Orphan drug loophole is endangering millions
We haven’t seen a case of fraud like this since Enron!
If you’re one of the two-thirds of Americans taking prescription drugs, there may be something about that trusty bottle of pills you’ve never been told.
It may have been rushed to market under very false pretenses — and based on almost no science — thanks to one of the largest government loopholes ever created.
It’s called the “orphan drug exception” and it’s meant to speed along cures for rare diseases.
But Big Pharma is using it to sell its newest blockbuster meds. And if you’re not careful, their scheme could put your health — and even your life — in danger.
But they should have named it the Orphans and Widows Act instead — because it’s doing a great job of creating both.
You see, the goals behind the law were sensible enough. To encourage Big Pharma to develop drugs for rare “orphan” diseases — like Huntington’s disease or unusual types of cancer — the FDA offered a sweetheart deal.
This “orphan drug exception” includes grants, tax breaks, a speedy review — they’ll even extend a drug company’s patent.
And the best part? Instead of running those long and expensive clinical trials that can take years, drug makers get a much shorter review process.
The only problem? It took Big Pharma about five minutes to figure out how to take advantage of the program — and to put you and everyone you know at risk.
Here’s exactly how they’re doing it.
Step #1 Play fast and loose on the drug application. Drug companies submit an application claiming their new med cures some rare disease. They take advantage of the government perks and fast review, and the drugs eventually end up being used for other, more common conditions.
Step #2 Start marketing for unapproved uses. Once a new drug skates through the orphan review process, the gloves come off. Big Pharma can start selling it, and doctors can start prescribing it “off label” for dozens of other uses that are worth a fortune.
Step #3 Watch the money roll in while people die. Remember, these drugs were barely studied and were rushed through the review process. And once doctors start prescribing them for conditions they weren’t designed to treat, it’s a recipe for disaster.
And nobody danced the orphan drug three-step like Genentech with its cancer med Rituxan. It was originally sped through the approval process to treat a rare type of non-Hodgkin’s lymphoma — but it wasn’t long before it was being prescribed for rheumatoid arthritis and lots of other diseases.
Genentech sold $7 billion worth of this stuff last year! I haven’t seen things turn out that well for an orphan since Annie!
But while companies like Genentech use our government like their own, personal Daddy Warbucks, an awful lot of lives are at stake.
Lives like Jesse Peetz’s. He was just 17 when he got an off-label prescription for Rituxan to treat a blood disorder.
And he spent the last years of his life as a quadriplegic before he died.
The orphan drug system is making Big Pharma a fortune — but it’s putting the rest of us in harm’s way. Here are two things you can do about it right now:
- Before filling a prescription, always check the FDA database to see what the drug was really approved for. Even your doc may not know. And if you don’t see your condition listed, demand something else.
- Contact your legislators and tell them to fix the Orphan Drug Act once and for all. Forty-one percent of the drugs the FDA approved last year were rushed through the process as orphans — and even blockbusters like Humira and Crestor have wormed their way into orphan drug status.
It’s a scam that Big Pharma is going to keep running until someone stops them. And it’s up to us to make that happen.
Sources:
“How a blockbuster drug can become a subsidized ‘orphan'” Dina Gusovsky, December 2, 2015, CNBC News, cnbc.com
