Pfizer Overdosing Kids in Trials (Now Act Surprised)
Like all of the major pharmaceutical companies, Pfizer has a history of misconduct, corruption and deceipt but when is enough really enough? They were overdosing children on Geodon in clinical trials marked by almost every kind of failure and misstep. It’s okay though, they got…(gasp!)…a warning.
Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.
The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:
… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.
…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…
The kids suffered from nervous tics and a loss of control of their limbs, among other symptoms. Pfizer said it conducts tests globally according to the highest ethical and scientific standards:
HIghest ethical and scientific standards? I would love to know what passes for standards at Pfizer because from where I’m sitting, it’s hard to recognize any. They’re treating children like guinea pigs — and poorly treated ones at that.
Of course the company responded in the industry’s typical own-up-to-it-and-say-you’re-trying fashion with a letter that reads like the kind we were made to write as schoolchildren about how we understood it was wrong to disrupt the class or make messes.
Pfizer recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA’s concerns. Many of the items cited by the FDA were first uncovered and reported to the FDA by Pfizer as far back as four years ago as part of our ongoing clinical trial monitoring and quality assurance processes. Since that time, Pfizer has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators.
Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Pfizer clinical trials in the future.
It just sounds like more talk about writing up new policies of the type they’ve already proven to be capable of sticking to. I guess when it takes the FDA five years to get around to giving you a warning when you’re abusing children with drugs, the sense of urgency kind of goes out the window, doesn’t it?
If the dosing wasn’t enough, it would appear as though their application for Geodon use in children was “intentionally misleading regarding its cardiovascular effects.” On top of that they were accused by the DOJ of marketing off label (but then who doesn’t these days?) and stated in a DOJ statement:
The government alleges that Pfizer also promoted Geodon for use by unapproved patients, including pediatric and adolescent patients, and promoted Geodon for higher dosages than were approved by the FDA. This conduct included direct promotion by Pfizer sales representatives and promotion through the hiring of physicians, or “key opinion leaders”, to give promotional talks to other physicians about unapproved uses and dosages of Geodon. Specifically, these talks included encouraging doctors to prescribe the drug for children, and to prescribe the drug at substantially higher than approved dosages.
There is a lot of money in the sale of antipsychotics, particularly among children, a captive market that seldom has the option of saying no to the drugs. Pfizer pays a lot of money to doctors and other promotional outlets for one simple reason. They stand to make a lot more. They’re paying millions to make billions. Doctors selling other doctors on off label drugging and groups like NAMI promoting the notion to the patients for which they claim to advocate affords the company a kind of sales force that even the slickest of television and print ad campaigns can’t match.
One doctor was paid $4,000 a day to fly his private helicopter to meetings where he promoted Geodon off-label, according to a separate whistleblower suit, which Pfizer also settled.
And Pfizer allegedly gave more than $1.3 million in funds to the National Alliance for the Mentally Ill, a non-profit advocacy group, and hired the president of the organization as a paid speaker, according to another whistleblower suit. In an amazing coincidence, NAMI published a web page which advocated off-label use of Geodon in children.
So when is enough enough? if a company (really an industry) can lie about health risks, experiment on children, abandon ethical and scientific standards and engage in all manner of misconduct — what is too much? Why does it seem that all issues relating to pharmaceuticals and mental health seem to be relegated to smaller outlets of information and opinion put out by people who already have a position on one side or the other? Openly corrupt companies overdosing kids is not a special interest piece specific to mental health but a statement on our mistreatment of our nation’s youth regardless of the methods. I guess it’s easy to quell the outrage now that a warning from the FDA has set everything right again.