Posts Tagged ‘Cures’

The psychiatric Rush to Market

Monday, February 17th, 2020
Psychiatry has always given the impression that cures were the rule, rather than the exception. However, the psychiatric industry itself admits it has no capacity to cure.

Psychotropic drugging is big business — a high-income partnership between psychiatry and drug companies that has created an $80 billion industry in psychotropic drugs.

Psychiatrists tell us that the way to fix unwanted behavior is by altering brain chemistry with a pill. But unlike a mainstream medical drug like insulin, psychotropic medications have no measurable target illness to correct, and can upset the very delicate balance of chemical processes the body needs to run smoothly. Nevertheless, psychiatrists and drug companies have used these drugs to create a huge and lucrative market niche. And they’ve done this by naming more and more unwanted behaviors as “medical disorders” requiring psychiatric medication.

Thus there is a continuing need to find or create new patients to which to market new drugs, and a continuing rush to market for the latest drugs regardless of their harmful side effects.

The Risk of Side Effects

In a study of 68,730 individuals it was found that psychotropic drugs (SSRIs, mood stabilizers, antipsychotics, and benzodiazepines) are independently associated with a significantly increased risk of hip fractures and other major osteoporotic fractures.

Lead author Dr. James Bolton at the University of Manitoba says, “So physicians need to think about fracture risk as they are prescribing these medications, especially in patients who are vulnerable to fracture.”

Psychiatric Marketing Campaigns

Almost a third of drugs cleared by the U.S. Food and Drug Administration pose safety risks that are identified only after their approval. Thus we say “rush to market”; you can find hidden drug marketing campaigns practically everywhere.

Many of these marketing campaigns come from industry?funded front groups operated by psychiatrists but posing as compassionate patient support groups. Of all these programs, one of the most successful is the benevolent?sounding mental health screening campaign; it uses broad?based psychiatric screening questionnaires to diagnose common life situations such as sadness, nervousness and occasional loneliness.

Currently running is the “suicide prevention” campaign. But statistics show that there is no teenage suicide epidemic; and participants in these programs are more likely to consider suicide a solution to a problem after the screening program than before the program.

With a long and well-documented history of failure, psychiatrists and their drugs are under attack by government safety warnings, legislation, and tens of thousands of lawsuits.

Interestingly, underlying most psychiatric problems is an undiscovered and untreated physical illness. And when that is cured, so is the “mental problem.” But because of the powerful hold psychiatrists and drug companies exert over the rest of the medical field, this is rarely told to patients. To protect yourself and those you love, insist on a full and accurate consent: an accounting of all risks and benefits of the treatment recommended, of other treatments and of not doing anything at all.
Modern World

Power to the Patients

Monday, January 27th, 2020
Listening to a radio program about considerations of political power in the Middle East made us wonder more generally about the concept of power. Their main consideration was the accumulation of power in order to control various elements of society. We noticed how this might apply to abuses in the mental health industry.

Power is one of those English words with multiple definitions. Generally it means “the ability to act or produce an effect”. In other contexts, for example in physics, it has the definition “the time rate of doing work.” In the referenced radio program it meant “relating to political, social, or economic control.” There are other specific definitions in mathematics, religion, business, law, etc.

In a very practical personal sense power means “being able to do what one is doing when one is doing it.” In another practical sense it means “the ability to hold a position in space.” Power represents total abundance where nothing can strike you down. A Zone of Power could be considered the area over which one has responsibility and control.

We ask how all this might relate to patient abuse in the mental health industry.

Coercive Psychiatry

When we speak of “coercive psychiatry” we mean that psychiatry is used as a means of social control against which one has no recourse and cannot fight back. Prime examples are involuntary commitment and enforced treatment.

As the late Professor Thomas Szasz said, “coercive psychiatrists function as judges and jailers not physicians and healers” with the power of life and death over the most vulnerable people.

“Disguising social control as medical treatment is a deceit which conceals an abuse.” This is a de facto abuse of power, as it seeks to limit and control the individual instead of helping the individual to get better and improve their conditions in life.

Coercive psychiatry is not intended to cure anything. On the contrary, psychiatry is the science of control and entrapment, and having power over distressed and vulnerable individuals. Wherever men have advocated and advanced totalitarianism, they have used psychiatric principles to control society, to put limits on individual freedom, to suppress and punish dissent, and to trap people into worsening conditions. It is actually a mis-use of power, since its intentions are to make less of a person’s self-determinism and give more power to others and the state.

All too often people may mistakenly disparage their own strength or power; do not allow psychiatry to crush you even further.

Click here to read more about psychopolitics — the art of asserting power over the thoughts and loyalties of individuals and the conquest of enemy nations through “mental healing”.

Supporting and Treating Officers In Crisis Act of 2019

Sunday, August 18th, 2019

Introduced by Republican Missouri Senator Josh Hawley, the “Supporting and Treating Officers In Crisis Act of 2019” (S. 998) was signed into law by President Trump on July 25, 2019.

This bill reauthorizes and expands certain Department of Justice grant programs to provide mental health, stress reduction, psychological services, suicide prevention services, and training for identifying, reporting, and responding to officer mental health crises and suicide, for law enforcement officers and their families. The bill authorizes up to $7,500,000 in appropriations each year for fiscal years 2020 to 2024, a maximum total of $37.5 million.

This sounds eminently socially acceptable, and indeed the bill was widely supported by Congress and various national advocacy groups.

The Real Crisis in Mental Health

While society certainly owes significant consideration and support to law enforcement officers (LEOs) and their families, we can’t help noting that in today’s environment, “mental health and suicide prevention services” really means psychiatric drugs and other harmful psychiatric treatments.

The real crisis in mental health care today is not officer stress, but psychiatric fraud and abuse.

While the bill specifically calls for evidence-based programs, the evidence actually shows that psychiatrists don’t know what causes mental trauma, are unable to predict violence or suicide, and cannot cure any mental disorder they claim to treat.

Psychiatric Fraud

By their own admission psychiatrists cannot predict violence or suicide, and often release violent patients from facilities, claiming that they are not a threat. In 1979, an American Psychiatric Association’s task force admitted in its Brief Amicus Curiae to the U.S. Supreme Court that psychiatrists could not predict dangerousness. It informed the court that “‘dangerousness’ is neither a psychiatric nor a medical diagnosis, but involves issues of legal judgment and definition, as well as issues of social policy.” In addition to not being able to predict violent behavior, psychiatrists certainly have no cures for it, a fact that even they admit.

Psychiatric diagnoses are not based on science, but opinion. Psychiatrists do not have any scientific or medical test to diagnose a person’s mental condition and rely upon faulty observation and opinion of behavior. They admit to not knowing the cause of a single mental disorder or how to cure them. The error in their opinions is enormous — they condemn the innocent, release the dangerous, induce violence in others through drugs and commit people who are not in need of help or turn those away who may genuinely be in need of it.

Recommendations

Rather than training psychiatrists and psychologists about LEO mental health, the grants should be used to train LEOs, security personnel, teachers, coroners, and other professionals to recognize that irrational, violent and suicidal behavior could be caused by psychiatric drugs.

Click here to download and read the CCHR report “Psychiatric Drugs Create Violence & Suicide — School Shootings & Other Acts of Senseless Violence.”

Click here to download and readPsychiatrists Cannot Predict or Cure Violence.

Now They Are Arguing About Exercise

Thursday, September 13th, 2018

Psychiatric researchers from Yale University and other brain research institutions have analyzed 1.2 million people to see how exercise affects a person’s mental health.

The results and subsequent discussions have been blasted across all news media, and are proliferating rapidly.

Anyone with an exercise bike has been chiming in; some say their depression didn’t go away with exercise, some say it did. With glee, many reporters emphasize one particular result of the study, that “there is such a thing as too much exercise.”

The researchers measured “self-reported mental health.” Naturally, they also reported that more study was needed; needing more study (i.e. needing more research funds) is a standard result of many self-perpetuating studies. One could say they are exercising their right to continue working.

For this study, the only mental health disorder that the researchers took into account was “depression,” using something called the “Behavioral Risk Factor Surveillance System,” with questions such as “Now thinking about your mental health, which includes stress, depression, and problems with emotions, for how many days during the past 30 days was your mental health not good?”

We’re incredulous that this ridiculous research is given so many column inches of press, and that it took 1.2 million people to decide that sometimes exercise helps one feel better and sometimes it doesn’t.

If exercising sarcasm were a disease, we’d probably be dead by now.

OK, let’s look at this from another point of view. First, what do people actually mean by “good mental health?” We often say that psychiatry produces no cures, and for good reason. But what would a mental health cure look like? We’d probably call that “good mental health.” Here’s what we think:

We generally take cure to mean the elimination of some unwanted condition with some effective treatment. The primary purpose of any mental health treatment must be the therapeutic care and treatment of individuals who are suffering emotional disturbance. The only effective measure of this treatment must be “patients recovering and being sent, sane, back into society as productive individuals.” This, we would call a cure.

So, good mental health must then be “operating sanely in society as productive individuals.”

Second, what do people actually mean by “depression?” We often say that there is no such disease as depression, since there are no clinical tests for it. There are two main possibilities — one is an undiagnosed and untreated medical condition; the other is the opposite of good mental health, which would be “operating insanely in society as non-productive individuals.”

So what is the cure? In the first case, using standard clinical tests (blood tests, urine tests, x-rays, DNA tests, MRI, ultrasound, etc.) find and treat the actual medical condition. In the second case, get busy being productive; and hence we get the occasional benefits of exercise as it relates to the productivity of one taking some responsibility for one’s own health.

We might say that depression could actually be low morale; and since morale is based on production, find something useful to do and hop to it!

Psychiatry & Psychology Have Embraced the Entrepreneurial Spirit

Friday, July 20th, 2018

Entrepreneur: One who organizes, manages, and assumes the risks of a business or enterprise, often with an additional connotation of far-sightedness and innovation with boldness and energy. [French, from Old French, from entreprendre to undertake; entre- between  (from Latin: inter-) + prendre to take (from Latin: prehendere to grasp)]

The U.S. government funded training for substance abuse researchers in entrepreneurship at Yale, so they could learn how to get more funding for their health care startups about substance abuse.

Scholarly articles have been published about “The Psychology of Entrepreneurship“. One such study we noticed focused on industrial and organizational psychology (it has its own abbreviation, I/O); many of its key conclusions were to plead for more research in that area. We think that one of the primary goals of this kind of psychobabble is to set the stage for getting more research funds, rather than coming up with anything truly useful.

Another news article in the Washington Postnoticed that entrepreneurs seem inclined to have mental health issues.” There are any number of news reports about “the problems entrepreneurs with mental illness often face,” and “managing your mental health as an entrepreneur,” and yet again “the psychological price of entrepreneurship.”

So it seems that psychiatry and psychology have latched onto entrepreneurs as a new category of those needing “help,” a new pool of potential customers. Entrepreneurs have been targeted by the mental health industry both as a new customer pool and a new way to do business. The competition for government funding and grants to address the problems of entrepreneurship is heating up, and the psychobabble is deafening.

Research also confirms that minorities are more likely to be misdiagnosed as having serious psychiatric problems, leading to the psychiatric targeting of  entrepreneurial minorities.

And, like any entrepreneur, psychiatrists are looking to the future. Since they have never been required to cure anyone, they continually come up with new disorders, new drugs, and new treatments which they can apply to new communities of potential patients.

The news is full of these “miracle” treatments — marijuana, cannabidiol, electric shock (yes, they still do this, and it is a big money-maker), MDMA (Ecstasy), trauma-informed therapy, Ketamine, cognitive-behavioral therapy, transcranial magnetic stimulation, assisted suicide (yes, this is considered a “treatment”), deep brain stimulation, involuntary commitment, vagus nerve stimulation, addiction therapy (ignoring the fact that psychiatric drugs are addictive), and one drug after another — each new one designed to combat the adverse side effects of the one before.

Not to mention the profusion of new mental health related applications for your mobile device and the startups that create these. Not to mention this recent headline: “Entrepreneur Teams Up with Leading Psychiatrist to Address Depression, Anxiety, and Suicide“. Not to mention that the producers of “Shark Tank” mandated that “all entrepreneurs meet with a psychiatrist after giving their pitch, regardless of the outcome.

The news is devoid, however, of one thing — actual cures for mental trauma.

Click here for more information about fraud and abuse in the mental health industry. Read about how Full Informed Consent can help.

Patients For Life

Monday, April 2nd, 2018

A leading cause of death in patients diagnosed with a serious mental condition (such as schizophrenia, bipolar disorder, and depression) has been preventable medical conditions such as cardiovascular disease (CVD) and diabetes, metabolic disorders which are typical side effects of being treated with second generation (atypical) antipsychotics.

The majority of those who screen positive for these types of metabolic disorders do not receive treatment for these medical conditions. Even worse, the majority of patients being treated with these antipsychotics are not even screened, with simple blood tests, for these side effects.

A tremendous amount of effort, lasting over at least the last 15 years, has been expended in trying to change the U.S. medical system to implement simple blood test screening protocols for patients being prescribed antipsychotics. Many reasons have been given for this reluctance to change, but the most obvious reasons were not among them — the fact that no one knows how these drugs work, that they are addictive, harmful, and are causing side effects that produce continuing income from these patients for life, a life albeit shortened by the metabolic disorders caused by the drugs.

The general attitude of the mental health care industry is that mental disorders are comorbid with metabolic disorders. This means that there is a simultaneous presence of these two chronic conditions in a patient, with little thought given to the fact that metabolic disorders can be the side effect of the drugs being given for the mental disorder. Since the drugs are addictive, harmful, and have nasty side effects, the obvious solution is to stop prescribing the drugs and use one or more of the many non-drug alternatives. This, however, would deprive the industry of one of its top money-makers.

Patients already presenting with CVD or diabetes, or who have known risk factors for these, should not even be considered as candidates for antipsychotics, and should also be screened for any other undiagnosed and untreated medical conditions which may be causing mental symptoms.

A case could be made for malpractice if blood test screening for metabolic disorders is not being performed for patients vulnerable to these diseases, especially since the medications that psychiatrists prescribe increase vulnerability to metabolic syndrome. [Metabolic syndrome is a cluster of metabolic disorders, usually including increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels — that occur together, increasing the risk of heart disease, stroke and diabetes.]

Psychiatrists should be responsible for monitoring any potential side effects associated with the drugs that they prescribe; therefore, it is negligent if monitoring is not being done.

We are seeing a huge increase in the rate of antipsychotic prescriptions among younger pediatric patients, yet the younger one is, the lower one’s chances of being monitored.

Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), statistics are touted about near “epidemic” rates of mental illness in order to demand more government funds and sell more harmful drugs, making people “patients for life” as the drug adverse events then require more drugs to handle these harmful side effects.

Contact your local, state and federal authorities and legislators and demand that funding for psychiatric promises be revoked until the mental health industry can prove its effectiveness with actual cures.

What is Happiness?

Monday, November 6th, 2017

If you want happiness for an hour — take a nap.
If you want happiness for a day — go fishing.
If you want happiness for a year — inherit a fortune.
If you want happiness for a lifetime — help someone else.

[Chinese Proverb]

What is happiness, really? Is it “happy pills?” Mother’s little helper? Is “happiness” the opposite of “depression,” so that an anti-depressant should make one happy? Unfortunately, what anti-depressants do is actually detach one from reality; and the only happiness accrues to pharmaceutical companies who rake in $80 billion a year worldwide for psychiatric drugs.

As is usual with English words, “happiness” has more than one definition: 1) transient pleasure; 2) overcoming not unknowable obstacles toward a known goal; 3) a condition or state of well-being, contentment, pleasure; 4) joyful, cheerful, untroubled existence; 5) the reaction to having nice things happen to one.

Psychiatry, however, redefines happiness as a manic or hypomanic indication (associated with a bipolar diagnosis) which occurs in 14 separate entries in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5.)

Manic: characterized by frenetic activity or wild excitement; excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganization of behavior and elevation of mood.
Hypomanic: A mild form of mania, marked by elation and hyperactivity; a mood state characterized by persistent dis-inhibition and pervasive euphoria.

“Treatment” generally includes psychotropic mood stabilizers, unless the state is a result of drug abuse or drug side effects — in which case the “treatment” may include psychotropic sedatives. All of these psychotropic drugs are addictive, mess up the central nervous system, and can have many disastrous side effects including violence and suicide.

For more information about mood stabilizers such as Lithium, Depakote (sodium valproate), Depakene (sodium valproate), Lamictal (lamotrigine), Lamictin (lamotrigine), Lamogine (lamotrigine); download and read the booklet Mood Stabilizers — the facts about the effects.

One psychologist even overtly proposed happiness as a psychiatric disorder. [From the website of the National Center for Biotechnology Information, U.S. National Library of Medicine, a division of the National Institutes of Health]. One might think this was an April Fool’s joke, except that it was published in June.

Published in the Journal of Medical Ethics – J Med Ethics. 1992 Jun;18(2):94-8
“A proposal to classify happiness as a psychiatric disorder”
Richard P Bentall, Professor of Clinical Psychology at the University of Liverpool in the UK:

“It is proposed that happiness be classified as a psychiatric disorder and be included in future editions of the major diagnostic manuals under the new name: major affective disorder, pleasant type. In a review of the relevant literature it is shown that happiness is statistically abnormal, consists of a discrete cluster of symptoms, is associated with a range of cognitive abnormalities, and probably reflects the abnormal functioning of the central nervous system. One possible objection to this proposal remains–that happiness is not negatively valued. However, this objection is dismissed as scientifically irrelevant.”

We think we can safely say this psychologist’s attitude is a misanthropic manifestation; the DSM-5 might call it “Adult antisocial behavior”, “Antisocial personality disorder”, or maybe just “Unspecified anxiety disorder”.

It is true that a euphoric condition is often associated with certain hallucinogenic drugs. We wouldn’t actually call that “happiness”, however; and the mania associated with many psychiatric drugs is not sustainable.

What would promote happiness is an actual cure for mental distress. The psychiatric industry itself admits it has no capacity to cure. We generally take cure to mean the elimination of some unwanted condition by some effective treatment. The primary purpose of any mental health treatment must be the therapeutic care and treatment of individuals who are suffering emotional disturbance. The only effective measure of this treatment must be “patients recovering and being sent, sane, back into society as productive individuals.” This, we would call a cure.

While it is illegal for FDA-regulated products to make cure claims, there are in fact many non-drug and non-psychiatric alternatives which may prove effective in handling traumatic conditions. The trick is in finding out what is really wrong and fixing that, not just suppressing the central nervous system with drugs so that one does not feel the bad emotions.

Click here for more information about alternatives to fraudulent and abusive psychiatric treatments.

Click here for the truth about psychiatric drugs.

Click here for The Way To Happiness, the first moral code based wholly on common sense, containing twenty-one basic principles that guide one to a better quality of life.

Passage of the 21st Century Cures Act

Saturday, December 17th, 2016

If you contacted your Senators and Representative about the dangers of the 21st Century Cures Act, thank you very much.

Unfortunately it passed — 392 to 26 in the House, and 94 to 5 in the Senate.

While some of the $6.3 Billion funded by this legislation is not controversial and may even be beneficial, a large chunk of the money will go to fund suicide-prevention programs, mental health services for children, and programs for court-ordered psychiatric outpatient treatment. It reinforces current laws that require insurers to treat mental illness as they do any other illness in terms of benefits (“parity“). And it creates a new position in the US Department of Health and Human Services called the Assistant Secretary for Mental Health and Substance Use for coordinating mental health programs across the federal government.

The bill also lowers the regulatory bar of the Food and Drug Administration,  which may result in less safe and effective products reaching the market by putting less emphasis on clinical trials, which has caused some critics to label it the 21st Century Quackery Act. The FDA insists it will not compromise safety and efficacy; but they have already shown their fake reliance on safety and efficacy by approving psychotropic drugs and trying to make it easier to approve electric shock machines.

How concerned should we be? Very concerned. Proliferation of coercive and abusive mental health “care” by the current psychiatric industry is a waste of lives and funding.

Instead, here is what we should be doing:
1. Mental health hospitals must be established to replace coercive psychiatric institutions, where appropriate medical diagnostics and treatments can be performed. Proper medical screening by non-psychiatric diagnostic specialists could eliminate more than 40% of psychiatric admissions.
2. Establish rights for patients and insurance companies to receive refunds for harmful and abusive mental health treatment.
3. Clinical and financial audits must be done for all psychiatric facilities to uncover and correct fraud and abuse.
4. All mental disorders in the DSM should be validated by scientific, physical evidence.
5. Abolish mental health courts and mandated community mental health treatment.
6. Citizens groups and responsible government officials should work together to expose and abolish psychiatry’s hidden manipulation of society.

The Cure Conundrum

Saturday, September 19th, 2015

The Cure Conundrum

We often say that psychiatry produces no cures, and for good reason. There is a lot of history behind the concept of “cure;” we’d like to touch on a small piece of that.

The psychiatric industry itself admits it has no capacity to cure.

“We do not know the causes [of any mental illness]. We don’t have the methods of ‘curing’ these illnesses yet.” [Dr. Rex Cowdry, psychiatrist and director of National Institute of Mental Health (NIMH), 1995]

“The time when psychiatrists considered that they could cure the mentally ill is gone. In the future the mentally ill have to learn to live with their illness.” [Norman Satorius, president of the World Psychiatric Association in 1994]

“What’s a cure?…it’s just that it’s a term that we don’t use in the medical [psychiatric] profession.” [Dr. Joseph Johnson, California psychiatrist during court deposition, 2003]

We generally take cure to mean the elimination of some unwanted condition with some effective treatment. The primary purpose of any mental health treatment must be the therapeutic care and treatment of individuals who are suffering emotional disturbance. The only effective measure of this treatment must be “patients recovering and being sent, sane, back into society as productive individuals.” This, we would call a cure.

Interestingly enough, elements in this society have systematically tried to downplay or eliminate the concept of cure, especially in the area of mental health. Consider the following quote:

“In the early 1900s, years of exaggerated claims finally caught up with the rest of the patent medicine industry. Inspired by muckrakers like Samuel Hopkins Adams, the official medical community embraced his expose called The Great American Fraud and began their battle against the nostrum-peddling industry. The public demanded appropriate labeling for patent medicines. But the newspaper lobby, supported by the advertising dollars from an $80 million patent medicine industry, kept national legislation tied up for months. Finally, the Pure Food and Drug Act was adopted in June of 1906 with regulations forcing the sellers who made patent medicine to disclose contents and give quantities of ingredients such as alcohol, morphine, opium, cocaine and heroin. Six years later, the government passed an amendment forbidding the use of the word ‘cure’ on a bottle.” [page 141, Pure Sea Glass, Richard H. LaMotte, Sea Glass Publishing, 2004]

[A nostrum is a medicine, especially one that is not considered effective, prepared by an unqualified person; from Latin meaning our, used in the sense ‘(something) of our own making’.]

While it is illegal for such FDA-regulated products to make cure claims, there are in fact many non-drug and non-psychiatric alternatives which may prove effective in handling traumatic conditions. The trick is in finding out what is really wrong and fixing that. Or at the very least, using a broad-spectrum, many-pronged approach aimed to handle a wide variety of possible conditions. In any case, the point is to use a treatment that does not itself cause further harm, such as is the case with psychiatric drugs and other “treatments” promoted by the psychiatric mental health industry.

Click here for more information about alternatives to fraudulent and abusive psychiatric treatments.

21st Century Cures Act

Sunday, July 12th, 2015

21st Century Cures Act

H.R.6, the 21st Century Cures Act, is rushing through Congress now. This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) budget, and to make some major changes in the NIH, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), Medicare, the Controlled Substances Import and Export Act, and the Department of Health and Human Services.

We are pretty sure that not all of these changes are going to be benign. We invite you to read the Act and read the rebuttal, decide for yourself, and contact your Congressmen now with your personal opinions.

Warning: the text of the Act is difficult to read in the context of the laws it is proposing to change, since it does not print the revisions in line of the original law, as in proposed Missouri legislation for example, but instead just prints the text being removed and the text being inserted.

Here are some salient quotes from the rebuttal:

“The Act is a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.”

“The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consent.”

“But if pharmaceuticals are no longer required to have evidence that they improve health outcomes, how are they any better than snake oils? One only needs to look as far as the recent history of psychiatry to see that the line between snake oils and ‘evidence based medicine’ is already woefully thin.”

“The 21st Century Cures Act diminishes the rocks on which modern medicine are based – informed consent, individual body autonomy, the Hippocratic Oath, and basing medicine on scientific evidence.”

Obviously we are not diagnosing or recommending treatments here. We want to alert you to this Congressional action, and make sure you are informed so that you can exercise your own judgment. While sections of this proposed legislation are likely useful, there are other sections that may be damaging in the long term and may be passed into law in haste.

Here is an example of a section called out in the rebuttal (“With the passage of the 21st Century Cures Act, drugs will be rushed to market with little testing required.”):

“SEC. 2022. Accelerated approval development plan. In the case of a drug that the Secretary determines may be eligible for accelerated approval in accordance with subsection (c), the sponsor of such drug may request, at any time after the submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, that the Secretary agree to an accelerated approval development plan described in paragraph (2).”

This refers to paragraph (2) which describes the use of a “surrogate endpoint” in an accelerated approval development plan. The term “surrogate endpoint” means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit. So a result of this could be that clinical trials no longer measure the clinical benefit of a new drug on the fast track to approval, just unspecified changes in various measurements that may, or may not, be beneficial to the patient. This is the kind of change that causes us to question the haste and wisdom of this proposed Act.

Let us know when you contact your Congressmen about this, and any response you may receive.

And read what we have to say about Informed Consent.