Surgeon Seeks to Cut Influence of Device Industry

by Melissa Davis - 11/23/2009 5:51:37 AM

Charles Rosen is a soft-spoken spine surgeon who has earned the kind of reputation that’s normally assigned to a hard-nosed cop.

He first blew the whistle on a giant healthcare company a decade ago, when a hospital owned by Tenet – the second-largest publicly traded hospital chain in the country – failed to inform him that its operating-room sterilizer had not been working properly for months. As the hospital’s chief of surgery, Rosen was asked to minimize the problem during an upcoming inspection by the Joint Commission on Accreditation of Healthcare Organizations. Instead, Rosen sounded an alarm during JCAHO’s annual visit and promptly resigned in protest when the agency – which counted one of the hospital’s directors among its own board members – ignored his concerns.

By the time Tenet came under fire for bilking Medicare for unnecessary heart surgeries at another facility, Rosen had moved on to academia – where the focus on profits might be less pronounced – at the University of California-Irvine. Still, he continued to see troubling signs of profit-driven medicine throughout the world of surgery that could place innocent patients at risk. He worried about payments from medical device makers to physicians in particular.

At the time, Johnson & Johnson had just won regulatory approval to sell the nation’s first artificial disc based upon studies carried out by physicians who received generous payments from the company. Shortly after the device hit the market, Rosen began seeing signs that the disc – intended to last a lifetime – was already starting to fail, with disastrous results, in some patients.

Like a seasoned detective, Rosen combed through a thick transcript of the FDA’s hearing on the device in search of answers. Upon finishing, he decided that the FDA had approved Johnson & Johnson’s “Charite” disc based on a flawed study performed by conflicted surgeons that – at best – proved the device worked as well as a failed operation long abandoned by the medical community. Moreover, he learned, patients would face a life-threatening operation that could guarantee no relief if their artificial discs ultimately failed.

This time, suspicious of so-called industry watchdogs, Rosen went public with his concerns when the press decided to get involved. He was later approached by the offices of Charles Grassley and Herb Kohl, two U.S. Senators known for their support of whistleblowers in the healthcare arena, when they launched an effort to reshape the entire industry. He also established a new organization, known as the Association for Medical Ethics, for healthcare providers who share his concerns about industry payments to physicians and refuse to accept such payments themselves.

Since then, Rosen has gone on to testify before Congress in support of the “Physician Payment Sunshine Act,” a measure drafted by Grassley and Kohl that’s now included in the Senate’s healthcare reform bill. He also wound up on the short list of candidates for U.S. Surgeon General under an Obama administration that ranks sweeping healthcare reform as its number-one domestic priority.

In a recent interview with The Street Sweeper, Rosen discussed the fruits – and the frustrations – that have resulted from his hard-fought campaign.

The Street Sweeper: You have a reputation for blowing the whistle on big device makers that pay physicians who test and/or use their products. What inspired you to launch a campaign against this widespread industry practice?

Rosen: I saw so much suffering in patients who came into my office with failed Charite disc replacements. I was stunned by their horrible pain. They had lost their jobs, their houses – and sometimes even their spouses. When I looked at the transcript from the FDA’s hearing, I saw what appeared to be a poor study with a flawed design authored by physicians who almost always had huge conflicts of interest. Most of them were being paid by the company that made the artificial discs. That is not independent validation, which is the hallmark of scientific objectivity. You can choose any set of data, and you can make it look good, bad or ugly. If you’re getting paid millions of dollars to conduct the study, you’re going to suffer from some degree of unintentional bias in my opinon.

The Street Sweeper: Why are these arrangements so attractive to device makers and the doctors who participate in them?

Rosen: For a small amount of money – compared to the profits that result when doctors use their devices – companies can generate significant returns. That’s why they do it. They also receive validation for their products when the high-profile physicians they have paid publish articles on their devices. As for the doctors, I would like to think that they believe they’re conducting unbiased research even though they’re being paid. I hate to believe the worst.

I think that the vast majority of physicians -- 90%-plus -- are not even aware of these multimillion-dollar arrangements and the degree of money that’s involved. They don’t know that the authors of these studies may be biased. They assume that they’re reading independent research.

The Street Sweeper: Have you ever been tempted to ink similar deals yourself? If not, why?

Rosen: Over the past 20 years – up to recent days – I have been approached about serving on advisory boards for companies that make medical devices. Knowing how much money you can make off those relationships, I have to admit that it can sometimes be tempting. I just know that, ethically, I would be biased if I received a lot of money from a company for researching its devices. I don’t object to other people who do that – it’s the American way – but I do think that needs to be disclosed, and not in some obscure way. That’s all I’m saying.

The Street Sweeper: You launched a new organization, called the Association for Medical Ethics, several years ago in an effort to unite concerned physicians like yourself. What type of response has your organization received so far?

Rosen: It has been tremendous. Any physician or healthcare provider can join as long as they sign an online affidavit stating that they will not accept money from industry. I thought I was going to be the only member – my wife even joked about that – but I’ve been very pleased. We’ve attracted hundreds of members from all kinds of specialties and 11 different countries. I think I tapped into a raw nerve in medicine, where the vast majority of physicians are trying to do the right thing. They feel angry that industry has encroached on their area, which is medicine, by corrupting data for the sake of profit.

The Street Sweeper: Can you give examples of the backlash you’ve endured as a result of your crusade?

Rosen: After I started the society, my previous chairman said he was going to fire me. I had been at UCI for seven years – and I had been working my way up through the ranks – but he made up some excuse to get rid of me. He wound up stepping down and leaving the university, while I ended up staying. We got a new chairman who is highly ethical, and I am thriving now.

There have been other issues, too. A lot of these highly paid consultants started spreading rumors that I was only criticizing the industry so that I could make money off of malpractice lawsuits against other physicians. I don’t participate in lawsuits against doctors – and I haven’t in 18 years of practice. They kept saying that I had ulterior motives, and I just didn’t. I would also try to publish research papers, and they were almost routinely rejected. So it’s been hard all around.

The Street Sweeper: Have the rewards been worth the pain?

Rosen: I would like to think that most physicians would want to do something if they were exposed to the huge amount of suffering I’ve seen in the failed disc-replacement patients. I’m just more suspicious than most – I guess I’m part-cop – because I looked into all the details. But that exposure has apparently had a tremendous effect on sales of artificial discs. Based on what I’ve heard, the industry is now using the Charite as a case study of how NOT to market something. So I feel pretty good about that.

The Street Sweeper: Describe the biggest signs of progress you’ve seen since launching your campaign.

Rosen: Three years ago, I was writing a letter to Sen. Grassley about industry payments to physicians. Now the “Physician Payment Sunshine Act” will hopefully be passed soon. That’s the biggest thing. There’s also the current challenge to direct-to-consumer advertising (of drugs and medical devices) that is occurring – and should be occurring – so hopefully we’ll get rid of that. And finally, there’s the fact that medical societies are being forced to make financial disclosures now. So that’s progress as well.

The Street Sweeper: In your view, what steps must still be taken in order to properly reform the industry?

Rosen: If you go to our website, www.ethicaldoctor.org, you’ll see that we’ve developed a list of ethical rules for disclosure. In a nutshell, it says that doctors who are publishing research or editing medical journals or serving as officers of societies should disclose the money they receive from industry. And if they’re editing a major medical journal or serving as an officer for an important medical society – which would make them very influential – then they should not accept more than $50,000 a year in industry payments period. This is no different than the rules imposed on Senators or Congressmen, and it is something that needs to happen. There should be restrictions on journal editors and full-time academics and medical society officers – three groups that really affect the flow of information and the practice of medicine – that keep them insulated from bias. If they want to stick with private practice and make a fortune, they’re entitled to do that. But they shouldn’t be able to do both.

The Street Sweeper: As you probably know, the FDA’s expert panel recently recommended against approval of a Zimmer device tested by physicians who received payments from the company. Why do you think the FDA took that action, and how do you feel about it?

Rosen: I’m very encouraged that the FDA is starting to recognize the issue of unintentional bias. I don’t know how on G-d’s earth someone can get millions of dollars – sometimes without disclosing it – and not be biased about the research. So I think it’s absolutely great that the FDA is finally looking into this.

The Street Sweeper: Congress is currently attempting to overhaul the entire healthcare system. What are the biggest changes you would like to see implemented under healthcare reform?

Rosen: Financial disclosures and evidence-based medicine are the main things I would like to see. Those two things could halt the use of expensive drugs and devices that don’t work, while saving huge amounts of money – literally billions of dollars – in the process. Some companies won’t do so well if that happens. The majority of products could fall by the wayside, but the really good ones would rise to the surface. That’s what a lot of companies fear. They’ll have to spend more money on better products, and the unproven devices – or instruments or pills – simply won’t get sold. That will probably have a negative effect on profits at some companies and, I believe, rightly so.

* Editor’s Note: The website for the Association for Medical Ethics can be found at www.ethicaldoctor.org. The site features a patient-friendly search function that allows readers to identify doctors who are industry consultants and the amount of money they are paid. It also offers independent, unbiased analysis of many new procedures and devices using evidence-based medicine.