Drugs/Medical Archive
Tribeca Film Festival Must-See: “Off Label” Looks at Big Pharma’s Human Guinea Pigs
April 15th, 2012. By AbiK
If you’re lucky enough to be in New York City later this month, try to make it over to the Tribeca Film Festival for a showing of “Off Label”. The movie, by Michael Palmieri and Donal Mosher, takes a look at America’s drug culture—how drugs are tested, marketed, sold and consumed. And it reveals an oft times less-than-pretty picture of big pharma’s ‘twilight zone’, where drugs are tested by human guinea pigs and the results can be shady at best, devastating at worst.
Just as LawyersandSettlements.com brings you the stories of victims who’ve had their lives irrevocably changed by harmful drug side effects, “Off Label” brings you up close and personal with its subjects’ narratives–and it’s definitely worth seeing. Here are the times & venues where you can catch the film:
4/19 – Thursday, 7:00pm, at AMC Village 7, located at 3rd Ave and 11th St.
4/20 – Friday, 7:30pm, at ClearCinemas Chelsea, located at W 23rd @ 7th and 8th Ave
4/23 – Monday, 10:00pm, at AMC Village 7, located at 3rd Ave and 11th St
4/24 – Tuesday, 3:30pm, at ClearCinemas Chelsea, located W 23rd @ 7th and 8th Ave
How Generic Drugs Discriminate Against the Poorest Patients
April 10th, 2012. By AbiK
No one wants to come right out and say it, but that’s basically what’s going on with generic drugs. Poor patients are effectively discriminated against simply by having no choice other than to buy the cheapest version of whatever pill they’ve been prescribed. Cheaper meds are fine—until you factor in that the more expensive brand name equivalents come with a bit of an extra ‘insurance policy’—no, not the type of insurance you’re thinking of—it’s insurance in the sense of legal recourse should something go wrong as a result of taking the drug.
Let’s face it, outside of those who claim to buy the cheaper equivalent on ‘principle’, for the most part the folks who are buying generics are those who either simply cannot afford the brand-name drug or those who’ll lose prescription coverage benefits unless they opt for the generic shown on the approved formulary from their insurance company. We’re not talking the 1% here, folks.
Sure, it’s great that cheaper generic versions of big-name blockbuster drugs are available—we’d all be broke otherwise. But generics have a hidden cost, too…
Legally speaking, that cost can be tremendous. How so? Well, what if something goes wrong—horribly wrong—upon taking the drug? What if there’s a serious reaction to the drug, like a ruptured tendon from a fluoroquinolone? Or tardive dyskinesia from a ‘good as Reglan’ generic? Sure, the generic drug should in most instances perform like its pricier twin—but there’s a catch: unlike with brand name drugs, if something goes wrong, there’s not much legally at present that can be done (from a strict product liability standpoint—not talking malpractice here).
The issue with generic drugs has to do with liability—being liable when harmful side effects occur. And simply put, generic manufacturers are not held liable.
Currently, it’s the brand name drug manufacturers who are responsible for ensuring their drug has gone through a rigorous FDA-approval process and they’re also responsible for making any label changes should new warnings be applied to a drug they’ve produced.
Generic manufacturers, however, don’t have quite the same responsibility. The Hatch-Waxman Act—officially, the Drug Price Competition and Patent Term Restoration Act of 1984—made it easier for generics to find their way to market. Generic drugs do not have to go through a lengthy FDA approval process if they’re able to prove that the generic drug is equivalent to the brand name version. And, as such, the generic drug simply picks up the labelling information and package insert information from the brand name drug. When any changes are necessary (e.g., adding a black box warning), the generic is required to duplicate what’s happened with the brand name drug.
The most significant benefit of the Hatch-Waxman Act for blockbuster brand name drug manufacturers is that it allows the big pharma companies a period of exclusivity in the marketplace before the generic drug enters the market.
Now, the difference between a drug liability lawsuit for a generic vs a brand name is most glaring when you look at lawsuit outcomes. One of the most publicized examples showing the difference between a brand name drug lawsuit and a lawsuit with the same, but generic, drug involves phenergan.
In both cases the plaintiffs—both women who were administered the anti-nausea drug in a hospital and then subsequently lost an arm due to gangrene—sued the drug manufacturers. In the brand-name case, it was v. Wyeth; in the other, the generic, it was v. Baxter Healthcare. The upshot was that the plaintiff who had the ‘good fortune’ to have been given the brand name version received a multi-million dollar settlement. The generic patient? Her lawsuit against Baxter was dismissed. She had also filed a malpractice lawsuit, the final terms of which were undisclosed.
Both women had life-altering injuries; only one received settlement money from the drug manufacturer.
While the phenergan lawsuits began in a hospital setting where the choice of brand name or generic may not have been the patients’ to make, the outcomes of their lawsuits show the stark difference in terms of liability claims. And, for patients who simply cannot afford to choose a brand-name drug, choosing the generic becomes a more or less de facto decision to give up the right to sue the drug company. And in that sense, generic drugs do discriminate against the poorest patients.
You’ve Heard of Thalidomide Babies, what about DES Babies?
February 21st, 2012. By AbiK
It’s a startling reality that DES Mothers, DES Daughters and DES Sons live with—that not many people know about or have heard about the pregnancy drug DES—diethylstilbestrol—or the harmful effects its had on both mothers who took the drug, and children who were exposed to the drug in utero.
DES was prescribed during the 1940’s to the 1970’s to expectant mothers who were at risk for miscarriage or pre-term delivery. The drug, however, was found to potentially cause clear cell adenocarcinoma (CCA), a rare form of vaginal and cervical cancer; reproductive tract structural changes such as a T-shaped uterus; complications in pregnancy such as ectopic (tubal) pregnancy and pre-term delivery; and infertility.
DES finally had its FDA approval revoked in 2000 (it had been recommended that doctors not prescibe it in 1971)—but not until potentially millions of mothers and children had been negatively affected by it. And those children are now between forty and seventy years of age or so—some of whom have lived through infertility or miscarriages of their own with out knowing that the reason could be connected to exposure to DES.
And that begs the question: why do so few people know about DES and the damage its caused? DES seems to be in the shadows of thalidomide—so much so that it’s been referred to as the ‘silent thalidomide’ in the press.
There are some possible reasons why, of course.
First, thalidomide was never approved for use in the US. DES was approved which perhaps made it appear less pernicious—after all, ‘my doctor prescribed it’.
Second, thalidomide babies could not help but evoke the collective sympathy and outrage of all who had seen a picture of an innocent newborn with severe birth defects such as missing or shortened arms or other severe disfigurement. There are no alarming pictures of DES victims—only faces; and those faces look just like you or me.
And finally, thalidomide, by its horrific nature, wove its way into popular culture—probably the most familiar evidence of this for many is the Billy Joel lyric from “We Didn’t Start the Fire”.
Diethylstilbestrol (DES), however, has potentially affected many more women in the US—and their children and perhaps their children’s children (aptly called ‘DES Third Generation’)—than thalidomide and is in some ways a much more heinous drug in that DES is the one that slipped through the proverbial cracks—the one that the FDA didn’t put the brakes on—soon enough.
Perhaps you now know about DES. But more importantly, do you know if you were on DES or exposed to it?
Propecia Isn’t Supposed to Make Things Disappear, is it?
February 15th, 2012. By AbiK
Funny thing happened on the way to the Propecia website—it wasn’t there! LawyersandSettlements.com recently posted an article about the disappearing act that Merck did with its Propecia site (see image) but one can’t help but appreciate the irony of something that’s supposed to be marketed to make hair appear now, well, disappearing. Stay tuned. And meanwhile, if you or someone you know has used Propecia and lost more than you gained (i.e., lost sexual desire or the ability to perform sexually), read more about Propecia lawsuits here.
Top 10 Drugs with Heart Side Effects on LawyersandSettlements.com
January 31st, 2012. By AbiK
In recognition of American Heart Month, which kicks off tomorrow (Feb. 1st), and National Wear Red Day (Feb. 3rd), LawyersandSettlements.com takes a look at our most-viewed drug lawsuit topics for 2011 in which heart attack or heart side effects were the alleged primary injuries.
Unfortunately, while a lot of focus this month will be on the positive measures we all can take to improve heart health—and that’s certainly important—it can be easy to overlook the negative heart side effects some drugs can have—and attention should be given to those as well.
As the chart at left depicts, Actos, Paxil and Zoloft accounted for the majority of 2011 traffic related to heart side effects, with Actos receiving the most at 25 percent. The Type 2 diabetes drug was released as an alternative to Avandia, which as you’ll recall came off pharmacy shelves as a result of the new FDA REMS program that became effective in November, 2011. Still, Avandia came in as the fourth most popular heart lawsuit topic.
Paxil, the popular antidepressant, has been linked to heart birth defects in infants and the drug drove in 18 percent of traffic last year. Ditto Zoloft, which accounted for 10 percent of the pageviews among readers concerned over the potential for heart birth defects.
The ten prescription drugs on the list fall into four distinct classes: Actos and Avandia are prescribed for the treatment of Type 2 Diabetes; Vytorin helps to control cholesterol, which has a direct impact on heart health; Trasylol is used during surgery to mitigate blood loss; the remaining drugs address depression and anxiety.
Reader interest in Prozac, Lexapro, Effexor, Celexa, Zoloft and Paxil shows continued concern surrounding pregnant women using selective serotonin reuptake inhibitors (SSRI) drugs and potential heart birth defects.
Here’s the full list:
Top 10 Drug Lawsuit Topics for Heart Side Effects in 2011
- Actos (Pioglitazone HCl)
- Paxil (Paroxetine)*
- Zoloft (Sertraline)*
- Avandia (Rosiglitazone)
- Celexa (Citalopram)*
- Effexor (Venlafaxine)*
- Lexapro (Escitalopram)*
- Prozac (Fluoxetine)
- Trasylol (Aprotinin)
- Vytorin (Ezetimibe/Simvastatin)
*SNRI (serotonin-norephinephrine reuptake inhibitor) or SSRI (selective serotonin reuptake inhibitors) drugs associated with heart birth defects when taken during pregnancy
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