FDA To Require Suicide Studies In Clinical Trials
61 CommentsBy Ed Silverman // January 24th, 2008 // 7:31 am
The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly, The New York Times reports.
The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the FDA to put a comprehensive suicide assessment into their trials, the paper writes. In recent months, the FDA sent letters - but wouldn’t say how many - to drugmakers requiring they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical trials being conducted now.
The seeds for the new effort were planted four years ago with the discovery that antidepressants may cause some children and teenagers to become suicidal. Top agency officials at first discounted the finding but commissioned researchers from Columbia University’s department of psychiatry, led by Kelly Posner, to reanalyze the drugs’ clinical trials. This work caused the drug agency and its experts to view the risk as real.
“Clearly we were somewhat surprised when this signal emerged in the pediatric antidepressant data,†Tom Laughren, director of the FDA’s division of psychiatry products, tells the paper. “So various groups within FDA are now looking at suicidality more broadly as a possible adverse event.â€
The FDA later received an application for Sanofi-Aventis’ Acomplia, but as agency medical reviewers discovered hints that it could cause psychiatric problems, too. In June, an FDA advisory committee voted unanimously that the agency reject Acomplia because of psychiatric effects, and Sanofi-Aventis withdrew the application although the drug is sold in Europe.
Just this month, the results of a trial of Merck’s obesity drug were published showing similar psychiatric problems. Meanwhile, fears have grown that drugs used to treat epilepsy, seizures and mood disorders may have similar effects. An extensive examination of these medicines by the drug agency should be completed this year. Suddenly, agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems.
The FDA’s concerns are consistent with a growing body of research confirming that behavior is heavily influenced not only by genes but also by seemingly innocuous changes in body chemistry. Drugs not reaching the brain were once thought to be largely free of mental effects. “One lesson from pharmacology is that you can see effects on emotion and cognition without the drug entering the brain if a drug leads to peripheral changes in†other chemicals that enter the brain, Tom Insel, director of the National Institute of Mental Health, tells the Times.
Some critics say that the agency’s new-found focus on psychiatric side effects is long overdue. “The list of drugs that causes psychiatric problems is a very long one,†Sid Wolfe of Public Citizen tells the paper.
There are two reasons that the FDA for years was inattentive to the psychiatric effects of new medicines. First, distinguishing between mental problems that spring from a disease and those that result from its treatment is often difficult. For antidepressants, many researchers suggested that suicidal behaviors resulted because, as patients’ depression lifted, they suddenly had the energy to carry out previous suicidal thoughts.
Second, drug side effects are often first identified in clinical trials when multiple doctors treating hundreds of patients record similar problems in trial notes, the Times points out. But terms to describe depression or suicidal thoughts can vary widely, making them hard to discern.
Posner tells the paper that so many companies and academic research programs were adopting the suicide questionnaire that she was having trouble keeping up with the demand for its use. The questionnaire has been translated into 80 languages, and she’s trained scores of teams of investigators from around the world on how to use it.
“If a drug makes people depressed but doesn’t make them suicidal, what do you conclude?†asks Eric Colman, the FDA’s deputy director of the division of metabolic and endocrine products. “There will always be some uncertainty.”
Source: The New York Times
Nathan
I’m all for looking for genuine adverse effects that drugs have (and they all DO have them). However, I hope that the FDA and the public keeps in mind that many, many health disorders (especially depression and obesity) have a well known and well documented side-effect: Suicide. The cost of non-treatment can be very, very high.
Lisa Van S
Nathan,
This issue is far from new,.. FDA, including Dr. Laughren, knew, as early as 1991, that Antidepressants increased the risk of Suicide in adults. And as early as 1995-96 in children. One can find this information in the Sept 2004 Congressional Record. Dr. Kelly Posner should be commended for Exceptional work.
So Nathan, when, or if, you ever reach Dr. Posner’s “Credentials” and “Expertise” than one might lend some weight to what you have say.
ol cranky
Lisa:
You do Nathan a disservice to summarily dismiss his comment. In truth, living with chronic health conditions does increase the risk of depression due to decreased quality of live, social stigma/social isolation, etc. This can become quite a viscous cycle that often can lead to suicidal ideation just to the burden of dealing with the condition, lack of treatment and/or treatment not miraculous making everything better. Additionally, some meds or combinations (drug-drug, food-drug, etc. interactions) can exacerbate other conditions including mental health conditions as does the American need for the quick fix to make everything better.
Adriana
This seems easy: determine the number of suicides attempted or completed by a large group of people with migraines who’d never been treated with antidepressants. Then determine the number of attempted and completed suicides for people whose migraines were treated with SSRIs or other antidepressants. Compare.
What’s not so easy is finding the COI-free researchers who won’t massage the numbers, delete the higher-risk age groups (older and younger) from test subject pools, won’t wash out subjects with inconvenient reactions nor stack the controls with people who have a higher-than-test-subject-suicide-risk history or who’d already been exposed to high-risk drugs.
Lisa Van S
Ol Cranky,
Point well taken,.. And I offer this public apology.
Would love to have your opinion,.. On this opinion
http://www.azstarnet.com/allheadlines/221888
ol cranky
Adriana:
Unfortunately, things related to various disorders especially mental health issues aren’t straight-forward and a lot of the the things that impact mental health/emotional lability and suicidal ideation would confound analysis. You’re dealing with multiple, complex factors and, possibly, some unknowns as well. To be blunt, I think critical factors that are ignored by many when evaluating suicidal ideation/attempts in patients being treated pharmacologically is non-pharmacologic intervention (psychological and/or behavioral counseling, as well as the quantity and quality of social support) and managing expectations. In this country, we have a dangerous attitude that everything can be corrected if you throw some pills at it. This leads to too many people being prescribed drugs that they don’t need because their condition could really be treated with non-pharmacologic intervention because we don’t want to have to do the work we’d need to do to take corrective action. When pharmacologic intervention is appropriate and necessary, drugs are often prescribed and used with a patient expectation of drastic and noticeable improvement in the absence of appropriate adjunct/ancillary care. While this problem exists in all facets of medicine, the impact frequently more pronounced and severe in patients with mental health problems. The country as a whole (companies, HCPs, the media and the general population) needs to take a more logical and pragmatic approach instead of knee jerk reactions and sensationalism.
Lisa:
I am always weary when religious organizations try to impose their personal views on the public. I agree with Dr. Johnson’s assessments of the potential risks and problems to the COS sponsored bill. As you can tell from my above rambling, I don’t think the problems that have arisen with many psychoactive drugs are necessarily and completely due to the drugs themselves but more likely due societal problems that include an absolute need for instant gratification, lack of insight and unwillingness to do some hard work coupled by physicians not being particularly judicious when prescribing.
Lisa Van S
Ol Cranky,
What are the benefits of prescribing powerful antidepressants and antipsychotics for Infants and Toddlers? And as Tax Payers, dont we have the right to ask why our hard earned tax dollars are being spent on Haphazard prescribing habits, I believe we do..
Lisa Van S
Atlex,
Would you please expalin to me,..again, about Medicaid Reimbursement for FDA unapproved use, Thank You
Lisa Van S
Adriana
A study of an antidepressant in patients w/ Migraine’s was conducted. The Neurologist rcved a Grant from a major Pharmaceutical Co. To my knoweledge this Study has not yet been Published. This same Neurologist prescribed this antidepressant to a few Teenagers who were diagnosed w/ Migraines. One Teen became suicidal, and I believe another committed suicide.
ol cranky
Lisa:
I can’t address use of psychoactive agents in infants or toddlers as I have no direct knowledge or experience with this or the clinical/scientific rationale for this use. It would make much more sense for a joint task force of the American Pediatric Association, American Neurological Association and the American Neuropsychiatric Associations to query and investigate use of these agents in children so young. Are these drugs really being used to treat psychiatric disorders or are they being used for other medical reasons (i.e., the way some of these drugs are used to treat pain in adult populations)?
As taxpayers, we do have a right to be assured that tax dollars are not being wasted due to kick-backs via sham research/educational grants and other non-compliant sales/promotional activities, etc. It is a very slippery slope to interject the taxpayer argument into medicine/clinical practice as this has been a tact used by religious groups to impose their personal views into specific personal medical decisions. If you are legitimately concerned about wasting tax-payer dollars for medical treatment vs a more logical and utilitarian use of public healthcare funds you’ll find the greatest financial burden of medical support is in the first and last year of life. It’s amazing how many kids who don’t get routine and preventative treatment to live a healthy life would be able to be receive this care for the cost of trying to keep a baby born at 24 weeks gestation (not to mention the continued cost of care of babies with long-term morbidity due to prematurity).
Brian
From the Journal Neuron and todays WSJ (My point: Treatment resistant patients make up most of the probable suicides after ineffective SSRI use)
Only about one-third of depressed patients feel better after taking any given antidepressant. And there’s no way to tell in advance which drug will work for a particular patient.
A person’s response to antidepressants is thought to be related, in part, to how well a drug can move from the bloodstream into the brain. And the ease of access appears to vary. The walls of blood vessels feeding the brain form a barrier that protects the organ from infections and toxins. But the barrier can also block some helpful substances, such as drugs.
Researchers from the Max Planck Institute of Psychiatry in Munich, Germany, used mice with missing genes to determine that some drugs were able to penetrate the blood-brain barrier more easily when a gene similar to the human one called ABCB1 was turned off.
And the researchers then examined the gene in 443 depressed individuals and found that some variations were associated with significantly greater improvement in depression symptoms in patients taking Forest Laboratory’s Celexa, or citalopram, and Wyeth’s Effexor, or venlafaxine.
Lisa Van S
Ol Cranky,
Their is a 17 year old in my community who suffers from a Heart Condition, and the family cant afford life saving heart medicine, NJ Medicaid pays for Psychotropic drugs for healthy infants. I just dont see any rationale in this is. Religion has no debate in this issue, it is about informed Consent.
ol cranky
Actually, it’s about access/barriers to access to medical care and has nothing to do with taxpayer dollars or informed consent.
I don’t know why the 17 year old isn’t eligible for treatment under medicaid but, if the patient is un/underinsured, most manufacturers have patient assistance programs to supply free medications where clinically warranted in this case. There are other organizations that also provide assistance to pay for medications. Apparently, in paying for psychotropic drugs for these infants, NJ Medicaid does not agree with you that these children are healthy. You’re comparing apples with oranges here. You’d also be quite naive to think the Medicaid payment for psychoactive drugs show more strong arming/manipulation by pharma companies who manufacture these products vs those who manufacture cardiovascular drugs (these companies lobby hard to get reimbursement for any drug that can turn increase their bottom line; CV/metabolism & Oncology are the primary therapeutic focus and blockbuster generators that most companies focus on).
Bob Freeman
To Lisa van S. & the question about Medicaid reimbursement for off-label prescribing: It’s very difficult to define off-label use because the physician’s diagnosis is not linked to the prescription. (You can go back in time and link all of these data, as you know, and this is frequently done.) Most software that is in the community pharmacy is to catch potential drug-drug interactions but not off-label prescribing. Given that a physician may prescribe off-label there would be reluctance to implement these kinds of controls. In oncology, for example, as much as 60-70% is off-label.
Off-label prescribing should not be confused with “experimental” drug therapy, which is a type of prescribing that is not covered. Again, it’s difficult to catch unless you see an unusual dose being given or some other red flag.
Lisa Van S
Ol Cranky,
I did inform the family about the Manufacture’s Patient Assistant Program, and they were grateful for the information. Havent heard from them in a few weeks so I am assuming they rcved the assistance needed. Industry is “not all Bad”. I just despise the Disease Mongering part of it.
I thank both of you for your insight.
Mr. Freeman,.. I wont touch the Oncology issue, my grandfather died due to prostate cancer, and a girlfriend’s son lost his long courageous battle with a childhood cancer.
shade
I read the WSJ article yesterday, but Brian’s post has given me a new thought. If the majority of anti-depressant scrips are being written by primary care doctors (something I’ve read a few places), seemingly in lieu of counseling, and 2/3 of the patients aren’t helped by them - doesn’t this mean that there are a large number of people out there who are getting_no_treatment for their depression, even when they think they are?
And for those who get no benefit - do they still suffer the side-effects? Is_all_depression caused by chemical imbalances in the brain? Perhaps not all of the people who’ve been prescribed anti-depressants are suffering from a chemical imbalance. What do the drugs do to a normal person who takes them? Do they get super happy? Ok - that last was facetious, but I doubt the drugs have no effect. Now I have to do more research. :(
Donna
Lisa,
How doe’s any Dr. diagnose an infant or toddler with anything that require’s an antidepressant or anything else???…I’m thinking at that stage of life they are prescribing something more for the parent who , maybe has a full time job,stressed…just can’t, or does’nt have the time to deal with KID’S….
Donna
also I have another problem, my son everytime i’m siting on the couch with him the whole thing is shaking, he alway’s no matter what, the leg is alway’s going……someone please tell me, should I seek the help of a DR. or just unplug the IPOD…….
ol cranky
Shade:
I think you may have hit the proverbial nail on the head wrt GPs prescribing patterns and lack of appropriate ancillary counseling. When a patient is prescribed a med for clinical depression and isn’t given additional psychological treatment they are being set up for failure as they do expect very obvious changes in their mood/energy/overall mental state that will make everything better; this is an unrealistic expectation even for patients who respond to medical treatment.
It’s quite possible that those whose condition doesn’t warrant pharmacologic intervention or who don’t receive benefit from the particular drug that is prescribed may well experience more adverse events (and/or AEs of a more significant degree or nature). This has been seen with other medications and is yet another reason to be concerned about physicians who have a knee-jerk reaction to prescribe (and patients who, essentially, want their doctors to be pill dispensers).
FYI I don’t recall reading that the healthy volunteers in the phase I studies experienced any degree of euphoria but, with some drugs that cross the blood-brain barrier, you may find euphoria as one dose and dysphoria with increasing concentrations of the drug/metabolites being available systemically.
Truthman
Nathan :
I’m all for looking for genuine adverse effects that drugs have (and they all DO have them). However, I hope that the FDA and the public keeps in mind that many, many health disorders (especially depression and obesity) have a well known and well documented side-effect: Suicide. The cost of non-treatment can be very, very high.
.. From reading your comments Nathan, I would almost suspect that you are being paid by some pharma industry group or organisation to sprout stuff that clearly lies in the favour of pharma…
First of all obesity is not linked to depression…
Secondly, Suicide is not an absolute outcome of a depressive episode by any means… To imply that it is is a complete and utter fallacy… Suicide rates are actually quite low compared to the ammount of people who do suffer depression at any one time…
So to automatically imply that Depression and suicide go hand in hand is misinformation and sounds to me like drug company SSRI propaganda…
To call “suicide” a side effect of depression is not accurate… Depression is too complex a condition to make such assumptions… Suicide can be an outcome of depression in some cases, yes that is true, but with the right support, information and care, it never has to be…
The Fact of the matter is Nathan, In SSRI clinical trials such as Paxil , people given paxil were up to 6 times more likely to attempt suicide than those on dummy pills..
So the Paxil was making people more suicidal than the ones whos depression was left untreated and left to run its course..
So why dont you call this news what it is Nathan?…
Good for the interests of patients but bad for the profit interests of pharma…
Its about bloody time the FDA got its finger out of its ass( or should that be Pharmas Ass)…
This can only be good news , and i do hope the FDA will take more actions like these in future…
The whole SSRI debacle has been an absolute disgrace, the way these drugs were marketed has been an absolute shame and as for SSRI clinical trials, most of them were a sham…
Truthman
I meant to say obesity is not linked to suicide(not depression)…. in my first paragraph (just to correct myself)…
Nathan
Truthman:
A few responses:
1) “From reading your comments Nathan, I would almost suspect that you are being paid by some pharma industry group or organization to sprout stuff that clearly lies in the flavor of pharma…”
This is absolutely true and I’ve never denied it. I work as a scientist at a big pharma company. They pay me to do research. I spout stuff in favor of the industry on my own time. It sure would be great if I got paid for some of the stuff I write on this site…
2) “In SSRI clinical trials such as Paxil , people given paxil were up to 6 times more likely to attempt suicide than those on dummy pills..”
I’m sure you have a link to the specific trial that you speak of, right? Or is this just hearsay? Seriously — if this is fact, then it must be published in a reputable place: The FDA? A peer-reviewed journal? A regulatory or watchdog agency?
3) “First of all obesity is not linked to depression…”
According to a study by Gregory Simon published in “The Archives of General Psychology” in 2006, obese people are: 21% more likely to suffer major depression and 47% more likely to suffer bipolar disorder.
4) “Suicide is not an absolute outcome of a depressive episode by any means”
I never claimed that it was an absolute outcome. However, they are certainly linked – would you argue otherwise?
Nathan
Truthman:
You are correct about one thing (in your follow-up): Obesity is NOT linked to suicide, as far as I could find. It’s actually rather interesting. Depression is strongly linked to suicide. Obesity is strongly linked to depression. So you would ASSUME that obesity is linked to suicide. But that is not the case. See this article:
http://www.nytimes.com/2007/03/13/health/13scal.html
Maybe a good prescription for depression is a few large portions of food. They may stay depressed, but at least they won’t try suicide!
Anyway, as I was looking up that information, I did find again and again that untreated depression is the leading cause of suicide. Note: UNTREATED. If you have anxiety, then maybe taking an antidepressant isn’t the best answer. But if you are seriously depressed, you need some help. Maybe from drugs, maybe not. But discouraging depressed people from taking drugs is just as unethical as what you are accusing the pharmaceutical industry of doing.
Lisa Van S
Patient visits a Doctor, and says, wow Ive been pretty depressed lately, and life has been hectic. The Dr. tells the patient, let me prescribe you an antidepressant to help you. The Dr. then states to the patient that the antidepressant carries an FDA Black Box Warning for increased risk of suicide, aggressive and violent behaviour. The patient’s response to the Dr.,.. I said Im depressed,.. I dont want to commit suicide, and I sure dont want to become violent. The patient states, thanks, but, no thanks. In the end, sometimes, the patient knows best, and determines that the side effects, are worse than the Disease.
Nathan
Lisa — that’s a great illustration. The person you describe is probably in no need of an antidepressant.
But there are many, many who are more seriously depressed — to the point of becoming debilitated and isolated from society. Trivializing the use of antidepressants is wrong, whether done on the one extreme (Truthman’s) or the other extreme (Pharmaceutical companies).
Truthman
http://truthman30.wordpress.com/category/seroxat-link-8-adult-suicide-norwegian-study/
The Link above will take you to a study which indicates Paxil causes a 6-fold increase in suicide …
And on a personal note to you Nathan, if you are paid by pharma to do research then you are nothing but a minion for them, and if you think that they don’t own you, your reputation and your opinion then you are wrong… But maybe you don’t care…
The sad truth is even those who work for Pharma have to use prescription drugs or will have to at some point in their lives…
So when the industry covers up, suppresses and denies dangerous side effects it’s a matter for everyone to be worried about…
Even pharma execs, researchers or drug reps could be next victim of a defective or dangerous drug…
Back to the subject of suicide, yes, of course i am not denying that depression can lead to suicide, but driving your car can lead to a car crash… Do we blame the car then for deaths too? Do we scare people off driving ?… Loads of things can lead to death… But unfortunately the concept of Depression has been bastardised by psychiatry and pharma for financial gain, they have exploited people who are already in a vulnerable state.. prescribing them bogus drugs for what are mostly psychological and emotional problems which would be best dealt with by a good psychotherapist or councellor..
The fact that depression can lead to suicide is not the issue, the issue is the public needs to have access to information about the real dangers of SSRI’s and all drugs before they decide to take them…
This hasn’t happend with SSRI’s, and many other drugs too..
Drug companies can do 100 trials for a drug, and if 99 are negative and 1 is positive then they only have to submit and publish the positive one… That’s unfriggin-believable.. But it’s true…
Nathan
Truthman,
I read the Time article and did a little research about the topic. I agree with you that it’s something to be concerned about. As I said, I work in the pharma industry and I do not question the honesty and integrity of most researchers. If there is a problem, I do not believe that it is some sort of intentional cover-up.
Here’s a quote from a research study by UCLA that was published in 2005. While circumstancial in nature, it goes against what you are saying. If there is such a strong correllation between SSRIs and suicide, then you would expect to see suicide rates going UP as SSRI scripts have gone up. But exactly the opposite has actually occured:
(the rest of this post is a quote from the article – link at end)
“Suicide rates rose steadily from 1960 to 1988 when Prozac, the first SSRI drug, was introduced,” said Licinio. “Since then, suicide rates have dropped precipitously, sliding from the 8th to the 11th leading cause of death in the United States.
Several large-scale studies in the United States and Europe also screened blood samples from suicide victims and found no association between antidepressant use and suicide.
Researchers found blood antidepressant levels in less than 20 percent of suicide cases,” said Licinio. This implies that the vast majority of suicide victims never received treatment for their depression.
Our findings strongly suggest that these individuals who committed suicide were not reacting to their SSRI medication,” he added. “They actually killed themselves due to untreated depression. This was particularly true in men and in people under 30.”
http://www.sciencedaily.com/releases/2005/02/050205102643.htm
Nathan
Truthman:
You say: “The sad truth is even those who work for Pharma have to use prescription drugs or will have to at some point in their lives… So when the industry covers up, suppresses and denies dangerous side effects it’s a matter for everyone to be worried about… Even pharma execs, researchers or drug reps could be next victim of a defective or dangerous drug… ”
That’s exactly true! That’s why THERE IS NO COVERUP! Of course there are always people that try to “spin” things slightly one way or the other — but the vast VAST majority of people in the industry are honest, law abiding people who just want to get life saving drugs to the public — my relatives get depressed, get cancer, get heart disease, and get viral infections JUST LIKE EVERYONE ELSE. Of course I want to sell drugs that are safe — I’d be an idiot not to!
Nathan
Here’s four more studies that come to the same conclusion (all in peer-reviewed journals). Not quite as simple as you thought? Or are you going to try to refute these studies one-by-one? This issue is complicated, as science often is, but THERE IS NO COVERUP!
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030220&ct=1
http://www.sciencedaily.com/releases/2006/06/060613072733.htm
http://www.sciencedaily.com/releases/2006/01/060102123919.htm
http://www.sciencedaily.com/releases/2007/09/070907095628.htm
ol cranky
Nathan:
I work in the pharma industry too, on the clinical drug development side so you can understand why I would find the following statement patently offensive:
“And on a personal note to you Nathan, if you are paid by pharma to do research then you are nothing but a minion for them, and if you think that they don’t own you, your reputation and your opinion then you are wrong… But maybe you don’t care…”
Just like any industry, there is good and bad in pharma. The fat that one works in the industry, even doing the research, doesn’t mean that we lie, cover up, and unethically manipulate data for the pharma gods just because we receive a salary to do our jobs. While it’s become apparent that some people don’t do their jobs well and some are willing to lie and manipulate data (something most on the R & D side find vile), most of us in R & D are people of integrity who put safety first and know that good quality data (as in accurate data) is necessary. While an approval and launch of a drug that shouldn’t be approved will help a company’s bottom line and make execs rich, bad press about safety issues/recalls/withdrawals hurt a company, the industry as a whole and those of us in development. You have no idea how many drugs I have killed because the therapeutic index was just too tight to warrant further development; you have no idea how many battles I’ve had and the extremes I’ve gone to ensure the safety of study subjects and patients; and you absolutely no idea of how badly I’ve worked to ensure compliance. My postings and those of other in the industry have been a mix of pro and con, we’re not sheeple and you are way off base to disparage the integrity of everyone in research who receives remuneration from the pharmaceutical industry.
Brian
Truthman [sic]
I think you discount the possibility of biology in the human brain. Let’s assume counseling was tried and was effective in a depressed patient. What has happened between the patients ears? The depressed brain is made up of neurons and synapses together with support tissue. I might ask: what do you think is the role of the parts of the brain in emotion and emotional recovery? How do you explain the effectiveness of counseling? I might posit that a synapse or two thousand was strengthened and maybe increased firing and neurotransmitter release was enhanced. Let’s now advance the possibility that there was a physical deficit in transmitter release due to neuronal damage or decline. What if you did increase the levels of that neurotransmitter? Is there anyway it could help? What if nothing worked and the patient was deemed treatment resistant. Let’s say he commits suicide. Would we sue the counselor even if he gave it his best effort or not bother because he’s not worth what a pharma company is worth? If you are inconsistent there does that make you immoral? After all, one might accuse your outrage as mostly monetary. I must confess, I believe yours it is purely a wealth based advocacy. Don’t believe you can take the moral high ground from those who are trying to understand what is happening in patients you can only feel sorry for. The church of scientology has a weak argument which is based on myths. They are the big pharma of religion in the public eye.
Lisa Van S
Nathan
“Thats a great illustration. The person you describe is probably in no need for an antidepressant”.. Nathan,.. this is a scenario that occurs in a Physician’s office every day, with one exception, the physician fails to disclose the risks. The outcome can be deadly!!!
“Trivialising the use of antidepressants is wrong”….. You are absolutely correct!!
A physician prescribes an antidepressant to a 15 year old girl for a diagnosis of warts on her hands, three weeks later she blows her head off with her father’s revolver.
A 16 year old is prescribed an antidepressant for “Shyness”, weeks later he takes 23 classmates and a teacher hostage at gunpoint. This young man was an honors student and working towards becoming an Eagle Scout.
A 14 year old is prescribed an antidepressant for the
treatment of Migraines and then becomes suicidal, and another commits suicide.
Let’s remember one thing here; With the exception of Prozac, FDA has not approved the use of antidepressants in the treatment of MDD in the Child, Adolescent population because their is “No Efficacy” and they increase the risk of violence and suicide. The Industries own clinical trials verify this.
A 14 year old boy is prescibed an antidepressant because his Military family has moved to another state. One month later he stabs and kills a store clerk.
Id like to add Physicians to your list.
I am an Episcopalian by choice, I have married and raised my children in the Catholic Faith. This issue “never has” and “never will be” about Scientology. Scientolgy is a scape goat for Industry and its getting old!!!
Lisa Van S
Brian,
Since you are so into the human brain, would you please describe for more the difference between an adolescent, to that of an adult. Looking forward to hearing from you…
Lisa Van S
Ol Cranky,
What are your thoughts on children and adolescents being placed in clinical trials without parental consent.
Melody
Nathan–
Your comments imply that we (non-pharma) see the entire industry (from the lowly secretary to the Ph.D. chemists, medical experts and management) as evil. Believe it or not, we DO understand that corporations are comprised of people–most of whom ascribe to honesty, integrity and hard work. And we even understand how/why you advocate for your employer . . . to do otherwise might somehow be considered an endorsement of the misdeeds of which pharma is continuously being accused. Pharmagossip has a post that shows how pharma’s misguided business model has harmed–not only patients, but the integrity of the employees who people it. As Pharma chose to embrace a ‘Hollywood’-blockbuster model, [Pharmagossip reports] . . .”this business model couldn’t work forever. The strategy had a flaw that executives have long ignored: It required extraordinary amounts of promotion at the expense of scientific creativity.
To make the strategy work, the drug industry put its marketers in charge; scientists were given a back seat. Is it any wonder that executives at many companies have watched their pipelines of new drugs slow to a trickle?”
Pharma once sat at the pinnacle of corporate America. Greed and mismanagement (and yes, COVER UPs)have tarnished that standing. Are you to blame? No. Unfortunately, you stand close enough to the miscreants to be painted with the broad brush that the public uses when headlines get their attention.
ol cranky
Lisa:
It’s a violation of CFR and ICH for children to be enrolled in a clinical trial without parental consent (or consent of a legal guardian) in the same manner as it is to enroll an adult without his/her consent (there are certain allowances for studies in emergent care situations). Most IRBs also require assent of the child at certain ages as well. I assume you are referring to the heinous actions in NYC in which foster children were treated in HIV/Aids trials and even foster parents weren’t allowed to withdraw consent in the face of some nasty AEs. . . this was due to the laws of NYC’s ACS in which the state was the legal guardian of the foster children and ACS had these children enrolled in the trials. When I first read about it, I sent the info to all of my friends who work in clinical trials (CRAs, Program Directors, cQA people, etc.) and none of us had every heard of anything like this nor would any of us allowed it in our trials. The only thing that bothers me more than NYC ACS’s stance and actions was that, from the reports I read, it doesn’t appear as though any of the CRAs that monitored the sites noted any irregularity or concern that these kids weren’t dropped from the studies in the face of the safety issues (this is the sort of thing that should have been called into the sponsor’s study manager immediately and documented in the monitoring report). I did blog about it (back when I actually blogged) when I read about it and was surprised this story was never picked up by main stream media nor do I recall ever hearing of any follow up report being issued by the Vera Institute, who was supposed to investigate. This is one of the reasons I think that pharma execs and any other responsible party who was or should reasonable been aware of non compliance should be held accountable and, where appropriate, charged criminally or debarred so they can not work in research at any level.
One big problem we face with this industry is the fact we have laws and regulations but the FDA/DHHS/DOJ doesn’t act on them so they have no teeth. They also don’t seem to go after the small fish (small companies) and a lot of companies don’t realize the absolute importance of monitoring and keeping an eye on the investigational sites to ensure compliance (they don’t want to make waves with their customers or KOLs so they’re not going to have a problem with monitors that don’t document problems because it gives them plausible deniability and they really just think a monitor is a trained monkey).
AS to address some of the examples of violence after use of antidepressants you cite above. I don’t know of any clinical justification for prescribing an anti-depressant for warts (I’m pretty sure this wasn’t an off-label indications a sales person pushed either and, if a psychiatrist prescribed this, I’d have to wonder why she was under psychiatric treatment for warts). You cite these ases as if there were no other factors that could have played a key role in the violence, just that the acts happened some time after the start of these medications. The shy kid could have been bullied for a period of time prior to the med and afterwards; Migraines can be extremely debilitating - is it possible that the kids expected relief from the med and got so frustrated and despondent when the meds weren’t the cure they hoped they became suicidal (it’s also quite possible they even considered it prior to starting the meds as well and didn’t discuss it with their doc or family). There are many confounders to these cases that are ignored and yet they are used as if there is a clear direct causal link.
FYI if you’re wondering why CO$ comes up in discussions, it’s because of a limited focus to psychoactive drugs. We are a quick-fix pill poppin’ culture, we are also willing to find another doctor who will give us what we think we need if our doctor won’t (even in managed care, it happens a lot). All drugs have pros and cons; due to the nature of some drugs, extra caution needs to be taken in their use (psychoactive drugs included). There is blame all around for these problems to lay on the industry, the FDA/DHHS/DOJ, the physicians and, yes, even patients.
PS/ Nathan, please accpt my apologies, my earlier post was directed at “Truthman”, not you.
Melody: you (and Pharmagossip) are absolutely correct about the totally screwed up pharma industry model. This model is also exacerbated by the constant reorganizations of clinical development groups which lead to communication problems, and poorly designed and executed trials. The people who tend to get promoted (and promoted very early in many cases) are those with little depth and breadth of experience who look nice and play the game - some often get promoted when they don’t deliver (there’s always some CRO or big mouth raising concerns to blame things on). Clinical development has taken on the be nice, be pretty model of sales and why bother with a real pipeline when you can just merge with the competition when your 18th to market “me too” drug isn’t the $2B moneymaker you disregarded the gap for.
Melody
Ol’ Cranky, you state: “There is blame all around for these problems to lay on the industry, the FDA/DHHS/DOJ, the physicians and, yes, even patients.”
That pretty well covers the bases, well, perhaps I could add a few others: disease-specific advocacy groups; the media, who either by their noise or silence, favor one position over another; pharmacists (at least to the degree that they cannot truly claim disinterest or non-involvement–they are part of the healthcare system); medical associations, who also shape policy, and often with hidden COIs; and perhaps medical schools, again because they are often beholden to industry funding. Whoops . . . suppose trial lawyers should be included, too. But, since they form the only interface between individuals and the justice system, this is a case of can’t live with ‘em and can’t live without ‘em. For every lawyer who seeks justice for an injured patient, they are untold others who ‘game the system’ for personal greed.
So much blame
Brian
Lisa,
No one can address the differences between the adolescent brain and the adult brain with certainty but. during the transition to adulthood is when the combination of human experience, parenting and genetics reach the point of no return. He’s what I do know: A parent’s (or a teacher) observation of their children’s behavior leads to a visit to the doctor’s office. That is where the transaction takes place from untreated to treated. I hope the right decision is made. If the treatment works, everyone is happy and no one commits suicide and we hear nothing. The only thing we hear is when things don’t work out. Unless you live in Wyoming, you have heard there are treatments for adolescent misbehavior. This combined with the fact that some percentage of teenagers and others have and will commit suicide obscures the number of patients who have been mistreated. I believe that latter number is very small but will always be there. There is a large population of treatment resistant patients for which the future looks grim. For them , society walks away and says “First do no harm”.. Like Pontius Pilate..
Truthman
To Brian And Nathan…
Rather than adress seperate replies to each of you, I have decided to combine one reply as you both seem to beating on the same pro-pharma drum…
First of all, Brian , I find it Laughable when you say :
“one might accuse your outrage as mostly monetary. I must confess, I believe yours it is purely a wealth based advocacy. Don’t believe you can take the moral high ground from those who are trying to understand what is happening in patients you can only feel sorry for. The church of scientology has a weak argument which is based on myths. They are the big pharma of religion in the public eye.
.. For the record, I have NOTHING to do with scientology or any organisation! At one time I was on Paxil(Seroxat in the UK), and I have been researching the pharmaceutical industry and its practices reagarding SSRI drugs for 4 years… I know my stuff very well on the subjects i discuss, from personal experience and from research…
Moral high ground you say Brian? Well go and google “seroxat” and tell me where the morality lies in GSK’s suppression of negative Clinical trial data in Children which led to the precription of Paxil to young people whom then went on to commit suicide , driven to it by the drugs disturbing side effects…
Side effects which i have first hand patient experience of myself… Side effects which patients were not warned about, side effects which GSK failed to disclose for 15 years… And a withdrawal syndrome which GSK admitted actually happens in 1 in 4 people NOT 1 in 1000 which they originally said years before…
Tell me i don’t have a right to be angry at an industry which almost cost me my life, my mind and my livelihood! .. An industry which is second only to the arms industry with its record of human rights abuses, corruption and sinister practices…
You are harping on about Biological changes in depressed individuals… Do you think I don’t know about biological changes? .. The point is not that there are biological changes during or at the onset of a depressive episode.. The point is the source of most depressive episodes is NOT BIOLOGICAL… Don’t you get it???
So effectively by tinkering with neourtransmitters and tricking the brain into thinking it is no longer “depressed” is not a CURE and NOT A SOLUTION to the UNDERLYING CAUSE which is NOT BIOLOGICAL.. The biological changes are a SYMPTOM of the condition.. Is that CLEAR enough for you to COMPREHEND???
SSRI’s appear to be “helpful” treatments because they numb the individual , they numb emotions and they numb the feelings which caused the depression in the first place! But they do not deal with the CAUSE , which needs to be addressed by a psychotherapist or trained councellor
As a short term treatment in severly depressed people, drugs might be only thing they can use to prevent suicide..
By numbing the individual, drugging them to a point where their brain is flooding with serotonin is an UNNATURAL way of dealing with a totally valid and justified reaction which is part of the human condition and has been as long as humans have walked this earth! ..
I am not totally anti-SSRI’s , but I am against concealing of negative data by drug companies about potential dangers from use of their drugs, this causes people to die! Avandia, Paxil, Vioxx, Zyprexa ??? HELLO ?
Nathan…
On the subject on the study you presented..
First of all this study was done by two psychiatrists, and psychiatrists along with pharmaceutical companies are the biggest exploiter of depression and the human condition, most of them are in pockets of the drug companies…
The UCLA Neuropsychiatric Institute (where this study originated) has many connections with pharmaceutical funding over the years…
http://www.bipolargrandrounds.com/grants.html
http://fiddaman.blogspot.com/2007/03/say-good-things-about-our-drugs-and-get.html
Personally i wouldn’t rely on information from anywhere which has such close ties to pharmaceutical funding…
Brian
Truthman
Sorry, I was too tough on you before but the fact is if you are getting some benefit from counseling it is coming from strengthening the neuronal connections and improved neurotransmitter release and capture in the physical structure of your brain. This is , believe it or not, the idea behind increased residence time for serotonin via SSRIs. I agree there is a large number of treatment resistant patients and we are starting to understand why but SSRIs as a class have a good safety profile. No worse than counseling….
One thing you could do is see if your legislators would support making these drugs illegal. Rather than test each case in court..let’s go before the US Senate and House. You have a lot of support among the scientifically illiterate members. It’s your country as much as mine..
Lisa Van S
Ol Cranky,
Im aware of the Clinical Trials and the NYC foster children with aids. Doug Montero was the NY Post reporter who broke the story and made it front page news., and finally the Govt. decided to listen. I believe Vera found more children during their investigation, and I believe that AHRP.org reported on it in her infomails.
I have my own personal experience, my child was placed in a clinical trial w/out my consent. My daughter was diagnosed w/Depression and Anorexia and was prescibed Paxil She began to self mutilate , became psychotic and attempted suicide. It turned out that the original diagnosis was wrong; she had Lyme Disease.
Report: UMDNJ Placed Funding, Patients at risk
http://www.pharmalot.com/2008/01/lack-of-compliance-put-university-trials-at-risk/
Corey Baadsgaard is the name of the teen who took his classmates and teacher hostage at gunpoint. He attended, and with great courage, testified before the FDA and PDAC on Feb 4 2004. A Court believed it was Effexor that caused his actions and was released from Juvenile Detention.
The 14 year old who was treated W/Effexor for Migraines also testified before the FDA. Her Neurologist rcved a grant from Wyeth to study Effexor in Adults with Migraines.
The 14 year old who was on Effexor and stabbed the store clerk, rcvd a 25 year suspended sentence, Judge determined Effexor was a Mitigating factor.
The 15 year old girl w/warts who blew her head off was prescribed Zoloft by her G.P. Pfizer settled this case.
Lisa Van S
Brian,
“SSRI’s as a class have a good safety profile”…..
If they had a good “Safety Profile”,… They wouldnt carry a Black Box Warning.
The difference between an adult brain and the teen brain.,,,the teen Brain is still growing and developing, and their neuro transmitters are continously pruning themselves.
Brian
Black box warnings are routinely placed on drugs without evidence. What evidence did you present besides your emotions?
Ha ha…What do you mean by neurotransmitters pruning themselves….How much bigger do teen brains need to grow..was there some empty space? It’s all biochemistry and biophysics 101. When you answer your own question you should ask someone besides yourself
Stick to CSI reruns..there’s one on now..
Lisa Van S
Brian,
“Black Box Warnings are routinely placed on drugs without evidence”…. The empty space appears to be between “your” ears..
Truthman
“No worse than counseling…. ” says Brian…
SSRI’s “no worse than councelling? ..
Really.. you have nerve Brian, were you ever on an SSRI?..
How many people have you talked to who were on SSRI’s long term? How many people have you spoken to who have suffered terribly because of the side effects of these drugs? ..
You should check out :
http://www.paxilprogress.org/forums/
( you can read tens of thousands of heartbreaking stories from people who have been severely damaged from Paxil and other SSRI’s)
And while your at it check out the paxil petition ..
There are almost 10,000 signatures of people who are outraged from having being precribed this poison and lied to about its efficacy (or lack of)
http://www.petitiononline.com/mod_perl/signed.cgi?oky71
To say that SSRI’s are no worse than councelling, makes them appear to be safe drugs.. Considering the emormous ammount of evidence about the debilitating side effects and withdrawals of these drugs , how can you justify saying they are no worse than councelling?!? ..
Councelling doesn’t cause downgrading of neuroreceptors..
SSRI’s do! ..
Most people who were pushed on to these drugs were told they had a chemical imbalance, which we all know now is bull.. Most people who were prescribed these drugs were suffering crisis in their lives, be it grief, loss, disappointment or depression… The last thing they needed was misinformation and deception from the very people they looked to for help and guidance… God help you if you ever get depression or develop serious anxiety.. Arrogance can be an achilles heal… This kind of thing can happen to anyone… Thats why it is so important for people to be aware of the true dangers..
“SSRIs as a class have a good safety profile” says Brian..
That has to be the biggest lie I have ever heard…
SSRI’s have more safety issues and side effects than most other drugs… Tell the truth Brian… (come on now, stop playing the Big Pharma Propagandist)
http://truthman30.wordpress.com/category/seroxat-link-9-pil-1996-to-2006/
“Black box warnings are routinely placed on drugs without evidence. What evidence did you present besides your emotions?” says Brian
Black Box warning were fought for by parents of children who Killed themselves because of these drugs , how insensitive are you? …
“One thing you could do is see if your legislators would support making these drugs illegal. Rather than test each case in court..let’s go before the US Senate and House. You have a lot of support among the scientifically illiterate members. It’s your country as much as mine..”
Says Brian…
I wonder why it concerns you that these cases could be tested in court? What pharmaceutical companies do you work for? And as a mtter of fact I have spoken to the minister for mental health in the country where I live (not the US) about these drugs…
“support from the scientifically illiterate members”?
Sarcasm really doesn’t become you , if you are trying to be taken seriously I’d recommend you be a little more earnest and sincere…
“I agree there is a large number of treatment resistant patients and we are starting to understand why” says Brian…
If there are a Large numbers of “treatment resistant” patients ( as you put it) then why was this not investigated in original clinical trials? …
Could it be perhaps that this new “treatment resistant patient” concept is yet another new pharma-catch phrase?…
A little like “treatment effects” instead of side effects?
Or “discontinuation sybndrome” instead of “withdrawal” …
It is not the patients who are “treatment resistant” Brian.. Its the drugs which are crap !.. and well you know it…
Nathan
Truthman:
“First of all this study was done by two psychiatrists, and psychiatrists along with pharmaceutical companies are the biggest exploiter of depression and the human condition, most of them are in pockets of the drug companies…”
Up till now, I was willing to concede that there MAY not be hard evidence that SSRI’s help prevent suicide. But you are now denying that they have any positive effect what-so-ever, even in adults? Amazing. I’ve known friends and family members who have taken SSRIs who have very positive things to say about thier efficacy. But maybe their affiliation with me (an evil pharmaceutical scientist) has tainted their honesty….
I’ve said it before, and I’ll say it again: The science of drug discovery and drug development is very difficult. There are differing opinions even among scientists within a single project at a single company. Sometimes drugs are pulled from the market due to safety issues or efficacy issues. Sometimes we make a wrong judgment call. That doesn’t mean that there was a conspiracy. It usually means that we didn’t understand the disease or the drug as well as we thought that we did. That’s part of science. If you don’t want to deal with the inherent uncertainty of science, then I would suggest that you don’t take ANY drugs and don’t visit a physician. Medical science is always evolving — 100 years from now, drugs will still be pulled from the market due to safety concerns that were not identified in clinical trials. Hopefully in 100 years, SSRIs will be a historical artifact. But I can tell you one thing: In 100 years, whatever replaces SSRIs will still be criticized by people like you. Contrary to your screen-name, you don’t want to see the truth — you want to see the world as black or white. The reality is that most drugs (including SSRIs) are various shades of gray.
Truthman
Truthman:
“First of all this study was done by two psychiatrists, and psychiatrists along with pharmaceutical companies are the biggest exploiter of depression and the human condition, most of them are in pockets of the drug companies…”
“But you are now denying that they have any positive effect what-so-ever, even in adults? Amazing. says Nathan …
I never said that Nathan, you took my comment entirely out of context.. Actually you read into something which wasn’t there at all…
I think you are consistently missing my stance on SSRI’s..
Let me make it a little clearer for you…
SSRI’s do not treat the underlying cause or trigger for anxiety or depression, would you agree?
SSRI’s have a high rate of reported adverse side effects such as aggression , hostility, irritability , Akathisia and withdrawal symptoms , would you agree? …
If what you deem a positive effect of an SSRI includes the numbing , disempowering and disabling of emotions then yes you are right , SSRI’s do have this effect and this effects could be thought as having a “positive effect”.
A positive effect in the sense that , they effectively dull and blur the individual to a point where they don’t know how they feel about anything. If that to you is a solution for Life crisis and mental suffering then why don’t you advocate the use of Alcohol or heroin? both do the same thing for many people…
If , for example, you lost your job tomorrow , your wife left you and you had a nervous breakdown from the stress of it, then you sunk into a depression because of the loss and anguish ,is a drug going to fix that? …
Is a drug going to help you deal with regret, grief, hurt, loneliness, anger, resentment, rage, bitteress, low self esteeem? … Is a drug going to empower you ?
No.. It is not…
What they do is disempower people..
And even worse that can increase depression, anxuet and worsen sucididal impulses..
So to prescribe drugs which can push a person who is already in a fragle and vulnerbale state further towards the edge , but not tell them about it, is a human rights abuse as far as I am concerned…
I am always amazed at the complete lack of empathy from “scientists” when discussing these drugs ..
The Brain is not a seperate entity to the human body..
Human beings are complex sentinent beings, we are not just a brain , with our bodies , minds , emotions and feelings seperate from that… The sooner you begin to grasp that, the quicker you will start to comprehend what these drugs do, why they can be dangerous and why people such as myself(a former user of these drugs) speaks out against them and their (mis)use …
The mentally ill have always been expolited one way or another by psychiatry and drug companies, they are societies dirty little secrets, which no one else wants to deal with…
SSRI’s were mass marketed not as “medicines” but as “lifestyle drugs” , Pharmaceutical companies such as GSK in their promotion of Paxil in the early 90’s spent billions advertising these drugs as cures for every human insecurity, fear and neurosis, from shyness to depression…
The true dangers were not adverstised and the public, GP’s and doctors were duped into believing that these drugs were harmless,safe and effective, when in fact, as the evidence shows, they can be unsafe, ineffective and cause considerable harm to many people…
Thats a known fact, it’s just people such as yourself Nathan who don’t want to believe your pharmaceutical science and industry could actually be responsible for mass suffering and reckless deceit…
“Amazing. I’ve known friends and family members who have taken SSRIs who have very positive things to say about thier efficacy. But maybe their affiliation with me (an evil pharmaceutical scientist) has tainted their honesty” Says Nathan …
It doesn’t taint their honesty Nathan, but you will find it very rare for any member of the public to believe as truth anything which comes from a pharmaceutical angle…
The public are becoming more and more suspicious, aware and wary of anything that the industry says or anyone associated with it says… People just don’t trust it anymore…
And considering the state of pharma today, with its reckless lies, fraud and aggressive marketing campaigns, is it no wonder that people are so cynical about it?..
It has been a reputation ill-earned…
“If you don’t want to deal with the inherent uncertainty of science, then I would suggest that you don’t take ANY drugs and don’t visit a physician” says Nathan..
Well , possibly i could suggest that if you don’t want to deal with the uncertainty of drugging mass numbers of people like guinea pigs with drugs which haven’t been adequately tested and regulated then you should refrain from being in the industry altogether?…
This is not about science Nathan, stop hiding behind the veil of science, my best frined is a scientist, studying for a Phd , I understand the mind of the scientist… And i am not anti-science.. But i am well aware that scientists are human too and can make mistakes…It’s just they don’t like to admit it most of the time..
SSRI’s were a mistake ..
..and if you could swallow your pride a bit, and come down to a human level maybe you would come to realize the level of truth in that statement…
Take the elitist scientist hat off for a while and be a human being…
“Contrary to your screen-name, you don’t want to see the truth — you want to see the world as black or white. The reality is that most drugs (including SSRIs) are various shades of gray” .. says Nathan
No, as a matter of fact Nathan, it is you who fails to see what’s going on here, you don’t consider the people who have suffered because of these drugs, you don’t see the grave injustice from suppression of clinical trial data, which costs people their lives… you don’t see the bigger picture because you refuse to accept the truth..
ol cranky
Lisa:
Your daughter was placed in a bona fide clinical trial(as opposed to off-label use) w/o your consent? Unless someone else, who was her legal guardian, consented that is outrageous. Just out of curiosity Was this a sponsored clinical trial or an “investigator sponsored study”? You can email me at olcranky@gmail.com so we can take this off line.
Nathan
Truthman,
At risk of descending this discussion further and further into a name-calling food fight, I think I’ll refrain from addressing those various “issues” that you raise. It’s quite clear that both of us have made our minds up about the issue and come to very different conclusions. Fortunately (in my opinion), the FDA and the millions up millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you.
Best of luck convincing a court of law that your views are correct. I think you’ll need it.
PS. I’ll reiterate yet again: I’m not saying these drugs are perfect and without side effects. I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time. We do the best we can. Unlike what you seem to think, we aren’t just in it for the money. (If I were just in it for the money, believe me I would work elsewhere.)
Lisa Van S
Nathan,
“Best of luck convincing a court of law that your views are correct”
Id like to cite court case “Tobin vs GSK”.. And Sept 9 & 24, 2004 Congressional Record, Energy and Commerce, Subcommittee on Oversight an Investigations.
Brian
Lisa,
“I have my own personal experience; my child was placed in a clinical trial w/out my consent. My daughter was diagnosed w/Depression and Anorexia and was prescibed Paxil She began to self mutilate , became psychotic and attempted suicide. It turned out that the original diagnosis was wrong; she had Lyme Disease.”
Do you expect us to seriously believe that a self righteous person as yourself would allow your daughter to be put on a clinical trial without your consent? Why wouldn’t you be open for criticism of your parental style as a cause of this entire issue? Now you expect to make a reasonable impression on us..
See the following published article on this incident
From Neuropsychopharmacology (2006) 31, 689–699
“The transcript of the Joint Meeting of the CDER Psychopharmacologic Drugs Advisory Committee and the FDA Pediatric Advisory Committee, held during September 13–14, 2004, vividly presents the concerns of FDA officials, committee members, and parents of children who killed themselves or others while taking prescribed SSRI medication (HHS, 2004). The families were outraged that they had not been informed of the increased likelihood of a suicidal fatality from antidepressant treatment. They argued that such notification would have led them to refuse such dangerous treatment, thus preventing their tragic, unnecessary, losses.
Representative quotes follow:
MS VAN S: Good afternoon. My name is Lisa Van S. The FDA and the pharmaceutical industries have repeatedly stated that it is the disease, not the drug, that causes our children to become violent and suicidal. It wasn’t the disease that caused my daughter to viciously mutilate herself; it was the drug. It wasn’t the disease that caused my daughter to become violent and suicidal and out of control. It wasn’t the disease that caused her to scream the words ‘I want to die.’ And, it sure as hell was not the disease that caused Christopher Pittman to kill the two people he loved the most, his grandparents. He had been on Zoloft just three weeks and he was 12 years old. Christopher is now facing life in prison as an adult. Pfizer refers to me and others as a detractor of SSRIs and that I am misinforming legislators with oversight responsibilities. As an adult, I am considered fair game for verbal attacks but, ladies and gentlemen, Pfizer crossed the line the day they attacked a dead child. They viciously attacked a dead child and you all know it. And you, ladies and gentlemen, as adults, need to tell Pfizer that they need to stop.”
“The aggrieved families assumed that taking the medication directly caused the tragic outcome. The suggestion that a child’s suicide may have been the result of their illness, rather than the medication, was dismissed as an outrageous aspersion. Some believed that the FDA failed by allowing such dangerous medications to be on the market, or by failing to recall them. Others believed that, since these drugs are apparently useful under some circumstances, a stern warning of pharmacological risk would suffice.”
“These presentations deeply concerned the Committee. However, its members recognized that self-selected clinical anecdotes cannot establish causality because of the post hoc ergo propter hoc fallacy.”
Again your emotional testimony was presented without examination of the parental upbringing of this girl and because it was a political forum a black box warning was issued. No way to run a railroad..
ol cranky
Brian:
“Do you expect us to seriously believe that a self righteous person as yourself would allow your daughter to be put on a clinical trial without your consent?”
Since enrollment in the trial was done WITHOUT her knowledge (until after the fact) or consent, I don’t think she allowed it. What she did do was raise high holy Hell when she found out. The majority of findings on audit of investigational sites are related to consent issues; including, but not limited to improperly obtained/documented consent, & lack of consent. There are also cases of patients being coerced and/or mislead to obtain consent. I have personally had to make this finding on monitoring reports during my CRA days and have ordered for cause audits of sites due to these sorts of issues but not every monitor has the sense/guts to document these irregularities (especially if the investigator is a company friend/KOL though some do document and are told by their manager/study sponsor to remove negative findings).
Lisa Van S
Brian,
You want to site neuropsychopharmacology, Then you are a retart,.. have no better explanation, I will leave my case up to the US Attorney General. I see you have done you homework. My question to you is this: How much money did GSK pay you to Verbally attack ME…
Brian
Lisa,
What law firm pays your bills?
Nathan
Lisa,
I’m sure GSK didn’t pay him a penny — as it hasn’t paid me a penny either. I’ve looked up the stuff about you too. You’ve made yourself a rather easy target on this website. It strikes me as very odd that you are completely confident that the drugs caused this behavior and not the lyme disease…which is (now) well known to cause encephalitis accompanied by various neurological problems when left untreated.
It sounds to me like you just wanted to find someone to blame. The evil drug companies make a great target.
There may well be problems with the drugs. But its not as clear of a link as you and Truthman like to think.
My question is this: I’m certain that GSK hasn’t paid me or Brian anything. But how much has it paid YOU?? You’ve probably been paid a pretty penny for raising all the hell you have in the last few years…
Lisa Van S
Nathan,
Actually,.. GSK hasnt given me a “DIME”…. Unlike you, and, Brian,.. I cant be bought!!!
As far as Lyme Disease is concerned,.. I am grateful that you are taking the time to educate yourself. My daughter had the best medical team money can buy!! Including Dr. Brian Fallon, Asst Professor of Psychiatry, Columbia Presbyterian, NIH Investigator,.. Lyme Disease Research.
Go Ahead,.. take another shot.
Lisa Van S
Brian,
“What Law Firms pay your bills”,… None,.. I dont accept charity. Thank You for asking.
Lisa Van S
Nathan,
Jury awarded the Tobin Family more then 8 Million,…. HMMMM,.. I wouldnt consider that pennies.
You are becoming an easy target by being so “Naive”‘
truthman
Nathan Says …
At risk of descending this discussion further and further into a name-calling food fight, I think I’ll refrain from addressing those various “issues” that you raise. It’s quite clear that both of us have made our minds up about the issue and come to very different conclusions. Fortunately (in my opinion), the FDA and the millions up millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you.
Best of luck convincing a court of law that your views are correct. I think you’ll need it.
PS. I’ll reiterate yet again: I’m not saying these drugs are perfect and without side effects. I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time. We do the best we can. Unlike what you seem to think, we aren’t just in it for the money. (If I were just in it for the money, believe me I would work elsewhere.)
How convenient that you back out of our discussion Nathan just when the going gets tough .. Difficult to defend pharma when the evidence mounts up isn’t it?…
You might have run away from this discussion but i’m just beginning …
For one , the difference between our opinions is not that we have both reched different conclusions, it is a difference of knowledge and experience of the subject matter (ie … SSRI’s) .. You have no arguement, you just keep coming out with the same pharma propaganda..
You come to your conclusion not out of real scientific research, but out of a loyalty to your mommy pharma which provides you with all your monetary security…
You don’t have an opinion Nathan, you have a bag of corporate catch phrases which i have heard so many times before… (yawn)..
“millions of people who have taken SSRIs without suffering major side effects also have come to a different conclusion than you”
Where is the proof in that ridiculous statement Natahan?..
Find me just 100 positive SSRI testimonies from the Web… It will never match the 9,900 negative ones on the paxil petition…
http://www.petitiononline.com/mod_perl/signed.cgi?oky71
or the tens of thousands of negative stories from members of Paxilprogress
http://www.paxilprogress.org/forums/index.php
Or many tens of thousands more from the multitude of online SSRI support groups…
You back away form this discussion because you have no eveidence to support your views…
If SSRI cases were trialed in a court of law the truth would come out, thats why the drug companies pay out and gag!!! You know thats what happens… Don’t hide behind pharma tag lines which have no meaning.. It is pathetic..
“I’m saying that the science of medicine is an incredibly complicated process that has to work itself out over time”.. Says Nathan…
Well, i could say exactly the same thing about the “human condition”
It isn’t that complicated Nathan…
Either a drug is helpful and beneficial, has efficacy and is safe for patients, or it is not?…
Either a drug company is honest or it is not?
SSRI’s have questionable efficacy, very real dangers and very real side effects …
Which were not disclosed to patients…
That is fraud..
It is devious ,and it is not only morally wrong..
It is inhumane and sinsister to push drugs on people who do not need them, lie about the science (chemical imbalance theory) .. Suppress negative data( study 329 paroxetine) and then deny until the truth eventually comes out..
Brian
Truthman,
You never explain how counseling affects the brain. What physical process goes on during the healing process. Let’s keep it to one paragraph. Oh yes, try to do this without using any of your neurotransmitters…
Truthman
“Brian
Truthman,
You never explain how counseling affects the brain. What physical process goes on during the healing process. Let’s keep it to one paragraph. Oh yes, try to do this without using any of your neurotransmitters ”
Sarcasm.. Always the lowest form of wit Brian…
Ok, if you would like me to explain how councelling affects the brain I will..
Say you have someone who has been through a trauma, and they become depressed from this.. By working through the pain and expressing the emotions and feelings has a positive effect and release for the individual, so when they begin to feel better emotionally, their brain begins to produce more happy hormones and chemicals such as serotonin and dopamine.. Just like any emotion can induce chemical effects in the brain and body.. Anger produces cortisol , love produces dopamine etc etc… To cry also releases a buld of up chemicals … So to numb a person with an SSRI does not allow this release and natural process to take place..
Really i would have thought you clever scientists would have figured all this stuff out by now…