An interesting thought by the surviving spouse of a cancer patient:
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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
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I agree! I hope this guy and his foundation are pushing Imclone into action.
Good life,
JEB
verity.fda.gov |
