I’m not a big fan of big Pharma. There’s a good reason for my attitude. Many drug companies are selling hype rather than bona fide drugs. And some of those big drug companies have been caught outright lying.
Merck has already been shown to have killed tens of thousands of people as a result of its lies regarding the alleged safety of Vioxx. The well known lies of Merck involved the withholding of important data that suggested that Vioxx was more dangerous than Merck wanted to allow the public to know. “FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market.”
The April 17, 2008 edition of Nature (available online only to subscribers) indicates that Merck’s deception was more prevalent than previously suspected. These new accusations have come to light as a result of the extensive litigation regarding Vioxx. The discovery responses produced by Merck made thousands of documents available for analysis. This analysis, paid for by the litigants in a Vioxx case, “seem to show Merck’s extensive involvement in ‘ghost writing’ and ‘guest authorship’ of research and review papers.”
This new evidence seems to show that Merck had its own employees designing the drug trials, analyzing the data, writing the papers and then simply recruiting academic authors to give these papers supposed authenticity. This ruse was discovered by analyzing first drafts of the manuscripts compared to the final articles. The first drafts were written by Merck employees, whereas the final drafts indicated that allegedly independent academics had done the studies and authored those articles. Worse yet, the articles failed “to disclose relevant financial relations” regarding the participants.
The bottom line is that Merck apparently manipulated the authorship of dozens of “independent” articles in order to promote Vioxx.
But that’s not all. This same article in Nature reports on a second recent article based on documents obtained in a separate court case. This second article “reports ‘striking’ disparities between the mortality results for the drug in published papers and those contained in Merck’s internal analyses.”
It makes you wonder what other drug companies are manufacturing lies along with their drugs. It’s also further evidence that the FDA is largely a rubber stamp for the drug industry rather than a public watchdog. It’s also evidence that motivated trial lawyers can sometimes do an impressive job of puncturing corporate obstructionism and exposing disturbing wrongdoing that others fail to find.
Redcently, my DP gave me some samples of Celebrex for a pulled muscle. knowing that Celebrex is closely related to Vioxx, I decided to do a little digging on the net. If I understand the research corectly, the safety studies were done using 15 mg doeses, but the prescription product is 220 mg. Knowing a little about bio chemistry, but being no expert, I read up on the pharmacological action of COX-2 inhibitors such as Celebrex and Vioxx. I wass somewhat disturbed to find that a rather obvious side effect was not followed up in the studies. There was an indication that cox2 inhibitors caused an electrolyte imbalance which could result in a sharp rise in blood pressure. Also, absolutely no research was indicate concerning the effects on the cox-3 enzyme pathways.
It appears to me that the research was selectived on marketability criteria and without the safety of the comsumers at all.
Nine scientists at the FDA have now accused the agency of gross mismanagement in a letter they have sent to President-Elect Obama:
"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the letter said. "Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal."
http://www.cnn.com/2009/POLITICS/01/09/fda.scient…