Less Dangerous Drugs Given to Children Without Sales Rep Influence
New research suggests that when drug company sales representatives are around, doctors are more likely to prescribe risky antidepressants and antipsychotics to children for uses that are not approved by the FDA as safe or effective, suggesting sales reps may be finding a way around legal restrictions on drug marketing.
In a study published in the June issue of the medical journal Health Affairs, researchers from the University of California – Los Angeles, and Brigham and Women’s Hospital in Boston report that when sales representatives are banned from interacting directly with doctors, those doctors do not tend to prescribe powerful psychotropic drugs to children, or at least do so significantly less.
“The treatment of pediatric depression is controversial because it includes substantial prescribing of drugs for uses that have not been approved by the Food and Drug Administration and are not evidence based,” the researchers state.
While doctors are able to prescribe medications even for uses that have not been approved, it is illegal for drug manufacturers to promote such “off-label” uses until the FDA determines that the indication is safe and effective.
In some cases, academic medical centers, or teaching hospitals, restrict what is known as “detailing” by sales reps; when they promote drugs directly to prescribing physicians through sales calls. The study looked at data from 31 teaching hospitals and looked at the effects of anti-detailing policies from January 2006 through June 2009.
Where the policies were put in place, off-label drug prescribing to children of antipsychotics and antidepressants that were actively promoted to doctors fell off by 11% and on-label prescribing fell by 34%. Prescriptions of drugs that were not being actively promoted actually rose 14% for on-label prescribing and 34% for off-label prescriptions.
Researchers said that the findings clearly show that sales representatives are breaking the law and promoting antidepressants and antipsychotics to doctors for off-label uses.
Antidepressant and Antipsychotic Drug Risks For Children
Both antidepressants and antipsychotics have been linked to a number of side effects for children, which can result in potential adverse health effects. However, many of the medications are widely prescribed off-label, with prescriptions for children accounting for a substantial portion of sales, even for drugs not approved for use among children.
Potential side effects of medications may be different for children when compared to adults, and concerns have been raised about whether the impact on developing children has been properly evaluated with many popular medications.
Johnson & Johnson currently faces several hundred Risperdal lawsuits brought on behalf of young boys who developed breasts after taking the antipsychotic. The complaints allege that the drug maker failed to adequately warn consumers and the medical community about the potential side effects of Risperdal for boys.
Risperdal and other similar antipsychotic medications, such as Abilify, Seroquel, Zyprexa and others, have also been linked to an increased risk of diabetes in children. According to a 2011 study published in the medical journal in Pediatrics, 3.23 out of every 1,000 children given the drugs will be diagnosed with diabetes just 4.5 months after beginning treatment, which compares to just 0.76 children per 1,000 who are diagnosed with diabetes who did not take an antipsychotic. However, use of the medications remain popular among children.
A popular class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which includes drugs like Paxil and Zoloft, have also been linked to potential risks for children, including a risk of suicide among young patients given high doses. The larger the starting dose, the greater the risk of suicide and self-harm. According to those findings, a suicide or self-harm event occurred for one out of every 150 patients treated with high-dose SSRI therapy.
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