This is Scary Enough

Christmas is coming, and for a belated Christmas present, we can look forward to Pfizer's raising drug prices in January, thus ending the price-hike deferment Trump had persuaded Pfizer's CEO to enact in July. But it's not all bad news. With these price raises, said the CEO, there would be increased rebates and discounts offered to insurance companies and pharmacy benefit managers, who, he said, were sure to pass along these savings to consumers. Of course they will!  Don't you feel reassured?

But what can we expect from a corporate giant who thinks its desire trumps all, and who regards its view of things as the truth? For a stunning example of this, we can revisit the infamous Nigerian Clinical Trial. Return with us now to those thrilling days of yesteryear -- to 1996, to be exact, when the African Continent was being ravaged by a Bacterial Meningitis outbreak of unusual severity. At the same time, Pfizer was testing in its laboratory a new wide-spectrum antibiotic, trovafloxacin, which they named Trovan. Pfizer needed to test it in the field, so Pfizer, according to the Washington Post, launched the biggest clinical trial in their history to that date -- an investigation involving 13,000 patients in 87 studies in 27 countries.  As part of this, the drug maker launched an experiment involving 200 children, testing the efficacy of Trovan against another drug -- ceftriaxone, in those days regarded as the gold standard of treatment.  One hundred of the kids got the Trovan, the other 100 received the ceftriaxone. After 45 days, the researchers pronounced the test a "success."

But there was more to it than met the eye -- a lot more. According to Wikipedia it turned out that the children receiving the ceftriaxone got one third the recommended dose. This was done, said those administering the drug, to "minimize injection-site pain," though critics said it was done "to skew the test in favor of its [Pfizer's] own drug." The "success" touted by Pfizer: 5 children receiving Trovan died, while 6 receiving the ceftriaxone also perished.

In the brouhaha that followed, Pfizer was accused of conducting an "illegal trial of an unregistered drug," and it was alleged that the families were not told they were part of a trial. The children, in effect, were guinea pigs. The lead investigator, one Dr. Abdulhamid Isa Dutse, produced a letter approving the human trial -- a letter which was subsequently proven to be fake. International lawsuits ensued. Though Pfizer piously protested that they came to Nigeria only to help out in an epidemic, in less than three months they were out of there.  

To anyone who has seen the excellent movie, The Constant Gardener (2005), this will seem eerily familiar. When I saw it back in the day, I remember thinking, this is terrifying, and I wouldn't put any of it past big corporations. It turned out I was more right than I knew.

It later came out, via Wikileaks, that Pfizer hired investigators to dig up dirt on Nigeria's Attorney General to get him to drop the lawsuit.   In the upshot, Pfizer settled out of court, to the tune of $75million (very little of which ever made it to the families of the victims).  Pfizer said that it settled "in good faith," and that "any notion that the company hired investigators in connection to the former Attorney General is simply preposterous." But the Wikileaks revelation not only disproved that, it quashed Pfizer's false claim that Doctors Without Borders (likewise on the scene doing their excellent work) had also dispensed Trovan during the Nigerian epidemic.

Now with the Nigerian business behind it -- they unrealistically hoped -- Pfizer focused on marketing the drug in the US, for the FDA, amazingly, had approved its use in various bacterial infections.  But an employee whistle blower, Dr. Juan Walterspiel, alleged unethical practices in the Nigeria trial.  He was fired. Pfizer reported sales of $160Million in its first year, and things were looking good (for Pfizer, if not for the rest of us), when our government got around to noticing Trovan's high toxicity to the liver, ultimately forcing Pfizer to drop the drug.

The movie, The Constant Gardener was based on a novel by John LeCarré, in turn very loosely based on the events set forth here. It won all kinds of awards. In the credits after the film, there appeared, over LeCarré's name, the following: Nobody in this story, and no outfit or corporation, thank God, is based upon an actual person or outfit in the real world, but I can tell you this, as my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.  

I have a question for you: Having heard all this, does any of you think that Pfizer would give up one dollar in profits for the sake of the public good? I didn't think so. I don't either.  And horrifying as all this is, you might as well know that the Nigeria incident is not the worst such scandal to have tarnished the name of Pfizer. Don't worry: I'm not going to reveal it today.

This is scary enough.

Dio

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