Controversial FDA Official Tom Laughren Retires

Good Riddance. A Big Pharma toady his entire career. It won't be long until we see him giving depositions on behalf of Risperdal, Zyprexa, et al. for some big fat consulting fees. No other figure in FDA history has ever been chastised as often by the FDA's OWN PANELS for his incompetence and inaction. There are many deaths at his doorstep.

Tom stayed at the agency as long as he did because Dr Paul Leber provided cover for him. Leber was one of the most powerful people in the FDA. As long as TL had Leber's blessing he was safe. By the time Leber left Laughren was too big to move.

Observer is right. Laughren will have a lot of pharma offers, but he can't accept any of them for at least one year, I believe because of FDA's non-compete rules. They may have eliminated that rule so that guys like TL can bet a bite of the golden goose that much earlier.

Good riddance to the worst of rubbish. He has many deaths on his hands, and perhaps in retirement will repent in some way, doing good deeds instead of continuing to shill for pharma.

Well I remember testifying - in the public part of the FDA hearings - and this man appeared/pretended to be asleep, always looking down.

Tracing his "track record", as Pharmalot has done to some degree here, shows a sorry story of refuting, time and again, his own advisory committees in his quest to be the perfect Pharma Boy.

Here's hoping this is the beginning of a thorough housecleaning in CDER.

This is a most chilling story - of a man who sold his soul, and of a country whose public health has been hijacked by an industry.

The statistics of innocent people killed due to the side effects of psychiatric drugs is a long one. Though it is almost impossible to get the figures from the FDA itself, SSRI Stories tells of some of the carnage from this class of drugs. As for deaths from the atypical antipsychotics, the toll - of young people with mental health conditions (real or imagined)and old people given these drugs in nursing homes as sedatives - is high with numbers hard to come by.

Would that the Congress, whose members are elected to look after their constituents, would do so instead of protecting pharma and those at the FDA who do its bidding. And that the Administration, which oversees HHS and the FDA, would revamp the entire system and prosecute those responsible for what are clearly crimes within the industry.

I attended one of those "emotional" FDA hearings - the second one - in which consideration was being given to raising the artificial ceiling on at what age the SSRIs caused people to commit suicide versus when they no longer did - a cockamamie idea if I ever heard one, but nonetheless.

The FDA, first of all, moved the hearing with no warning. The public comment period was gut and heart-wrenching, with many family members testifying that their loved one had committed suicide because of the drug, and urging stronger warnings on the labels.

It is beyond me how this man, Dr. Laughren, could have sat through all these stories over the years and yet continue to do what he did - defeat every attempt as long as possible to place any warnings on the SSRI/SNRI and atypical antipsychotic drugs, thus assuring that thousands of innocent people would die from their lethal side effects.

Unless the CoI regulations have changed, he can "bite the apple" immediately by consulting in the background. He just can't have direct dealings with the Agency, esp tag along to meetings, until the requisite amount of "cooling off" time has passed.

Unlike Leber, who seemed to relish a good argument, he seemed to prefer avoiding confrontation. Once he was the "decider", he had industry in his face a lot, thanks to frequent PDUFA-mandated meetings. By contrast, the public and academia got to tell him what they thought a lot less frequently (esp. AC meetings). If you're a ref calling a game, and you know one of the teams is going to yell at you later, it's probably tempting to let the yelling team be the one you're shielded from.

An institution like the FDA cannot become the protector of for-profit global corporate interests at the expense of the national sovereignty of the nation's people whom it exists to serve...too dangerous and insidious because it frames its actions outside of things like genocide even while it commits genocide.

from wikipedia:

"Generally speaking, genocide does not necessarily mean the immediate destruction of a nation, except when accomplished by mass killings of all members of a nation. It is intended rather to signify a coordinated plan of different actions aiming at the destruction of essential foundations of the life of national groups, with the aim of annihilating the groups themselves. The objectives of such a plan would be the disintegration of the political and social institutions, of culture, language, national feelings, religion, and the economic existence of national groups, and the destruction of the personal security, liberty, health, dignity, and even the lives of the individuals belonging to such groups."

Wow, why do the articles on psychiatric drugs consistently bring out the conspiracy theories and undocumented claims of mass deaths.

Epidemiologically, the warnings against prescribing antidepressants in young people had no detectable impact on suicide rates. http://www.ncbi.nlm.nih.gov/pubmed/19367564

According to CDC statistics, the 2003 warnings led to no change in the suicide rate among children in the US. For children age 5-17,the suicide rate in 2001-3 NHANES study was 1.8 per 100,000. (0.0018%). After the discussions of antidepressant-related suicides in 2004 to 2005 and the addition of black box warnings against using SSRIs in children, the rate remained constant at this same value in the next available measurement period, 2007-9.

How about all those thousands of deaths among adults? According to CDC, the rate of suicide among adults peaked in the year prior to the advent of SSRIs (1986) at 13 cases per 100,000. It fell steadily to 10.4 in the year 2000, and has slowly climbed back to 11.8 post 9/11. Its still 10% lower than it was the year before Prozac was approved.

A veteran's administration study of 225,866 veterans found that among veterans with diagnosis of depression, antidepressants exerted a protective effect against suicide. http://www.ncbi.nlm.nih.gov/pubmed/17606656

A Canadian study found that adults with a diagnosis of schizophrenia who regularly filled their prescriptions were are significantly reduced risk of suicide and all cause mortality. http://www.ncbi.nlm.nih.gov/pubmed/17213012

A Danish study found similar effects for antidepressants in recently discharged depression patients. http://www.ncbi.nlm.nih.gov/pubmed/17453694

I can go on, but take a look in Pubmed. The weight of scientific evidence that antidepressants and antipsychotics have a protective or at worst neutral role on suicide and overall mortality in adults is quite strong.

Or maybe its just a vast conspiracy.....

John, what's your point? Is it that because there can't be an epidemiological case made that the warnings lowered the suicide rate, there was no reason to bother putting them on? Surely you jest.

I guess you didn't attend either hearing to listen to the parents of children, or spouses, describe what happened when family members - perhaps after being given an SSRI for something nebulous like a stomach ache (remember, these drugs were and are heavily marketed to primary care docs) committed suicide from akithisia-induced side effects from them. I guess you haven't lived the long, lingering years having outlived your child who died of one of so many possible side effects from an atypical antipsychotic.

Laughren may have avoided confrontation, but he sat there year after year listening to families beg for stronger warnings, and refuting the advice of advisory committeess, going in favor of industry, always. All I can do is be thankful he's gone.

Ed states that Laughren worked at FDA around 20 years. Does anyone know if he was there 20 years?

The reason that I ask is that 20 years of employment in the federal govt was and may still be a pension milestone. Budget negotiations may cause federal employee pension and other benefit reductions, so it would make sense for someone like Laughren to leave before any cuts are made.

While everyone is saddened by the loss of life, especially those clinicians working with patients in need, the clinical research community was aware that some of the families, if not all of the families were prepped and groomed by anti psychopharmacology groups. Interestingly, at those hearings, families that supposedly never met each other had the same sized pictures of their loved ones and similar posters and similar stories. It was an orchestrated circus with political overtones and undertones and not enough data to dupport the cause. (sorry to say it but it is true). If clinicians soon realized that SSRIs caused sexual dysfunction, even before the FDA databases showed this to be true, then how could those same clinicians not have been aware of the events of death by suicide. A clinician discussing the risk:benefit assesment with any patient may accept sexual dysfunction in a percentage of their patient population but under no circumstances would any clinician ever accept suicide or not begin an investigation for clinical and even legal reasons. Why use this as an example, the incidence of sexual dysfunction is much highervthan the presumed incidence of suicide. In the initial Prozac trials sexual dysfunction was notvseen as an issue but clinicians realized it very quickly. How could clinicians not have realized that suicide was not an issue, because ut wasn't, notvattributable to the meds! In polling the clinical community I heard first hand that scratching, cutting, biting, chewing, and other forms of non-suicidal self injury would be categorized as suicide attempts bt the FDA. Why? Due to this categorization by the FDA, clinicians elected to not rely on the FDA warning but rather to work with each patient individually in order to determine the bast treatment paradigm. Effectively disregarding the database or electing to work based on the needs of the individual? I was interested in knowing how many of the suicides came out of homes with physical, sexual, or mental abuse? How many came out of homes with parents that were substance a users, wife a users, and other sordid situations? How many of the teens were substance a users themselves? How many of the teens were non-compliant with any aspect of their treatment? How many we're truant from school? How many had issues of lower intellectual capacity, lower resilience to life stressors, and increased incidences of impulsivity and/or aggression against self and others? How many had previous acts of self harm prior to treatment versus after treatment? How many we're misdiagnosed and actually had bipolar disorder or were pre morbid to some other psychiatric condition? We had a problem, jumped to a political but not scientific conclusion and may have adversely affected clinical judgement as well as public opinion of psychiatry. How much of the legal judgements collected from Pharma and clinicians was donated to any foundation studying or working to prevent suicide?

Hi Anne,

Thanks for the note. Laughren joined the FDA in 1983. Before that, he was affiliated with the VA Medical Center in Providence, Rhode Island, and was on the faculty of the Brown University Program in Medicine.

Hope that helps, ed

@asclepios, "...the clinical research community was aware that some of the families, if not all of the families were prepped and groomed by anti psychopharmacology groups. Interestingly, at those hearings, families that supposedly never met each other had the same sized pictures of their loved ones and similar posters and similar stories. It was an orchestrated circus with political overtones and undertones and not enough data to dupport the cause...."

And you would be caviling about how unprofessional and not serious the people presenting their stories to the FDA were if they weren't all "prepped and groomed". In order to families to collect enough data to match the data the FDA and sponsor HAVE, they'd have to hire a CRO to do data management for them.

The "circus" was FDA's creation - they set the rules for the format - how they will accept information from the public. You're complaining that there was a net under the tightrope walker....

I've spoken at many FDA hearings - in the 3 minutes allotted before the microphone is shut off. I've never seen other families with similar signs. Most people I know, including myself, get to these meetings on their own dime, feeling urgency to get the FDA to act to place stronger warnings on the label. Imagine the odds when we speak - 25 business reporters (none interested in our stories), a huge table at the front full of people from Pharma, the advisory committee, and members of the FDA. In most instances, the people "at the front" don't even have the courtesy to look our way when we speak, and not one person from the FDA has ever said that they were sorry for the loss of my child (dead from Zyprexa).

Asclepios can caterwaul all he/she wants. Read David Healy's excellent "Pharmageddon", or Martha Rosenberg's "Born With A Junk Food Deficiency"or, for that matter, Robert Whitaker's "Anatomy of An Epidemic" to get a real sense of the damage these drugs have done.

Jim, the point is that that claims that these drugs are causing thousands of suicides have not been supported in studies designed to address exactly these questions, which generally find a neutral or protective effect.

The claim of large numbers of excess suicides is further excluded by the absence of an increased suicide rate in the total population after they were introduced.

Schizophrenia and depression were known to be associated with elevated risk of self harm long before SSRIs and atypical antipsychotics became available.

Yes, sometimes people do commit suicide after taking a drug. Lots do without taking drugs too. Anecdotes, no matter how tragic, are not a firm basis for making policy.

And if your doctor prescribed an SSRI for a stomach ache, I'd call your state medical board to discuss having his license pulled.

Chet is correct. The fact that the public comment section of the meetings often takes place after reporters have left to file their deadlines means that these stories are often not heard by the reading public. Rarer still does an individual that does not represent a public interest group even get to speak.

When, for example we have seen the same people get up there time after time after time representing the National Association for the Advancement of Fat Acceptance (yes, that's a real group) testify at a weight loss drug hearing, the room tends to empty faster than a New York Jets crowd losing a game to the Patriots 35-0 at halftime. Need some new folks up there.

oii - The business reporters were still sitting there during the public comment period the times I testified, but only once did one report on what some of us said (Miriam Hill, I think, Philadelphia Inquirer)...she interviewed some of us the night before as well (families of soldiers with PTSD who died of sudden cardiac arrest from Seroquel).

However, the process (public comment period) has been made stressful and demeaning by the FDA...it's like a cattle call. Take a number and start to speak when the light goes on...if you are in mid-sentence and the three minute time is up, the microphone is shut off. One would think the FDA would welcome actual input from family members, even if anecdotal, but clearly the only reason the comment period happens is that it is in the regulations or law. At least this is the way things were handled in Dr. Laughren's psychiatric drug advisory committee meetings.

As for SSRI/SNRIs and atypicals causing suicidal impulses/akithisia, I am not a researcher but I know many families who have lost children and spouses to this very thing. One family I knew, the son had manic depression and had done fine on lithium, never feeling suicidal, but an atypical was added and he had to go into the hospital several times to be safe from self-harm.

John, the point is that harm caused by psych. drugs has been swept under the rug by the profession of psychiatry for far too long, and the news about poor outcomes has as well. The one book that makes this perfectly clear is Robert Whitaker's "Anatomy of an Epidemic". After it came out, it had a strong impact in some quarters, and one result was the forming of the "Foundation for Excellence in Mental Health Care." This group is up and running, has a distinguished board, and hopes to influence how people with "mental health conditions" are treated here in the U.S. The "throw drugs at them" regime needs to have had its day. It is not only inhumane, it is also ineffective.

Chet, I have done research in this area, and it is not rare when someone with diagnosed bipolarity on lithium develops symptoms that make it very difficult to distinguish extreme mania from a psychotic break. The risk of developing a psychotic depressive reaction with suicidal ideation or frank suicidality is real, and in such cases an antipsychotic is added for their own protection. These are extremely difficult cases to manage, and as you allude to the result is often tragic.

Jim, I think there's a lot more we can do for them than throw drugs at them. Looking around LA, I'd say a place to sleep indoors would be a good start.

Having said that, I think its important to avoid the temptation to throw out the conclusions of large controlled studies based on tragic anecdotes. Most people who die of heart failure are taking beta blockers. Many of the die shortly after starting beta blocker therapy. But we know from both randomized clinical trials and large case control studies that beta blockers extend rather than reducing life expectancy in HF.

John, you may see them as "tragic anecdotes"...I see them as individuals who might well be alive today but for the drug that killed them. Whitaker has shown conclusively that life expectancy for people deemed "mentally ill" and put on "modern" regimes - especially the atypical antipsychotics - now have shorter life expectancies. In short, the drugs kill, in numerous, awful ways. As for outcomes, such as being able to work, the drugs are so disabling that many people on them get stuck living half-lives, subsisting on disability payments.

There are alternatives. Read the book and think about it. It is a hopeful read in this regard.

Chet wrote, "...Take a number and start to speak when the light goes on…if you are in mid-sentence and the three minute time is up, the microphone is shut off...."

No way to collect data, which is what we are talking about here.

The rules of how data is collected at a site participating in a clinical trial can absolutely be applied in this situation as well. All these families have medical records, no? Develop a case report form to collect the information that is KNOWN not to have been collected through the process currently in place for spontaneous reporting of adverse events after a drug is on the market.

Here's the last paragraph of Robert Whitaker's "Mad in America", which says alot - " But, none of this, I'm afraid, is going to happen. Olazapine is now Eli Lilly's top-selling drug, surpassing even Prozac. There will be no re-thinking of the merits of a form of care that is bringing profit to so many. Indeed, it is hard to be optimisitc that the future will bring any break with the past. There is no evidence of any budding humility in American psychiatry that might stir the introspection that would be a necessary first step toward reform. At least in the public arena, all we usually hear about are advancements in knowledge and treatment, as if the march of progress is certain. Eli Lilly and Janssen have even teamed up with leaders of U.S. mental-health advocacy groups to mount "educational" missions to poor countries in East Asia, so that we can export our model of care to them. Hubris is everywhere, and in mad medicine, that has always been a prescription for disaster. In fact, if the past is any guide to the future, today we can be certain of only one thing: The day will come when people will look back at our current medicicines for schizophrenia and the stories we tell to patients about their abnormal brain chemistry, and they will shake their heads in utter disbelief.

Robert Whitaker, "Mad in America- Bad Science, Bad Medicine, and the Enduring Mistreatment of the Mentally Ill", Perseus Publishing, 2002.

Hey Flora, you ever hear of the word PROGRESS, eh? Of course each generation looks back at the previous generations of treatments with disbelief. My dad was a surgeon and my mother was a nurse and worked st a state mental hospital in the 1940's. Dad did lobotomies and mom laced up straightjackets cause these were state of the art back them. Whitaker can stick his retrospectoscope deep into where the sun ain't never gonna shine for all I care about these Monday morning quarterbacks.

I don't know what to tell you Chet. The esteemed Mr. Whitaker has a single paper published in a peer reviewed journal to his name. Even that paper is in the journal "Medical Hypotheses", known for publishing pretty much anything that anyone wants to send them. He has never run a controlled clinical trial, never performed a case control study.

My neighbor, Will Stevens, is a plumber who wrote an excellent book on theromodynamics last year. He's having a little trouble getting it published, but he has proved conclusively that is possible to prevent global warming with a worldwide array of power stations that generate electricity from water as the only input.

Obviously the mainstream engineers have had it criminally wrong for over 100 years now, but hopefully once Mr. Steven's book comes out the worldwide conspiracy of the utility companies will be brought to a halt.

depression is everywhere - SAD?:

http://rt.com/news/ferret-circus-ape-parrot/

Robert Whitaker's most recent book, "Anatomy of an Epidemic", published last year, won many awards - he is an esteemed science writer. I urge you not to make jokes about him until you've read it. The sad part of the book is that he proves conclusively that people with a "mental illness" label are dying younger than ever in this country due, mainly, to lethal side effects of the atypical antipsychotics but also to suicides caused by the SSRI/SNRI class of anti-depressants. The hopeful part is that he cites programs in this country and others, which are using minimal to no drugs, and in which the outcomes are way better in terms of people being functional, working, etc. This book has galvanized many to change the practice of mental health care in this country and the ship is slowly turning.

John, your neighbor's discoveries are far more important than Johnny one hit wonderboy Whitaker. In fact, along the same lines as your neighbor's findings I would also rank high, and certainly higher than Whitaker, the finding being that fermenting cow manure will generate enough methane gas to power a small sized city. Cow flatulence is more valuable than the hot air coming out of the psychopharm scolds.

http://www.riverdeep.net/current/2002/03/032502t_cowpower.jhtml

To oii - How can you speak so disrespectfully of this topic, one filled with the solid tragedy of thousands of deaths of innocent people killed by psychiatric drugs? Drugs whose lethal side effects were hidden by the very industry you represent? Drugs supported and pushed by Dr. Laughren - he who fought to keep warnings off labels, not to have registries, and so forth? I don't understand the depths of your cynicism.

I own a limited partnership in a dairy farm.

@oii - "...Of course each generation looks back at the previous generations of treatments with disbelief. My dad was a surgeon and my mother was a nurse and worked st a state mental hospital in the 1940′s. Dad did lobotomies and mom laced up straightjackets cause these were state of the art back them...."

When you step back and take a look at the time period in which this was state of the art therapy, the only explanation for this is cultism and elitism in the profession. This treatment evolved OUTSIDE of the science-based culture present in the USA during the same time frame. Meaning, no one was recruited to be on the team who would have given the *blink blink* incredulous emoticon to the dominating medical authority who was selling this cockamani idea.

Considering that the industry is finally admitting to a less than stellar pipeline and is solving the immediate economic problem for *shareholders* by dismantling science-driven teams in favor of small elite cults chasing the sci fi fantasies of *inwestors* with snappy computer software presentations, progress is definitely not around the corner.

At least in astrophysics, they are not making the claim that *gravity* might not be as important of a factor as they previously thought and tweaking gravity here and there is a good idea to bend the curve in favor of profit - or wha'ever theory one woke up with today hoping to win the a---hole of the day award....

Gravity is to physics as DNA is to biology. Hey, it's a *theory*.

Dz I know when you have watched too many episodes of the X Files. The esteemed Portuguese neurologist Egas Moniz won the 1949 Nobel Prize in Medicine for the lobotomy. Dad learned the procedure from Moniz' colleague Dr Walter Freeman and even was even given one of Freeman's leucotomes for having assisted him on a number of prefrontal leucotomies. One thing I can promise you. Dad was no cult follower.

http://www.nobelprize.org/nobel_prizes/medicine/laureates/1949/moniz-bio.html

http://www.thefreedictionary.com/headshrinker

And who inspired Egas Moniz?

http://www.google.com/search?q=headshrinkers&hl=en&tbo=u&rlz=1C1AVSA_enUS424US424&tbm=isch&source=univ&sa=X&ei=ZjzGUJrlLJOy0AGbxYHIAg&ved=0CEgQsAQ&biw=1366&bih=635

Don't try this at home.

http://www.head-hunter.com/prep.html

@oii - look, it wasn't all in vain - progress gave us a weapon - the taser, and we even invented a crowd control product from hot peppers.

Meanwhile, we have a visual for *benzene abuse" for those out there who are either self-medicating or trying to keep up with working 3 jobs:

http://www.huffingtonpost.com/2012/12/06/horrors-of-methamphetamin-rehabscom-photos_n_2240401.html

Socioeconomics - FDA doesn't get involved with meth lab quality control, and neither does the IRS with taxing the job creators...

Way off topic, but the single rock thrown in the pond sends out circle after circle of ripples...and, ultimately, there are dead bodies to bury. Hurt *feelings* all around...?

Should have gone to dental school .

http://beta.photobucket.com/images/Meth+Mouth/#/images/Meth+Mouth/?&_suid=135517148997604590511364679476

@oii - no kidding - but are you sure the photos are all meth heads...?

http://www.hindawi.com/journals/ijd/2010/786503/

http://en.wikipedia.org/wiki/Walter_Freeman_(neurologist)

This is the cultism and elitism to which I was referring to - what, exactly, was the problem that the housewife, Alice Hood Hammatt, from Topeka, KS have that made her his first subject?

@Chet - I'm working on a documentary film investigating deaths caused by antipsychotics. I would be very interested to hear about your story. If you are interested, please send me an email on codufilm@gmail.com

Anniken, I will certainly contact you. I know of many people who lost their children, in various awful ways, to this class of drugs and some of them, at least, will most likely be willing to speak to you. Are you aware of the one book written by a family member - about the death of her son who was killed by Zyprexa? It's called "Not Just Another Mother's Son", by Kaye Welsh Sexton, and was written in 2008...Scott was her only child.

Chet, don't waste your time. I already emailed this so called Anniken. No response. As one of my gurus, Bob Grant says, "fake, phony, fraud".

well, if the FDA had not turned into a cultist and elitist protector of profit, there would be no Annikens cropping up - just sayin'...

Ah, yes, the FDA as industry co-conspirator/lackey. But I'm still struggling to understand why Pharma wants FDA to repeatedly fine them billions of dollars, reject drugs they've spent a decade developing, and shut down their manufacturing sites.

Much too complicated of a conspiracy for me, I'll have to leave it to others to sort out.

@John, good question. I never bought the whole "creative destruction" business model, either.

@original industry insider: Sorry for not replying to your email, it was too cryptic for me wanting to share any information with you. But; no fraud going on here.

Anniken - I look forward to seeing your documentary one day. Were you aware that LeCarre's "The Constant Gardener" (book and movie) was based on a real life situation - Pfizer went into the jungles of Nigeria and many children died from whatever clinical trials on a drug they were doing there - and, of course, the families were not informed of risk.

Well, It's been almost 13 years since I testified before the FDA, and from the posts here I see that nothing has changed. As for Dr. Laughren, I will leave his fate in the hands of Saint Paul.

For our documentary film investigation of the atypical antipsychotics; if you have well documented information regarding Dr. Laughren, you are most welcome to take contact with us at codufilm@gmail.com

@Flora: there are similar things going on today on a number of sites around the world.....

Well it's fitting that comments for this post-mortem on the career of Tom Laughren be represented by the caustic cynicism and pseudo intellectualism of the denier class. Congratulations John, if you aren't being paid by industry for your time consuming comment posting you really aren't selling your skill set very wisely. But that's kind of been the point all these years, the not only eagerness but seeming delight within the lay community sympathetic to industry for casting derision upon an obvious and not even very controversial side effect. If the day comes when you can be bothered to read the background on this issue before charging in to diminish all the wretched human loss, you will find that the suicide rates neither rise nor fall very appreciably in conjunction with the appearance of antidepressant drugs or the warnings on their labels because the act is too rare and the numbers on its incidence too intertwined with decades-long patterns and unrelated reporting characteristics like autopsy rates to show up in your ten minutes work on the Pubmed. You may want to branch out, your enthusiasm for statistical significance and other mechanisms for diminishing rare events in clinical trials is not as persuasive today as it was before books like Pharmageddon.