma company as an option to supplement the PDUFA, which is freely accepted by the FDA.

In order for our innovation to progress regarding pharmaceutcals, the process is in dire need to take a more authorative stance.

CL Psych said...

Anon,

I don't know if that is an "addition" -- I've previously noted the low efficacy bar set by the FDA. Taking a tougher stance may indeed spur innovation, or, conversely, it may result in Pharma going bankrupt if they can't develop enough drugs that could meet a tougher efficacy standard.