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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