Drugs/Medical Archive
Guardians Gone Bad: Elder Abuse Report Reveals Startling Stats
November 3rd, 2010. By LucyC
At the end of October, Lawyers and Settlements reported on a government investigation into hundreds of allegations of elder abuse. Sadly, the investigation found that court appointed guardians of incapacitated seniors are not screened or monitored, with serious, if not life threatening consequences.
The probe by the Government Accountability Office (GAO), an investigating arm of the US Congress, looked into review practices in 45 states. The GAO report was done at the request of the US Senate’s Special Committee on Aging, which has been studying allegations of abuse and diversion of federal benefits from elderly and disabled wards of the court for some time.
Their findings? Nothing short of shocking. Hundreds of allegations were discovered by the federal auditors, allegations of physical abuse and mistreatment by guardians entrusted with the physical, emotional and financial well-being of elderly and disabled people. For example, 20 cases involved criminal or civil penalties against guardians who had stolen at least $5.4 million in assets from some 158 seniors. According to a report on CNN.com a case in Missouri involved a convicted bank robber who had been appointed guardian of an elderly man who developed Alzheimer’s disease. As the senior’s condition deteriorated, the guardian was able to steal over $640,000 from him by writing checks out of the senior’s estate to pay for exotic dancers and a new Hummer.
With respect to physical abuse and neglect, an attorney for the National Guardianship Association provided the investigators with information on over 300 cases of alleged abuse, neglect and exploitation by guardians nationwide between 1990 and 2009. And, an advocate in Houston, who had personal experience of abuse of guardianship through her mother, provided information on 30 different families that submitted cases of abuse, with her help. “As Read the rest of this entry »
The Mass Tort Muser Ponders Yaz Lawsuits
October 26th, 2010. By Mass Tort Muser
Yaz (and its sib, Yasmin) has been under fire over the past couple of years. Hell hath no fury, right? And there are definitely some women out there feeling a bit scorned by big pharma on this one…
But talk about the pendulum swinging back in the opposite direction. It wasn’t all that long ago that we (women, that is) were ecstatic that finally, yes finally, there was a mere pill—such a teeny tiny helper!—that could save us from unwanted pregnancy and that God-forsaken monthly interruption—cramps and all. (Insert a “Right-on!” shout-out to Ms. Steinem, women’s lib and a few burnt bras…).
Fast-forward almost forty years…and the pill delivers zit relief, too—our cup runneth over! Breakout banisher is basically how Yaz positioned itself on
center stage of the contraception market—and how it netted not only a whole new generation of pretty young things as groupies but also a wrist-slap from the FDA. Seems telling women about how clear their skin would be without telling them about potential little side effects like deep vein thrombosis or perhaps the need for gallbladder surgery wasn’t such a slick marketing move. At least they didn’t try to get shelf space next to Clearasil.
But you know all that. And here’s where the musing and pondering kick in…
Given what’s been going on with Yaz, you may be wondering why on earth there isn’t some big brouhaha going on—you know, one of those class actions. It seems whenever there’s a product—be it a lawnmower, Expedia.com’s hotel reservations, or Similac baby formula—that doesn’t do what it says it will do or causes undo harm, there’s a class action. So, what’s up with Yaz? Where the heck is my “opt in” claim form? Was I not invited?!?
Let’s look at how some of the details rack up: indeed, lots of women allege to have been harmed by Yaz—enough perhaps to even be considered a “class” or at least a sizeable cocktail party. And possible Yaz side effects are numerous—and not just your run of the mill “honey I’ve got a headache gonna lie down” type. No, these are biggies: gallbladder problems, deep vein thrombosis, pulmonary embolism, heart attack, stroke… Keep in mind, too, the women getting Yaz prescriptions filled are, obviously, within child-bearing age, so they’re younger—not the typical age-range for heart attack or stroke, for example.
So why not a Yaz class action? Why not a little “you may be part of a Yaz lawsuit” postcard in the mailbox or a full-page ad of legalese in People magazine? The answer is because Read the rest of this entry »
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.
Menaflex: Influence Peddling at the FDA
October 22nd, 2010. By Hunter West
The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down.
That’s because, according to a report October 14th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner.
Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel.
And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy?
Oh…my…God…
The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval.
It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »
Job Alert: Novartis Seeks Sr. Brand Manager – Prevacid
October 21st, 2010. By AbiK
Need a job? If you’ve got 5+ years experience in CPG marketing with prior healthcare industry experience and knowledge of regulatory issues, well, get that resume submitted over at Novartis pronto! They’re apparently looking for a Senior Brand Manager for Prevacid—the prescription and OTC proton pump inhibitor med used to treat gastroesophogeal reflux disease (aka GERD).
No, I’m not getting a “finder’s fee”, though all donations gratefully received.
The interesting thing about such a job post, if you step back for a moment and really think about it, is what level of soul-searching goes into accepting the role of marketer for a big pharma drug? Does conscience even enter into the equation at any time?
It did for me a while back when I was recruited for a job at a pharma ad agency. The role entailed repositioning a contraceptive (manufacturer and brand need not be mentioned here). But here’s the thing—when I researched it, I found there were a number of adverse events Read the rest of this entry »
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