The controversy centers on Dr. Jonathan Leo's criticism of a Lexapro study published in the JAMA. Dr. Leo is a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn.
Earlier this month, Dr. Leo published an online letter in the British journal BMJ that criticized how the study's results were reported in the JAMA last year. Dr. Leo also said the JAMA didn't disclose the author of the study's financial relationship with Lexapro's maker, Forest Laboratories Inc. Forest has confirmed it has paid the study’s author for speeches, but not for his research, the Journal said.
Following publication of his letter, the JAMA's Editor-in-Chief called the dean of Dr. Leo's college demanding a retraction. In an earlier Wall Street Journal report on the “dust up”, the editor-in-chief called Dr. Leo a “nobody and a nothing”. According to The Wall Street Journal, Dr. Leo has also claimed that the JAMA's Executive Deputy Editor had told him "You are banned from JAMA for life. You will be sorry."
As we reported last week, the flap prompted the Alliance for Human Research Protection to call for an investigation, as well as the suspension of both the Editor-in-Chief and Executive Deputy Editor at JAMA. The Alliance is a group that has long criticized the ties between the drug industry and academia.
In a letter to the chairman of the JAMA board of trustees, the Alliance said medical journal editors have a responsibility “to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest.” The Alliance contends that the JAMA editors not only “failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes.” The Alliance letter charged that the incident involving Dr. Leo has raised questions about whether drug advertising influences JAMA’s publication of biased reports.
In a statement, the AMA said it has "formally referred" the matter to a seven-member Journal Oversight Committee. According to The Wall Street Journal, the oversight committee is a standing body that has editorial responsibility for JAMA, including evaluating the performance of the Editor-in-Chief. The committee is made up primarily of medical academics.
According to The Wall Street Journal, the AMA statement said it takes the concerns raised over the Dr. Leo matter "very seriously." It said the AMA board will "give careful consideration to whatever is reported to it" by the oversight committee.
In a letter to the chairman of the JAMA board of trustees, Vera Sharav, President of the Alliance, wrote that the organization was "deeply concerned about the unbecoming and unethical conduct of the Editor-in-chief and Executive Deputy Editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic, Dr. Jonathan Leo."
According to The Wall Street Journal, Dr. Leo criticized how results were reported in a JAMA study published last year that looked at the use of the antidepressant Lexapro in stroke victims. Dr. Leo also said JAMA didn't report the study's author had a financial relationship with Lexapro's maker, Forest Laboratories Inc. Forest has confirmed it has paid the study's author for speeches, but not for his research, the Journal said.
Dr. Leo is s a professor of neuroanatomy at Lincoln Memorial University in Harrogate, Tenn. His criticism of the JAMA Lexapro study appeared in a March 5 letter published by a British journal, BMJ, the Journal said.
The Alliances' letter charges that JAMA's Executive Deputy Editor threatened Dr. Leo, and its Editor-in-Chief called the dean of Leo's college demanding a retraction. In a Wall Street Journal report on the "dust up", the editor-in-chief called Dr. Leo a "nobody and a nothing", the Alliance letter says.
According to the Alliance, medical journal editors have a responsibility "to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest." The Alliance contends that the JAMA editors not only "failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes."
The Alliance letter charges that the incident involving Dr. Leo has raised questions about whether drug advertising influences JAMA's publication of biased reports. The conduct of the JAMA Editor-in-Chief also "touched off an outpouring of 158 angry responses posted on the Wall Street Journal Health blog, the majority posted by physicians, several respondents indicated they are canceling their JAMA subscriptions," the letter claims.
The letter concludes with a call for a public apology to Dr. Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in the matter, a thorough investigation, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies.
According to Forest Laboratories, about two million teenagers in this country have experienced MDD in the past year, said HealthDay News; a fact used to market Lexapro to young patients despite evidence showing that Lexapro promotes suicidal thoughts in pediatric patients. The U.S. Justice Department recently charged Forest Labs for such inappropriate marketing to children. Now, less than one month later, Forest Labs received approval for Lexapro to be prescribed to the very group it was accused of improperly marketing, points out Modern Medicine.
In a prior Wall Street Journal (WSJ) article, the same prosecutors charged Forest Labs with violating anti-kickback laws by paying doctors to prescribe Lexapro to vulnerable, pediatric patients. The suit also accused Forest Labs of violating the False Claims Act when it marketed the drug and accuses Forest of covering up a medical study that concluded that Lexapro and Celexa—another antidepressant—were not effective medications for children, said WSJ. An earlier Bloomberg.com article said the complaint charges that Forest was unwavering in its marketing of the drugs.
Knowing that the drugs were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs, hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) had not approved the drugs for use in children at that time.
Lexapro was approved for adults in 2002 and is one of a class of antidepressants called selective serotonin reuptake inhibitors—or SSRIs. Lexapro and other similar drugs now include a “black box” warning label indicating that the medications are linked with an increased risk of “suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders,” quoted HealthDay News, adding that those considering Lexapro use in pediatric patients “must balance this risk with the clinical need.”
Reuters said federal prosecutors alleged both Lexapro and Celexa have been inappropriately used to treat pediatric depression and that after a five-year investigation, the U.S. Justice Department accused Forest of urging pediatricians to prescribe the drugs, enticing them with bribes and perks, said Reuters. The complaint also accused Forest of ignoring a study that revealed that Celexa, which is chemically similar to Lexapro, was ineffective in children and then having its sales staff use a second study that with more positive outcomes for Lexapro’s pediatric use, reported Reuters.
Using the complimentary study, the FDA approved the controversial medication for use in the vulnerable population despite established research to the contrary and that the study used did not indicate the drug’s efficacy; Forest also admitted that there was no clinical proof that Lexapro could control symptoms in teens taking Celexa. Regardless, the FDA said such “maintenance efficacy” could be “extrapolated” from adult data.
According to the Wall Street Journal (WSJ), the same prosecutors have charged that Forest Labs also violated anti-kickback laws by paying doctors to prescribe Lexapro and Celexa to vulnerable, pediatric patients. A lawsuit filed by the department now accuses the drug maker of violating the False Claims Act when it marketed the drug, The civil complaint also accuses Forest of covering up a medical study that concluded that Lexapro and Celexa were not effective medications for children, said WSJ. The complaint was unsealed in Boston federal court yesterday.
According to Bloomberg.com, the complaint charges that Forest was unwavering in its marketing of the drugs. Knowing that they were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs and hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) never approved the drugs for use in children.
According to the DOJ, Forest’s bribes and inappropriate marketing resulted in false claims submission for reimbursement to federal health care programs said the Journal. Bribes included not just cash payments—falsely described as grants and consulting fees—but pricey meals and other expensive gifts which violated anti-kickback laws, said Bloomberg. “By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study, and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs,” Massachusetts U.S. Attorney Michael Sullivan said in the complaint, reported Bloomberg.
Now, under the federal False Claims Act, the DOJ is looking for triple the financial damages from Forest in addition to other penalties; the total compensation sought is unknown, said the Journal. Bloomberg noted that under the Act, the government is eligible to receive treble damages and civil penalties of up to $11,000 per violation.
This case and others may be evidence that the DOJ is making a concerted effort to crack down on the illegal drug marketing practices. The Journal pointed out that just last week, the DOJ joined a whistle blower lawsuit against Johnson & Johnson in which the drug maker is charged with illegally marketing its cardiac medication Natrecor. Also, last month, Pfizer Inc. and Eli Lilly & Company both agreed to payouts in two separate cases involving illegal marketing, said the WSJ. Pfizer agreed to pay over $2 million in response to charges it illegally promoted it now-withdrawn painkiller Bextra. Eli Lilly agreed to pay $1.4 billion in fines to settle similar claims over its antipsychotic Zyprexa.