Posts Tagged ‘ Big Pharma ’
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.
Big Pharma’s Big Credo: Money is King
September 8th, 2011. By Hunter West
A long time ago, in a different life, the instructor in a business course I was taking asked the class the Number One Reason why people go into businesses. The answers varied from creating jobs, to bringing new products to market, to the prestige that can come with being a business owner, to ultimately helping mankind and make the world a better place.
As I sat there, listening to all of this, it suddenly struck me what the basic foundation for any business enterprise was, is and always will be.
“Making money,” I blurted out.
And apparently, I was right.
The successful former businessman in his own right, the founder of his share of multi-million dollar corporations, maintained that different businesses would have different credos, goals and objectives.
But all of that takes a back seat to profits. You don’t have any of the other stuff—prestige, job creation, R&D, charitable good works—without the money.
It’s all about the money, stupid. Show Me The Money.
Think about that the next time you take that pill for the umpteenth time, or undergo that hip replacement, or accept that pacemaker.
The drugs, the devices available to prolong our lives in the modern age are, in many ways, nothing short of remarkable. They really are. And I like to think that the doctor, who prescribes all this stuff to me, truly has my best health and welfare uppermost in his mind.
But you have to wonder at a regulator like the US Food and Drug Administration (FDA) that is partially funded by the industry over which it is charged to police on our behalf.
You have to wonder about the various loopholes and shortcuts that allow manufacturers to bring ‘promising’ new product to market faster—with minimal testing—only to have a lot of these drugs and medical devices turn out to be hugely problematic, if not outright dangerous.
You have to wonder at an FDA that acknowledges side effects as a necessary evil to the ingestion of chemicals whose benefits outweigh the risks for the largest segment of the population (there is no such thing, therefore, as a completely safe drug…).
You also have to wonder, the next time your grandmother breaks out her pill organizer and proceeds to ingest an insane number of different-colored pills…
How many of those pills are actually prescribed to treat an actual condition, v. the number that are needed to counteract the side effects from other pills?
And I wonder just how important that is to the drug companies, and their respective bottom lines? (And, I’m not the only one who’s wondered–I’m recalling the documentary “Big Bucks Big Pharma” from a few years ago.)
Their profits…
Pharmaceutical companies, and medical device manufacturers appear to be licenses to print money—especially with the large Baby Boomer sector approaching retirement. There’s so much money, in fact, that the cost of defending lawsuits is simply a cost of doing business.
There’s that word again. Business. Profits, and revenue, and dividends for shareholders. How important is it for drug companies to know their products are helping us to live longer, v. the money they are making off of us to their ultimate benefit and that of their investors?
I know what my business instructor, all those years ago, would say…
There’s nothing wrong with running a business—with making profits. That’s what business does.
What bothers me about the pharmaceutical and medical device industries, is that the consumer doesn’t have a choice…
Need a car? You can buy GM, or Toyota, or Honda, or Chrysler Fiat, or Mitsubishi…
If you need a TV, there’s Samsung, or LG, or Sony, or…
Or maybe you don’t want to buy one at all…
The difference with prescription drugs and medical devices is that more often than not, we don’t have a choice. We are mandated to take it, conscripted to do it. We rarely have the capacity to choose. And, if we’re lucky, the one choice we might get is to go for the generic version.
I’m at the age now where I’m on a low-dose aspirin a day, to keep my blood from getting as thick as my own head. I’ll probably be doing that for the rest of my life. But I’m also on a statin for high cholesterol, and I hate it. The sooner I can get my bad cholesterol in check by my own hand—diet and exercise—the happier I will be, and I can kiss the statin goodbye.
Ultimately, I don’t want to take something that I don’t need. But beyond that, I loathe being made to take something against my free will—something with which Big Pharma is laughing all the way to the bank.
I’ve always maintained that health—products, devices, drugs, health care of any kind—should be not-for-profit, free from greed and the blind pursuit of revenue.
But then, it wouldn’t be America, would it?
Deadly Medicine, Even More Deadly Oversight…by the FDA
January 26th, 2011. By Hunter West
Anyone with any misgivings about the state of the Drug Union in this country and the role the US Food and Drug Administration (FDA) plays—or doesn’t—would not want to pick up a copy of the January issue of Vanity Fair in their doctor’s office.
Especially if their doctor is about to prescribe yet another drug…
In ‘Deadly Medicine,’ writers Donald Barlett and James Steele reveal troubling aspects of the prescription drug culture in America.
In sum, it is estimated that prescription drugs kill more than 200,000 Americans each year. That figure is based on information from the Institute for Safe Medication Practices that identified 19,551 people who died as a direct result from a prescription medication.
That, in itself is a huge number. However, according to Vanity Fair that figure is low, given the widely held belief that only about 10 percent of such deaths are ever reported. Thus, a ‘conservative’ estimate would be 200,000 deaths a year from drugs that the FDA considers, according to its mandate, as safe and effective and whose benefits outweigh the risks.
When compared against other maladies and behaviors that are known to have life-ending outcomes, that’s three times the number of people who die from diabetes, and four times the number who succumb to kidney disease. Prescription drugs claim more lives than heroin and cocaine. Fewer people die each year in car accidents in America, than those whose lives are cut short from a drug written to their care by a physician.
It gets better…
Clinical trials are moving offshore, where regulatory authority is lax and drug companies have greater control over the outcomes than they otherwise might on US soil.
By the numbers, the Department of Health and Human Services reported 271 clinical trials 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.
Vaccines: Just in Time for Big Pharma
January 1st, 2010. By janem
Big Pharma breathed a big sigh of relief when it realized vaccines can give a lot more bang for the buck than many “blockbuster” drugs. For pharmaceutical companies like Wyeth (now owned by Pfizer), Glaxo, Sanofi-Aventis and Novartis AG, pandemic flu threats–H1N1 in particular–couldn’t have come at a better time.
For instance, Wyeth’s pediatric pneumococcal vaccine Prevnar makes over $3 billion in annual sales–that should help cover product liability claims for its diet drug Fen-phen. (To date, the drug giant has set aside $21 billion to cover claims.)
And Merck & Co, already making shingles and cervical cancer vaccines, recently got into the US market via a deal to distribute seasonal flu vaccine made by Australia’s CSL Ltd, just in time to pay $4.85 billion in its Vioxx claims.
“Vaccines, vaccines, wonderful business,” quipped Chris Viehbacher, CEO of Sanofi-Aventis, which anticipates earnings of $6 billion in vaccine revenues this year and double its sales by 2013. In the last quarter of 2009, its H1N1 vaccines sales reached $500 million.
Novartis expected to generate $700m in fourth-quarter sales alone from its H1N1 vaccine, but GlaxoSmithKline is the main player in vaccines, holding 22 percent of the global market, and is set to cash in with Brazil, China and India as their burgeoning economies spell bigger budgets for healthcare spending. Glaxo is betting big time on the vaccine business: it just purchased a vaccine operation in Quebec for $1.4 billion, which may tighten the purse strings after paying almost $1billion to resolve lawsuits over its antidepressant Paxil.
Other big spenders are Abbott Laboratories ($6.6 billion on Belgian flu vaccine maker Solvay) and Johnson & Johnson (it just bought 18 percent of Dutch vaccine firm Crucell). “More companies are investing in vaccines as a way of diversifying away from prescription drugs,” says Michael Boyd of the International Federation of Pharmaceutical Manufacturers & Associations. “New technologies, such as cell culture, are enabling them to produce more sophisticated vaccines.”
With nearly 1 billion doses of H1N1 vaccine ordered in 2009, analysts predict the global vaccine industry will reach $40 billion by 2012: Cha ching. Perhaps this means we won’t see so many “blockbuster” new drugs entering the market in the next few years. After all, product liability litigation has been expensive.
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