Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Monday, March 23, 2009

GSK's Paxilcom... still a wealth of [dis]information

Search through the archives of GSK's, paxil.com and you'd be convinced that they had come up with a miracle cure for depression, panic disorder, Obsessive-compulsive disorder [OCD] and a host of other 'manufactured illnesses' as the years progressed through the paxil.com domain.

The beauty of the Internet is that it is a resourceful tool in an advocates fight for the truth. It's Pharma's achilles heel if you like.

Dec 12th 1998 - paxil.com:

A bland looking page, with animated icons:

PANIC DEPRESSION OCD

Let's click on 'PANIC'

Nothing much here from the manufacturers, at the time, SmithKline Beecham. Instead they opt for a supermodel to talk about panic disorder.

Here is some of what she had to say:

Supermodel Beverly Johnson talks about panic disorder:

When were you diagnosed?

With the help of my internist, he made the diagnosis, which was panic disorder, and I was given a prescription of Paxil® (paroxetine HCl). And, I am very happy to say that I no longer suffer from panic attacks.

What advice do you have for others?

So, if you think you have panic disorder, or suffer from panic attacks, ask your doctor, that's what I did.

---

Pretty clear then that Beverly Johnson was happy with her treatment, so much so that she promoted it for the manufacturers.

It is unknown whether she received a payment for this promotion.

A quick Google search shows that Beverly Johnson is quite the advocate.

In this article from 2008, Beverly speaks about Uterine Fibroids:

"It is my personal mission to help ensure that women are informed about uterine fibroids and feel empowered, if they think they have fibroids or are diagnosed with them, to talk with their healthcare providers about their treatment options," said Beverly Johnson. "When I was diagnosed with uterine fibroids, I didn't know a lot about the condition, and as a result I suffered for a long time, both physically and emotionally. My hope is that women will not be embarrassed to talk about uterine fibroids or afraid to discuss treatment options with their doctors."

Beverly's new Web site, Ask4tell4.com, highlights the four questions she thinks all women should ask themselves and their healthcare provider about uterine fibroids, whether they currently have the condition or not. The site also includes the answers to these questions and information about a variety of treatment options that wll help them have a more informed discussion with their doctor. Additionally, women can join Beverly's cause by sharing the information with four or more of their friends or family members through an instant email message sent from the Web site.

The Ask4Tell4 campaign is sponsored by BioSphere Medical, Inc. BioSphere is a pioneer in commercializing minimally invasive therapeutic applications based on proprietary bioengineered microsphere technology. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE

----


Let's click on the next icon from SmithKline Beecham's 1998 home page, paxil.com

DEPRESSION

Once again, nothing much on the subject of depression from Paxil manufacturers. Once again they opt for a 'well-known' face, this time they go for a famous baseball player.

Here Professional baseball pitcher Pete Harnisch talks about depression:

What did your doctor recommend?

I went to see my doctor and he diagnosed the fact that I had depression. He recommended medication, an antidepressant, and it didn't work out for me - I had some side effects. I wound up switching to Paxil® (paroxetine HCl). I wound up taking that for the better part of 5 or 6 months.

What advice do you have for others?

I would tell the millions of Americans who are suffering that there is help. It seemed tough. I didn't know what was going on with me - it was really a hard thing on me. But I got the right kind of help and it's all worked out. There is definitely a light at the end of the tunnel no matter what it may seem.

----

You notice a pattern here?

It is unknown whether Pete Harnisch was paid for his Paxil promotion.

Yet again Google throws up an interesting fact about Harnisch and Paxil manufacturers.

This from the New York Times:

Harnisch a Reluctant Role Model

''I'm no crusader; don't give me this bold, stepping-out stuff,'' Harnisch said last week. ''I just think a guy should do what's right, which is letting people know you can get through this thing, you can get your life and your personality back.''

Harnisch, a bluff, direct 32-year-old, crew-cut and bull-necked, steered away from such abstract discussions last week during a two-hour conversation at a Freehold, N.J., diner near where he is living. The interview had been promoted by a public relations firm representing SmithKline Beecham, the pharmaceutical company that manufactures Paxil, the antidepressant Harnisch took for six months. The company pays Harnisch to make appearances and give interviews.

----

The third 'illness' to click on from SmithKline Beecham's 1998 page of paxil.com is:

OCD

Strangely, no spokesperson [promotor]... then again, OCD had just been 'invented' then so I guess they [SKB] would have found it pretty difficult to hire the services of someone who claimed to have been cured by Paxil for an illness that hadn't yet been recognised.

However...

Skip to paxil.com as it was by the end of December 2002 and SmithKline Beecham seem to become more actively involved rather than leave it to 'famous faces.'

Here they spin out the old chemical imbalance theory... though they are careful by placing the words 'may be' in front of their theory:

Paxil® (paroxetine HCl) is an agent in a newer class of antidepressant medication known as selective serotonin reuptake inhibitors (SSRIs). It is an effective treatment for OCD.

Disorders like obsessive compulsive disorder (OCD) may be caused by a chemical imbalance in the brain. One such chemical is serotonin, which helps send electrical signals from one nerve cell to another. In the process, serotonin is released from one nerve cell (the sender) and travels to the next (the receiver), where it is either absorbed or returns back to the original sender cell.


----

Can I become addicted to Paxil?

If you were asking me I would say, Yes. 21 to 22 months to taper would suggest an addiction problem. But let's stick to what SKB were saying back then.

Incidently, before I continue, SKB had added a further icon to click on in 1999. Social Anxiety Disorder [SAD] - they had also added a 'self test' to their website. By completing the test you could see if you had anything that could be treated by Paxil.

Anyway, addiction.

Up to and including Dec 2002, the website throws up a glossary, frequently asked questions.

In 2002 - Can I become addicted to Paxil was answered with:

Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction.

They also added, "...Do not discontinue taking Paxil unless your doctor says it's all right. Even if you might be feeling better, you may need to continue taking Paxil to avoid having your symptoms return."

It's a genius bit of spin. On one hand your 'illness' may no longer require the treatment of Paxil, yet on the other hand if you 'discontinue' it, your symptoms may return? Sounds like a necessity rather than a stop gap doesn't it? Ironically the 'symptoms' they refer to are pretty much what one goes through when discontinuating [withdrawing] from Paxil. Glaxo, had their cake and ate it.

In 2003 the question had changed [only in wording structure] to, "Is Paxil addictive?"

GlaxoSmithKline [Now merged with Glaxo] answered:

'No. Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction.'

So, a definitive answer it would seem.

But further on they add: "Don't stop taking Paxil before talking to your doctor since symptoms may result from stopping the medication or from your original condition. Some patients experience the following symptoms on stopping Paxil (particularly when abrupt): dizziness, sensory disturbances (including electric shock sensations), abnormal dreams, agitation, anxiety, nausea and sweating."

It seems 'discontinuation', what you and I know as withdrawing, was fast becoming an issue.

Step forward a year to 2004:

Same question, same answer.

2005:

IS PAXIL ADDICTIVE?

No. Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction. However, you may have symptoms on stopping Paxil (see "What do I need to know about stopping Paxil?").



Their advice on stopping:

Don’t stop taking Paxil before talking to your doctor since symptoms may result from stopping the medication, particularly when abrupt. Some patients have experienced symptoms on stopping Paxil, including: dizziness, sensory disturbances (including electric shock sensations and tinnitus), abnormal dreams, agitation, anxiety, nausea, sweating, mood fluctuations, headache, fatigue, nervousness and sleep disturbances.

Yet more side effects!

2006:

Dec 31:

"The Web site for Paxil® (paroxetine HCl) Tablets is no longer available."

Followed by:

Important Safety Information

Prescription Paxil CR and Paxil are not for everyone. Don't take with MAOIs, thioridazine, or pimozide. Paxil CR and Paxil are generally well tolerated. As with many medications, there can be side effects. Some of the side effects may include infection, injury, nausea, diarrhea, dry mouth, constipation, decreased appetite, sleepiness, dizziness, sexual side effects, nervousness, tremor, yawning, sweating, abnormal vision, weakness, or insomnia. Talk to your doctor if you are taking prescription medication known as triptans, which are used for migraine or cluster headaches. When used in combination with Paxil CR or other anti-depressant treatments, these drugs may lead to potentially life-threatening complications.

Paxil CR and Paxil are approved only for adults 18 years and over. In some children and teens, antidepressants increase suicidal thoughts or actions. Young adults, especially those with depression, may be at increased risk for suicidal actions. Whether or not you are taking antidepressants, you or your family should call the doctor right away if you have worsening depression, thoughts of suicide, or sudden or severe changes in mood or behavior (for example feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, hyperactive, overly excited, or not being able to sleep), especially at the beginning of treatment or after a change in dose.

Don't stop taking Paxil CR and Paxil before talking to your doctor since side effects may result from stopping the medicine, particularly when abrupt. Symptoms some patients have reported on stopping Paxil CR and Paxil include: dizziness, sensory disturbances (including electric shock sensations and tinnitus), abnormal dreams, agitation, anxiety, nausea, sweating, mood fluctuations, headache, fatigue, nervousness and sleep disturbances.

Tell your doctor if you are pregnant or plan to become pregnant, as there is a potential risk to the fetus with paroxetine. Some studies of paroxetine in pregnant women have suggested an increased risk of heart malformations. In addition, babies born to mothers who have taken antidepressants, including SSRIs such as Paxil CR and Paxil, in the latter half of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing, and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil CR and Paxil.

Like many antidepressants, Paxil CR and Paxil can be present in breast milk so tell your doctor if you are nursing.

Quite a U Turn from the days where Beverly Johnson would claim, "I was given a prescription of Paxil® (paroxetine HCl). And, I am very happy to say that I no longer suffer from panic attacks." Pete Harnisch's words also seemed to have been forgotten. Remember Pete spoke of his 5 or 6 months on Paxil: "I would tell the millions of Americans who are suffering that there is help. It seemed tough. I didn't know what was going on with me - it was really a hard thing on me. But I got the right kind of help and it's all worked out. There is definitely a light at the end of the tunnel no matter what it may seem."

Not to be outdone by Paxil's controvosy by the end of 2007 GlaxoSmithKline found a workaround. Paxil CR [Controlled Release]

Premenstrual dysphoric disorder [PMDD] was now added to list of Paxil treatments.

Strangely, no frequently asked questions appear on the site, instead there are links to:

Important Safety Information
Prescribing Information including Medication Guide
FDA Press Release on Updated warning May 2, 2007
FDA's revisions to Medication Guide

It seems their baby, Paxil, had taken one hell of a beating.

2008 is pretty much the same as 2007 which brings us to the current state of affairs on paxil.com.

The eye-opening tag reads:

'GET BACK TO FEELING LIKE YOU AGAIN'

Amazing isn't it? Here we have a product that started life on the Internet in 1998. It was 'bigged up' [promoted] by a couple of famous Americans. 10 years down the line, despite all the problems this drug has caused to men, women and children, despite all the out of court settlements made by GlaxoSmithKline, despite the MHRA investigation into GlaxoSmithKline... despite all this, the drug is still being promoted for use by GSK.

Meanwhile the good folk over at the MHRA bust small online pharmacies who sell fake Viagra even though it is blatently obvious that there is a much bigger problem with the supposed 'real drugs'.

I'll leave you with a quote from Alistair Benbow. Benbow is The Head of European Clinical Psychiatry at GlaxoSmithKline.

In 2003, Benbow went on national TV in front of millions of viewers and said that; "...the wording [addiction] was poorly understood by patients."

As you can see from the archives I've dragged from paxil.com, the 'wording' is pretty clear to those that read it at the time.

Paxil/Seroxat/Aropax, call it what you will, is one hell of a drug. A drug that has been promoted in such a way that leaves the consumer in no doubt that it is safe and effective.

The times [like paxil.com] are definately changing.

Fid

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
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