Drugs/Medical Archive

FDA vs Attorneys: Who Really Protects Us?

September 27th, 2010. By janem

There’s always some whining going on about how much money lawyers make from pharmaceutical class actions. But do those whiners ever think about how safe we would be were it not for the lawyers, lawsuits and the courts? Let’s add advocacy and consumer groups too—their actions have also kept us safe from dangerous drugs and their side effects.

Relying on the FDA for post-market surveillance once it has approved a drug reminds me of this old adage: Close the stable door after the horse has bolted. All too often it takes consumers and their attorneys—like a band of Davids against the Goliath drug company—to resolve adverse drug events that occur by underhanded tactics such as off-label promotion and false advertising.  Case in point: the diabetes drug Byetta.

The FDA received reports of adverse health events (kidney problems and pancreatitis) from Byetta users since the beginning of 2005 but they did diddly squat until last November, when in their infinite wisdom, finally said, “Byetta can heighten the risk of kidney problems, including kidney failure, in people suffering from type 2 diabetes.” But not before attorneys were filing class action lawsuits against the manufacturer.

And what about Avandia? In 2007, a report in the New England Journal of Medicine, linked Avandia to a 43 percent increased risk of heart attack, and more than 700 lawsuits—with GlaxoSmithKline agreeing to a $60 million settlement. Yet it took the FDA until September 2010 to severely restrict sales of the drug (sales have been completely suspended in Europe).

And let’s consider Zyprexa. Class action lawsuits alleged that the manufacturer, Eli Lilly and Co., negligently made, marketed and sold Zyprexa without properly warning of the risks prior to June 6, 2007. Eli Lilly paid out approximately $1.5 billion to settle civil and criminal claims alleging illegal marketing—promoting the drug for use in seniors with dementia when it is not approved for that use.

As well, Eli Lilly paid millions of dollars to settle claims alleging the increased risk of diabetes and related health problems, but the settlement does not imply liability or wrongdoing, so are we safer as a result? The drug is still sold, but with the labeling clearly showing diabetes-related side effects. But Zyprexa treats psychosis—how many people with schizophrenia or bi-polar disorder are going to read the label? Attorneys have taken the drug company to court; now isn’t it up to the FDA to take the drug off the market? Or at the very least, the agency should be more diligent with post market surveillance.

Tags: Avandia, Byetta, Zyprexa
Posted in Drugs/Medical | 2 Comments »

Children’s Motrin: Another Example of a Toothless FDA

September 24th, 2010. By Hunter West

A controversy emerged this week over an alleged agreement between the US Food and Drug Administration (FDA) and Johnson & Johnson subsidiary McNeil HealthCare over a ‘soft’ recall of Children’s Motrin and other products that were thought to be defective due to lax GMP (Good Manufacturing Practice) at one of McNeil’s facilities. 

The allegation, if true, suggests that one arm of the FDA doesn’t know what the other is doing. It also appears to suggest—again—that so long as the FDA does not have the mandate to force a drug company to conduct a recall, or do anything it doesn’t want to, for that matter, the federal drug regulator is like a tiger without teeth. 

As for the drug companies, it appears as if they subscribe to the credo, “don’t ask permission, beg forgiveness.” 

According to documents and testimony at a congressional hearing this week, the FDA had decided that Motrin product, which had been identified as defective due to GMP problems at the facility where it was manufactured, should be subject to a Class 2 recall. 

There are various levels of recall identified by the FDA, with a Class 1 as the most serious. The latter is urged if there is a problem that could lead to serious health effects or even death. Class 2 is suggested if the problem could cause temporary, or medically reversible adverse health consequences. 

Further, a Class 3 is issued if a product defect is not likely to cause serous health consequences at all. 

Then there’s the ‘market withdrawal,’ which according to CNN Money on Tuesday is not a recall Read the rest of this entry »

Tags: Children's Motrin, FDA, J&J, Johnson & Johnson, McNeil
Posted in Drugs/Medical | No Comments »

Here’s What’s Wrong with Botox

September 3rd, 2010. By AbiK

Think I’m going to say that it’s the way Botox can turn a once-expressive face into one that looks like it’s just come out of the freezer? Nope. Or that it’s spurred on our youth-obsessed culture thereby driving the insecurities of aging women to new heights? Nope again.

The issue with Botox is this: it’s easy to get and easy to steal. Too easy. It’s getting to the point where it might as well be right up there with the more “commodity” beauty that you find on drugstore shelves. Heck, when you see reports of former Miss USA Shannon Marketic allegedly shoplifting Olay Pro-X and then read about the recent string of Botox Bandits, is there really any difference?

For those of you who haven’t been following, yes, there is a brand of thief known as Botox Bandit. The latest arrest was Maria Elizabeth Chrysson (who’s 29—again? one can’t help but ask) in Miami. Funny thing is that this is Chrysson’s third charge of Botox “theft”. Botox, mind you, can run $300 – $500 per visit and can get over the $1,000 mark. The theft happens when the patient, post-injection, either writes a check that’ll bounce or says that she needs to hit an ATM or she left her purse in the car (whoops!).

Ok, it’s not the theft that’s actually the issue. To be more precise, the theft is more like a symptom. Think about it. What other medical—yes medical—procedure can you walk into Read the rest of this entry »

Tags: Botox
Posted in Drugs/Medical, Emerging Issues | No Comments »

Seroquel Settlements Continue…but What Drug is Next?

September 2nd, 2010. By LucyC

During the past few weeks we have seen AstraZeneca (AZ) settle some 17,500 Seroquel lawsuits—give or take. That puts them about two thirds of the way through a staggering 26,000 cases currently pending against them. So far the estimated amount of those settlements is around $198 million, according to media reports. That certainly isn’t chump change. But then the drug reportedly did about $4.9 billion in sales last year. You do the math. 

According to a report on Bloomberg, AZ is still facing “at least 8,000 cases in both state and federal courts.” The cases allege that the drug, which was approved by the federal Food and Drug Administration for treatment of schizophrenia and mania associated with bipolar disorder, causes—or at least is associated with—the onset of diabetes. All the settlements so far have been negotiated out of court, so this week it was decided to give AZ a little more time to see if they could finish the job—settle all the outstanding cases—without having to go to court. We’ll see. 

The average amount of the settlements per case is around $11,000. I wonder how much diabetes medication that buys?

But it seems that Seroquel isn’t the only drug associated with the development of adverse Read the rest of this entry »

Tags: FDA, Janumet, Januvia, Seroquel
Posted in Drugs/Medical | 2 Comments »

Kevin Bacon Game helps Decipher Diabetes-related Drug Lawsuits

September 2nd, 2010. By AbiK

If you’ve ever wondered why certain drugs (Zyprexa, Avandia, Seroquel, Cymbalta…to name a few) seem to have something in common, but you just can never really put your finger on it, well, it’s time to look to the Kevin Bacon Game (aka, Six Degrees of Separation, with some liberties taken) to find out what those connections are…so here goes…

Tags: Avandia, Cymbalta, Diabetes, Janumet, Januvia, Kevin Bacon, Risperdal, Seroquel, Symbyax, Zyprexa
Posted in Drugs/Medical, Emerging Issues | 2 Comments »