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Add to My Group(s)
Add to My Group(s)
By Evelyn Pringle (about the author)
Become a Fan -- Page 9 of 12 page(s)
"Many of these suicides likely could have been prevented," he said, "had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer."
Neurontin was recommended for approval by the Neuropharmacolgical Drug Products Division of the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw the FDA 's analysis of the clinical data supplied by the sponsor seeking approval to sell Neurontin.
Mr Finkelstein obtained the FDA 's 1992 analysis of the New Drug Application for Neurontin, and in reviewing the data, he told Dr Katz he found "shocking information."
"During your evaluation of serious adverse events that occurred during original clinical trials," he advised Dr Katz in the letter, "the risk of Neurontin causing suicide was both known and a major concern."
The FDA reviewer from your Division, Mr Finkelstein pointed out, "specifically stated in December, 1992:
"Serious adverse events may limit the drug 's widespread usefulness. Depression, while it
may not be an infrequent occurrence in the epileptic population, may become worse and
require intervention or lead to suicide, as it has resulted in some suicidal attempts during
clinical trials.
"In fact, during the clinical trials ... Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty two participants reporting depression so severe it required pharmacologic intervention.
"Additionally," he said, "nineteen of the seventy eight participants who reported depression during the clinical trials had no prior history of depression."
"Clearly," Mr Finkelstein wrote, "the FDA did not approve this drug with any expectation of use beyond the approved indication."
"Even though the FDA knew Neurontin caused depression that may lead to suicide and that Neurontin 's effects were never fully tested on people who suffered from chronic pain, bipolar disorder or other psychiatric conditions," he told Dr Katz, "the FDA acted with no urgency."
Mr Finkelstein reminded Dr Katz of the company's 2004 conviction for fraud in the DOJ case and said: "The complicity by the FDA in Parke-Davis 's scheme to defraud physicians and consumers is more egregious than the underlying fraud itself."
"The governmental body charged with the responsibility of protecting the health and safety of Americans has done absolutely nothing to prevent entirely preventable deaths," he continued. "Such complicity borders on criminality," he added.
On October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized the efforts by his law firm to get the FDA to warn people about the risk of suicide over 2 years and began by saying: "Due to the continued public danger facing a substantial class of prescription drug users, I am compelled to write to you regarding the FDA 's ineffective oversight related to appropriate warnings for Neurontin."
"On March 31, 2004," he reminded Mr Katz, "you were advised of thousands of serious psychiatric adverse events that occurred while Americans were taking Neurontin."
"At that time," he said, "the FDA recognized a potential imminent health crisis existed, yet nothing was done to require enhanced warning labels."
"Due to the FDA 's inaction," Mr Finkelstein continued, "my firm filed a citizen 's petition on May 17, 2004 with the hope that the FDA would investigate the potential for Neurontin contributing to self-injurious behavior."
Become a Fan -- Page 9 of 12 page(s)
Neurontin was recommended for approval by the Neuropharmacolgical Drug Products Division of the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw the FDA 's analysis of the clinical data supplied by the sponsor seeking approval to sell Neurontin.
Mr Finkelstein obtained the FDA 's 1992 analysis of the New Drug Application for Neurontin, and in reviewing the data, he told Dr Katz he found "shocking information."
"During your evaluation of serious adverse events that occurred during original clinical trials," he advised Dr Katz in the letter, "the risk of Neurontin causing suicide was both known and a major concern."
The FDA reviewer from your Division, Mr Finkelstein pointed out, "specifically stated in December, 1992:
"Serious adverse events may limit the drug 's widespread usefulness. Depression, while it
may not be an infrequent occurrence in the epileptic population, may become worse and
require intervention or lead to suicide, as it has resulted in some suicidal attempts during
clinical trials.
"In fact, during the clinical trials ... Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty two participants reporting depression so severe it required pharmacologic intervention.
"Additionally," he said, "nineteen of the seventy eight participants who reported depression during the clinical trials had no prior history of depression."
"Clearly," Mr Finkelstein wrote, "the FDA did not approve this drug with any expectation of use beyond the approved indication."
"Even though the FDA knew Neurontin caused depression that may lead to suicide and that Neurontin 's effects were never fully tested on people who suffered from chronic pain, bipolar disorder or other psychiatric conditions," he told Dr Katz, "the FDA acted with no urgency."
Mr Finkelstein reminded Dr Katz of the company's 2004 conviction for fraud in the DOJ case and said: "The complicity by the FDA in Parke-Davis 's scheme to defraud physicians and consumers is more egregious than the underlying fraud itself."
"The governmental body charged with the responsibility of protecting the health and safety of Americans has done absolutely nothing to prevent entirely preventable deaths," he continued. "Such complicity borders on criminality," he added.
On October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized the efforts by his law firm to get the FDA to warn people about the risk of suicide over 2 years and began by saying: "Due to the continued public danger facing a substantial class of prescription drug users, I am compelled to write to you regarding the FDA 's ineffective oversight related to appropriate warnings for Neurontin."
"On March 31, 2004," he reminded Mr Katz, "you were advised of thousands of serious psychiatric adverse events that occurred while Americans were taking Neurontin."
"At that time," he said, "the FDA recognized a potential imminent health crisis existed, yet nothing was done to require enhanced warning labels."
"Due to the FDA 's inaction," Mr Finkelstein continued, "my firm filed a citizen 's petition on May 17, 2004 with the hope that the FDA would investigate the potential for Neurontin contributing to self-injurious behavior."
Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.
The views expressed in this article are the sole responsibility of the author
and do not necessarily reflect those of this website or its editors.
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