Posts Tagged ‘ Drugs ’

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?

Tags: Big Pharma, Drugs, FDA, medical devices, pharmaceuticals
Posted in Drugs/Medical | 3 Comments »

Counting Your Blessings, Counting Your Pills

November 25th, 2010. By Hunter West

Can we talk?

Today is Thanksgiving—a time to count your blessings, in spite of an economic climate that may have left us with fewer blessings overall to count. And tomorrow may be a blacker Black Friday than normal, because we may not have the financial wherewithal to hit the stores and take advantage of all the deals. 

Be that as it may, on this day we count our blessings nonetheless—in between counting the various pills designed to keep us comfortable, to keep us alive. 

And to keep the drug companies not only in business, but thriving. 

Here’s the question… 

Do we really need to take all these drugs we are using? Have we become soft? Always looking towards the path of least resistance? 

We all learned from a young age that shortcuts often get us into trouble. “Do it right, do it once, measure it twice, cut it once, take no short-cuts,” Daddy always told us. 

You can’t take a short cut to a university education. Some do—by applying for those spiffy, legitimate-looking online diplomas that are worth nothing more than the paper they’re printed on. Taking a short cut to the corner office at work often means stabbing others in the back, or worse… 

My point is, you can’t take a short cut to your health. A person can’t expect to exude health by eating crap, drinking excessively and sitting on the couch all day (Thanksgiving aside, of course…). 

You can’t lose weight and keep it off without changing your lifestyle and getting regular exercise. 

You can’t put your faith in a pill and trust it will fix everything—particularly when the likes of Meridia, Avandia or Paxil are what’s in the pill bottle. 

But that’s what appears to be happening… 

There are pills for everything. Having to get up to pee in the night. Having heartburn. Having Read the rest of this entry »

Tags: Drugs
Posted in Drugs/Medical | 2 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 »

Criminal Medicine: Best Defense, Sadly, is a Good Offense

October 6th, 2010. By LucyC

If finding the right medication feels a bit like a minefield lately, it’s no wonder.

It’s not been a banner time for Pharma—these past few years. So many drugs and medical products in general seem to be linked with serious, if not life-threatening adverse events. You may recognize some of the names on the hit parade: drugs such as Accutane and a possible link with inflammatory bowel disease (IBD); proton pump inhibitors (antacid drugs) and increased risk for hip fractures; Reglan and its link with Tardive Dyskinesia; Byetta—a diabetes medication linked with kidney failure… 

And of course no list would be complete without Avandia—another diabetes medication—and its infamous association with serious, sometimes fatal cardiovascular events. 

Oh—there’s also allegations surrounding the class of antidepressants known as SSRIs and links with newborn heart defects. In fact the list is exhaustive.  

And to be clear, it’s not just drugs. Products such as the DePuy metal hip replacement are also in trouble. DePuy is currently facing a class action lawsuit over failure rates seen with its ASR acetabular cup. DePuy, which is owned by Johnson & Johnson, has also had global product recalls.

Gadolinium is another one. It’s a clear, non-radioactive chemical compound used with patients undergoing magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). In 1988 the FDA approved gadolinium as a contrast agent to provide a clearer picture of organs and tissues. Since that time, more than 200 cases of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) have been linked to the product. 

This week, news out on Bloomberg indicates that the powers that be at Pfizer Inc, ‘failed to properly warn doctors and consumers that its Prempro menopause drug could cause Read the rest of this entry »

Tags: Accutane, Avandia, Byetta, DePuy, DePuy Orthopaedics Metal Hip Replacement, Drugs, Gadolinium, Medical, Norian SRS, Prempro, Proton Pump Inhibitors, Reglan, SSRI
Posted in DePuy ASR Hip Recall, Drugs/Medical | No Comments »

What the Heck Does “Off-Label” Mean, Anyway?

January 7th, 2010. By Kristine B

One of the phrases we at LawyersandSettlements.com see frequently is “prescribed for off-label uses.” In fact, we see it a lot. But, we realized that not everyone understands what “off-label uses” actually means, or what its implications are. So, this week’s Pleading Ignorance examines the off-label use of drugs. (I promise this won’t be too painful). 

When a drug is approved by the FDA it’s approved for specific circumstances (meaning, for specific health problems) and, often, for specific people (usually defined by an age range, e.g. adults). That’s because the drug has been tested and shown to be beneficial in treating those health problems in that group of people. 

When a drug is prescribed for off-label use, the drug is being used either for a condition that it was not approved to treat or for a person outside the group listed in the prescribing information or both. 

According to a report at USA Today (11/25/08), a study published in Pharmacotherapy listed 14 drugs that should be studied further regarding their off-label use. Those drugs include Seroquel, an antipsychotic medication that is approved to treat schizophrenia and short-term manic or depressive episodes in bipolar disorder. However, according to researchers, in three out of four cases, the drug has been used off-label, for maintenance therapy of bipolar disorder. Other drugs included on the list, as cited at The Wall Street Journal blog (11/25/08) were Coumadin, Lexapro, Risperdal and Singulair. 

It’s not illegal to prescribe drugs for off-label uses. Doctors are allowed to prescribe an FDA- Read the rest of this entry »

Tags: Drugs, FDA, Off-label, Pleading Ignorance
Posted in Pleading Ignorance | 2 Comments »