Police LIne Photo Credit www.esbtrib.com

Photo Credit www.esbtrib.com

“The Journal of Clinical Psychiatry” just published an article in which a host of MD’s and PhD’s explored the idea that many individuals who use antidepressants have no current or lifetime history of mental disorders.

Of those currently taking anti-depressant drugs, researchers found that 38 per cent of SSRI users did not meet the criteria for a mental disorder, and 69 per cent did not meet the criteria for major depressive disorder.

But instead they had been prescribed anti-depressants for a variety of   physical problems – back pain, hypertension, bladder control problems, etc.

The study conclusion stated: “Many individuals who are prescribed and use antidepressant medications may not have met criteria for mental disorders. Our data indicate that antidepressants are commonly used in the absence of clear evidence-based indications.”

Dr. Howard Forman, medical director of the Addiction Consultation Service at Montefiore Medical Center commented on the study saying,

“We all experience periods of stress, periods of sadness, and periods of self-doubt. These don’t make us mentally ill, they define us as human.”

However, the business model of the psychiatrist and drug manufacturer has taken the opposite view:

  1. Create more and more psychiatric labels so that more aspects of normal life require treatment with an anti-depressant or anti-psychotic drug.
  2. Find ways to get these psychiatric drugs approved for treatment of  physical problems as well as mental ones
  3. Market the drugs heavily to psychiatrists, psychologists , family physicians, pediatricians, and anyone else who can write a prescription –including off-label use
  4. Market the drugs directly to the consumer with media video and print ads
  5. Promote the idea that if the first SSRI doesn’t work then a combination of anti-depressants is the answer. Or one can add an anti-psychotic drug to the patient’s daily prescriptions.

The plan has been wildly successful. Data from the US shows 11 per cent of Americans over 12-years-old use anti-depressants.

A psychiatric drug continued to hold the number one spot when compared to all prescription drugs sole in the US – more sales volume than any drug for blood pressure, cancer, diabetes, etc.

This antipsychotic Abilify (aripiprazole) continued to have the highest sales, at nearly $6.9 billion, according to the latest data from research firm IMS Health.

The data from (April 2013 – March 2014) on the top 100 drugs by total sales and total prescriptions in the United States.

1. Abilify        $6,885,243,368

Holding down position 8 in sales was an anti-depressant.

8. Cymbalta    $4,095,537,942

How Did Cymbalta Rise to Make the Top Ten?

Partly because it was approved to treat conditions other than depression such as anxiety, fibromyalgia, OCD, insomnia, and neuropathic pain, it instantly became more popular.

“As this drug gained approval to treat conditions other than depression, it quickly leaped to the top of antidepressants in regards to both sales and number of prescriptions. The primary reason that this drug is the top antidepressant is related to the number of conditions that it can be used to treat. Additionally it has only been on the market for approximately 10 years, meaning it is still considered a very new antidepressant.” A study in the French medical journal “Prescrire” found Cymbalta to carry significant side effects and be no more effective than other antidepressants.

Partly because new drugs are Flashy – “Let’s face reality… if you’ve tried a bunch of medications on the market and haven’t experienced relief from your depression, you’re probably waiting for the next big drug to get approval. So many people end up hoping that the next drug that comes out will be better than the rest – and usually this is not the case. Many times, people find that new drugs end up making them feel worse than older options. However, it’s the initial flash that can lure people into trying a new drug.”

Finally it’s the marketing campaigns: “These days drug companies have become more innovative with their marketing. Especially for antidepressants like Cymbalta that have been approved to treat multiple conditions. Everywhere you look: TV, internet, doctors’ offices, street corners, etc. there’s an advertisement for the drug. The heavy marketing is what gets many people to consider trying the drug.”

How Did Abilify, an Anti-psychotic Not Unlike Thorazine That Can Numb a Raving Psychotic into Apathetic Docility, Become the Number 1 Selling Prescription Drug in America?

Breaking the law is how it was done.

“Did Bristol-Myers Squibb (BMS) offer kickbacks and push Abilify for off-label uses? Some former sales reps-turned-whistleblowers claim it did. And given the fact that Bristol-Myers already paid $515 million to settle some off-label marketing claims related to Abilify, they say, the company violated its “we’ll behave” promises to the Federal Government.

The whistleblower suit, now spearheaded by the U.S. Department of Justice, also ropes in the U.S. unit of Japan’s Otsuka, which co-promotes the drug. Otsuka has its own corporate integrity agreement, too.

So, with their latest amended complaint in the False Claims Act suit, filed last month, the former reps say the court is looking at a couple of repeat offenders.”

The reps are saying BMS and Otsuka pushed Abilify for use in children before the drug was approved to treat anyone under 18 and then promoted Abilify for indications still not FDA-approved for kids. The company also doled out the usual speaking fees, free meals, paid programs, and other incentives to persuade doctors to write more prescriptions.

A website ironically named “Everyday Health” described what to expect if you take Abilify.

  • Children, teenagers, and young adults (up to age 24) who took Abilify for depression were more likely to become suicidal.
  • Children under 18 years old shouldn’t take Abilify to treat depression, but in some cases, a doctor may decide this medication is the best option for a child.
  • Abilify may affect your mental health in unexpected ways, even if you are older than 24. You may become suicidal, especially at the start of treatment.
  • Thoughts of suicide or harming yourself
  • New or worsening depression
  • Panic attacks
  • Extreme worry
  • Agitation
  • Aggressive behavior
  • Difficulty falling asleep or staying asleep
  • Acting without thinking
  • Severe restlessness
  • Mania (feeling frenzied or abnormally excited)

Also we learn this medicine is in the FDA’s Pregnancy Category C, which means it’s not known how Abilify will affect an unborn baby.

  • Tell your doctor if you are pregnant or plan to become pregnant before you take Abilify. Taking this medicine during the last months of pregnancy can cause problems in newborns after delivery.
  • You should also talk to your doctor before breastfeeding while taking Abilify. The drug has been detected in breast milk, but there’s little information on the risks Abilify might present to a breastfeeding infant.

Tell your doctor if any of the following side effects become severe or don’t go away:

  • Headache
  • Drowsiness
  • Dizziness
  • Heartburn
  • Nervousness
  • Diarrhea or constipation
  • Stomach pain
  • Increased appetite
  • Pain
  • Increased saliva
  • Weight gain is a common side effect of Abilify.

After all that we get to the “Serious Side Effects of Abilify”

Call your doctor right away if you experience any of the mood or behavior effects listed in the Warning section or any of the following serious symptoms:

  • Fast, slow, or irregular heartbeat
  • Difficulty breathing
  • Tightening in the throat or difficulty swallowing
  • Seizures
  • Chest pain
  • Vision changes
  • High fever
  • Uncontrollable face or body movements
  • Confusion
  • Sweating
  • Rash, hives, or itching
  • Swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or legs
  • Muscle stiffness

One poor psychiatric drug victim asks:

Q: I’ve been taking Abilify for more than two years to treat severe anxiety. I get side effects, too: I’ve gained about 100 pounds in two months, and I have bad tremors, dry mouth, blurred vision, and severe back pains. Are these side effects normal or should I talk to my doctor about lowering the medication? I take Prozac and Luvox as well. Would these medications increase the side effects of Abilify?

The Answer is typical of the caring responses offered by drug manufacturers:

A: Abilify is an atypical antipsychotic and antidepressant used in the treatment of schizophrenia, bipolar disorder, and clinical depression. It has many reported side effects, but the less common ones include blurred vision, dry mouth, weight gain, stiffness, myalgia (muscle pain), and muscle spasms. It’s unclear whether your other two medications could be amplifying these effects. You should consult with your doctor or pharmacist for guidance based on your specific condition and current medications.

Writer Jay Michaelson at “The Daily Beast” summed up his unbelief that this drug can be number one in sales:

“While Abilify’s advertising depicts it as a kind of supplement to anti-depressants, with sad women giving it a try when mother’s little helper no longer seems to help, Abilify actually is like a bazooka to conventional anti-depressants’ revolver. Critics such as Britain’s Joanna Moncrieff have argued that anti-psychotics don’t treat anything at all; they just zone people out so they don’t notice much. They’re effective in the short term, but essentially, that’s because they are really just powerful tranquilizers.

“But the notion that Abilify is simply a thermostat that you adjust up or down—I’m feeling a little blue today, I think I’ll kick it up a notch—is surely hard to justify. I’d wager most users aren’t even aware that it’s an anti-psychotic drug that’s used to treat schizophrenia. I wonder if they’d be paying $6.9 billion for it if they did.”

 SOURCES:

http://www.psychiatrist.com/jcp/article/Pages/2015/v76n01/v76n0106.aspx

http://www.dailymail.co.uk/health/article-3024604/More-two-thirds-people-taking-antidepressants-NOT-actually-depression-Doctors-discover-not-meet-official-criteria.html

http://mentalhealthdaily.com/2014/08/30/most-popular-antidepressants-in-2014-cymbalta-pristiq-viibryd/

http://www.thedailybeast.com/articles/2014/11/09/mother-s-little-anti-psychotic-is-worth-6-9-billion-a-year.html?source=TDB&via=FB_Page

http://www.medscape.com/viewarticle/825053

http://www.fiercepharma.com/story/bristol-myers-otsuka-ask-judge-nix-abilify-kickback-suit/2014-10-10

http://www.everydayhealth.com/drugs/abilify