The Story of This Dangerous Prescription Drug Will Shock You!

JonathanEmord: A lot of people are surprised to learn that the Food and DrugAdministration does no testing of drugs, does not test drugs. It does not testdrugs for safety or for efficacy. Instead, it asks the drug companies thatsubmit the drug applications to perform their own safety testing and their ownefficacy testing.

Ofcourse, they have an inherent conflict of interest. They have an interest inavoiding communication of information that suggests a safety problem andmaximizing the information that suggests that the product is efficacious. Andso the drug reviewers, the medical reviewers, at the FDA are disabled becausethey receive this information and they have to evaluate everything on paper.They don't have the wherewithal from either the FDA, Congress, or otherwise thestatute doesn't provide for them to do their own independent testing andassessment of these drugs. 

Frequently,they never see the actual substance. They don't even know what the drug isthey're dealing with. They just see the paper reports that come to the agencyas part of the application. These reports, even with this, many of thesemedical reviewers are quite savvy and it is not the case that FDA approves adrug in the ordinary course, unaware of the risks. They frequently are informedby the medical reviewers of those risks. 

We cantake a good example of that in the case of Vioxx, the Merck drug. In the Merckapplication for Vioxx, Merck compared Vioxx with another pain reliever calledNaproxen. Now, based on the data in the information they submitted andreconstructing it, the medical reviewers were able to show that Vioxx had athree to five times higher risk for adverse cardiac events, heart attack andalso stroke, than the competing product that was in the comparative trials thatwere submitted as part of the application, Naproxen. When queried about this,Merck said cutely that it wasn't that Vioxx was significantly more toxic to theheart than Naproxen, it was that Naproxen was unusually beneath par as far asrisk to cardiac events, and that really, Vioxx was at par. The relative riskwas not higher than would ordinarily be expected.

This wasnonsense, but it didn't matter because the determination to approve a drug is apolitical determination. It's always made by the Commissioner of the FDA, oneperson. The FDA is a dictatorship. The Commissioner of the FDA can overrule thescientists, even if they're 100% opposed to approval of a drug, if he or shewants to, and frequently they do. They set up their own review panels. TheCommissioner has direct input in choosing who's on the review panels andconflicts of interest are routinely waived. The Commissioner knows by who he orshe chooses to be on a panel the likelihood of how they will vote on approval,and so these things are stacked and the bias is set, and it's well establishedthat there is such a bias. There have been surveys and there have beenInspector General Reports and so forth, all evaluating this corrupt system.

It doesnothing. Congress never changes it. The FDA certainly doesn't do anything tochange it. So with Vioxx, the drug was put on the market, and true to form, asthe medical reviewers suspected, it increased the risk of heart toxicity somuch so that there were 140,000 heart attacks caused by Vioxx and there were60,000 deaths caused by Vioxx from heart attack. 60,000 is a number comparableto the number of people who died in the Vietnam War, all from a pain relieverthat had multiple substitutes in the market. The FDA put it out on the marketand gave it its typical push as a breakthrough drug. It was considered asuperior pain reliever and it was used in hospitals all over the United Statesand all over the world as a routine pain reliever, a post-surgical painreliever, and it was inducing these heart attacks.

Thefrequency of these heart attacks was so great that doctors were concerned andbegan to do scientific research, and it resulted in peer reviewed studies thatwere published in Lancet and JAMA establishing that Vioxx was heart toxic, wasvery dangerous and significantly increased your risk of heart attack andstroke. This information was presented by the medical reviewers to the FDACommissioner who was then Lester Crawford, and he was told also of theexistence of numerous adverse event reports. There were tens of thousands ofadverse event reports coming in about Vioxx.

Heoverruled their objections, didn't take any measure to take the drug off themarket, and in fact declared that the information was anecdotal and that hebelieved in the product. He thought it was a good drug and wanted to keep it onthe market. Not only that, within two weeks prior to Merck withdrawing the drugfrom the market on its own against an avalanche of products liability suits,Lester Crawford approved the drug for use in pediatric rheumatoid arthritispatients, for the use in kids, even with the presence of this massive evidenceof heart attack.

What happened to Lester Crawford? Well, he left the agency in disgrace because hefailed to answer his government employment forms correctly. He had ownershipinterest in pharmaceutical company stock and in large food companies which areregulatees of the FDA. Ordinarily, they put that into a blind trust or theyassign it or they sell it before they get into office. He apparently didn'twant to do that. It was under his wife's name but it is cognizable interestbecause it's still recognizably him even though he put it under his wife's nameor his wife had it. So he answered "no" to the question, "Do youhave a cognizable ownership interest in regulated company stock?"

The FBIapproached him about it. As they oftentimes do, they bend over backwards toaccommodate these government officials. "Excuse me, sir. Are youabsolutely sure that your answer to this question is correct? Do you think thatyou ought to change the answer to "yes" to this question? It's underpenalty of perjury. It would be a false statement if it's untrue." "Nope.I don't want to hear any more of this. I don't have any cognizable interest inthe stock." So he forced the government's hand.

TheJustice Department charged him with false statements under the False StatementsAct, but as is oftentimes the case, he settled the difficulty with thegovernment. He paid them a couple hundred thousand dollars and then popped outinto the private sector where he went to work for a company called PolicyDirections, Inc., which is a lobbying firm in Washington. It represents, amongothers, Merck, which is the maker of Vioxx, and he received a very handsomesalary, much greater than he received as the commissioner of the FDA. He'sdoing quite well today as well.

It's arare circumstance when a person can knowingly cause 140,000 heart attacks or countenancethem and countenance 60,000 deaths, and then even go to the point of advocatingthe very drug that's causing this be used in children with rheumatoidarthritis. But that's the course of events, and this is not atypical. Let megive you just two quick examples. Ketek is a Sanofi Aventis drug that's asuper-antibiotic. The medical reviewers, when they were looking at the Ketekdrug, discovered that one primary clinical trial upon which Sanofi Aventisrelied for approval of Ketek looked too perfect. It just seemed too pristine,and their experience with other antibiotic drug applications gave them pause tothink that perhaps something's remiss here. It's just too pristine. They askedthem to supply the agency with the empirical data underlying the trial;basically, who are all the patients, where are their informed consents? We wantto see them. Show us the evaluative data as it has taken place for each ofthese testing centers and we'll evaluate that to double-check your assessment.

Well, theinformation they requested wasn't forthcoming. It made them seriouslysuspicious that perhaps there wasn't a clinical trial. The FBI investigated anddiscovered that it was a fraud. They made up the clinical trial. There was noclinical trial performed, and this was a key trial supporting the claims ofefficacy for the drug and the very claims that they were seeking about thissuper-antibiotic. In addition, the medical reviewers found troublinginformation about liver toxicity from the drug and they recommended to theCommissioner, in light of the fraud, that the application be summarily denied.

TheCommissioner, however, had another view in mind and ignored the fraud, andordered that the application continue to be processed and then approved theapplication even though it was based on fraud, and then authorized in theindications for the drug, indications that were based on the fraudulentclinical trial. That drug is in the marketplace now carrying those indications,and it is causing the liver toxicity problems. There are adverse event reportscoming in about Ketek with regularity.

There areother instances, too, but this gives you a good idea. David Graham, who's theAssociate Director of the FDA Office of Drug Safety, has been bold in hiswhistle-blowing about the FDA. Here he is in that position, a very highposition with full knowledge of this whole process, and he has said franklythat the FDA considers the drug industry its client, that it will approve asmany drugs as it can, regardless of whether they're safe or effective.