My Letter to Dr. SPosted: August 24, 2011
Here is the copy of the letter I sent to Dr. Sebelius for your review and comment.
August 22, 2011
Dr. Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Ave. S.W.
Washington, D.C. 20201
Re: Darvocet Citizen’s Petition
Dear Dr. Sebelius:
I am the attorney who filed the formal Citizen’s Petition on behalf of myself and other similarly situated individuals, requesting that the FDA revoke the recall of Darvocet. A supplemental petition was also filed and enclosed in a letter to Dr. Margaret Hamburg advising that numerous lawsuits have been filed throughout the country by the plaintiff”s bar, naming 12 plus manufacturers as defendants. Those actions are now consolidated in Multi-District Litigation (The MDL) in Eastern Kentucky. (The purpose of the MDL is to consolidate the discovery). It is anticipated that once discovery is commenced that the circumstances of this recall will not “paint” the FDA in a very a “good light”, meaning the recall was politically motivated.
I have indicated that it is my intention, once Administrative Procedures are exhausted, to file a declaratory judgment action (DJA) in federal court. The basis for the DJA is to have the court find , as a matter of law, that the FDA has failed to follow its own policies and procedures, in recalling this drug. I believe I can prevail on that. One need look no further then the media to see that this has become the rule and not just an anomaly.
I have written to Dr. Hamburg, who didn’t give me the courtesy of a reply. Everyone is busy, so that’s not an excuse. Also, I’m paying her salary and yours as well. In addition, my dealings with various individuals at CDER has been unproductive and for the most part “stonewalling”. What happen to “transparency” and being “for the people” not the “politicians”. After waiting 6 months for a decision on the petition, the FDA elected to give itself a continuance, claiming the issues are complex. There is nothing complex in FDA determining whether it followed its own policies and procedures in recalling this drug. More significantly, many people are left without a remedy and in chronic pain, for no apparent reason.
I would request you review the petition , supplement and attachments, and if you can find any evidence that Darvocet causes heart problems that the source be identified. An unidentified pharmacist at the FDA confirmed that the only study correlating Darvocet with heart problems is the Xanadyne Study done at the request and direction of the FDA. That study consisted of 18 individuals (including controls), two of whom dropped out of the study. The individuals in the study were administered 2- 3 times the therapeutic dose of Darvocet. As result, the data is not statistically significant and the interpretation of that data is not without it’s flaws, as pointed out in the actual report. That report is attached to the Citizen’s Petition.
The drug was removed from the market in other countries because of accidental or intentional overdose, not heart problems. No doubt this can be the basis for removal of the hydrocodones as well. Of interest is that the FDA recommended Lortab, Vicodin, Oxycontin etc. as substitutes. What, these drugs are less prone to overdose and addiction etc.? To the contrary.
If this drug had significant side effects this should have been apparent years ago, given its long history of use having been on the market since 1957. Surely, if this drug caused significant side effects why would CDER advise certain individuals that the drug could be purchased in Australia? There are no alternatives for many people, Darvocet is the only drug that works, the recall needs to be revoked.
If there are concerns regarding Darvocet use then, “black box” it and have patients sign a waiver, but don’t remove the only drug that provides a decent quality of life for many. I would appreciate it if you would look into this as soon as possible. I am willing to come to Washington to discuss this with you.
I look forward to your earliest reply,
Barbara L. Maw