Corrupt academia

by Henry on June 18, 2010

Via “Trudy Lieberman”:http://www.cjr.org/campaign_desk/a_laurel_to_the_milwaukee_jour.php at _Columbia Journalism Review,_ an “excellent story”:http://www.jsonline.com/features/health/95198129.html on the dubious linkages between medical academia and drug companies.

bq. Richard Page thinks Multaq is an excellent new drug for treating atrial fibrillation, a type of irregular heartbeat that affects more than 2 million Americans. And Page, chairman of the department of medicine at the University of Wisconsin School of Medicine and Public Health, should know. He co-authored a large, international study that led to the drug’s approval by the Food and Drug Administration last year, a move that could mean hundreds of millions in sales for Sanofi-Aventis, the company that makes the drug. But in putting his name on the influential paper, Page allowed Sanofi-Aventis to dictate the terms. He vouched for the accuracy and completeness of the study despite not seeing the raw data. The company, which paid for the study, collected that information and performed the analysis without an external audit for accuracy or completeness. Page says it comes down to trusting the drug company. “These companies, if they were falsifying data, wouldn’t be kept in business if that were found out,” he said. “I was satisfied and remain satisfied that the study was conducted in an appropriate way.” … In the Multaq case, Page and all six co-authors had financial ties to Sanofi-Aventis at the time of the study. Two authors worked for the company and owned its stock. Page and the four other authors moonlighted as consultants or speakers.

Genteelly corrupt relationships are a really big problem for medical research. The “Boston Review”:http://bostonreview.net/BR35.3/ndf_pharma.php has an “excellent forum”:http://bostonreview.net/BR35.3/ndf_pharma.php on this broad topic up on their website, including a quite preposterous “defense”:http://bostonreview.net/BR35.3/stossel.php by “Thomas P. Stossel”:http://www.sourcewatch.org/index.php?title=Thomas_P._Stossel of medical-industry research ties against _any_ suggestion that formal standards, requirements of transparency etc might be helpful.

{ 26 comments }

1

Steve LaBonne 06.18.10 at 7:59 pm

It has amazed me for years that this stuff has never reached the public consciousness as the major scandal that it is. It is unquestionable that people have died because of such conflicts of interest.

2

chris 06.18.10 at 8:51 pm

These companies, if they were falsifying data, wouldn’t be kept in business if that were found out

Good thing they have people like Page to make sure they won’t be found out, then!

3

Tom 06.18.10 at 9:29 pm

Whole drug development process is a farce. I once worked for a well known big pharma company in a temp role. Regularly used to hold approval meetings with GPs at hotels near Heathrow airports. Doctors would turn up, fall asleep for an hour, sign to agree with trials data or somesuch and receive a cheque, written by me for £1,500 for their “expenses”. Whole thing stank to high heaven.

4

Frank 06.18.10 at 9:35 pm

Thank goodness Oil companies would never do something like this.

5

Chris Johnson 06.18.10 at 10:11 pm

I was in academic medicine for 20 years. Three decades ago most research funding came from the NIH, American Heart Association, other foundations. That’s where I got mine. There was a little from drug companies, but not much. As the federal/foundation dollars went down, folks felt intense pressure to find money somewhere, and the drug companies were there to hand it out. With strings attached, of course. I hold the researchers responsible for what they do, but the system we’ve now got is hard-wired for conflicts of interest. Fortunately for my soul I was never investigating anything of much interest to drug companies.

6

Matt McIrvin 06.18.10 at 10:37 pm

Oh God, there’s another one where John Stossel came from.

7

M. Gordon 06.18.10 at 11:07 pm

Thank god economists and political scientists never have financial conflicts of interest!

8

Chris Johnson 06.18.10 at 11:21 pm

@6:
An explanation is not a defense.

9

ScentOfViolets 06.19.10 at 12:21 am

With strings attached, of course. I hold the researchers responsible for what they do, but the system we’ve now got is hard-wired for conflicts of interest. Fortunately for my soul I was never investigating anything of much interest to drug companies.

I thought that Zappa’s Central Scrutinizer with his explanation of deliberately working the laws to make everyone a criminal was just a conceit to get potheads to buy the album . . .

10

ScentOfViolets 06.19.10 at 12:29 am

@6:
An explanation is not a defense.

Hmmm. Maybe not. But suppose that funding was deliberately cut in order to foster dependence on pharmacy money? You can call that a wild conspiracy theory if you like, but just assume it for the sake of argument. Does this explanation then become a defense?

11

Henry 06.19.10 at 1:50 am

bq. Thank god economists and political scientists never have financial conflicts of interest!

Can’t speak for economists, but political scientists in my experience don’t, for the very obvious reason that no-one is interested in our validating credentials, and our research has zero commercial impact. If you have any actual examples of said conflicts among political scientists – as opposed to misfired tu quoques – perhaps you could share them with us for discussion.

12

Chris Johnson 06.19.10 at 2:01 am

“But suppose that funding was deliberately cut in order to foster dependence on pharmacy money? You can call that a wild conspiracy theory if you like, but just assume it for the sake of argument. Does this explanation then become a defense?”
No, it would still be an explanation. Stossel, self-serving toady that he is, would probably still defend it, though.

13

Chris Johnson 06.19.10 at 2:10 am

I have a related complaint about drug company research. The vast majority of useful, basic research, the sort that drug companies need to design their drugs, was paid for by NIH — the government. I think it’s wrong to allow Pharma to profit from that research, at least without somehow paying back the public investment, say with unrestricted funds given back to NIH.

14

sg 06.19.10 at 3:27 am

I hardly think that the phenomenon described in this post counts as “genteelly corrupt”! Words like “hideously” spring to mind. Signing off on data analysis you haven’t seen or done, which was done by people with a financial interest in the outcome? That makes you a reputation-for-hire, not an academic.

I’ve noticed that libertarians I know are really strongly of the view that these sorts of cozy arrangements are all cool, because arguments should be “judged on their merits,” not assessed against the possibility that the person putting them is lying for a fee. It confuses the (relatively unimportant) issues of formal rhetorics (“argument by authority,” etc.) with the much more important issue of public faith. How can ordinary people not connected to an industry or field of research judge the accuracy of the product/work if they don’t know whether or not the reporter is being paid to lie?

The great irony of this is that the Andrew Wakefield MMR controversy in the UK was driven by newspapers making a meal out of people’s distrust of Big Pharma, who everyone knows pay for research results; but the paper that sparked the controversy was itself in the category of a researcher producing lies for their own gain. Public trust is indeed a fickle thing…

15

Bill Gardner 06.19.10 at 11:03 am

There are two ethical issues here. The first concerns conflicts of interest. The COI policies at medical schools allow you to accept industry money if you disclose that. I didn’t find a suggestion in the article that he had failed to disclose his ties to Aventis. (Many of us believe, however, that COI policies should be more restrictive.)

The other concerns the responsibilities of authorship. It seems that Page signed off on a manuscript where he had not analyzed the data, had not looked at the data, and did not even have access to the data. This is wrong. I wonder whether he even wrote any part of the paper, because sometimes the manuscript is written by industry ghostwriters.

Curiously, the main problem with the article wasn’t that the data were manufactured. The problem was that the company deviated from the design of the study by collecting additional patients until they got a statistically significant result. If Page did not know about this — although of course he may have known — it wasn’t because he did not have access to the data. It was because he had little if any role in the collection of the data.

16

Bill Gardner 06.19.10 at 11:16 am

I would love to see one of the moral philosophers among the CT readers become engaged in the issue of authorship norms. There are hard questions here.

One example: It is not clear what it means to “look at the raw data.” I am presently analyzing a secondary data set on neonatal intensive care unit admissions. I’m not looking at raw data. All I have is a file of numbers, I do not have access to the underlying medical records (nor should I have such access).

By the way, I don’t mean to suggest that what Page did was acceptable.

17

Barry 06.19.10 at 11:39 am

Bill, that’s true. However, your file is presumably at the point where it would be quite practical to audit it, and you can do a number of tests to spot obviously phony or problematic data.

This guy can’t do that, and it’s not by accident. To move from your situation to where they are, you’d have to start by having the charts transcribed by parties with a tie to the outcomes.

18

Steve LaBonne 06.19.10 at 2:52 pm

This guy can’t do that, and it’s not by accident.

Exactly. If the quoted account is accurate, all he did was put his name on (i.e. lend his prestige to) a study he knew little about, much less genuinely participated in. This is plainly a corrupt quid pro quo, again assuming that the account is accurate. That such arrangements don’t attract vociferous moral outrage within the academic health science community is deeply troubling.

19

Bill Gardner 06.19.10 at 4:40 pm

Barry @17: I certainly do find preposterous data (a birthweight of 5 grams?). But I can’t audit the data. Even if I had the resources, I wouldn’t be able to access the source medical records for legitimate privacy reasons.

Steve @18: Agreed. There is, however, vociferous moral outrage within the academic health science community. For example, Marcia Angell, to whom Henry linked, is a former editor in chief of the NEJM. But money speaks even louder.

20

Steve LaBonne 06.19.10 at 6:34 pm

My admiration for Marcia Angell knows few limits, but she seems to me more a vox clamantis in deserto than a representative of the general state of opinion in the academic health sciences. (I would like nothing better than to be wrong about that.) And of course there are still the administrators, who like academic administrators in general are the biggest whores around.

21

ScentOfViolets 06.19.10 at 7:00 pm

Exactly. If the quoted account is accurate, all he did was put his name on (i.e. lend his prestige to) a study he knew little about, much less genuinely participated in. This is plainly a corrupt quid pro quo, again assuming that the account is accurate. That such arrangements don’t attract vociferous moral outrage within the academic health science community is deeply troubling.

Agreed that this is troubling, but is this just a case of academia tolerating a few bad apples, or is this a systemic problem exacerbated by the lack of public funds? No one is saying that drug dealing is okay, for example, but the dealer’s claim that if it’s not them it will be somebody else certainly has merit, particularly during times when earning money in a legitimate manner becomes much harder.

It seems to me that in this instance how one deals with the problem is going to heavily depend on the which of the two alternatives (or a third, or a fourth) is the case.

22

Thomas 06.19.10 at 7:19 pm

I agree with Bill Gardner. When I am on a monitoring committee for a clinical trial (so far, none run by industry) I don’t have access to the raw data. I can ask for particular summaries and particular extra details, but there isn’t any way I can see original records. I have to trust that the numbers reported for, say, cardiovascular deaths really are correct. In fact, even with the raw medical records I would have to trust someone on diagnosis — I’m a statistician, not a medic. Even the independent analysis that JAMA requires will have to trust a lot of the data collection and recording.

However, the distortion of results quoted in the article is one that would not require access to the raw data to know about. The trial was extended from the planned duration, and the results only became statistically significant because of that addition. That’s something Page should have known and that should have been mentioned.
The biggest problem with the trial, however, wasn’t at all secret. The drug is a variant of the seriously nasty amiodarone, and even though it is supposed to be safer, the primary outcome measure really should have been all-cause mortality rather than cardiovascular deaths.

Disclosure just of the existence of a financial relationship or even of amounts isn’t enough. The type of consulting is important. Data monitoring committees in clinical trials need people with experience on data monitoring committees, and as industry funds most clinical trials this experience is ipso facto a previous financial relationship. That’s different from being paid for saying nice things about a drug to a medical audience, and it’s different from having your research group dependent on industry funding. Or, to put it another way, there’s a difference between being flown to Maui to talk to a company’s customers and being flown to Rahway, NJ, to talk to their employees.

23

lgm 06.19.10 at 11:54 pm

Here’s another war story, this one from the math wars. It’s not about evil companies maximizing profits, but well intentioned but ignorant people in the wrong place.

Back in the day (late ninties?) key people in the education branch of the NSF because convinced that what we now call fuzzy math (at the time called math reform) could dramatically improve math ed. They made it their mission — the mission of the US National Science Foundation — to get “reform” curricula into classrooms throughout America. They made sure that NSF funded research supported these curricula. You could get grants if the proposals talked up reform. You could get cut off if your results did not support reform.

So now when conservatives accuse the NSF and other science supporting agencies of reinforcing the global warming orthodoxy, I know that’s not impossible. It happened in math ed. I don’t think it is happening in global warming research.

The story has a happy ending of sorts. The most extreme fuzzy math curricula are now discredited, along with whole language literacy programs. The ed school establishment seems to have gained respect for well controlled experiments and carefully collected data. They have returned to the belief that someone designing a math curriculum should know some math.

24

sg 06.20.10 at 3:31 am

Bill Gardner, I don’t think your example is the same kind of problem at all. Secondary data of the form you cite is collected for routine monitoring of service provision, it’s not first and foremost research data, and most routine monitoring data of this sort is multiply audited by people unconnected to any ultimate research project. It’s usually also cleaned by a central clearinghouse, and when it is published everyone knows it is secondary data and they view your conclusions on the data in that light. You don’t need to “see the original data” because many other people with no connection to your professional career already have. Also, in many cases the data you’re looking at essentially is the original data because it was entered digitally directly into a central database without ever passing through anyone but the clinician/admitting clerk’s hands. That was certainly the case for the hospital databases I designed.

Being able to “see the original data” is much more relevant when the data was collected by someone connected to the research project, which obviously increases significantly the risk that they might be tempted to commit fraud.

Incidentally, and on an unrelated note, I think the privacy concerns about routine service data that are currently floating about are spurious and ridiculous. I particularly hate the ONS’s stupid rules about hiding “cells with numbers less than 5” even in areas the size of PCTs. Completely ridiculous.

25

Bill Gardner 06.20.10 at 10:20 am

Thomas @22: Agreed on all points.

sg @24: I think you have captured some important distinctions between my case and Page’s. Most importantly, as you point out, the eventual scientific audience for my article is likely to understand that there is a database intermediating between me and the electronic health records of the patients, whereas they would rightly expect that Page had direct access to the data. The larger point that I wanted to make was that notions like “direct access to the data” or “raw data” are complex (if not naive), and they require explications, like your’s, to apply them to a case.

26

M. Gordon 06.21.10 at 11:50 am

Harry: Priceless. It was a mild ribbing. Don’t take yourself so seriously.

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