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Opinions on Senior Issues
New Drugs: The Choice We Face
'The real problem with drug development is not the
loudly proclaimed drug safety but the growing shortage of newer, more
effective medicines'
By Robert Goldberg
 June 5, 2006 - More and more Americans suffer from
Alzheimer’s disease either as victims or caregivers. So when a vaccine
was developed that may actually reverse this terrible, degenerative
process, you would think it would be welcomed and fast-tracked through
the federal bureaucracy.
Think again. FDA reviewers abruptly called a
complete halt to the study – and delayed development for two whole years
– because about 4 percent of those in the safety study contracted
encephalitis, a very treatable disease.
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Opinions on Senior Issues |
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Clearly, the FDA review system has become far too
bureaucratic. But don't look for a quick reversal of such bizarre
rulings. Policymakers seem intent on making the FDA approval path
increasingly labyrinthine.
The General Accounting Office just released a
report that reads like a battle plan to expand the regulatory reach of
the FDA. Worst of all, politics – not science or suffering – is playing
the lead role in this controversy. Requested by Senator Charles Grassley
(R-Iowa), the GAO review suggests creating yet another level of control
– an independent Drug Safety Board that could intervene and demand
additional safety studies of any size and quantity at virtually any time
before -- or after -- approval.
Federal regulators would be given virtually
unlimited power to dictate terms of development in a wondrous and
rapidly evolving field of knowledge. Certainly, this would make the
approval process far less efficient, and limit a patient’s access to new
life-saving developments. But would it at least improve drug safety?
Unfortunately, the answer is no.
It’s simply not true that more studies make safer
medicines. Over the past 40 years, the percent of medicines withdrawn
from the market because of dangerous side effects has been essentially
constant at about 2-3 percent, even as the number of required clinical
studies – an average of 120 per drug approval – has mushroomed.
In fact, improper use of otherwise safe medicines
remains the problem. Common over-the-counter painkillers such as
aspirin and ibuprofen cause thousands of hospitalizations and hundreds
of deaths each year.
With more advanced drugs, consider the now
notorious Vioxx. Sen. Grassley’s approach would have required studies
involving 250,000 people running several years and costing billions.
There’s also an additional cost of all the people who cannot access the
drug. The millions who benefit would have no voice.
Even the FDA is aware of the problem. The Agency
has undertaken a Critical Path Inititiative because, despite the
explosion in potential new targets for treating serious illnesses, fewer
new medicines are being approved than ever before. What’s more, the
number of drugs being withdrawn from development before they reach the
market has increased under current methodologies.
Remedies are available. For instance, the use of
biomarkers (a biological measure of response to a drug or disease
progress) with links to health outcomes could shave years and billions
of dollars off drug development. What’s more, drugs developed with newer
methods are demonstrably safer. Plus, the new science produces medicines
which are more personalized and better targeted to genetic profiles.
Such thinking is at the heart of the FDA’s Critical Path Initiative. But
it’s nowhere to be found in Grassley’s proposals or the GAO report.
Innovations like biomarkers and Critical Path
require cooperation between regulators and the drug industry. But
politicians and self-styled public advocates continue to demonize the
drug industry and accuse the FDA of being too “cozy” with those it
regulates. But introducing new science is impossible without significant
collaboration between the public sector and drug companies.
Together, the FDA and industry have the resources
at hand to build a “toolkit” to speed research and development. Such a
toolkit includes genetic tests that can be used at the very beginning of
a product’s development as well as while the drug is on the market to
predict and monitor both effectiveness and potential safety problems.
Today’s newest computer models and imaging tools
can predict not only the onset of illnesses such as Alzheimer’s but
which drugs will work best for which patients. Such information can be
captured with no invasion of privacy using the electronic records of
existing patients or from other health information technology platforms
such as those being developed by Kaiser Permanente. The result can be
medicines which come on line faster, are safer and better targeted to
individual patient situations.
The real problem with drug development is not the
loudly proclaimed drug safety but the growing shortage of newer, more
effective medicines that can treat or prevent the most costly and
devastating diseases. Without them, the human and economic costs of
illness will continue to rise.
Congress has a choice: support initiatives like
Critical Path and biomarkers to ensure that America enters a new era of
more predictive and preventative medicine. Or endorse the GAO approach
and tie biomedical innovation up in the restraints of outdated methods
for generations to come. Sufferers of diseases like Alzheimer’s deserve
better.
About The
Center for Medicine in the Public Interest
The mission of the Center for Medicine
in the Public Interest (CMPI) is to discuss, debate, and demonstrate how
exponential and accelerating technological progress coupled with smart
public policy will enhance and advance 21st century health care by
predicting, preventing, diagnosing, treating and disease with greater
speed, more precision, and less cost. The Center is a non-partisan,
non-profit educational charity.
The centerpiece of the CMPI is a drug
policy web log –
www.drugwonks.com.
>> Primary Website –
click here.
About Robert
Goldberg
Dr. Goldberg is co-founder, Vice
President and Director of Programs for Center for Medicine in the Public
Interest. Prior to founding CMPI, he was senior fellow at the Manhattan
Institute working on research and activities surrounding health care
issues. Dr. Goldberg's current research interests include the impact of
price controls on biopharmaceutical innovation, FDA reform, the future
impact of medical progress and new medical technologies, the enemies of
medical innovation, and the impact of government regulation on health
care quality.
Dr. Goldberg is the author of numerous
articles and reports including "Vaccinating Against Disaster," "False
Economy on Drugs," "Importation Nightmare," and "Fight AIDS With Reason,
Not Rhetoric." He has testified before the Senate Special Committee on
Aging, the Senate Small Business Committee, and the House Commerce
Committee. He has written for The Wall Street Journal, The Washington
Post, the Los Angeles Times, National Review Online, and The Weekly
Standard, and he writes regularly for The Washington Times.
He received his Ph.D. in politics at
Brandeis University in 1984.
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