Recently, AbleChild requested that the FDA run their own PSA (Public Service Announcement) to educate the public on how to report Adverse Drug Reactions directly to the Agency. The FDA’s response to our request is shocking, as they state that because MedWatch is a “voluntary” program, there is no need to run the PSA to educate the people on its existence and importance.
Ablechild often is contacted by parents concerning a number of issues surrounding psychiatric diagnosing and psychiatric drugging of children, but the recent information forwarded to us is troubling.
A Connecticut mother, who receives state health benefits, was concerned about a recent letter she received from Acurian Health, a company that “specializes in matching people to clinical research studies,” and forwarded the correspondence to Ablechild.
The mother was concerned about the implications of offering money to low-income mothers willing to enroll their child in a pharmaceutical clinical trial. More than that, she had no idea how Acurian Health obtained her personal information in order to make the “offer.”
Ablechild was equally curious how Acurian obtained this mother’s information and contacted the Behavioral Health Partnership Oversight Council, inquiring whether the state was providing this information to third parties. Ablechild did not receive a reply.
The question is, of course, does Acurian Health have access to the state’s health data? Is it possible this mother unwittingly signed a waiver allowing her personal information to be shared? The mother in question has no memory of providing authorization to release the data, but admitted that the waiver could have been in the “fine print.”
Nevertheless, Ablechild is providing this information to its members in an effort to make families aware of “offers” such as this from Acurian Health. The “offer” is targeting children 7-17 years old who “have Depression or may be experiencing symptoms of Depression,” and the “offer” further explains qualified participants “may receive Depression medication approved for use in adults.”
The only antidepressant approved by the Food and Drug Administration (FDA) for adolescents is Fluoxetine or Prozac. All other antidepressants have not been approved for children and adolescents ages 8 and older. The FDA conducted a study including 2,200 children treated with Serotonin Selective Reuptake Inhibitors, (SSRI) medications and 4 percent of those taking SSRI’s experienced suicidal thinking or behavior, including actual suicide attempts – twice the rate of those taking placebo, or sugar pills.
In response to this study, the FDA adopted “black box” warnings – the FDA’s most serious warnings – indicating that antidepressants may increase the risk of suicidal thinking and behavior. However, there are many other known adverse reactions associated with antidepressants, including mania, psychosis and hallucinations to name a few.
Ablechild cannot help but wonder if these low-income families are being targeted and lured by the pathetic “$50 per visit” offer. We are alerting families to be aware of unknowingly providing authorization for release of personal information to third parties. When applying for state health services, it is important to ask if personal information is shared with third parties and how you may opt out.
Ablechild, and the mother who provided this “offer,” is concerned that families going through tough financial times may be tempted to participate in clinical trials that admittedly will be using dangerous psychiatric drugs that are not approved for children and without informed consent.
When applying for state benefits, it’s important to know your rights and, specifically, to know if personal data will be provided to third parties.
