Drug Company Fined $3,000,000,000 for Fraud

[Andara Bledin]

GlaxoSmithKline has plead guilty to pushing two of it's drugs for non-approved uses and failing to disclose after-market research data on a third and is fined US $3billion.

Article at Manufacturing.net

Prosecutors said GlaxoSmithKline illegally promoted the drug Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18. The corporation also promoted the drug Wellbutrin from January 1999 to December 2003 for weight loss, the treatment of sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was only approved for treatment of major depressive disorder.

Justice Department officials also said that between 2001 and 2007 GlaxoSmithKline failed to report to the FDA on safety data from certain post-marketing studies and from two studies of the cardiovascular safety of the diabetes drug Avandia. Since 2007, the FDA has added warnings to the Avandia label to alert doctors about potential increased risk of congestive heart failure and heart attack.

This is the reason why we need government oversight of pretty much anything that is promoted to be ingested or taken internally; we can't trust corporations to be interested in anything beyond their bottom line, even if it risks the lives of anyone affected.

The part I find most reprehensible is where they push one of their drugs for use with children despite having not gotten the ok for it's use on minors - I am unclear on whether there was even any testing to ensure it wouldn't do irreparable harm to them.

^-.-^

[crashhelmet]

But Andara!!! The Free Market System is best for the country! Government regulations are why we all suffer!

[fireheart17]

This is the reason why we need government oversight of pretty much anything that is promoted to be ingested or taken internally; we can't trust corporations to be interested in anything beyond their bottom line, even if it risks the lives of anyone affected.

The part I find most reprehensible is where they push one of their drugs for use with children despite having not gotten the ok for it's use on minors - I am unclear on whether there was even any testing to ensure it wouldn't do irreparable harm to them.

Doesn't the FDA oversee these things? (Aussie here, we have the TGA which DOES oversee this kind of stuff)

Of the two antidepressants, medicating kids under 18 for depression should only be used as a last resort. And that should be an extreme last resort.

As for the Wellbutrin, while it shouldn't be touted as a weight loss drug (one of the side effects is that it CAN cause weight loss), down here it's been used as an anti-smoking aid. There hasn't been a lot relating to ADHD or substance abuse though. So while promoting it as a "miracle" drug is extremely stupid and wrong, there was some element of truth to their claims. (I am debating going on the Wellbutrin, but we'll see)

I can't comment on the diabetic drug.

[Nekojin]

Doesn't the FDA oversee these things?

Yes, but like any government agency, it requires a bit of cooperation and goodwill from the companies it's regulating. If they actively hide what they're doing, there's not a lot the FDA can do to stop them, it can only punish them after the fact.

Which, really, is all law enforcement is - scare people into behaving with threats of punishment, or follow through on punishing them after they don't behave.

[Crazedclerkthe2nd]

Yes, but like any government agency, it requires a bit of cooperation and goodwill from the companies it's regulating. If they actively hide what they're doing, there's not a lot the FDA can do to stop them, it can only punish them after the fact.

Which, really, is all law enforcement is - scare people into behaving with threats of punishment, or follow through on punishing them after they don't behave.

Also consider the fact that in a lot of cases the FDA's penalties are largely toothless. You think a big pharma company is going to give two shits over being fined $500 000 for some violation? It's pocket change to them. In a lot of cases they make more money breaking the rules and paying the fines than by abiding by the rules.

Off label use issues are not limited to Paxil or GSK. Several years ago Pfizer got in hot water for actively promoting off label uses for neurontin (gabapentin). Form the wikipedia page on the drug:

By some estimates, off-label prescriptions account for roughly 90 percent of Neurontin sales. While off-label prescriptions are common for a number of drugs and are perfectly legal (if not always appropriate), marketing of off-label uses of a drug is strictly illegal.[49] In 2004, Warner-Lambert agreed to plead guilty and pay $430 million in fines to settle civil and criminal charges regarding the illegal marketing of Neurontin for off-label purposes, and further legal action is pending. The courts of New York State, for example, have refused to certify a class of injured parties who took Neurontin for off-label use, finding that they had failed to state that they had any injury

[bara]

You think a big pharma company is going to give two shits over being fined $500 000 for some violation? It's pocket change to them.

I think 3 billion is an amount that will convince them to follow the rules. But, they will most likely just try to hide it better next time. Id honestly like to see jail time for those responsible as well.

[Andara Bledin]

Maybe and yes and I wish.

However, the FDA is getting really ticked off at such situations and is starting to up the ante and ferret out wrongdoing rather more proactively and vigorously than prior.

They may not really care about the health of the people, but they'll be damned if they can't make the drug companies respect their authoritah.

^-.-^

[Dreamstalker]

When I was a pup, doctors apparently saw no problem with prescribing tricyclic antidepressants to little kids (we discovered too late that said drug was not approved for use on minors at that time).

I've been seeing more and more commercials for drugs that were originally developed to be used for X, as being great for Y (and probably Z through G).

There's one glaucoma drug that's now being marketed for "treatment of minimal or not enough [eye]lashes"...in that case the initial testing did find that it caused lashes to grow, but how long until someone ignores the "DO NOT APPLY IN EYES" caveat, does it and sues.

[wolfie]

What would be interesting would be, instead of a specific dollar amount as a fine, "aging" the patent on the drug involved by a year (i.e. make it expire a year earlier than it normally would have). For really bad cases, wipe out the patent, or "age" ALL patents held by the drug company.

[HYHYBT]

The patents are a big reason companies are tempted to do this in the first place. It takes forever to get a drug approved in the first place. Even if, once it's on the market, it turns out to work well for other purposes, by the time that's proven to the FDA's satisfaction it's many more years wasted, with the patent's timer running the whole time.

Yes, they need to be fined through the nose for this. But also: there needs to be an easier way to get drugs approved once they're known (as nearly as can be known before they're widely distributed) to be safe, especially for other uses.

Every time something like this comes up, I wonder... supposedly, Monoxidil began as a blood pressure treatment, but trial subjects sprouted extra hair. So what I wonder is this: first, whether it was *effective* for treating blood pressure and, if so, why it isn't used for that, and second, since presumably for that use you'd take a pill rather than rubbing it on your head, if it wouldn't work better for growing hair if it were in an ingestible form.