Hetlioz: The Body Clock Brain Pellet

It's been a while since I last blogged. GSK has, seemingly, been good boys and girls for a while and Twitter seems to be where all the action is these days regarding the defence of brain pellets and some shocking behaviour from the field of psychiatry. More on that if you follow me on Twitter.

Today, I'm going to revisit a 2014 blog post of mine that was recently brought to my attention by a reader. The post, Blind Date With Vanda's Hetlioz, can be viewed here.

Hetlioz (tasimelteon) is an FDA approved medication for the treatment of Non 24 Sleep-Wake Disorder in the totally blind and is marketed and manufactured by Vanda Pharmaceuticals.

What is Non 24 Sleep-Wake Disorder?

According to Vanda Pharmaceuticals Hetlioz webpage, it's a "serious, chronic disorder that disrupts a person's circadian rhythms. Non-24 affects up to 70% of people who are totally blind, whether you were born blind or became so later in life."

All seems to be above board until you peel back some of the layers.

The clinical trials for Hetlioz are surrounded in controversy:

 - The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

 - The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

 - Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

 - Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

The marketing of Hetlioz has also come under close scrutiny too. Back in 2015, Stat News ran an article regarding the airtime that Vanda Pharmaceuticals had bought to advertise its sleep/wake disorder drug, $29 million worth of airtime to be exact.

Stat News posed a pertinent point, they pointed out that the target audience for Vanda Pharmaceuticals were blind members of the public, so why the heavy promotional push on TV?

Here's one of the ads they ran across America.

Stat News also claimed that the adverts helped Vanda Pharmaceuticals net a tidy profit of $73 million in revenue.

Hetlioz Indications

The product labelling for the drug does not specifically state that it is to be used by blind people only. This leaves the door open for Vanda Pharmaceuticals to target other patients (non-blind).

Public Citizen, a nonprofit consumer advocacy organization, has filed a petition asking the FDA to correct the labeling to indicate the drug is only for patients with the disorder and who are totally blind, a population numbering approximately 100,000. Public Citizen is concerned the existing labeling may encourage off-label use in people who are not blind and have some other type of sleep disorder.

A Concerned Citizen

A concerned citizen recently wrote to me and told me he, and others, were digging into recent activities of the promotion of Hetlioz. He told me, "We are extremely confused by what we are finding. First off, it appears they are targeting Medicaid patients for Hetlioz with an estimated 80% of revenue coming from Medicare part D. Second, how can they be seeing 2x-3x demand from sighted patients vs blind if non-24 affects mostly blind people and is rare in sighted patients? Third, Cafepharma and glassdoor posts seem to indicate that there is rampant off-label promotion of Hetlioz going on via the company's psychiatric initiative.  This is just a sampling of what we are finding."

Vanda Drug Reps

The same citizen sent me two videos in which we can see Vanda Pharmaceuticals drug reps target patients and not doctors, as is the norm for drug company reps. The first video sees two reps for Vanda speak with what appears to be a mixed audience of visually impaired and blind subjects at Lighthouse, an organisation that promotes the independence, equality and self-reliance of people who are blind or have low vision. What is striking is the Vanda rep at the beginning of the first video asks the audience to fill out the paperwork if they feel they have any symptoms and give it to her and she will contact their physician. I'm unsure of the legality of this. The second rep throws out the question, "How many of you have difficulty sleeping at night?" When 6 or 7 raise their hands he tells them that it could be because they have 'Non 24 sleep/wake disorder'. He then goes on to tell the audience how everyone has a "master body clock in their brains."

I have to point out that neither of the reps mentioned the drug Hetlioz.

One of the audience members tells the rep she has Non 24 and takes Seroquel for it. Hmm.

If anything, this video gives an insight into how drug company reps play their audience. I found it fascinating, I hope you do too.

PS - He's not very good.

**Raw copies of both videos have been downloaded.

So, just as brain pellets were promoted because people had a 'chemical imbalance', along comes another mystery brain anomaly, this time it involves some sort of ticking clock. If you watched the video above you'll note how many times the rep drums home the 'body clock' claim.

The second video is much shorter than the first and shows pamphlets left behind by the Vanda reps. The leaflets, although visible are also written in braille and direct readers to http://www.non-24.com/ - where there's more talk about the 'body clock.' Again, there doesn't seem to be any direct-to-consumer advertising of Hetlioz on the webpage but there's plenty of talk about patients going to see their doctor to explain they may have symptoms of Non-24.

I can only speculate that Vanda reps have already visited their doctors and planted the 'Non-24' seed and what new drug can treat it.

As I mentioned above, I'm not sure if drug company reps targeting patients is entirely ethical so I wrote to a former drug company rep turned whistleblower for her opinion. I asked her if this was legal. She replied:

"No, this is not legal in the U.S. but I cannot provide any documentation to this effect. We were just instructed by the companies that I worked for that it was illegal to interact with patients regarding care/drug regimens. Unless something has changed...I left the industry in the year 2000."

In my 2014 blog post I mentioned the link between Vanda Pharmaceuticals and The National Sleep Foundation (NSF). 

New information I've learned is that Charles A. Czeisler, an American physician and sleep researcher, was President of NSF and is/was on Vanda's scientific advisory board. Also, Dr. Stephen Lockley, the Harvard sleep expert overseeing the Hetlioz clinical trials, received grant support from Vanda Pharmaceuticals.

Blogger, 'Frugal Nurse', has also been investigating Non-24 and Hetlioz. She writes:

On January 31, the Food and Drug Administration announced its approval of tasimelteon for treatment of Non-24.

Approval was based on results of 2 trials: . . . a 26-week study that included 84 patients, . . . and a 19-week trial that included 20 patients . . .

Really? Market approval based on 104 patients over 6 months?

And what were they testing for exactly? Patients experiencing a better night’s sleep, or less daytime drowsiness? No, something called “entrainment” or re-setting of circadian rhythm, measured by melatonin byproducts in the urine.

Frugal nurse also has an opinion on the Non-24 website. She writes:

The informational website for Non-24 is classic pharmaceutical advertising.

It’s not about selling a drug—at least not directly. It’s about helping you understand what Non-24 is and why you might suffer from it. The site helpfully (and slyly) provides a sidebar of symptoms to aid self diagnosis:

Not being able to sleep when you want

Excessive sleepiness during the day

Daytime napping or dozing off during the day

Periods of poor sleep quality at night

Sleeping through the night, but not waking up feeling alert and refreshed

Problems with focus and concentration; trouble with memory

Difficulty with daily tasks

Feeling irritable

Oh my God, I’ve got Non-24!!

If you are “experiencing any of these symptoms,” you are invited to fill out your name and address and “give permission” for Vanda to send you “information about Non-24 and about medicines that treat Non-24.”

As an added incentive, when you sign up, Vanda will make a $24 donation to the “blindness community.”

We can see from her research that Vanda's marketing is widening the net. They don't just want blind or partially sighted people to ask for this drug, they want, it appears, people with insomnia too, a condition that Hetlioz is not indicated for.

Jet Lag

In March this year, Vanda Pharmaceuticals announced that Hetlioz demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder. The press announcement stated:

Vanda intends to seek marketing approval for the use of Hetlioz in the treatment of jet lag disorder.  Vanda believes that if Hetlioz is approved by regulatory authorities for the treatment of jet lag disorder it will potentially offer a therapeutic solution to many travellers and will likely represent an important commercial opportunity for the company. 

You're not kidding! According to drugs.com the cost for Hetlioz oral capsule 20 mg is a staggering $15,186 for a supply of 30 capsules, depending on the pharmacy you visit.

It's no surprise that Vanda are trying to tap into the market of jet lag. It is reported that more than 30 million US residents make trips abroad each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in Europe, Middle East and Asia. That's an awful lot of potential customers for Vanda.

Another market they will no doubt be persuading doctors to prescribe to is the insomnia market. Around 1 in 3 people have at least mild insomnia. Many poor sleepers have developed poor sleep habits.

So, the body clock drug that was initially aimed at blind people now has a much larger potential. Jet lag and insomnia will become the new 'Non 24 Sleep/Wake Disorder'. Sufferers will be spun the story about 'body clocks' and the importance of setting the timing of that clock back to normal.

What next?

Will we see Hetlioz pushed on kids who can't sleep because they have normal teenage worries, or perhaps the man or woman who are facing employment stresses and can't sleep? Remember, the FDA left the door wide open when they agreed that this drug could come to market. Hetlioz has not been studied in children and it is not recommended for use in children but history shows that drug companies always try to widen the net when selling to the public. One only has to look at the group of SSRIs that are currently prescribed off-label to children.

How Does Hetlioz Work?

Hetlioz works to enhance the effects of the receptors for melatonin. In particular, it binds and augments the MT1 and MT2 receptors within the brain. This induces sleep.

So, is Hetlioz merely another brain pellet then, one being sold on the back of a spinning story that involves body clocks in the brain, just as SSRIs were heavily promoted on the spinning story of a chemical imbalance in the brain?

Finally, last month the FDA issued a warning letter to Vanda Pharmaceuticals. The warning letter chastized Vanda for failing to warn Hetlioz users of its most common adverse reactions, namely; headaches, increased alanine aminotransferase, which is the term used for elevated liver enzymes, nightmares or unusual dreams, and upper respiratory or urinary tract infection. These are common adverse reactions, folks!

Nightmares or unusual dreams? Nothing like taking a drug to help you with sleep, huh.

Bob Fiddaman

Back Story

Blind Date With Vanda's Hetlioz

Psychiatry Journal Clutching At Straws

Hey you?

Who, me?

Yeh, who did you think I was talking to?

I'm sorry, who are you?

I'm you, we are but one.

Oh, okay, let's smoke.

I don't mean to make light of schizophrenia, I'll leave that to the Lancet Psychiatry Journal, who have recently published a study - um, a theory, on the association between smoking and schizophrenia.

When the story appeared on my Facebook timeline I had to do a double-take. What were the white-coated lunatics trying to blame mental illness on now, I thought?

Well, it appears that yet another theory has been put forward. The chemical imbalance theory, which psychiatry relied on so heavily has now been debunked so many times that the field of psychiatry have to come up with another causation for mental illness.

Create a study, add what looks like a scientific protocol, ie, a series of confusing maths, and Voila! A new cause is created.

I do laugh at some of the nonsense - um, nonscience, published in the Lancet. It's quickly becoming one of my choices of light-hearted reading, the first two choices being The Beano and The Dandy.

The British arm of the Citizen's Commission on Human Rights (CCHR) sum it all up quite eloquently in a post entitled, 'Psychiatrists can’t even define ‘schizophrenia’'.

"There can be no doubt that people do experience problems and upsets in life that may result in mental troubles, sometimes very serious, but to represent that these troubles are caused by incurable “brain diseases” that can only be alleviated with dangerous drugs is dishonest, harmful and often deadly. Neuroleptic (nerve-seizing) drugs, used to treat schizophrenia, cause damage to the body’s nervous system and result in permanent impairment, even death."

I couldn't agree more. To me it seems as though the white-coated lunatics are running out of ideas, remember, this is the same profession who, years ago, would have drilled a hole in the side of your head if you told them you were hearing voices.

Nothing has changed really. Okay, no drilling but plenty of brain altering drugs dished out to cure or 'help' control the illness that the field of psychiatry put a badge to (labelled) many years ago.

I am of the impression that these studies, um theories, are designed just to test the water, just to see how far psychiatry can go without a public backlash. It amazes me that people can't see through this latest attempt at pushing more drugs.

Think about it for just one minute folks.

Scare people into thinking that smoking can cause a brain disorder - those same people (addicted to nicotine) may seek help.

**Psychiatrist hands them Zyban (GSK) a smoking cessation drug that is really an antidepressant (Wellbutrin) or maybe offer them Champix (Pfizer), another smoking cessation drug, this one has been the subject of inducing suicidal thoughts for years.

The scam continues, folks.

One of the study authors, James MacCabe, a physician at King College’s Institute of Psychiatry, Psychology and Neuroscience, said, "While it is always hard to determine the direction of causality, our findings indicate that smoking should be taken seriously as a possible risk factor for developing psychosis, and not dismissed simply as a consequence of the illness."

Apparently he was under no influence of hallucinogenics when he made that statement.

Hopefully, the Lancet will soon be sold in my local shop, it's so hilariously entertaining that I, sometimes wet myself whilst reading it. (Impulse Control Disorder)

This story was brought to you by Benson & Hedges and Marlboro.




Bob Fiddaman.

Jaws and the Pharmafia

We remember it all, well most of us. The scary musical score from John Williams, Da-dum... da-dum, dum-dum-dum-dum-dum-dum. Then the shark, the great white, the killing machine. Next came the chief of police, (Brody) played brilliantly by Roy Scheider. Brody is told one morning that the cause of death of a mangled and mutilated body recently washed up on Amity beach is down to a shark attack. On hearing this news he does what any sane human would do - he attempts to close down the beach until the problem is fixed (the shark is killed)

The Mayor of Amity, Mayor Larry Vaughn (Murray Hamilton) realizes that by closing the beaches he, along with all the retail outlets on Amity island, will lose money. He somehow convinces the coroner to lie to Brody about his original 'shark attack' report. Brody, knowing no better, decides not to warn the public about the danger roaming the Amity waters.

Sadly, just days later, Brody witnesses a young boy (Alex Kitner) being killed by a shark. The beaches are closed and days later a shark is caught. The Mayor is obviously delighted, but for all the wrong reasons. He's delighted because the cash can once again flow. However, there's one voice who questions if the fishermen caught the shark responsible for the two shark attacks - he tells them that the bite radius on the first victim do not match with the shark they caught. They ignore him and the beaches are reopened - more deaths ensue.

Now, does any of the above remind you of the way pharmaceutical companies, mental health specialists and medicine regulators behave regarding antidepressant use?

Jaws (the novel) was written byPeter Benchley, he, along with Carl Gottlieb, wrote the screenplay for the movie. The message, to me at least, is obvious - it's all about the money, baby.

I'd like to say that Messrs Brody, Quint (Robert Shaw) and Matt Hooper (Richard Dreyfruss) represent the medicine regulators (MHRA/FDA). Sadly they represent everything that the current medicine regulators aren't about. Three working class men who wish to right a wrong because they care about the safety of the residents of Amity.

My experience of the British drug regulator is that they do not care about the safety of you, I or our children. If they did then they would have moved hell and earth to thoroughly investigate the link between antidepressant use and suicide (not just in children but in adults too) - Making recommendations is simply not good enough.

Next time you sit down with your kids (who may have not yet seen the movie Jaws) tell them that it is purely fictional - in fact shark attacks are rare.

Induced antidepressant suicide on the other hand...

This quote goes out to medicine health regulators globally.

"I think that I am familiar with the fact that you are going to ignore this particular problem until it swims up and BITES YOU ON THE ASS!"

Quote from the movie JAWS



Bob Fiddaman

GSK: Racketeer Influenced and Corrupt Organizations Act

So, what exactly is the Racketeer Influenced and Corrupt Organizations Act [RICO]?

Basically it's a federal law designed to combat organized crime in the United States, it was introduced in 1970 and has been used to prosecute members of the Mafia.

On June 30, 2014, Attorneys representing GlaxoSmithKline, asked the Court of Appeals to throw out racketeering claims in three class actions that had accused them of hiding heart disease risks associated with the diabetes drug Avandia.

In 2013 Pennsylvania U.S. District Judge Cynthia M. Rufe refused to dismiss claims made by three union benefit funds under the Racketeer Influenced and Corrupt Organizations Act, ruling the plaintiffs had adequately alleged a scheme whereby GSK suppressed evidence of Avandia’s cardiovascular risks to increase the number of prescriptions written and covered.

The crux of GSK's appeal is that District Judge Cynthia M. Rufe erred in her initial ruling. They claim, “A plaintiff cannot be injured by a misrepresentation about a health care product unless the plaintiff personally receives a ‘compromised or diminished’ benefit from the product as a result.”

More on GSK allegedly violating the Racketeer Influenced and Corrupt Organizations Act here [Subscription only]

Back in 2011 GSK also failed in their efforts to have Plaintiffs' Proposed Specific Causation Expert Witnesses Nicholas DePace, M.D excluded from giving testimony. Their motion was denied, once again by Pennsylvania U.S. District Judge Cynthia M. Rufe   [More here]

Bob Fiddaman

Blind Date With Vanda's Hetlioz

An American friend of mine sent me an email the other day. She told me how she had seen an ad aired on TV for a drug called Hetlioz (tasimelteon). Apparently, it's a pill to help those who suffer with Non-24-hour Disorder.

I admit I had to look this disorder up. My first thought was, Christ! They want to treat people who refuse to watch Kiefer Sutherland's character Jack Baur in FOX TV's 24?

Alas, I was wrong.

Non-24-hour Disorder, according to Hetiloz manufacturers, Vanda Pharmaceuticals, is...

... a chronic circadian rhythm disorder that occurs when individuals are unable to synchronize their endogenous circadian rhythm to the 24-hour day. Non-24 is most commonly found in blind individuals lacking the ability to perceive light, the primary environmental cue for synchronizing the circadian system daily. In general, individuals with Non-24 suffer from a variety of clinical symptoms as they cycle in-to and out-of phase resulting in disrupted nighttime sleep patterns and/or excessive daytime sleepiness.

Vanda had to convince the American drug regulator, the FDA, that their drug worked and was safe through a series of clinical trials. These trials have been slammed.

For instance...

• The design of Vanda's primary phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced

.

• The replacement primary endpoint installed to assess tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.

• Vanda was forced to cut in half the patient enrollment into the tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.

• Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.

[Source]


Despite all of the above, Hetiloz was approved by the FDA earlier this year.

Astroturfing

Now there's a word.

Astroturfing is the practice of masking the sponsors of a message or organization (e.g. political, advertising, religious or public relations) to make it appear as though it originates from and is supported by grassroots participant(s). It is a practice intended to give the statements or organizations more credibility by withholding information about the source's financial connection.

Step forward The National Sleep Foundation.

Trawling through their website I learned that their Non-24-Hour Sleep Wake Disorder section is sponsored by Vanda Pharmaceuticals. I flicked the following email to Vanda...

Dear Sirs,

Many pharmaceutical companies are now suggesting that they are going to be more transparent in regard to clinical trials and sponsorship's etc.

I noticed that the sleep foundation have a section on their website that is sponsored by Vanda Pharmaceuticals.

As a matter of public interest could you tell me if this was a financial arrangement, if so, how much?

In typical Pharmafia fashion Vanda did not reply, opting instead to check me out [fig 1] - Click image to enlarge.

Fig 1

I posed pretty much the same question to the National Sleep Foundation via their Twitter page. [Fig 2]

They had the decency to answer me but didn't really answer the question I put to them.

Fig 2

Not related in any way to Vanda?

Here's the sponsored section on the Sleep Foundation's website [Fig 3] - Click on image to enlarge and read the bottom left of the image.

Fig 3

Alternatively, click here.

I pressed the Sleep Foundation for an answer - to date, they have failed to respond.

I dug a little deeper regarding Vanda's drug Hetiloz.

In July 2013 it was reported that Vanda Pharmaceuticals Inc. were facing at least one shareholder lawsuit surrounding late-stage trials for the company's sleep disorder drug Hetiloz.

In one class-action complaint, Small v. Vanda Pharmaceuticals Inc. et al., it's alleged that Vanda and its officers issued materially false or misleading statements about Tasimelteon’s efficacy and the results of its Phase III clinical trials. Specifically, it is alleged that Vanda changed the design of the  primary Phase III study several times, including a complete replacement of the primary endpoint  one month before results were announced, because the company was in possession of data suggesting that the original primary endpoint was not going to be met; used a replacement primary endpoint that had never been used before in sleep-drug clinical trials and was not endorsed by the FDA; enrolled patients in the Phase III trials by “stretching” the clinical definition of Non-24; and combined data from two Phase III studies in order to demonstrate a benefit for Non-24 patients, where the two Phase III studies failed individually.

The full complaint can be read here.

Amazing that the FDA went ahead and gave a licence to Hetlioz... then again, the FDA are basically an extension of the pharmaceutical industry.

Non-24-hour Disorder is a new one on me. As for the treatment of it, Hetiloz, experiments with rodents revealed fertility impairments, an increase in certain cancers, and serious adverse events during pregnancy at dosages in excess of what is considered the "human dose". [1] [2]

I can only presume that these warnings will be printed in braille for expectant blind mothers?

Then again since when have pharmaceutical companies protected their patients?

Bob Fiddaman 

Blind people need all the facts too

References

[1] "Side Effects Drug Center: Hetlioz Clinical Pharmacology". RxList. February 10, 2014.

[2] Side Effects Drug Center: Hetlioz Warnings and Precautions". RxList. February 10, 2014. "In animal studies, administration of tasimelteon during pregnancy resulted in developmental toxicity (embryofetal mortality, neurobehavioral impairment, and decreased growth and development in offspring) at doses greater than those used clinically."

You can follow the National Sleep Foundation on Twitter here.

  

GSK Under Pressure From UK Authorities... Experts Claim

GSK, the British pharmaceutical company who, time and time again, break global laws, are in danger of running foul of the UK Serious Fraud Office (SFO), claim experts.

Why now?

Glaxo have been violating rules and regulations for many years. They pay the fines, [handed down in US Courts] make limp-wristed promises not to be naughty again, promise to be more transparent in the future yet only offer that transparency to people they want to, run "Patient First" programs that have nothing to do with putting patients first... then...continue to violate rules and regulations.

The Serious Fraud Office may or may not investigate Glaxo's latest bribery allegations in Poland, China, Iraq and Jordan - thing is, they should have been investigating GlaxoSmithKline years ago.

• Investigate the deal Glaxo struck with the US Department of Justice and how that deal protected GSK CEO Andrew Witty.
• Investigate the way they systematically hid the Seroxat addiction link in the UK.
• Investigate Glaxo's ties with the UK drug regulator, the MHRA.
• Investigate Glaxo's promotional push for Seroxat in pediatrics, even though it was never recommended for pediatric use.
• Investigate the MHRA's half-assed investigation into GlaxoSmithKline where key witnesses were ignored, resulting in a failure to prosecute GlaxoSmithKline.

According to Nathan Peacey, regulatory partner at law firm Bond Dickinson, "If GSK was charged by the SFO, the most likely outcome would be a deferred prosecution arrangement (DPA), a new sentencing option which holds back prosecution as long as the company agrees to take certain measures to address any issues. DPAs were introduced in February as an alternative to prosecution, which under the Bribery Act could involve a ban from public contracts."

Amazing isn't it?

With an abhorrent history of breaking the law it would appear that, even if prosecuted, GSK could use "We promise to be good boys and girls in the future" as a defence. In essence that's how the deferred prosecution arrangement works.

So, next time your local council or TV licence authorities threaten you with a hefty fine for non-payment... just quote the deferred prosecution arrangement and make promises that you will be good boys and girls in the future.

Even when you have this pharmaceutical company by the balls there's always some hidden clause that will let them off the hook.

In any event, what has the British drug regulator, the MHRA, been doing all these years?

One word, four syllables.

Pharmafia.

Bob Fiddaman.

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

Pharmafia: An Interview With Peter Gøtzsche

Interview with Peter Gøtzsche

Peter hits the nail on the head throughout this 15 minute interview.

He points out that drugs are the third leading cause of death in the world today, after heart disease and cancer. He also points out that the business model of the drug industry is organised crime and that they steal far more money and kill more people than the mob.

I'm thinking the word Pharmafia should now be used by as many patient safety advocates and groups as possible.

#Pharmafia



Gøtzsche is Co-Founder of The Cochrane Collaboration, and Director of the Nordic Cochrane Center in Copenhagen, Denmark.


Bob Fiddaman