X-Message-Number: 33391
From:
Date: Mon, 28 Feb 2011 03:05:05 EST
Subject: Melody Maxim's Distorted Reality 24
Content-Language: en
Regulation is extremely costly in both time and money and most nascent
enterprises cannot sustain the burden. In fact, not only can they not bear the
burden, they usually cannot even qualify to do business in the first
place. A concrete example is in order here. In the US prior to ~1970 if you
were
an entrepreneur-scientist with an idea for a new drug or medical device
you simply gathered the necessary capital, leased a small industrial bay and
set to work. You paid your city business license fee and your taxes and
that was pretty much the extent of your regulatory burden. You could typically
subdivide your leased space without permitting as long as you did not put
up load bearing walls and followed common sense safety measures such as
having easy access to exits in the event of a fire.
Today, by contrast, you would first need to get a conditional use permit
(CUP) if you are working with animals at a typical cost of ~$40,000. You
would need a United States Department of Agriculture (USDA) animal research
facility license. What comes with that license is a requirement to comply with
a vast body of regulation, much of it unwritten and which consumes
thousands of hours and tens or hundreds of thousands of dollars to comply with.
As one small example, every aspect of animal care and of the biomedical
procedures to be used by a research laboratory in the West must be documented
by a written standard operating procedure (best practices in the UK &
Europe). In practice, this means you must have an SOP for how the can opener
and food handling utensils will be cleaned and cared for. You will need three
sinks in order to clean-up food handling equipment (soapy wash, chlorine
disinfection, hot water rinse). You will be required to document refrigerator
temperatures, dry food storage conditions (temperature, humidity,
precautions against vermin, expiry, etc.) and just about every other imaginable
aspect of the facilitys environment and maintenance. There are minute
requirements for animal housing including the number of air changes per hour,
the
amount and cycle of lighting, the square footage of space available to each
animal, the nature and condition of all animal contact surfaces, the
temperature and relative humidity... I could go on for pages.
Additionally, you will be subject to (at least) quarterly local fire
inspections with an ever growing list of safety requirements; you must keep
updated facility maps documenting where your hazardous materials (hazmats) are
stored and a continually updated roster of all hazmats along with the
current material safety data sheets (MSDSs) on every chemical (including
household cleaners and typewriter correction fluid) you have in-house. You must
have a written evacuation plan with drawn to-scale maps of your operation, and
if you have any significant quantity of inflammable liquids you may be
required to be in a fire-sprinklered building. You must also have costly
contracts with state-certified haulers/disposers of both environmentally
hazardous and biohazardous wastes; and what constitutes a hazmat or biohazard
now
includes almost all waste generated from any laboratory or surgical
procedure.
You must also have an Institutional Animal Care and Use Committee (IACUC)
that must be appointed by the Chief Executive Officer and consist of at
least five members; including a veterinarian with program responsibility, a
practicing scientist, an individual whose expertise is in a non-scientific
area and an individual who is not affiliated with the institution. This
Committee must use the Guide for the Care and Use of Laboratory Animals
prepared
by the Institute of Laboratory Animal Resources, National Academy of
Sciences. to review the animal facilities and the institutional program for
humane care and use of animals at least once every six months and prepare
reports of these evaluations for the responsible institutional official. The
Committee must review and approve animal-related components of proposals and
significant modifications made in ongoing activities involving the care and
use of animals. The Committee is responsible for reviewing concerns
involving the care and use of animals and making recommendations to the
Institutional Official regarding any aspect of the animal program, the
facilities, or
the personnel training. The Committee is also authorized to suspend
activity involving the care and use of animals as set forth in the public
health
service policy... again, I could go on for many pages listing the various
regulatory requirements and the associated costs.
The vast majority of these regulations make sense and almost all of them
have come about because of stupidity, negligence and abuse. Nevertheless,
they are incredibly costly and they serve to effectively exclude the most
innovative , revolutionary and paradigm changing enterprises from gaining a
foothold and proving themselves (or failing) as the case may be.
By contrast, if you want to start a small computer or software business,
such as Apple or Microsoft, you can do so in your garage or spare bedroom
and you will be almost completely free from regulation until you reach a size
that is sufficient to bring you to the attention of the authorities. A
consequence of this disparity in regulatory burden and associated start-up
costs is that technological progress in software, computing and consumer
electronics is lighting fast compared to progress in biomedicine.
Why the disparity in regulation? The answer is that regulation (in a
largely non-corrupt society) occurs first and most aggressively when one or
more
of the following conditions pertain to the enterprise or its products or
services:
1) They have the potential to cause serious, lasting or irreversible
physical and/or psychological injury or death.
2) They offend or disrupt social norms, morals or accepted ethical
practices of society.
3) They alter the sensorium, impair judgment or performance, or are
addictive or can result in severe habituation (i.e., gambling and psychoactive
drugs, including alcohol).
4) There is a large, difficult to address disparity in the quantity and
quality of critical information necessary to make an informed decision
between the consumer and the vendor (favoring the enterprise) with the potential
for serious and lasting economic (or other) harm to the consumer as a
result.
5) The enterprise generates goods or services which could be used to
threaten national security or to facilitate terrorist attacks.
Without question, biomedical enterprises qualify for regulatory oversight
on the basis of 1, 2 and 4 above. If you buy a program or an MP3 player
that is unsatisfactory, or doesn't work, the loss you have suffered is
confined to the time, money and frustration involved. You can remedy the loss by
buying an iPod or another software package. If you are blinded in an eye
during routine cataract surgery, or lose your life because of a badly designed
or manufactured drug or medical device, you cannot replace those
commodities at any price; these are (currently) irreversible losses.
Birth control, assisted reproduction, abortion, organ transplantation, and
resuscitation and critical care medicine are all examples of the potential
of biomedical innovations that cause social disruption and change the
bedrock functioning, and ultimately the values, norms and morals of a
civilization. Control over reproduction radically altered the role of women in
society and critical care medicine is forcing a redefinition of the how, when,
where and why of death.
Along with real estate and high finance, biomedicine suffers from an
imbalance of the critical information required for good decision making
available to the provider, as opposed to the consumer. For instance, it is
almost
impossible for a patient know all the facts necessary for him to make a
truly informed decision about most prescribed drugs and medical procedures few
people who regularly take non-steroidal anti-inflammatory drugs (NSAIDs)
such as aspirin, ibuprofen, and naproxen are aware that ~50,000 people in the
US die each year from complications arising from NSAD use roughly the
number of people killed in motor vehicle accidents annually in the US!
Physicians face the same problem when dealing with large pharmaceutical
companies as the recent Vioxx (a new type of NSAID) debacle demonstrated. It
is difficult, and indeed arguably impossible, for the physician to have the
same volume and quality of information about a drug that its developer and
marketer has. This is not an uncommon phenomenon and examples of drugs
where there are such information gaps as of this writing are the
psychotherapeutic drug Zyprexa (Lilly), the oral anti-diabetic drug Avandia
(GlaxoSmithKline) and the cholesterol lowering drug Zetia (Merck and
Schering-Plough).
In all three of these cases the drugs either do not perform as advertised,
and as most physicians expect (Avandia and Zetia), or they have serious and
potentially lethal side effects which are not adequately appreciated by
most clinicians prescribing the drug (Zyprexa).
Complex and long term financial instruments, as well as most consumer real
estate transactions, suffer from some of the same problems. Most people
buy a home only once or twice in a lifetime and are thus unfamiliar with the
complexities and contingencies involved. Certainly, they are nowhere near as
familiar with these issues as are the realtors who handle the
transactions. Complex or long-term investments of a critical and typically
irreplaceable nature such as retirement and pension funds are also susceptible
to
exploitation and fraud in part because of the inherent imbalance in the quality
and quantity of information available to the consumer versus that which the
seller necessarily possesses and all too often fails to disclose.
For these reasons society has chosen to regulate these enterprises. The
costs of failure, whether due to incompetence, negligence or malfeasance are
deemed to be too high either to the individual or to the society as a whole.
One thing that should be immediately apparent when considering all the
examples given above is that regulation is driven largely by actual adverse
consequences associated with the regulated enterprise. In other words, there
are injured parties whose losses are evident and who, not infrequently, will
be agitating for regulatory control. The mutilated or incapacitated
patient testifying in the courtroom or before a legislative body is not just a
clichAC of cinema, it is a potent force enabling and driving regulation in
biomedicine. Animal rights activists pressing to effectively ban most animal
research use harrowing images and stories to evoke similar empathy and to
emphasize the irreversible physical and emotional harm done by biomedical
research employing animals.
How does cryonics fit into this picture? The answers to this question turn
out to be both subtle and complex in large measure because cryonics is
fundamentally different from most other enterprises that deal with health and
wealth and life and death.
Without question, cryonics has the potential to impact the following
entities in the following ways. First, if it becomes possible to recover
individuals cryopreserved with today's technology there is the obvious
potential
for harm to the patient ranging from loss of memory or alteration in
personality or mentation to loss of life (i.e., inability to be resuscitated)
due
to improper cryopreservation. Next, there is the psychological and financial
impact of the procedure on the survivors. The closure associated with
death may be clouded or completely compromised. Additionally, any perceived
malpractice or misconduct may cause lasting distress in those survivors who
are also cryonicists, or who have a strong emotional investment in the
patient getting the quality of care he wanted and paid for.
Assets that would usually pass to survivors may be used for
cryopreservation; in some cases depriving dependents of financial security or
advanced
education. The aesthetic and perceived religious and moral implications of
the procedure may cause distress in survivors and lead to psychological
turmoil and possibly lasting harm.
The impact of cryonics, was it to become a widespread practice, on society
as a whole, and in particular on social norms, morals or accepted ethical
practices as well as on its financial and cultural institutions, is so vast
as to be inestimable. Inheritance, the pattern and structure of long-term
investment, religion, reproduction, marriage, critical care and end of life
medicine, mortuary practices, and almost every other cornerstone
institution of contemporary society would be deeply impacted by the widespread
adoption of cryonics.
The problem with the analysis above is that in most instances, the crucial
qualifier if applies. If and not when: if cryopatients can be revived and
if cryonics becomes a widespread practice... A deeper (but intimately
related) problem is that society cannot have it both ways. When George writes on
CF that, Unfortunately, CI is not being regulated as a cryo provider, but
only as a cemetery he hits the nail squarely on the head. Given that the
contemporary biomedical and legal classification of cryopatients is as dead
bodies what other regulatory framework does the state have at hand? Since it
is apparent that many cryonicists with a history of long involvement as
both clients and activists have been unable to agree on what, if any,
self-imposed regulation should exist, how would the state or its bureaucrats
even
know where to begin? What kinds of regulations and accompanying penalties
should be put in place? How much such regulation will cost both directly and
indirectly, and who will pay for it?
If, under the law and by common consent and understanding, cryonics
patients are simply dead bodies, then it is not possible to address the issues
which have been the focus of so much discussion and angst here on CF. Air
embolization, long delays to initiation of care with consequent ischemic
injury, inadequate cryoprotection and incompetent personnel become moot points.
The state will necessarily be concerned with issues that are tangible and
that threaten the wellbeing of its citizens in fairly direct and perceptible
ways. And, above all, the state will, of equal necessity, mostly concern
itself where there are aggrieved parties with clear and unequivocal losses
bringing pressure to bear for regulatory oversight.
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