Dr Peter Rost on Paxil/Seroxat : “Want To Kill Yourself”? (2006)


http://www.huffingtonpost.com/dr-peter-rost/want-to-kill-yourself_b_20880.html

Want to Kill Yourself?

The LAST thing you may want to do if you are young and want to kill yourself is to take a drug that will make you feel better. I’ll explain:

The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned today in a letter to doctors.

An analysis of trial data from nearly 15,000 patients treated with both Paxil and placebo (dummy pills) revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the FDA letter. And if Paxil has this problem, it also means that other new antidepressants in the same class may have the same problem.

Clearly, antidepressants used under careful medical supervision are still likely to outweigh the risks, but the FDA letter highlights a serious issue. When doctors and patients find out about a problem with a new drug it may already be too late. The fact that a drug is approved for use doesn’t mean that it is safe. And once a drug is on the market it takes almost as much bad data to get the drug off the market as it took to get it approved in the first place.

But there are lots of early warning signs. Increased suicidal thoughts for young people on antidepressants have been discussed for years. And now the FDA has the data to say that this was actually true.

But your doctor can’t wait until the FDA has enough data. It is your life and your physician has to make sure that he doesn’t take unnecessary risks with your life. One way to do this is to not use a new drug right away, but wait, until there is good data demonstrating the drug is safe. Unfortunately, many cowboy docs have a problem waiting.

Only a week ago it was revealed that Vioxx — a drug which used to be very popular for the treatment of pain and inflammation — could cause heart attack within the first two weeks of use.

A quarter of patients who suffered a heart attack while taking Vioxx did so within the first two weeks of their first Vioxx prescription.

Is this conclusive proof that Vioxx actually killed after only a couple of weeks? Of course not, but it is an indication that the problem with Vioxx may be even worse than what was initially thought.

In medicine, “Primum non nocere,” applies today more than ever before: “First do no harm.”

(Vioxx was voluntarily withdrawn from the market by Merck on September 30, 2004 after a study showed that it doubled patients’ risk of heart attacks and strokes after 18 months of use.)

———————————————————————————–

Additional information just arrived from AHRP:

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.ahrp.org/cms/

A faith-based belief system masquerading as science is collapsing under the weight of evidence that has, for so long been denied by drug manufacturers, by the FDA, and by psychiatry: the best selling, most profitable antidepressants pose an increased risk of suicide for children and adolescents, for “young adults”–in fact, no age group is exempt. [1]

1. GlaxoSmithKline (GSK) has submitted documents to the FDA and other regulatory agencies, contradicting its decade long denial that its antidepressant drug, paroxetine (Paxil / Seroxat) increased the risk of suicidal behavior in the company’s controlled clinical trials,. http://www.gsk.com/media/paroxetine_adult.htm

2. In a letter to healthcare professionals this week, GSK warned about the increased suicide risk stating:
“There is a possibility of an increased risk of suicide related behavior in young adults ages 18-29” — whether the drug is prescribed for depression or for other conditions not associated with suicide. http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

3.GSK is the first of the SSRI drug manufacturers to acknowledge in the Paxil label that the drug may trigger more than “suicidal thoughts.” The drug increases the risk of “suicide attempts.” The Paxil CR label now includes the following warning:

“young adults, are at an increased risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.”

GSK added warnings acknowledging that patients on the drug may experience “persistently worse” depression, or may “experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality” and “these symptoms” may be “severe, abrupt in onset, or were not part of the patient’s presenting symptoms.”

The company advises doctors: “”Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication.”

When was the link between SSRI antidepressants to suicide first reported?

In 1990 by Dr. Martin Teicher warned that Prozac (the first SSRI antidepressant) could cause suicidal behavior: “At the present time we recommend that this drug be used cautiously and that the practitioner be attentive to the possible emergence of suicidal ideation, even in those patients without a previous history of suicidal thoughts or actions.” [2]

In 1991 Dr. Robert King reported that the same phenomenon happens in children. [3] Yet, for more than a decade, drug companies indignantly denied any suggestion of such a risk, attacking those who were able to see the risk and dare to disagree.

In 1991, the FDA convened an advisory committee whose financial ties to Eli Lilly, allowed them to equivocate enough for the FDA to conclude “there is no credible evidence” that Prozac increases the risk of suicide… This imprimatur became the watchword of the industry and the new antidepressants skyrocketed to a $17 billion dollar market.

But the human casualties who had been prescribed Paxil and other SSRIs mounted, and in October, 2002, the BBC-Panorama aired an investigative report whose after-effects still reverberate on both sides of the Atlantic, as well as in Australia. BBC not only introduced the public to victims of irresponsible prescribing of the drug, and GSK’s drug marketing tactics, making visible the collision between patients’ physical and mental well-being and corporate marketing tactics, but the program laid bare the indifference of regulatory agency officials to a serious threat to public health safety.

In May, 2003, a BBC follow-up report provided the opportunity for two expert psychiatrists to express their opposing views publicly. Dr. David Healy, psychopharmacologist, medical historian, and Director, North Wales Department of Psychological Medicine, cited evidence of a suicide risk, and Dr. Alastair Benbow, GSK’s Head of European Psychiatry, defended the drug and denied the risk. [4]

Dr. Healy: “The evidence is that roughly one person in sixty that goes on this drug makes a suicide attempt. Now you have to contrast that with the people going on placebo or sugar pill, and the rate there is one person in five hundred and fifty. That’s nine or ten times less. The risk on the drug is nine or ten times greater than the risk on sugar pill.”

Dr. Benbow: “We have been asked by the regulatory authorities to provide all our information related to suicides and I can tell you the data that we provide to them clearly shows no link between Seroxat and an increased risk of suicide – no link.”

BBC reporter asked Dr. Benbow if he was “absolutely confident” that Dr. Healy is wrong on this issue and will be shown to be wrong?”

Dr. Benbow replied: “Yes, absolutely. Not only that but Doctor Healy has made the same claims about a range of other medicines. He made the same claims about Prozac… [repeats]…he made the same claims about a range of other SSRIs. On every occasion he has been found to be wrong.”

In September, 2004, Alan Metz, GSK North American medical director told the Wall Street Journal: “Each time it has been looked at, there is no suggestion of an association with suicidal tendencies in adults, with relation to SSRIs.”

For more than a decade, they claimed that depression causes suicide, not the drugs. Since then, the backtracking of the naysayers has taken on an almost comedic air. In 2004, they acknowledged “suicidality” in kids, but not suicide, and certainly not adults. Now, GSK admits the drug is associated with increased risk of suicide attempts in adults, but only in young adults. Well, okay, the fine print states “the higher frequency observed in the younger adult population may extend beyond the age of 24.” But “it is difficult to conclude a causal relationship.”

No it’s not difficult to conclude a causal relationship. This double speak is reminiscent of comedian Steve Martin’s admission to smoking marijuana:

“I used to smoke marijuana. But I’ll tell you something: I would only smoke it in the late evening….. Oh, occasionally the early evening, but usually the late evening – or the mid-evening…… Just the early evening, midevening and late evening. Occasionally, early afternoon, early midafternoon, or perhaps the late-midafternoon. Oh, sometimes the early-mid-late-early morning. . . . But never at dusk..”

This week’s GSK acknowledgements put to rest the hackneyed defenses: “it’s the disease not the drug” and “no evidence of a drug-induced suicide risk in adults.”

The simple truth is this: these drugs can cause violent suicidal behavior and death: in kids and in adults, in depressed people and in nondepressed people. The data do not demonstrate that any segment of the population is not susceptible to this risk.

Industry’s denials were buttressed by the FDA.

Daniel Troy, FDA’s former chief counsel, intervened in judicial procedures on behalf of drug companies by invoking FDA authority which he falsely claimed pre-empts state laws protecting public health safety. In a 2002 Amicus Curiae brief, Troy wrote: “…had Pfizer given a warning as to a causal relation between Zoloft and suicide, FDA would have disapproved the warning. Indeed, based on its current scientific knowledge, FDA would still do so today.” [5]

Then, senior FDA officials tried to suppress a report by FDA’s own safety officer, Dr. Andrew Mosholder, whose pediatric SSRI data analysis confirmed a twofold suicidal risk. [6]

Only under intense pressure (in 2004) from parents whose children became suicidal after an SSRI was prescribed; and only after Congress applied pressure on the FDA were warnings of suicidality added to these drugs’ label. However, complaints by drug companies led the FDA to weaken the warnings, removing the following sentence from the label: “A causal role for antidepressants in inducing suicidality has been established in paediatric patients.”

Even as black box warnings were being crafted senior FDA officials denied the existence of evidence the drugs increase the risk of suicide. Dr. Robert Temple testified before a Congressional committee: “At the time … it was not an issue that was prominent in our thinking,” Temple testified. “We had never seen a signal for suicidality in the adult data.” [7] And Dr. Thomas Laughren said his agency had a database of about 40,000 adult patients involved in clinical trials and that “so far, we have seen no signal” indicating the drugs might increase suicide risk.”

GSK’s public admission that in fact, in some cases, young adults (18-24) who take Paxil (paroxetine) are at increased risk of suicide, is based on clinical trial data that GSK and the FDA have been sitting on since the early 1990’s. This acknowledgement of the evidence contradicts its repeated pronouncements and contradicts the sworn congressional testimony of these FDA officials.

Despite the acknowledged suicide risk, GSK attempts to persuade physicians (in the letter to healthcare professionals) to continue to prescribe their drug, offering the company’s faith-based “belief” in the drug’s benefit: “GSK continues to believe that the overall risk-benefit of paroxetine in the treatment of patients with MDD and other non-depressive disorders remains positive…”

http://www.gsk.com/media/paroxetine/adult_hcp_letter.pdf

But here again, the evidence does not support GSK’s claim of SSRI drug efficacy. A meta-analysis of the clinical trial evidence from short and long-term clinical trials by Professor Irving Kirsch and colleagues, showed that 83% of the effect of these drugs is duplicated by placebo. [8]

The question is: Should drugs be approved and marketed on the basis of what the drug company believes, or what the evidence shows?

The pharmaceutical industry is regulated because drugs have the potential to cause serious harm, and industry, with its obvious financial conflict of interest cannot be relied upon to serve the public interest. This is the reason we have an FDA–its mission is to protect us from harmful drugs that companies may want to market. How has this regulatory system been working?

For 15 years the FDA has stood firm in support of drug companies even as they misinformed physicians and the public with false assurances about the safety of these drugs, claiming that there is no evidence of a drug-related risk of suicide. FDA’s policy allowed drug companies to market SSRI’s aggressively by flooding the media with deceptive advertisements. The drugs became blockbusters and companies raked in billions of dollars in sales. All the while, both the industry and the FDA covered their eyes and ears to the human tragedies and the rising number of drug-related casualties.

GSK now reluctantly acknowledges the evidence linking the risk of suicide to its antidepressant, evidence whose existence GSK had denied for so long. That evidence is not new. Dr. Teicher, Dr. King, and all the physicians and lay people who recognized the red flags about these drugs’ hazards, and were courageous enough to speak out, were right all along. And the FDA was wrong all along. Even today, the FDA has not acknowledged the lethal risk that GSK has finally admitted. The evidence has been in FDA’s files for years. Thus, its failure to warn to protect the lives of children and adults is either due to their incompetence or their complicity with drug manufacturers. Either way, their inaction is a dismal failure and betrayal of the public trust.

Earlier this month, the GAO issued a report about its investigation of the FDA, concluding that the FDA is broken and unable to fix itself. [9] The GAO suggested that new legislation is needed to correct the corruption at the current FDA that today is costing people their lives. This latest installment in the book of FDA failures confirms the GAO report. The only question now is whether congress cares more about public health or the financial interests of the pharmaceutical industry.

References:

1. Juurlink, DN, Mamdani, MM, Kopp, A, Redelmeier, DA. The Risk of Suicide With Selective Serotonin Reuptake Inhibitors in the Elderly, The American Journal of Psychiatry (May 2006).

2. Teicher, M. H., Glod C., & Cole J. O. (1990). Emergence of intense suicidal preoccupation during fluoxetine treatment. American Journal of Psychiatry, 147, 207-210. See also case report by Creaney, W, Murray, I, and Healy, D. Antidepressant Induced Suicidal Ideation, Human Psychopharmacology, 1991, Vol. 6:329-332.

3. King, R. A., Riddle, M. A., Chappell, P. B., Hardin, M. T., Anderson, G. M., & Lombroso, P. (1991). Emergence of self-destructive phenomena in children and adolescents during fluoxetine treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 30, 171-176.

4. BBC Panorama: Postcards from the Edge, 5/11/03
5. Daniel E. Troy, Chief Counsel Food and Drug Administration Amicus Brief, September 3, 2002 ; See also: Gary Young, FDA legal strategy would pre-empt tort suits National Law Journal March, 2004, vol. 128; Pg. 3 ww.law.com/jsp/nlj/PubArticleNLJ.jsp?id=1076428430132
See also, http://www.ahrp.org/infomail/05/09/30.php

6. Dr. Mosholder’s embargoed report and the accompanying FDA memos are posted on the AHRP website at: http://www.ahrp.org/risks/SSRImosholder/index.php

7. Anne C. Mulkern, Panel hammers FDA on antidepressant issue Kids’ suicide risk cited, Denver Post, September 24, 2004.

8.Irving Kirsch, Alan Scoboria, Thomas J. Moore, Antidepressants and Placebos: Secrets, Revelations, and Unanswered Questions, Prevention & Treatment, Volume 5, Article 33, posted July 15, 2002 http://journals.apa.org/prevention/volume5/pre0050033r.html

9. GAO Report http://www.ahrp.org/cms/content/view/148/28/

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org

RxISK – Making medicines safer for all of us


New Post from “Seroxat Secrets” highlighting Dr David Healy’s new Website. Check it out..

seroxat secrets...

This is good.

Here’s a new website that Prof David Healy’s involved with. RxISK is a free, independent drug safety website where you can research a prescription drug to see what side effects have been reported and also share your experience and get a free RxISK Report to take to your doctor if need be.

This from RxISK:

A Good Drug is a chemical + Good Information. Most of the information on what drugs actually do is missing. Only you can provide it. Using RxISK will tell you more about the drugs you are prescribed than anything else will. By reporting to RxISK you can help make Good Drugs. Less than 5% of drug side effects are reported. Your voice has been silenced – globally.

Little is known about the effects of drugs on our hair, sex and relationships, violent and other extreme acts or thoughts, and our skin and…

View original post 220 more words

GSK Flu Shot May Raise Adult Narcolepsy Risk Say Finnish Scientists


http://www.reuters.com/article/2013/05/23/us-gsk-vaccine-narcolepsy-idUSBRE94M0FJ20130523

(Reuters) – GlaxoSmithKline Plc’s H1N1 pandemic flu shot may put adults at higher risk of developing narcolepsy, not only children as previous studies found, Finland’s National Institute for Health and Welfare said on Thursday.

Growing evidence of a link between GSK’s Pandemrix vaccine and an increase in narcolepsy, a rare sleep disorder, among children who received it in Europe has delayed approval of a similar vaccine in the United States.

Data published this year in the British Medical Journal found that children in England who had been vaccinated with Pandemrix during the 2009-10 H1N1 swine flu pandemic had a 14-fold higher risk of developing narcolepsy, equating to about one in 50,000.

Finland’s National Institute said an analysis of hospital and primary care data in Finland found that people aged between 20 and 64 who had been vaccinated with Pandemrix were 3 to 5 times more likely to develop narcolepsy than unvaccinated people.

Narcolepsy is a lifelong, incurable and potentially debilitating sleep disorder that can cause hallucinations, bouts of daytime sleepiness and cataplexies – where strong emotions trigger a sudden loss of all muscle strength.

Previous studies in Finland, Sweden and Ireland have also found a link between Pandemrix and narcolepsy, and GSK says more than 800 cases linked to the shot have been reported in Europe.

The British drugmaker says some 30 million doses of the vaccine were administered across Europe during the 2009-10 H1N1 pandemic. The pandemic was declared over in August 2010.

The company acknowledges an association but says there is as yet insufficient evidence to show that Pandemrix is the cause.

(Reporting by Ritsuko Ando in Helsinki and Kate Kelland in London; Editing by Kevin Liffey)

More GSK Skullduggery… The 2013 GSK/FDA Avandia Whitewash…


Pharma & Healthcare
|
http://www.forbes.com/sites/matthewherper/2013/05/23/steven-nissen-the-hidden-agenda-behind-the-fdas-avandia-hearings/
5/23/2013 @ 7:30AM |3,227 views

Steven Nissen:

The Hidden Agenda Behind The FDA’s New

Avandia Hearings

Steven E. Nissen

This post was written by Steven E. Nissen MD, the Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic. This commentary expresses his personal opinions and not necessarily the views of the Cleveland Clinic.

On June 5 and 6, the FDA will convene an advisory committee meeting on the diabetes drug Avandia, which was removed from the market in 2010 in most countries and placed under severe restrictions in the United States. Currently, only 3000 patients take what was once the best-selling oral diabetes treatment in the world. Its maker, GlaxoSmithkline (GSK), did not seek this public meeting and has publicly stated that it did not request modification to the drug’s extremely restrictive label. In 2012, GSK pled guilty to criminal misconduct related in part to concealing the hazards of Avandia and paid a $3 billion fine, one of the largest in U.S. history. In this context, why is the FDA seeking a new review of Avandia?

The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER), is seeking to avoid accountability for its role in the Avandia tragedy. In 2005 and 2006, GSK secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%. This observation had grave implications: two thirds of diabetics, the intended recipients of the drug, eventually die of cardiovascular complications. Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings. FDA statisticians confirmed the risks, but, incredibly, CDER and GSK agreed privately to conceal this hazard from patients and practitioners.

In May 2007, my colleague Kathy Wolski and I published an independent analysis of Avandia in the New England Journal of Medicine (NEJM), showing a statistically significant 43% increase in heart attack. In Congressional testimony, CDER officials acknowledged that FDA statisticians had confirmed our findings, reporting a 40% increase in the risk of heart attack. The leadership of CDER was intensely embarrassed by these revelations and furious with us for publicly challenging the safety of Avandia (and indirectly the competence and integrity of CDER). The FDA appeared incredibly insensitive to the welfare of patients. GSK knew, FDA knew, but patients and physician were not warned.

Since 2006, CDER has expended considerable taxpayer dollars trying to absolve itself of responsibility for this inexplicable error in judgment that cost many lives. In 2010, CDER and GSK saw an opportunity clear Avandia of any cardiovascular hazard and scheduled an FDA Advisory Committee meeting to exonerate the drug. CDER had received the study report for a clinical trial known as RECORD, conducted by GSK in Europe to examine the long-term safety of Avandia. Because RECORD did not confirm a cardiovascular hazard, key senior CDER leaders saw this as an ideal opportunity to absolve themselves of culpability in the Avandia scandal. However, the CDER plan backfired during the public hearings for four reasons:

  1. Independent FDA statisticians confirmed the hazards of Avandia, this time reporting an 80% increase in the risk of heart attack.
  2. FDA Deputy Commissioner Joshua Sharfstein took a personal interest in the issue and insisted that the Advisory Committee include independent scientists who would fairly judge the evidence.
  3. Dr. Sharfstein supported me in my request to present my independent analysis of the Avandia safety data to the committee.
  4. The RECORD trial was analyzed by legendary FDA reviewer, Dr. Tom Marciniak, a physician of the highest integrity and independence, and his review was devastating.

Marciniak’s 2010 review of RECORD showed extraordinary bias in the conduct of the trial. For example, the trial was unblinded; meaning that physicians and patients were aware which drug each patient was taking. Even GSK was unblinded. Incredibly, whenever a study site reported a clinical event, GSK and its contract research organization (CRO), knew immediately which drug the patient was receiving. Marciniak’s review showed that events occurring in Avandia patients were changed or deleted, sometimes months after they should have been reported and counted. These and many other flaws make the RECORD trial totally unreliable.

With a balanced committee membership and a fair hearing for both sides, the advisory committee voted overwhelming in favor of either removing Avandia from the market or severely restricting its usage (of 33 members, 12 voted for withdrawal and 10 for severe restrictions). European regulators banned Avandia entirely and US regulators relegated the drug to usage only in patients who had failed all other diabetes drugs.

However, the CDER leadership refused to accept the conclusion of regulators around the world and its own advisory committee that Avandia is hazardous. Instead, CDER arranged for the RECORD trial to be “re-adjudicated” (re-analyzed) by an outside group, the clinical trial center at Duke University. These Agency officials hope to show that the RECORD trial really did “prove” that Avandia is safe. If the RECORD trial was reliable, the logic goes, then the 2006 decision by CDER to conceal the risks of Avandia did not represent a dereliction of its public duty.

But GSK was allowed to prepare the materials for the Duke reanalysis, undermining the independence of the process. Beyond that, the entire idea of reanalyzing a trial that began in 2003 is simply ludicrous. Such a long interval seriously compromises the ability of adjudicators to retrieve original hospital records, laboratory findings, and other relevant patient data. Marciniak’s 2010 review revealed such extraordinary irregularities in the trial conduct that no subsequent effort could possibly correct the flaws.

The ostensible purpose of the June 5-6 Advisory Committee meeting is to consider the “re-adjudicated” RECORD trial. However, this time the meeting seems systematically designed to absolve the drug of harm and the CDER leadership of any responsibility for ignoring the public health hazard of Avandia. The current effort is intended to “whitewash” the Avandia scandal and re-write history. Certain respected and independent members of 2010 Advisory Committee have been recused from the 2013 meeting. I requested the opportunity to present an independent analysis to the Committee, but was denied and offered a 5-minute statement in the “open public hearing.”

Keen observers should compare the roster of this new committee to the 2010 hearings to determine which participants have been re-invited and which have not. Similarly, assess whether prominent drug safety experts within FDA, such as Dr. David Graham, are listed as speakers or excluded. Finally, will any GSK consultants address the panel?

Why are these hearings important? The FDA has been rocked by a series of scandals over the last decade. One FDA commissioner resigned under a cloud and later pled guilty to charges he had not reported owning stock in companies the agency regulated. Another commissioner resigned during the investigation of the use of political influence to gain approval of a medical device that was subsequently withdrawn. We have endured a series of drug and device safety disasters (Vioxx, Avandia, Ketek, defective defibrillator leads, and recently, compounding pharmacy oversight, and the list goes on) that have harmed many of our fellow citizens. In each case, the permanent FDA bureaucracy has sought to deny responsibility and often failed to learn the appropriate lessons necessary to prevent future catastrophes. In the middle of the sequester, CDER is willing to spend a large sum of taxpayer dollars to conduct a 2-day advisory meeting on a drug nobody uses, for the sole purpose of absolving its own bureaucracy of responsibility for a terrible drug safety tragedy. The current Director of CDER, Janet Woodcock, has directed this division for nearly 20 years, increasingly insulated from the Agency’s true constituency, the American public. If CDER is allowed to re-write the history of Avandia, this vital FDA Center will continue to function as an unsupervised, self-regulating bureaucracy, accountable to no one. That’s just unacceptable when the public health is at stake.

Dr. Nissen consults for many pharmaceutical companies, including companies making or developing diabetes drug. However, he requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction.

Update: The FDA says that Nissen was invited to the previous meeting because his analysis was relevant, but that the topics he is covering would be covered by other speakers. “The FDA encourages participation from all public stakeholders in the open public hearing portions of advisory committee meetings,” the agency said. For the FDA’s full comment, click here.

Post Your Comment

Please log in or sign up to comment.
Enter Your Comment

Forbes writers have the ability to call out member comments they find particularly interesting. Called-out comments are highlighted across the Forbes network. You’ll be notified if your comment is called out.

  • thefox2020 thefox2020 11 hours ago

    Would it be impolite to ask where Hon. Dan Levinson, HHS OIG, has been all these years, given the number of scandals that have rocked the FDA?

    • Called-out comment
  • Author
    Matthew Herper Matthew Herper, Forbes Staff 7 hours ago

    Maybe it’s impolite, but it’s certainly germane.

    • Called-out comment
  • Up until recently it was not prudent to say what he is saying.

    The least that you can do is support these things when they are finally said.

    • Called-out comment
  • rickwo rickwo 10 hours ago

    We can beat our chests all we want about this, but until sufficient thought and energy are directed toward eradicating (1) deregulatory fever and (2) the ubiquitous business-government-business “revolving door” career path, this will be the predictable outcome and our outrage is merely “a tale told by an idiot, full of sound and fury, signifying nothing”. This applies not only to drug safety, but also financial regulation, environmental hazards, climate change, education reform and on and on… Ironically, bringing more data to the table can backfire by reinforcing the opposition’s boilerplate position that this is all just too complex, as in “complex financial instruments, complex science, complex social issues” that are better entrusted to the invisible hand of the free market.

    • Called-out comment
  • It’s all about money. Governments & pharmaceuticals have been working hand in hand to get Americans to pay through the nose for any drug that they can for a long time now. Americans spend astronomical amounts of money both out of pocket & in taxpayer funds via medicare & medicaid for these things.

    There is zero oversight of governments in America today. & there has been zero oversight of governments in America for about one hundred & thirty years.

    Everything that governments in America are doing today is bad for the American People. This is not the exception, this kind of thing, is unfortunately the rule.

    The medias, political dementia, many things contribute to our nations problems. & no one today is contributing to the solutions. It’s like it has become somehow against us to do for ourselves. & we will let others do for us no matter how bad it gets. Unanimously. America today is united in utter failure.

    • Called-out comment

GSK “Saves The Children” (Apart from the one’s dead and damaged from Seroxat!)


http://www.guardian.co.uk/commentisfree/2013/may/10/gsk-save-the-children-aids-drugs-africa

Charity and Big Pharma make uneasy bedfellows

The alliance between GlaxoSmithKline and Save the Children is a pragmatic one that will do good. But is it the best way forward?

andrew witty gsk

Andrew Witty on a visit to Katine … he has said that GSK must do what it can to improve the health of people in poor countries. Photograph: Martin Godwin for the Guardian

Development charities and multinational drug giants have not always appeared obvious bedfellows. The International Aids Conference that takes place every two years – last year in Washington DC – used to be famous for the trashing of drug company stands by activists who had at least the sympathy of mainstream charities. Red paint, for the blood of those who could not afford the price of drugs to keep them alive, flowed in the halls.

So the union of Save the Children and GlaxoSmithKline, launched yesterday in Kenya, is something of a landmark moment. It raises questions about Big Pharma and about the future direction of NGOs and development as a whole. And it has left a number of people working in aid feeling very uncomfortable.

Save the Children and GSK talk of the five-year partnership as a groundbreaking new deal. GSK will reformulate products and develop others in line with Save the Children’s advice on what poor countries really need to save babies’ lives, while helping to train healthworkers. GSK’s chief executive, Sir Andrew Witty, says it is all about speeding things up. From the realisation that babies die for lack of antibiotics to making available a dose-sized pack of powder that families in Africa can use (if they have clean water) takes too long. Witty wants to cut through grindingly slow bureaucratic processes. If he says “jump” in GSK’s west London or Philadelphia corporate HQs, people jump. Things get done. That’s what they are paid for.

Witty and Save’s chief executive, Justin Forsyth, have been moving towards this union for some time. Witty has declared that his company must do what it can to improve the health of people in poor countries. Since 2009, he has made a series of moves, from cutting the prices of GSK’s drugs in the poorest countries to reinvesting 20% of the profits they make locally. This is, he says, another step on that road.

Forsyth is a mover and shaker, who arrived to head Save the Children from Downing Street, where he was director of strategic communications for Gordon Brown, having previously worked for Tony Blair. He ran the communications strategy for the London G20 summit. He is another man who believes in getting things done. For Save, this is a pragmatic move. Money is short in development and getting shorter as the economic situation does not improve. Increasing amounts of the Department for International Development’s funding look likely to be spent on what used to be called defence. All aid organisations are looking for more help. Big Pharma has shedloads of cash. GSK made nearly $9bn in profits in 2011.

But does the link-up of GSK and Save wash away the sins of Big Pharma? It will do GSK’s reputation no harm at all, but it won’t stop the criticism. It was muted yesterday, because NGOs do not want to throw mud at each other, but there were plenty who did not feel like throwing confetti. If GSK really wants to do good, says Médecins Sans Frontières, it should pledge truly low prices for all its HIV drugs in the developing world.

Health Action International is blunter. It fears an agenda set in London, a programme of good works that will run in parallel with the domestic policies of the governments of Kenya and the Democratic Republic of Congo (DRC) and risk undermining them. “Has anyone consulted, and really found out, what is required or is this initiative driven by the needs of CSR [corporate social responsibility], and, it has to be said, an organisation that, like us all, is looking for funds in the face of economic crisis?” asked Dr Tim Reed, its executive director.

The partners aim to save the lives of a million babies. It’s hard to argue with that. And it’s a safe bet they will. But the debate over whether this is the best way to do it will run and run.

Seroxat by Kirk Brandon


 

Everyone smiling, and waving.

Paxil, Seroxat- Paroxetine Generation. 

Brave New World 

GlaxoSmithKline- Meet the Dealer. 

Millions of people in this world of confusion

And the company and its doctors actively pushed the solution

Happy pills that turned men into killers.

And the company even tried to get a license to give it to children. 

The will to kill- and the days filled with rage.

Addiction

Suicide

Halucinations.

GSK- Prophets of despair.

Daily rising.

There’s more than me- that’s watching you 

Glaxo Transparency… Plus Conflict of Interest Of Course…


http://www.pharmalive.com/glaxo-and-transparency-one-panel-member-has-a-conflict

Seven months after promising to release clinical trial data, GlaxoSmithKline has created an online system for researchers to request access to patient-level data and released the names of a group of experts who will review requests from outsider researchers seeking to examine trial data. The drugmaker maintains the effort will make it possible for outside scientists to study Glaxo data and develop their own findings about safety and effectiveness (back story).

However, one member of the panel – which is described as independent and will be tasked with reviewing data requests – has previously worked as a consultant to the drugmaker. Brian Strom, a professor of public health and preventive medicine, and also a professor of biostatistics and epidemiology of the University of Pennsylvania, received $5,500 last year, according to the ProPublica database (see the data here).

“That’s the challenge when individual companies set up their own review panels,” says a Glaxo spokewoman. “We won’t have influence over the panel decisions. We’ve said it won’t be perfect first time out, but the important thing is to be transparent about it… We’re trying to make this attempt to put this effort forward. Maybe this can accelerate the discussion about what is the right system.” She added that Glaxo wants to retain an independent third party to eventually oversee this system and, at that point, the panel may be superceded or even dissolved.

[UPDATE: Strom writes us this: “My role on the committee is completely independent. GSK does not have any say in our decisions…. The story here is someone in industry is looking to do it right. I’m an academic. I gave them advice about what this should include. This is a major scientific advance. There are big things that can come out of here, especially if other companies join… The fact that I did consulting in the past is not news… Our choices are going to be independent… I’m independent. My funding comes from an academic center… You can’t say go to industry and say get the best people in the industry and then criticize them when they do.”]

As noted previously, the move comes after years of controversy over the extent to which drugmakers disclose clinical trial data. The pharmaceutical industry has long been criticized for failing to fully make underlying patient-level data available to others who seek to verify results. Drugmakers have insisted the data is proprietary, but critics have said the reluctance to disclose such information can be a red herring for hiding unflattering results that may limit sales.

The debate has factored into numerous scandals in which drugmakers have been accused of withholding important information about side effects. Glaxo, in particular, was cited for such behavior with its Avandia drug, which figured prominently in a $3 billion settlement the drugmaker reached last year with the US Department of Justice for a number of infractions.

The feds claimed that, between 2001 and 2007, Glaxo failed to include certain safety data about Avandia in reports to the FDA. The missing info included data from post-marketing studies, as well as data about two studies undertaken in response to European regulatory concerns about cardiovascular safety. Glaxo (GSK) agreed to plead guilty to failing to report data to the FDA and to pay a $242.6 million criminal fine (see this).

In agreeing to disclose data, Glaxo also has been at odds with two industry trade groups. Three months ago, the drugmaker publicly supported the AllTrials campaign in its quest to have patient-level data released, a move that PhRMA and the Association of the British Pharmaceutical Industry have opposed (read more here).

Only one other drugmaker has taken any similar steps. Last month, Roche said it would make available data from all 74 clinical trials for its Tamiflu treatment to a team of Cochrane Collaboration researchers. That came after the drugmaker agreed to widen access more generally for clinical trial information for its medicines in response to increased pressure from academics and a widely publicized online petition (back story).

As for Glaxo, the drugmaker plans to list trials on a new web site once a medicine has been approved by regulators or terminated from development and the study has been accepted for publication. Studies that do not progress to publication will also be included. The site already includes global studies conducted since 2007. Over the next two years, global studies going back to the formation of GSK in December 2000 will be added. In addition, all studies starting in or after 2013 will be included, the drugmaker says.

The system would be run by an independent third party that would be responsible for appointing and overseeing a review panel to assess research proposals. “We are the first organization to develop a system for sharing detailed clinical data in this way. Now we want to see this initiative transition to a broader independent model that brings together data from multiple organizations,” says Glaxo pharma R&D president Patrick Vallance in a statement.

He did not offer a specific timeline for retaining a third party to run the initiative. For now, the members of the independent review panel – in addition to Strom – include Marc Buyse, an associate professor of biostatistics, Hasselt University Belgium and founder of the International Drug Development Institute; Bartha Maria Knoppers, who heads the Center of Genomics and Policy at McGill University; and John Hughes, the patient and public involvement member of the UK Clinical Research.

Irish Psychiatrist Jim Lucey Admits That Diagnosis In Mental Health Isn’t About The Cause


Irish broadcaster Pat Kenny regularly carts out the Irish Biological Psychiatrist Jim Lucey on his radio show. I’ve been listening (and reading between the lines) of his interviews. They can be listened to (and downloaded) on this link:

http://www.stpatrickshosp.ie/prof-jim-lucey-pat-kenny

One that is particularly interesting is “Does Depression Really Exist?“.

In this interview , Lucey admits that Psychiatric Diagnosis isn’t about addressing the cause, he says it’s about diagnosing the symptoms in order to label depression.

One listener asked a question, “would I be on Effexor for the rest of my life”? “I’m worried and I don’t know what to do”.

Lucey seems to think that if someone has 3 re-current depressions due to stopping treatment- which he calls re-lapses- that they should stay on medication.

What Jim Lucey doesn’t say is- SSRI medications – like Effexor- can cause a withdrawal syndrome which mimics and often increases symptoms of depression and anxiety- therefore how does a psychiatrist diagnose re-lapse and differentiate between re-lapse into depression and SSRI withdrawal induced depression?

While I don’t doubt Jim Lucey believes in the biological model of psychiatry – it amazes me how he fails to see the dangers of prescribing a one-size-fits-all model for depression. Not once does he offer other alternatives- such as changes in diet, exercise, alternative therapies, nutrition, psychotherapy etc.

Jim says recurring depression might need a mood-stabilizer such as lithium. Perhaps a recurring depression needs intensive talk-therapy- not merely chemical intervention? Ever consider that Jim, no?

What Jim Lucey doesn’t address is the cause of depression in the first place- many factors which he mentions- such as grief, life-changes, environmental factors etc- he brushes over these and sees the individual purely in terms of symptoms instead of focusing on the root-cause.

Jim-Lucey-profile-pic-150px_1

Until the root cause of the depression is dealt with- chemical band-aid psychiatric drugs will not aid an individual in overcoming their depression. I speak from experience..

Discussing Mental Health entirely in biological terms, and aiming to treat Mental Health solely in chemical treatments, is extremely limited and does a great disservice to sufferers of depression and anxiety. Chemical treatments have clearly failed the majority of mental health sufferers,  and perhaps it’s time that psychiatrists like Jim Lucey begin to see beyond the symptoms, the diagnosis and the ‘disease’, and into the essence of the individual.

The individual holds the key to their own recovery, but it seems psychiatrists like Jim Lucey are intent just on elevating their own status as experts on the human suffering of the patient, which is a process which while positive for his profession (in terms of validating the psychiatric ideology)- it results in dis- empowerment of the individual, therefore is negative for mental health sufferers.

On RTE radio  on Monday at the end of a debate on autism, Pat Kenny’s resident psychiatrist Prof Jim Lucey said Dr Gilsenan’s views were “a classic example of a single dimensional divide” that occurs in the suicide debate.

Not sure exactly what that means, but he went on to say there is “no evidence” that anti-depressants cause suicide, and referred to an “anti-psychiatry movement”. Prof Lucey instead preferred to blame alcohol for a rise in suicide. I was under the impression that we Irish had always drunk copious amounts, so why all of a sudden is it driving us to suicide? Perhaps the issue of alcohol mixed with legally prescribed drugs would be a more valid argument. Coroners up and down the country have been commenting on the number of cases where legally prescribed drugs are a factor in deaths.

Jim Lucey says that there is no evidence that anti-depressants cause suicide. This is blatantly untrue. Perhaps Mr Lucey would like to take a look at the tens of thousands of stories of SSRI induced suicide, murder and aggression on SSRI Stories- http://ssristories.com/

or maybe he would open his mind and read about the coroners reports of SSRI induced suicides on this website:

http://antidepaware.co.uk/

The Obvious Hypocrisies In The Irish Abortion/Suicide Debate


It might shock, or surprise, some of my international readers to know that abortion is still illegal in Ireland- and there is a right-wing Christian conservative element in Irish society that wishes to keep it that way- forever.

Thousands of Irish women leave Irish shores for the UK each year in order to have an abortion- a right they are denied in their own country.

The abortion debate has been re-ignited in recent times in Ireland, mainly because of the death of savita halappanavar. Savita was denied an abortion in Ireland even though there was a threat to her life. Because of her death the abortion debate has been thrust back into the Irish political and socio-cultural arena, with many opinions about abortion bandied about in the media- and elsewhere- throughout Ireland for the past few months.

In the Irish abortion debate- as in most countries- there are effectively two camps of divided opinions- the ‘pro-life’ side and the ‘pro choice’ side. But what makes this debate in Ireland particularly interesting has been the involvement of psychiatrists in the debate. I personally think it should be a woman’s right to choose, no matter what the circumstances, but for the purpose of this post I would like to concentrate mainly on the abortion and suicide issues– as I think as you will see- the raising of this controversial taboo has also flagged massive holes in the logic, legitimacy and credibility of Irish psychiatry in general- not just in relation to abortion and the threat of suicide because of it- but also in relation to the entire practice of Psychiatry in Ireland as a whole.

Current legislation is now being drafted in Ireland in order to address the blatant incongruities in Irish abortion laws. One of the controversial elements of this legislation includes a risk assessment of a hypothetical suicidal pregnant woman by psychiatrists. In Ireland- as it stands- there is a so called ‘equal right to life of both mother and fetus’. But there is also a stipulation that in cases where there is a substantial threat to the life of the mother- an abortion can be performed.This is where the threat of suicide comes in- as suicide is surely a valid threat to the life of the mother? Not so – it seems- according to some Irish psychiatrists.

David Quinn, director of the Iona Institute, a religious advocacy group which opposes abortion, said the organisation was “very concerned” at what was contained in the heads of the Bill, particularly in relation to the provision on suicide which he said, if implemented, would see Irish law “crossing a moral Rubicon”.

“The suicide provision is the most worrying provision in it because, if and when this becomes law, for the first time in Ireland, it will provide for the direct killing of an unborn child where there is an alternative treatment,” he said.

Mr Quinn reiterated the organisation’s contention that suicide was not a cure for suicidal ideation, a viewpoint which he said had been supported by 113 Irish psychiatrists who last week signed a statement indicating their opposition to suicidality as grounds for an abortion.

He said the organisation would also be reviewing the part of the Bill which deals with conscientious objection as to what implications this had for Catholic hospitals.

Anti-abortion organisation the Life Institute accused Fine Gael of “caving in” to Labour on abortion. Spokeswoman Niamh Uí Bhriain said the smaller Coalition party represented “less than 10 per cent of the people now, according to polls, yet they are deciding for the whole country on this issue of life and death”.

She said the Government “had ignored all the medical evidence that confirmed abortion was not a treatment for suicide”.

“This Government asked medical experts to give evidence on this issue, and the evidence they heard demolished the case for legalising abortion on suicide grounds, but now they have roundly ignored the evidence and moved to allow unborn children to be deliberately killed for the first time in Ireland.”

Although pro-choice groups welcomed the publishing of the heads of the Bill, they also expressed concern at some of the elements therein.

The Abortion Rights Campaign welcomed the publication as a step toward securing access to safe and legal abortion in Ireland but added that it was “deeply disappointed” by several sections of the draft legislation.

Spokeswoman Cathie Doherty said the campaign was “extremely alarmed” by the inclusion of the assessment of three doctors for termination when a woman is at risk of suicide.

“Requiring three doctors to assess a suicidal pregnant woman is outrageous. This legislation will be redundant if the women affected will continue to travel to England rather than face interrogation by multiple doctors,” she said.

Possible penalty

The organisation also labelled a possible penalty of 14 years in prison for illegal abortion in Ireland as “nothing short of barbaric”.

“To threaten women facing this difficult decision with imprisonment is not only wrong in and of itself, but it may prevent women from disclosing information about previous abortion to their doctors, or seeking medical care in the event of complications from illegal abortion,” said another spokeswoman, Sarah Malone.

Sinead Kennedy of Action on X said the organisation was “very disappointed” by elements of the Bill, particularly around suicidal ideation. She criticised the requirement for a suicidal woman or girl to receive the unanimous consent of three medical practitioners before an abortion could take place in these circumstances, describing it as a “callous disregard for women’s lives”.

Ms Kennedy also criticised the Bill for distinguishing between medical and psychiatric emergencies. “Psychiatric emergencies are medical emergencies and any psychiatrist will tell you that,” she said.

Now if you notice the play on words here, by David Quinn of the ultra-conservative Catholic Iona institute- he is claiming- with the apparent backing of 113 Irish psychiatrists – that ‘abortion is not a treatment for suicide’. Whoever said that it was? It is the threat to the woman’s life by suicide that is the issue. Nobody- apart from right-wing Christian fundamentalists- has alluded to abortion being a treatment for mental illness or suicidality but completed suicide and suicidality may indeed be the result of the trauma of an unwanted pregnancy. It seems that the ‘pro-life’ brigade are not so much ‘pro-life’ but merely anti-abortion in all circumstances- even if that means that a woman would take her own life because she cannot get access to an abortion procedure.

Psychiatrists in Ireland have been telling us for decades that suicidal thoughts should be taken with the utmost seriousness, that they are a sign of mental illness, clinical depression etc, and that psychiatric intervention should be sought immediately – because – they told us- suicide is life threatening and they tell us- depression itself is life threatening because of the risk of suicide.

Yet- 113 Irish psychiatrists have basically just come out and said that suicidality should not be taken seriously if that suicidal individual happens to be a pregnant woman- and suicidality- according to Irish psychiatry – should be viewed with suspicion, contempt and skepticism when that pregnant woman is also seeking an abortion because of it. In other words- they know that they can’t assess whether someone is really suicidal or not.

For decades psychiatrists have been telling us that they are the experts on suicidality but now they seem to saying that they can’t predict suicide. If – as they now admit- they cannot predict suicide, can they be trusted to diagnose ‘mental illness’ at all?

This undermines the credibility of the entire practice of psychiatry because it is their so called ‘expertise’ in matters of suicidality, in particular suicidality and its relation to mental illness -which are exposed under the spotlight by this debate. Their expertise in matters of mental distress are revealed to be –not so expert -after all.

Do you see the gaping holes in the logic here?

On the one hand Irish psychiatry have been saying for years that depression is a life threatening illness solely because of the risk of suicide inherent with depression. But on the other- they are now saying that up to three doctors have to assess the ‘suicide risk’ of a pregnant woman before she is effectively deemed authentically suicidal enough to have an abortion. Or at least convincing enough to warrant an abortion in order to protect her life.

This is not about ‘abortion as a treatment’ for suicidal pregnant women- it’s the so called ‘pro-life’ brigade who have inserted this baseless mantra into Irish media discourse- this is about Irish psychiatrists caught up in their own religious views clouding reality- it is also about psychiatry in Ireland being unwilling and blatantly ill-equipped for the position which for so long they have claimed legitimacy over:  the treatment of suicidality.

You can’t have it both ways.

Take for instance, the vociferous ‘pro-life’ opinion of Dr Patricia Casey, a member of the Iona Institute Catholic think-tank. Casey is a controversial Irish psychiatrist for many reasons which I won’t cover here but in the context of suicidality she says :

In practice, the risk of suicide, even in high-risk groups such as those with serious mental illness, is very low. And among pregnant women the risk of dying by suicide is lowest of all.

Casey states here that ‘the risk of suicide even in high risk groups such as those with serious mental illness is very low.’

That statement is completely at odds with what psychiatrists have been telling us for years- in particular in relation to the risk of suicide in depressed people. So all of a sudden- suicidality in serious mental illness is not really that much of a big deal?

She also says that the risk of dying by suicide is lowest of all in pregnant women. While this might be true- just because it’s a low risk- doesn’t mean it is zero risk. So effectively, Casey and her cohorts admit there is a risk – albeit low. Therefore what Irish psychiatry are really implying is- Irish women seeking abortions will lie about their suicidal states in order to get one and Irish psychiatrists don’t want to be involved in assessing or facilitating this process. Is this not insulting – not only to all women in Ireland? but does it not also demean the seriousness of suicidality itself? And furthermore does it not indicate the blatant hypocrisy of the Irish psychiatric profession, which for decades has claimed to be the only authority on ‘mental illness’, ‘suicide’, ‘depression’ etc?

Irish psychiatry have shot themselves in the foot once again. Abortion is a secular and civic debate, it is a human rights and personal rights issue. It is one of personal individual autonomy. Moral and religious persuasions should not influence professional and scientific opinions.

So hypothetically – if we be the devil’s advocate here- and take Irish psychiatry’s oxymoronic opinion that ‘abortion is not a treatment for suicidality’  then what do they suggest a distressed and pregnant Irish woman do if she is feeling suicidal? Presumably they will try to offer her psychiatric treatment? If so- what psychiatric treatment is available to a suicidal pregnant woman in Ireland. Well- according to Dr Moosajee Bhamjee– there is little or no ‘talk-therapy’ available in Ireland and the waiting lists for psychotherapy can be month’s long. Therefore- I presume that the ‘treatment’ available to a depressed and suicidal pregnant woman in Ireland would predominantly be SSRI drugs?

SSRI drugs are known to cause birth defects, they can also be addictive and cause severe side effects- which includes suicidal ideation, aggression, etc.

Is this really an adequate treatment for a woman who is already depressed, anxious, suicidal and traumatized by an unwanted pregnancy? Or will the panel of psychiatrists who are called upon to assess whether she is adequately suicidal enough, or at least convincingly suicidal enough -permit her to have a medical procedure which might save her life? Or faced with a draconian style inquisition of skeptical and intimidating psychiatrists- will, emotionally fragile and distressed, pregnant Irish women continue (as they have done for decades) to seek proper medical care elsewhere?

Only time will tell..

Personally I think Ireland needs to propel itself pronto into the 21st century.

The Catholic church has had a strangle-hold upon the monopoly of morals, how people live, their sexual persuasion, what they should believe, their marriage rights and their education for far too long.

Irish psychiatry has also had unquestionable authority upon the ‘mental and emotional’ health of Irish citizens for far to long too…

Despite the fact that both are utterly corrupt- and in the case of Irish Psychiatry – utterly devoid of compassion, logic and reason…

Ironically- the Irish psychiatrist Dr Veronica O’Keane seems to be the only one who sees sense.

Although I am not a fan of her opinion on SSRI drugs-  but when it comes to abortion and suicide -at least someone in Irish psychiatry seems to possess an iota of humanity and logic:

Professor of Psychiatry at Trinity College Dublin Veronica O’Keane has said psychiatrists are legitimately deemed best placed to assess suicide risk and if there was a mental illness in a woman it would be their role to treat that illness.

Speaking on RTÉ’s Today with Pat Kenny, Dr O’Keane said if there was the presence of mental illness it sometimes would make a doctor less likely to recommend an abortion.

She said situations are different, and she thought it was much easier to make a decision in the absence of mental illness.

“I think this legislation is primarily for women who are suicidal because they have an unwanted pregnancy and that is the only way of resolving their suicidal problems – is to have a termination,” she said.

Responding after the programme, Psychiatrist Prof Patricia Casey said that the legislation will allow for abortion in the case of women without mental illness, who simply do not wish to give birth to an unwanted baby.

Prof O’Keane also described as “an absolute farce” a survey by a “pro-life” group that claimed 120 psychiatrists who responded did not agree with proposed legislation to legislate for the X Case based on the suicide provision.

Prof Keane said it was a survey conducted by a statedly-biased group and it was done without the permission of the College of Psychiatry Ireland.

She said that those conducting the survey had not gone through the college’s procedures and the survey would not have passed through the college’s guidelines.

She said the survey did not represent psychiatrists.

Describing the survey as it stood as “incomprehensible, and garbled”, she said it did not make any sense.

Prof Casey threatened to leave the studio if she could not respond.

Prof Casey said that the reason they did not do the survey through the college was because they could not get the names of the college membership, in relation to a previous study.

So, she said, when this study was happening she said that “they could not get the numbers from them”.

In a statement following the programme, Prof Casey said: “This was not a College of Psychiatry survey, nor did it purport to be. It was a letter that was sent, asking consultant psychiatry colleagues if they agreed with a particular statement, relating to the involvement of psychiatrists in relation to the current abortion proposals.

“The issue of obtaining permission from the college does not apply. We received a 42% response rate, and it cannot be reasonably argued, by Prof O’Keane, that it was incomprehensive. The overwhelming majority agreed with the statement.

“The question of peer review does not arise.”

http://www.rte.ie/news/2013/0503/390162-fianna-fail-pregnancy/

For an interesting insight into the hypocrisies of the abortion/suicide debate – check out the podcast from RTE’s Pat Kenny here:

http://www.rte.ie/radio1/today-with-pat-kenny/podcasts/

http://www.tv3.ie/3player/show/41/62035/0/Tonight-with-Vincent-Browne

http://leoniefennell.wordpress.com/2013/05/04/patricia-casey-v-veronica-okeane/

Savita
Savita Halappanavar

tumblr_m5q4f8uwhI1qk63oqo1_400