Just last week, Merck & Co.’s “voluntarily” yanked the blockbuster arthritis drug Vioxx from pharmacy shelves because an ongoing clinical trail (read: a studying of a currently
UNAPPROVED use of the drug) indicated the medication posed an increased risk for heart attack and stroke among long-term users.
How convenient that our Food and Drug Administration is seemingly nowhere to be seen in the
press reports for this result. Typically, drug-makers pull a drug from the market only after pressure from the FDA, which only tends to happen after a lot of people fall ill, complain, die or more likely too many doctors get sued for prescribing the pill.
The stories in Reuters, the AP and others mentioned little, if anything, about the FDA’s position. So where was the FDA on the Vioxx issue? Are they even involved, have no comment (at least say no comment, or are they covering up for their own involvement in the approval/use of the drug?
According to an October 8th Associated Press story, the FDA silenced one of their top experts, Dr. David Graham, who raised concerns about Vioxx’s safety WEEKS BEFORE Merck yanked
the drug from shelves. Testifying before a panel of Senate investigators just days ago, the doctor told of intense pressure, exclusion and intimidation, even thinly-veiled threats by his colleagues at the FDA for raising a red flag about the drug’s safety. He further testified to the generally hostile environment at that government agency with regard to ANY evidence of drug safety issues. This partially shows that Big Pharma companies are forcing the FDA to push through drugs that are not thoroughly tested or ready to go to market.
Graham, the architect of a 40,000+ patient research project on arthritis medications, concluded well before Merck halted its Vioxx trial that high doses of Vioxx over long periods tripled the
risk of heart attack and sudden cardiac events. He was scheduled to present his findings at a conference in late August, but when the FDA reviewed the synopsis of his presentation, they killed his presentation!
So we have censorship from the FDA of a 20-year veteran FDA expert sounding an alarm about a popular prescription drug and gets gagged by his superiors. Days later, the Senate launches an investigation with the expert as a key witness. Meanwhile, the manufacturer “voluntarily” pulls the drug, citing its own research and good conscience… my ass.
Merck probably reached their tipping point and pulled the pill to stop the PR leak in the dam. There can be a large case made that pharma companies weight the financial risks of law suits from adversely effecting the patients they provide drugs for vs. the profits made after development, marketing and release of the products. If the profits over a certain number of years exceed the expected loss in revenue from suits and bad press, then they would conceivably move forward with the public release of a drug… All this regardless of risk to the actual patient.
Merck smelled shit storm in the mainstream media when Graham’s testimony became public
knowledge, so they positioned themselves as not only the source of the information, but also the solution. This attempt is to present themselves as a provider of useful information as well as “playing dumb” to the real side effects of the approved drugs. I don’t believe the FDA has a hand in formulating this strategy, however, there maybe a case where someone (or group of people) within the FDA are financially or politically benefiting from the collaboration with big pharma for the release of these “approved” drugs. A fringe benefit of Merck’s highly public handling of the situation would have been that it takes some of the accountability pressure off the agency.
Regardless, the FDA plays a role in the health of Americans by approving these drugs and can/should take some of the consequences for approving them. There would be an incentive to keep the close involvement of the FDA in these cases to a minimum. This it isn’t the only instance of the FDA sweeping drug safety findings under the rug in recent history and it won’t be the last with our current administration.
Vioxx isn’t the only arthritis drug causing health problems and Merck isn’t the only pharmaceuticals manufacturer engaging in some astute “damage control.” Ironically, the news you’re about to read appeared in print on the same day that the Vioxx cover-up story I just told you about broke. Shrewdly timed, as I’m sure you’ll agree in a moment.
According to a recent Associated Press article, a drug-making subsidiary of Johnson and Johnson named Centocor expanded its warning label on the 28th top-selling drug in the country, Remicade (a rheumatoid arthritis medication), to include language reflecting an increase risk of cancer. (Reuters Health reprint)
The company’s own research concludes that the arthritis drug contributes to a three-fold increase in the incidence of deadly lymphoma (cancer of the lymphatic system). This conclusion failed to reveal itself in the stacks of research Centocor submitted to the FDA when they applied for their patent. Is this either careless studies of the drug or just plain omitance of the facts for their own corporate gain?
As if this isn’t alarming enough, this announcement marks the second time in just a six-week period when Remicade’s warning label had to be changed to reflect a risk of death. In late August, Centocor added a caution against fatal blood and nervous system disorders after 12 people died in clinical trials of the medication.
Predictably, the FDA claimed those deaths couldn’t be definitively linked to the drug. Makes makes you wonder whose side the FDA is supporting – the health of Americans or the financial profits of the big pharma corporations…
Parts of this post taken from Dr. Douglass’ Real Health Breakthroughs e-news letter