Monday, April 25, 2011

Supremes to Hear Challenge to Vermont Law

We have not closely followed this story recently so an update/overview is provided by Natasha Singer of the New York Times:

Several states have now passed laws limiting the right of medical data brokers like IMS Health to collect patient-de-identified prescribing profiles for individual physicians and then sell these to drug companies, to allow their reps to do better-targeted marketing. Thanks to these data services the average drug rep walks into the physician's office knowing just how many prescriptions Doc wrote for that company's product, and how many for competing products. For many years the average doc had no idea that the reps had this info (which the reps were generally very cautious to conceal), but I think now it's more or less common knowledge.

The states passing such laws argued that even though patient names were not revealed, these data should be treated as confidential professional information, and that selling them to drug companies aided in pushing expensive, brand-name drugs that then broke the state's budget in Medicaid and other state medical programs.

A lower court upheld the relevant law in Vermont, but an appellate court overturned the law, and now the Supreme Court is set to hear arguments tomorrow (April 26).

The response from the opponents of the law is interesting. Companies like IMS Health trot out the usual version of "it's education, not marketing," about how knowing prescribers of specific drugs can aid the company in passing on critical new information, etc. Nothing new there. But what might be interesting is who has joined IMS in filing amicus briefs--along with the National Association of Chain Drugstores (who make bucks off selling these data to IMS, reportedly sometimes more than they make selling drugs), Bloomberg and the Associated Press, apparently seeing this as a freedom-of-speech issue.

Anyway, we'll know tomorrow how the arguments went, and court-watchers will predict how many votes each side will garner from the tenor of the questions asked from the bench. To my inexpert and non-legal mind, the outcome is a foregone conclusion. This court (at least the 5-member majority) seems completely committed to the idea that "commercial speech" is indeed speech and deserves just about as much protection as the sort of speech the framers had in mind when they wrote the Bill of Rights (which was certainly not commercial speech). I cannot imagine that the same court that threw out campaign finance reform, and stood up for a corporation's right to buy the White House and Congress, would not support a corporation's right to buy and sell whatever data they need to make a few bucks off selling more drugs, and the public health consequences be damned.

Singer's otherwise informative article left out one key player in this whole commercial transaction--the American Medical Association. The AMA makes money--some have estimated in the range of $44M annually--by selling the secret code that allows the data from drugstores and insurers to be translated into the names of individual physicians. Funny that the AMA did not submit an amicus brief alongside the drug stores and the Associated Press.

Thursday, April 21, 2011

The Great Medicare Cost Debate: Lessons from the Pharma Discussion

The media are now full of the first salvos in the political debate unleashed by two dramatically different plans to contain Medicare costs and cut the Federal deficit--Rep. Paul Ryan's proposal to pay seniors vouchers and force them to buy private insurance; and Pres. Obama's proposal that lays heavy responsibility on the Independent Payment Advisory Board (IPAB). Today's Kaiser Family Foundation Health Policy Report yields a cross section of opinion.

On the (moderate) Republican side, former Wisconsin governor and DHHS secretary Tommy Thompson hints at the sort of demagoguery being aimed at the IPAB from the "death panel" and anti-"rationing" crowd, though his version is quite tame by comparison:

Gov. Thompson objects strongly to the "unelected" IPAB being given any control over cost-cutting, which he says we should "put...back where it belongs -- in the hands of doctors and patients." So if the IPAB shouldn't be allowed to cut costs, then how should it be done? The Guv proposes, "the administration should use its discretion to begin to experiment with capitated payment, where one fee is paid for a patient episode of care, regardless of how many procedures are performed. This gives the physician a financial incentive to improve quality by performing the right procedure the first time. Under a capitated system, the government is not on the hook to pay for unneeded procedures." Hmm. I thought we tried that in the 1990s. We called it managed care, and the public rose up in rebellion at the idea that unelected insurance execs were denying them the expensive treatment they thought would save their lives. The improved version of this plan that is part of the new health reform law had to be called "Accountable Care Organizations" so that no one would imagine that it had anything to do with the bad ol' managed care.

Merrill Goozner at the Fiscal Times has a different take:

Gooz (as he goes by in the blogosphere) has the opposite worry--not that IPAB is too powerful, but that it's not powerful enough. We've tried giving Congress the power to cut Medicare costs and they have flunked every time. But some experts worry that IPAB will end up making silly across the board cuts, that will seriously affect seniors' ability to access good quality as well as wasteful care, simply because they are not empowered to make the precise surgical cuts that a panel of experts ideally would. But you'd never know that that was the issue, adds Gooz, so long as politicians are too busy using IPAB as a handy punching bag to address the real issues.

Meanwhile, in the sober realms, Meredith Rosenthal of Harvard Public Health offers what is supposed to be a balanced assessment of the Ryan vs. Obama plans in the New England Journal of Medicine:

Rosenthal makes a number of excellent points about how, if we are not careful, the most vulnerable patients could end up getting the short end of the stick. (Not that that's ever happened before in the US of A.) In the end, however, sober turns turgid when the best summary Rosenthal can offer is: "Debate over these options should recognize the inherent trade-offs among the certainty of cost control, the likelihood of achieving cost savings while preserving as much high-value care as possible, and the risk that the most vulnerable Americans will pay the highest price for fiscal discipline." Rosenthal makes some good points about how weak is the evidence base that the Ryan plan would actually achieve the cost savings promised without seriously cutting into access to affective care, especially among lower-income patients. But the analysis seems to go off target a bit in stating that the problem with the Obama route is that we cannot exactly predict in advance how much money would be saved, as opposed to whether the mechanisms being proposed would be likely to work. Rosenthal does not at all address Gooz's concern about whether the IPAB could actually make the cuts that are needed.

So what in heck does any of this have to do with the topic of this blog, which is not health reform? The question I ask is whether we can draw any lessons from our long conversation about medicine and the pharmaceutical industry, that has now, by the way, been going on since February, 2007, in case anyone is counting. I think at least one lesson can be drawn, which relies on economist's Uwe Reinhardt's basic law, Health care expenditures = health care incomes. When you talk about cutting future Medicare costs, you are talking about taking money out of the pockets of somebody who now gets that money, or thinks they will in the future. And the pharmaceutical industry has proven one thing for sure. If you take government out of the picture, and eliminate those evil "experts" who demand scientific evidence before they'll approve an intervention for payment, and instead put the decisions "back where it belongs -- in the hands of doctors and patients"--well, clearly you have put it in the hands that the historical record shows that industry marketing can most easily manipulate. Until we find a way to lessen the stranglehold that the for-profit marketers now have over how physicians and the general public now think about what care is good and what is bad, we can look forward either to Medicare costs zooming into space as they are now, or else some system of dysfunctional cost-cutting that fails to preserve the best medical care for all patients. And we can be sure that corporate lobbyists are working overtime behind the scenes to be sure that their industry suffers no financial loss in the name of cost containment and deficit reduction.

Update on Vermont's Disclosure Law and Meal Ban

Once again I can put up my feet and coast, thanks this time to our good friends over at Postscript:

It seems that since Vermont first required public disclosure of payments to physicians, and then went further and put limits on drug companies buying meals for docs, the total industry expenditure in that state went down. Postscript says that this does not mean that conflict of interest has disappeared as a problem, but it does suggest that if drug reps can't buy meals for their victims--sorry, for practicing physicians in need of "education"--then there are perhaps few arrows left in their quivers. (That's after the industry supposedly voluntarily gave up the "reminder items," the coffee mugs, pens, etc. emblazoned with drug logos, back in January 2009. I don't think I'd personally like to be a drug rep in VT these days.)

All that asssumes of course that companies are being above-board in reporting their payments. Some disclosure laws offer considerable loopholes; I am not up to date on the latest version of the VT law--is anyone out there who can comment?

Tuesday, April 19, 2011

What's Wrong with the FDA?

The author of this post on the Masters in Health Care blog approached me seeking a cross-listing, and the topic seemed pertinent enough for this blog to me to oblige:

Now, a few comments. Several of these complaints seem to me to be right-on. Others seem somewhat ambiguous or even contradictory. For example, the writer seems disturbed both that the FDA might be too quick to act to protect the public safety (risking ruining the reputation of an industry that later turns out blameless) and also too slow in taking action to protect the public. My main question for the writer would be: the Obama administration put new leadership in place at the FDA, and we know the old adage about turning around either an ocean liner or else a Federal bureaucracy. Is there any evidence that any change for the better is occurring as a result? Or is it same ol', same ol', assuming enough time has passed to judge?

Monday, April 18, 2011

Why Pharma's New Drug Pipeline is Dry

Back over again to the Health Care Renewal blog, this time from Dr. Scot Silverstein: Dr. Silverstein calls our attention to a post on another blog titled "What Is Really Killing Pharma," by Anthony Nicholls, well worth reading in full: Dr. Silverstein, whose work we have admired in the past, is HCR's main IT critic, and so he chooses to focus on those aspects of Nicholls's critique that especially relate to misuses of IT in the drug industry, and that carry lessons for misuse of IT in medical care. This is indeed worthwhile, but the general lessons Nicholls offers are perhaps of more interest to readers of this blog. In short, Nicholls passes the This Must Be True test with flying colors, by meeting the central criterion, Agrees with My Existing Prejudices. He proposes that Pharma has failed in its recent efforts to increase reasearch output of useful new molecules, based on its model that claims that drug discovery can be "commoditized, industrialized, and ramped up" in response to marketing demands. This imodel is flawed since drug discovery is an "art" because "an embarrassingly large fraction of drug discovery involves serendipity--while you're looking for one thing, you find another." The main target of Nicholls's rant is upper management in the drug industry, which, he claims, because they misunderstand the fundamental nature of drug discovery, manage only to get in the way of their scientists, when they are not cutting costs by laying off the most talented scientists in the company--basically the "Dilbert" comic strip writ large. And this in turn, Nicholls says, is what you'd expect when an industry whose CEOs were once drawn from the upper ranks of research chemists now hires marketers and lawyers. And this finally allows me once more to preach my sermon, that if the pharmaceutical industry ever really took us pharmascolds seriously and tried to reform itself so as to eliminate the ethical problems at the interface with the medical profession--which would require eliminating many of the excesses that arise from allowing the marketing tail to wag the scientific dog--the resulting benefit would not solely reside with enhanced professional ethics in medicine. The industry itself would actually be a better place, and better poised to make major new drug discoveries, if those reforms could be implemented.

More on Ghostwritten Psychiatry Textbook: What Coverup?

That ol' day job has been kicking up again, hence my long delay in posting, and a bit of a backlog to address. Once again our pals over at Health Care Renewal have been busy, in this particular instance, psychiatrist Bernard Carroll: Dr. Carroll is back to discussing the case I initially posted about last fall, in which the American Psychiatric Association was implicated in working on a psychopharmacology textbook for primary care physicians, that appeared to have been ghostwritten by a medical communications company with financing from the company that's now GlaxoSmithKline: Dr. Carroll updates us on the failure of the APA to release documents which presumably could absolve it of a lot of the blame for this debacle--suggesting that since they will not release the documents, we just might suspect that the documents are in fact incriminating. One key document is the contract signed with the communications company, Scientific Therapeutics Information. Dr. Carroll notes that this is the same company known to have ghostwritten the report of the now-infamous Paxil Study 329, and Healthy Skepticism has in its files a copy of the contract executed with STI to ghostwrite that paper, later released as a result of litigation: Dr. Carroll suggests, first, that this contract makes it quite clear that the article was ghostwritten, and second, if the APA won't release the contract with STI for its textbook, they invite concerns that it's because that contract looks just about the same as the Study 329 contract. He adds further that since this flap arose, STI, which used to have a page on its website boasting of its role in creating the textbook, has now removed all mention of the text from that site, again making us wonder who has what to hide. I suggest that if you have a few minutes you actually glance at the contract at the Healthy Skepticism site. It's only 12 pages. Who, you might ask, wants to read 12 pages of single-spaced legalese? Well, surprise--in addition to being easily comprehensible, the pages are mostly white space, with only a few sentences on each page. (Funny thing about our legal system. Apparently if you want to do something honest and above-board, like say buy a house, you have to sign page after page of gobbledygook, but if you want to do something nefarious, just dash off a few sentences and you're good to go.) The contract speaks of the academics whose names will be signed to the final article as "authors" and the head honcho of them as the "principal author," but it makes clear who's in charge. For example, the first draft will be written by STI and then shown to the company. The second draft, based on the corrections the company suggests to Draft 1, will then be completed by STI and shown to the company and to the "principal author." And also STI says that in the end, they'll provide each of the listed authors of the paper with a copy of the final submitted manuscript, "as a courtesy." How nice of them. NOTE ADDED 4/18: Folks, I again apologize that all the paragraph breaks I inserted into the above post have been erased in the process of uploading to the blog. I don't know why that is or what to do about it, as I tried to get info from Blogspot on how to fix this last time out and failed. I had hoped by now they'd have fixed the problem, but apparently not.