A Proposal for Jenelle’s Law to protect us from brain-damaging neuroleptic drugs
The Antipsychiatry Coalition
P.O. Box 1253, Topeka, Kansas 66601-1253
March 14, 2000
The Hon. Diana DeGette
1339 Longworth House Office Building
Washington, DC 20515
Dear Rep. DeGette:
Thank you for your sponsorship of The Patient Freedom from Restraint Act of 1999, H.R. 1313. Physical restraint immobilizing a person at the wrists, ankles, and neck or chest is a kind of torture psychiatrists too often wrongfully inflict on mental patients. I start to panic when I merely think about it being done to me. Thank you for your concern.
Another perhaps even worse horror psychiatrists inflict on people is permanent brain damage caused by neuroleptic drugs.
I recently met a charming young woman named Jenelle Dorner. Her story so moved me that I wrote an account of how she was damaged by neuroleptic drugs and, with her permission, posted it on the Antipsychiatry Coalition web site that I maintain. I’ve enclosed a copy of my article, which I titled “Jenelle’s Story.” Jenelle’s story illustrates what psychiatrist Peter Breggin, M.D., said in his book Psychiatric Drugs: Hazards to the Brain: By using drugs that cause brain damage, “Psychiatry has unleashed an epidemic of neurological disease on the world” one which “reaches 1 million to 2 million persons a year” (Springer, 1983, pp. 109 & 108). Jenelle’s story illustrates the failure of the U.S. Food & Drug Administration (FDA) to protect Americans from harmful drugs.
I propose the introduction of legislation to create a federal statute that would require the FDA to withdraw its approval of a drug if the drug causes permanent brain damage evidenced by tardive dyskinesia or dementia in more than 2% or 4% or whatever percent of patients and which would give federal district courts power to order the FDA to withdraw approval of a drug if any person files a civil action for the purpose of proving and does prove that the drug meets the statutory criteria for mandatory withdrawal of FDA approval. And I propose that the law be known as “Jenelle’s Law.”
Please read the attached article and give my proposal careful thought and let me know if you will introduce “Jenelle’s Law” for the purpose of stopping the epidemic of harm now being inflicted on millions of Americans by neuroleptic drugs.
Douglas A. Smith
Media Clip on Dangers of Xanax (This writer believes that ‘sudden withdrawal’ of medication method was used to intentionally cause a seizure to cause death (where heart stopped or was it lungs paralyzed, probably from drug overload and sudden withdrawal but did not die due to being apracticioner of yogic breathing exercises and being in general good health etc.) at the hands of a local pro-regime psychiatry outfit for activist work on anti-apartheid and perhaps LGBT issues (or being LGBT – more towards ‘Questioning’, but by section 377B’s 20 years and whipping, that regime thought they were being ‘merciful’ or ‘subtle’. To the largely ‘intended as anonymous’ activist who is most probably known to the local populace . . . that regime looks to have ceased this ‘chemical’ based method after implantation of ‘neurotech devices’, or systematic and complete bugging of the activist’s home, effectively imprisoning via mental duress conditions that has left the activist without any privacy : the activist has contacted the Bar Council in person but has received no response or advice relevant to prevention of further abuse, or removal of the devices implanted in a contrived car crash early 2000 s . . . – the spiritual damage caused by poisoning the victim and the poisoners souls has become quite severe on all parties . . . Xanax or any psychiatric drug administered by domestic terrorists dispensing poisons, does not only affect the physical body, but the ethereal and astral bodies, and in spiritually advanced persons who are here on a particular mission (i.e. ending apartheid), the consequences can be particularly disasterous . . . many otherwise viable candidats for politics could be consistently sabotaged in this manner, even throughout the 1st world, be aware and connect the dots before going on that shooting or knifing spree . . .
INFORMED CONSENT: REALITY OR MYTH?
Informed consent represents the single most important issue in the delivery of health care. Informed consent exists only when there is full disclose of known relevant information and known risk presented to the patient in a manner that they can understand. There are patients who did not understand that the surgical “mastectomy” they agreed to undergo involved removal of their breast. The text, shown above, a work of fiction by Roger Radford, hit close to home on the subject of adhesive arachnoiditis; a present and real worldwide health care problem.
In the “real world” in which we exist there are often procedural modifiers which influence “full disclosure.” Some of these have legitimacy and some do not. It is not unusual to see a court setting as the venue by which resolution of these issues is being attempted. One such situation is whether a medical treatment or surgery being recommended or performed is “accepted”, “standard” or “approved” and from whence the authority to determine this exists.
The challenge in determining “informed consent” becomes even greater when it becomes apparent that there are significant disparities in the definition of the terms being used. In fact this confusion may be taken advantage of this to promote secular interests and agendas. Medical malpractice cases based on informed consent issues (rather than negligence) as sometimes considered to represent the “soft” side of forensic medicine. This litigation is, however, an important “safety net” for society. It is unfortunate, but true, that informed consent sometimes been subject to serious abuse for the purpose of personal gain. Examples of such are failure to make patients aware of minimally invasive uterine artery embolization instead of surgical hysterectomy, minimally invasive aneurysm coiling instead of open cranial surgery and reconstructive spine surgery as opposed to multi-level pedicle screw and rod “fusions.”
It is true that the practice of medicine has never related to certainties. Treatment is based on best information. Evidence based medicine consists of careful clinical observation and experience combined with the best scientific data available. The notion that there is no empirical basis upon which to draw valid inferences and render reasonable judgments in the treatment of patients is false. On the other hand there also exists important scientific information which never seems to make itself known to physicians responsible for patient care. As medical practice progresses in time it becomes smarter and learns of risk factors which were previously unknown or unappreciated. Sometimes this knowledge is privy to some who purposely do not release it or act to obfuscate it for personal gain. The actions of the tobacco industry, over the past 50 years, makes this point. Yet, an important landmark in forensic medicine is “what was known, and when was it known” as a determinant of informed consent.
An interesting example of this is the issue of chronic respiratory disease related to exposure to asbestos fibers. There is a great deal of ongoing litigation against manufacturers of such products. For the most part exposure to asbestos occurred during a period of time when neither the manufacturers, the workers or their physicians were unaware of asbestos toxicity. Where the are the benchmarks? How can we create expectations which are smarter than we are?
The phenomenon of “managed care” has introduced additional challenges to the concept of “informed consent.” In their quest to justify denial of coverage for their subscribers many third party payors, seeking an opportunity to say “no” to treatment being recommended for a patient, often use the term “not proven” or “experimental” as a means of denying coverage. What is the legal ramification of this to the physician recommending treatment? What are the legal ramifications when care is denied and an alternative treatment goes “wrong.” Who has the legal responsibility? Well, up-to-now the physician has been left “blowing in the wind” on this issue. The “worm ” is, however, “turning.” Now that the unique immunity against legal suit provided by ERISA is in the slow process of being stripped away by the courts the health care “playing field” may, finally, become more level.
A level playing field is particularly needed in the arena of informed consent because full disclosure of risk is typically taken to be a medical “right” in the United States (as well as a primary “standard of care”). This is an interesting phenomenon because this concept varies considerably throughout the world (as demonstrated by the Burton Experience in the Soviet Union in the 1970s). In the real natural world there are no “rights” for animals (astutely pointed out by Charles Darwin). If each of us were placed naked in the center of a dense tropical jungle and we had to fend for ourselves we would discover what Darwin had in mind.
As the human race evolved on planet earth only those humans who possessed power had “rights.” In medieval times only the monarchs and the nobility held “rights. When the United States was young Thomas Paine and James Madison observed that rights were divided into “natural rights” (i.e. freedom of thought and speech) and “civil rights” (i.e. the right to trial by jury). Informed consent is a civil right”, more specifically a conceptual “patient right.” Other important conceptual “patient right” is that of the expectation of being provided with respect and consideration from a heath care system.
The Burton Report® is a strong advocate of real informed consent. This requires the clear presentation, to a patient, of all significant potential risk. The Burton Report® is also a strong proponent of providing patients respect and consideration.
Another position of Burton Report® is against the banning of any drug or therapy. Banning is the making of rules “which are smarter than we are.” One never knows when a toxic substance can be of benefit (i.e. thalidomide and botox). The better approach for the patient, and society, is real informed consent.
Clearly, the United States is the world leader in regard to disclosure of risk to patients. Even so there continues to be serious inadequacies and transgressions of this process which need attention. This is, at times, difficult to address because the concept of “rights” in the United States has burst asunder to finally reach a level of true frivolity. Perhaps this should not come as a surprise in a society where legal suits have become, as George F. Will has observed: simply a part of “a great American growth industry, litigation that expresses the belief that everyone has an entitlement to compensation for any unpleasantness.”
When one considers all the attention which has been focused on the issue of informed consent over the past few years it may seem surprising to learn that important areas of medical diagnosis and treatment still exist where full disclosure of risk has never been provided in the past and has continued to be seriously deficient in the present.
A look at the record confirms the point. Only recently have the adverse effects of particulate radiation, exposure to toxic chemicals and cellular damage resulting from nicotine and carbon monoxide poisoning (from cigarette smoking) been disclosed. It is important to note that most of this has occurred only as the result of litigation reflecting plaintiff rage and not as a result of governmental or medical intervention.
A good case in point is that of cigarette smoking. From a medical standpoint, the toxic effects of cigarette smoking appear to represent the single most adverse known chronic health liability, from an external source, directed to the human body. Remarkably, it has only been since 1997, when, as a direct response to legal actions, the actual ingredients of some cigarettes were finally disclosed to the public.
Once again, were it not for the existence of legal process to unravel the cover-up contrived by the tobacco industry the release of this important information might never have occurred. One indication of society’s patience wearing thin was the shock therapy administered to the tobacco industry on June 7, 2001 when a Los Angeles jury awarded $3 billon in punitive damages to a longtime smoker with lung cancer. A key element in the resolution of this case for the plaintiff was the introduction of a 1972 memo written by a Tobacco Institute executive pointing out how the tobacco industry had successfully undercut public health concerns about the cancer risk of smoking by “creating doubt…without actually denying it” (Geyelin M: Former Two-Pack-a-Day Man Finally Satisfied His Urge to Sue, Wall St. Jour., June 8, 2001). The fall-out from this decision continues with punitive damages being awarded against the tobacco industry for continuing “nefarious” behavior (Judge awards $15 million in punitive damages in tobacco case against R.J. Reynolds, Associated Press, June 22, 2002).
Most interested patients in the United States today are reasonably cognizant of risk factors as more trustworthy information continues to appear on the internet. There are, however, a number of areas where informed consent remains, quite remarkably, almost absent. In fact there are a number of examples of serious health risks which have continued unabated over many years (and sometimes decades). Many of these are still unassociated with adequate public disclosure and few in the legal profession have yet “stepped up to the plate” to assist in assisting the public interest.
One of the most serious examples of this has been, and continues to be, the disabling complications resulting from the introduction of foreign body substances into the subarachnoid space for the purpose of myelography as well as ill-advised epidural steroid injections. The disease complication is that of clinically significant adhesive arachnoiditis. This particular entity represents one of the most flagrant examples of a ongoing world-wide serious public health problem due to many years of industry misinformation and cover-up. Patient suffering secondary to adhesive arachnoiditis serves as a frightening example of an area where, at the beginning of the 21st century it is difficult to find a single patient who has ever been provided with real informed consent in this area.
What about the physicians? As adhesive arachnoiditis expert Sarah Smith points out:
“What concerns me is that if the person informing the patient is themselves poorly or inaccurately informed then how on earth can consent ever be truly informed?”
In association with this remain remarkable examples of continuing medical ignorance relating to commonly performed procedures. Medical informed consent is unlikely when the usual material provided to the public, by their physicians, ignores the most significant risk factors?
No area of informed consent is more important than that of medical research and the involvement of human subjects. How can patients know the risks if they are basically unknown to science as well as the medical profession? Unquestionably, gene research will play a very important role in future medical therapy. Gene therapy represents a challenging voyage into uncharted water where the benefits for all mankind may be historic. How do we know what we don’t know, and how does informed consent fit into this picture?
It is clear that there is no risk-free state in medicine. What then are the risks of surgery? In the field of spine surgery all patients run the risk of dying, being paralyzed, experiencing a nerve injury, wound infection, medical problem, drug reaction, etc. Actually most of these serious risks also exist when the patient drives to the hospital. As an example, the United States government reported that in 1998 alone 41,480 people died from auto accidents.
Informed consent is an essential requirement for the well-being of any modern health care system in the 21st century. Informed consent is based on full disclosure of known significant risk (the easy part). Full disclosure of all “relevant information” is the murky component, particularly from the standpoint of jurisprudal machinations and contrived governmental anomalies. Informed consent litigation has created a great deal of “busy work” for attorneys. Much of this litigation has wasted large amounts of time, talent and resource which could have been put to better use in the courtroom by pursuing more important areas of societal need. The need the create clearly defined requirements for patient protection, taking into account the rapidly changing landscape, is an important priority for the 21st century.
Lumbo-Sacral Adhesive Arachnoiditis – Introduction
There is no area of medicine today where greater, or more cruel suffering has been created in large populations of patients throughout the globe than those directly related to adhesive arachnoiditis of which the most common form is in the lumbo-sacral area. Whether due to apathy, disinterest, indifference or self-protective behavior by the medical, scientific and governmental communities lumbo-sacral adhesive arachnoiditis (LSAA) and it’s potential liabilities continues to remain essentially unknown, unreported, and unrecognized among both physicians and patients.
An important reason for this state of affairs has been the pattern of organized deception and obfuscation in regard to the safety and efficacy of oil myelographic substances such as Pantopaque® and Myodil® perpetrated by some of the originators and manufacturers of iophendylate for over half a century. This “bodyguard of misrepresentation” and “damage control” by company lawyers has been effective in insuring that governmental agencies, physicians and patients have not been allowed to fully appreciate the risks inherent in introducing highly toxic substances into the sub-arachnoid space. By not focusing, or adequately propagating, what is known scientifically regarding LSAA it has continued to be a serious world public health challenge and something which is continuously being perpetrated on unsuspecting patients by their uninformed physicians.
Even today the world community has still not yet come to grips with this cruel phenomenon nor has it yet demonstrated an appropriate social conscience regarding this disease entity. LSAA continues to be a trail of tragedy for many unfortunate patients and new cases appear on a regular basis because of our failure to learn from history. This regrettable situation has tended to cast those health care professionals who have tried to sound this alarm in a role similar to that of Dr. Peter Stockmann, the hero of Hendrik Ibsen’s 1882 play “An Enemy of the People.”
What determines whether or not the pathologic entity LSAA produces significant or disabling pain and neurologic impairment has a lot to do with how active or passive the meningeal reaction is. Because of the human nervous system’s remarkable abilities to recover from insult if given the opportunity many patients with LSAA are asymptomatic but exist in a precarious balance where things could easily change for the worse if a patient is subject to additional insult.
Remarkably there are still those who actually insist that the pathologic entity LSAA “does not even exist .” Fortunately these individuals belong to the ever-diminishing circle of those who also believe that:
The Holocaust never happened.
Americans never really landed on the moon (it was staged).
September 11, 2001 was really an Israeli plot.
The saga of adhesive arachnoiditis is not just something of historical interest. In no area of medicine has failure of “informed consent” been more evident than in the continuing saga of this disease process. The discussion of this rather incredible and continuing misadventure, which focuses on the neurotoxicity of foreign body substances being introduced into the subarachnoid space for the purposes of myelography and epidural steroid administration, begins with a review of these subjects:
Myelography, is an invasive diagnostic test in which a radio-opaque substance is placed in the subarachnoid space so that the space can be visualized by x-ray. The first contrast material used for this purpose was air. Air myelography developed from innovations in air ventriculography and air encephalography started in 1918, by Johns Hopkins neurosurgeon Walter Dandy. Because air was difficult to visualize on x-ray a search for alternatives began. In 1932 thorium dioxide (Thorotrast®) was first introduced. It appeared to be ideal for the purpose of myelography (and other diagnostic studies) and were it not for the fact that it was radioactive it would have been. Thorium dioxide turned out to be a highly toxic radioactive substance. It was only 20-30 years after its introduction that the medical profession began to suspect that the sudden and unusually high incidence of malignancies involving the brain and spinal cord (as well as adhesive arachnoiditis) might be related to thorium dioxide’s radioactivity. At this point this myelographic agent “fell into disuse.”
The “epidural” space is separated from the subarachnoid space only by the thin dura mater membrane and its associated filamentous pia mater. Epidural steroid administration is an empiric therapeutic modality commonly performed for the treatment of low back disorders. If the steroid is inadvertently injected into the subarachnoid space rather than the epidural space serious disability and incapacitation can result. Although all foreign body substances introduced into the subarachnoid space are “irritating” others can be highly neurotoxic. The most significant example of such neurotoxic agents are those containing ethylene glycols to allow for slow release (i.e. Depo-Medrol® , Depo-Medrone®, Aristocort® and Methylprednisolone Suspension®). When introduced into the subarachnoid space these materials can be highly neurotoxic and productive of a potentially disabling condition referred to as adhesive arachnoiditis. Since none of these steroids is approved, by their manufacturers, for epidural injection, and that they are clearly know to be toxic if misinjected, it is interesting to note that they still appear to be used by the majority of physicians now performing epidural steroid injections.
A prudent individual would assume that the medical leaders in performing, teaching, and publishing on epidural steroids would be acutely cognizant of the most potentially serious patient complication of “epidural” steroid administration. The facts suggest otherwise. A prominent medical publisher, publishing 16 spine-related patient manuals including “Lumbar Epidural Injection” and “Cervical Epidural Injection” has, under the section on “risks and complications”, made no mention of adhesive arachnoiditis, the most serious potential complication of epidural steroid administration. This is despite the fact that new cases of incapacitating adhesive arachnoiditis directly related to inadvertent subarachnoid administration of neurotoxic steroids are being diagnosed by spine specialists on a continuing basis.
Are there alternatives to potentially neurotoxic formulations of methyl- prednisolone for epidural administration? Indeed there are. Why are they not used? The best answer is colossal ignorance, indifference, deception, or worse. Methyl prednisolone “suspensions” have neither “fallen into disuse” nor have they been officially identified as being a serious potential risk to the public health in any country at this time. What does this revelation mean in regard to informed consent? Might viewing Burton Report® allow patients to ask the right questions as to just which drugs will be injected and techniques used prior to therapy? Will physicians, because of these questions from informed patients, begin to modify their practice? We certainly hope so. It is sad to observe that once again, the public may be forced to call upon the good offices of the legal profession to help in promoting awareness of this clear and present danger because of failure by the health care establishment and elected officials to accept responsibility and become involved.
The use of intrathecally placed (within the subarachnoid space) catheters for the purpose of delivering drugs (i.e. morphine for pain relief, baclofin for control of spasm) is not without risk of producing local adhesive arachnoiditis. These catheters can produce focal adhesive arachnoiditis, cysts and other inflammatory problems. That such risks exist should be explained to patients as part of the preoperative informed consent process. It should also be an important part of the risk versus benefit consideration for even considering such therapy in patients with normal life expectancies.
Clinically significant lumbo-sacral adhesive arachnoiditis is a particularly cruel disease because of the nature of the pain syndrome associated with it. Yet, its pathophysiology is well understood and is no mystery. Yet, for those desiring an objective determination of the existence or absence of adhesive arachnoiditis non-invasive high-resolution MRI scans have now allowed definitive determination of this frightening pathologic entity.
The nature of the pain associated with adhesive arachnoiditis is uniquely incapacitating and dolorologists have created the term “regional complex pain disorder” (RCPD) to describe it. Apologists for those who have created adhesive arachnoiditis and RCPD in patients have pointed out that only 1-5% of those with the condition actually have the full-blown clinical symptoms (which can include progressive neurologic deficit and even death). The reason for this is interesting and appears to relate to the remarkable ability of the nervous system, with its great reserve and redundancy, to cope with severe insult and injury (if applied in a gradual fashion). It appears that despite being enmeshed in solid collagenous scar tissue and being deprived of the nurturing of cerebrospinal fluid and its normal vascular supply nerve cells can often achieve a tenuous equilibrium. This delicate balance can, however, be easily upset by additional insult or injury (i.e. spinal surgery or a motor vehicle accident releasing blood into the subarachnoid space).
There are a number of other neurologic parallels to the phenomenon of nervous system acclimization. One such is the “post-polio syndrome” where individuals afflicted with poliomyelitis early in life may make complete functional recoveries but as they age they experience progressive weakness. In this circumstance polio has destroyed the neuronal reserve and normal function belies the fact that there is no reserve. As the normal process of aging occurs and neurons die by attrition the lack of reserve is evidenced by the inability of the few remaining viable neurons to handle the challenge of normal function. The human body functions well with only one kidney, one lung etc. No one would dare to suggest that the loss of these organs was not inconsequential to the welfare of the individual. In the case of adhesive arachnoiditis the story has, unfortunately to date, been different.
Expressions of plight by individuals suffering with adhesive arachnoiditis are common. The many individuals legitimately suffering from adhesive arachnoiditis often are undiagnosed only because of healthcare establishment inadequacies. The legitimate disability of these unfortunates is then looked upon with distain by the medical and legislative communities who, because of their own diagnostic limitations, tend too often to consider these patients to be malingerers (or worse). The sad result of this are legions of patients seeking only the dignity of a definitive diagnosis from professional groups and organizations whose skill at evasion and cover-up have unfortunately exceeded their other talents. The disrespectful manner in which many countries have treated these unfortunates, whose only crime was not knowing the right questions to ask before a “minimally invasive” myelogram or epidural steroid injection was performed, has been sad to see.
Sadly, the rare examples where recourse has occurred typically has represented the compassion of the legal profession again serving as a societal “safety net.” Even so legal attempts at legitimate recourse have been hampered by unrealistic “statue of limitation” requirements. Unfortunately, tort litigation reform has focused only on limiting the liability of transgressors so that their exposure becomes only a “business expense” and not something which will actually change their behavior.
The Editor, as a health care professional who has been concerned with the subject of neurotoxicity and patients suffering from adhesive arachnoiditis for over a quarter of a century has, as his only excuse for becoming involved in an issue emulating Hendrik Ibsen’s “Enemy of the People”, is not being “smart enough to know when to quit.”
Conspiracy Theory on Organic Drugs (if not a neurotech induced thought line) – by @AgreeToDisagree – 20th February 2012
Symbolism of the Opium bed = Psychiatrists couch dawned upon me while doing casual searches for old opium posters.
This is where the drug is administered under neuotech control, to induce neurotech control.
The NLP, perhaps psychic, links are based on/intended for sequestration of Opium’s ‘power’ by HUMAN BEINGS, namely psychiatrists who probably are chemically (enhanced) tghe same way non-psychiatrists are chemically suppressed so that the SOUL or tretment of SOUL nominally formerly the realm of shamans and soothsayers, are now dominated byu chemiocally drugged up people with no morals.
This allows ‘peaceful feelings’ to become a franchise CONTROLLED by psychiatrists and their drugged up natures (taking drugs to increase telepathy, stronger control of other minds via good drugs), as well as their drugged up (weakened via bad drugs) ‘clients’ who will have to PAY them for their addiction POSING as pharma drugs. This is denounced by ANY and ALL countries which have a legalized drug law. Instead of creating dependency and high fees for profiteering psychiatrists, the honest government legalizes.
The psyche establishment in the 3rd world is thus complicit in addicting populations unawares, perhaps via foods, or other beverages to addict at cost.
How does this theory sound?