If Pharma Made Trikes: Buyer Beware!


After 10 injuries were reported, a 2010 recall of over 7 million trikes manufactured by Fisher Price took place.  It seems as if some manufacturers have come a long way and child safety standards are a top priority.  For the pharmaceutical industry, should we continue to accept “buyer beware” as the standard?

By Maria Mangicaro

Dr. David Healy’s recent post, “If Pharma Made Cars“,  crafts several very clever analogies regarding mandatory compliance of consumer safety regulations imposed on the auto and airline industries, as compared with the safety expectations of products manufactured by the tobacco and the pharmaceutical industries. [1]

Healy’s points are well made and by further exploring various concepts of consumer protection,  his analogies become much more multi-faceted for mental health consumers, advocates and lawmakers to consider.

By far, the U.S. is the global leader in the consumer protection movement.  The Consumer Bill of Rights includes eight specific guarantees:  the right to satisfaction of basic needs, the right to safety, the right to be informed, the right to choose, the right to be heard, the right to redress, the right to consumer education, and the right to a healthy environment. [2]

U.S. consumers are protected against deceptive business practices by the Federal Trade Commission (FTC).  The FTC acts to protect consumers, prevent fraud and maintain competition in the marketplace.  The FTC vision is stated as:

“A U.S. economy characterized by vigorous competition among producers and consumer access to accurate information, yielding high-quality products at low prices and encouraging efficiency, innovation, and consumer choice.“[3]

The characteristics of the mental health care system deprive many individuals of this “vision” and consumerism, which in some cases is forced, is concentrated on the purchases of psychiatric services and pharmaceutical products.

A recent resolution introduced in the Illinois House of Representatives by Rep. Mary Flowers (D-Chicago), calling for the establishment of a “Task Force on Mental Diagnosis and Illinois Law“, may help break apart psychiatry’s “monopoly of the mental illness epidemic“.   Click here to read more.

The duty of the U.S. Consumer Product Safety Commission involves protecting the public from unreasonable risks of injury or death from consumer products under the agency’s jurisdiction.  Over the past thirty years, the CPSC has contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products and continues to use innovative methods, including social networking to communicate warnings of potential hazards, especially to children. [4]

Even products that have been around for decades and seem like they would be extremely safe for children are monitored and evaluated for every possible danger.  I would never have imagined that the bean bag chairs so common in the ’70s were a potential suffocation hazard to young children.

The CPSC announced a recall of 30,000 bean bag chairs that were sold in 1999 after 3 reported incidents of young children opening the zipper and handling the foam beads.  One child needed medical attention after inhaling some of the beads.

In the same year, the most severe case of Adderall Induced Psychosis occurred, resulting in a father killing his infant daughter.  The manufacturer of Adderall announced:  “Despite the slaying, Adderall remains a safe and effective drug for controlling ADHD.”  I would never have imaged the U.S. government accepting this statement from a manufacturer.

Not all consumers are protected equally – Buyer Beware of Adderall.

Thanks to an aggressive safety approach and risk management assessment practices, consumers are given many warnings to potential hazards to children that may seem like common sense.

Standard warnings and symbols are used to ensure consumers of plastic bins are aware of the product becoming a serious suffocation risk to young children.

Most plastic bags have warnings that they are not toys and should not be placed over a child’s head (apparently for very good reasons).

While the controversy of Mercury in Vaccines and symptoms of Autism continues, the CPSC has been instrumental in preventing lead poisoning and chemical poisoning in children for several decades.

Large recalls for popular toys for children like Thomas the Train involve lead-based paint from manufacturers in China.  The CDC has a number of recommendations to prevent lead poisoning in children on their website, as our government recognizes this hazard in children.

Lead-induced neurotoxicity acquired by low-level long-term exposure has special relevance for children. A plethora of recent reports has demonstrated a direct link between low-level lead exposure and deficits in the neurobehavioral-cognitive performance manifested from childhood through adolescence. In many studies, aggressiveness and delinquency have also been suggested as symptoms of lead poisoning. [5]

Fairfax economist Rick Nevin has spent more than a decade researching and writing about the relationship between early childhood lead exposure and criminal behavior later in life.  The possibility of childhood exposure to lead and criminal behavior should be a consideration for lawmakers and the psychiatric treatment of criminals in state or federal custody.

Our government does not want children to touch or ingest toys made of lead, but it somehow finds it o.k. to ingest medications to control behavior, even though they can be deadly or have adverse effects like drug causes boys and male adolescents to develop the serious and potentially irreversible condition gynecomastia (breast development).

“The antipsychotic drug Risperdal® was originally approved by the FDA for use in adults with schizophrenia.  The drug was used “off-label” in children and adolescents, meaning it had not been approved by the FDA, for bipolar disorder, autism, irritability, aggression and behavior disorders including Attention Deficit Disorder/Hyperactivity Disorder (ADHD).”

“The manufacturer of Risperdal® applied for approval for use in children and adolescents for certain conditions. In October 2006, the FDA approved the use of Risperdal for irritability associated with autistic disorder in children and adolescents.  Additional approval in August 2007 was for treatment of acute mania or mixed episodes associated with Bipolar 1 disorder in children and adolescents.” [6]

Not all of what children may ingest is considered equally – Buyer Beware of Risperdal

The “Tour Our Product Testing Lab” CPSC Youtube video states:  “For a recall to happen, a product needs to be found to be unsafe.  But exactly what does that mean?  Here’s an inside view.  Meet the scientists.  See some of the tests.  Think about these tests when you buy and use consumer products.”

Youtube Credits:  Uploaded by     on Dec 16, 2011

For the FDA to place a Black Box warning on a pharmaceutical product, the medication needs to be found to be unsafe.  But exactly what does that mean?  Here’s an inside view.  Meet the people, hear their testimonies and investigate these stories.  Mental health consumers continue to need protection where our government continues to fail.

Youtube Credits:  Uploaded by     on Dec 13, 2006


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