This is a follow up to yesterday’s post. This is Season 4 Episode 18 of ‘Boston Legal’, which aired on April 29th of 2008, so just months before the episode I used yesterday. You can use this as a reference to research previous FDA failures on approving dangerous drugs. I provide details on two of the most notorious ones here in this post.
John Larroquette’s character “Carl Sack” runs through a long list of drugs approved by the FDA and then pulled off the market. In the scene, “Carl Sack” is questioning an FDA official, and he hammers the FDA severely. ‘Vioxx’ is the first drug “Carl” mentions, and you can read about it here. The picture below also has a link, and the story talks about how Merck tested the drug on 5,400 patients in 8 different studies.
8 studies already sounds like a lot, doesn’t it? And 5400 people seems like a fairly large sample size for something so simple as a painkiller. Certainly a painkiller is not remotely like an experimental gene therapy that’s supposed to act as a “vaccine” by making your body produce spike proteins, so you’d think that might be thorough. Well that was only the first and maybe second phase, as Merck started another trial with 8,000 more patients to test Vioxx against naproxen.
The FDA actually approved Vioxx as this later and larger study was going on, and the drug stayed on the market in spite of evidence form that study in less than one year that Vioxx was twice as likely to cause heart attacks as naproxen:
November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel's November meeting note that "while the trends are disconcerting, the numbers of events are small." The panel votes to continue the study and to meet again in a month.
December 1999: The safety panel holds its last meeting. It's told that as of Dec. 1, 1999, the risk of serious heart problems and death among Vioxx patients is twice as high as in the naproxen group.
By all means read the linked article to see the shenanigans that went on to keep the drug on the market until September of 2004 (!!!), because my point here goes well beyond Vioxx. Vioxx is just the first drug that “Carl Sack” mentions, and the fictional FDA character he’s questioning gets very upset at that mention.
The next drug “Carl” brings up is ‘Bextra’, and the FDA guy admits that Bextra “got by us”. In case you’re too young or you forgot about it, Bextra lead to a 2.3 Billion (with a B) dollar settlement from Pfizer. In that linked article, CBS “News” provides a handy list of facts on Bextra, and it also shows real journalism occurred in the past from left wing media when it came to big pharma:
"This case alone impacted more than 10,000 postal employees on workers' compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service's Office of Inspector General.
Whose brand name will be tarnished by the company pleading guilty to a crime? Not Pfizer's. Rather, it's "Pharmacia & Upjohn Company," which will cop to felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. P&U is, of course, a Pfizer acquisition.
In what must be the dumbest act of off-label drug promotion ever, Pfizer once put out a press release touting Bextra as an effective morphine-sparing analgesic after knee surgery. Bextra was not approved for post-surgery pain.
Former sales manager Thomas Farina, who led a team of sales reps in Brooklyn who promoted Bextra off-label, is about one and a half months into a six-month sentence of home confinement with an electronic ankle bracelet for his role in the case.
Farina's team was called "the Highlanders" -- a reference to a movie and TV show about a cult of immortals living secretly among us who must kill or be killed. Farina signed his emails, "There can be only one," a reference to the motto of the show.
Farina became tangled in the probe when he was caught changing the timeclock on a computer in order to back-date certain documents. Farina did this after showing his team a compliance training video informing employees that they were under investigation on Pfizer.
At one point, about 100 reps were focused on selling Bextra off-label. Their boss was Mary Holloway, who paid a $75,000 fine and is currently on two years' probation.
At the time, Pfizer's medical directors thought Holloway's handling of the Bextra business was "awesome."
“Carl Sack” goes on to list many more bad drugs that got FDA approval and were then withdrawn due to serious side effects, and the FDA character actually has a line of “Left wing liberals love to dump on the FDA.” That is again quite remarkable compared ot how left wingers are all in for big pharma and the experimental gene therapy “vaccines” that have injured and killed so many over the past 2 plus years.
If only left wing liberals were investigating, questioning, and reporting on the FDA and big pharma now, instead of being bought and paid for by big pharma.
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