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|It's Not What, But How You Say It.||George Smith|
|Competitive Advertising||Robert Ettinger|
|Choice and the British National Health Service||Andrew Stephens|
|57th Update of My Fly Longevity Experiments||Douglas Skrecky|
|St John's Wort||American Botanical Council|
|Survival Calculations||Charles Platt|
|European Parliament Debates A Directive to Restrict Sales of Vitamins and Supplements|
|Cooling and Coroners||Mike Darwin|
Contents are provided for information only, under the right to free speech. Opinions are the authors' own. No professional advice is intended. If you wish others to be legally responsible for your health, life or finances, then please consult a professional regulated according to the laws of your country.
Volume 15 no 89. First published May 2002. ISSN 0964-5659.
It's Not What, But How You Say It.
George Smith < email@example.com >
Many years ago an aged healer with a wide reputation for success was approached by a young man who asked if he could apprentice and learn from the Old Sage.
"Since you have climbed this mountain and come to me with letters from your elders who attest to your character, you are welcome to study my methods," the Old Sage explained to his new Young Apprentice.
Later that same day, a man with a shaking palsy made his way up the long mountain trail to the small hut of the Old Sage. Looking at the approaching patient, the Old Sage said softly, "He needs to eat more green vegetables." When the patient finally arrived, the Old Sage spoke to him, placing his hand upon the shaking shoulder of the man.
"You have come such a long way and struggled so hard with this terrible ailment. I am so sorry you had to climb all this way to see me and it is clear that you are very determined to succeed in making a change in your life so that this ailment can be ended once and for all. Is that not so, my friend?"
And the shaking patient agreed and begged the Old Sage for help. "For many this ailment is a permanent curse and for them there is no hope. But for you there remains one possible escape from its clutches. It seems simple but is always effective for those few, like yourself, who can actually do it. Shall I explain it to you now or after you have rested awhile from your journey?"
"Tell me now!" the man gasped.
"If you from this day forward always eat at least one heaping bowl of green vegetables, your palsy will lift and you will see a cure. However, you must do this daily and not miss even one day, or this last slim chance for success will fail forever. I realize it seems a simple thing, but it is vital for you to do this with complete consistency or nothing else will save you. And I must also apologize for I have no green vegetables to offer you here atop my mountain to begin your treatment. Perhaps you will rest the night and return to your home in the morning."
"NO!" the man shouted. I will go immediately and eat many green vegetables at home this day!"
And so saying, the shaking man hobbled back down the trail to his village. The Young Apprentice asked the Old Sage how often this condition was cured by this diet and the Old Sage replied, "Every time without exception and usually within a day or two at the most. It is really quite simple to cure"
Later that week the Young Apprentice saw another man, shaking like the first, making his way up the mountain trail to see them. When the new patient arrived he said to the Old Sage, "I have shaken like this for ten years. Can you help me?"
The Young Apprentice blurted out, "Just eat more vegetables!"
The shaking man looked at the young man and started viciously beating him over the head with this walking staff.
"You idiot! Do you think that something that has plagued me day and night for ten years can be cured by eating a stupid salad!"
And the man abruptly turned his back and made his way back down the trail muttering to himself, still shaking like a leaf.
The Old Sage then pressed a cloth to the Young Apprentice's bleading forehead where he still lay on the ground, stunned by the attack, and said, "Sometimes it is not so much what you say but how you say it that is important."
The moral of this story?
Well, I know that almost all who read these words have struggled long and hard with the problems of cryonics - whether just trying to determine if it makes sense to pursue themselves or to interpret and perform research that may someday lead to the success of this noble effort.
And when we read things others write and these ideas seem to not agree with what we have learned and believe to probably be true through long study and effort, we feel betrayed, shook up.
But to truly succeed in learning what others may be thinking and attempting to do, and to pull together with others to strengthen this effort we call cryonics, there is a simple way to overcome the resistance we find to others accepting our viewpoints.
We need to consume what suggestions are useful and then see if the other person offering these suggestions is then more open to our questions.
Then we will not feel shook up when our ideas are rejected because we have attacked the intentions of the author rather than simply looking at the ideas expressed.
Brussel sprouts anyone?
by Robert Ettinger < firstname.lastname@example.org >
Forward by John de Rivaz:
In most commercial endeavours, competitive advertising can be helpful to the consumers, and certainly does no harm to the class of product being advertised. That is to say, people are not put off buying computers because one vendor points out disadvantages in a competitor's product. But cryonics has an unusual characteristics. Advertising pointing out shortcomings in a competitor may not just put the consumer off that competitor's service, but the whole concept of cryonics. On the basis that cryonics could work, then such practises deprive that consumer of a very large portion of his life. Unfortunately legislation prohibits any formal or even informal agreement, but those who promote cryonics organisations need to be aware of the dangers of competitive advertising not just to the opposition, but to themselves and their potential members. This article is presented under the right to free speech and is not to be considered an invitation to enter into any illegal conspiracy.
We could simply avoid comparisons completely. Never say "they are not as good" or "we are better," or even "we are bigger (or older or whatever)." Just say what you have and what you do (and how and why to the extent you wish), provide links to the other guys, and leave it at that.
Obviously this won't work perfectly. There will always be someone at another organisation who will say privately to newcomers that CI's Digger O'Dell operates with a rusty razor blade and uses a pump still contaminated with formaldehyde; and possibly someone (not me) at CI who will whisper little-known scandals about other groups to the potential recruits. But maybe it would help.
Yes, details can become bothersome. When we are asked why prices differ, there is a great temptation, and there might almost seem a duty, to tell it each from his own point of view. But the only real duty is to make sure the facts are available, and the temptation can be resisted. When someone asks us to make comparisons, or explain price differences, we can just say: "We prefer to let the facts, and the organizations, speak for themselves. Read our material and read theirs. Ask them and ask us to explain anything that isn't clear--but don't ask any of us to express opinions about the other people or their decisions. Obviously, each organization thinks it has something special to offer, and has made the best choices for its members and patients, but every newcomer must make up his own mind. And remember, it's not impossible to change your mind later--but it's impossible to make any choice after you're dead."
I can't quantify the likely benefits, but I think they will appear. Clearly, some potential recruits have been turned off by competitive sniping, official and unofficial--the "pox on both your houses" syndrome. Equally clearly, competitive advantages are likely to shift back and forth from time to time, and if too much effort and money are spent on jockeying for position, they will not be available for the real work of building the movement.
Some people like to focus on the business model and capitalism. But you don't have to be a communist to realize that some aspects of business competition are counterproductive, and even in a capitalist society there are non-capitalist institutions, e.g. the family and the church and the fraternal organizations, to name a few, and for the most part they don't find it necessary to compete with each other. Most cryonics groups are non-profit organizations that do not exist for the benefit of shareholders or management or labour or even society as a whole, but strictly for the benefit of their patients and future patients.
Some Catholics think that unbelievers are damned and doomed, but still they generally don't knock other religions or denominations. I think we also can benefit by collegiality.
Perhaps there are those in groups which charge higher prices who think that, to gain members in the face of the price difference, they are compelled to stress its alleged technical superiority. But that only leads to a shouting contest or a debating contest, and in the end the recruit will still have to look at the details and form an opinion. Better just to provide the facts in the first place, without presuming to tell the recruit how he should interpret them.
None of this rules out home-team enthusiasm. Members can still say, "Our people and our program are great!" -without saying, "We are better." You can convey competence and enthusiasm and so on without invidious comparisons. I might add, however, that even "enthusiasm" might not strike the right note. We are not selling fun and games, at least in the short run--just an unprecedented chance to live. We want to be seen primarily as sober and responsible, and anything with the taint of hype should be avoided.
Maybe the future of cryonics belongs to Frigidaire or Suspended Animation Inc. or whatever. Maybe after a while all of us unwillingly thrust into leadership of the present organizations can breathe a sigh of relief as our organizations are absorbed. On the other hand, maybe we will continue to think our own nonprofit organizations are safer and better for our patients and prospective patients, and maybe we will need collective strength to compete or to have an effect on public policy. After all, the time will come when Social Security and Medicare become issues related to cryonics.
Choice and the British National Health Service
by Andrew Stephens BVetMed MRCVS < email@example.com >
Choice is important - sadly it's not part of the current NHS 'ethos/style' which harks back to another 'age' in so many ways - as someone said the NHS is in many ways a last remnant of Soviet style institutions, where the 'clientele' is expected to be at the beck and call of the institution and to be humbly grateful for whatever level of service the institution deigns to provide however poor that might be. I'm not quite (born in 1948) old enough to remember/know quite how poor medical and dental services were for so many people prior to the foundation of the NHS - but from what little I do know it appears that many were indeed extremely grateful for what then seemed to them to be wonderful services provided free on the NHS.
Sadly it would always ultimately be the case that the demand for services - and advances in medical technology lead to increased expectations and demands - would always outstrip supply and exhaust any budgetary provision. As a society we are reluctant to address the issues that arise from that fact and of course the dramatic - but utterly predictable - changes in demographics. On example of this is that I read somewhere that 50% of the NHS budget is spent on patients in the last year of their lives. Whilst we are living longer we do not typically enjoy significantly more years of those 'extra' years in good health it seems.
The whole issue of informed consent is simply foreign to so many in the NHS it seems - they may pay lip service to the idea but very few seem to take it seriously and worse even fewer really seem to understand what it means to get INFORMED consent.
A friend of mine - who trained as a vet like me - recently resigned from her clinical audit post at a leading UK heart hospital because they would not take her concerns about informed consent seriously regarding a study she was involved with. At the heart of the issue as far as the researchers were concerned was the 'anxiety' that if they really sought informed consent then insufficient patients would agree to take part for the study to go ahead. As a consequence they fudged the issue and sought to claim that
a) they were following and complying with guidelines when it was quite plain that they were not and
b) tried to claim that informed consent was not really necessary for this study - on a 'technicality' - when it was quite plain that it was if they were to comply with the spirit/intent of the guidelines. This 'attitude' is widespread within the NHS I believe. Few vets would dare to take the 'liberties' with their patients that the NHS does routinely. In addition much of the research undertaken within the NHS is poorly designed and badly executed and often entirely worthless. But as long as there are rewards of various kinds offered for undertaking research studies the situation will continue.
I used to hope that the NHS was 'reformable' - sadly I've almost reached the conclusion that the institution is incapable of reform (it certainly for the most part shows absolutely no desire to reform and actively resists attempt at reform) and that revolutionary change - indeed the break up of the NHS as we know it - may be the only solution to providing better health care in the UK.
57th Update of My Fly Longevity Experiments
by Doug Skrecky < firstname.lastname@example.org >
This is the 57th update of my fly longevity experiments. Experiment #57 was originally run at the same time as #56, which I reported on some time ago. The fly experiments have continued, even if there was a hiatus on my reporting of results. I'll be catching up on my report writing for the next while. Recorded average temperature during this experiment was 25.6 C.
In this experiment I took another look at rice protein, and compared this with freeze concentrated (FC) purple and white grape juice, both separately and in combination. The poor survival of the control bottle I again attribute to pathogens - probably viruses. Grape polyphenols are known to exert an antiviral effect, so the increase in life expectancy was not unexpected. I was surprised at the massive longevity increase in rice protein supplemented flies, which yielded a survival curve comparable to the best laboratory results obtained with flies stored at similar temperatures, but under clean room conditions, and with fly food being renewed regularly. I do not attribute this to any "antiaging" effect of rice protein, but this supplement does look to be exerting a protective effect under the adverse conditions I conduct my experiments; that being no clean room, and no replacement of fly food after an experiment is started. Roughly speaking, at about 25 C, a day in a fly lifetime, is about equal to a year in a human lifetime.
Adding freeze concentrated grape juice to rice protein decreases its benefits, which again I suspect to be due to inhibition of protein absorption from acidic fly food.
There has been very little work investigating any proposed anti-viral effect of rice protein, although a very good anticancer effect has been documented in rodents. It is ironic that although the presumed viral infections, are preventing my looking for "antiaging" effects in flies, this may not be the case for humans. Maximum fly longevity is known to be limited by degeneration of motor neurons, but this is not a major lifespan limiting factor in humans, except for those few burdened with neurological diseases, such as Huntington's disease. Age associated increases in mortality follow a different pattern in flies and humans. Viral infections do appear to be a significant factor limiting human lifespan, both directly, as well as indirectly though increased risk of cardiovascular disease and cancer. Could a rice protein supplement help aged humans live much longer? I do not know the answer to this.
Percent Survival on Day
|rice protein 1 tsp||100||88||81||75||63||63||63||56||44||44||38||6||6||0|
|grape, purple FC||100||67||50||17||8||0||-||-||-||-||-||-||-||-|
|grape, white FC||100||50||36||21||7||0||-||-||-||-||-||-||-||-|
|rice protein + purple FC||86||71||57||57||14||0||-||-||-||-||-||-||-||-|
|rice protein + white FC||92||92||83||42||25||8||8||8||0||-||-||-||-||-|
St John's Wort
AMERICAN BOTANICAL COUNCIL
P.O. Box 144345, Austin, TX 78714-4345
Ph: 512-926-4900; fax 512-926-2345
Contact: Cheryl Dipper
American Botanical Council
512-926-4900 x 121
St. John's Wort Study Misinterpreted
Says Herbal Science Group
Austin, TX. (April 9, 2002).
The American public may be receiving misleading information about the effectiveness of the popular herbal dietary supplement St. John's wort, says the nonprofit American Botanical Council. ABC and some of its scientific advisors noted that a new clinical study being released to the media is being misinterpreted.
The long-awaited government-sponsored study on the effectiveness of the popular herb is being published this Wednesday, April 10 in the Journal of the American Medical Association. The study, conducted by researchers at Duke University and 11 other medical centers in the U.S., concludes that neither St. John's wort nor the drug sertraline showed any measurable benefit in patients with more severe forms of depression. Although the study was conducted in patients with moderate to severe depression, the herb has been tested and used mainly in patients with less severe forms of depression.
The study conducted from December 1998 to June 2000 included 340 moderate to severely depressed patients that were randomly assigned to three groups. Over an eight-week period, one group received a dose between 900-1500 milligrams of a leading brand of St. John's wort extract, one group took the antidepressant drug sertraline (50-100 mg), popularly know by its trade name Zoloft and the third group took a placebo, a sugar or dummy pill. Patients who responded to treatment continued to receive their assigned treatment for an additional 18 weeks. Curiously, fewer of the patients in both the herb and the drug groups responded to the treatments than did those in the placebo group.
According to Jerry Cott, Ph.D., former Chief of the Psychopharmacology Research Program, at the National Institute of Mental Health, the NIH designed this trial to include a standard anti-depression drug (sertraline) as "an active comparator" to document the sensitivity of the trial, that is, the ability of this trial to detect an actual treatment effect. "The fact that the sertraline was not effective in the primary measures of depression demonstrates (according to the NIH's own design protocol) that this trial lacked assay sensitivity and should not be considered a successful study." Dr. Cott was involved in the original design of the trial when he worked for the NIMH.
He added that "this study does not invalidate the use of SJW in clinical depression. There are still many well-controlled trials supporting the use of St. John's wort in mild to moderate depression, and additional studies with more appropriate patient populations are in progress."
In Dr. Cott's estimation, this study could be considered "neutral", one that simply fails to show effectiveness of either treatment rather than proving the test drug doesn't work. "This result is not uncommon in pharmaceutical industry-sponsored studies, though normally they are not published. The study simply lacked the sensitivity to detect a difference." Dr. Cott is an expert on the effects of herbs and conventional drugs on mental disorders, including depression. He also formerly worked at the Food and Drug Administration where he evaluated clinical studies on new antidepressant drugs. (More information available at jerrycott.com.)
Dr. Steven Bratman, a physician-author in Fort Collins, Colorado agrees "The conclusion of the study is taken too far. Both treatments have been found effective in the majority of clinical trials. This study, while not supporting the use of St. John's wort, doesn't discredit it either."
Dr. Bratman, co-author of the Natural Pharmacy: Clinical Evaluation of Medicinal Herbs, explained the intricacies of the interpretation of clinical studies of this type. "In many studies of antidepressants, perhaps as many as one-third, the tested drug doesn't do any better than placebo. The cause is probably a combination of the high placebo effect often seen in studies testing antidepressants and the relative coarseness and subjectivity of the type of rating scales that must be used to evaluate severity of depression." Dr. Bratman explained that these rating scales are by their very nature less precise than biomedical tests, such as those that measure cholesterol levels. "In consequence, it is quite easy for a truly effective anti-depressant, such as sertraline, to fail to prove efficacy in a given double-blind, placebo-controlled trial. The problem is not the treatment itself, but in the difficulties of studying such treatments."
Because this study included sertraline, a drug that previously has been shown effective, the inescapable conclusion is that details of the patient group and the methods by which the ratings were determined were such that this study could not discern the effectiveness of a known effective treatment. This also applies to St. John's wort (which has also been shown effective in many studies) as it does to sertraline.
Bratman took issue with the authors of the study when they used a secondary outcome measure to conclude that sertraline was more effective than placebo and therefore better than St. John's wort. According to the standard rules of interpreting clinical studies, one should take only the primary outcome measures as meaningful, he explained. On those measures, neither sertraline nor St. John's wort was effective. Digging into secondary measures is widely accepted as being inappropriate, he added.
Thus, when the authors conclude that St. John's wort is ineffective for moderate depression and shouldn't be used, noted Bratman, "it would be equally valid to say that sertraline is ineffective for moderate depression, and shouldn't be used," he added. "However, we know that this is not the case; looking at the body of published research as a whole, both sertraline and St. John's wort are effective."
"Herbs should be tested according to a reasonable expectation of their previously documented benefits," said Mark Blumenthal, founder and executive director of the nonprofit American Botanical Council. He referred to10 previous studies on St. John's wort extract where the herb preparation was compared directly with pharmaceutical antidepressants for treatment of mild to moderate depression. These studies indicated a comparable efficacy with St. John's wort and the conventional drugs.
He also noted, "In Germany many physicians use St. John's wort as a first-line remedy for mild to moderate depression; if it doesn't work, then they can always put the patient on more powerful, pharmaceutical anti-depressants."
Blumenthal added, "It is important for the NIH to continue conducting clinical trials on many popular herbal dietary supplements. This adds to the growing body of scientific information on their safety and efficacy. This process is a constructive contribution to the maturation of the herbal movement. At the same time, however, it is equally important that the results of these studies are accurately interpreted and communicated to the public. Unfortunately, it appears that some aspects of this first NIH-funded study are not being properly characterized." He also noted that the full text of the study is not available prior to this Wednesday, so it is not possible to adequately evaluate all the details.
The study was funded with $4 million from the National Institutes of Health's National Center for Complementary and Alternative Medicine. It was the first clinical trial established by the NIH to test the efficacy of herbal remedies. St. John's wort was chosen because at the time the study was designed and funded in 1996, St. John's wort had begun to significantly increase in popularity in the U.S. This new awareness was based on media reports of a meta-analysis (statistical review of clinical trials) of 23 European clinical trials that showed that St. John's wort was safe and effective in treating mild to moderate forms of depression.
Last April, another U.S.-based multi-center clinical trial on St. John's wort also failed to show any activity for the herb, again in more severely depressed patients. The placebo-controlled study was criticized for targeting patients that were too chronically and severely depressed and thus not consistent with the profile of patients normally included in clinical trials. It was also criticized for not including an active control, like the drug sertraline (Zoloft«, produced by Pfizer, the funder of the study), to determine the level of response by the patients. Both trials used the leading German St. John's wort extract (known in Germany as Jarsin« 300, made by Lichwter Pharma of Berlin, and sold in the U.S. as Kira« by Lichtwer Pharma USA).
St. John's wort, also known by its scientific name Hypericum perforatum, is a traditional European herb that has drawn significant attention for its ability to help elevate mood in mild or moderately depressed people. At least 22 controlled clinical trials have been published in European medical journals suggesting that St. John's wort extract is a safe and effective remedy for mild to moderate depression. An estimated 131 million doses of St. John's wort were prescribed by psychiatrists in Germany in 1999, according to German sources.
The American Botanical Council is the nation's leading non-profit organization addressing research and educational issues regarding herbs and medicinal plants. The 13-year-old organization occupies a 2.5 acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed journal on herbal medicine, and will publish a forthcoming book and continuing education course for healthcare professionals, The ABC Clinical Guide to Herbs, containing an extensive monograph on the safety and efficacy of St. John's wort. Information contact: ABC at P.O. Box 144345, Austin, TX 78714-4345, ph: 512-926-4900, fax: 512-926-2345. Website: www.herbalgram.org.
1. The study referred to in this release is Davidson JRT et al. Effect of Hypericum perforatum (St John's Wort) in major depressive disorder: A randomized controlled trial. JAMA. 2002;287:1807-1814.
2. The previous U.S. study referred to in this release that found no response by St. John's wort is Shelton RC et al. Effectiveness of St John's Wort in major depression: A randomized controlled trial. JAMA 2001;285(15):1978-1986.
3. A comprehensive monograph on St. John's wort from ABC's forthcoming book The ABC Clinical Guide to Herbs, including summaries of 23 clinical trials and 122 references, can be viewed on the ABC website, www.herbalgram.org.Also see http://www3.mpa.se/020206_stjohnswort.html
St. John's wort may influence other medication
From: "Ingrid Franzon" <Ingrid.Franzon@alpha-plus.se>
This is what we have received from our drug administration:
St. John's wort may influence other medication.
During the last few years The [Swedish] Medical Products Agency (MPA) has informed doctors and patients on several occasions of the risk that natural remedies that contains St. John's wort may effect other medication.
Reports and studies have shown risks of interactions between natural remedies containing St. John's wort and several drugs, including oral contraceptives, warfarin, ciclosporin and drugs against HIV.
St. John's wort has been seen to reduce the effect of several drugs by induction of drug metabolising enzymes, i.e. by increasing the amount of drug-degrading enzymes.
The Adverse Drug Reactions Database of the MPA reports two cases of pregnancy due to a decrease in effect of oral contraceptives when they were taken concurrently with products containing St. John's wort. Therefore, there are several natural remedies containing St. John's wort that should not be taken together with contraceptives.
The intention of the Medical Products Agency is not to warn against the use of products containing St. John's wort but the Agency would like to point out that problems may occur when other drugs are taken concurrently. Patients that use products containing St. John's wort together with other drugs should, therefore, contact their physician before withdrawal of treatment with St. John's wort or if they switch over to another product containing St. John's Wort, because an adjustment in dosage of other drugs may be needed.
You can check out their website in English at http://www3.mpa.se/ie_engindex.html
by Charles Platt < email@example.com >
It has been suggested that an alternative use of cryonic preservation funds as being the cost of an extra year retired (roughly), which was estimated roughly the same as an extra year added to life. So the trade is a possible 100 years vs 1 year, so for revival probabilities above 1%, cryonics is a good choice.
This is an interesting calculation. Unfortunately, for people such as myself who suspect that the revival probability may be less than 1%, that calculation suggests, "don't bother"!
However, it makes a couple of assumptions that I don't share. First, why only 100 years of additional life? I would expect that if I am revived at all, it will be at a time when human mortality is no longer a problem, either because of advances in anti-aging medicine or (more likely, I think) because a Moravec-style transition to robotics has occurred, and we won't have to rely on biology to sustain thought processes anymore. Therefore I would expect at least 1000 years of revived life, which would make cryonics a rational bet (by your logic) if I believe the chance of revival is a mere 0.1 percent.
Unfortunately this still doesn't work for me, because I have always viewed cryonics as having a success probability around 1 in 10,000, which is 0.01 percent.
However, if you are assuming that just because you make $x per year, this is what a year of future life is worth. This assumption is not reliable. If I suffer a stroke that eliminates higher brain functions irrevocably, I may still be revivable but my life will be worth $0 per year. Conversely, if the future offers greatly enhanced powers and capabilities, as I think it will, life at that time could be worth considerably more than it is today.
Also when we consider any additional amount of good-quality life, we have a situation which, as I recall, economists refer to as "marginal utility." Suppose I have $100,000 saved. Someone comes to me and says, "You are about to die. You can will your savings to your relatives, or you can spend it on just SIX MONTHS of life in the future." Obviously from a strict position of self-interest, I should spend the money on those six months, since the choice is between life and no life, and the marginal utility of good-quality life is very high indeed, at least for those of us who are not suicidally depressed.
Therefore I conclude that cryonics is a rational bet, no matter how low the odds are, and no matter how much it costs, if you have sufficient money to pay for it at time of death.
However, if you are considering paying for it by depriving yourself of some quality of life at the present time, in the hope of buying life in the future, no rational choice can be made, because future life could turn out to be a nightmare just as easily as it could turn out to be a blessing. For instance, I believe a lot of cryopatients have sustained brain damage that will be irreversible by any means. An extreme case would be the Alcor patient, whose case I wrote about years ago, who was shot in the back of the head and then kept relatively warm for a day or two at the city morgue, after which his brain was removed from the skull and autopsied. Even the most gung-ho nanotechnologist would surely agree that this situation will pose an extreme challenge for the "Engines of Creation."
But of course I won't die like that ... will I?
European Parliament Debates
A Directive to Restrict
Sales of Vitamins and Supplements
The European Parliament is considering a wide ranging restriction on the sale of vitamins and nutritional supplements. Published here without comment are some points from English speeches made during the debate, as found on the Internet. The proposals were put forward for a second reading, ie they are likely to be enacted. As I understand it, there is no outright ban on anything, but the regulatory overhead is going to be so large that many products will disappear from the shelves of health food stores all over the European Community.
McKenna (Verts/ALE). - I believe this directive is an unacceptable assault on the right of citizens to choose how they look after their health and well-being. Huge numbers of EU citizens choose to take supplements to reduce the possibility of their falling ill and needing to seek medical advice to obtain prescribed drugs. People should have the right to opt for a healthy approach, rather than waiting for disease to set in and then having to resort to pharmaceutical drugs, many of which have dangerous side effects.
I am not surprised that the pharmaceutical industry is supporting this directive, since it plays right into their hands and means more business for them. Products which have been widely and safely used for many years in several EU Member States are being restricted without any health and safety justifications. I believe this is lawnmower harmonisation at its best, where everything is chopped down to the lowest common denominator. Consumers should be free to choose their own level of potency and nutrients, provided that they are safe and appropriately labelled. Availability of supplements should not be restricted for any reason other than safety. This proposal is profoundly flawed, in that it is based on the old-fashioned research which relies on RDAs of vitamins and minerals. For the past fifty years, RDAs have formed the basis of conventional nutritional wisdom. However, according to many reports which I have read on this issue, RDAs are set far too low and should be revised upwards. Instead, legislators should rely on the upper safe limits, which are a much better device. For example, the RDA for vitamin B6 is just 2 mg while the upper safe limit is 200 mg. Two studies published in the New England Journal of Medicine in 1993 demonstrated that taking supplements containing 100 IU of vitamin E for at least two years reduced the risk of heart disease in both men and women by approximately 40%. Despite this, the RDA for Vitamin E remains a measly 10 IU. I believe that countries with a restrictive policy should relax it, but not on the condition that we tighten our system and restrict the access of our consumers in our countries to vitamin and food supplements. (Applause)
To achieve these two objectives, it is necessary, as the rapporteur has said, to appropriately define what food supplements are; it is necessary to put in place a scientific assessment of all the ingredients and their minimum and maximum doses; it is necessary also to outline the key criteria for requirements with regard to consumer protection; and of course, the quality of standards has to be looked into as well.
The protection of the European Union's 370 million consumers is of paramount importance. Under the Amsterdam Treaty, Parliament has the power of codecision with the Council in the area of consumer protection and public health matters. I have always supported the need for improved labelling provisions so as to ensure that the consumer information is transparent and effective. The fact of matter is this: we live in an internal market where there is free movement of goods, services, persons and capital. We need to guarantee the safety of our food chain from farm to table. It is important that we have the framework proposal to put in place uniform systems for the full certification of food supplements. If there is any possible likelihood of endangering public health by means of the implementation of any particular proposal, one must always veer on the side of caution, and I compliment the rapporteur on her report.
I say to Commissioner Byrne: be careful. This directive tries to reconcile very different national approaches to allowing these products onto the markets and it fails in that attempt at reconciliation. Small businesses have been allowed too little time to submit the required safety dossier on their products. We may put that right tomorrow, but why, Commissioner Byrne, is it that there is no cost impact assessment on small businesses in this directive? When it came forward two years ago there was no cost impact assessment attached.
Just as important, we need to have the whole process of reviewing what there is on the market much more out in the open. It should not be done by secret committees. MEPs on the Committee on the Environment, Public Health and Consumer Policy will insist that we are much better informed on this, so that we can keep track of what is happening on behalf of our anxious constituents. We hope that we will be able to block any heavy-handed attempt to deprive people of the products they know and continue to need.
I remember the Commissioner telling us not long ago that under his regime we would have less interference of the kind which angers many European citizens for no good reason. However, when it comes to Brussels proving that it wants to treat people like an interfering nanny, this directive really does take the biscuit. (Applause)
We owe our constituents our judgement, and mine is that for all its flaws and deficiencies, the directive is one that should be commended, with amendments, to those many people who are frightened and nervous, who depend on these food supplements to preserve their health, and some of whom even believe it is a matter of life or death. They fear this directive because they have been told that these products will be banned, that testing will be prohibitive, and that what remains will be swallowed up in a restrictive and prescriptive regime. We owe it to them to make certain that is not the case, and shallow populist rhetoric is not the way to do it. We need to make certain that small producers can come forward and be reassured that it will not be a costly and prohibitive process. Time after time, we see that this is ignored in directives. It has been ignored in the PPP Directive.
The people who have the greatest need of our protection now are the small producers and we should help them. They should be able to register their product for simple and cost-effective evaluation. It should be a positive list which is rapidly expanded, with maximum dosages linked to real needs and not to outmoded daily allowances. People such as Mr Davies have said: 'well, we have not done this for alcohol'. My God, we have tried! We know what lobby it is that stops us doing this on alcohol, which stops us having the labelling that is necessary. Two wrongs do not make a right. We have to look at this directive in terms of the way in which it will be interpreted. The more people make claims about their health, the more we see that this needs a safety evaluation. You cannot have the one without the other. If you make the claims, you must expect to see them tested, but they should be tested fairly, simply and in a cost-effective way to leave a regime of light-touch and user-friendly practices. That is what my country has had and I believe we can keep it. It is also possible to fit that in to the framework of this directive. (Applause from the left)
I believe that this directive is an own goal. The European Commission has stated that its goal is the extension of the internal market. However, many Member States have put national interests first and lobbied to keep their markets closed. This is because the liberal regime in Ireland, the UK and the Netherlands is not acceptable to other Member States such as Germany and France. This means that products that are safe and widely available will be withdrawn from the market. The only criterion for taking products off the market should be one of safety. As I said, this is an own goal and we will end up importing products from the US via the Internet. Is this really what you want?
First of all, the objective of this legislation - and I must emphasise this - is not to ban food supplements. It has to do with maximum safety levels. I regret very much that I have to disagree with my friend Mr Bowis, for whose opinions I have the utmost respect, when he says that the position at the moment is that there are upper safe limits. That really is not the position. This will be the position after this legislation comes into place. That is the purpose of the exercise. This exercise will be based on scientific evidence and scientific evaluation. It also dismays me to some extent to hear people in this House - also for whom I have enormous respect - express the view that this legislation is motivated by, of all things, lobbying of the pharmaceutical industry. That is a slander. It is absolutely wrong. It is unfair to say that I or the people who work for me would be motivated by such things. But sometimes people who make these allegations are the ones who are inordinately concerned about the role of industry. But what about the role of industry that profits from this piece of legislation not going through? What about that? Have they questioned themselves to determine whether they have been subjected to such a degree of lobbying from that industry that they have themselves been duped by that industry and tried to tar the Commission and those who advocate the passing of this legislation with a brush in a way that I find quite reprehensible?
The subject is not an easy one. We currently have very different attitudes, rules and practices among Member States. These impede the free circulation of food supplements within the European Union, and can deprive consumers from access to a wide range of these products.
So the case for harmonisation is obvious and is strong. I believe that the vast majority of stakeholders share that view. You will not, therefore, be surprised that I cannot support the views of those who propose, with Amendment No 7, to reject the common position.
A substantial number of Members of Parliament and of the Commission have been subjected to an orchestrated and misleading campaign against the adoption of this directive. This campaign has only been waged by those who do not share the general European interest.
I should also emphasise to Mr Blokland and others who make reference to being lobbied by consumers who have written letters, that may be the case. I suspect they may very well be people who have been seriously misled by those who profit by this legislation not going through the system. (Applause)
The consumer organisations who are there to look after the best interests of consumers have not been misled. They are in favour of this legislation. BEUC has come out and said that it supports this legislation. This is a strong endorsement, in my view, rather than anecdotal accounts of individual consumers who, in my opinion, have probably been misled by the statements made by many which are simply untrue. They have misrepresented the aims of the directive, used misleading arguments and misinformed consumers. This was made clear during the debate in the Committee on the Environment, Public Health and Consumer Policy. Mrs Miller has done an excellent job as rapporteur. Her contribution to the advancement of the draft directive has been invaluable. I sincerely congratulate her and thank her. I would also like to acknowledge the responsible and very constructive role of Mrs Corbey, as shadow rapporteur.
The common position provides a very good framework for the regulation of food supplements in the European Union. It is designed to ensure that a very wide range of such products is available to consumers. The underlying criterion for a single market in food supplements is safety: adequate and appropriate labelling designed to inform consumers. Of course, these products must be used in the context of a diversified diet and in line with manufacturers' instructions. The deadline for preparing dossiers for the evaluation of substances that are already on the market is an important issue. I have listened carefully to the concerns expressed, concerning small and medium enterprises, that a period of 18 months for the preparation of evaluation dossiers may be too short.
If that were to be the only amendment to the common position, I would be prepared to consider an extension of the period mentioned. I can, therefore, accept any one of Amendments Nos 1, 3, 4 or 5 that relate to this point, provided that this would contribute to the adoption of the common position without further changes. I have also taken careful note of the interventions with regard to good manufacturing practice for food supplements, which is the subject of Amendment No 2. I would like to reiterate what I said at first reading. The adoption of principles of good manufacturing practice by legally binding measures for specific categories of products is not appropriate in the case of foodstuffs. This already exists in relation to foodstuffs in many pieces of horizontal legislation. I am happy to take comfort from Mr Nistic's contribution on the basis that he is certainly one of the MEPs I know here who is a scientist himself. He supports this legislation. He has asked me to take careful note of the risks to ensure the elemination of low-quality products when this framework legislation goes through the system. I am happy to say that will be taken into account. The vast majority of these principles are covered by horizontal legislation, particularly in the directives on hygiene and control. These will apply also to the manufacture of food supplements. In the draft directive, we are referring specifically to the issue of purity criteria for the vitamins and minerals to be used. We have improved the relevant provisions following your amendment at first reading. We also foresee adopting specific technical rules with regard to the margins of tolerance for the amounts of vitamins and minerals declared to be present in food supplements. We believe that these rules are important for ensuring the quality of these products.
I am firmly of the view that this array of horizontal and specific rules fully covers all concerns expressed that these products should be manufactured to high-quality standards. I cannot, therefore, accept Amendment No 2 to adopt provisions on GMPs for food supplements. However, I reiterate that I will give priority to adopting the technical rules on margins of tolerance mentioned in Article 9(1).
Amendment No 6 refers to the criteria that will be used for setting the maximum levels for vitamins and minerals in food supplements. This point was the most difficult one to reconcile in the Council. The text of Article 5 is now carefully balanced. It is my belief that any disruption would jeopardise the whole proposal. Finally, Amendment No 8 proposes an addition to the text that concerns principles for the functioning of the Standing Committee on the Food Chain and Animal Health and of the Scientific Panels of the European Food Safety Authority. I believe that these issues are adequately covered in the recently adopted general food law. They should not, therefore, be repeated in this specific directive. For this reason I cannot accept Amendment No 8. But I repeat and emphasise that the role of the European Food Safety Authority in this area will be of paramount importance and that this work will be done by independent scientists. The evaluation of that work by the Board of the European Food Safety Authority will be done in a fully transparent way - indeed, in public.
In conclusion, the Commission considers that the common position as such is satisfactory on all substantial points. The Commission would be ready to accept a technical modification of the common position to extend the period mentioned in Article 4.6.b. as in one of the amendments - Amendment No 1, 3, 4 or 5 - if that would help the adoption of the Directive at second reading. The Commission cannot accept Amendments Nos 2, 6 and 8 and certainly does not support Amendment No 7, that calls for the rejection of the common position.
Before the vote:
Jackson (PPE-DE). - Mr President, I rise on a point of order as the chairman of the committee which is bringing this report to Parliament, and particularly on behalf of the rapporteur. Members of this Parliament will be aware of the very high degree of public interest in this issue and of the lobbying to which we have all been subjected. I am not against that lobbying - a lively parliament should welcome lobbying from all sides. (Applause)
But the situation regarding this particular directive is unusual and serious. Firstly, the rapporteur, Mrs Miller, who has done her job very gallantly, has been subjected to unacceptable harassment and threats. Lies have been disseminated as to her motivation. Secondly, the people in question, led by Dr Rath from Germany, have practised deception on Parliament. They gained entry as a news team to the committee meeting when her report was adopted, and used the material to make a video that caricatures the views of the Committee on the Environment and its rapporteur. Mr President, I ask you to consider what can be done about this. I would like to ask the Presidency to find a means of dealing with such excessive, fraudulent and oppressive approaches. (Loud applause)
It is true that in this instance they have done more harm than good, as Mrs McKenna has said; and it has to be said that there is a perfectly good case against this directive; but we need to put in place a procedure, as a parliament, to guard ourselves in the future. In some national parliaments in this instance the person concerned would certainly be called before the parliament, reprimanded and asked to apologise, and we might consider putting that in place. (Applause)
But given the fact that there are now electronic means to overwhelm us with lobbying, we need to do something. I ask the President of Parliament to consider this very urgently. (Applause)
President. - I should like to make it clear that Mrs Jackson was speaking, quite rightly, as chairman of the committee and defending the rapporteur of her committee. I do not want to have a full-scale debate on this. Mrs Banotti has already said that the Quaestors are going to look into this matter. I do not think, therefore, that we need further discussion at this point. If people have points to make about this they should transmit them to Mrs Banotti who will make sure they are taken into account when the Quaestors look at this matter
Cooling and Coroners
by Mike Darwin < Mgdarwin@cs.com >
Concerning a CryoNet suggestion that there won't be any objection to placing a self contained head cooling device over the patients head until a proper suspension can be done.
You cannot touch a patient (literally) let alone put a cooling helmet on him if he is a Coroner's or ME's case until you obtain permission. Permission is virtually never granted. In my many years of involvement in cryonics and medicine I have had only one exception to this; a gentleman in a small town with a known history of heart disease who was expected to die at any time and who was a known cryonicist. (But see footnote) Over the Coroner's deputies objections his teenage son packed his father's head in ice. They chose not to intervene and later allowed the local cryonics people to pack the patient's entire body in ice once the physician had been contacted and agreed to sign the death certificate.
In most medico-legal situations you literally cannot touch the patient (not so much as a finger tap) without an ME's release number. A number of patients have spent hours unrefrigerated in morgues or riding around in steaming hot vans all day long because the case was medico-legal and the ME could not deviate from the strict protocols that would allow his findings to hold up in court. Keep in mind that the ME/Coroner and their deputies are peace officers and frequently carry guns. They have all the powers that regular police officers do. They are often police officer wannabes and are frequently very rigid and authoritarian.
Another reason for this stance is that they answer essentially to no one. The rights of the dead are virtually nonexistent. I have dealt with many, many Coroners and MEs and they come in all stripes. Most are inflexible because their job calls for it. You can't play fast and lose with police procedure: reproducibility is the key to credibility (witness the OJ trial fiasco with Dennis Fung and the myriad other screw ups in handling and processing evidence). Some are more than inflexible; they are malicious idiots. Having been handcuffed and carted off to jail by one such fool I advise caution and discretion in dealing with them. Pulling a manoeuver like chilling a patient's head with a helmet and attached machinery without prior and explicit authorization is one of the best ways I know of to buy an E ticket to a full blown autopsy and a long wait before you get the finely sliced brain in the bag with the rest of viscera given to you. Not to mention finding yourself in the Graybar Motel.
I understand that Bill Faloon recently obtained release from the ME in Dade County to get access to an Alcor member who was found dead (and in rigour mortis) with only a modest prior medical history of debility (Parkinson's disease). I don't know if Bill or anyone else was allowed to proceed before getting the Coroner's release but it is extraordinary that they got expedited release and no autopsy. In LA this would be very unlikely.
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