The Doctor Weighs In

I have to admit that when the Avandia story unfolded I considered writing a strong defense of the researchers who toil anonymously in the bowels of drug companies for years on end, dedicating their life careers to bringing out a drug that may save millions of lives and improve the health and quality of life of literally billions.

I have been there, albeit not with a mammoth drug company, but rather with a smallish biotech company endeavoring to develop immune-based treatment for cancer. The pressures are enormous; a company invests hundreds of millions of dollars in development of a drug, and one wrong decision can sink the whole project.

Preliminary data come in from the lab or the clinic that don’t look good; what do you do? Call for a screeching halt? Rationalize and ignore? None of the above. You ask for more data, for a repeat of the experiment, for more detailed analysis. From my own personal experience, if you keep your cool during this emotional roller coaster, 99 out of 100 times you’ll realize that the sky hasn’t fallen, that the worst possible interpretation is not valid, and most important: a another well-designed experiment will clarify the situation. If you look at it in this light, you’ll have more empathy to the daily dilemmas confronting scientists in the drug industry.

And now for the underbelly

I was also privy to internal sales meetings of some large pharma companies. And there the picture was not as wholesome. Astounding budgets for “educational” meetings, where doctors are brought in, all expenses paid, for some hard sell talks masquerading as scientific reviews of the field. But what was most telling was the attitude; salespeople snickering about docile ‘reliable’ academic and clinical researchers, undisguised disdain for money grubbing “collaborators” and physician-spokespeople, an attitude of “everything and everyone is for sale”.

Again, a disclaimer: I personally know hundreds of honest academic and clinical researchers who do stellar work. We owe them the most amazing advances in drug therapy of diseases that only a few years ago were tantamount to a verdict of death. But it is the proverbial bad apples, on both sides of the equation, which spoil the whole lot.

How could that happen?

“Deep throat” provides the answer: follow the money.

A significant portion of the FDA budget comes from users’ fees, specifically earmarked to hiring more clinical trial examiners. The drug industry is more than eager to comply; they get an accelerated review of the drug, which translates to earlier sales to the tune of millions of dollars per day.  They also gain something less tangible—the loyalty, or at least the sympathy, of the very examiner who is supposed to regulate them. Now, if you knew that your salary is paid for by GSK, would you run out and blow the whistle at the first sign of irregularity? Wouldn’t you be tempted to rationalize? To try and delay by asking for more data? To ask for a second, and third, and fourth opinion? Convene a panel of experts (many of them in the pay of the very same drug company)? This is only human, and that is exactly what happened to the FDA. This agency was created expressly to protect the consumer from unsafe or ineffective drugs. It is now an advocate of the industry it is supposed to regulate, and has to be dragged kicking and screaming to protect the consumers.

How did we get here?

"Mad Money's" Jim CramerFor this, my favorite answer comes from Jim Cramer, a successful Wall Street investor, who is known mostly for his mad antics on the TV show "Mad Money". He never tires of educating his viewers that our Republic is “of the corporation, by the corporation and for the corporation”. Mind you, this is not some left wing rabble rouser speaking. This is a multi-millionaire, Republican by his own admission, who calls it as he sees it when it comes to putting his money where his mouth is. Need a short reminder? Here is a partial list of how our government agencies have been corrupted by the flow of cash:

· The Department of Interior: the Secretary and other political appointees refused to act on evidence brought by a departmental civil servant that oil and mining companies are cheating the federal government of royalties worth billions (with a B) of dollars per year! The whistleblower was reprimanded, “transferred” to a meaningless job, and quit in disgust.

· The Department of Defense: Halliburton, or as Jim Cramer calls it fondly, Prince Hal (William S. please forgive our sins)—need I say more?

· The Department of Justice: under Attorney General Gonzales’s leadership and political appointees who passed
Attorney General Alberto Gonzales the “Bushie loyalty test”, the anti trust division turned a blind eye to outrageous mega-mergers that created monopolies, duopolies and cartels. The poor career lawyers were reduced to going after the proposed merger of Whole Foods and Wild Oats, a terrible threat to consumers of organic rhubarb and Belgian endives.

· The FCC: allowed the tremendous concentration of print, radio and TV in the hands of a few Murdochs controlling mega-corporations. Expect the unvarnished truth about China from the News Corporation? Fuggedaboutit!

· The Department of Education: the Secretary refused to act despite an auditor's report about financial irregularities by student loan companies to the tune of billions of dollars a year, stemming from a loophole in departmental regulations. The auditor proposed plugging the loophole but Departmental political appointees argued that they had no legal authority to do that.  A few days before congressional hearings on the issue the Department miraculously discovered its legal authority, changed the regulation and plugged the loophole. The courageous auditor was reprimanded, "transferred", and prohibited from dealing with student loan issues. When questioned by Congress why was this employee treated so shabbily, the answer was that he was too obsessed. Such chutzpah can bring your blood to the boiling point. Yes, I almost forgot: Did you know that the student loan industry is one of the largest political contributors? You can bet the money did not go to promote Civics classes.

· The EPA. The agency had to be ordered by the Supreme Court to enforce the clean air act, bitterly opposed by the coal industry and owners of coal-fired power plants. The EPA sort of responded this weekend, by watering down the clean water act.

· The White House. Do you know who met with Cheney in 2002 to draft our environmental policy? Nobody knows, except that no environmentalist was invited. But a clue can be found if we follow the money trail: The energy industry was one of the largest political contributors to the presidential campaign of the Bush/ Cheney ticket.

Again, in case you missed it: this is not a political rant: these cases were pointed out by a money manager, multi-millionaire Republican, who saw an opportunity to make money out of the corruption by investing in coal, electricity generators, defense contractors , monopolists, and the like.

Can we really blame the FDA or the pharmaceutical industry for playing the game by Washington's rules?

Dov Michaeli MD, Ph.D