"Someone in our society must make decisions with regard to the safety and effectiveness of new drugs. This someone, of course, is the Food and Drug Administration. We have this responsibility — and a very grave one it is — by law. The decision -making process can conveniently be regarded as a three-step operation:
Step 1. Determine the benefit to be derived from the drug;
Step 2. Determine the risk;
Step 3. Weigh the benefit against the risk and decide whether it is in the public interest to approve the drug for marketing or to withdraw approval if the product is already on the market.
The decision to approve a drug for marketing, or to withdraw an earlier approval requires a weighing of the benefit to be expected from the use of the product against the risk inherent in its
use. While this is the same type of decision a physician makes each time he prescribes a drug for a patient, the government must consider a number of factors not pertinent to the individual
physician's decision.
The government must make a judgment as to the hazards likely to be encountered when the drug is employed: by physicians of varying skills and abilities, in patients with a multitude of disease processes, many occurring concurrently, and in patients incorrectly diagnosed or inadequately tested with accepted laboratory procedures."
former Commissioner of the FDA, George P. Larrick in Hearings Before Subcommittee of Committee on Government Operations, Drug Safety, fi.R., 88th Cong., 2d Sess., 149-154
(1964)
Step 1. Determine the benefit to be derived from the drug;
Step 2. Determine the risk;
Step 3. Weigh the benefit against the risk and decide whether it is in the public interest to approve the drug for marketing or to withdraw approval if the product is already on the market.
The decision to approve a drug for marketing, or to withdraw an earlier approval requires a weighing of the benefit to be expected from the use of the product against the risk inherent in its
use. While this is the same type of decision a physician makes each time he prescribes a drug for a patient, the government must consider a number of factors not pertinent to the individual
physician's decision.
The government must make a judgment as to the hazards likely to be encountered when the drug is employed: by physicians of varying skills and abilities, in patients with a multitude of disease processes, many occurring concurrently, and in patients incorrectly diagnosed or inadequately tested with accepted laboratory procedures."
former Commissioner of the FDA, George P. Larrick in Hearings Before Subcommittee of Committee on Government Operations, Drug Safety, fi.R., 88th Cong., 2d Sess., 149-154
(1964)
This post shares some of the testimony offered in Senate Hearings that took place in July and August in 1975. The hearings were part of an investigation into the off label use of psychotropic drugs in general and neuroleptic drugs, called "antipsychotics" or "major tranquilizers" off label to control behavioral problems exhibited by children with mental retardation, (now called intellectual disabilities, or developmental disabilities) in institutional settings. The DRUGS IN INSTITUTIONS
HEARINGS
BEFORE THE
SUBCOMMITTEE TO INVESTIGATE
JUVENILE DELINQUENCY
OF THE
COMMITTEE ON THE JUDICIARY
UNITED STATES SENATE
NINETY-FOURTH CONGRESS
FIRST SESSION
Pursuant to S. Res. 72, Section 12
INVESTIGATION OF JUVENILE DELINQUENCY IN THE
UNITED STATES
THE ABUSE AND MISUSE OF CONTROLLED
DRUGS IN INSTITUTIONS
What struck me in reading the transcript of this Senate Hearing from 1975, is the similarities to the Senate Hearing chaired by Senator Tom Carper held on December 1, 2011 the same underlying problems were identified:
1. The indiscriminate use of psychotropic drugs off label in quantities and combinations that belie ethical medical judgement, for symptoms that the drugs are not known to treat.
2. Illegal marketing of psychotropic drugs, false claims exaggerating the effectiveness of the drugs used juxtaposed with minimizing the risks, including rates of adverse effects and adverse outcomes.
3. The medically negligent care provided to patients prescribed psychotropic drugs in standard clinical practice, both in community clinics and in institutional settings. The abusive inhumane methods used by professionals when patients are difficult, uncooperative, or considered a problem.
4. The abject failure of the FDA to perform it's regulatory duties in a manner consistent with it's legislative mandate, i.e. to protect the American people from the dangers posed by FDA-approved drugs. The failure of the FDA was clearly and eloquently outlined in the testimony offered in 1975; and if anything, it has become worse since then.
5. The utter failure of Law Enforcement to criminally prosecute or even investigate obviously criminal conduct of medical professionals and pharmaceutical representatives---The only difference now is the criminal behavior is more common, more visible, and more is now vehemently defended by psychiatrists and the pharmaceutical industry; who are effectively aided and abetted in their criminal complicity by the regulatory authorities that theoretically protect and serve us.
Excerpts from the testimony offered by Dennis J. Lehr, a partner in the Washington, D.C. law firm of Hogan & Hartson:
We went to the FDA on July 16, 1974, and filed a detailed petition, saying, in effect; gentlemen, here is the evidence that shows drugs are being used in 300-, 400-, 1,000-percent dosages above their prescribed use. You know that Stelazine, Thorazine, Mellaril, and all of the other psychotropic drugs are being used for uses for which they were never proven safe and effective. Do something about it. Unfortunately, Thorazine came in for most of the raps today, but all of the psychotropics are being overused.
The Food, Drug and Cosmetic Act and the FDA's own regulations and relevant legislative history, say that when you are using a drug for an unapproved use or for an unapproved patient population for which it has never been heretofore been proven safe and effective, there must be a new drug application filed. This was never done and the FDA has not meaningfully addressed itself to the issues we have raised. Instead they referred us to a learned panel of doctors. Again, very well-meaning learned people; psychiatrists, pharmacologists, and psychologists. We sat with those people defended again, the very facts that they are fully aware of : That there are abuses.
We are making a legal argument to the FDA. But they are responding to us with anecdotal reports from a psychiatrist's practice.
MAKE FDA ABIDE BY OWN RULES AND REGULATIONS
In summary, what I am saying is, we want the help of this committee to tell the FDA : Do what Congress has told you to do. We have made seven recommendations, four of which go to revising the package inserts on these major tranquilizers, one of which goes to the institutions to put them on notice to stop this abuse. The fifth one deals with attacking the problem of not fully qualified and licensed physicians, and I will get back to that in one moment. And the last one, and this is the great sacred cow, asks for an investigation of the detailed practices of the drug companies. That is, the sales techniques used by the drug companies to sell psychotropic drugs to institutions. (emphasis mine)
The FDA will act even though the ultimate use of the drugs might be pursuant to valid prescriptions where, as in the case of phenothiazines, the practice of prescribing a new drug for an unapproved use "becomes widespread or endangers the public health." In such circumstances, the FDA's own proposed regulations recognize that the agency is "obligated to investigate . . . thoroughly and take whatever action is warranted to protect the public. . . ."
In our paper, we consider the legislative history of the Act and the relevant case law which supports the proposition that drugs cannot lawfully be used for purposes or patient populations not specifically approved by the FDA. A broad range of administrative and legal sanctions is available to both the FDA and the courts to deal with the unapproved use of approved drugs. Since the use of phenothiazines for the control of retarded persons is not in accord with the provisions of Section 355 because a supplemental new drug application has not been filed, the penalty and injunctive provisions as well as the seizure provisions of the Act become applicable. Moreover, as I mentioned earlier, the FDA has issued proposed regulations outlining its administrative responsibilities with respect to the unapproved use of approved drugs. The Notice of Proposed Rulemaking specifically would give the FDA authority to pursue, among other things, one or more of the following courses of action where the unapproved use of a new drug becomes widespread or endangers the public health :
(1) Revision of the package insert may be required to add a specific contraindication or warning against the unapproved use.
(2) The manufacturer may be required to obtain and submit the available data with respect to the unapproved use, or to sponsor clinical trials to determine the safety and effectiveness of the drugs for the unapproved use.
(3) Revision of the package insert may be required to state that the drug should be distributed only through specified channels (e.g., hospital pharmacies) and/or should be prescribed, dispensed, or administered only by physicians with specified qualifications.
(4) The approval of the new drug application may be revoked.
Thus the FDA has adequate authority to deal effectively with the unapproved use of phenothiazines. Yet, the agency has done little in the year since we filed our petition. Instead of undertaking a careful review of the scope of the problem and a scientific analysis of existing literature, the FDA has pursued a tortured course characterized by long delays and a desperate effort to find some evidence, regardless of quality or the existence of contrary evidence, upon which to justify a finding that the drugs are safe and effective. For example, there was so little action at the FDA in response to our July 1974 petition that it was necessary to file a supplementary petition in November of 1974. In that supplementary petition, we restated our position that the drugs had never been approved by "the FDA and that the FDA was therefore obligated to take
immediate action to do what it could to prevent continued unapproved use of an approved drug.
The Food, Drug and Cosmetic Act and the FDA's own regulations and relevant legislative history, say that when you are using a drug for an unapproved use or for an unapproved patient population for which it has never been heretofore been proven safe and effective, there must be a new drug application filed. This was never done and the FDA has not meaningfully addressed itself to the issues we have raised. Instead they referred us to a learned panel of doctors. Again, very well-meaning learned people; psychiatrists, pharmacologists, and psychologists. We sat with those people defended again, the very facts that they are fully aware of : That there are abuses.
We are making a legal argument to the FDA. But they are responding to us with anecdotal reports from a psychiatrist's practice.
In summary, what I am saying is, we want the help of this committee to tell the FDA : Do what Congress has told you to do. We have made seven recommendations, four of which go to revising the package inserts on these major tranquilizers, one of which goes to the institutions to put them on notice to stop this abuse. The fifth one deals with attacking the problem of not fully qualified and licensed physicians, and I will get back to that in one moment. And the last one, and this is the great sacred cow, asks for an investigation of the detailed practices of the drug companies. That is, the sales techniques used by the drug companies to sell psychotropic drugs to institutions. (emphasis mine)
In our paper, we consider the legislative history of the Act and the relevant case law which supports the proposition that drugs cannot lawfully be used for purposes or patient populations not specifically approved by the FDA. A broad range of administrative and legal sanctions is available to both the FDA and the courts to deal with the unapproved use of approved drugs. Since the use of phenothiazines for the control of retarded persons is not in accord with the provisions of Section 355 because a supplemental new drug application has not been filed, the penalty and injunctive provisions as well as the seizure provisions of the Act become applicable. Moreover, as I mentioned earlier, the FDA has issued proposed regulations outlining its administrative responsibilities with respect to the unapproved use of approved drugs. The Notice of Proposed Rulemaking specifically would give the FDA authority to pursue, among other things, one or more of the following courses of action where the unapproved use of a new drug becomes widespread or endangers the public health :
(1) Revision of the package insert may be required to add a specific contraindication or warning against the unapproved use.
(2) The manufacturer may be required to obtain and submit the available data with respect to the unapproved use, or to sponsor clinical trials to determine the safety and effectiveness of the drugs for the unapproved use.
(3) Revision of the package insert may be required to state that the drug should be distributed only through specified channels (e.g., hospital pharmacies) and/or should be prescribed, dispensed, or administered only by physicians with specified qualifications.
(4) The approval of the new drug application may be revoked.
Thus the FDA has adequate authority to deal effectively with the unapproved use of phenothiazines. Yet, the agency has done little in the year since we filed our petition. Instead of undertaking a careful review of the scope of the problem and a scientific analysis of existing literature, the FDA has pursued a tortured course characterized by long delays and a desperate effort to find some evidence, regardless of quality or the existence of contrary evidence, upon which to justify a finding that the drugs are safe and effective. For example, there was so little action at the FDA in response to our July 1974 petition that it was necessary to file a supplementary petition in November of 1974. In that supplementary petition, we restated our position that the drugs had never been approved by "the FDA and that the FDA was therefore obligated to take
immediate action to do what it could to prevent continued unapproved use of an approved drug.
We also specified the action we thought was required :
"(1) Require that all package inserts contain a statement that the drugs have not been approved for tlie control or management of resident behavior in institutions for the mentally retarded, absent a diagnosis indicating the presence of a specifically identified psychotic condition or other specifically identified conditions for which the drug has previously been approved.
"(2) Require that the term "disturbed children" in the package inserts for Mellaril, Thorazine or any other phenothiazine be deleted and be replaced with more precise language which indicates that the drug is approved for the treatment of only those children who have been diagnosed as having a specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.
"(3) Require that all package inserts for phenothiazines contain a clear warning that recent studies show the drugs may impair cognitive abilities in the short run, that no acceptable studies have been done which indicate whether and to what extent the drugs may impair cognitive abilities in the long run, and that impairment of cognitive abilities is particularly harmful to children and mentally retarded persons. (emphasis mine)
"(4) Require revision of the package insert for each phenothiazine to state that special precautions and monitoring must be used because institutionalized mentally retarded persons may not be able adequately to verbalize or communicate adverse effects.
"(5) Notify all institutions for the mentally retarded that phenothiazines are not approved for the control of behavior unless a mentally retarded resident has a diagnosed, specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.
"(6) Require revision of the package insert for each phenothiazine to state that the drug should be prescribed only by fully licensed physicians and not by medical personnel with licenses limited to institutional practice.
"(7) Initiate immediately an investigation of the advertising, distribution and marketing practices of the phenothiazine manufacturers to determine whether and to what extent they are promoting or knowingly shipping phenothiazines for the purpose of managing and controlling the mentally retarded in violation of Section 505 of the Food, Drug and Cosmetic Act."
It was not until January 30, 1975, however, that we received any formal response from the FDA. By letter dated January 30th, a copy of which is submitted herewith as Exhibit D, we were advised that the FDA had ordered minor changes in labeling of one drug and that hearings had been scheduled before the Pediatric Advisory Panel of the Psychopharmacological Agents Committee.
In preparation for those hearings, the staff of the Bureau of Drugs reviewed the NDA files for phenothiazines and prepared a memorandum which was forwarded to us under cover of letter dated February 5, 1975, a copy of which is submitted herewith as Exhibit E. As was indicated above, that memorandum concluded that of the 24 studies of phenothiazines which included mentally retarded subjects, (only one was controlled, and even that was of limited value
because, of the 60 subjects participating in the study, only seven were retarded, and it is likely that those seven also suffered from psychotic disorders. Along with its analysis of NDA files, the FDA also provided a list of citations to published articles : however, one did not involve phenothiazines, two did not involve the mentally retarded, three failed to meet at least four of the six minimal criteria for a controlled study, one was not published, one was not available from the National Medical Library and one was inconclusive.
"(1) Require that all package inserts contain a statement that the drugs have not been approved for tlie control or management of resident behavior in institutions for the mentally retarded, absent a diagnosis indicating the presence of a specifically identified psychotic condition or other specifically identified conditions for which the drug has previously been approved.
"(2) Require that the term "disturbed children" in the package inserts for Mellaril, Thorazine or any other phenothiazine be deleted and be replaced with more precise language which indicates that the drug is approved for the treatment of only those children who have been diagnosed as having a specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.
"(3) Require that all package inserts for phenothiazines contain a clear warning that recent studies show the drugs may impair cognitive abilities in the short run, that no acceptable studies have been done which indicate whether and to what extent the drugs may impair cognitive abilities in the long run, and that impairment of cognitive abilities is particularly harmful to children and mentally retarded persons. (emphasis mine)
"(4) Require revision of the package insert for each phenothiazine to state that special precautions and monitoring must be used because institutionalized mentally retarded persons may not be able adequately to verbalize or communicate adverse effects.
"(5) Notify all institutions for the mentally retarded that phenothiazines are not approved for the control of behavior unless a mentally retarded resident has a diagnosed, specifically identified psychotic condition or other specifically identified conditions for which the drug has been previously approved.
"(6) Require revision of the package insert for each phenothiazine to state that the drug should be prescribed only by fully licensed physicians and not by medical personnel with licenses limited to institutional practice.
"(7) Initiate immediately an investigation of the advertising, distribution and marketing practices of the phenothiazine manufacturers to determine whether and to what extent they are promoting or knowingly shipping phenothiazines for the purpose of managing and controlling the mentally retarded in violation of Section 505 of the Food, Drug and Cosmetic Act."
It was not until January 30, 1975, however, that we received any formal response from the FDA. By letter dated January 30th, a copy of which is submitted herewith as Exhibit D, we were advised that the FDA had ordered minor changes in labeling of one drug and that hearings had been scheduled before the Pediatric Advisory Panel of the Psychopharmacological Agents Committee.
In preparation for those hearings, the staff of the Bureau of Drugs reviewed the NDA files for phenothiazines and prepared a memorandum which was forwarded to us under cover of letter dated February 5, 1975, a copy of which is submitted herewith as Exhibit E. As was indicated above, that memorandum concluded that of the 24 studies of phenothiazines which included mentally retarded subjects, (only one was controlled, and even that was of limited value
because, of the 60 subjects participating in the study, only seven were retarded, and it is likely that those seven also suffered from psychotic disorders. Along with its analysis of NDA files, the FDA also provided a list of citations to published articles : however, one did not involve phenothiazines, two did not involve the mentally retarded, three failed to meet at least four of the six minimal criteria for a controlled study, one was not published, one was not available from the National Medical Library and one was inconclusive.
My summary:
Regulatory failure and unethical psychiatric diagnosis and treatment standards are the two main reasons subsequent investigations have been required; these failures have propelled a criminal enterprise wherein illegal marketing and off label drugging have continued unabated, and have actually flourished into a multi-billion dollar criminal enterprise. The American people are being defrauded in order to pay for ineffective, dangerous treatments that are prescribed to poor children on Medicaid who are vulnerable due to poverty, particularly children in the custody of the state through no fault of their own, men and women serving in the Military, and elderly citizens in long-term care facilities, are three marginalized groups that are targeted by the illegal marketers working for pharma. The regulatory failure allows rampant fraud to continue unabated. The illegal marketing and indiscriminate off label use of psychotropic drugs is a marketing scheme supported by fraudulent claims that psychotropic drugs "medically treat" undesirable behaviors and emotional difficulties effectively, downplaying the serious risks of disability, and death---it is fraud.
The fact that this medical malfeasance and criminal fraud appears to be helpful to some psychiatric patients; or at least is not obviously detrimental to every single one, is not significant when considered in context. When one considers that we do not even try to keep track of the number of patients who are harmed by adverse effects of FDA approved drugs, the number of patients who are disabled from the adverse effects FDA-approved drugs; and how many die from FDA-approved drugs used as prescribed. The fact that psychiatry it is not harmful to every patient is not a sufficient justification to continue using an unethical, fraudulent Standard of Care. It is very telling that the American Psychiatric Association and American Academy of Child and Adolescent Psychiatry continue to vehemently defend what clearly are unethical and criminally negligent standards of practice. Consensus and excuses, i.e. it's all we have; are no substitute for the empirical EVIDENCE that is theoretically required to validate ethical medical standards of practice.
In psychiatry, consensus is substituted for medical science, and lame excuses are proffered to justify deceit and other unethical and coercive behaviors that are endemic to psychiatric practice. There is no ethical substitute for empirical evidence, there is no room for deceit or corrupt data in the development of any medical Standards of Care. Psychiatry has exploited psychiatric patients and has relied upon the general public's unearned, unwarranted trust and respect that historically has been freely granted to medical professionals. Psychiatry has exploited the presumption that trust and respect of medical professionals is warranted and based upon a presumption that medical professionals have ethical integrity; psychiatry used this erroneous presumption as a shield while it distorted the truth about what is and is not known about psychiatric diagnoses and treatments, and abused it's power and authority to effectively quell dissent from psychiatrists who questioned the methods used and the corrupt data. The hierarchy of the APA and AACAP have both been known to attempt to discredit ethical professionals who refute the methods used and the conclusions reached in corrupt research, and/or object to the deceit and the coercive methods used in standard practice; particularly those professionals who successfully treat patients without resorting to abusing their authority and rebuke the coercive methods of control. Psychiatry has wielded it's authority over patients like a tyrannical abusive parent and abuses psychiatric authority to effectively (de)voice patients who are harmed by it's abusive methods and dangerous treatments. Well founded complaints of abuse, torture and trauma are minimized or dismissed as "crazy talk."
A current example of the psychiatric profession's pathological avoidance of the truth, is the outright lie that psychiatry used for decades after it was disproved as a hypothetical cause of depression. The story that depression is or may be caused by a chemical imbalance was only a metaphor; some psychiatrists have said. When this "metaphor" was effectively demonstrated to have no basis in reality, unapologetic psychiatrists then claimed that psychiatrists had never believed depression was caused by a chemical imbalance; stating that the story was simply a harmless metaphorical explanation told to patients in order to help them understand the medical nature of their diagnosis!? This lame excuse is yet another lie. The reason patients were told this "metaphor" is in the hope that if patients believed their diagnosis was an actual medical condition, this belief would convince them of the necessity of being treatment compliant. It is and was always a means to manipulate patients; to coerce compliance with psychiatric treatment. A metaphor used to perpetrate fraud.
What is truly horrifying is that this metaphor has become an urban legend; it is accepted as a medical fact by the uninformed who believe it is based on genuine ethical medical finding. It is considered "common knowledge" by the mainstream advocacy groups who with the help of psychiatry, continues to (mis)inform the general public using this metaphor as if it was not discredited. In truth, it is a metaphor used with insignificant variations explain the cause of virtually every psychiatric diagnosis... The purpose is not now, and never was, to enable a patient to understand anything; the purpose is and always was to deceive, to convince a patient to accept psychiatric authority, and to ensure a patient's compliance with psychiatric treatment. The primary purpose for the "metaphor" was to manipulate people's behavior and instill the belief that their symptoms meant they had a "medical disease" or a genetic defect that required medical treatment. Like all effective propaganda, the fact the metaphor is demonstrably false and that it has been discredited, does not meant it can't still be used quite successfully to deceive patients and parents.
Metaphor is used as evidence in Courts of Law to deprive psychiatric patients of their liberty. The diagnosis equals medical disease metaphor is the evidence proffered when Involuntary Treatment petitions are filed for Court Orders to deprive people of their liberty, and compel forced psychiatric treatment. With the advent of community treatment orders, the deprivation can be a life sentence...
Currently, just like the testimony offered in Senate Hearings in 1975, which was specific to the off label use of neuroleptic and other psychotropic drugs to "treat" undesirable behaviors of intellectually disabled children, psychiatric professionals continue to claim to be providing effective medical treatment to children with behavioral problems. The evidence does not support this claim, since the evidence clearly demonstrates that the drugs used are not safe, the drugs have significant risks and even for the children the drugs seems to help, there is little to no understanding of how or why the drugs "work" for a minority of patients, but do not help others...
What is horrifyingly clear is that a massive criminal enterprise is harming the most vulnerable members of society and American's hard-earned tax dollars are paying for it. The pharmaceutical industry's corrupt marketing coupled with psychiatric fraud is decimating the social service safety net. The exact same issues of illegal marketing, off label prescribing and drug safety have been repeatedly investigated, Senate Hearings have been held with credible testimony offered outlining the same underlying deficits which have enabled illegal marketing, fraudulent claims of safety and effectiveness of psychiatric treatment, and describing the abuse of authority endemic in psychiatry. How can it be ethical or justifiable to substitute consensus for empirical evidence when developing diagnostic criteria or adopting treatment standards used in clinical practice? Psychiatry effectively standardized medical negligence of psychiatric patients, by exaggerating the safety of the drugs while denying the harm the drugs caused. Even worse, the iatrogenic injuries patients sustained were attributed to the original psychiatric diagnosis; or attributed to an emergent co-occurring psychiatric diagnosis... In real world clinical practice, iatrogenic injury, iatrogenic disability and iatrogenic fatalities ("natural" death) are common, acceptable outcomes of "successful treatment."
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