August 6, 2001
ABIOMED CEO Explains Information Policy For Initial Human Trial Of AbioCor
Replacement Heart
In advance of its Annual Meeting in Boston on August 8, 2001, ABIOMED, Inc.
(NASDAQ: ABMD) today released the text of a letter to the Company's
stakeholders from Dr. David M. Lederman, Chief Executive Officer.
Dear shareholders, employees, clinical partners and their patients:
A very important and perhaps historical medical event took place on July 2,
2001. A patient, in consultation with his wife and family, agreed to be part of the
first human trial of a revolutionary and potentially very important new medical
device - the AbioCor™ Implantable Replacement Heart. Because our
information policies for the clinical trial have been the subject of substantial
discussion in the media, including strong support but also some criticism, I
want to explain to you how we arrived at them and why we are committed to
them.
As founder of ABIOMED, Inc. and initial member of the technical team that
developed the AbioCor heart, I long ago made a commitment that our human
clinical trials would give very high priority to the interests and quality of life of
each patient. To accomplish that, we developed communications policies for
our clinical trials that put the patients first. We have been extremely pleased by
the initial patient's early experience, but we have been equally gratified that his
confidentiality has been maintained and that he and his family have been able
to live through this experience in dignity and relative peace.
The success of the AbioCor is not dependent on it being able to simply pump
blood. Rather, success will depend on the replacement heart's ability to allow
quality of life to continue even after the natural heart fails. In our view, quality of
life involves not only the medical status of the patient and the technical
performance of the replacement heart, but also the personal and spiritual
dignity of the patient. That is why we invested a great deal of time and resources
into deciding how to conduct the trials, and made those decisions with the
same care that we devoted to the replacement heart's technical capabilities.
Personal quality of life means living a full life with mental capacities intact and
free of pain or discomfort. It also means, among other things, that every action,
clinical development, personal detail and change in medical status - typically
the most private information for any person - is not broadcast in a play-by-play
manner reminiscent of a sporting event. For us, spiritual quality of life includes
being able to live in dignity and privacy without the public spotlight and
on-lookers gawking at every move. We are all looking forward to the day when
the patients and their families feel that they are ready and decide to share their
experience with the public at large.
ABIOMED did not just make up this notion of quality of life. For the past twenty
years we carefully studied the successes and failures of prior human clinical
studies of breakthrough devices. We consulted ethicists, physicians, and
government officials. Most of all, we spoke with patients facing end-of-life as a
result of heart failure.
The result was a set of patient protection measures and ethical guidelines that I
believe to be among the most thorough and effective ever implemented for a
medical device trial. We set up an Independent Patient Advocacy Council with
an irrevocable trust funded by ABIOMED for the duration of the initial clinical trial.
Members of the Council, who are experienced in counseling end-of-life patients,
are available to give patients and their families advice totally independent of the
interests of ABIOMED, the hospital, or the clinical team. In cooperation with our
clinical partners and consultants we developed detailed informed consent
documents that are as open, complete and understandable as we know how to
make them.
We prepared in advance to do all that was possible to insure that
communications and media relations were patient-centered, not
publicity-centered. Working with all of our participating clinical trial sites and
their surgical and medical teams before the trial began, we established ground
rules intended to guarantee the patient's complete anonymity and maximum
privacy. We also thought it was important to insulate the clinical teams, as well
as the many ABIOMED technical personnel providing onsite support to those
teams, from the distractions and turmoil attendant to close daily scrutiny. To this
end, we have resisted demands for daily or real time release of patient
information. Based on our constructive interaction with responsible local,
national and international journalists, I believe that our intentions have by and
large earned us the respect and cooperation of the media.
Some objectors have argued that our policies are wrong because "the public
has a right to know" about the patient and the progress of the clinical trial. It is
certainly true that the public, the larger medical community, and the media all
have an understandable interest in the replacement heart and the initial
patients, and ultimately a right to know about the clinical trial and the technology
being tested. But we absolutely reject the notion that any public purpose or right
is served by releasing information minute by minute, day to day, or even week to
week, in a manner that compromises the rights, the feelings, or the dignity of
the patient and the patient's family. No one has anything to gain by having this
information a day, a week, or even a month earlier. Public curiosity, and the
appeal of what is admittedly a fascinating human interest story, does not
constitute a right. It certainly cannot override the privacy right of the patient and
his family. Our policies, consistent with the obligations we have to the FDA,
other clinical sites, and the medical community, have in fact made plentiful
information available in a clear, reasonably timely and responsible manner.
We have also heard that our unwillingness to allow unfettered access to every
detail of the clinical trial on a real time basis will somehow compromise the
integrity of the trial. This is nonsense. ABIOMED has worked very closely with
the FDA, and our participating institutions and physicians to make sure that
information is accurately recorded, reviewed, and appropriately shared. The
research record and ultimately the public record is being maintained at the
highest level of integrity. Premature release of partial clinical information is
more a threat than a safeguard to research integrity. Our research methods,
records, and findings will be subject to the highest level of scrutiny by regulatory
agencies, institutional review boards, peer organizations, medical journals, and
individual researchers. We began the process of sharing detailed information
about the trial with the clinical community at the first AbioCor Grand Rounds
held in Boston on Saturday, July 28, and will continue to regularly share
information through such events, presentations at medical society meetings,
and peer reviewed publications.
Some have argued that funding from the National Heart, Lung and Blood
Institute (NHLBI) to ABIOMED for preclinical development of the AbioCor
replacement heart creates an obligation to give freer public access to real time
information about the clinical trial. ABIOMED has often acknowledged and
reiterates the critical role of NHLBI funding in allowing us to come as far as we
have. We are proud to be a party to what we think is a model for public-private
partnership in advanced medical technology development in the United States.
But again, our debt to federal funding does not create an obligation to provide
patient information on demand to the public. As recipients of federal contracts,
our obligations began and continue with our best effort to fulfill the terms of our
contracts and to accurately report on our progress and results to the funding
agency. The agency, in this case the NHLBI, is responsible for reporting the
results of its contracting activity to the Congress and to the public, and it has
done so through a variety of mechanisms. No one has any legitimate grounds
for complaint on this score.
Some have opined that our information policy is designed to protect ABIOMED's
financial interest, to control the dissemination and mitigate the effects of bad
news. This argument betrays a profound lack of understanding about how
ABIOMED approaches its fiduciary responsibility. As a public company,
ABIOMED does have a responsibility to act in the best interests of our
shareholders. In that regard, we work to become a profitable company and to
increase our shareholder value. In my view, continued growth of shareholder
value will be attained by successful patient-centered conduct and completion of
the AbioCor trial, gaining FDA approval to market the replacement heart, and
managing the company's existing business operations in an efficient and
effective manner. Our goals are best achieved by avoiding hype, by setting
reasonable expectations, and behaving in a scrupulously honest way. Anything
that lessens the integrity of the clinical trial diminishes our ability to achieve our
objectives. And in our calculus, the very worst thing we could do would be to
appear to try to hide a negative event.
Some of the decisions that we have made for the AbioCor clinical trial are
ethically complex and subject to debate and refinement. We have and continue
to welcome discussions concerning elements of our informed consent,
conflicting views about how to deal with the issue of advanced medical
directives, and the like. Frankly, I am disappointed that some academic
commentators have opted to air their criticisms in the media while declining
invitations to engage in a direct dialogue with us. We have had a few vocal
critics, particularly with regard to our news release policy, but the vast majority of
physicians and medical ethicists have been strongly supportive. Most important
for us, the patient and his family have been supportive and appreciative.
A patient should not have to sacrifice privacy and quality of life in order to be part
of a process that potentially gives them, and hopefully to tens of thousands of
others, extended quality of life. I am confident that by championing the patient's
interest we also champion the public interest and lay the strongest foundation
for our corporate success. This may be frustrating to some, but it is good public
policy, good business policy, and good personal policy.
As shareholders, we recognize that elements of this healthy public debate may
be confusing. And, we understand that you need to be, and should be, kept
informed of our progress in this important AbioCor initial clinical trial. We have
spent considerable time and effort preparing for this clinical trial. We are using
our experience to minimize trial delays and maximize probability of success. We
look forward to communicating with you on a timely basis as we reach
important milestones and other significant events in the clinical trial and urge
you to evaluate opinions on our progress based on what is in the overall
interest of the patients. By focussing on the patients in this trial, we help
ourselves succeed.
Sincerely,
David M. Lederman, Ph.D.
Chairman and Chief Executive Officer
abiomed.com |
