Wayne gets very wet; departs in downpour, no umbrella

The Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce met before a standing-room-only audience on June 13, 2002 to receive testimony on the Imclone imbroglio and its drug, Erbitux.

Panel members hearing the testimony: James Greenwood (R-PA), chairman, W. J. "Billy" Tauzin (R-LA), Cliff Stearns (R-FL), Richard Burr (R-NC), Ernie Fletcher (R-KY), Bobby Rush (D-IL) (well, sort of, he said he had a fascinating opening statement that, in the interests of time, he would just place in the record; then he departed never to be seen again), Bart Stupak (D-MI), and Diana DeGette (D-CO).

First up were Dr. Frank Papineau (Committee on Energy and Commerce), who apparently conducted the initial investigation for the committee, and Dr. Raymond Weiss, an oncologist with the Lombardi Cancer Center at Georgetown University, who reviews clinical-test data for a variety of organizations (NCI since 1981). Dr. Papineau's presentation was a recitation of the history of this affair to date — there was nothing in it you haven't read in the newspapers.

1. 37 of the 139 patients (27%) were ineligible to participate as they did not meet the criteria of the test protocol (he understated that this percentage is "atypical").
2. 15 of the patients were given exemptions — he did not know why or by whom — which would skew the results.
3. 17 of the patients did not receive the same dosage each time and the frequency of dosage was not consistent.
4. 20 of the patients may have shown some signs of regression in their lesions, but radiologists from various organizations reading the CT scans and other tests later could not agree on which they were.

Furthermore, Imclone and the FDA did not agree on what protocol was to be used for this trial. The original protocol was for a single-application test; a subsequent revision produced a double-application test. When the FDA agreed to place Erbitux in the fast-track approval category, it noted that the test protocol would be the original single application. Imclone's test followed the revision combining Erbitux with Irinotecan (this name was a continuing pronunciation challenge to the panel). Imclone apparently was aware of the discrepancy but did not inform the FDA of the mistake.

All in all, Weiss commented, Imclone's test results were not only inadequate but clinically and statistically meaningless.

This led to Tauzin's statement that perhaps the legislative restrictions on the FDA's public disclosure policies need revision. He pointed out that there would have been a real need for the public to know in this case, and he also wondered if the FDA's forced silence might not have contributed to the ability of Imclone's senior management, family, and friends (doubtless Martha Stewart will be relieved to know that she was not overlooked here) to indulge in their stock-selling frenzy before the FDA's RTF was publicly announced.

Harlan did not refuse to testify although he noted that he had only been CEO for three weeks (this seems a little disingenuous since he was Imclone's COO before that, had founded the company with his brother, and stated proudly that he had "worked very hard" for the company for 18 years — a statistic he later cited to justify the rather handsome profits he received from subsequent stock sales).

He expressed continuing confidence in the value of Erbitux. He allowed that Imclone could have done a better job of documenting the test results (although he denied any problem with methodology; he passed on answering a question as to why no one had pointed out the protocol differences to the FDA — he merely said that the FDA had both protocols — and dismissed without comment the observation that the FDA fast-track approval document specifically referred to the single-application protocol and said that results from any other type of test would not be considered). He said Imclone plans to continue working closely with the FDA as it has in the past (hmmmmmm) and plans to offer new data "as soon as it is available". Imclone, he said, is still fully committed to bringing Erbitux to market.

Markison's testimony mostly involved who knew what when. He had "an inkling" as early as 12/4 that the FDA might lower the boom, he was pretty sure of it by 12/13, and he knew for certain that the FDA would issue an RTF on 12/24 (this issuance was publically announced on 12/28). He passed this information on to Harlan Waksal on 12/25 (before or after present opening, one wonders). Waksal said he didn't specifically call his brother about this, but informed Imclone's senior management — which presumably included Samuel — in a conference call on 12/26. All of this was in regard to the insider trading charges.

The hearing was scheduled to begin at 9:30 a.m., and I arrived at about 8:45. It did not get underway until 11 a.m. So we stood in line in a hallway for an hour-and-a-half. A very kind woman, noticing my walking stick, snared a chair from someplace and offered it to me. With absolutely no shame, I took it. The stick also got me a seat in the hearing room courtesy of the C-Span cameraman. If you've got it, flaunt it. There was a half-hour break at 2 p.m.; otherwise it was all business. But when I found myself counting the upholstery tacks in the back of the chair in front of me, I knew it was time to go.