"fear that people would make bad decisions if given truthful information cannot justify content-based burdens on free speech." This quote is from Justice Anthony Kennedy who seemed to imply that pharmaceutical companies have no duty to be truthful in regards to the utility of their products. Drug companies have a right to say whatever they want to about the drugs they manufacture in order to sell them or market them "off-label."
Edwards points out that "off-label promotion has previously opened up drug companies to a whole raft of different and often expensive legal liabilities. It may also harm patients by subjecting them to drugs that don't work for what the companies say they work for."
I can and do say what I want; but I cannot yell fire in a crowded theater if I wanted to without fear of being prosecuted; and rightly so. Freedom is within limits, and is not absolute. Why can drug companies mislead medical professionals and people who are ill or in distress with drug marketing agendas and/or advertising campaigns? Does the Consumer Protection Act not apply to FDA approved drugs?
The damage is potentially the same in the above scenarios: people can be maimed and killed by a panic-stricken, stampeding crowd; people can be disabled or die from taking FDA approved drugs used for FDA-approved uses, as prescribed; or from taking prescription drugs prescribed "off-label" as directed. The FDA refers to off-label use of FDA approved drugs as "experimental use" which sounds more risky than the innocuous term, "off-label." The FDA is not doing it's job ethically, with due diligence. This is painfully apparent when a person is disabled or dies from an adverse effect they were never informed of; particularly when the risk was known to the manufacturer and the FDA. Even worse, the risks are minimized or denied altogether so that the drugs can be FDA approved. The FDA proclaims that it has no ethical duty to share even fatal risks with the American public; supposedly the risks are "trade secrets." The FDA drug approval process is rarely revisited; nor is required after-market drug studies rarely done for drugs approved under PDUFA. The FDA and the drug companies deny adverse effects of the drugs, and deny responsibility for the harm caused. When the FDA approves a drug based on deception and fraud, professionals are intentionally misinformed about the the safety and effectiveness of the drug; consequently, doctors cannot give their patients accurate information. Is "Informed Consent" even possible with the pervasive corruption and collusion between the FDA and Big Pharma?
In 1999, an article in published in Science Direct concluded, "The atypical antipsychotics should be critically assessed and compared to psychosocial interventions; if effective, a combination of both types of treatments should be evaluated." Judith Rappaport, Child Psychiatry Branch at the NIMH is listed as one of the authors in the article, "Antipsychotics in Children and Adolescents." (behind a paywall) The article is not readily accessible even though it was funded by the American people through the NIMH.
In the last few decades, it has become abundantly clear that this duty is not being met: The NIMH has historically partnered with Big Pharma in funding and conducting drug research. When joint ventures are conducted there is a universal failure to effectively protect the public's safety interests. Protecting the public from dangerous drugs,medical devices, etc. is theoretically the primary responsibility of the FDA, and it's failing miserably. People recruited into Federally funded research projects are at a serious disadvantage; but so are many ordinary patients, since professionals are also being misinformed by the FDA and Big Pharma. A degree, or even several, does not signify that a person has ethics or good judgement, neither does a license to practice medicine! A degree is recognition of a person's education, and a medical license is legal permission to provide medical care. Blindly trusting that pieces of paper signify that a person is always honorable and always provides medical care in accordance with the Ethical Guidelines for Informed Consent is killing some of us...
My son was given neuroleptic, or "antipsychotic" drugs, drugs that did not work; drugs that have caused him real, lasting harm. He is not the only one who had these horrifying experiences---I cannot change what I could not stop; but as long as I live and breathe, I will try to keep the same thing from happening to any one else...A MadMother doesn't need a degree to have honor or ethical integrity---no one does.
No one asked my son's or my permission; we were not informed about the risks or told that the drugs were NOT APPROVED for pediatric use; therefore, we could not and did not give an "Informed Consent." As I see it, my son was sacrificed on the altar of NIMH funded psychiatric research and corporate greed, by Jon McClellan. The man never thought it necessary to ask if the debilitating effects of neuroleptic drugs that ultimately disabled my son would suffice in lieu of the recommended treatment which may have helped him. Instead of treatment for his severe PTSD, my son was repeatedly traumatized while being held prisoner in a locked psychiatric facility. I was lied to by Jon McClellan, Medical Director of CSTC, and research psychiatrist. Jon mcClellan illegally assumed an authority he did not have and falsely claimed that my consent for my son's "treatment" was not needed, or required. It took me almost two years to rescue my son---after McClellan finally acknowledged my son no longer needed to be in CSTC---then almost immediately obtained a Court Order for Involuntary Treatment in Pierce County Superior Court in order to prevent me from taking my son home---simultaneously, in Yakima County Superior Court, CSTC was recommending that Isaac be discharged; and the permanent plan to return my son home was implemented.
What makes me angry? The subterfuge and criminal conduct of the State's agents who act with seeming impunity, without conscience; and the knowledge that my son's experience is not uncommon. No government agency in this State has ethically fulfilled the legal duty it owes my son. When he was a 3 year old child in the State's foster care system, he was the victim of violent crime due to State negligence--so the State tried to cover it up, to shield itself from being held liable for damages---Washington State protected the State and the perpetrator; it did not act in defense of my son, a crime victim to whom the State owed a legal duty.
Once my son was a crime victim with profound PTSD and Left Temporal Lobe Epilepsy from brain trauma, the State made no effort to provide the recommended treatment for his injuries. The State was criminally negligent when it placed my son in the foster home since there had been 12 CPS reports for abuse and neglect prior to the State putting my son there.
The State ultimately violated federal Child Welfare and Medicaid law when it coerced me into signing a "Consent to Place" agreement using the fraudulent claim that it was the only way that Medicaid would pay for my son's continuing medical care. Once again in state custody, my son was repeatedly abused and medically neglected; he was heavily drugged with multiple drugs being used concomitantly, none of them approved for pediatric use. My son was repeatedly traumatized, in effect, my son was tortured by Jon McClellan in the State's psychiatric research facility for children until he was profoundly neurologically and cognitively impaired.
Why was I falsely led to believe that CSTC is a hospital, when it is not? Why was I coerced into signing a Consent to Place agreement? I can't help but conclude it was so the State could commit child welfare fraud, and also so the state's lead psychiatric researcher for children, Jon McClellan, could use my son in federally funded neuroleptic drug trials. The State never acted to protect my son, or his best interests. In truth, I don't believe my son, or his "best interests" were ever a consideration of the State's employees who had a legal duty to protect my son and his best interests. Under Color of Law, instead of acting in my son's best interests, State employees committed fraud, perjury, and Human Rights Crimes which left my precious son terrified of medical settings and permanently disabled.
Every wrong seems possible today, and is accepted.
I don't accept it.
I don't accept it.
photo credit: technoayurveda.wordpress.com