Guest Post: Irresponsible Reporting Harms Parents & Children

Kristina Kaiser Gehrki

Irresponsible Reporting Harms Parents & Children 

By Kristina Kaiser Gehrki

In 1987 I was an optimistic college student earning my first degree in journalism from a top 10 university program that was then, and remains today, highly ranked by the Associated Press.

I vividly remember class discussions about the Washington Post—a newspaper that had diligent reporters such as Bob Woodward and Carl Bernstein who exposed wide-scale corruption to include President Nixon’s Watergate scandal. Back then, venerable Washington Post reporting was often seen as a public service for the greater good. It was good journalism about which Academy Award-winning movies like “All the President’s Men” were made. 

Flash forward to the present decade and it appears journalism ethics and responsible reporting has gone the way of the dinosaurs. Yesterday’s article in the Washington Post titled, “Your Child is Nervous About the New School Year, Which May be Normal—or Not,” is just one of a long string of examples.

In an effort to sell and publish articles, journalists often write stories called “evergreens.” Such articles have a long shelf life and keep their leaves when autumn arrives. I suspect the “Your Child is Nervous” article by Jill U. Adams was likely written as an evergreen, and the back-to-school marketing headline was later crafted to catch the attention of concerned parents who want to ensure their kids are happy and healthy.

As a parent, trained journalist and former teacher, Adams’ article caught my attention because of what she claims and what she chooses to omit.

Jill Adams -  freelance science journalist

Former Pharma Employee-Cum-Reporter Promotes Risky Drugs for Kids

Adams states kids with anxiety can benefit from cognitive therapy—and certain drugs. She specifically asserts: “Medications can help, too, particularly the class of antidepressant drugs known as selective serotonin reuptake inhibitors, or SSRIs.” 

Really? Given that Adams is also a trained pharmacologist, one presumes she is aware of research that finds SSRIs are neither safe nor effective for children. Adams neglects to mention such nor does she inform her Washington Post readers that she studied psychoactive drugs for Johnson & Johnson. 

I can’t help but wonder, was Adams working for Johnson & Johnson when the company criminally marketed Risperdal for unapproved use by children? More than 30 children died and more than 1,000 reported serious complications. The US Dept. of Justice effectively forced Johnson & Johnson to pay more than $2.2 billion to resolve these criminal and civil charges. 

Parents Denied US FDA Black Box Warning Info

US FDA Black Box Warning

While promoting SSRIs to reduce childhood anxiety, Adams also fails to mention that SSRIs carry the US FDA’s most serious Black Box warning. (Above image). She doesn’t note SSRIs cause akathisia which often causes psychosis and unwanted deaths. Reporters are not legally required to communicate FDA Black Box warnings with the readers who trust them. Doctors are not legally required to share FDA Black Box warnings with the parents who trust them. But that doesn’t mean it is ethical for either to withhold such life-saving information.

Failure to Share Conflicts of Interest

Adams also neglected to inform readers that her quoted source, psychiatrist John Walkup, has several potential conflicts of interest to include taking free drugs and money from many pharmaceutical companies.

Adams’ Health and Science section article is simply the latest of many accountability and ethics problems found in mainstream newspapers. Years ago after my teenaged daughter died a prescription-drug-induced death, I contacted the Washington Post about similar omissions and reporting errors. My valid concerns backed up by published data were met with a virtual pat on the head and false promises to contact me should they ever again cover this topic.

A Constant Pattern of Zero Accountability

Systemic errors of omission don’t just occur in newspaper articles; they also rear their ugly heads in the Letters to the Editor and Op-Ed pages.

The Washington Post Letters to the Editor section requires writers to “disclose any personal or financial interest in the subject matter of their letters.” However, in 2014, the newspaper published a letter that appeared to be written by your average Joe, a man named David from Vermont. David’s letter was in response to a Washington Post article about SSRIs, depression and children. His letter expressed concern for children who are depressed and supported the use of pharmaceutical products as effective treatment.

I noticed the letter writer’s last name was “Fassler” and realized this seemingly average Joe from Vermont was Dr. David Fassler, a child psychiatrist and frequent testifier to the FDA in support of the pharmaceutical industry. Fassler describes himself on his LinkedIn page as a specialist in “child and adolescent psychiatry” and “forensic psychiatry” and notes he’s worked with the Executive Director of NAMI-Vermont. NAMI, is the National Alliance for the Mentally Ill and has been the subject of Congressional investigations into its deep financial ties to the pharmaceutical industry. 

Fassler testified at the 2004 FDA SSRI hearings in support of prescribing SSRIs to children. Specifically, “David Fassler of the American Psychiatric Association cautioned that the FDA should not scare patients away from treatment.” Ironically, this was a quote from the Washington Post.

The FDA also heard testimony from many family members who carried photos of their dead loved ones while recounting the torturous SSRI Adverse Drug Reactions they suffered before dying. After the hearings, the FDA responded, albeit far too late, by placing the Black Box suicide warnings on SSRIs.

Fassler’s more recent FDA testimony supported prescribing atypical antipsychotics to children.

Who “Works” for Whom?

But back to 2014. I contacted Fassler to inquire why his Washington Post letter to the editor didn’t disclose his medical credentials nor any personal and financial interests in the subject matter. Our correspondence is below:

On 7/11/14 12:32 PM, Kristina G. wrote:
--------------------
Hi David,

I read with interest your letter to the Washington Post. I was wondering why you didn't share your expertise as a child psychiatrist, experience testifying, and work with pharmaceutical companies? If you write the Post again, perhaps you should include your background so readers can better respect and understand your viewpoints. 

Regards,
Kristina Gehrki

--

On 07/11/14 5:36 AM, David F. wrote:
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Hi Kristina

I did tell the Post I was a child psychiatrist, but they chose not to include any identification. 

I don't do any work w/ pharmaceutical companies.

David

--

It’s important to note Fassler stated: “I don’t do any work w/pharmaceutical companies.” Perhaps he also has no personal or financial interests in the subject matter he wrote about? What is not debatable is that Fassler is an active member of The American Academy of Child and Adolescent Psychiatry (AACAP) and ran for their national position as AACAP Treasurer in their 2013 election. It must be an important position considering AACAP states that in 2012 their “60th Annual Meeting Sponsorships” included “Pharmaceutical sponsorships” that “totalled $175,000.”

I can’t help but wonder if Fassler sat next to Dr. John Walkup at this annual conference when Walkup was a featured speaker at AACAP’s 2013 Psychopharmacology Update Institute. I also wonder if Fassler read AACAP’s 2013 Report to the Council that stated:

“August 14, 2012 Informed on August 4 that Wayne Batzer, M.D. resigned as a member of AACAP stating, “The Academy is clearly reliant on continued pharmaceutical industry funding and I am no longer able to accept this.” 

Looking back on it, I’ve come to accept Fassler’s statement “I don’t do any work w/pharmaceutical companies” at face value. To me, its relevancy depends upon how one first personally defines the word “work.”

Experience is the Best Teacher

Today I’m no longer an optimistic college student. While I’ve earned more advanced degrees and certificates, the most important knowledge I’ve gained since my daughter, Natalie's, prescribed demise comes from experience and research. Independent research and unbiased “journalism” uncovers unimaginable fraud, collusion, corruption and ethical violations in nearly every nook and cranny—from university medical schools to medical associations, from pharmaceutical headquarters to neighbourhood pharmacies, from national papers to your hometown rag, and right on down to your local doctors.

As a former high school marketing teacher, I understand parents want their children to start the school year off right. Parents want to believe things that will provide comfort. Seeking comfort is a basic human trait. But I implore parents who might read yesterday’s Washington Post dribble or another newspaper’s misleading article tomorrow: Remember, just because something sounds comforting doesn’t mean it is true.

When Natalie was 10, I took her to a therapist because of concern about mild school anxiety. I wanted the best for my child. Unfortunately, what we anticipated would be talk therapy soon turned into drug “therapy” prior to the FDA’s SSRI Black Box warning. It’s tragic that misinformed parents who read such articles might unwittingly go down the same dangerous drug path from which there may be no return. I speak up simply because I don’t want to see other trusting parents caused permanent discomfort when later they find themselves visiting their children’s graves.

Natalie’s prescribed demise is featured here & here. Like Anne Frank, Natalie's diary documented her torture and it is hoped society can learn from these systemic atrocities.

Kristina Kaiser Gehrki is a public health and safety advocate and educator. She holds degrees in crisis and strategic communication, journalism and education but feels her most relevant knowledge stems from personal experience. Her teenage daughter, Natalie, died a prescription-drug induced death after suffering SSRI Adverse Drug Reactions and SSRI withdrawal that was undiagnosed by her doctor and improperly treated with SSRI dose increases.

Petition Put in Place Regarding MHRA

Just a quick one - I will be writing more about this in the future.

A petition is now online regarding the British drug regulatory agency, the MHRA.

In a nutshell, those who have created the petition, want to see the financial ties the MHRA have with the pharmaceutical industry to end.

I could think of a lot more to add but it will have to wait for a future post.

Meantime, here is the head of the MHRA, Dr Ian Hudson, being depositioned by attorneys. It came at a time when Hudson was Head of World Safety for SmithKline Beecham, better known today as GlaxoSmithKline (GSK)

In the video you will see how Hudson completely dismisses and evades the questioning regarding the propensity of Paxil (known as Seroxat in the UK) to cause suicide.

During the time the deposition was taken, it is alleged that company officials at SKB already knew about the Paxil suicide link.

Begs the question why Hudson didn't!

The petition can be read and signed HERE.

For more information, including news that this petition has the backing of Leah Wood (Daughter of Rolling Stones, Ronnie Wood) please visit the very active Facebook Group - Reform The MHRA.

Here's that video deposition.

More about the MHRA here

Bob Fiddaman.

Lilly's Cymbalta Expert

Late last week a jury ruled that Eli Lilly and Co. isn’t liable for withdrawal symptoms including brain zaps experienced by a woman, Claudia Herrera, after she quit the antidepressant Cymbalta.

The crux of the argument, it seems, was that Lilly faced claims of not disclosing, on the warning label for Cymbalta, that 44% of users, in its own studies, suffered discontinuation side effects. Instead, plaintiff lawyers argued, Cymbalta’s label initially disclosed that 2% or more experienced certain side effects.

Lilly's legal team hit back suggesting that  the 44% figure wasn’t relevant to prescribers because, in the same studies, 22% of subjects discontinuing a placebo also reported side effects. The label discloses the Cymbalta withdrawal side effects that occurred significantly more frequently than those of people who took a sugar pill.

Obviously, both sides would need more evidence to provide to a jury. Lilly's expert. it appears, may have tipped the balance.

Douglas Jacobs, a psychiatrist, told jurors there’s no evidence in the medical literature of withdrawal symptoms lasting for months. Herrera’s symptoms might have been a manifestation of her underlying depression and anxiety disorders,

It's classic pharma defence, blame the "illness" and not the drug. So exactly who is Lilly's expert, Douglas Jacobs? Well, he and Eli Lilly go way back.

In 1991, Jacobs' brainchild, "National Depression Screening Day" was launched throughout America/ Two years later, in 1993, it was learned that "National Depression Screening Day" were funded by a number of organisations. The year 1993 saw them receive around $300,000 to $400,000." About half of that came from Eli Lilly Co (1)

Human rights organisation, the CCHR, wrote extensively about Jacobs ties with Lilly here. The article, entitled, "SIGNS OF SUICIDE – A MENTAL HEALTH QUIZ THAT FAILS", highlights how The Signs of Suicide® Prevention Program was produced and sold to schools by a non-profit organization called Screening for Mental Health. (SMH)

Founder and Director of SMH was... you've guessed it, Dr. Douglas Jacobs.

Here he is (below) receiving a cheque on behalf of SMH. The cheque of $500,000 was presented to Jacobs by Bob Pitsal of... you've guessed it, Eli Lilly.

In fact, from 1996 to 2008, Eli Lilly handed over a staggering  $3,920,425.00 to SMH. (2)

Further reading about Lilly's connections with National Depression Screening Day can be found here.


More recently, Jacobs has been in the news for controversial statements made in regard to Daniel Marsh.

Marsh was just 15 when he broke into the home of an elderly couple and brutally stabbed them to death.

Three years previously Daniel Marsh, who at that time was just 12, was honored by a local American Red Cross chapter for saving his father’s life when the elder Marsh suffered a heart attack behind the wheel of the family’s car.

So, what could change a seemingly thoughtful caring 12 year-old into a sadistic killer just three years later?

On day 7 of the trial of Daniel Marsh it emerged that he was on a number of psychiatric medications. This, from Charmayne Schmitz (3)

Wellbutrin was added to Daniel’s existing medications with the first visit to Dr. He on January 30, 2013, and was started at 50 mg. On the second visit, February 12, 2013, it was increased to 100 mg. This was after Daniel’s mother told the doctor that Daniel was attending school daily, eating properly and had no problems with the additional medication. It was noted in the file that the medication may be increased later to 150 mg. On February 27, the mother called and asked that the medication be increased to 150 mg.

Daniel was seen by Dr. He again on March 14, 2013. Daniel’s mood and anxiety were noted as improved, but he was still depressed, and somehow anxious about his friends. As on the initial visit, he answered, “No,” to Dr. He’s questions about having homicidal/suicidal feelings or tendencies. The doctor’s summary was that he “tolerates” the medication.

On April 16, 2013, the next office visit, Daniel appeared more depressed and anxious. Daniel told the doctor that he had become angry and kicked the family dog. His mother said he had stopped taking the Seroquel that had been prescribed since December of 2012 because he didn’t like how it made him feel. It was noted that he was in the severe clinical range. The Zoloft, also being prescribed since December, was increased to 150 mg at that time.

By telephone on May 1, 2013, Daniel’s mother reported that Daniel was in crisis. He refused to restart the Seroquel and she requested different medications to calm him down. Abilify was prescribed. Lab tests were ordered because Dr. He wanted to know what triggered the crisis. The tests came back positive for marijuana.

The next office visit was on May 30. Daniel showed signs of severe depression, anxiety, muscle tension and anger. The Wellbutrin was increased to 300 mg. Daniel had been recently suspended for bringing a pocket knife to school. Daniel’s mother reported that he would only take the Abilify as needed, when he had extreme anxiety, not as prescribed on a daily basis. This was the last time Dr. He saw Daniel.

Jacobs, who was an expert for the prosecution in the Marsh trial,  was adamant that drugs and doctors could not be blamed for Daniel’s violent acts, in fact Jacobs, who was paid $15,000 to review the medical records of Daniel Marsh and testify about his findings, was later cross-examined by Deputy Public Defender Ron Johnson.

Once again, Charmayne Schmitz covered the story (4)

Dr. Jacobs was disciplined once for failure to diagnose in a suicide case. He charged half his fee despite the discipline. Johnson read the finding: “Dr. Jacob’s opinion was naïve and not with common sense,” from the State Board of Maryland. Dr. Jacobs claimed that he never read their finding.

Johnson then raised the issue that Dr. Jacobs was paid by a drug company, Roche, about $30,000 to $40,000 in 1998. He also testified at a Congressional Hearing in 2000 for Roche, about a relationship between the drug Accutane and suicidal tendencies. Afterwards, the FDA issued a black box warning for Accutane. Dr. Jacobs also worked on two other cases of wrongful death for Roche.

Eli Lilly and Company was one of the contributors to his non-profit. Lilly makes Prozac. Up to 200,000 people were screened by the program. 60% of those would have possibly seen a physician, so Lilly stood to gain 120,000 patients.

Zoloft is not approved for pediatric patients, except for OCD (obsessive-compulsive disorder). This is stated in the black box warning. Jacobs said in clinical trials children have a high placebo response. So, there is no stated evidence that Zoloft works for pediatric patients. When questioned, Jacobs said the clinical experience has shown it to be beneficial.

Dr. Jacobs said there isn’t a lower dosage of Wellbutrin for a 15-year-old. It would be the same as for an adult.

Johnson raised the issue of the medical guide again. It mentions anger, violence and aggression. The doctor treating Daniel “made a clinical judgment.” Daniel was asked about these symptoms and said he had none. Daniel did tell the therapist, but he wasn’t explicit.

Trials of drugs are usually 16 weeks. There are no trials for combinations of drugs. The only evidence is from case reports. The case reports are not evidence of causation unless the FDA gets a large number of them. The doctor then dismissed a case study mentioned by Johnson from a medical journal, stating that “young kids have violent thoughts” on Prozac. The doctor said there weren’t a lot of them reported.

Daniel Marsh was sentenced to 52 years to life.


Hardly surprising then that months later Jacobs is once again in court giving evidence regarding another antidepressant, this time Eli Lilly's Cymbalta, where he told the jury that "there is no evidence of withdrawal symptoms lasting for months." Adding that, "Herrera’s symptoms might have been a manifestation of her underlying depression and anxiety disorders."

It leaves me wondering if the Jury in the Cymbalta lawsuit were made aware of Lilly's expert witness.

Google "eli lilly douglas jacobs" and see what it throws up.

A similar case to that of Herrera's is set for trial in California later today.



Bob Fiddaman.



(1) 1,300 Sites Nationwide To Test For Depression - October 05, 1993
(2) Signs of Suicide – A Mental Health Quiz That Fails - Citizens Commission on Human Rights
(3) Testimony by Marsh Psychiatrist – Part Two - Charmayne Schmitz 
(4) Harvard Psychiatrist Puts Blame on Patient and Family - Charmayne Schmitz 

MHRA - "Your Views Matter"

I think it's safe to say that I, over the years I've been writing this blog, have had a lot of correspondence with the British drug [ahem] regulator, the MHRA.

Most of my correspondence with them, at least 80%, has been bog standard replies that they send out to anyone questioning their stance on antidepressants. I've publicly chastised them on here and in my book many times. Had a meeting with their CEO and met other officials on numerous occasions both in London and Birmingham.

Thing is... they've never really invited me to leave any comment about how I rate their performance.

Imagine my surprise then when I learn that they are now offering that service to members of the public who request information from them.

The MHRA Customer Services Feedback, aptly run via the surveymonkey website, invites you to leave comments regarding their performance of answering requests you have made to them. Hmmm, they have never offered me any such link in any of the emails they have sent me.

Anyway, why look a gift horse in the mouth. Armed with a snipping tool I've filled in the forms on the survey and added them as jpgs for your perusal.

The MHRA recently appointed a new CEO. His name is synonymous with Paxil litigation. Dr Ian Hudson took over the helm from Kent Woods last year. Hudson had previously been depositioned by US Attorneys in a Paxil suicide case. You see, the man who is now head of the MHRA once worked at GlaxoSmithKline, moreover, he was head of World Safety at GSK [Then Smith Kline Beecham] and worked closely with Paxil.

Nice to have some impartial at the head of a drug regulatory agency, huh?

Hudson, unlike Woods, chooses not to correspond directly with consumers [stakeholders], instead emails are answered by other employees at the MHRA.

Anyway...I've wrote about the conflict of interests at the MHRA many times before. Back to the The MHRA Customer Services Feedback.

Here's my feedback...

Bob Fiddaman

Related

Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA - More on the Mysterious "Ghost Specialists" 

UK Drug Regulator [MHRA] Cosy Up to Sir Andrew Witty

Pfizer team up with the Medicines and Healthcare Products Regulatory Agency

MHRA: Disrespectful, Uncaring or just Downright Liars?

MHRA Described As "Toothless Watchdog

SEROXAT - The Legal Questions that must be answered

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money

MHRA Consultant Calls for Antidepressant Use in Young

Karen Wagner on Treating Kids With Antidepressants

Dr Karen Wagner, "no financial relationships with pharmaceutical companies"

You'd have to be from the planet Zog if you didn't know who Karen Wagner was.

Her name is synonymous with antidepressant pediatric studies. She added her name to the Paxil 329 ghostwritten paper without actually looking at the raw data [which showed an increased rate of suicidal thoughts in kids taking Paxil] - The result of that piece of Pharmafia fraud told millions of prescribing physicians that Paxil was safe to use in children and adolescents...when in actual fact it wasn't.

Wagner has been relentless to disprove those who believe antidepressant use in kids is wrong. She sees no problem with it...despite overwhelming evidence that shows just how dangerous antidepressant use in kids can be.

An article published in Clinical Psychiatry News a couple of days ago shows Wagner, once again, promoting the use of SSRi medication in children and adolescents.

Wagner was present at a psychopharmacology update held by the American Academy of Child and Adolescent Psychiatry where she claimed that "...60% of youngsters will respond favorably to their first antidepressant medication – generally a selective serotonin reuptake inhibitor (SSRI)"

Wagner also went on to claim that Switching to a different antidepressant will help about 50% of those who don’t respond. But adding psychotherapy will grab about 10% more – bringing the total response rate up to around 70%". She was referring to a 2008 study, TORDIA (Treatment of Resistant Depression in Adolescents)

So, Wagner hits the stage at these types of events, she's a key opinion leader, in other words, those employed in the same field as her look up to her, respect her, hang on to her every word. She is the Geldof of the pop world, pushing her message at every given opportunity. Quite why she sticks her middle finger up at evidence that shows kids kill themselves whilst on these drugs kind of alarms me.

So, is Wagner on a mission to help depressed children and teens, does she genuinely care about this population or are there more sinister undertones?

It would help if she and the article published in Clinical Psychiatry News was actually more transparent about her relationship and financial ties to the pharmaceutical industry [Pharmafia].

Upon reading the article I had to do a double take at the end... "Dr. Wagner has no financial relationships with pharmaceutical companies."

Um, excuse me?

Was this a line Wagner told the writer of the article, Michele Sullivan, or has Sullivan just not done her homework?

The content of the article doesn't interest me. Anything that comes out of the mouth of Karen Wagner should be carefully scrutinised given her links to the Paxil 329 study...and other studies for that matter.

What interests me is the startling revelation that Wagner has "no financial relationships with pharmaceutical companies."

Let's just dispel this shoddy piece of journalism.

An article from Alicia Mundy in 2009 [Wall Street Journal] shows that Wagner didn't report some $150,000 in funds such as speakers fees received from GlaxoSmithKline, she also failed to report a trip to Paris.

In fact the then Iowa Republican, Senator Charles Grassley, claimed that the amount Wagner didn't report may have been as high as $230,000.

Wagner, who at the time was working out of the University of Texas, had the backing of her peers who told Grassley they were never aware of any discrepancies regarding Dr. Wagner’s reporting of income from GSK.

Wait a minute... Let's just go back to the recent article in the Clinical Psychiatry News. "Dr. Wagner has no financial relationships with pharmaceutical companies."

Maybe someone should inform Michele Sullivan that she has dropped a clanger in her article.

Sullivan should have also noted that Wagner, according to documents disclosed by GSK under court order, was paid to deliver lectures promoting the use of Paxil for depressed kids and teens to both GSK’s sales reps and doctors.

At a training session for the sales reps, Wagner told the sales force that depression in adolescents was a lethal disorder that, if untreated, could lead to suicide and linger into adulthood. Wagner told the sales reps that the study in question demonstrated that Paxil was both safe and effective treatment for adolescent depression, and that they could expect the positive results for the first of the Paxil studies to be published in early 2000. [Complaint, United States v. GlaxoSmithKline, et al. (“GSK Complaint”), para 52, and Ex. 3 thereto]

Wagner also appeared at no less than 5 “Paxil forum” meetings, which were resort holidays sponsored by GSK for high-prescribing psychiatrists. In these meetings, Wagner falsely claimed that adolescent patients who received Paxil in GSK’s study “showed significantly greater improvement.”

She was also persuasive: according to internal memos, to psychiatrists attending the meetings who reported feeling more comfortable prescribing Paxil to young patients. Paxil revenues went up at least $900,000 from these doctors in 2000 alone. [GSK Complaint, para. 72-76]

Wagner has also been named in a complaint against Forest Labs. In a nutshell the complaint alleges that Forest promoted its antidepressants for pediatric use without FDA approval, and paid kickbacks to doctors to encourage prescriptions. The complaint also alleges that  Forest Labs arranged for Karen Wagner to give promotional presentations on the pediatric use of Celexa and to serve as the chair of a seven-city Continuing Medical Education ("CME") program on treating pediatric depression.

Are we expected to believe that Wagner received no payment for this and she just attended the promotional presentations out of the goodness of her heart?

As, I said earlier, the content of Sullivan's article in the Clinical Psychiatry News is irrelevant. It should, however, be scrutinised given what we know about Wagner's links to the Pharmafia dollar. If the author of the article cannot even get one simple fact correct, a very important fact, then the content, in my opinion, is highly questionable.

I'll leave it to Michele Sullivan to rectify.

Forest Pharmaceuticals and Forest Labs are on the verge of getting a severe spanking after a lawsuit filed by two mothers from Missouri has alleged that Forest Pharmaceuticals and Forest Labs “misrepresented and concealed” information concerning the effectiveness of two company drugs for the treatment of depression in pediatric patients. It will be interesting to see if Wagner is brought to task over her dealings with Forest in this particular case. The suit was filed on behalf of the two Missouri mothers by Baum, Hedlund, Aristei & Goldman, PC and Pendley, Baudin & Coffin LLP.



Bob Fiddaman

Plea For MHRA and EMA to Get Their House in Order

Bravo to Patrick H for starting this petition. It takes courage and resilience to stand up for what you believe in. Too many people sit around and wait for others to act, whilst others criticize those for standing up to be counted. Respect Patrick.

This from the online petition:


To the UK’s MHRA and EU’s EMA: The drugs on our shelves and those recommended by our doctors should first do no harm. As concerned citizens we call on you to put safety first and implement the reforms below:

1) Investigate and act against pharmaceutical companies employing illegal marketing activities by appointing an independent watchdog not funded by the drug industry who can be freely contacted by patients and by doctors witnessing bribery and encouragement to prescribe a drug ‘off label’- for a condition it has no licence to treat - by pharmaceutical representatives.

2) Tighten up requirements for licensing new drugs to include a thorough assessment of benefits versus risks, as well as withdrawal effects.

3) Record and minute meetings to be made publicly available, including representation from consumer groups.

4) Enforce pharmaceutical companies to publish their trial data, without hiding adverse effects, on their website for free access.

5) Take patient reported adverse reactions seriously and encourage patients who have had adverse effects to share them on the website rxisk.org so other patients and doctors are informed.


Why this is important

The profit-hungry drug company GlaxoSmithKline has been peddling a diabetes drug they knew was causing heart attacks without informing doctors or patients of the risk. Regulators in the EU knew about the dangers but failed to act fast enough, putting lives unnecessarily at risk. Previously, UK regulators knew about anti- depressants causing suicide but took over ten years to do anything about it. The same complacency is happening again with new anti-depressants and other drugs.

Earlier this month GSK pleaded guilty to criminal charges relating to anti-depressant and diabetes drug frauds and agreed to pay a $3 billion fine. That brings total fines against big pharma in the US in the last four years to almost $10 billion! But no fines in the UK or EU. Why do we put up with it?

A massive push from thousands of people right now will add to pressure from the media and force regulators to act faster and more decisively against dangerous drugs. As a citizen of the UK I need to know that my family and I are safe and that drug companies put patients before profits. But drug companies will only do the right thing if regulators force them.

Let’s join together in a gigantic outcry for the UK’s Medicines and Healthcare products Regulation Agency and EU’s European Medicines Agency to put safety first. Sign the petition!

----

I truly hope the petition will make the MHRA stand up and listen. I suspect they will, as usual, pretend to listen then do absolutely nothing about the issues raised. They are limp-wristed and powerless and claim to be the best regulator in the world. To be the best of a truly awful bunch is not something I'd be proud of.

The MHRA are in bed with the pharmaceutical industry, they are not just sleeping with them they are performing all sorts of kinky sex acts. Just follow the money trail folks, case in point being these 4 articles I wrote back in 2010.


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician


GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money


Fid

ORDER THE PAPERBACK 'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

MHRA's Kent Woods Defends His Corner

I always love a good old ding-dong in the national press, especially when it involves a highly paid chief executive of the MHRA.

Kent Woods [CEO MHRA] has saw it fit to defend his agency this morning in a letter that has appeared on The Guardian website.

Woods is responding to an earlier article by George Monbiot who had accused the MHRA of being 'unbalanced' , pointing to the facts that the MHRA's board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme...he failed to mention GlaxoSmithKline.

Woods, seemingly incensed at Monbiot's reference, has decided to go public with his response in which he defends the agency's position in hiring previous employees of the pharmaceutical industry. Woods states:

"Given the highly technical nature of the agency's work, a proportion of senior scientific staff are recruited from, or have past employment in, the pharmaceutical industry. First-hand knowledge of industry practices and working methods is essential for effective regulation."

Meh.

Limp-wristed again, eh Kent?

He adds:

"All the agency's staff have complied with the staff conflicts of interest policy, which does not allow any staff member to hold interests in the pharmaceutical and medical technologies (devices) industries."

I think you are missing the point Kent.

I also think Woods is burying his head in the sand - 'What happens in Vegas, stays in Vegas'?

Does Kent Woods honestly believe that employing ex-employees of the pharmaceutical industry can help for a better regulation of prescription drugs?

The current Head of Licensing at the MHRA, Dr Ian Hudson, must have hugely failed Woods. Hudson was the former World Safety Officer at SmithKline Beecham [Now GSK] - he worked closely with Seroxat during his spell at GSK yet when the MHRA carried out a four-year investigation into GSK [for hiding pediatric data and putting children at risk] Woods chose not to:

1. Cross-examine Hudson

and

2. Press criminal charges against GSK

Also interesting to note is that former MHRA employee, Rashmi Shah, is now an expert witness for GSK in the UK Seroxat group action. It was an investigative journalist friend of mine, Evie Pringle, that coined the term, 'The regulatory revolving door'. One out, one in, eh Kent?

At this point it may be worth stating that the MHRA's Chairman, Alasdair Breckenridge, is also a former employee of SmithKline Beecham [Now GSK]

What happens in Vegas, stays in Vegas, eh Kent?

Woods and I have had our disagreements over the years, it's all in my book, the disagreements, the email correspondence, the denial that Seroxat is a teratogen, despite overwhelming evidence to the contrary.

I've also met with Kent Woods. I met with him to discuss the problems people facing SSRi withdrawal are having. I also arranged for the MHRA to meet with the world's leading expert on SSRi withdrawal, Dr David Healy.

Healy presented an SSRi withdrawal protocol to the MHRA almost one year after I met with them... that protocol still remains on the table collecting cobwebs.

The MHRA recently rolled out an 'SSRi Withdrawal Module' for GP's up and down the country. Part of their recommendations to GP's was to refer those suffering severe SSRi withdrawal to 'withdrawal specialists'.

When I asked the MHRA for a list of these so called SSRi withdrawal specialists they could not provide me with one single name. Furthermore, they told me, after three emails, that they would not discuss the matter with me any more. [Links at foot of this post]

What happens in Vegas, stays in Vegas, eh Kent?

The MHRA like to believe that they are helping people, when in actual fact they aren't.

They are, if you will, an agency for the pharmaceutical industry. They hold out the hand of friendship to patient advocates and invite them to meetings to appease them. Nothing more, nothing less.

A much better service is now in the offering, a service that encourages patients to send in adverse reaction reports by way of anecdotal emails, something the MHRA refuse to address. [See RxISK]

To be honest, the MHRA lost my respect many years ago. Former CEO of MIND, the mental health charity, summed it all up for me when he wrote a piece for The Daily Mail:

Last week I resigned from the Government's watchdog on anti-depressants after it tried to cover up its own ten-year failure to identify serious side-effects of the controversial drug Seroxat.

The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide.

But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings.

Brooke added, "Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this."

What happens in Vegas, stays in Vegas, eh Kent?

Chapter 18 of my book [link at bottom] is entitled, "Is Seroxat a teratogen...Goodbye MHRA", all correspondence between myself and Woods can be read in there.



Related:


Another Boob From the MHRA

MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

MHRA In Buck-Passing Specialist Cahoots

MHRA - More on the Mysterious "Ghost Specialists"

MHRA Wishing To Call The Shots

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Australian Psychiatrist Ian Hickie's Lancet Paper Heavily Criticised

Prof Ian Hickie

Things have gone belly-up down under, it seems.

Psychiatrist Graham Burrows has recently been in the news for prescribing unapproved drugs to his patients, resulting in a class action lawsuit against him.

Yesterday an article appeared on the subscription based online website The Australian Doctor. Professor Ian Hickie had co-authored a review that appeared in The Lancet, a review that has been heavily criticised for failing to reveal Hickie's ties with Valdoxan [agomelatine] manufacturer, Servier.

Hickie has also been accused of down playing the side effects of  Valdoxan, an antidepressant marketed for the treatment of major depressive disorder.

So far six letters, in response to the Hickie review, have been published in The Lancet, all of which are critical. Hickie and his co-author Naomi Rogers have both replied to the criticism.

It comes as no surprise, to me at least, that Hickie is seen promoting the use of a psychiatric medication, he is after all part of the DeLorean Mob [EPPIC], a psychiatric service that can jump into the future to see what lays in store for the patients [adolescents] they treat. In a nutshell [pardon the pun], EPPIC can predict if a child may fall foul of psychosis. No prizes for guessing the kind of treatments used for psychosis these days.

Critics slammed Hickie for not revealing his ties [conflict of interests] in the review, something which he has since changed with his response to the critics. One has to question why he never shared this when he and Rogers submitted the review to The Lancet.

I find it difficult to understand how anyone could take his review seriously after reading the disclaimer at the foot of his latest response. Even more so that the disclaimer has only appeared after he was pulled up about it by the critiques.

IBH [Hickie] was previously Chief Executive Officer and Clinical Adviser of beyondblue, an Australian National Depression Initiative. He has led projects for health professionals and the community supported by governmental, community agency, and drug industry partners (Wyeth, Eli Lily, Servier, Pfizer, AstraZeneca) for the identification and management of depression and anxiety. He has served on advisory boards convened by the drug industry in relation to specific antidepressants, including nefazodone, duloxetine, and desvenlafaxine, and has participated in a multicentre clinical trial of agomelatine effects on sleep architecture in depression. IBH is also supported by a National Health and Medical Research Council Australian Medical Research Fellowship. He is a participant in a family-practice-based audit of sleep disturbance and major depression, supported by Servier, the manufacturers of agomelatine. NLR [Rogers] has received grant support from Vanda Pharmaceuticals, Servier, Pfizer, and Cephalon, and has received honoraria for lectures from Pfizer, CSL Biotherapies, and Servier. She has previously received research funding from Vanda Pharmaceuticals, manufacturers of tasimelteon. She has also received an unrestricted educational grant from Servier. Research studies done by IBH and NLR are mainly funded by NHMRC project and programme grants.

Here's just two letters sent to The Lancet in response the Hickie's review, the other four are similar in content. [1]  [2]

Last year I wrote about Hickie regarding his connections to former Australian of the year and psychiatrist Patrick McGorry - Hickierie Dickory Doc - McGorry Turns Back the Clock

Also - The Defence of Prof. Ian Hickie


"If my calculations are correct, when this baby hits eighty-eight miles per hour... you're gonna see some serious shit." - Dr. Emmett Brown [Back To The Future 1985]

MHRA's June Raine Sticks Fingers In Her Ears

It appears that I'm not the only one with a gripe against the MHRA.

Dr June Raine, Director, Vigilance, Risk Management of Medicines, MHRA

All Party Parliamentary Group for Involuntary Tranquilliser Addiction [APPGITA] website is sharing an email sent to June Raine by John Perrott.

Perrott points out that Raine, for reasons unknown, refuses to answer his questions regarding Wyeth withholding safety data from the UK Ativan data sheet or explain why it took a further 18 years for warnings to start being listed by the MHRA.

Perrott's email asks further questions of the MHRA, questions that I doubt will ever be answered. What his email does show, however, is that once again the MHRA are under the spotlight for all the wrong reasons and when they are called to task by members of the public they either label them 'vexatious' or just simply refuse to answer questions.

There's me thinking they had a duty and moral obligation to answer queries.

John Perrott's email can be read in full HERE


RELATED: - MHRA In Buck-Passing Specialist Cahoots

Who Are You?

It appears the World Health Organisation [WHO] took an interest in myself and Ablechild this morning. Quite what they are looking for is unknown, unless of course they are pissed off that Ablechild will be appearing on CNN this weekend or that I've been covering the media interest that's surfaced over the past week or so?

They seemed to be pretty interested in the Seroxat/Paxil withdrawal guidance I have available for download, will they be endorsing it for me or perhaps offering an alternative? They should ask GlaxoSmithKline for their withdrawal protocol, or perhaps they should ask the MHRA for a list of SSRi withdrawal specialists they claim exist.

I've wrote to the MHRA again asking them to list all the SSRi experts and if those experts are available on the NHS. Ironically, the MHRA paid a visit to my blog about a minute before the World Health Organisation.

You see, the MHRA have devised an SSRi Learning Module for doctors in the UK, it's basically a module of buck-passing and looks, to me at least, as if it was ghost-written by the pharmaceutical industry.

If I wanted to withdraw safely from an addictive drug the last people I would turn to would be an agency that is wholly funded by the pharmaceutical industry, particularly when that drug is GlaxoSmithKline's Seroxat and particularly when that agency [MHRA] have a Chairman [Alasdair Breckenridge] who is a former employee of the Seroxat manufacturer and whose Head of Licensing [Ian Hudson] is former World Safety Officer at Seroxat's manufacturers and whose former Senior Medical Officer [Rashmi Shah] is now a paid expert witness for Seroxat's manufacturer in UK litigation .

It appears to me that these mystical SSRi withdrawal specialists that the MHRA refer to in their SSRi Learning Module, actually don't exist, they are passing the buck to someone...or something that is not answerable.

So, I'm left wondering why the World Health Organisation would appear on my page this morning, a minute or so after it is visited by the MHRA?

Are they going to tell me that I should not offer out withdrawal guidance or are they concerned that the MHRA's SSRi Learning Module is, like their Yellow Card Reporting System, deeply flawed?

Time will tell.

I'm still waiting for an answer from the MHRA, it wasn't a Freedom of Information request so it should only take them a couple of days...even though I sent the email on the 28th November!

Related


MHRA To 'Re-educate' UK Doctor's on SSRi's Part I

MHRA To 'Re-educate' UK Doctor's on SSRi's Part II "Keeping A Stiff Upper Lip"

MHRA To 'Re-educate' UK Doctor's on SSRi's Part III - MHRA's Ghosts In The Machine

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part I of IV

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part II of IV - Witness For The Defence

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part III of IV - Expert Statistician

GlaxoSmithKline/MHRA - When Ignorance Turns To Bliss - Part IV - The Colour of Money




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European Drugwatch Agency Under Investigation

The Independent is reporting that The European Medicines Agency [EMA] is under investigation by the European Anti-Fraud Office (OLAF) over allegations of conflicts of interest.


The investigation into the European medical regulator, writes Jeremy Laurance for The Independent, relates to the scandal over the French diabetic drug, Mediator, which was withdrawn from the European market in 2009, a decade after initial signs that it could be responsible for fatal heart problems.

Mediator, a weight loss drug, was banned in Europe after it was found that it caused between 500 - 2000 deaths and, it appears, the EMA didn't act quickly enough.

The crux of the investigation stems from the fact that the EMA are 80% funded by the pharmaceutical industry, much like the UK regulator who are wholly funded by the industry.

I find it odd that an investigation would start now, surely it's been public knowledge for years that this is how the system works?

It's simple really.

A drug is put up to be granted a licence - The regulator reads the supporting evidence - The pharmaceutical company provide the positive results from the clinical trials of that drug - The regulator doesn't bother asking for the negative trial results - The drug is granted a licence.

Some years down the line consumers complain of side effects, some so severe that they cause death - The regulator review the drug and give it a clean bill of health, on the odd occasion they send out warning letters to doctor's to "monitor" the patient. This covers their ass should any future deaths occur.

Everyone is happy and conscience free.

At some point a bunch of patients may kick up a stink about the drug, the regulator will hold meetings with them, appease them and make promises to investigate. They then go all out to target fake drugs flooding the European market - they can't have poor quality drugs going up against the 'safe' drugs that they have granted licence to you see.

I see no point in a regulator that is funded by the very same people it is supposed to be regulating, it's akin to asking an alcoholic to look after a crate of Vodka or giving an arsonist a gallon of petrol and a book of matches.

A spokesman for the EMA said, "We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything.

Yeh, and I've just seen a cow jump over the moon.

Related video:



 *Hat - Tip - Leonie Fennell



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Make-Up of the MHRA Falls Under the Spotlight

The Daily Star, a British tabloid, today ran with a story regarding the safety of  Tamiflu and the conflict of interest that exists within the UK drugs regulator, the MHRA.

Regular readers of this blog with know how, in the past, I have corresponded and met with MHRA officials, discussing various aspects of SSRi safety, in particular the withdrawal issues concerning this class of drugs.

The article, by Jonathan Corke, shows how, when reviewing the safety of Tamiflu, the swine flu anti-viral, the MHRA had insisted that the product was not responsible for 13 deaths in the UK.

Corke writes:

We also told how the Medicines and Healthcare products Regulatory Agency (MHRA) had received reports of 2,084 suspected adverse reactions, including suicidal thoughts, convulsions and psychotic episodes.

The MHRA insisted Tamiflu handed to more than 1.1million people in 2009 is safe and was not “directly responsible” for the deaths.

But health professionals have questioned the make-up of the MHRA as many members who sit on its committees have links to drug firms.

We found at least 18 people on committees and advisory groups with links to Tamiflu makers Roche.

Some declared “personal interests” in the Swiss company, others received cash for lecturing or consultancy work and some sit on advisory boards.

Welcome to the world of reality Mr Corke, I'm surprised that you have just learned of the *revolving door at the MHRA, it's been going on for years and nobody seems in the slightest bit interested.

If you think 13 related deaths on Tamiflu is serious, check out the related deaths from SSRi type drugs.

The following from the MHRA website:

Citalopram [Cipramil] - 148

Escitalopram [Cipralex] - 28

Fluoxetine [Prozac] - 240

Paroxetine [Seroxat] - 177

Sertraline [Lustral] - 102

"Safety reviews carried out by the MHRA have seen them give each and every one a clean bill of health.

In my book, The evidence, however, is clear...the Seroxat scandal, I highlight the conflict of interest and lack of help patients have received over the years from the MHRA. They are an influential body but they influence nothing. Why would an "independent" body, wholly funded by the pharmaceutical industry, bite the hand that feeds it?

There's an ever bigger problem, the MHRA, despite being sent evidence, refuse to acknowledge that GlaxoSmithKline's wonder drug, Seroxat, is a teratogen [1]. This is putting many lives at risk. In fact their protection of Seroxat over the years hasn't gone unnoticed. Hardly surprising that a body of regulators whose Chairman, Alasdair Breckenridge, is a former employee of GlaxoSmithKline, would sway on the side of the industry. Their Head of Licensing, Dr Ian Hudson, is former World Safety Officer at GlaxoSmithKline too.

Earlier this year I was mildly surprised to learn that the UK Seroxat litigation will feature witnesses [experts] for GlaxoSmithKline. One such witness is Rashmi Shah, his former job? -Senior Medical Officer at the MHRA.

Whilst the Tamiflu deaths are poo-pooed by the MHRA they will continue backslapping each other, devoid of any conscience that they are clearly not doing their jobs properly. They've been doing it for years... and will continue to do it with pharmaceutical funding.

On September 2, 2008, I met with the MHRA to discuss the management of withdrawal on SSRi type medication [2] - During the meeting they agreed to meet with Prof David Healy, an SSRi withdrawal expert.
Both my meeting and the meeting with Healy [3] proved to be fruitless - they still bury their heads in the sand regarding the SSRi withdrawal issue and they still refuse to accept that Seroxat is a teratogenic substance, despite evidence to the contrary.

Stakeholder Analysis MHRA June 2008

In fact, it would appear that the MHRA are more concerned about their own reputation than that of the patients they are supposed to protect. In 2008 they commissioned a web consulting firm to analyse the influence and popularity of various online information sources for people interested in learning more about Seroxat and the MHRA, [4] quite why they did this still remains a mystery.

I refuse to liaise with the MHRA any more, the reasons of which are covered in my book.


*revolving door - A term coined by investigative journalist Evelyn Pringle.

1. Teratogen - any substance, organism, or process that causes malformations in a fetus.
2. Guidance on the Management of Withdrawal from Seroxat (Paroxetine) and Other SSRIs
3. Meeting to discuss awareness and management of withdrawal reactions with SSRIs and related antidepressants
4.Stakeholder Analysis MHRA June 2008


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MHRA Go Hi -Tech

To be honest, I can't tell them apart.

Pharmalot's Ed Silverman is reporting that the British drug regulator, the MHRA, are considering using Twitter and Facebook as a way of reporting adverse reactions to medicine.

Silverman writes:

The MHRA is now “actively working on introducing other ways of reporting to make it easier and encourage more reporting,” Mick Foy, the MHRA group manager for vigilance and risk management of medicines, tells GP. “Applications for smartphones, improved web reporting forms and the use of social media such as Twitter and Facebook are being carefully considered as potential routes for reporting.”

But this is not a slam dunk, because the MHRA wants reports to contain info on drug reactions, the patient and the person conveying the info. And the agency must be able to conduct follow-ups. “It is important to consider the structure of the information for inclusion on our database, something Twitter and Facebook do not easily lend themselves to,” he says.

Forgive me for my cynicism for a moment but don't you think the MHRA have rather more important matters to address first?

Their Chairman [I still don't know what he actually does] Alasdair Breckenridge is a stout defender of Seroxat, he is also a former employee of GlaxoSmithKline.

Their Head of Licensing, Dr Ian Hudson, is former World Safety Officer of GlaxoSmithKline.

The current UK Seroxat litigation sees both GSK and the claimants call upon expert witnesses. GSK have called upon Rashmi Shah. Shah's former positions at the MHRA were Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor. He worked for them for 17 years. [Back story]

To be honest, it would appear that this is just another token gesture by a regulatory authority who really don't have any authority at all when it comes to making decisions on whether a drug should or shouldn't remain on the market.

Their four and a half year investigation into GlaxoSmithKline's suppression of pediatric clinical trial data resulted in the MHRA's CEO, Kent Woods, sending the, then Head of Glaxo, JP Garnier, a "Whose been a naughty boy" type of letter. Glaxo were not criminally charged because the MHRA claimed there was a loophole in the EU law. It took them four and a half years and millions of pounds before they came up with that particular excuse.

I can't imagine for one minute that the MHRA actually believe that they have an untarnished image. Anyone who has ever wrote to them with simple requests will find that they either don't hold the information you request any more, can't give it to you because of some exclusion clause in their rules and regulations or, worst of all, they will label you vexatious if you debate with them about their ethics.

The current reporting system is called the Yellow Card Scheme. Their webpage proudly boasts, "This site can be used to report suspected side effects to any medication including vaccines."


If they do decide to move with the times and enter into the world of social networking, I'm sure the increase in reporting will rise. What I'm unsure of is that the MHRA will do nothing but log the adverse reports then claim that the benefits still outweigh the risks.

To be honest, I've heard it all before. I wouldn't trust the MHRA if my life depended on them...much like the poor souls who have died, and who continue to die, at the hands of antidepressant type medication that the MHRA continue to claim does more good than harm.

By the way Kent, there's still an SSRi withdrawal problem. You still haven't done anything about it. [Notes of meeting with Kent Woods 2008]

You can read more about the MHRA on the excellent Social Audit website. The author, Charles Medawar, was trying to convince the MHRA back in 1997 that there was an SSRi problem. As history unfolded and more children and adults suffered at the hands of these drugs, the MHRA stood firm. It's abundantly clear, to me at least, that the MHRA will never budge, it is, after all, the pharmaceutical industry that pay their wages.

I ceased communication with the MHRA back in 2009. I've sent them the occasional Freedom of Information request since. My reasons for ceasing communication with them is clearly marked out in my book, The evidence, however, is clear...the Seroxat scandal. Basically, the MHRA won't admit that Seroxat is a teratogen neither will they accept any such evidence that points to Seroxat being a teratogen.

I'm bored writing about them...they always leave a bitter taste in my mouth.



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Seroxat Lawsuit Settlements - A review

At no time did Seroxat manufacturer, GlaxoSmithKline, admit liability.


**Paxil is the brand name of Seroxat in the US.

Some of the successful Paxil lawsuit settlements include a case involving violent and suicidal tendency as a side effect of using Paxil. In this case a man using Paxil killed all members of his family then shot himself to death. A lawsuit was filed against GlaxoSmithKline and a settlement of $6.4 million dollars was awarded to the family of the man. [SOURCE]

Another successful Paxil lawsuit is about a case involving child birth defects. A family of a boy born with severe heart defects whose mother used Paxil during pregnancy won a lawsuit and was compensated $2.5 million. [SOURCE]

A class action lawsuit, involving users of Paxil and manufacturers in some states selling defective tablets was also filed. Such tablets broke apart or were being absorbed too fast or irregularly into the body. Paxil lawsuit settlements totaling $28 million dollars were awarded for compensation to patients who were affected in any way by defective tablets within the timeframe that the drugs were manufactured. [SOURCE]

According to information from the courts and people familiar with the cases, Paxil lawsuit settlements involving birth defects, suicide and other class action suits have cost GlaxoSmithKline over $1 billion. Successful birth defect Paxil lawsuit settlements have attracted compensation of between $1.5 -$ 4 million with over 600 cases remaining unsettled. Most suicide and suicidal tendency related cases have been settled with only a few remaining; compensation of about $2 million for suicide cases and $300,000 or attempted suicide. Other cases related to addiction, withdrawal symptoms and side effects attract around $50,000. - September 7, 2011 - Author: D. Jefferson


Remarkably, Seroxat is still given a clean bill of health from the UK medicines regulator, the MHRA, this despite there being at total number of 32,919 reports of 'reactions', 10,568 of which have been 'adverse reactions.' To cap it all, the MHRA still believe Seroxat to be safe and effective and also believe that the benefits of taking Seroxat outweigh the risks. They report that there have been 177 reports of fatalities whilst patients have been on Seroxat. [Fig 1]

Fig 1

In 1997 Glaxo reps were told to 'play down' the withdrawal problem with Seroxat [FULL STORY]

In 2011, GlaxoSmithKline will still not help consumers suffering severe withdrawal problems from their product. [FULL STORY]

Alasdair Breckenridge is Chairman of the MHRA - His former employees were GlaxoSmithKline

Dr Ian Hudson is Head of Licensing at the MHRA - His former employees were GlaxoSmithKline

You don't have to be Einstein to work out what's going on here folks.

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