It’s Memorial Day and I hope you and your loved ones are taking some time to remember those who sacrificed their lives for our freedoms.
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.
Don’t tread on us
“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 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.
Sources:
“Drugmaker sues F.D.A. over right to discuss off-label uses” Katie Thomas, May 7, 2015, The New York Times, nytimes.com
“Under pressure, FDA to hold public meeting on off-label use” Toni Clarke, May 6, 2015, Reuters, reuters.com
