An Inquiry into the ImClone Cancer-Drug Story

Subcommittee on Oversight and Investigations
June 13, 2002

 

Prepared Statement of The Honorable Billy Tauzin

Thank you, Chairman Greenwood, and let me commend you for holding this hearing on ImClone Systems and its much touted "miracle" cancer drug, Erbitux.  We have much to learn from the story of this drug. And I believe the story of this drug provides an opportunity to examine the drug development and FDA review systems.  We need to make sure these systems work for patients.

Cancer patients and their families had great hopes that Erbitux would be on the market by now.  They and the media believed all that was asserted by ImClone and its prominent backers.  ImClone's CEO, Sam Waksal, promised that 'Erbitux is going to be huge.  It is going to be one of the biggest drugs in the history of oncology - a drug that is going to alter the way cancer therapy is done.'

Imagine what cancer patients thought when they heard that statement.  ImClone reportedly received 400 calls a day from patients desperate to get Erbitux outside of clinical trials.  By late last fall -- when ImClone filed its application with the FDA -- there were very sick colon cancer patients holding onto hope that Erbitux would be on the market by this Spring -- by now.  But when ImClone's clinical research package was finally unveiled to the FDA, it had so many problems, the FDA could not even review it. 

ImClone certainly deserves credit for its years of research into monoclonal antibodies, which still may pay off for patients in the future.  Unfortunately, when the company should have been paying more attention to the quality of its clinical trials, its leadership appeared more intent on immediately cashing in on Erbitux's promise -- and delivering for cancer patients later, if ever. 

ImClone had the selling points to boost its stock and raise the hopes of dying cancer patients.  Erbitux is a targeted therapy, and targeted therapy is supposedly the future of cancer treatment.  It had the names, the giants of clinical oncology on its board - John Mendelsohn, Vincent DeVita.  It had a growing anti-cancer drug market.  And, most important, it had virtually total control over what information would be released to the public about its studies since the FDA is restricted under Federal law from talking about such proprietary information.

Yet it appears, as our Committee investigation has revealed, that ImClone was so excited by preliminary response rates in very sick colon cancer patients, it tried to take a mediocre clinical trial and gussy it up as a study worthy of an accelerated approval by itself.  But when it became crunch time to get FDA approval, the failure of ImClone's key executives to ensure the quality of its clinical trials collided with the hype.  And, all the while, ImClone's insiders were lining their own pockets with millions, as ImClone's publicly-traded stock soared on false, public promises. 

Now the SEC has alleged that Sam Waksal knew about the FDA's refusal-to-file letter two days before it was issued and that he tipped off family members who sold $10 million of ImClone stock.  As Vee Kumar, a 47-year school psychologist and colon cancer patient from Kirkland, Washington, told Vanity Fair magazine:  'There is no excuse for raising patients' hopes and then not delivering.  There's been a lot of talk about ImClone's monetary rewards from Erbitux, but not enough about getting it to the patients who need it.  They really ought to have done their homework better.'

I understand that the preliminary Committee staff report reveals additional problems in the clinical package ImClone submitted to the FDA, and lays out the series of actions by ImClone, its strategic partner Bristol-Myers Squibb, and FDA that led to this debacle.  This Committee's investigation opens the black box of the FDA process, and reveals a drug-development and FDA review system that is not serving the interests of the American people. 

Through this inquiry, I hope we can prevent such train wrecks in the future.  Drug companies and the FDA should develop drug approval strategies that work in the patient's interest -- not so that companies can hype stock, personally enrich executives, and short-change clinical research; not so that the FDA hangs back while a company falls on its face with a high-risk approval strategy, as if it's just the company's gamble.  It may be the company's gamble, but if it fails, cancer patients are the ones who really lose.

Mr. Chairman, I look forward to working with you to improve the drug development system and to make that system really deliver for our sickest patients.

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