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May 21, 2002

Tommy Thompson, Secretary                                                  
Department of Health and Human Services
200 Independence Avenue,
Washington, DC 20201

Dear Secretary Thompson,

The purpose of this letter is to strongly urge you to bring criminal charges against Abbott Laboratories for illegally withholding from the FDA important information concerning eight deaths and other adverse effects of their big-selling obesity drug, sibutramine (Meridia), a drug we asked you to ban in March of this year. 

April 3, 2002 FDA Inspection Report (ATTACHED in pdf format)

I have obtained a copy of a recent, 3/21/02-4/03/02, FDA inspection report of the Abbott Laboratories plant in Abbott Park, Ill. which found that “[one]* death associated with Meridia was not reported and several records [involving seven other deaths] reviewed showed that the adverse drug information reported to FDA was either not accurate, not supported by source data, or was missing additional information found in the source data.”

In addition, FDA inspectors found that  “complete case files containing any documentation as to follow-up investigations conducted and information obtained therein [concerning deaths associated with Meridia] were missing.”  The FDA also charged that “records relating to all adverse drug experiences known to you [Abbott], including raw data and any correspondence, have not been maintained for the required (   )*  year period.” 

Information in the inspection report concerning the deaths includes the following five cases. Two other cases had too much material redacted to understand what had occurred:

NOTE:

*all rounded brackets (  ) which are blank inside,  within quotes from the FDA inspection report refer to information redacted from the FDA inspection report; squared brackets [   ] are our explanation, based on other parts of the inspection report, of the meaning of the quoted material 

            “ a)  (        ) report (     ) documents that a (         ) patient who died several weeks after stopping Meridia was reported to the contract research organization 

(      ) formerly  (       ) by a (        ) sales representative on 11/10/2000, however this adverse event was not reported to FDA. This (      ) reported was located only after a query for all “deaths” related to Meridia stored on the (         ) computer system was requested to be performed during the inspection. Abbott had not performed this type of query prior to the inspection.” 

          “c)  (    ) dated 11/22/00, reports the death of (    ) taking Meridia who had adverse events of (   ) and (    ). A source document reports that the (    ) was in 

(   )early  (    ) and was not  known to have any type of (     ). This information was not reported in the MedWatch report.” 

            “e)  (   )ed  1/18/99 reports the death of a (      ) patient taking Meridia who had adverse events of (         ). A follow-up MedWatch report , dated 4/8/99, states that further information is unavailable. However, source records document that attempts to obtain the autopsy report were discontinued per instructions from the (     ) legal department.” 

            “f)  (     ) dated  9/16/98, reports that (    ) patient with (          )n (    ) initiated Meridia for weight loss, was transferred to the hospital with (    ) date unknown, and subsequently died. In a MedWatch report , dated 4/7/99, the sponsor stated that it is likely that the patient expired due to complications of 

       ), underlying (       ) however, the original  (    ) report indicates that the patient’s preexisting conditions were unknown, and there is no source data documenting that the patient had preexisting (     ) prior to initiating Meridia therapy.”

“g)   (     ) dated  10/21/98, reports the death of a (      )  patient taking Meridia who had adverse events including (      )ecord dated 3/22/99 stated that the patient developed (   )  and the (   ) does not attribute the death to Meridia. There is no documentation of how or from whom this information was obtained.”

Under “Observation 3” in the FDA inspection report is a discussion of an additional death which occurred during a “postmarketing clinical investigation”:

“Specifically, (     ) is an adverse event report of a (          )  patient who was in a blinded sibutramine vs.  (    ) study from 9/23/98 until 2/21/01 and died suddenly on 2/22/01. The initial study, serious adverse event form reported the causality as unrelated. The form stated post mortem/ autopsy report to follow. The review and evaluation of this event did not include documented attempts to obtain a copy of the autopsy report. The case was closed on 1/2/02. The blind was broken, and the patient had received sibutramine therapy.”

As the FDA summarized in the beginning of the inspection report, Abbott filed adverse reaction reports with the FDA which were “either not accurate, not supported by source data, or was missing additional information found in the source data.”  In addition to illegally withholding a report of a death in a patient using sibutramine, the attempts to get an autopsy report on another patient which could implicate sibutramine were “discontinued per instructions from the (     ) legal department.”

Additional Grounds for Criminal Prosecution of Abbott

From our review of FDA’s AERS (adverse event reporting system) computerized data base we have found three cases, including one death, in which the company failed to notify the FDA of an adverse event within 15 days after the company became aware of it, as required by law. The one death, occurring in Great Britain, was reported to the company 41 days after the company became aware of it. In the two other cases, one was reported to the FDA 232 days after the company learned of it and the other 79 days later. All three, acknowledged by the company to be categorized as the kind of adverse event which requires a 15 day report, violate FDA law and regulations for which criminal sanctions can be imposed.

Relevance to Public Citizen’s March 19, 2002 Petition to Ban Meridia

As you are aware, in March of this year we filed a petition to ban sibutramine because of evidence from pre-approval placebo-controlled clinical trials of significantly increased blood pressure, cardiac arrhythmias and pulse which caused the FDA physician in charge of the drug  and the FDA advisory committee to recommend against its approval. After it was approved despite this advice to the contrary, 29 deaths, including 19 from cardiovascular causes were reported to the FDA. Abbott’s immediate response to the petition was to deny that there was any evidence that sibutramine had been responsible for the deaths and to point out that obese people have a higher risk of cardiovascular death, thus explaining deaths “unfairly” attributed to sibutramine. 

The pattern seen by FDA inspectors in their recent inspection of the company reveals an Abbott scheme to conceal important information that could establish the causal role of sibutramine in the deaths of specific patients using the drug. Unless this and all other companies engaging in such activity are promptly and vigorously criminally prosecuted, patients in this country will be harmed by not having access to the full scope of information about Meridia and other drugs.

I urge you to take this matter very seriously.

Sincerely,

Sidney M. Wolfe, MD
Director,
Public Citizen Health Research Group

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