WSJ Attack on Sham Surgery Is About Healthy Profits, Not Patients

Feb 20 2014, 7:09pm CST | by

In an op-ed piece in the Wall Street Journal Scott Gottlieb, a former FDA official under George W. Bush, argues that the FDA should stop requiring medical device companies to use sham procedures when they test certain new products. To support his argument he uses the example of renal denervation, a once highly promising new technology for lowering blood pressure. Unfortunately, Gottlieb extracts exactly the wrong lesson from this story, because the renal denervation story is a perfect example of why sham procedures can be both necessary and more ethical than any alternative.

At first glance it’s hard to disagree with Gottlieb. The idea that patients would receive an invasive surgical procedure that could do no good appears abhorrent. “Research that introduces harm or risk with no opportunity for benefit would seem to conflict with the principles governing research on humans,” writes Gottlieb.

But the same exact words could and should be used to describe medical devices with no proven benefit. In such cases, however, instead of the relatively small number of patients potentially exposed to harm in clinical studies, the number of patients exposed to harm in the real world may be larger by many orders of magnitude.

Let’s examine this issue using the same example used by Gottlieb: renal denervation. In case you haven’t been following this story, for the last few years renal denervation– the zapping of the renal artery with electric energy to lower blood pressure– has been widely considered to be one of the most exciting and promising new medical technologies around. Based on preliminary– and uncontrolled– studies renal denervation was thought to consistently lower blood pressure by an astounding 25-30 mm Hg and was hailed by many hypertension experts as a potential breakthrough cure for people who had persistently and dangerously high blood pressure even after taking several blood pressure pills.

Then reality intruded. Medtronic announced last month that its pivotal trial of renal denervation had not met its primary endpoint. It became clear that renal denervation was neither a cure nor a breakthrough. Although the details of the trial have not been revealed, the underlying cause of the trial’s failure is fairly well understood. Last summer a few skeptical British researchers carefully examined the underlying science and concluded– contrary to what industry and the experts had been saying– that the true blood pressure lowering effect of renal denervation wold be much smaller than predicted. And the reason was simple: because all the early studies had been either uncontrolled or poorly controlled, the companies and the researchers had greatly overestimated the true effect of renal denervation. The Medtronic trial, by contrast, was much more rigorous, in part because it included the notorious sham procedures decried by Gottlieb.

As Gottlieb notes, renal denervation “is already available in Europe, where regulators approved it based on traditional studies.” Gottlieb fails to notice how this undercuts his point. After all, many thousands of people in Europe have received a device from which they may have received no or little benefit and may have experienced harm. But this doesn’t seem to concern Gottlieb. Here, writing about the effect of well-controlled trials, is what does concern Gottlieb:

All of this raises development costs—and it encourages firms to skip the U.S. market and commercialize new products overseas. This can suppress innovation. When a sham trial doesn’t produce positive results, the company may have exhausted its resources and have no capital left to refine a good idea into a beneficial product.

But, as the renal denervation story demonstrates, the trial didn’t “suppress innovation.” Instead it showed that the so-called “innovation” was, well, a sham.

Although he waves the flag for ethics, it’s clear that what really motivates Gottlieb to stand up and salute is business profits. He’s far more interested in the health of businesses than he is in the health of patients. If he were actually interested in the welfare of patients he would pay attention to the medical details of his examples. But instead his real concern seems to be the health of the bottom line.

This isn’t the first time Gottlieb has confused ethics and economics. In 2012 he wrote about another new medical technology, transcatheter aortic valve replacement (TAVR), and argued that the FDA and CMS had prevented the American public from benefiting from the procedure. As I wrote then, Gottlieb completely ignored the complex issues of the story, spinning an untrue but compelling tale in which the forces of government were preventing desperately sick people from getting a new life-saving therapy.

It seems clear that Gottlieb has very little interest in a serious discussion of clinical trials or the best way to test and introduce new medical technology. What he really wants is to provide a basis for campaign slogans that undermine the FDA and government involvement in medicine. It doesn’t matter that sham surgery is a complex issue or that TAVR had as much potential danger as benefit. It’s easy to score polemical points by scaring people, telling them that they will be subject to harmful procedures or that their government is preventing them from getting life-saving treatments. It’s much harder, and less politically advantageous, to consider the full complexity of these issues.

Update:

Sanjay Kaul sent the following comment:

“Those who cannot remember the past are condemned to repeat it”.

There are many examples where the “scam” of some device-based therapies has been exposed by the “sham” procedure. How can anyone forget the classic examples of laser TMR (TransMyocardial Revascularization) or Pacemaker for hypertrophic cardiomyopathy, both touted as breakthrough interventions. It would not surprise me one bit if RF ablation for atrial fibrillation ends up with a similar fate!

Source: Forbes Business

 
 

Don't miss ...

 

<a href="/latest_stories/all/all/30" rel="author">Forbes</a>
Forbes is among the most trusted resources for the world's business and investment leaders, providing them the uncompromising commentary, concise analysis, relevant tools and real-time reporting they need to succeed at work, profit from investing and have fun with the rewards of winning.

 

blog comments powered by Disqus

Latest stories

Lucintel Profiles Top Global Home Care Products Manufacturing Companies
The global home care products industry, which has experienced good progress in recent years, expected to carry on with its growth momentum for the near term. The market is expected to reach $146 billion in annual revenue within the next five years.
 
 
Keyideas Celebrates 5 Years of Successful Web Application Development
Attaining five years of success for a software development company in India or elsewhere is quite an accomplishment, Keyideas leaders point out.
 
 
GL Announces Enhanced UMTS IuCS and IuH with Iu-UP Protocol Support
Gaithersburg, MD, April 16, 2014 --(PR.com)-- GL Communications Inc., announced today the release of enhanced MAPS™ UMTS IuCS and IuH Interface Emulator with Iu-UP protocol layer of the Radio Network that is...
 
 
Connecticut Real Estate Investors Association (CT REIA) Announces April 2014 Real Estate Investing Seminar with REO Expert Sue Nelson
On April 21, 2014 the Connecticut Real Estate Investors Association (CT REIA) will be hosting its monthly meeting with Sue Nelson in Meriden, CT. Attendees will learn how to buy notes and real estate directly from banks.
 
 
 

Latest from the Network

Jamie Foxx: Being 'fly' is costly
Jamie Foxx says being "fly" is too expensive. 'The Amazing Spider-Man 2' star has had a varied career since rising to fame over twenty years ago, and although he's a multi-millionaire he confesses living up to the...
Read more on Celebrity Balla
 
Goodbye And Good Riddance, Alibaba?
A survey by the Asian Corporate Governance Association, a corporate governance group whose members manage more than $14 trillion of assets, has found little support for changes in Hong Kong listing rules that would...
Read more on Business Balla
 
What Free Agents? Melo's Not Going Anywhere, Nor Are LeBron, Wade, Dirk...
This isn’t what the wretched of the NBA expected after slashing payrolls and trading front-line players for No. 1 picks. If the 2014 draft class wasn’t all it was supposed to be, there may barely be a 2014 free agent...
Read more on Business Balla
 
The 9 Best Jobs In Africa Don't Exist Yet
Sixty percent of the best jobs in the next 10 years haven’t been invented yet. At least that’s what futurologist Thomas Frey is fond of saying. This is great news because lots of good, new jobs will be needed in order...
Read more on Business Balla
 
The College Degrees And Skills Employers Most Want
The hiring picture is improving for the college class of 2014. According to a new survey by the National Association of Colleges and Employers (NACE), employers are planning to hire 8.6% more graduates for their U.S....
Read more on Business Balla
 
Do You Have The 'Stickability' To Be A Successful Entrepreneur?
It’s no secret that successful entrepreneurs have something special that sets them apart from just the dabblers and hobbyists, but exactly what is it that’s different? Every business venture runs into obstacles,...
Read more on Business Balla
 
The Masters Post Mortem And Prognosis Without Tiger Woods
null Before the Masters, I suggested the leaders of golf carefully examine this 2014 event without Tiger Woods. It would be a forecast of the future of golf without him, which is, of course, inevitable. The examination...
Read more on Business Balla
 
'X-Men: Days Of Future Past' Gets One Last Trailer
I suppose I should have seen this coming. I spent the last three months praising the relative restraint of the X-Men: Days of Future Past marketing campaign. Up until three weeks ago, we had only seen a single trailer,...
Read more on Business Balla
 
 
Auto Balla Sexy Balla Sport Balla TV Balla Politics Balla Movie Balla Apple Balla Business Balla Ad Balla Celebrity Balla