Subject: In Cancer Research, Put the Patient First 
Date: Published: 8/7/91 (129 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    In Cancer Research, Put the Patient First
    ----
    By Robert K. Oldham

    In one stirring moment, Rock Hudson made it clear to the
 American people that the AIDS epidemic was a real and public
 problem.  The deaths from cancer of Michael Landon and Lee
 Remick in just the past few weeks have underscored the fact
 that while many people are now cured of cancer, it still
 kills many more.
    About half a million Americans die from cancer every year,
 compared with about 150,000 deaths from AIDS since the
 beginning of that well-publicized epidemic more than eight
 years ago.  Yet the federal government now spends more on AIDS
 research than on cancer research.  And often the fruits of
 cancer research fail to reach the patients who desperately
 need them.
    As I sit in my office at the Biological Therapy Institute
 each day, phone calls come in from referring physicians
 across America.  Recently, Charlie Thomas called from
 Charlotte, N. C. His patient, whom I will call Ben Harwood,
 needed Interleukin-2 therapy.  Mr. Harwood, age 38, has an
 advanced case of melanoma, a particularly virulent form of
 skin cancer.  He is a sophisticated patient, a mid-level
 insurance executive, who asked Dr. Thomas about new
 treatments.
    First, Charlie called the National Cancer Institute, but
 Mr. Harwood was found ineligible for IL-2 because a small
 tumor nodule had been removed from his brain.  Charlie then
 called me to ask if IL-2 would be available through my
 program, which is one of only a handful offering such
 therapy.  My answer was also "no.  " The Food and Drug
 Administration has ruled that patients with a previous
 metastasis to the brain, a previous heart attack or a whole
 list of other previous illnesses are not eligible for IL-2,
 which has still not received full approval from the FDA,
 after seven years of testing.
    In spite of the fact that I have safely treated many
 patients with IL-2 who have had brain tumor nodules removed
 or who have had previous heart attacks, Mr. Harwood will not
 receive IL-2 because of the FDA rule.  He will not be the one
 person out of three who improves with IL-2, nor will he be
 the one out of 10 who enjoys a complete disappearance of
 cancer with this new treatment.  If IL-2 were approved by the
 FDA, I would treat Mr. Harwood to give him a chance to live.
    Why do we do cancer research?  Why have taxpayers provided
 more than $20 billion for the "War on Cancer" since President
 Nixon signed the bill in 1971?  Why does the American Cancer
 Society knock on our doors each year?  Why do our
 universities, our cancer centers, and the pharmaceutical
 industry spend billions of taxpayer and drug-profit dollars
 each year attempting to determine the causes and cures of
 cancer?  Is this simply research to understand cancer better?  
 Are we really interested in understanding the mouse and
 test-tube experiments so important to the process of cancer
 research?  Isn't there a more fundamental objective?  
    Perhaps our institutions have lost sight of the real
 agenda for all this activity:  to cure cancer and to alleviate
 suffering for individual human beings afflicted with the
 hundreds and perhaps thousands of disorders collectively
 grouped under the name "cancer."  My purpose and that of Dr. 
 Thomas is to cure Ben Harwood, a possibility that would be
 substantially greater if the FDA would approve IL-2.
    When the FDA's activities are analyzed in the light of the
 needs of cancer patients, it becomes evident that this
 government agency, serving in the public trust, does not put
 the patient first.  What value does it have for Mr. Harwood
 not to have access to IL-2?  Many very dedicated cancer
 researchers have suggested that the process of drug approval
 is much too slow and much too expensive to be truly
 responsive to the needs of cancer patients.
    The activism of AIDS patients has quite clearly made a
 difference for them.  The initiation of a "dual track system"
 made anti-AIDS drugs such as DDI and DDC available sooner to
 patients.  But despite many requests by cancer patients and
 researchers for a similar system for anti-cancer drugs, no
 such system is in place and no public statement in support of
 such a process has come forth from the National Cancer
 Institute, the American Cancer Society or the comprehensive
 cancer centers across this land.
    What do patients think of the drug approval process?  In
 1987, a biotechnology company I was then associated with
 conducted a national poll and the results were quite clear.
 Patients want access to new drugs and new technology sooner.
 Mr. Harwood needs IL-2 today!
    There has been much rhetoric from the FDA on more rapidly
 developing new biological therapies for cancer.  Alpha
 Interferon is often used as a "fast track" example.  It took
 seven years of testing for approval.  IL-2 has been given to
 more than 10,000 patients and is clearly effective in a
 subset of patients with kidney cancer and melanoma.  Still, it
 is not approved in the U. S. although it has been broadly
 available in Europe for more than two years.
    New drugs are only part of the process.  We must also
 commit to distributing new drugs and technologies to patients
 in their communities and get insurers -- both public and
 private -- to pay for them.
    More than 80% of the patients with cancer receive
 treatment in their communities, rather than through a major
 cancer center.  Many are old and debilitated with other
 diseases.  Therefore, any improvement in the system that is
 truly patient-centered must be dedicated to taking the newest
 and best treatments out to patients in their communities.
 This is currently not the case now.
    Finally, who will pay for these new drugs and
 technologies?  Putting the patient first means government,
 through Medicare and Medicaid, must take a leadership role in
 providing reimbursement.  The current Medicare policy of not
 paying for hospital costs when a drug such as IL-2 is
 "experimental" is a crime.  Government must provide leadership
 and guidelines to encourage private insurance carriers to pay
 for these new treatments as well.
    The whole system must be revised to put the patient first.
 For Ben Harwood to die without the opportunity to respond to
 IL-2 is a travesty.  For 500,000 Americans to die yearly
 without the opportunities cancer research can provide is a
 nightmare.
    ---
    Dr. Oldham is director of the Biological Therapy Institute
 in Franklin, Tenn.

[This article is made available here by Dow Jones Co. for the
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 hope that it will be of some help to those who are suffering
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