Posts Tagged ‘ GSK ’

Whistle while you Work? Sad Reality in American Business

November 2nd, 2010. By Hunter West

Anyone who is aghast at the recent $750 million GlaxoSmithKline (Glaxo) whistleblower judgment to settle manufacturing deficiencies at a former plant in Puerto Rico shouldn’t be surprised that such things are going on. Happens all the time, it seems. And not just to Glaxo, either. 

In actual fact, that $750 million—of which the whistleblower earns a share of the penalty totaling a whopping $96 million—pales in comparison to the $3.1 billion that the US Department of Justice has recovered under the federal False Claims Act so far in just this fiscal year alone. 

Last year the haul was almost twice that—$5.6 billion. 

Some will say that the whistleblower is an opportunist hoping for a big payday in the end, and will take any amount of criticism and crap en route to the pot at the end of the rainbow. Hell, I’d put up with a lot of grief to collect $96 million. 

I would even eat liver. 

But to those who view whistleblowers as ambulance chasers, consider the amount of fraud and wrongdoing that serves as a persistent blight on the business landscape. Somebody has to expose such misdeeds—and if the government can’t route out the evil-doers (sorry ‘W’…) on their own, then they have to provide incentive for those who can. 

We would all wish that whistleblowers were not necessary. In a perfect world every business and corporate entity would operate with integrity and play by the rules.

Sadly, that’s not the case. 

According to Taxpayers Against Fraud, a not-for-profit that supports whistleblower lawsuits, Read the rest of this entry »

Tags: Avandia, Eckard, GlaxoSmithKline, GSK, paxil, Qui Tam, Whistleblower
Posted in Whistleblower | No Comments »

Big Pharma Lawsuits – Who Got Hit with the Biggest Settlement?

October 25th, 2010. By LucyC

It seems that every month practically, one pharmaceutical company or another makes the news for bending rules around marketing. Mis-marketing, which could also be called consumer fraud, can  result in serious, if not life-changing consequences for people making decisions about their health. 

Recently, I came across a list of the largest settlements paid by 11 pharmaceutical companies for bending the rules. The fines total a staggering $6 billion. The more frequent offender, according to the company that compiled the list, is Eli Lilly. They paid more than $1.4 billion in fines all for various violations for just one drug—Zyprexa.  

And then there’s Pfizer, who paid $2.3 billion for ‘mis-marketing’ a number of drugs including Bextra, Geodon, Lyrica and Zyvox. 

These drugs are used to treat everything from schizophrenia to epilepsy to diabetes, and the consequences of not having the correct information may have resulted in serious adverse health events, possibly even death for some. 

Not surprisingly, people tend to be very interested when the big boys get caught behaving badly, for a variety of reasons, not the least of which being that we feel our trust has been betrayed. We trust drug companies, and the medical profession in general, to give us the straight goods because it’s a matter of life and death. Why would you not be straight about that? Well, the answer is, not surprisingly, money. And lots of it. But eventually the offenders do get caught. And that leads to drug lawsuits, criminal investigations and ultimately, very large fines. 

So, without further ado—here’s a list of the big offenders—who took them on, what for and how much they paid, with acknowledgement to FiercePharma.com who actually did the homework on this. 

Novartis
With: U.S. Attorney’s office for the Eastern District of Pennsylvania
When: Sept. 30, 2010
Why: Novartis agreed to a $422.5 million settlement with the Eastern District of Pennsylvania for its off-label promotion of Trileptal and other allegations against Diovan, Exforge, Sandostatin, Tekturna and Zelnorm. (oh, and ps, Novartis is recruiting for a Senior Brand Manager for Prevacid…)

Forest Labs
With: Dept. of Justice
When: Sept. 15, 2010
Why: After marketing Levothroid, an unapproved thyroid drug, Forest Labs received a $313 million penalty.  The settlement also covered Forest’s off-label use of Celexa for children’s use.

Allergan
With: Dept. of Justice
When: Sept. 1, 2010
Why: Allergan’s was fined $600 million by the Department of Justice. The settlement was broken into two parts: $375 million in fines and $225 milion in civil penalties, all of which stemmed from its off-label use of Botox for headaches, pain management and cerebral palsy. 

Elan
With: U.S. Attorney’s Office in Massachusetts
When: July 15, 2010
Why: Elan received a $203.5 million fine for its marketing of Zonegran, an epilepsy drug.

Johnson & Johnson
With: Department of Justice
When: April 29, 2010
Why: Though J&J is most recently famous or a rash of phantom recalls, two of the troubled drugmaker’s subsidiaries received a $81 million penalty for off-label promotions of Topamax, an epilepsy drug.

AstraZeneca
With: U.S. Attorney’s office in Philadelphia
When: April 27, 2010
Why: In the same week as the J&J settlement, AstraZeneca was fined $520 million misleading doctors and patients about the safety of its antipsychotic drug Seroquel.  

Abbott
With: Twenty-three states
When: Jan. 7, 2010
Why: In a case involving 23 different states, Abbott Laboratories and its partner, Fournier Industrie et Sante, were ordered to pay $22.5 million for blocking the states from obtaining a cheaper alternative for its cholesterol drug, TriCor. (btw, Abbott Labs is the one who brought you beetle parts in Similac, causing the recent Similac recall…)

Eli Lilly
With: Connecticut
When: Sept. 29, 2009
Why: A total of 13 states total had filed suit against Eli Lilly for Zyprexa marketing issues, but the company was ordered to pay $25 million to Connecticut in this ruling.

Eli Lilly
With: West Virginia Attorney General
When: August 21, 2009
Why: In another Zyprexa case, West Virginia Attorney General Darrell McGraw levied $2 billion in fines against Eli Lilly. In the end, the company agreed to $22.5 million in fines.

Merck
With: 35 states’ attorney offices
When: July 15, 2009
Why: Following a 35 state investigations into the Enhance study of Vytorin, Merck paid $5.4 million in fines, without admitting fault in the cases.

Sanofi-Aventis
With: Department of Justice
When: May 28, 2009
Why: In an agreement with the federal government, Sanofi paid $95.5 million total, to the federal government, state Medicaid agencies and other public health service agencies, all for its subsidiary Aventis’ nasal spray price inflation between 1995 and 2000.

GlaxoSmithKline
With: U.S. Attorney’s office in Colorado
When: Jan. 29, 2009
Why: After seven years of off-label promotion on nine of its best-selling drugs, GlaxoSmithKline (GSK) was ordered to pay $400 million to the U.S. Attorney’s office in Colorado.

Pfizer
With: Department of Justice
When: Jan. 26, 2009
Why: Right after acquiring Wyeth, Pfizer dropped a bombshell in its fourth quarter earnings report; the company was charged $2.3 billion for off-label promotions of its COX-2 drugs.

Eli Lilly
With: Department of Justice
When: Jan. 15, 2009
Why: In the first Zyprexa settlement (and one of three on our list), the Department of Justice levied $1.4 billion in fines against Eli Lilly. Also, as part of the settlement, the company pled guilty to a misdemeanor: violating the Food, Drug and Cosmetic Act.

Tags: Abbott Labs, Allergan, Bextra, Big Pharma, Botox, Celexa, Diovan, Drugs, Eil Lilly, Elan, Exforge, Forest Labs, Geodon, GlaxoSmithKline, GSK, J&J, Johnson & Johnson, Lilly, Lyrica, Merck, Novartis, Pfizer, Sandostatin, Sanofi Aventis, Seroquel, Tekturna, TriCor, Vytorin, Zelnorm, Zonegran, Zyprexa, Zyvox
Posted in Drugs/Medical | 3 Comments »

Is Your Doctor Getting Cash from Big Pharma? Find Out

October 20th, 2010. By AbiK

It’s been a good year for Dr. Firhaad Ismail. Indeed! Financially speaking, that is. See, according to the info over at ProPublica, in their Dollars for Docs report, Dr. Ismail took in no less than $303,558 from big pharmaceutical companies GlaxoSmithKline (GSK…the folks who brought you Avandia and Paxil), Eli LIlly, and Merck.

Now, Dr. Ismail is just one of 384 doctors nationwide who’ve received payment from big pharma. Ismail is based in Vegas (clearly, if ProPublica’s involved, what goes on in Vegas is not staying in Vegas) and his specialty is Endocrinology and Metabolism. And he appears to do a fair amount of consulting on the topic. On big pharma’s dime.

Dr. Ismail may be the best damn doctor there is in his specialty. I don’t know. But what I do know is that the ProPublica report indicates that Dr. Ismail received a total of $209,400 from GSK alone. Recall what area of practice Dr. Ismail is in…Endocrinology. What does Endocrinology deal with? Well, diabetes for one. And last I checked, Avandia is a type 2 diabetes drug made by GSK.

I’m just putting on the table what’s already out there. I’m not saying there’s any unsavory relationship here…but I the jaded skeptic in me does raise a little eyebrow…

Needless to say, I’ve been checking out my own doctors over at ProPublica.com. You can, too. Just hop over to Dollars for Docs and do a search for your doctor’s name, by state. You can also find a full list there of all the doctors nationwide.

Let us know what you find…and if you think doctors receiving funds from big pharma presents a conflict of interest.

Tags: Dollars for Docs, Dr. Firhaad Ismail, Eli Lilly, GSK, Merck, ProPublica
Posted in Drugs/Medical | 1 Comment »

How the FDA Advisory Panel Vote Affects Avandia Patients

July 15th, 2010. By Kristine B

If you’re like other Avandia patients out there, you probably waited for the FDA advisory panel’s vote yesterday with some concern (or maybe you didn’t). Yesterday was the day the FDA advisory panel voted on whether or not to remove Avandia from the market. So, today we examine how the panel voted and what that means for you.

First, what you need to know about the panel. The panel is only advisory. This means that the FDA doesn’t have to follow the panel’s recommendations. Sure, it usually does, but that doesn’t mean it always will. So, all the panel can do is make recommendations. Whether those recommendations will be followed is up to the FDA.

So, what did the panel recommend? Well, depending on how you view it (and whose articles you read) Avandia was either dealt a severe blow by the FDA or won a major victory. Hunter’s Avandia post today calls it a “muted win” for GSK, which probably sums it up best.

On the question of what to do with Avandia, panel members voted as follows:

12 voted to withdraw the drug entirely

10 voted to allow it to remain on the market with strong label revisions and possible sales restrictions

7 voted to add further warnings to Avandia’s label

3 voted to allow continued sale of Avandia with no changes

1 abstained

So, there are two ways of looking at this: Either the majority of panelists (22) voted to either withdraw Avandia from the market entirely or only allow it under stronger warnings and sales restrictions, or the majority of panelists (20) voted to keep Avandia on the market rather than withdrawing it. Nothing is ever simple when it comes to pharmaceutical decisions.

What does that mean for patients taking Avandia? Right now, it doesn’t mean anything. You haven’t been told to stop taking the drug, although 18 panel members voted that they are concerned Avandia causes heart attacks (nine said they weren’t sure about the risk of heart attacks and six said they weren’t concerned about the risk of heart attacks).

So, if you’re concerned about taking Avandia, you should speak with your doctor about the risks. But don’t stop taking it without first speaking to your doctor about your concerns.

The FDA will make a decision later about whether or not to continue to allow Avandia on the market.

Meanwhile, GlaxoSmithKline has reportedly settled 10,000 Avandia lawsuits for approximately $460 million. If you think you may have an Avandia claim, your best bet is to file your claim with a lawyer who is specializing in Avandia claims.

Tags: Avandia, Avandia Lawsuit, FDA, GSK, Pleading Ignorance
Posted in Drugs/Medical, Emerging Issues | No Comments »

Avandia Study Conflicts – and Conflicts of Interest?

June 30th, 2010. By AbiK

So after the latest two Avandia studies came out earlier this week, we then see a third Avandia study—this one will also be debating fodder for the advisory panels at the FDA’s July meeting—the one that will determine Avandia‘s fate. The study was presented late Monday at the American Diabetes Association’s annual meeting by Dr. Richard Bach, associate professor of medicine at Washington University School of Medicine in St. Louis.

Here’s the thing though—the fist two studies basically added a few nails in Avandia’s ever-growing coffin. But this latest study to hit the airwaves actually digresses from the previous two in its findings—it states that there is no increased risk of heart attack, stroke or death associated with taking Avandia.

Hmm. Doesn’t that just make things a little…less definitive?

However, upon looking more deeply into this third study, some things about it just sort of pop out. For example, according to an article from healthfinder.gov, this third study if of a smaller sample size: 2,400 patients—compared to over 35,000 from the study done at the Cleveland Clinic.

There’s more..

• The third study was funded by the National Institutes of Health (NIH). Oh, and GlaxoSmithKline (GSK). Oh, and if you recall, GSK just happens to make Avandia. Conflict of interest? (just asking).
• While death, heart attack and stroke incidence rates were apparently 28 percent lower in the third study for those taking Avandia vs. those not taking a thiazolidinedione (TZD) medication, congestive heart failure was higher—just not at a rate “considered significant”. What was significant was a 45 percent increase in risk of fractures for those who took Avandia. (Ok—not heart-related, but 45 percent sounds more than significant to me).
• Apparently the ages of the participants in the third study were lower than that of the other studies. Translation: the other studies’ participants may have been more frail. Two things here: first, I don’t care what ages folks are who are affected by a drug–everyone’s well-being matters. So if an older population is more adversely affected, they’re still adversely affected. And second, so the tests are not comparing apples to apples–which should detract from the ability to make comparisons and draw conclusions.

Hard to say where the FDA advisory panel will net out in July. Will we still see Avandia on the market? Stay tuned.

Tags: Avandia, Glaxo, GlaxoSmithKline, GSK
Posted in Drugs/Medical | No Comments »