Commander Donald J. Farber, Esq., USN (Ret.)
Introduction and Background
Thank you Mr. Chairman. My name is Don Farber. I am a Navy veteran, 25 years in the line; half that time sea duty. For the past 17 years, I have practiced law in San Rafael, California—with a large portion of my practice representing victims of antidepressant suicide. I have gathered information on antidepressants and suicide over the years, including:
- deposing pharmaceutical CEO’s, FDA officials, pharmacists, industry psychiatrists, and treating physicians;
- reviewing many of industry’s so called “trade secrets” on antidepressants and suicide—documents the public and the FDA never see.
- acting as a co lead counsel from 2002-2006 in federal court, Los Angeles, on the Plaintiffs’ Steering Committee on a mass tort case involving Paxil and 3,000 plaintiffs who alleged addiction from the drug;
- addressing the last three (3) advisory committee hearings on antidepressants and suicide convened by FDA.
A “Religious War”
The antidepressant suicide debate has been ongoing since Prozac entered the market in 1988—the FDA’s having received 350 reports of completed suicides by Prozac patients by early 1991. The debate has always been intense, one medical historian quoted as calling it a “religious war.” My testimony today excludes the related issue of third party violence which may relate from antidepressants, such as the rising number of unexplained school, workplace, and shopping mall massacres.
Of Course, They Do!
Do antidepressants cause suicide? Of course they do! Antidepressant manufacturers would not secretly settle wrongful death lawsuits for large sums that they do if these were just nuisance suits. In antidepressant clinical trials going back to the 1980’s, the manufacturers’ own principal investigators have assessed several hundred suicide related adverse event as “caused” by the antidepressant.
Antidepressant manufacturers cannot credibly deny their medications cause suicide. Their voluntarily adopted “Warning” labels entitled “Clinical Worsening and Suicide Risk,” on their medications translate to a meaningful conclusion. By federal regulation, the companies’ cannot issue these “Warnings” unless there is reasonable evidence of a QUOTE causal association UNQUOTE between the drug and suicidality. In short, the companies--with their labels--legally acknowledge causation despite their continuing overtures to the contrary.
No Clinical Trials on the Subject—Ever!
Looking to this Committee’s focus on hopeful solutions to the suicide problem, if there is one point I’d like to emphasize today, it is this. A major scientific gap exists in the 20 year antidepressant suicide debate. There has never been a prospective trial designed to test the link between the antidepressants and suicidality. Do not take my word for this. I leave with the Committee my work product in the packet—citing 27 sources affirming what I just reported. (“Work Product”) The irony is that antidepressant enthusiasts, before the debate starting going against them, criticized plaintiffs’ experts as “junk scientists” for opining on medication induced suicide. What is “junk science” is the implication real science exists to deny antidepressant suicidality when nary a scientific trial has ever been conducted to make that determination.
20 Years of “Ethics”—or Self Preservation?
Why no testing? One theory for the historical failure to test is because the companies fear the likely results. Documenting the scientific link between antidepressants and suicide would significantly erode consumer and provider confidence in the medications, even more so than the events of 2004 when the FDA first acted on the subject. It is noteworthy that the FDA has not invoked its powers under the Food Drug & Cosmetic Act (“FDCA”) to require antidepressant manufacturers to specifically test for suicide. While safety is a threshold requirement for any drug approval, “two well controlled trials” demonstrating efficacy are all that is required under FDCA to get the drug on the market. Safety is more of a subjective call, and is a requirement the FDA can often satisfy by adequate labeling. Over the years industry has offered shifting explanations for it’s “no testing” posture in antidepressant suicide:
- Early on they claimed was no reason to test because the preliminary data, through meta-analyses and the like, indicated there was no suicide problem. That excuse went away early last decade when data on pediatric and young adult populations showed a high suicidality rate.
- Then they claimed that a prospective randomized clinical trial (“RCT”) to test a suicide hypothesis was not practical because it would entail too large a test population. That excuse became questionable when it was shown that a “challenge/dechallenge” protocol could be designed with only a few hundred patients in each treatment arm, with only a slight decrease in the confidence interval to detect the problem.
- The next excuse was that it would be unethical to specifically test for suicide, given that placebo, or sugar pill treatment in a clinical trial for a patient known to be suicidal would breach medical ethics, such as the Nuremberg Code. That turned out questionable, as well, when it was pointed out that “placebo” is routinely used in psychotropic drug trials endorsed by the FDA, that European countries traditionally restricted placebo testing as a matter of course, and that in any case, a non-medication treatment arm involving therapy would avert any prohibition based upon non-treatment of an at risk patient.
- The final excuse is one from a manufacturer of a major SSRI who, having avoided testing for 20 years, simply claimed it was not QUOTE methodologically possible to design and conduct a scientifically reliable clinical study that would yield greater scientific understanding between ...(the drug)….and suicide than now exists.”
In 1990 at the height of the initial Prozac controversy, the FDA, itself, requested Eli Lilly to perform such testing. (See “EliLillyFDAMemo”) The FDA backed off after Lilly produced a 1991 meta-analysis, an analysis later highly criticized for its gaps in the data, showing Prozac had no statistical significance with suicidality. In later times, a senior FDA official, contrary to its original persuasive powers to get Eli Lilly to agree to the testing, seemed to reverse itself. In a 2004 interview the FDA’s Director of Medical Policy, Dr. Robert Temple, in charge in 1990 when his office persuaded Lilly to test, told PBS:
“Nobody is going to let you do a placebo control long-term trial to see if there are more suicides in one group than another because that would involve leaving people who are grossly depressed off therapy. I don’t think anybody would do such a trial.”
Dr. Temple’s gratuitous concession was as unnecessary as it was counter-productive. FDA has more than enough tools in its arsenal to ensure persuade industry to do the testing. In 2003 the FDA banned the dietary supplement Ephedra, doing so only after the highly publicized death of Baltimore Orioles pitcher Steve Bechler who took the supplement before succumbing. Ephedra’s 155 deaths reported to the FDA when the drug was banned were dwarfed by Prozac’s 350 completed suicides reported a decade earlier--which the FDA summarily dismissed at the time as anecdotal. Another FDA legal enforcement tool short of banning, if the affected company does not participate in making its drug safe, is to declare the drug misbranded and prosecute. This could properly occur if the company refused to comply with an FDA labeling request to place in the labeling the high incidence of suicide events and the company’s failure to have tested for suicidality. The essence is that the federal government has the power, indirectly if not directly, to compel companies wishing to market antidepressants to conduct specific suicide testing. While manufacturers can contest such FDA actions in court, the judiciary gives great deference to the FDA’s mission of ensuring drug safety and enforcement actions in support. Since 2004 consensus in the research community, save the pharmaceutical industry, is that focused antidepressant suicide testing was long past due. Dr. Temple’s interview notwithstanding, FDA officials themselves, including Dr. Janet Woodcock and Dr. Thomas Laughren, are on record stating prospective testing on the antidepressant suicide issue is needed.
Antidepressant Suicide Reports—from Healthcare Providers!
Ephedra’s adverse event data at the time of its banning were minor compared to antidepressants. Prozac, Zoloft, and Paxil, the first three (3) SSRIs (“selective serotonin reuptake inhibitor”) on the market combined for 638 reported deaths between the period November 1, 1997 and the time FDA banned Ephedra on December 30, 2003. The FDA’s “Adverse Event Data System” (AERS) and its pre-1997 predecessor system recording “MedWatch” reports of adverse events constitute merely a drop in the bucket of the overall drug induced adverse events occurring in the general population. Except for pharmaceutical companies and other selective entities, reporters of “MedWatch” submissions do so voluntarily. Adverse events filed with AERS constitute, depending on what expert you talk to, from 1% to 10% of the actual adverse events occurring throughout the country. AERS filing is not proof that the reported drug caused the adverse event, especially when consumers and lay people file the reports. However it is commonly accepted that health care providers, already burdened by substantial medical paperwork, file “MedWatch” submissions to the FDA because they believe there may be causation in the particular patient. Filings of antidepressant adverse events are voluminous. Prozac, Zoloft, and Paxil “MedWatch” reports constituted 20,142 filings from 1997 to 2009. Fifty five (55%) percent were originated by health care providers. Two thousand four hundred fifteen (2,415) suicide attempts by antidepressant patients were reported in that timeframe, of which 64% were reported by health care providers. Of that total, eight hundred three (“803”) were completed suicides.
FDA Issued First Suicide Warnings in 2004
After many years of dismissing the antidepressant suicide problem, the Food & Drug Administration, confronted the issue anew in 2004. That year the Agency, after advisory committee hearings, directed the issuance of generalized suicide warnings for adults taking antidepressants, and “black box” warnings for patients under 25. The FDA’s database did not show statistical significance in suicidality causation for adults between 25-64 years of age. That, however, is not proof antidepressants do not cause suicides in that group. The FDA’s data comprising 100,000 adult patients from placebo controlled trials only going back to the early 1980’s is hampered by the significant vacuum I referred to earlier—incomplete data from old trials never designed to link antidepressants and suicidality. An “either or” approach on antidepressant suicide causation, which antidepressant advocates selectively now apply to the 25-64 age group, is misleading as well as simplistic.
“Statistical Significance”—As Used in the Debate—Is Not Very Helpful
Industry traditionally has relied upon the concept of “statistical significance” to debunk causation. The fact that the pediatric and young adult patient pools shows statistical significance between antidepressants and suicidality despite the limited scope of nature of data for all populations suggests, according to experts of all stripes, the increased sensitivity of youth to antidepressants. The antidepressant suicide risk, when and where it presents itself, cannot be accurately detected and measured with the swoop of the broad brush. The FDA’s suicide warning highlights what are believed to be the medication’s high risk periods, stating that close observation for suicidality should occur “during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.” Suicidality can then abate, giving way to what antidepressants advocates call the “therapeutic” effect of the medications. Most experts testifying for plaintiffs in antidepressant suicide cases do not contend they are per se opposed to the medications or wish them banned. On the contrary, they prescribe antidepressants for carefully screened patients and monitor them for suicidality in accordance with the FDA warning.
Antidepressants Both Cause and Prevent Suicides
Just last August, seven (7) FDA authors, including the Director of Medical Policy, published in the British Medical Journal their conclusion, a correct one in my view, stating “Antidepressant drugs can have two separate effects: an undesirable effect in some patients that promotes suicidal ideation or suicidal behavior and a therapeutic effect in others.” Stated succinctly, and I paraphrase: Antidepressants both cause and prevent suicides!
Most of my plaintiff experts in antidepressant suicide lawsuits agree with this in terms of the short term trials that the databases reflect. Long term adverse side effects are another issue. With some patients driven to suicide by antidepressant inducement, other patients, including those suffering from Major Depressive Disorder (“MDD”) and otherwise statistically bound for suicide, yet saved by the effect of antidepressants at least in the short term, the effect is a statistical dead heat when viewed in the large numbers of these many, short term trials.
Saturated Propaganda and True Believers!
Then why are we still debating this? Because of twenty (20) years of saturated propaganda. Antidepressant suicide risk has been and remains suppressed by basically two factions: (1) the pharmaceutical industry and (2) organized psychiatry. No “conspiracies” here—it is pure self interest.
In industry’s case, the products sell. Reuters reports antidepressant use doubled in a decade, to $9.6 billion in U.S. sales in 2008. Any loss of consumer and provider confidence due to a documented suicide risk cuts directly into sales. Universities and professors depending on outside research money take pharmaceutical funds to test antidepressants—and other drugs?executing non-disclosure agreements to obtain the pharmaceutical contracts. And ghost writing! The favorable results of the drug trials get written up by the drug company—while the negative trials are quelled. The draft to report the favorable results is turned over to the Professor who, after a few minor changes, becomes the lead author on the article which is submitted to a prominent medical journal. After publication, the next day the news of this effective drug is published in the New York Times or Wall Street Journal. The net result of what was implied to the public as credible science by independent academics was actually carefully choreographed data by a drug company. Stung by criticism, companies have attempted to defuse the issue by claiming they have posted on their websites, the results of all their clinical trials, “whether positive or negative.” While these postings have accurately represented whether efficacy results were “positive or negative,” they continue to suppress overall suicidal data. The “causation” assessments by the principal investigators mentioned above are censured out of the websites. Nowhere, for example, on Glaxo SmithKline’s website does it disclose that 42 patients out of the 2963 patients taking the drug during pre-marketing clinical trials attempted suicide, a “frequent” occurrence of this serious event.
“America is not Maoist China”
Organized psychiatry suppresses awareness of the antidepressant suicide risk for another reason. They are true believers. Organizations like the American Psychiatric Association (“APA”) and the American College of Neuropsychopharmacology (“ACNP”) are examples. I also include the National Institute of Mental Health (“NIMH”) in this grouping. Organized psychiatry is very professional, does a lot of superb work in mental health, and cares for their patients. Their opposition to suicide warnings while in good faith, is misguided. The true believers insist antidepressant suicide Warnings scare patients away from their medications—causing more suicides in the long run. One industry sponsored statistician echoing this concern, writing in 2007 stated: “If the intent of the pediatric black box warning was to save lives, the warning failed, and in fact it may have had the opposite effect; more children and adolescents have committed suicide since it was introduced.” A medical commentator for the American Enterprise Institute criticizing the FDA’s implementation of the “black box” was surprisingly candid in asserting that societal impact of the warning trumped all, and that individual suicides are not the question.” The Committee should take note of the invidious nature of this rationale, which lurks throughout the pro-antidepressant lexicon. Even if it were true that Warnings add to the nation’s suicides, which I doubt, the notion that keeping individual patients in the dark about antidepressant suicide risk for the overall good of society is Maoist China, not the United States of America where individual informed consent is central to medical ethics. More frightening than organized psychiatry’s opposition to warnings out of patient concern is that the attitude, if it carried the day, would have denied risk information to fellow physicians. It is here, e.g. primary care, where the majority of antidepressants are prescribed and label information counts. No rationale can justify withholding medical risk information from fellow providers. While the “Warnings” issue is settled history, its core issue addresses us once again as the Veterans Administration (“VA”) and Department of Defense (“DOD”) deal with rising suicides in their constituent populations.
Lack of “Completed Suicides” Is Nothing to Brag About
A retort now universally put forth by antidepressant advocates who opposed the FDA’s warnings is that there were no “completed suicides” within the 4100 pediatric patients comprising the clinical trials that spurred the “black box” warning. Taken from a controlled clinical trial environment of psychiatric monitoring, the absence of completed suicides gives little solace when, with 109 “possibly suicide related” events out of the 4100, causation of suicidality from the medication is established. Downplaying the fact of no “completed suicides” in the short term pediatric trials is revealing as one notes how far industry has moved the goal posts as more and more revelations on the adverse effects of the medications have surfaced with each passing year. The claim itself manifests a degree of desperation. One can imagine the ridicule a tire manufacturer would receive testifying before Congress if acknowledging his company’s deficient tires have caused a large number of highway accidents, but he didn’t view it as a big problem because most of the accidents were not fatal. This Committee should treat the “no suicides” claim in these short term trials with the same curiosity.
Antidepressant Advocates—Playing “Politics” Themselves
Industry and organized psychiatry claim, usually subtly, that the FDA caved in to politics and media, in issuing the warnings. One APA headline proclaimed “The FDA May Have Overreacted.” These swipes at the FDA have no basis in fact. The 15-8 advisory committee vote recommending the “black box” was cast entirely by independent experts. It should be pointed out that industry and organized psychiatry use politics and lobbying on the matter as much as anyone. That was demonstrated during the 2004 hearings. From 1990 onward both groups fought vigorously, to dissuade the FDA from instituting any suicide warnings for antidepressants. In early 2004 when FDA’s preliminary antidepressant data on children showed causality with suicidality, both groups continued their past argument that the sky would fall if the Agency imposed suicide warnings. This time, however, on March 22, 2004 the FDA went the other way, issuing the generalized suicide warnings for both children and adults. The Agency, at the same time, farmed the data out for a second opinion. It simultaneously announced it would convene additional hearings when the re-evaluation was complete. The re-evaluation was completed in the summer of 2004, confirming the causation in children. With verification of the risk now placed before the advisory committee, the FDA, among other options, placed the “black box” warning option, the highest form of drug risk warning, before the committee for a vote. Confronting the looming “black box,” industry and organized psychiatry in preparing their presentations executed an about face. Rather than decry the generalized suicide “Warning” issued March 23, 2004 as contrary to their long held views, both groups pivoted quickly to make it appear the recently instituted generalized suicide warning was something they always supported. The sky will fall argument was now directed to the “black box” option. The tactic failed. The committee voted 15-8 to impose the “black box” in regard to the children’s risk, and it was implemented by the FDA on October 15, 2004. The 2004 hearings further illustrated how Psychiatry differs from General Medicine on the matter of the antidepressant warnings. Non-psychiatrists on the advisory committee voted 10-3 in favor of the black fox. Psychiatrists split 5-5. Psychiatry’s opposition flew in the face of the fact that non-psychiatrists dispense the great majority antidepressant prescriptions, about 70% by many accounts, with non-psychiatrists generally supporting the warnings. Since the implementation of the “black box” in 2004, both industry and organized psychiatry have lobbied vigorously to remove the boxed label.
In the Debate—Who to Believe?
I do not contend that the antidepressant skeptics’ voices should dominate this discussion. Both antidepressant benefit and risk information should be weighed proportionately for treatment, but when investigating suicides, it is a risk driven inquiry only. For honest brokers pursuing the issue, such as this Committee, VA, and DOD----it is necessary that history and credibility of the voices speaking on the antidepressants be objectively evaluated Going back centuries, one would not place great credence on the “flat earth” advocates after Columbus’ and Magellan proved the world to be round. The same analogies might be drawn from the history of the antidepressant debate. There were those from the early and mid 90’s, after Prozac came on the scene, calling attention to the antidepressant suicide issue—names in psychiatry like Peter Breggin, David Healy, and Joseph Glenmullen. There were others, the majority from industry and organized psychiatry, who vigorously promoted the medications and went out of their way to discredit these voices who were saying “not so fast.” The “flat earth” advocates from the early 90’s are still around—and still on the same side of the issue, now claiming, that the FDA’s “black box” warnings have increased suicides nationally. I am not here to name names or criticize personally those who have a contrary view to mine. After all, I’m only a lawyer opining on what certainly involves medical and scientific issues. But lawyers, as well as the public, look at the evidence and make judgments—both in the jury docket and in our daily lives. It is thus more than fair to point out these antidepressant enthusiasts were wrong from the start, proven wrong by a demonstrated statistical significance in suicidality in pediatric populations determined in 2004, and wrong again in 2006 when statistical significance was shown with young adults. History has shown the skeptics were right from the beginning—and should in this search for truth command at least as much deference as those Investigators now participating in the process who were on the wrong side of events that the FDA decided.
Lurking Beneath the Polite Exterior—NIMH v FDA
Where does the strategic situation stand today? As much as the FDA has moved the ball since 2004, the antidepressant suicide issue remains stuck in the quicksand. Lurking beneath the surface of the antidepressant suicide debate are polar opposite positions of two federal agencies: the Food & Drug Administration (“FDA”), and National Institute of Mental Health (“NIMH”). This opposition is not, for comity purposes, openly acknowledged and can be explained, in part, by the agencies’ different statutory missions.
This Committee should note the sharp distinction between the antidepressant suicide warnings emanating from the FDA, and the continued suppression of the antidepressant suicide risk by the NIMH. One would not expect NIMH to give medication induced suicide equal billing with a “take your meds” approach in psychotropic therapy. On the other hand, NIMH is obliged to be accurate in its public pronouncements. That has not always been the case in regard to antidepressants, and unfortunately remains so in some applications. Examples are useful. On September 20, 1991 NIMH was instrumental in the FDA’s decision to deny suicide warnings to the public in regard to Prozac, erroneously framing the labeling issue in terms of banning antidepressants, urging the FDA voting panelists on that day “instead of trying to withhold these drugs, there should be much more aggressive effort to make…(antidepressants)…even more widely available to the appropriate patients.” Banning Prozac was never on the table, the FDA having rejected that option weeks earlier. (“APANewsReleaseProzac”) NIMH should not suppress awareness of the risk as pointed out by the FDA, and should give representative information on the limited effectiveness of antidepressants, articles of which have increased substantially in the last few years. Today one is hard pressed to find existence of the FDA’s suicide warnings on the NIMH website. One finds, instead, a skewed selection of literature on the Institute’s website, mostly all strongly endorsing antidepressants and omitting mention of the articles in the scientific literature citing the drawbacks. In May, 2008, I notified the Director, NIMH that the Institute’s publication “Depression,” distributed to the public misrepresented, by under-statement, the breadth of the FDA’s suicide warning by omitting the fact adults were included in the FDA’s warning. (FarberLtrtoNIMH) Responding to my letter, NIMH simply misstated the facts, again, by asserting its publication was issued before the FDA’s issuance of the warning. (NIMHLtrtoFarber) NIMH continues in 2010 to misrepresent the FDA’s suicide warning. (NIMHWebsite & NIMHLtrto Farber)
FDA Suicide Warnings Are Detailed and Balanced
Since 2004, FDA “suicide warnings” on antidepressants have been detailed and balanced. In 2007 the FDA was fair enough on the issue to ensure the labeling reflected that failure to treat depression, impliedly by antidepressants, could be hazardous as well. NIMH, by contrast, continues its longstanding policy of silence on the antidepressant suicide risk. NIMH further highlights articles criticizing the FDA’s suicide warnings. I praised the Director for the good work the Institute does—but the skewed coverage of antidepressants has to be troubling for citizens expecting neutrality and objectivity from NIMH. The FDA’s directed suicide warning is excellent, entailing monitoring of symptoms and follow up, including advising monitoring by caretakers and family members to be alert for symptoms of suicidality. (Feb2010FDAAntidepressantWarnings)
Antidepressant Suicide Monitoring
For veterans and service members, I fear this 3rd party monitoring is not being done—it certainly won’t be unless the VA and the command structure recognize the value of the FDA warning, and implement it in way appropriate to the veterans’ setting. The setting of a VA clinic, and any combat zone, obviously poses unique issues for considering such 3rd party monitoring. Patient privacy and the “macho” persona are also issues in mental health treatment that have to be confronted in treating veterans and active military. Whatever the difficulties, the Veterans Administration and DOD will be doing their members a disservice if risky drugs are administered to patients without the safeguards that patients in private practice receive at the recommendation of FDA. In medical malpractice cases, physicians who don’t warn patients of the potential dangers of a drug as recommended by the FDA are generally considered to violate the standard of care.
NIMH Tags Along—But Still Silent
When the turbulence of 2004 over pediatric data arose and the FDA had to change its policy and issue antidepressant suicide warning, and again in 2006 when young adults were added to the “black box,” the NIMH was effectively forced to tag along. In November, 2006, the NIMH issued five (5) grants to study the antidepressant suicide situation, including adult suicide. (NIMHPressRelease061113)) Presumably these grants were a byproduct of the numerous pleas heard during the 2004 FDA hearings that the cited scientific vacuum be rectified. Notwithstanding what transpired before 2006—or since, this prolonged gap and NIMH silence continues to exist in an area which arguably it has responsibility to lead. (NIMHEmail) The lack of progress in this 20 year problem is unsatisfactory in public health, regardless of which agency or agencies have lagged.
VA (and DOD) on “Suicide”—Fish Out of Water?
My current observation on the issue of veterans’ and military suicides leaves me concerned. In dealing with rising number of suicides, VA and DOD appear to be relying on NIMH to lead them to enlightenment. Noted on the Institute’s website is the Army’s memorandum of agreement and frequent references to the issue of veterans’ suicides. It is natural that NIMH would be a source of federal assistance given that neither DOD nor VA, despite huge constituencies for treatment and certain specialties in research, e.g. combat stress and prosthetics, have never been institutional leaders in drug safety or suicide. Traditionally, the military has medically discharged members with serious mental health problems. In 2004, I learned from Navy Times of the large numbers of suicides in the Pacific Fleet. Stating the background and relevant facts on antidepressant suicide litigation, I wrote a letter to the Commander in Chief of the Pacific Fleet with specific recommendations. (FarberCINCPACFLT). The issue was turned over to Navy medical bureaucrats in Washington, where it died a sudden death; at least no one ever followed up with me. While in theory a NIMH partnership is the correct call for VA & DOD to make in alleviating the very serious problem of rising veterans’ and active duty suicides, for reasons I’ve stated I fear NIMH will not be robust in sufficiently highlighting antidepressant risk from benefit, and that investigative avenues to determine the full causes of the rising rates may be bypassed. Maybe antidepressants are responsible for half the suicides—or maybe just a few, or possibly none. Whatever it is, it is scientifically unacceptable and a breach of duty to approach this complicated problem pretending the issue of antidepressant induced suicide does not exist. Mr. Chairman, your leadership here today ensures that question won’t be swept under the rug—as it was for so long.
My two recommendations to the Committee are:
- Direct the VA to conduct independent antidepressant suicide testing through one or more neutral, third parties, and
- Direct the VA to ensure all psychotropic drug labeling warnings and precautions are made available to all patients.
Thank you for the privilege of testifying before this Committee.
Donald J. Farber
 Quoting University of Toronto medical historian Professor Edward Shorter, by Benedict Carey in New York Times, December 13, 2006 article “Panel to Debate Antidepressant Warnings.”
 May 28, 2004 PBS Newshour, Interview Dr. Robert Temple by PBS Correspondent Susan Dentzer.
 FDA Transcript of Psychopharmacological Drugs Advisory Committee December 13, 2006, page 456 line 12 through 457 line 17, and Transcript of Hearing Subcommittee on Oversight & Investigations of Committee on Energy & Commerce, September 23, 2004, 2nd session, Serial No. 108-125 (“FDA’s Role in Protecting the Public Health Examining FDA’s Review of Safety and Efficacy Concerns in Antidepressant Use by Children” Tab 38, page 368, 369. e.g. “(At CDER meeting)…there was general agreement that more studies would be desirable…. ‘Dr Woodcock suggested that a trial was needed to examine the emergence of behavioral toxicity in children and adolescents treated with antidepressants. She added that the focus of the trial should not be efficacy.”
 On November 1, 1997 FDA commenced AERS recording in a new computer system. All reported adverse events to the FDA prior to that date were accounted for in a separate system, and remain segregated. The “350” Prozac completed suicides reported earlier are thus not compiled in AERS.
 BMJ (British Medical Journal) 2009;339:b2880 Published 11 August 2009
 On January 21, 2004, ACNP (www.ACNP.org)... attempted a preemptive strike against the FDA and the agency’s plan to review pediatric antidepressant suicide data February 2, 2004. Not in possession of the FDA’s then newly obtained antidepressant data showing an association with pediatric suicidality, the ACNP in its 22 page release highlighted sections in its report entitled “Weak Evidence Links SSRIs to Suicidal Behavior in Youth” and “No Significant Increase in Suicidal Behavior in Clinical Trials of Youth. ACNP’s lack of updated data was hardly of concern to the organization. The report acknowledge “because the Task Force did not have access to a substantial amount of unpublished data, including detailed findings held by drug sponsors, this report is preliminary.” ACNP’s attempt to ward off FDA action failed with the Agency’s imposition of suicide warnings based on the Feb. 2nd hearing. Additionally, the FDA’s ultimate determination of the data showed serious lapses in the ACNP’s proclamation. (Source: “Preliminary Report of the Task Force on SSRIs and Suicidal Behavior in Youth.” January 21, 2004. The ten (10) authors of the preliminary report had substantial ties to industry. One author of this report is an Investigator assisting the U.S. Army in its current study to assess rising Army suicides.
 “Is it possible, then, that SSRIs have precipitated some actual suicides? Yes... But the larger question the FDA must answer for the public is whether these medications have prevented more suicidal activity than they have caused. Almost surely they have.” “The Rush to Black Label (or blackball) SSRIs.” September 30, 2004, by Sally Satel, MD, http://www.aei.org/article/21316..... "
 See page 157, bottom line, FDA “Psychopharmacological Drugs Advisory Committee” transcript, September 13, 2004
 “Psychiatric News” May 4, 2007, http://pn.psychiatryonline.org/content/42/9/1.1.full
 At the initial February 2, 2004 hearing, the APA representative declined to offer recommendations for labeling based on the new data and further admonished the FDA on the antidepressant suicide issue concerning children, stating “we are concerned that the publicity surrounding this issue may frighten some parents and discourage them from seeking help for their children…” (FDA PDAC Transcript 2/2/04 Page 226 line 25 thru Page 227 line 3) After the FDA issued the generalized suicide warnings March 22, 2004 and the “black box” option was before the panel on September 13, 2004, the APA representative told panelists: “(W)e support the continuation of the current FDA warnings with respect to antidepressants. We believe the language is appropriate and consistent with our current knowledge, understanding and scientific data.” (FDA PDAC Transcript (FDA PDAC Transcript 9/13/04, bottom page 300, top of page 301).
 FDA Transcript of Psychopharmacological Drugs’ Advisory Committee September 20, 1991, Page 177 Lines 1-7.