Yes, Big Pharma, there is a Santa Claus.

And helping Santa make his early visit to the nation’s capital are around 1,300 elves – also known as lobbyists, mostly from giant pharmaceutical companies.

They helped convince a majority of lawmakers from both political parties that the 21st Century Cures Act is the solution to finding new cures and speeding up drug approvals that will save lives.

But as I’ve been warning you since last year, “Cures” is a dangerous bill that’s guaranteed to kill.

And now that President Obama has signed it today, no doubt drug and device makers are high-fiving each other as never before.

While we couldn’t stop this “grab bag” of goodies for Big Pharma, it’s still very important to know just how this legislation can effect each and every one of us.


‘A wolf in sheep’s clothing’

After the 21st Century Cures Act was passed by the Senate last week, President Obama wasted no time in declaring how enthused he is about it.

He dropped sound bites such as “We are now one step closer to ending cancer,” also claiming that this legislation will help unlock cures to other terrible diseases like Alzheimer’s.

Wow, that sure sounds promising. But anyone who believes “Cures” can do all that also believes Santa Claus travels the world on a sleigh pulled by reindeer every Christmas.

But I sincerely doubt that the president has actually even read the cover of this giant 1,000-page bill.

And while some especially devious parts were removed — thanks to the efforts of people like us who wrote and called their lawmakers, as well as numerous consumer interests groups — there’s still a whole lot about Cures that will make things a whole lot worse.

It will, for example:

  • Allow the FDA to grant new uses (to treat different conditions) to drugs already on the market, with little evidence to back them up. This is one of the biggest cash cows in pharma land. And that means millions more will be exposed to risky meds for no good reason at all.
  • Mean that more fast-tracked drugs and devices will make it to market with little to no assurance of safety.
  • Expand insurance coverage for off-label drug prescribing. Off-label prescribing is commonplace and extremely risky. Now, drugmakers will have more leeway in pushing insurance companies to pay for it.

The bottom line is that this bill takes our already rickety approval process for meds and medical devices and makes it even more precarious.

And while you’ll read plenty of headlines saying how billions will now be devoted to finding better medical treatments, even cures, The National Vaccine Information Center hit the nail on the head when it called the legislation nothing more than “a wolf in sheep’s clothing.”

Seriously, the last thing we need right now are laxer standards where drugs and devices are concerned.

Remember the eAlert about the Medtronic spinal fusion device that resulted in chronic pain, bizarre bone growth and even cancer? Or about the power morcellators used in hysterectomies that have spread uterine cancer throughout women’s’ bodies? Or when I told you about the medical scopes that infected patients with deadly superbug infections?

Well, with Cures coming down the pike, all that may soon look like the good old days of patient safety.

As I’ve said many times, as patients or caregivers we must take many of the things federal agencies like the FDA are supposedly charged with into our own hands.

And that means before taking any drugs or allowing devices to be put inside of us or our loved ones we need to make our own list and check it twice!

Because now, more than ever, we know that no one else will be doing it for us.

“Congress passes 21st Century Cures Act with billions for new research, treatments” Dennis Thompson, December 8, 2016, CBS News, cbsnews.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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