Originally Published MX January/February
2002
INDUSTRY ASSOCIATIONS
Industry Gets Prepared
AdvaMed's Preparedness Council seeks to streamline the delivery of healthcare technologies in response to major public health crises.
Pamela G. Bailey
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Pamela
G. Bailey is president of AdvaMed (Washington, DC), a trade association
for the medical technology industry.
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The terrorist attacks
of September 11 and the subsequent mail-borne attacks with anthrax caught America
and its public health system off guard. Many people simply never believed that
these kinds of atrocities could ever occur in America, so the necessary time,
energy, and resources were never invested. As a result, during those attacks
a wide array of problems surfaced which, if not corrected, could severely jeopardize
America's ability to effectively respond to and treat the victims of future
large-scale terrorist attacks.
Immediately following the attacks on the World Trade Center and the Pentagon,
AdvaMed (Washington, DC) conducted a survey of its member companies to determine
whether they had encountered any difficulties getting their products to New
York City and Washington, DC. The results underscore the importance of a collaborative
effort between industry and government officials to close several gaps in the
nation's ability to respond to major public health crises. Among the key
results of the survey were the following.
- More than half of the respondents (60%) experienced delays in shipping products following the September 11 attacks because of the lack of air transportation.
- More than a quarter of respondents (29%) experienced increased demand for specific products, including blood collection, processing, and testing supplies; wound-care products; and critical-care supplies.
- More than a third of respondents (39%) experienced business interruptions due to travel-related issues, employee-relations issues, and delays in delivery of products.
No one disputes
the notion that medical technologies are an important element of a strong defense
against terrorism. As industry knows, however, hospitals typically stock medical
technologies and supplies on a just-in-time basis, leaving them only enough
to meet the needs of the first 24 hours of an emergency. Such medical centers
rely on manufacturers and regional distribution centers to quickly replenish
their stocks when needed.
The unprecedented grounding of all U.S. commercial aircraft on September 11
raised many issues about the availability of rapid transportation for critical
medical supplies. No contingency plan or point of contact existed for coordinating
the movement of large quantities of such medical technologies and supplies to
hospitals in affected areas when the main transportation arteries were severed.
Many of America's medical technology companies had to go to extraordinary
lengths to ship their crucial products, such as bioengineered skin for burn
victims, to New York City and Washington. Tragically, it turned out that there
were few victims to treat, so the emergency rooms never had to face life-threatening
supply shortages.
Untangling the
Web
Improving the nation's ability to respond to large-scale terrorist attacks
has quickly become one of the top priorities of health officials, Congress,
and the Bush administration. In the week following the attacks, Department of
Health and Human Services (HHS) Secretary Tommy Thompson called together a group
of chief executives from the nation's leading health industry trade associations,
including AdvaMed. In the discussions that followed, it was clear that he recognized
the need to work with the various sectors of the health industry to adequately
prepare America for future threats and emergencies.
To help organize and coordinate the roles of the medical technology industry
in this effort, AdvaMed has formed a Medical Technology Preparedness Council,
which includes more than 50 representatives from member companies with expertise
in a range of scientific, technological, and product-distribution issues. Soon
after its formation, this group of industry leaders and AdvaMed staff began
meeting with key government officials and health organizations to identify critical
technology needs and potential problems that could hamper the distribution of
medical products to physicians and public health officials.
What the council has uncovered so far is a morass of local, state, and federal
government agencies and offices with intermingled responsibilities. Emergency
management in the United States is primarily a function of state and local authorities
that work in concert with various national and international support organizations.
Federal resources are provided to train, coordinate, and offer guidance to state
and local entities to develop emergency preparedness programs. However, supplemental
federal resources, including medical supplies, are immediately mobilized once
a federal disaster has been declared.
The Federal Emergency Management Agency (FEMA) is the primary federal agency
for coordinating emergency responses. FEMA coordinates the activities of 27
different federal response plan partners across the federal government.
Emergency medical care issues are delegated to the HHS Office of Emergency Preparedness
(OEP). OEP coordinates the National Disaster Medical System, an effort that
includes FEMA, the Department of Defense, the Veterans Administration, and a
range of nonfederal sources, including drug companies, hospital supply vendors,
and the American Red Cross.
Such a web of interrelated programs and agencies can be confusing to companies
with vital technologies to offer but little or no experience in government procurement
methods, stockpiles, or regulations. Ultimately, this confusion could hamper
the ability of such companies to provide potentially lifesaving products in
a time of need. Hence, one of the council's main functions will be to serve
a coordination role with the nation's medical disaster preparedness agencies.
The council will also serve as a liaison between medical technology companies
and public health agencies, helping to resolve supply-chain and logistical problems
that affect companies' ability to respond to emergencies with mass casualties.
Combating Bioterrorism
Another area where medical technology companies will play a major role is in
the fight against bioterrorism. In its recent survey of medical technology companies
in the United States, AdvaMed found that many are developing technologies that
could improve the nation's readiness against terrorist acts. These include
rapid tests for anthrax and smallpox, more-effective vaccine delivery systems,
and health information systems to improve surveillance. As public health officials
identify specific threats, the preparedness council will offer a valuable link
to companies that can potentially develop technologies to address them.
The group has already had some success in this area. Soon after anthrax-laden
letters started appearing in the mail, officials from FDA turned to the council
to locate companies that might be developing rapid tests for anthrax. Within
a very short time, the council identified the partnership between Roche Diagnostics
(Indianapolis) and the Mayo Clinic (Rochester, NY) on such a test and facilitated
initial contact between the researchers and the agency.
Innovative gene amplification tests like Roche's have the potential to
detect anthrax in humans in a few hours, rather than the few days required by
the blood-culture tests currently in use. Using the company's LightCycler
technology, the test would enable physicians to diagnose patients by quickly
amplifying a DNA sample and scanning it for anthrax bacteria. Other testing
platforms such as those based on flow cytometry and antibody detection also
show promise in speeding the detection of bioterrorism agents. In turn, quicker
diagnosis of an anthrax infection would make it possible to start the patient
on appropriate treatment regimens earlier, when full recovery is more probable.
FDA and Roche are now discussing the steps necessary to expedite review of the
diagnostic test and make it available to laboratories across the country. This
interaction between the preparedness council, FDA, and Roche is serving a critical
public health need because rapid detection of diseases caused by bioterrorism
represents the nation's first, crucial line of defense. The council is
also working to ensure that FDA has the policy mechanisms and resources needed
to give priority premarket review to new technologies such as this that can
help minimize the effects of bioterrorism.
The situation with anthrax illustrates why availability of rapid tests for these
agents is critically important. First, they can provide an earlier warning of
an outbreak. Second, they can help ensure that healthcare facilities are not
overwhelmed by the "worried well" and that critical medical interventions
such as prophylactic treatment with antibiotics are directed only to those who
have been exposed to the disease.
However, the ability to rapidly diagnose infection by a bioterrorism agent will
be of limited value if this information cannot be centrally analyzed and broadly
disseminated to public health providers and officials. The current paper-based
system for reporting suspicious symptoms or confirmed infections leaves plenty
of opportunity for errors and delays.
In November, Homeland Security Director Tom Ridge outlined his plans to build
a data network linking federal, state, and local health officials. By using
advanced information technologies already in existence, public health officials
could monitor data in real time from region to region or nationwide. Such technologies
could play a key role in helping officials quickly design and implement effective
treatment and containment measures. Ridge anticipates that funding for the new
system, which would be run by HHS, will be included in the Bush administration's
fiscal year 2003 budget.
The preparedness council has already identified and contacted several companies
that make such advanced health information systems. It is also working to meet
with officials in Ridge's office and HHS to see how AdvaMed member companies
can assist in developing this network that could ultimately play a crucial role
in how effectively the nation can stop or prevent disease outbreaks caused by
bioterrorism.
Detection and surveillance are just two facets involved in effectively containing
a bioterrorism attack. Attention must also be paid to our ability to implement
effective countermeasures. One problem confronting health officials is how to
contain a large-scale smallpox attack when only a limited supply of vaccine
is available and production of adequate doses to treat the entire U.S. population
is nearly a year away. The federal government is looking to spend more than
$400 million to produce enough doses of smallpox vaccine to inoculate more than
270 million people; however, it is important that health officials also consider
ways to stretch the current supply. The National Institutes of Health have been
actively studying the effectiveness of diluted vaccine, and medical technology
companies such as BD (Franklin Lakes, NJ) are developing breakthrough systems
for vaccine delivery. Several of these technologies could ultimately reduce
the amount of vaccine needed for an effective dose—making dilution unnecessary
and potentially stretching the nation's stockpile of smallpox vaccine to
cover more people.
Such innovative technologies in the areas of detection, surveillance, and prevention
are just a sample of what America's medical technology industry can contribute
to the war on bioterrorism. AdvaMed's preparedness council is actively polling
the association's membership and working closely with leaders in the government
and healthcare community to identify other research and development priorities.
It also seeks to foster an environment that supports rapid research and development
of new technologies for the fight against terrorism, which could include federal
R&D funding. On the preparedness council section of AdvaMed's Web site (http://www.advamed.org),
members can locate information on how to obtain research and development grants
from various government agencies, such as the Department of Defense. In addition,
AdvaMed plans to hold an educational seminar on the subject at its annual meeting
in Carlsbad, CA, March 3–6, 2002.
Executive Leadership
For a preparedness council to be effective, it is imperative to have a breadth
of knowledge at its disposal. We sought to bring together a group of senior
executives from across the industry—with expertise in technology development,
product distribution, and government regulation—to lead the group. I am
proud to say that the response to our recruitment efforts was overwhelming,
and we assembled an all-star team of council directors.
The current chairman of AdvaMed's board of directors and CEO of C. R. Bard
Inc. (Murray Hill, NJ), William H. Longfield, enthusiastically volunteered to
chair the effort. Other directors of the preparedness council are as follows.
- Richard A. Gonzalez, executive vice president, medical products, Abbott Laboratories.
- Ronald K. Labrum, group president, Allegiance Corp.
- Dennis N. Longstreet, group chairman, Johnson & Johnson.
- Edward J. Ludwig, president and CEO, BD.
- Richard J. Meelia, president and CEO, Tyco Healthcare Group.
The preparedness council also named the former director of FDA's Office of Device Evaluation, Susan Alpert, MD, PhD, to serve as its medical adviser. Alpert is currently vice president for regulatory sciences at C. R. Bard. With more than 30 years of medical and government regulatory experience (13 years spent at FDA), she will provide the council with dual perspectives of a physician and a government official when tackling issues to improve the readiness of the nation's public health system.
Getting Involved
Over the coming months, the preparedness council will seek to grow as it identifies
more issues or areas where its experience and input can help shore up the nation's
ability to respond to national emergencies. It has already formed three working
groups, consisting of mid- to senior-level company executives, that are making
progress on product development, supply-chain and logistics issues, and outreach
and coalition building.
The preparedness council offers an opportunity for medical technology executives
to get involved in this important effort to improve America's public health
system. For more information on the group, visit AdvaMed's Web site at
http://www.advamed.org/publicdocs/med-tech-preparedness.html.
Copyright ©2002 MX
