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Humanist, humorist

Friday, February 09, 2018

Masterfully Harming Kids for Profit

eu·phe·mism (noun)
1. the substitution of a mild, indirect, or vague expression for one thought to be offensive, harsh, or blunt.

"Part of my job is to create ‘masterful’ euphemisms to protect Medical and Marketing." -- Guess Who?

If you think the above quote is from a sleazy character in the hit TV series Mad Men, you'd be partly right. It is indeed uttered by a sleazy character, but in this case, it's a real person, a mad woman named Amy Rubin. When you learn what Rubin did, you'll understand why this woman can't accurately be called a lady.

As a Regulatory Affairs Manager for Forest Pharmaceuticals, Rubin proudly used her marketing skills to help pull the wool over the FDA's eyes regarding Forest's dangerous, ineffective drug, Celexa, which carries the generic name of citalopram. Rubin made her self-aggrandizing declaration in a memo sent to Dr. Charles Flicker, Senior Medical Director of Forest Laboratories as the two concocted ways to stretch the truth so that more doctors would prescribe Celexa for children and adolescents.

Spin Doctors At Work

Forest Pharmaceuticals conducted the MD-18 study involving Celexa, an SSRI now owned by Allergen. MD-18 was supposed to be a double-blind, placebo-controlled clinical trial of pediatrics. According to unsealed documents and testimony, MD-18 was only able to achieve a positive result by including nine patients in the study that were, as Forest’s medical director stated, “automatically unblinded” due to a supposed dispensing error. (Blinded means that a study's investigators are not supposed to know who consumed the product and who consumed the placebo.) The MD-18 investigators did know who was consuming Celexa and who was consuming placebo. And Forest Pharmaceutical execs knew this, too. The MD-18 study was flawed and biased.

The company then whitewashed the data in a draft letter to the FDA stating that incorrectly dispensed pills could have “potentially unblinded the study,” - After the draft was passed around Forest Labs they decided to rephrase the term and acknowledged that the wrongly dispensed pills could have the  “potential to cause bias.” By omitting the word 'unblinded' Forest was deliberately trying to hoodwink the FDA and create the false impression of positive results.

Forest then actively promoted the MD-18 study to encourage doctors to prescribe Celexa for children. The company later used the flawed MD-18 study to gain FDA approval for its other SSRI, Lexapro (escitalopram) and promoted it for adolescents. The result: Forest made money peddling snake oil to doctors knowing that unsuspecting parents would likely later make funeral plans for their children.

Last month Los Angles law firm, Baum, Hedlund, Aristei & Goldman, wrote a letter to Greg Shapiro, Chief of the Affirmative Civil Enforcement Unit, regarding a series of agreements that Forest made in 2010 with the United States Attorney’s Office for the District of Massachusetts. (USAO). Baum Hedlund points out that the 2010 settlement agreement missed some crucial evidence.

Baum Hedlund states:

"Over the past several years, our litigation has revealed that the scope and extent of Forest’s fraud was not honestly disclosed to the USAO (or, to the Food and Drug Administration) and that Forest misrepresented material facts underlying the USAO’s prosecution.  Documents and testimony obtained in our litigation have been unsealed, over Forest’s objection, and we have prepared a detailed memorandum outlining Forest’s misconduct and fraud with the hope the USAO will consider reopening its investigation."

The unsealed correspondence between Rubin and Flicker shows how pharmaceutical companies intentionally and routinely put the public--including children and teens--at great risk of harm and death from their products.

Wreckless Endangerment of Children

I tried to find a photo of Amy Rubin to show you what an evil spin doctor looks like, but it seems Rubin is camera shy. For her role in creating a medical holocaust that harms and/or kills thousands of innocent children, I've chosen a makhsheyfe or Baba Yaga photo to represent Rubin. If today Rubin is a mother, I imagine the reckless endangerment she helped unleash in neighborhoods across the globe isn't something she'd want to do to her children or grandchildren. But harming children is merely business as usual for Amy Rubin and her pharma colleagues.

So, as Forest's Rubin once wrote that it was part of her job to "create ‘masterful’ euphemisms to protect Medical and Marketing", it's part of my job to protect children and adolescents.

I hope Amy Joyce Rubin, age 64, has no contact with the innocent children in her Paterson, New Jersey neighborhood.

There are many appropriate adjectives we could use to describe Rubin, most of which are four-letter words. I'll leave it to you to fill in the blanks.

Bob Fiddaman

Baum Hedlund's letter to the Chief of the Affirmative Civil Enforcement Unit can be read here.

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