Former FDA Reviewer Reveals Shocking Intimidation and Retaliation Within Agency
Kavanagh: Yes. Largely because of my presentation, the advisory committee voted 12-1 against approval but Cephalon claimed in the press that the rash was viral and was not from the drug. The next year, armodafinil, a related drug, was approved with a contraindication for children with a contraindication following three months later for modafinil. Contemporaneously, Cephalon agreed to pay $425 million for off-label marketing of modafinil. That means that for 18 months, the FDA kept quiet about the issue of SJS in children, while Cephalon continued off-label marketing at full steam. Later I found that the FDA had internal documents that had the same conclusion as my analysis but it had been withheld from the advisory committee.
All drugs have dangers including death, and psychiatric drugs tend to be particularly dangerous, but as long as we make reasonable attempts to minimize risks, and provide adequate information for prescribers and patients, I am not opposed to them. On multiple occasions I have stood up for smaller drug companies against FDA management.
Rosenberg: The recent revelations of reprisals against FDA device reviewers must not have surprised you at all.
Kavanagh: No they didn't. After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with. I saw strange cursor movements on my computer when I was just sitting at my desk reading that I suspected was evidence of spying. After I gave Representative Waxman's (D-CA) office a USB drive with evidence, FDA staff was admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with a drug company to Senator Grassley's office, I was threatened with prison if I should release trade secret information to Congress.
Rosenberg: That is similar to the FDA's claim with the device reviewers. Why do efforts to silence free speech always seem to be couched as "trade secrets"?
Kavanagh: Because much of the information we receive are trade secrets and companies explicitly label everything they provide the FDA as such and explicitly prohibit their dissemination. In spite of this, the Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley's staff to destroy the evidence I provided them. The threats however can be much worse than prison. One manager threatened my children who had just turned 4 and 7 years old, and in one large staff meeting I was referred to as a "saboteur." Based on other things that happened and were said I was afraid that I could be killed for talking to Congress and criminal investigators.
Rosenberg: Still, the FDA transparency meeting transcripts indicate you not only went to members of Congress, you appealed to the Health & Human Services Inspector General.
Kavanagh: Congress did put me in contact with the Justice Department however, I don't believe my complaints were taken seriously or investigated. I believe that actual felonies may well have occurred. For example I found evidence of insider trading of drug company stocks reflecting knowledge that likely only FDA management would have known. I believe I also have documentation of falsification of documents, fraud, perjury, and widespread racketeering including witnesses tampering and witness retaliation.