Glaxo’s Imitrex Kids…


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“….Mr. Witty explained that consumers may not be actively visiting their physician for a chronic problem like migraines, so when new drugs come along, they must find out about them through advertising….”

(Andrew Witty -then VP-General Manager of Marketing for GSK- speaking in the Advertising Age October 1997)

“...The new “breakthrough” Imitrex (sumatriptan) turned out to be a big disappointment. The pain magically disappeared for a time, but then the zigzag would return out of the blue a few hours later. It was almost worse than letting it happen to begin with. Other variations of Imitrex didn’t help much more…”

(Imitrex user in Salon.com article 2015).

According to Greg Thorpe’s Department of Justice Complaint which led to the 2012 fine of 3 billion dollars for GSK:

GSK maintained an elaborate illegal marketing regime for the prescription drugs included in today’s settlement, including, according to filed documents:

  • Paying physicians (who could be counted on to influence their peers) as much as $25,000 for being a GSK “advisory board” member;

  • Enrolling 49,000 physicians and health professionals to be part of its speakers bureau;

  • Identifying physicians in academia to pay to speak on behalf of one of the company’s drugs;

  • Creating the PowerPoint “slide kits” that  physicians would  use to deliver canned presentations;

  • Using an elaborate “FaxBack” system allowing drug marketing reps to suggest articles related to off-label uses. The physicians would order these -off-label promotional materials by calling a toll-free number, and thus not appear to be responding to an illegal marketing effort by the drug marketing representative;

  • Pushing Imitrex, an adult medicine for migraine, for mild headaches, as well as for use in children, despite the FDA’s rejection of GSK’s application for child use due to lack of efficacy;

  • Pushing Lamictal, a drug approved only for partial seizures, in adults for other diagnoses.  In at least one case a patient died from a reaction that the company had evidence could occur;

  • Marketing Paxil, the antidepressant, to children under 18 when it had not been approved for youngsters, and despite GSK’s own clinical trails that had shown that the drug was ineffective for children  and also heightened the risk of suicide or other self-harming behavior three-fold; and,

  • Marketing the antidepressant Wellbutrin as superior to other antidepressant alternatives due to increased sexual functioning and weight loss, pushing the drug as the “happy, horny, skinny drug,” to concisely encapsulate GSK’s off-label Wellbutrin marketing campaign.

If Andrew Witty was Glaxo’s VP-General Manager of Marketing in 1997, then what did he know about the various marketing scams, suppression of side effects etc- which went on in the company at that time?

I was prescribed Seroxat in 1998 and information (or misinformation) about side effects was likely contained in some kind of ‘educational’ promotion to doctors back then. How much was Witty aware about Seroxat prescribing to kids? or Seroxat side effects generally? how much input did he have in the promotion of these drugs?

And how much was he aware about Imitrex, or off label prescribing of Imitrex in kids? He seemed to be involved in Wellbutrin marketing also, and Wellbutrin was one of the drugs named in the complaint, alongside Imitrex, and Paxil of course.

According to the aforementioned AdAge article from 1997, Mr Witty, as VP general manager of marketing, was very much involved in all aspects of GSK’s marketing of its drugs at this time-

“…We started experimenting with DTC early and made a relationship with the rulemakers,” says Mr. Witty.

Indeed, Glaxo has been the top advertiser in DTC prescription drug advertising-a business expected to hit $1 billion this year-for two years running. Last year alone, Glaxo’s nasal spray Flonase received $32.7 million in support, migraine remedy Imitrex got $20.4 million, Serevent asthma inhaler had $16.4 million.

Mr. Witty also is adding more product firepower this year with Glaxo’s new anti-smoking pill Zyban getting an estimated $55 million in support (the brand is even getting TV teaser ads prior to its launch)….”


We know now that Seroxat/Paxil was extremely dangerous for under-18’s (causing kids to kill themselves, self harm etc).

The RIAT study proved that beyond doubt.

We also know that GSK’s Zyban also proved to be dangerous also, resulting in suicidal and neuro-toxic side effects similar to the one Seroxat/Paxil induces (see my recent post on Zyban here)

And what do we know about Imitrex (sumatriptan)? The drug which Witty mentions in the 1997 article above?

Well, we know it was illegally pushed off label to kids and according to a recent comment to me by GSK Whistle-blower Greg Thorpe, in regards to Imitrex he said (in a very brief synopsis):

“….Selling to kids , very young as migraines tend to run in families. They told us for years, the indication for kids was weeks away, seriously so everyone pushed it… also we paid off hundreds of physicians to promote it with lectures…not only for kids…but sinus headaches, tension headaches, menstrual migraine etc
 
 All off label ..and yes it was a dangerous drug. ..a Vasoconstrictor one that not only worked on cranial blood blow, but also cardiovascular blood flow. Not for kids, and despite years of studies it was never proven safe or effective in kids under 18.
In spite of that at least 25% was underage and another 25% off label.
More money was spent making hundreds of docs, literally millionaires, speaking to groups about off label use.
I can name many of them and did…”

However after nine years of decimating (or ignoring) Greg’s Formal Complaints, GSK paid nothing for promoting the use of Imitrex in children, or any other off label use (for that matter) he also mentioned that-
-The lead investigator, Sarah Bloom, at the end of the 9 year saga, told Greg…that “she was unaware that Imitrex never was proven safe or effective in children”..

As with Imitrex, this was also the case on some 8 other drugs- including Paxil/Seroxat- where they diminished his ability to mine government data, even as the Federal Court gave him permission to do. Furthermore, in spite of a clear order  by a Federal Judge, the DOJ did not let Greg data-mine any data including a lot of specifics on Paxil marketing that only he claimed.
Greg was the only major whistle-blower who was retaliated against and terminated by GSK and also the only one who reported misconduct to the company first, and did not do it for a possible  award.
All of the others were terminated and/or planners and initiators of GSK Fraud and corruption, some slipping into the case some 8 years after Thorpe’s initial complaints in 2001.
Greg went on to comment upon other aspects of the department of justice investigation- he said :

“….Although, I did not directly sell Paxil, I witnessed everything the Paxil reps said and did. I believe with what I knew and looking in the right places, a fine of much greater than 3 billion should have been paid for Paxil alone, and at least the same for Imitrex.
GSK sold 3 billion dollars of Paxil the year I filed, 2003..most off label, and denying addictive properties.
Obviously the DOJ was in coverup mode. Who was the ringleader,  Sarah Bloom ?
I highly doubt it. I also highly doubt they will do anything serious in other countries,  after seeing what was done here”….

I found an old article online from around 2004/2005 (advertising disguised as objective medical information) which shows the lengths Glaxo were willing to go in order to push this dangerous drug to kids.
If you google the article, you’ll see that it was widely disseminated online at that time.

OFF-LABEL USE OF MIGRAINE DRUG GIVES CHILDREN RELIEF, STUDY SAYS

COLUMBUS, Ohio – A new study suggests that when over-the-counter medications fail to help children who suffer from chronic migraine headaches, those children may find relief with a drug traditionally prescribed to adults.

Ann Pakalnis

Around one out of every 10 children experience chronic migraines, said Ann Pakalnis, a study co-author and a clinical associate professor of pediatrics and neurology at Ohio State University and Columbus Children’s Hospital.

She and her colleagues treated 57 children with sumatriptan (Imitrex) nasal spray. More than three-quarters of the families in the study reported good to excellent relief of their child’s headaches after using the spray, and nearly 100 percent of the children in these families continued using the drug.

But sumatriptan isn’t approved by the U.S. Food and Drug Administration for use in children. The participants in this study were prescribed sumatriptan on an off-label basis, a common practice in which a medication is used to treat a group of people or a problem it wasn’t originally intended to treat.


“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes.”


“By the time children see us at the headache clinic, they’ve already tried over-the-counter medications or milder prescription drugs,” said Pakalnis. “Their parents want a more aggressive treatment. They understand that it’s probably the best thing to do for their child, even if means an off-label use.”

The findings appear in a recent issue of the Journal of Child Neurology. Pakalnis conducted the study with Donna Kring, a nurse at Columbus Children’s Hospital, and Juliann Paolicchi, a pediatrician at the hospital.

The researchers took a retrospective approach to appraising sumatriptan’s effectiveness in children. They reviewed the medical charts of children 5 to 12 years old who were patients at Columbus Children’s Hospital, tallying the number of children prescribed the nasal spray. Each child’s family then received a questionnaire asking about the child’s use of the spray, its effectiveness and any concerns regarding the off-label use of the drug.

The majority (77 percent) of the 57 families who responded to the questionnaire reported that sumatriptan nasal spray had significantly helped their child, and 93 percent of these families noted that their child still used the drug.

Thirteen patients (23 percent) reported side effects from using the spray. Each of these children said the spray tasted bad, and five in this group stopped using it altogether. Sumatriptan nasal spray tastes very bitter and metallic to some children, Pakalnis said. Four of the 13 patients complained of dizziness. Two children found the spray difficult to use, and stopped using it.

“A nasal spray is the preferred way to deliver sumatriptan to children as their migraines tend to be very short, and the spray starts working in about 15 minutes,” Pakalnis said. “Some kids have a lot of nausea and vomiting with their headaches, which rules out giving them a tablet. Injection is another choice, but not a great option for children.”

Migraine triggers such as dehydration, fatigue and hormonal changes cause changes in nerve impulses that in turn affect blood vessel diameter and biochemical release. Blood vessel dilation causes pain, which analgesics can help alleviate. But analgesics don’t address the symptoms that often accompany migraines, such as nausea, vomiting and sensitivity to light and sound, which are usually caused by blood vessel constriction.

Sumatriptan and related drugs stop pain by restoring the nervous system’s ability to block pain impulses and help constrict blood vessels. And the triptans also help dilate the constricted vessels that contribute to they symptoms that accompany migraine attacks.

About 30 percent of the patients coming to Pakalnis’ office seek help for migraines. She and her colleagues currently prescribe sumatriptan nasal spray to about three-quarters of these patients.

“It’s an effective and safe treatment for children who don’t respond to over-the-counter pain killers,” she said.

The study was supported in part by Glaxo Smith Kline, makers of sumatriptan nasal spray.

#

Contact: Ann Pakalnis, (614) 722-4605; pakalnisa@pediatrics.ohio-state.edu
Written by Holly Wagner, (614) 292-8310; Wagner.235@osu.edu


So if Glaxo were misleading their drug reps to sell drugs like Imitrex to under-18’s, and obviously the marketing department were creating content for product placement disguised as objective information (such as the article above) then who (or whom) was directing this behavior from the top?

You’d have to wonder, would Andrew Witty  have allowed any of his kids to take drugs like Imitrex, or Seroxat, or Avandia, or Pandemrix?

I very much doubt it…

Because he would have known their full side effect profiles perhaps wouldn’t he?..

Or he would have at least been aware of the rumors about their dangers within the company…

If you look at the latest prescribing information leaflet (PIL) for Imitrex you will notice that it’s just as frightening as Seroxat..

How many kids and adults were misinformed and harmed?

See document (directly) below (from Greg Thorpe’s complaint) for an example of how GSK pushed Imitrex off-label.

 Imitrex doc


IMITREX®
(IM-i-trex)
(sumatriptan succinate) Injection

Read this Patient Information before you start taking IMITREX and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about IMITREX?

IMITREX can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking IMITREX and get emergency medical help right away if you have any of the following symptoms of a heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

IMITREX is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

What is IMITREX?

IMITREX Injection is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches.

IMITREX is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

IMITREX is not used to prevent or decrease the number of migraine or cluster headaches you have.

It is not known if IMITREX is safe and effective in children under 18 years of age.

Who should not take IMITREX?

Do not take IMITREX if you have:

  • heart problems or a history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
  • uncontrolled high blood pressure
  • severe liver problems
  • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • taken any of the following medicines in the last 24 hours:
    • almotriptan (AXERT®)
    • eletriptan (RELPAX®)
    • frovatriptan (FROVA®)
    • naratriptan (AMERGE®)
    • rizatriptan (MAXALT®, MAXALT-MLT®)
    • sumatriptan and naproxen (TREXIMET®)
    • ergotamines (CAFERGOT®, ERGOMAR®, MIGERGOT®)
    • dihydroergotamine (D.H.E. 45®, MIGRANAL®)
      Ask your healthcare provider if you are not sure if your medicine is listed above.
  • an allergy to sumatriptan or any of the ingredients in IMITREX. See the end of this leaflet for a complete list of ingredients in IMITREX.

What should I tell my healthcare provider before taking IMITREX?

Before you take IMITREX, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure
  • have high cholesterol
  • have diabetes
  • smoke
  • are overweight
  • have heart problems or family history of heart problems or stroke
  • have kidney problems
  • have liver problems
  • have had epilepsy or seizures
  • are not using effective birth control
  • become pregnant while taking IMITREX
  • are breastfeeding or plan to breastfeed. IMITREX passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take IMITREX.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

IMITREX and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take IMITREX?

  • Certain people should take their first dose of IMITREX in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting.
  • Use IMITREX exactly as your healthcare provider tells you to use it.
  • Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
  • For adults, the usual dose is a single injection given just below the skin.
  • You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine or cluster headache attack.
  • If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider.
  • If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner.
  • Do not take more than 12 mg in a 24-hour period.
  • If you use too much IMITREX, call your healthcare provider or go to the nearest hospital emergency room right away.
  • You should write down when you have headaches and when you take IMITREX so you can talk with your healthcare provider about how IMITREX is working for you.

What should I avoid while taking IMITREX?

IMITREX can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of IMITREX?

IMITREX may cause serious side effects. See “What is the most important information I should know about IMITREX?”

These serious side effects include:

  • changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
  • stomach and intestinal problems (gastrointestinal and colonic ischemic events).
    Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
  • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
    • cramping and pain in your legs or hips
    • feeling of heaviness or tightness in your leg muscles
    • burning or aching pain in your feet or toes while resting
    • numbness, tingling, or weakness in your legs
    • cold feeling or color changes in 1 or both legs or feet
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • medication overuse headaches. Some people who use too many IMITREX injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with IMITREX.
  • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using IMITREX, especially if IMITREX is used with anti-depressant medicines called SSRIs or SNRIs.
    Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
  • seizures. Seizures have happened in people taking IMITREX who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take IMITREX.

The most common side effects of IMITREX Injection include:

  • pain or redness at your injection site
  • tingling or numbness in your fingers or toes
  • dizziness
  • warm, hot, burning feeling to your face (flushing)
  • discomfort or stiffness in your neck
  • feeling weak, drowsy, or tired

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of IMITREX. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store IMITREX Injection?

  • Store IMITREX between 36°F to 86°F (2°C to 30°C).
  • Store your medicine away from light.
  • Keep your medicine in the packaging or carrying case provided with it.

Keep IMITREX and all medicines out of the reach of children.

General information about the safe and effective use of IMITREX

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use IMITREX for a condition for which it was not prescribed. Do not give IMITREX to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about IMITREX. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about IMITREX that is written for healthcare professionals.

For more information, go to http://www.gsk.com or call 1-888-825-5249.

What are the ingredients in IMITREX Injection?

Active ingredient: sumatriptan succinate

Inactive ingredients: sodium chloride, water for injection

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Patient Instructions for Use

IMITREX STAT dose System

Read this Patient Instructions for Use before you start to use the IMITREX STATdose System. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about IMITREX Injection when you start taking it and at regular checkups.

Keep the IMITREX STATdose System out of the reach of children.

Before you use the IMITREX STATdose System

When you first open the IMITREX STATdose System box, the Cartridge Pack and the IMITREX STATdose Pen® are already in the Carrying Case for your convenience.

The grey and blue Carrying Case is used for storing the unloaded Pen and the Cartridge Pack when they are not being used.

The Cartridge Pack holds 2 individually sealed Syringe Cartridges. Each Syringe Cartridge holds 1 dose of IMITREX® (sumatriptan succinate) Injection. The Cartridge Pack for the 4-mg strength of this medicine is yellow, and the Cartridge Pack for the 6-mg strength is blue (as shown). Refill Cartridge Packs are available.


http://lighthouselegal.com/imitrex-lawsuit-can-go-forward-in-washington

Imitrex lawsuit can go forward in Washington

Dr. David Wilson can pursue a medical malpractice lawsuit against the hospital where his daughter, Dr. Sandra Wilson, was on staff and received treatment prior to her death in 2006, reports the Yakima Herald-Republic. Individuals in need of financial assistance to pursue medical malpractice lawsuits can often secure legal loans.

The lawsuit alleges doctors at Sunnyside Community Hospital improperly administered a migraine medication, Imitrex, to 35-year-old Sandra Wilson, who sought treatment for symptoms including nausea and speech problems, the Herald-Republic reports. The news source says Wilson began having seizures after being on the medication for three days. She died after being transferred to a Spokane hospital, where it was discovered the Imitrex had exacerbated a preexisting constriction of one of her major brain arteries.

According to the Herald-Republic, a previous ruling in the case found David Wilson could not sue Sunnyside in part because his daughter had been a contracted physician there. An appeals court recently reversed this dismissal, meaning the case will go to trial if a settlement is not reached.

Before the tablet version of Imitrex went on the market in 1995, Mother Jones reported on Dianne Riley, a 41-year-old mother of four who died from a heart attack that seemed to be the result of an adverse reaction to the drug.

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