Posts Tagged ‘ medical devices ’

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 »

Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect Read the rest of this entry »

Tags: FDA, medical devices
Posted in Drugs/Medical | No Comments »

Recall Notice: Dirty Words for Medical Devices

October 1st, 2010. By Hunter West

There are people walking around with faulty hip implants. If they can even walk at all. This month DePuy Orthopaedics, a division of the giant Johnson & Johnson family of companies, finally recalled troublesome hip implants after removing them from the market last year. DePuy undertook the latter response amidst a hail of criticism that the metal-on-metal implant featured a flawed design.

Okay, so recalls are nothing new. Cars and appliances are recalled all the time. But hip implants, and heart defibrillators are not cars and appliances. They are devices implanted in a patient’s body and not easily resolved. 

Who could forget the pacemaker lead from a few years ago that was recalled? The device, which made fans of surgeons who liked the ease and flexibility of the new, thinner leads that proved easier to thread to the heart, was initially hailed as a breakthrough. 

And then they started to break. Fracture, really. Hairline fractures. But just enough to affect the performance of the device. Patients who required life-giving shocks to keep their hearts going weren’t getting them; while others were injured or killed when a properly performing heart was suddenly hit with a rogue electric shock because the fractured lead impeded the flow of information from the heart to the pacemaker. Believing the heart to be failing (it wasn’t), the device went into action to re-engage a heart that in reality had not failed—often with tragic consequences. 

Which begs the question—why does this keep happening? 

Johnson & Johnson has been under siege of late, with a spate of recalls from the DePuy hip, to artificial knee joints, to medication such as Motrin. The company has had to shut down one of its manufacturing facilities due to a departure from GMP (good manufacturing practices), and there have been questions raised about the behemoth company’s oversight. The management and conduct of J&J has been the subject of congressional investigation. 

But a larger question remains, and it is one not tied to any one company—but any company Read the rest of this entry »

Tags: Defective Products, medical devices, Recall
Posted in Defective Products, Drugs/Medical | 2 Comments »

Guidant Forced to Toe the Moral Line

May 1st, 2010. By Hunter West

Tuesday a federal judge in Minneapolis rejected a plea deal arrangement that would have seen Guidant, the medical device manufacturer acquired by Boston Scientific about four years ago, plead guilty to a couple of misdemeanor charges and pay a fine. A big fine, mind you—$296 million, described as the largest fine ever thrown down in front of a medical device manufacturer. The relatively small fine paid by Toyota for leading the feds down the garden path is niggly in comparison. 

But that’s not the point. Given the risks associated with playing in the medical devices sandbox, one can assume that the players plan for this sort of thing. Their revenues are staggering as it is. And a plea of guilty to two misdemeanors, when the company knowingly vended life-saving devices that were faulty and led to the deaths of at least six individuals, just seems so wrong. 

A judge agreed, and rejected the deal. Donovan W. Frank noted in his ruling that the deal allowed the company to escape accountability. 

At least there were misdemeanor charges. How often have you heard companies of any stripe pay a huge fine for a proven misdeed but admit to NO wrongdoing? 

That’s like telling a child who knowingly was responsible for bad behavior, “okay Johnny, give Mummy five bucks and we’ll forget this ever happened…” 

No parent in his, or her right mind would ever offer that deal to a child. What are we teaching them? 

And yet, it appears de rigueur in big business. Do something bad, cop a plea where you don’t have to admit to anything, pay a fine for the privilege and move on. 

It is assumed that any new deal surrounding the Guidant situation involving those defective defibrillators will include a probationary structure as recommended by the judge, together with a fine. 

How big that fine will be, remains to be seen. Perhaps the same, perhaps smaller than the original. Either way it will be in the millions. 

As for where that money goes, I profess ignorance. Maybe it goes into a specific budget line, or to general revenues. A better place would be to help pay for the nation’s health care, just as fines levied to automotive manufacturers should go to fix up our roads and bridges—or finding a way to segregate massive trucks away from smaller cars, in an effort to mitigate the carnage on America’s roads when the ever-expanding rigs meet up with an increasingly-shrinking car. 

Or how about giving that money to the families of the victims? 

Sure, fines are important—even assuming big companies build that kind of thing into their business plans. The money could benefit someone, somewhere. 

But the payment of a huge fine should not prove a whitewash for moral irresponsibility. 

That’s the point the judge was making Tuesday.

Tags: guidant, medical devices
Posted in Defective Products, Drugs/Medical | No Comments »

Calls for End to Medical Device Maker Immunity

May 13th, 2009. By Evelyn Pringle

On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.

In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleging injury from a device that received marketing approval from the FDA.

“The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings,” according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009. Read the rest of this entry »

Tags: immunity, medical devices, Medtronic
Posted in Defective Products | No Comments »