More on IOM Report on FDA Scrutiny of Devices

We posted previously on the device industry pushback against the new IOM report urging major reforms of how the FDA regulates medical devices:
http://brodyhooked.blogspot.com/2011/08/medical-device-industry-to-iom-drop.html

Now the New England Journal of Medicine:
http://healthpolicyandreform.nejm.org/?p=15108&query=home
--in a "Perspective" authored by their executive editor, Dr. Gregory Curfman, and Dr. Rita Redberg, the editor of Archives of Internal Medicine, adds their word of support to the IOM proposal. Some highlights from the Perspective:

Despite its reasonable (and relatively modest) recommendations, the report has been aggressively attacked by the device industry and by politicians from states where device companies are located. In fact, the attacks began even before the report was released, which is highly unusual for an IOM report.

We believe that the IOM report is insightful, judicious, sensible, and long overdue. ... Unfortunately, the FDA leadership has already suggested that it does not intend to implement this key recommendation of the report, although it may be open to other changes. As the best long-term improvements are contemplated, there are important steps that the agency can take now.

We strongly believe that, in the interest of advancing human health, patients must have easy access to innovative medical devices and that the approval process needs to be sensible and efficient. But no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health care dollars, and may kill jobs when they are withdrawn. It is essential that the FDA be adequately funded to carry out its mission to ensure the safety and effectiveness of medical devices. The IOM report charts a path that is right for the future, and despite well-financed outside pressures, we urge the FDA to initiate an action plan with congressional support to adopt these important recommendations.

Sunshine Laws Having an Effect? Maybe

A stray e-mail that came across the ol' transom today seems to hint that sunshine laws, requiring the public disclosure of names of physicians who receive payments/gifts from the pharmaceutical industry, might actually be changing the landscape. At least a consulting firm called Alliance Life Sciences thinks so:
http://www.alscg.com/company/events/kolwhitepaper

Alliance, their website explains, currently works with 8 of the 10 largest pharmaceutical firms around sales and marketing. They have produced this new white paper on what's new with physician Key Opinion Leaders (KOLs) in an era of sunshine. From their e-mail/press release:

“Firms may wish to embrace new marketing paradigms, such as disease-centric product offerings that enhance value propositions for physicians, patients and payers, to compensate for KOL physicians that may no longer be willing or able to collaborate with them,” says Ed Masterson, senior vice president, consulting operations, ALSCG. ... “The new marketing paradigm won’t come from having renowned academics simply present a firm’s PowerPoint deck to auditoriums of doctors,” says Masterson. “It will be based upon research demonstrating improved patient outcomes and avoided costs associated with better compliance that delays or reverses disease progression and acuity.”

What a revolutionary idea--to successfully market new drugs, you might actually have to show that they work. Not simply bribe a famous doctor to show slides over dinner.

The debate over sunshine laws, as we've discussed in numerous previous posts as well as in HOOKED, is how much mileage you get purely out of disclosure. Disclosure of unethical behavior does not turn it into ethical behavior, so if physicians continue to take freebies from industry, and don't care if their names show up on a public website or not, nothing may change. The theory behind the sunshine laws is that if physicians know their names will be made public, they may think twice about their relationships with industry and actual behavior may improve. Alliance Life Sciences seems to be betting that this likely effect is real.

In Praise of Good Corporate Behavior: Medtronic

I last spoke of Medtronic's shenighans with their spinal surgery devices and products here:
http://brodyhooked.blogspot.com/2011/06/taking-professionalism-seriously.html

It's critically important that if this blog is to be about ethics at the interface between medicine and for-profit industry (drug or device), that I am equally attentive to good corporate behavior as to scandals. This can be challenging as we've seen numerous examples of egregious corporate behavior spun by creative PR so as to appear virtuous. But if it really seems that a company has seen the error if its ways, we should take note and be appropriately respectful.

So is Medtronic now in this august category?
http://tcbmag.blogs.com/daily_developments/2011/08/medtronic-pays-yale-to-review-controversial-bone-product.html
Two things make me accept this account as indicative of genuine corporate responsibility. First, the person who sent me the link is a hard-headed critic of industry and has often seen through PR fluff in the past when I could have been fooled. Second, the person selected to do the study of Medtronic's products, Dr. Harlan Krumholz, has what I believe to be an unassailable position as an independent industry critic. If you want somebody to paper over your misdeeds, he would be a pretty pooor choice.

If we ever want to have a relationship between the medical profession and the industry that takes full advantage of the benefits of collaboration while avloiding the ethical cesspool of today's conflicts of interest, we need models of effective neutral turf where industry and professional folk can foregather to address the issues and see what sorts of new developments might be proposed, without the setting itself creating new conflicts of interest or dangers of one side controlling the discussion for its own ends. I am not sure that this Yale study will be a model applicable to other such settings, but it's certainly a welcome development if it is what it seems to be.

Econ 101 and Drug Patents

I know that all of you out there keep a copy of HOOKED at your bedside and read a chapter each night before retiring. But in case you've not yet committed the volume to memory, I can take the opportunity of these news items to do a bit of review of a basic concept:
http://keionline.org/node/1147
http://www.guardian.co.uk/commentisfree/cifamerica/2011/may/31/healthcare-pharmaceuticals-industry

The latter article, from The Guardian, is a commentary by economist Dean Baker (whom I quote in HOOKED) on legislation proposed by Sen. Bernie Sanders (I-VT), which is summarized in the first link.

Here's how Baker starts off his commentary: "Drugs are cheap. There are few drugs that would sell for more than $5-$10 a prescription in a free market. However, many drugs in the United States sell for hundreds of dollars per prescription and, sometimes, several thousand dollars per prescription. There is a simple reason for this fact: government-granted patent monopolies."

Now, this comment may strike you as strange, especially if you were to check out the Pharmaceutical Research and Manufacturers of America website (http://www.phrma.org/about/phrma) There you will find the following statement of the drug industry's core values:

PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical and biotechnology research companies. To accomplish this mission, PhRMA is dedicated to achieving these goals in Washington, the states and the world:
• Broad patient access to safe and effective medicines through a free market, without price controls;
• Strong intellectual property incentives;
• And transparent, efficient regulation and a free flow of information to patients.

In case you don't know what "intellectual property" is, read "patents." So how can it be that an economist explains that in a free market, drugs would be really cheap, and the reason they cost so much is because of patents that amount to government monopolies (which are of course a violation of the free market); yet PhRMA insists it is for the free market (and against price controls), yet also for patents?

I mentioned in passing (http://brodyhooked.blogspot.com/2011/07/kid-gloves-on-corporate-crime-different.html) that I hope soon to be able to announce the availability of a new book on the subject of economism. Economism, briefly, is the worship of the "free market" as an item of religious faith, though it disguises its religious nature by posing as hard-headed science. Economism, I hope to show, is shot through with internal contradictions and inconsistencies, explaining why its believers have to be faith-based, because neither facts nor logic would support it. PhRMA's two claims of being pro-free-market and pro-patent is just one tiny example of the sorts of contradictions that economism generates--yet at the same time obscures, so that most US politicians and policymakers repeat this nonsense without realizing that it's nonsense.

Baker goes on to explain that a patent is a government-granted monopoly based on a hunch that the extra cost to the public, forced to pay monopoly prices for goods until the patent expires, is a good trade, because the patent forms an incentive to innovate and invent which in turn is a public benefit. This hunch could be well or poorly grounded. Baker argues that right now, we are paying a lot more for drugs through patent monopolies than we are getting benefits from real innovation. If you don't think this is true, you have not been following this blog.

Enter Sen. Sanders. There are wo possible solutions to the mismatch between drug patents and real public benefit. One would be a strictly regulatory approach--change the rules regarding granting patents for new drugs. Demand more evidence of real benefit before granting a patent, or shorten the period of patent protection, or some such. The other approach, which is what Sanders actually has proposed, is a quasi-market approach, using financial incentives rather than regulation. The idea is to impose a tax on both public and private health insurers. The money from the tax would create a prize fund. The prize fund would be used to buy up patents for really useful drugs, as opposed to "me too" drugs. These useful drugs would quickly become generic drugs and would be available cheap.

This, say both Sanders and Baker, would be a win-win. The insurers would more than save in lower drug costs what they paid in the new tax. Drug companies would then have a powerful incentive to discover really useful new drugs, because then they could easily sell the patent for a tidy profit. Baker is perhaps overly sanguine in imagining that in this new system, drug companies would gain no benefit from deceptive marketing of marginally useful or harmful drugs, so they'd simply quit doing that.

Since true believers in economism hate government programs and hate new taxes, and probably hate Bernie Sanders, you can bet there will be little support in those quarters for this proposal. But thanks to Dean Baker for again revealing the hypocrisy of the drug industry's wrapping itself in the "free market" mantle.

ADDENDUM 8/6: A reader much more alert than I was when I wrote this post last night informed me that I had inserted the word "patient" when I obviously meant "patent." This has been corrected above.

Ghostwriting, Again: This Time, Consequences

Some time back--
http://brodyhooked.blogspot.com/2010/07/still-awaiting-academic-physician-to.html
--I mentioned that we were still awaiting a case where an academic physician suffered clear, negative consequences as a result of being guest author on a ghostwritten paper, though I described a case that provided circumstantial evidence of such consequences. (That particular physician had two strikes against him, of which involvement in ghostwriting was just one, so it was not clear just what offense produced the consequences.)

Thanks to a regular reader of this blog, I now can report what seems a clear case of cause and effect re: ghostwriting and guest authorship, from our neighbors to the North:
http://www.montrealgazette.com/news/montreal/McGill+reprimands+prof+over+ghostwriting+scandal/5209461/story.html
This case involves a punishment meted out in 2010 (apparently, as it was not then publicly announced) by McGill University for a paper published in 2000. We need to note that while on the surface, it might seem unduly vengeful and petty to look back so far for a punishable offense, in reality this is often what the academic medical center has to work with. It is often the case that revelations about ghostwriting come to light only following litigation and the release of internal company documents, which most often occurs many years after the actual incident.

A possible defense of this academic was that back in 2000, this sort of behavior seemed routine and noncontroversial, and it was only years later that all the attention began to be paid to the ethical issues related to ghiostwriting. That is, in my view, a fair comment, and if you read the Montreal article closely you'll see that the level of punishment meted out was consistent with that level of seriousness (in my view).

Even More on Ghostwriting, Or, They Don't Get It in Toronto

Two big questions this time around--first, can academic medicine police itself regarding ghostwriting, or do we need to invoke the law? Second, does the Toronto Globe and Mail get it, or rather, who got to them?

First, on how to police ghostwriting, we start with an article by our old friends Jonathan Leo and Jeffrey Lacasse, this time aided by Andrea Cimino (subscription required). This group tells us that there has been a lot of huffing and puffing among academics and editors as to why ghostwriting really is not that at all, or if it is, well, it's still okay. So the authors try to simplify for us by saying--this is ghostwriting, and if it happens, then it's wrong and you should be throwing the book at somebody. They argue that the essence is: "If a person who should have been listed as an author was left off the byline, then the paper has been ghostwritten."

This would be a nice, concise formula if it were acceptable. I am fearful that it's not. As to why, stay tuned. But anyway, Leo et al. are optimistic that if we academics could just get clear on what ghostwriting really is, we could manage to police it properly. Now along come Simon Stern and Trudo Lemmens from Toronto:
http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001070
--to say, no way. They review the various conflicts of interest that both journals and academic medical centers have with the drug industry, making it unlikely that either would find the backbone really to put an end to ghostwriting-related practices. They suggest that the only thing left is legal remedies, and they then develop specific legal arguments as to why ghostwriting is fraud, and drug companies conspiring with medical writers and academic "guest authors" is racketeering under the law. (Along the way, they dig up an interesting case from 1944, said to be the only U.S. Supreme Court decision on ghostwriting--it involves a patent on glass manufacturing, of all things.)

Okay, so there you have the debate on the first question. On to the second question. It is pretty unusual for the local newspaper to come out with an editorial that says that a paper just published by two members of the local university faculty, in an academic journal, is all wet. But that's just what the Toronto Globe and Mail did with the Stern-Lemmens paper: http://www.theglobeandmail.com/news/opinions/editorials/in-praise-of-ghostly-scribes-for-scientists/article2118829/

Now, this editorial is such a serious misrepresentation of all the ethical issues in ghostwriting that you have to wonder what prompted it. The point of the editorial is that ghostwriting is good because academic physicians can't write worth beans (mostly true), so if professional writers take over and render one's article readable, then they are doing a great service, and how can you call this fraud and racketeering, etc. They admit grudgingly along the way that "guest authorship" is of course wrong, and if you did not truly contribute to the research or the writing, your name doesn't belong on the paper. But they act as if the ghostwriter is the innocent victim in such a case. They totally fail to address the basic problem, that ghostwriting and guest authorship, together, are part of a larger system by which the drug industry can manufacture "science" to its marketing specifications. They say they are opposed to this, and make this incredibly naive comment: "If, on the other hand, pharmaceutical companies are paying, in whole or in part, for the research, and they supply the ghostwriters, there is a need for particularly vigilant reading of the draft by the researchers, so that no advertising spin creeps in." This of course ignores the reason that the entire process exists, and that the money needed to hire the ghostwriter fell out of the sky to begin with--that "advertising spin" is not an accidental byproduct but the entire intent.

So where did such a wrongheaded and ignorant editorial come from? I can only relate back to our earlier post:
http://brodyhooked.blogspot.com/2011/06/ghostwriting-bolder-than-ever.html
We saw that the medical communications companies that supply the ghostwriters for industry, and that helpfully coordinate the care and feeding of the guest authors, are tired of being sneered at and are launching their own PR blitz (which is, after all, what they are supposed to be good at), trying to take back the ethical high ground. All I can imagine is that some of these dudes captured the ear of a gullible editor at the Globe and Mail and managed to plant their own advertising spin into the editorial. Which tells you a little something about the ethical integrity of that industry.

Back to my comments on Leo et al, in case you're not asleep yet. Why do I doubt that they got it right on their crisp definition of ghostwriting? Here's a case we talk about in an "Ethics of Scientific Research" course we teach here. Prof A goes to do a sabbatical in Prof B's lab. He does an experiment there, using Prof B's lab equipment and support team. Later he goes back home and then works with Prof B to write up the results of his experiment. When he gets the final draft of the paper for his review, he's shocked to see Prof C's name on it, who works at a distant university and had nothing to do with the experiment. Prof B explains that he and Prof C have a deal. They worked together in the past and they simply agreed always to list the other as co-authors of any future papers. When Prof A objects, quite correctly, that this is an unethical violation of the rules of authorship, Prof B retorts that if Prof A will not honor his deal with Prof C, then the B lab will simply take A's name off the paper and publish the results themselves.

Okay, imagine that B carries out his threat. C is a guest author, which is unethical. A, who should ethically have been listed as an author, is not so listed on the paper. Does this make the paper a ghostwritten paper? There is no ghost writer. The people who wrote the paper, B and his colleagues (except for C who's being included unethically), did in fact do the experiment along with A, and legitimately are part of the scientific team responsible for the data. Plus, the case has nothing whatever to do with commercial spin. Yet by the Leo et al. definition, this is an example of ghostwriting. So I think their definition needs more work.

Leo J, Lacasse JR, Cimino AN. Why does academic medicine allow ghostwriting? A prescription for reform. Society (epub July 21, 2011)

Medical Device Industry to IOM: Drop Dead

The Institute of Medicine (IOM) of the National Academy of Sciences recently issued a report on FDA regulation of medical devices--unfortunately only a brief summary, which is frankly not all that informative, is available:
http://www.iom.edu/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx

As explained in the press coverage:
http://seattletimes.nwsource.com/html/health/2015771871_medevice30.html?syndication=rss
--the FDA had commissioned this review by the IOM a couple of years ago, and the IOM now argues that the entire system that the FDA uses to regulate and evaluate devices is seriously flawed and should be replaced. As I said, it's hard to get the whole picture from the 4-page summary of the report released thus far. As best as I can tell, the issue is with the so-called 501(k) process, which is based a law passed between 1976 and amended in 1990 and 1997.

By this process, a device can largely escape the need to prove that it's both safe and effective for human use if the company can demonstrate that it's "substantially equivalent" to an already approved device, known as a "predicate device." The IOM committee seems to have two problems with this approach. First, in many cases, the "predicate device" itself was never proven to be safe and effective. Second, the IOM report calls for a continuum of pre-and post-market surveillance for safety issues, and feels that the current 501(k) system fails to address that continuum adequately.

Bottom line, says the IOM: stop tweaking 501(k) and figure out a new regulatory framework to replace it. Problem: the FDA has never gathered enough data about the practical impact of 501(k) to determine what would be a better system; so step one called for by the IOM report is to do that study.

Full disclosure: I am a member of the IOM. IOM is part of the National Academy of Sciences and is supposed to represent an elite cadre of medical thinkers, working independently of government, to address pressing issues in a scientifically informed manner. The IOM's earlier report on medicine and the pharmaceutical industry has generally received the high marks typically granted to the IOM's work, as we summarized: http://brodyhooked.blogspot.com/2009/05/iom-report-on-coi-yes-we-really-mean-it.html

So, if the IOM says that the regulation and safety monitoring of medical devices is in serious trouble, you'd imagine that the device makers would, if not exactly kissing the hem of IOM's gown, at least feel some need, strategically, to offer an appearance of deference before they start to beat up the findings. But, as Steve Martin might say--naaaah. Matthew Perrone reported for the AP: "The device industry's chief lobbying group also dismissed the proposal, saying its conclusions 'do not deserve serious consideration from the Congress or the administration.'"

Now, just where did that "also" come from? Funny, it seems that the FDA is not itself very pleased with the report that it comissioned. Dutifully, FDA announced they'd convene a public meeting and take comments on the IOM recommendations. But in their press release--
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265908.htm
--Dr. Jeffrey Shuren, head of the device agency within FDA, was quoted, “Medical devices in the U.S. have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for the patients who need them.”

Are you having difficulty telling who's a flack for the industry and who's speaking on behalf of the government agency that's supposed to be regulating the industry? Hmmm. In defense of the FDA, they have been busily at work proposing refinements to their 501(k) process, and basically object that we should give them a chance and see how these improvements work before we set off the more arduous and politically fraught process of trying to rewrite the legislation.

So that's where we are with the IOM report. I mainly want to note the arrogance of the device makers. As we have previously summarized. In some recent press coverage that I now see I may not have gotten around to reporting on this blog, it seems clear the device makers are feeling their oats. They are throwing around their big donations to key Congresspeople, and threatening to take US jobs offshore if the FDA tightens up on device regulation. And this despite major recent revelations about the rampant corruption of medical science and practice by major device manufacturers, as we have noted:
http://brodyhooked.blogspot.com/2011/06/whos-at-fault-company-or-physicians.html
http://brodyhooked.blogspot.com/2011/06/taking-professionalism-seriously.html

So when you have government in your back pocket, I guess you can thumb your nose at the IOM with impunity.