Greed And Money Are Winning The Battle For Your Health
We just keep getting hit by the greed and madness on all sides. When will it stop?
EXAMPLE #1:
There’s a law making it’s way through the US Congress, The 21st Century Cares Act, that among other things, would allow drug manufacturers to use a drug designed to treat one condition, to treat a different condition and to expedite the development of these drugs, establishing a “streamlined” data review program. Folks we don’t need to streamline most drug approval processes.
I actually agree with most of the 21st Century Cures Act—on the surface.
I am all for research and development. There is no doubt that we have plenty of diseases and conditions that need answers and this legislation would certainly help funding and fast tracking. But if you dig a little deeper and look into research by organizations not associated with big pharma and medical industry “think tanks”, you will see a different picture.
Too much of today’s research is done by those who benefit most from fast tracking risky drugs to treat made up diseases and conditions. It’s all about big bucks and it’s killing us. By all means, find the answers! Increase funding opportunities and come up with innovative approaches but DO NOT fast track and streamline research review! If nothing else all research should be subject to more review if human health could be endangered. We are not paying enough attention to side effects that are always present when you fool around with Mother Nature. Sadly, money is the root of all evil here because too much of it is at stake. Without the streamlining research part, this bill would do much to help us move forward.
EXAMPLE #2:
Apparently there is a lawsuit in the works by a small drug manufacturer against the government claiming it has a First Amendment right to say whatever it wants about any medication it produces — even if those claims have never been approved by the FDA! Are we out of our minds here??!! This would disastrous to our health.
Get more details below from my friends at The Health Sciences Institute https://hsionline.com/
They say the price of freedom is vigilance, and right now there’s a legal battle happening in New York that we all need to watch closely.
Because our freedom… particularly our freedom to protect our health and lives from risky and unapproved drugs… is under attack.
A small company most people have never heard of has just sued our government on behalf of the entire drug industry. They’re claiming they have a Constitutional right to claim whatever they want about their drugs — even if those claims have never been approved (or have been outright rejected) by the FDA.
Now, a district court judge in New York holds the key to possibly opening that risky and lucrative door for Big Pharma. But I’m sure this wasn’t what our founding fathers had in mind when they sought to protect our right to free speech.
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Don’t tread on us
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“If this lawsuit were to prevail, it would be devastating for drug safety,” said Dr. Michael Carome, an expert on prescription drugs and the FDA.
He’s talking about a federal lawsuit Amarin Corp. filed against the FDA earlier this month, claiming it has a First Amendment right to say whatever it wants about any medication it produces — even if those claims have never been approved by the FDA.
If Amarin doesn’t ring a bell, you’re not alone. It’s a small company that makes just one drug, Vascepa, that’s only been approved for very high triglyceride levels linked to diabetes, kidney failure and pancreatic cancer.
And when the FDA wouldn’t let Amarin expand the drug’s use without some supporting science and clinical trials, the company lawyered up.
But the lawsuit isn’t about one company or one drug. Amarin is going to bat for the entire drug industry, which has long claimed it should be able to say anything it wants to doctors.
Big Pharma even wants to present information such as early clinical trials — which have been paid for by drug companies and have never been peer reviewed — to promote a wide and unapproved range of uses for its meds.
It’s a billion-dollar scheme called off-label marketing, and it’s not (quite) legal. Not just yet, anyway.
Right now, doctors are free to prescribe drugs off-label at their discretion. Like the use of risky antidepressants for hot flashes. Or a med intended to lower blood pressure being prescribed to calm your nerves.
But drug companies like Amarin are demanding the right to directly promote these off-label uses to doctors and encourage them to prescribe drugs for unapproved — and potentially dangerous — uses.
Being able to offer that information is worth billions to the drug companies — and it’s long been their holy grail.
There’s even a coalition called the “Medical Information Working Group,” made up of the biggest names in the business like Eli Lilly, Pfizer and Sanofi. Its entire purpose is to push the envelope when it comes to being able to tell doctors whatever they please.
Dr. Joshua Sharfstein, who once worked at the FDA and is now an associate dean at Johns Hopkins, said that people do not realize that the consequences of this new approach to free speech “will be measured in lives.”
But the drug industry has been pressuring the FDA over off-label marketing for years, and previous rulings have already set some dangerous precedent.
A 2012 decision, for example, overturned the conviction of a drug salesman for promoting the off-label use or a narcolepsy drug to physicians, citing the First Amendment.
As a result, the FDA has said it’s looking to “realign (its) regulatory posture.” Translation: even the agency isn’t sure how much it can police what Big Pharma says anymore.
So it looks like drug companies will try this maneuver again and again until they succeed. Or until the FDA gives up and gives in.
For Dr. Rita Redberg, editor of JAMA Internal Medicine, the issue of giving drug companies carte blanche to claim whatever they want about their meds comes down to a pretty simple principle.
“You don’t ask the barber if you need a haircut.”
She’s watched drug sales reps push the envelope with wild, unproven claims for years — and then she banned them from her medical center.
But companies like Amarin know there are still plenty of doctors out there that they can reach. In fact, Amarin wrote a letter to doctors letting them know that it has new training and promotional materials it’s ready to send right away — if it wins its suit.
As a columnist for Forbes said about the Amarin case, “free speech is paid for, often handsomely.”
And the more than $24 billion a year Big Pharma spends on drug marketing can buy an awful lot of it.
To Your Good Health,
Jenny Thompson
The key is to be vigilant, stay informed and stay thirsty my friends—thirsty for good health!
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mickdolansez 
very true and very scary…excellent blog… 🙂
Reblogged this on realeyezlife and commented:
Please read this excellent blog…It’s very true and very scary