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Biotech / Medical : Imclone systems (IMCL) -- Ignore unavailable to you. Want to Upgrade?

To: StockMiser who wrote (285)	2/16/1999 3:07:00 AM
From: JEB	Read Replies (1) \| Respond to of 2515

An interesting thought by the surviving spouse of a cancer patient: ******************************************************************** DR. DUTCHER: If there are no further questions for FDA, I think we should move along. We do still have five more minutes of open public hearing. Is Mr. Erwin here? Could you please identify yourself and your associations, as well as your financial support? MR. ERWIN: Sure. I am Robert Erwin. Thank you for agreeing to my request to speak after the data was presented. I have no financial interest in Genentech. I am Chairman of the State of California Breast Cancer Research Council, which spends about 10-15 million a year in cigarette tax money on breast cancer research. I work for a small private biotech company which neither collaborates with nor competes with Genentech. I am here today, representing the Marti Nelson Cancer Research Foundation, and the cancer patients that we assist to enroll in clinical trials to obtain access to experimental medicine to evaluate off-label uses of drugs approved for other indications, and to assess the potential value of treatments unavailable in the United States. My wife, Marti, died of breast cancer in 1994 after unsuccessfully attempting to gain access to the drug now known as Herceptin. Since that time, Genentech has demonstrated its moral leadership in the biotechnology industry, and its compassion, by establishing an expanded access protocol for Herceptin, whereby as of now over 400 women with advanced, HER2 overexpressing metastatic breast cancer have been able to obtain this drug in the realistic hope of extending life, or at least improving its quality. Although a scientist might not call these cases significant and refer to them as anecdotal, the benefit experienced by each individual who was helped by this protocol was as clinically real as the benefit experienced by any individual in the pivotal studies. The data presented today, in my opinion, speak clearly, and there is no doubt that this drug should not only be approved, but should become a part of the standard of care for HER2-overexpressing metastatic cancer. The patient groups that we work with tend to be quite aggressive and we extrapolate aggressively from early stage data. We would be very likely to recommend Herceptin plus Taxol over AC as first-line therapy for HER2-expressing metastatic breast cancer. Two very important questions remain, however. One, why has it taken so long to get to this point when it was so clear to so many people in 1994 that this drug could extend life? I believe that something is wrong with our institutional approach to providing effective treatment for cancer. We are not talking about a healthy population in this regard but about people who are dying. When every day counts we are losing years, as was illustrated in the early slide showing the regulatory time line going back to the completion of the Phase 2 study. The fast track is not fast enough. The sacred cows of the research funding process and the drug development and approval process are clogging up the road and, in the absence of data suggesting actual divinity, I think they need to be put back to pasture to enable innovative researchers and companies like Genentech to move more quickly, and move significant discoveries into general use. Those of you in the FDA know which experimental drugs are working and which are not early enough to pull the promising candidates to the process proactively and rapidly, perhaps into pivotal Phase 2 studies. You also know which combinations of as yet unapproved biologics have rational medical promise but are unlikely to be tested in combination for years to come. How long do we have to wait to find out whether or not Herceptin in combination with Theratope, or some other proprietary biologic, can extend life beyond either alone? Under the current system, it will be well into the new millennium. Why? Disclosure of risk is essential, as is monitoring for unexpected toxicity. Delays in access are fatal. The second question is why is Genentech the only company to have an established practice of providing expanded access to promising cancer therapeutics? Where are Chiron and Biomira and Janssen and Bristol-Myers and ImClone and Medarex, and all the other companies who plan to profit from cancer? Those of you out there from the corporate world who sell Taxol and Adriamycin, and other chemotherapeutics, are selling products that usually benefit less than a third and harm 100 percent of your customers. People buy your products not because most of them benefit, but because all of them hope for benefit, and your profit is the same whether your customer lives or dies. I believe that this truth carries with it a moral and ethical mandate to rethink the status quo and factor compassion into your operating practices, as Genentech has done. And, it is not just the corporations who develop and sell oncologic drugs that share this obligation. It doesn't really matter whether your currency of choice is the profit you might derive from the sale of marginally beneficial products or the tenure that you have derived from the tragically disappointing war on cancer. Everyone whose profession exists because of the suffering of cancer patients has a moral obligation to step up to the line and deliver the best that science has to offer to people who need it the most as rapidly as possible. This includes insurance companies, managed care organizations, and the FDA itself. Herceptin may be the first drug for the treatment of metastatic breast cancer that actually helps more people than it harms, but I hope it won't be the last. With this new generation of cancer drugs, expanded access is not only a matter of altruism. Genentech has demonstrated that everyone can win from expanded access and from a close and constructive relationship between a company and the community of people most affected by cancer. Genentech has also shown that expanded access is compatible with good science and good medicine. I urge you to accept the challenge of Genentech's leadership and remember that each individual is more than an anecdote. Each person is a valuable, loving, loved and irreplaceable individual. Expanded access for all of the new generation of cancer therapeutics is what we need. And, don't wait around until organizations like ours and the broader coalitions of cancer activists engage you in this issue. Do it now because it is the right thing to do. As Marti was dying, I promised her that her death would not be in vain. I intend to keep that promise. We have only made a very small start. We are going to continue because it is the right thing to do. Thank you. Committee Discussion and Vote ******************************************************************** I agree! I hope this guy and his foundation are pushing Imclone into action. Good life, JEB verity.fda.gov