Wednesday, January 30, 2008

The More Things Change, The More They Remain The Same

We’re getting déjà vu all over again this morning, reading the story about spine surgery in this morning’s New York Times. It’s not just that it reminds us of Zyprexa – although it does – with a Times reporter talking to the plaintiff’s side and somehow gaining access to “confidential documents from a plaintiff’s lawsuit.” Query what confidentiality orders or arrangements may have been breached in the making of this article.

No, our reminiscences go back much further – back to Bone Screws, the litigation where Beck and Herrmann first met. That, too, was sparked by a questionable journalistic piece (a television program) featuring plaintiffs, plaintiffs’ experts, and plaintiffs’ counsel.

Not only that, but Bone Screws was as much about “conflicts of interest” as it was about anything else, and the refrain was the same: Isn’t it awful that spine surgeons are investing in (and otherwise making money from) companies that make the same new medical devices that they’re studying in clinical trials?

We have heard that all before, over a decade ago. Even the names bring back memories, with the article pitting the eminent spine surgeon Dr. Richard Balderston against long-time anti-technology guru Dr. Richard Deyo.

The litigation strategy seems familiar, too. Plaintiffs try to dig up all they can about “conflicts of interest” and get that information publicized by the press. If the publicity causes enough embarrassment for the surgeons with whom the defendant company works, then those surgeons will presumably pressure the defendant to settle suits regardless of merit.

Beyond history repeating itself, there remains an important unasked question – then and now: Who do you think invents new orthopedic medical devices? The surgeons, that’s who.

And who do you think has the best idea of whether somebody else’s invention is likely to work in spinal fusion surgery? The surgeons, that’s who.

In the spinal surgery area, as with a lot of other types of medical devices, the primary moving force behind technological improvement comes from the surgeons who use these products day in and day out.

Medical devices aren’t drugs. They’re mechanical things. You put a piece in here to hold something else in place over there. Well, nobody knows the benefits and drawbacks of these mechanical things better than the surgeons who spend hours and hours in complex operations assembling them in people’s spines. Having done all they can, the surgeons then have to hope that these devices will help their patients heal before the tremendous physical forces at work on the human spine (the curse of standing on two legs) inexorably tear their mechanical creations apart.

There’s a fundamental fact that the Times article glosses over, and that the plaintiffs (and their experts) who were the primary sources for this article want everyone to forget: Spinal fusion surgery has a pretty high failure rate. That’s inevitable. It’s a last resort sort of procedure. There’s no such thing as elective back surgery. The people forced to endure such surgery are in great pain and have really messed up backs. They’ve been through Hell. But more importantly, these patients have been through all sorts of more conservative treatments, from chiropractic to nerve block, to less invasive spinal surgery, without success. There’s no guarantee that surgery with innovative (and invasive) technologies such as artificial spinal discs will be any more successful.

Of course, for the plaintiffs quoted in the story – and evidently for New York Times reporters – all surgeries must be perfect and if not, somebody has to be blamed. It’s the usual scapegoats here, the spinal device companies and the surgeons themselves.

Without internal spinal fusion devices, recovery from back surgery would take six months and the patient would have to be totally immobilized in one of those cartoonish full body casts – stuck in a hospital bed and unable to do anything at all for him or herself. Even then, the success rate was well south of 50%. Ever since the first spinal fixation devices came on the market decades ago – Harrington rods (straight metal pieces with a couple of hooks here and there) and the like – almost all of the progress in making spinal fusion surgery safer and more effective has been driven by spine surgeons with bright ideas that a hook here, a screw there, a new kind of cage somewhere else, would help solve some of the problems that they saw in their practices.

And it’s unrealistic to expect these surgeons – especially the best and brightest ones who think up most of these things – to work for free. It takes money to turn a sketch on a notepad into something that the FDA will approve for marketing and sale. Like any other inventor, spinal surgeons take out patents, receive royalties, sell their intellectual property, and (gasp) even form companies themselves. Not only that, they talk to their friends and colleagues, and when they see somebody else’s promising idea, they have the money to invest in that.

So it’s always going be the same in spinal fixation devices – twenty years ago and twenty years from now. The surgeons who come up with the ideas are going to be making money from the technology that they in large part helped create. The Times may view this as a “conflict of interest,” but in reality, it’s how bottom-up capitalism works in an innovative field.

But the article’s real beef seems to be that the same spine surgeons who invent the devices also participate in the clinical trials that lead to FDA approval. As our kids would say, “Well … duh.”

Remember, we’re not even talking about ordinary spinal surgeons here (all of whom have to have obscene amounts of training just to get into this specialized field). We’re talking about the best of the best, like Drs. Ziegler and Balderston in the article, who have the prestige to be in a position to run a clinical trial, the inclination (and institutional resources) to perform cutting edge research, and, yes, the financial incentive to carry it through.

The NYT article makes some allegations of failure to report “conflicts of interest,” and we don’t have anything good to say about anybody who deliberately conceals something that either the government or professional ethics require be disclosed. We think FDA disclosure is a good thing (whether doctors should have to tell patients is a lot iffier). But from what we can tell, most of the financial ties mentioned were either properly disclosed, or didn’t need to be disclosed. The disclosure issue is for atmospherics; the thesis of the article seems to be that the very existence of these sorts of financial incentives, in and of itself, is a bad thing.

That’s where we disagree. In a perfect world, everybody acts altruistically, but that’s not the world we live in. Who else is supposed to develop the technology if there’s no financial incentive to do so? The government’s not about to do it, and would probably impede technological advance more than assist it if it tried to assert a research monopoly. How about the big universities and teaching hospitals? Surprise, they already do, but they also do it for money, too, and thus have many of the same financial issues that the article considers problematic.

Technology doesn’t grow on trees – it takes inventiveness to create it, and then it takes $$$ to develop. There has to be a source for these funds, and if it’s the doctors using the devices who put their own money on the line, well, we see that (defense lawyers that we are) as a sincere endorsement of the technology. And if you want the best docs to conduct the research, well those are precisely the docs most likely to have invented the technology to start with.

If one removes the profit motive from the development of technology, the result will be less technology. That may be fine with some of the Times’ commentators (academics and insurers who would have to pay for it), but it’s a bad thing for the thousands of non-plaintiffs who have been helped by this particular device, and for the millions helped by similarly developed medical devices.

But do the financial “conflicts of interest” actually cause the clinical studies themselves to be conducted less than ethically? The article – even using “confidential” documents spoon-fed to the reporter by somebody on the plaintiff’s side – doesn’t provide any indication that it did. We’d call that all bun and no beef.

So what can be said about the validity of the studies themselves?

First, the article says that the studies were peer-reviewed. That means that disinterested scientists had the opportunity to look at these studies, critique them, and if they had found serious problems, veto publication. It’s time-honored scientific practice. It means, if there were serious statistical funny business going on, it would be ferreted out according to accepted scientific method, just as happened with the Korean stem cell scandal.

Second, as the article states, the FDA “subjects research to a higher level of scrutiny” if there’s financial involvement among the researchers. That’s as it should be, too. It’s yet another argument against second guessing by private plaintiffs looking for a buck when unfortunately they end up in that seemingly irreducible segment of the population for whom nothing – not even the most state of the art, cutting edge medical procedures – works to stop their back pain. There’s no indication here (and, believe us, if there were, it would be in the article) that, even under increased scrutiny, the FDA found any problems with how these studies were conducted.

Third, the proof, as they say, is in the pudding. The article mentions that the device in question, something called a “Prodisc,” has been “used on thousands of patients, has been shown to benefit many people with back pain.” How a device performs in clinical practice is ultimately the test that matters. The article, however, didn’t interview anyone in the (it seems anyway) vast majority of the patient population with successful outcomes – just a few plaintiffs. The squeaky wheel gets the grease. One doctor mentioned a patient who “had trouble standing before her Prodisc but was able to go hiking afterward.” Why not let us hear from her, too?

Fourth, the article doesn’t even address the structure of FDA-approved clinical trials, which involve hospitals and independent review boards of various types, all of which act as checks on the freedom of financially-interested surgeons (were they so inclined) to manipulate protocols to generate unrealistically favorable results.

Thus, while the article is long on reciting various investments and other financial ties, it’s notably short on any concrete allegations that any research was ever affected. Why? Because that sort of thing is quite rare. Again, these are eminent doctors. They aren’t the sort to risk their professional reputations (not to mention being sued) with funny business that might bring them a few more hundreds of thousands of dollars atop the millions they already have. Sure, there is an occasional bad apple, but this article seeks to indict the system. It needs to show more than a couple of plaintiffs giving anecdotal impressions about how, in litigation hindsight, their doctors seemed to them to be acting.

As far as we’re concerned, anybody who’s going to cast aspersions on the scientific ethics of medical device development needs to be able to show that the science itself has actually been adversely affected. This article provides zero evidence that it has.

The only criticism of the science, if it can be called that, is at the tail end of the article from a Medicare official (with his own financial incentive to avoid paying for surgeries that use innovative devices) suggesting that a 10% exclusion rate (reasons for exclusion not given) from one study “was unusually high.” There’s not even an allegation that financially interested surgeons serving as investigators in the study excluded patients at a higher rate than those without such financial interests. So even if the exclusion rate was high, which we can’t comment about one way or the other, there’s nothing indicating that these exclusions were affected by any financial ties.

So we just don’t find any “there” there. To us it’s another example of plaintiffs’ lawyers playing the media, something we’ve commented on before. And the media loves to be played. Here, unnamed counsel have supplied a friendly reporter with plaintiffs, experts, and confidential documents. Just add innuendo.

All the news that’s fit to print? We don’t think so.

3 comments:

CloserLook said...

The DDL piece repeatedly suggests that the surgeons about whom the NYT reports were "inventors" of Prodisc. This is simply untrue.

Related to Duke's policy on inventors and investors, the article notes:

"Duke, Dr. Schulman said, would generally not allow a doctor with a significant financial stake in a drug or device to be involved in a clinical study of it. An exception might be made for a surgeon who invented a new device and had special expertise in its use, Dr. Schulman said. But the Prodisc doctors appear to be simply investors."

Duke recognizes the exception. DDL clouds the distinction.

Beck/Herrmann said...

We never said any particular person invented any particular device. We don't know who did and didn't. Besides, that's basically beside the point. The question is did any supposed "conflict of interest" actually affect any research. The article provides zero evidence that this happened.

It's product placement for a plaintiff's lawyer masquerading as news.

Anonymous said...

Documented in plantiffs medical file that patient improves, surgery successful. However, documents patient completed at each visit indicated otherwise. In addition, it is illegal not to disclose to patient that doctor has financial ties in a clinical trial. In addition, the patient met exclusion criteria for the surgery, but the doctor proceeded anyway. The mfg reviewed films indicating that a preexisting condition existed, but did not care for the patient after they were informed. They dumped her from the study instead, so her data could not be included in the results reported to the FDA. Disgraceful behavior by all parties involved.