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Setting The Agenda: The Vital Role of Patients' Groups
Presented by Nicki Hobson
Executive Director, National Association of Cancer Patients-a grassroots
patients' advocacy organization
I want to talk to you about very special friends today.
About Dani Grady, an outstanding athlete, diagnosed with breast cancer
at age 29.
About Bill Otterson, a dynamic business entrepreneur and community leader,
diagnosed with multiple myeloma at age 46.
Jim Berkovec, electrical engineer and melanoma patient.
Kim Pierce, a medical school business administrator, breast cancer.
Dan Negroni, a young attorney, testicular cancer.
Ron Taylor, a biotechnology venture capitalist, prostate cancer.
Alan Smith, a public affairs director, thyroid cancer.
These are real people, and I hope you will remember them during every
discussion that takes place during this conference, and afterwards, too.
They are cancer survivors. They can tell you exactly what it means to
have the most powerful weapons possible in their battle against cancer.
If they were here today, they would tell you that the use of radioisotopes
in medicine and research has been crucial to their survival. They'd tell
you that policies and regulations made in the rarefied air of Washington,
DC, have real life consequences for cancer patients all over the nation.
They represent the millions of American faces turned to the medical
establishment today, faces filled with hope for a longer, healthier life,
for relief from suffering. And while I represent the National Association
of Cancer Patients, I want to stress that our concern is not limited to
cancer patients. There are many other patients, with ailments from AIDS
to Alzheimer's, from heart disease to diabetes, who depend on radiation to
diagnose or treat their diseases. And where radiation doesn't play a
direct role in managing their condition, radioisotopes are vital in bringing
to the patient's bedside new and improved pharmaceuticals that extend and
improve the quality of life. And will someday eradicate these scourges
of mankind.
So why don't we just get out there, with legendary American know-how
and can-do spirit, and find a cure for cancer, a vaccine for AIDS, new
ways to prevent birth defects? I'll be the first to admit that I don't have
all the answers. But I do have plenty of questions, and some ideas about
where the problems lie and how the situation can be improved.
For much of this century we're about to put behind us, decisions affecting
patient care have all too often been treated as either a political issue
or administrative burden by bureaucrats. And all too often, the impacts
these policies have on patients and their families have been pushed into
the shadows. Budgets are approved and regulations are written and implemented
in a bureaucratic environment far, far removed from the people most affected
by them. From a patient's perspective, it is very difficult to accept
that political and administrative decisions often determine the path
and pace of medical progress.
Patients are partly to blame. They are generally engrossed in their
own private health battles, with little time, energy or financial resources
left over to engage in policy debates. We've tended to assume that someone
else will look out for us. Well, we're working hard to erase that complacency.
We're urging patients and their families to stand up for themselves and
participate in the policy dialogues going on in Washington. But even when
they are willing, how can we make sure their views are heard? I believe
it will take a concerted effort not only by patients, but also by the
federal government's medical bureaucracy and the medical care provider community
to inject a rational, needs- and science-based paradigm into the decision-making
process.
What are our bottom line issues?
- We want leading edge technologies for diagnosis and treatment of
disease to be available, easily available;
- We want to see broad access to these technologies for patients
in every socio-economic group;
- We believe the strong influence of political factors in shaping
health research budgets ought to be replaced by a standard that puts
the needs of patients first;
- We'd like to eliminate the inappropriate intrusion of non-medical
factors into all health care decisions;
- We support adequate funding for medical research and clinical
trials; and
- We're working hard to remove existing regulatory, bureaucratic
and economic roadblocks to obtaining better patient care.
I'd like to discuss a few specific areas and offer some examples where
I believe the patient is being short-changed. Where you agree, I hope
we can unite in an effort to change things.
One of the most important issues, as you might have guessed, is money--money
for medical research. Cancer patients are intensely concerned about speeding
up medical research because it represents their best hope for the future.
Just consider this: The equivalent of three 747 planeloads of people
die from cancer in the United States every single day--more than 1500.
Imagine the public outcry and rapid political response if 747s literally
began falling out of the sky day after day, killing everyone on board!
But this truly outrageous cancer statistic is largely ignored when research
dollars are budgeted and allocations are made at the national level.
A paltry $2.4 billion went to the National Cancer Institute for cancer
research in FY 1997-the lion's share of the national program. An additional
$400 million or so is in the Defense Department's budget for breast and
prostate cancer research, for some mysterious reason. The total amount
devoted to cancer research--less than $3 billion--is totally inadequate
even for today's needs. But today's needs will pale by comparison to the
snowballing health care requirements that can be expected as millions
of baby boomers become senior citizens early in the next century. With
the total National Institutes of Health budget hovering at only about $14
billion, it's easy to see why our national medical research budget must
be at least doubled, and quickly-to prepare for what's ahead of us, and to
benefit all patients, not just cancer patients.
There's a parallel issue that also needs to be addressed, and that is
the need for a reliable program to produce the isotopes needed to support
this research, a need that has continually grown over the years without comparable
increases in DOE's isotope production budget. This year's budget is actually
down from last year.
The fact is, medical research cannot get along without the use of radionuclides,
and most researchers depend on DOE-produced isotopes. They need some
assurance that the isotopes will be available when needed, at a predictable
cost. That has not always happened in the past, primarily because budget
constraints have caused DOE production schedules to be very uneven and
costs to the researcher to fluctuate significantly. The increases in the
DOE budget have not been enough to keep pace with the increased-and steadily
increasing-demand for isotopes, so cancer patients would like to see more
money allocated to this vital activity.
Let's shift gears and look at how at the cumbersome, time-consuming and
costly process of obtaining FDA approval of new drugs affects cancer patients.
Patients have to wait far too long-sometimes in vain-for new drugs that could
help them to come out of the FDA pipeline. By the time approval is granted,
the increased cost added by the regulatory process frequently places the
drug beyond the economic reach of most patients.
Let me elaborate. When research identifies a promising new drug, pharmaceutical
manufacturers make an educated guess as to how long it will take and how
much it will cost to obtain FDA approval. Unfortunately, many promising new
drugs wind up on the cutting room floor, so to speak. Why? Because prior
experience shows that the FDA review process might take too long-an average
of 5.3 years for radio pharmaceuticals- and be too costly--$25 to $50 million
or more-to pencil out economically. When a company decides to continue
the financial risk by submitting the drug for approval, there are still
many pitfalls. In particular, there seems to be excessive, ever-growing
requirements for proof of safety and efficacy.
In the past, once a drug was recommended for approval by the FDA's scientific
subcommittees, it quickly moved through the balance of the approval process.
Today, that is not true. More often that not, additional studies are
required. These studies extend the regulatory timeline, increase the cost,
and add an extra element of risk to an already-uncertain process that
can be financially devastating to the applicant. Astonishingly, the decision
to require additional studies is often made by people with no competence
in medicine. Is it therefore fair to wonder whether added safety is actually
gained, and if so, does it justify the higher regulatory costs imposed?
Let me offer a specific example of how a beneficial, safe technology
is being strangled by excessive reviews and arbitrary regulatory decisions.
PET, or Positron Emission Tomography, is a diagnostic technique that uses
radioactive tracers-generally glucose labeled with a short-lived radioisotope-to
image parts of the body. Many diseases like cancer, cardiovascular disease
and Alzheimer's can be seen with PET at their earliest stages. PET is a
remarkably accurate, cost-effective way to assess many types of cancer.
So what's the problem? Not only is approval of new and improved PET
drugs agonizingly slow, the FDA announced last October that compounding
the radio pharmaceuticals needed for PET in a local nuclear pharmacy will
become illegal as soon as the FDA nuclear pharmacy guidelines can be rewritten.
Because of the ultra-short radioactive half-lives of the isotopes used--half-lives
measured in just minutes--the radio pharmaceuticals required will become virtually
unavailable to most PET centers. Why? Because they cannot be prepared locally.
Local production of the radio pharmaceuticals needed for PET has been
going on for decades, without one single incident where anyone was harmed.
A perfect safety record. So what is the purpose of this measure? It will
deprive cancer patients of a technology that can tell you almost instantly
if cancer is present, and if so, what stage it is in and whether it has
metastisized to other organs of the body. I ask you to take a second to
imagine how you would feel if this illogical new rule denied timely diagnosis
and care to someone you love.
There's another government agency that also plays a major role in whether
clinically useful drugs are available--or not available-to patients.
That's HCFA, the Health Care Financing Administration. Although HCFA guidelines
apply primarily to Medicare patients, they are generally adopted by other
health care payers also. Consequently, HCFA rulings wind up affecting
a huge population of patients and health care providers.
Under a proposed HCFA rule, radiologists, radiation oncologists and
nuclear medicine physicians who practice in independent imaging and therapy
clinics are faced with a 24 percent reduction in reimbursement for certain
costs incurred in treating the patient. This can include medical supplies,
medical equipment, non-physician clinical labor, and other critical medical
care components. HCFA's rule, if adopted, will directly impact cancer patients
by reducing the quality and accessibility of important patient services.
Inevitably, many imaging and therapy centers will stop offering these
vital services if they can't cover their costs. Economics 101. For those
practices not forced out of business, the payment reductions will limit acquisition
of new, state-of-the-art technologies as they become available in the
future. As is too often the case, the real loser is the patient.
I can't tell you how to fix the problem. But it needs to be fixed.
Our nation needs a workable plan that puts patients' needs first. If
it requires congressional action, this would be a good year to bring it up,
with Social Security and Medicare reform on the agenda.
And while we're tackling reform, why not ask Congress, HCFA or the National
Institutes of Health to help ensure that so-called "experimental" treatments
and especially clinical trials are more broadly available and easily accessible
to patients? Today, a mere 2% of adult patients can choose to participate
in clinical trials. This is primarily because most health plans won't
cover them, and there is inadequate funding from other sources. That
slows down the process of bringing powerful new drugs to the marketplace-and
to patients who would benefit from them. We need to rethink the policies
that today limit patient access to clinical trials.
There are other impediments that limit or block research, and cancer
patients would like to see them removed. For instance, NACP vigorously
supports the humane use of animals in research, because they are a vital
link in the chain that brings forth new treatments. We support the continued
production of radioisotopes for use in research and in the diagnosis and
treatment of patients.
And that brings me to my next topic, a mundane but important issue.
As we all know, medical research generates wastes of various kinds. Disposing
of one type of waste-low-level radioactive waste-has become a huge problem,
and not because of any significant scientific or technical problem. The
problem is purely political. This has happened in spite of the national
policy adopted by Congress nearly 20 years ago. The Low-Level Radioactive
Waste Policy Act laid out the national plan for disposing of this waste,
and was adopted at the urging of three states (Washington, Nevada and
South Carolina) who were tired of shouldering all the responsibility. They
thought it was time for other states to do their share.
That's what the Policy Act did. It gave each state responsibility for
disposing of its own waste, and encouraged them to enter into Interstate
Compacts to deal with the waste regionally. The states responded by forming
nearly a dozen regional compacts, which were in turn ratified by Congress.
The idea was to develop several new disposal facilities to serve the
nation. It all looked good on paper, and expectations were high that the
new national policy would solve the problem.
Now, nearly 20 years later, not a single new site has been opened and
there are none on the horizon. Of the 12 compacts formed, only one, the
Southwestern Compact, has progressed to the point of licensing a site. That
site, in the Mojave Desert's Ward Valley, has been embroiled in a dispute
between California and the federal government since 1993. Meanwhile,
California's waste producers are storing waste in hundreds of urban locations
as they await a resolution. Two other compacts, the Texas Compact and
the Central Compact, recently had license applications rejected by state
regulators. All of the other Compacts have given up on the effort, for all
practical purposes.
In the meantime, what has happened to the three sites that existed when
all this began?
The Nevada disposal facility was permanently closed in 1990. Washington's
site accepts waste only from eleven western states producing about 5%
of the nation's waste. The Barnwell, South Carolina, site has been open
intermittently to waste from outside the Southeast Compact region since
1986. At the moment it is open, but newly-elected Governor Jim Hodges
says he intends to close the site to most other states just as soon as he
can.
Where does that leave medical researchers and pharmaceutical companies
in the 39 states outside the Northwest and Rocky Mountain regions-states
that produce more than 90% of the waste? On the outside looking in. Should
the Barnwell site close, as I believe it will, there will be no fully
licensed disposal facility available to accept all of the low-level waste
produced by medical uses in those states. That is of great concern to cancer
patients.
Most troubling is the fact that research has already been affected.
Some institutions are restricting or even forbidding research requiring
the use of radioactive materials. (What if that research project that wasn't
done would have produced a cure for cancer?) Other researchers are substituting
less effective non-radioactive techniques because of waste disposal concerns.
Research hospitals and universities have spent millions of dollars building
facilities to temporarily store waste until permanent facilities are available.
That's money better spent on research, patient care and education. Ironically,
money wasted on failed compact disposal site efforts could have paid for 150
new PET imaging centers, one at every major medical facility in the United
States.
Obviously, the Low-Level Waste Policy Act is not working as Congress
intended. We can't just pretend that everything is OK, because it isn't.
It is now time for the Clinton Administration, the Nuclear Regulatory Commission
and Congress to acknowledge the impasse and come up with a solution.
I've offered a few examples of government policies and regulatory actions
that I believe are detrimental to patients. Let me add just one more
before I finish. As many of you in this audience know, the Nuclear Regulatory
Commission is currently revising its regulations for medical uses of isotopes,
10 CFR Part 35. These proposed regulations will add significantly to
the cost of nuclear medicine-in the range of $500 million to $1 billion a
year. And remember, HCFA will not reimburse the regulatory costs associated
with nuclear medicine. Often, patients will have to pay themselves or
do without. And again, it is not at all clear that these new regulations
will add one iota of safety. Nuclear medicine has built an extraordinary
safety record under the current regulations, so I think it's fair to ask
why major changes are needed now. If the proposed changes enhanced patient
care, they might be worth the additional cost. Instead, we believe that
the higher regulatory costs will make nuclear medicine procedures less
accessible to patients while adding little or no benefit. Patient care will
decline.
OK, you say, enough carping and complaining. And I agree. It's time
for patients to take a more active role in shaping policies and regulations
that affect their own care. Cancer patients especially can't afford to wait
while others-politicians, regulators, animal rights activists and the
anti-nuclear lobby-set the agenda. We as individuals and as patient organizations
have got to get more involved-to make sure radionuclides continue to be produced-that
research and medical advances are not slowed by the lack of proper facilities
to dispose of low-level radioactive waste-to make sure that a valid cost-benefit
standard is applied to regulations that affect health care delivery-that federal
reimbursement policies do not penalize patients-and that an adequate share
of our national resources go to medical research, fairly allocated to
do the most good for the most people.
But patients can't do it alone. Speaking for the National Association
of Cancer Patients and the one in three Americans who will someday battle
cancer, we urgently need the support of people in the private sector who
share our goals, and those in government dedicated to development of
rational health care policies based on sound science and patient needs.
I hope we can count on your help.
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