Posts Tagged ‘pharmaceuticals’

Crisis: The big pharmaceuticals’ “Holy Grail”

“They do not measure the difference between infection and noninfection as a primary motivation.”
Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed

“Vaccine efficacy is typically proved by large clinical trials over several

years. The pharmaceutical companies intend to do trials ranging from thirty thousand to sixty thousand participants. This scale of study would be sufficient for testing vaccine efficacy. The first surprise found upon a closer reading of the protocols reveals that each study intends to complete interim and primary analyses that at most include 164 participants. “

“For Moderna, the initial interim analysis will be based on the results of infection of only 53 people. “

“Johnson & Johnson is the only trial that requires the inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.”

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I’ve posted the Lancet editor’s comments before, but here is more, and from the US National Institute of Health, no less:

Skeptical of medical science reports?

 

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as editor of The New England Journal of Medicine
-Marcia Angell (New England Journal of Medicine)

“The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness”
-Richard Horton (Lancet)

And the WHY:

The first article showed how the relationships between pharmaceutical companies and academic physicians at prestigious universities impacted certain drug-related publications and the marketing of prescription drugs. Potential conflicts of interest seemed to abound: millions of dollars in consulting and speaking fees to physicians who promoted specific drugs, public research dollars being used by a researcher to test a drug owned by a company in which the researcher held millions of dollars in shares, failure of university researchers to disclose income from drug companies, company subsidies to physician continuing education, publishing practice guidelines involving drugs in which the authors have a financial interest, using influential physicians to promote drugs for unapproved uses, bias in favor of a product coming from failure to publish negative results and repeated publication of positive results in different forms.

 

Reality strikes again.

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New Report From The NEJM On Clinical Trial Reporting Further Tarnishes Biopharma’s Image

New England Journal of Medicine destroys the bullshit monkey wrenching of pharmaceutical trials and cover-up. It’s difficult to find any aspect of our top-down corporatocracy that isn’t completely full of shit and running on fraud and propaganda.

The action may put a stop to the practice of cherry picking outcomes for public disclosure. An investigation published in March found that during the following 12 months after completion of industry funded trials, only 17% of trial outcomes had been reported.

This number increased to just 41% after five years. Results for the trials funded by the National Institutes of Health produced only 8% disclosure after 12 months, and 38% after five yearsIt is logical to assume that the results presented to the public were supportive of study hypotheses.

This film won Matthew McConaughey the Oscar for best performance. The story is trueish, and concerns an eye-opening tale of a corrupt, rigged federal drug approval system.

But the actions on screen are about a Texas rodeo rider / oil rig electrician who finds out one day that he has AIDS. Ron Woodroof is an unlikable, homophobic jerk.  His life consists of drugs, hookers and boozin’ with his crew.  The news that he has been infected is such a shocker and a wake-up call that he literally doesn’t believe it for a while.  When doctors give him 30 days to live, he suddenly has a mission and a purpose.

From here Ron enters the early days of HIV treatment, when doctors, drug companies, the feds and the desperate, dying patients of the world don’t know what works or what doesn’t.  What’s been approved, AZT, has so many side effects that it could be said to help kill off the patients it purports to help.  When Ron is unable to get this, the only treatment known, he heads down to Mexico to make it happen.  That’s when his eyes are truly opened.

A doctor in a Mexican clinic has an assortment of other drugs, better drugs from around the world that are not approved in the US.  Suddenly the opportunities are clear, and this is life or death.

Ron goes into business, a drug/supplement/treatment channel that would come to be known as the Dallas Buyer’s Club. 

This serious drama touches many nerves, including homophobia, our shared humanity, corruption, the control of medicine, freedom and medical necessity.  The entire story of AIDS is interwoven in the background, as one take no prisoners cowboy will not hear “no.”  Ron ends up in Japan, in Europe, Israel, anywhere there is promise of a cure.

What’s more, the story presents Ron and his Mexican doctor as being on the forefront of understanding the disease, miles ahead of regulators and bureaucrats.  Even doctors are shown as compromised and corrupted by the money changers.

How true the science is, one cannot say without more research.  The drive and determination of the character, however, are done well enough to take that Oscar home.  This is a character driven film, and Ron Woodroof shed his old self in pursuit of a better life where he made a difference in the world.  The supporting cast are fantastic, believable and provide the humor and charm along the way.

Definitely a must-see.

4.5 / 5

 

PS

McConaughey and Jared Leto are in this actor’s roundtable:

 

Corporate thugs need to be hunted down and locked up.  What good is having Special Forces and SEALs if they can’t go after the real bad guys?

iStockPhoto SLC Minilypse-Judicial Court

Katherine Eban Exposes Massive Fraud at Generic Lipitor Manufacturer

I uncovered a presentation that was given in 2004, to a subcommittee of Ranbaxy’s Board of Directors. It was the result of an internal investigation into the fraud. The presentation, before the CEO, board chairman and others, made clear that Ranbaxy had lied to regulators and falsified data worldwide. “More than 200 products in more than 40 countries” have “elements of data that were fabricated to support business needs,” the PowerPoint stated. It noted that in entire markets — including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru, and the Dominican Republic — the company had simply not tested the drugs and had invented all the data.

…The Japanese drug maker Daiichi Sankyo, Ranbaxy’s majority owner, announced that it may be pursuing legal remedies against “certain former shareholders” (perhaps the former CEO Malvinder Singh, and his brother, who sold their shares for $2 billion) for misrepresenting the true state of the company, and the FDA’s investigation, at the time it purchased the company. But the real question for American consumers is, what are the FDA and Congress doing to ensure that generic drugs from overseas are safe?

 

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Sorta mediocre

I guess I’m rightfully annoyed at this one as it promised two different sorts of things, but delivered something different entirely.  At the risk of giving away the big twist, the genre flipping is the central problem with this movie.

Unfortunately Rooney Mara starts off giving a very identifiable performance as a mentally disturbed woman in need of help.  She then meets up with Jude Law, who wants sincerely to help her, but the tools in his toolbox are of course the anti-depressant drugs given away thorughout the society like candy.  I was very on-board this first half of the film, and I genuinely believed they were going somewhere.

http://www.youtube.com/watch?v=QGe2ZE0prGg

Spoilers

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