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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline: Don't miss Derek Lowe's excellent commentary on drug discovery and the pharma industry in general at In the Pipeline

In the Pipeline

« Senator Hatch And His Wonderful Industry | Main | Cladribine Is Gone »

June 22, 2011

The NIH and Conflicts of Interest

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Posted by Derek

The NIH has, it appears, been getting quite sensitive about conflicts of interest. There have been some rather ugly scenes involving ghostwritten articles (and entire books), and NIH director Francis Collins has said that the agency's guidelines are in the process of being revised.

You'd have thought that the existing ones would have banned that sort of thing, anyway. And in fact, it seems as if many scientists at the NIH already find the rules too restrictive. From the original paper that looked into this:

Eighty percent of respondents believed the NIH ethics rules were too restrictive. Whereas 45% of respondents believed the rules positively impacted the public's trust in the NIH, 77% believed the rules hindered the NIH's ability to complete its mission.

The problem, as so often happens, is whether your goal is to look good or to do your job, and you don't want to solve that conflict by redefining your job as just to look good all the time.

The reason I'm talking about all this is that I've heard of instances where people from NIH have refused (or felt as if they have had to refuse) invitations to give talks in industrial settings, because they feared conflict-of-interest problems. This seems perverse, especially for an agency that's talking about getting heavily into translational drug research. That'll have to lead to numerous contacts with industry, I think, in order to be much good at all. So how will the NIH manage that if the drug industry is seen as contaminating their Purity of Essence?

Comments (27) + TrackBacks (0) | Category: Academia (vs. Industry) | Why Everyone Loves Us


COMMENTS

1. drug_hunter on June 22, 2011 11:17 AM writes...

As a sanity check, I'd love to hear from folks within the NIH on whether they think Derek's summary is accurate -- is the situation really that grim? I, for one, hope that under the guise of "purity" we don't lose these sorts of opportunities for collaboration and interaction, which help everyone...

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2. drug_hunter on June 22, 2011 11:20 AM writes...

As a sanity check, I'd love to hear from folks within the NIH on whether they think Derek's summary is accurate -- is the situation really that grim? I, for one, hope that under the guise of "purity" we don't lose these sorts of opportunities for collaboration and interaction, which help everyone...

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3. lynn on June 22, 2011 11:22 AM writes...

One way the NIH could proceed to get drug discovery insight without POE contamination is talking to ex-industry scientists! Plenty of us consultants and great numbers of the downsized with extensive discovery experience. Alas, methinks it is just the taint of industry that turns them off...

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4. SP on June 22, 2011 11:32 AM writes...

Whenever NIH staff visit a site, they have to reimburse the site for anything as simple as meals provided during the meetings to avoid the appearance of an improper gift. So extra paperwork to be filed on both ends because of an $8 sandwich.

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5. Anonymous on June 22, 2011 11:50 AM writes...

Derek you can't have back to back posts, one lamenting deregulation of an industry and the other cursing over regulation.

Its too much!!

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6. Hap on June 22, 2011 12:47 PM writes...

Why not? Regulation shouldn't an on-off switch, but a dimmer switch, because different amounts of regulation are appropriate at different times. And sometimes you might not have it wired right, anyway - this is probably one of those cases - so perhaps you should have someone competent come and fix it.

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7. Derek Lowe on June 22, 2011 1:14 PM writes...

Anon (#5): sure I can. It's like arguing about whether chocolate is a good thing. In my dessert (or even my mole sauce) it is. But I don't want it in my scrambled eggs, or my chicken soup.

In the first case, I think that having the supplement industry free to run wild is inequitable conduct - either they should have to jump through more hoops (in the name of public safety) or we in the drug business should be freed up (in the name of whatever rationale Hatch used for the supplement people). In this second case, though, I think that these regulations are actually hurting the ability of the NIH to do its job.

I don't see Regulation as some sort of abstract force that has to be judged as Good or Evil as a whole. Depends on the case. You may be more of an abstract thinker than I am, though.

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8. gippgig on June 22, 2011 1:42 PM writes...

Off topic, but the latest issue of Science News magazine has an article on detecting counterfeit drugs (June 16 page 22). The technology is getting to be reminiscent of Star Trek...

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9. Jonathan on June 22, 2011 1:57 PM writes...

#4 - that applies to all federal employees, that's not an NIH thing. Feds aren't allowed to accept travel, honoraria, you name it. If we're organizing a workshop or a meeting and the majority of attendees are feds, it's illegal for us to provide food without asking the attendees to pay for it themselves.

I believe it's Senator Grassley who's responsible for most of the recent scrutiny though.

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10. Jim H on June 22, 2011 2:10 PM writes...

These "draconian" conflict of interest restrictions clearly affect innovation and creativity. They prevent NIH scholars from talking to or visiting with private companies. They presume guilt before innocence, which is not an American virtue. The NIH is all about not taking risks. I'd prefer to spend my tax money funding projects that are risky and innovative, not just to maintain the status quo. Wishful thinking, I know, but in Industry most of these NIH plebes would have been fired a long time ago for lack of productivity.

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11. drug_hunter on June 22, 2011 2:19 PM writes...

Regarding #9 (Jonathan) and #10 (Jim H) -- if I understand this correctly, interactions of any kind are prohibited. So my worst fears have come to pass. This is insane. Is there anyone from the NIH, or Congress, who has bothered to defend this policy in the light of the incredible damage it does to the world's ability to discover new medicines? Or who would be willing to do so right here, right now? We've got drug companies with compounds, assays, clinical expertise, ... but we can't collaborate or even have a conversation under the current regime.

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12. lynn on June 22, 2011 2:30 PM writes...

As a point of information, industry scientists do participate in (at least some) NIH peer review study sections, especially for SBIRs.

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13. JAB on June 22, 2011 2:47 PM writes...

As an NIHer, I pretty much agree with Derek that we're actively discouraged from interacting with industry by the current ethics rules. Formal consultancies were prohibited several years ago, and I don't believe that's changed. Most of my colleagues shy away from anything that might require ethics office approval. It IS possible to give a simple seminar at an industrial site, with prior approval, and I know of folks who do so. Formal collaborations under a CRADA are permitted, but that's two orders of magnitude more work to set up. It's not quite as bad as #11 says - all interactions are not prohibited, but it's not a good situation either for the public health or for the NIH scientist.

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14. CMCguy on June 22, 2011 3:39 PM writes...

Doesn't this go beyond NIH staff and intent is to apply strict rules to the academics who receive NIH funding? That's were it could provide serious inhibition to interactions and innovation. Even though involves NIH grants which always comes with strings attached and should include ethical behavior expectations this would seem to be further mindset that NIH/Big Government can do things better alone and as implied by others the "taint of industry" smacks of presumption of guilt with any such relationships per Angell's mantra.

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15. Innovorich on June 22, 2011 4:36 PM writes...

Aren't the NIH guidelines on ethics not in conflict with the Bayh-Dole act anyway? In which case the NIH should stop handing out money because the US government is telling every university to break their rules!

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16. drug_hunter on June 22, 2011 6:12 PM writes...

#13 (JAB) said "It IS possible to give a simple seminar at an industrial site, with prior approval, and I know of folks who do so." I believe him. But, as a practical matter, is the NIH researcher, in these times of cutbacks, likely to have the money in his budget to cover the travel costs? Let's say a flight, a hotel, and a dinner -- even with nothing fancy, could easily be $1,000. If the NIH researcher doesn't have that money available, he won't be able to give the "simple seminar." So the opportunity for interaction is lost.

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17. Spiny Norman on June 22, 2011 7:57 PM writes...

Conflicts of interest? Rly?

http://www.pharmalot.com/2011/06/nimh-director-tom-insel-did-someone-say-recusal/

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18. Otis Blanchard on June 22, 2011 8:33 PM writes...

Sen Orin Hatch R-UT has a major supplemen manufacturer in his home state. It's also connected to the book of Mormon, where their is a belief in "natural cures from the earth". A rattlesnake is natural, and that'll kill you... So is E.Coli, etc...

So money, faith, and voters..

I think I have an expose from Wired, I think, on my home computer.

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19. John David Galt on June 22, 2011 9:06 PM writes...

Avoiding both the fact and appearance has always been required of accountants who audit companies. And these days, corruption in the science field has the potential to cost everybody sums that make the Enron and Worldcom scandals look tiny.

Bravo to NIH for implementing these rules, and I hope they'll soon be extended to all agencies and universities that receive tax-funded science grants or conduct studies to answer important questions such as that of "climate change."

Sweeping under the rug corruption such as that shown by the ClimateGate e-mails only discredits the organization doing the sweeping, even if it's the Nobel committee of the Swedish parliament.

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20. MIMD on June 22, 2011 9:17 PM writes...

As they taught us at Merck, once upon a time, about how to judge what's ethical and what's not:

"If it would look bad in the newspaper, it's probably not ethical behavior."

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21. Joel West on June 22, 2011 10:48 PM writes...

Of course, this is just the standard problem of any heavy-handed government regulation instituted without a meaningful cost-benefit analysis.

Whether a welfare agency, conflict of interest office or handing out free cheese (remember that?), government tends to spend money to prevent the possible waste of one embarrassing decision, while hiding the greater and more certain waste of bureaucratic costs (both internally and imposed on others).

It would be nice to argue for common sense, but given the stakes, the visibility, and the outcry that comes with abuses, the pendulum seems to swinging away from common sense.

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22. SR on June 23, 2011 1:54 AM writes...

When I first joined grad school, I used to think the safety and disposal regulations were too restrictive. I don't think so now. Maybe it is the same with these ethical guidelines. For people who conduct themselves ethically, doing the paperwork to prove that they are, may be cumbersome. Also, some of the regulations maybe over the top. Initially, this will probably have a negative impact. Once people get used to it, I don't think it will be a big deal.

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23. Immnunoldoc on June 23, 2011 6:27 AM writes...

What this encourages is even greater investment by Pharma overseas. If I can't bring in NIH people or am inhibited from having conversations, etc well then I'll just spend even more time and money in China. That's where we've decided the market is anyway. In another few years I suspect a fair number of Chinese expats will have returned home, enhancing the quality of their science even further. The comments regarding appearance and assumptions of guilt are right on. This is (mostly) political grandstanding. Meanwhile other governments are laughing quietly and aiding their national industries as much as possible.

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24. JAB on June 23, 2011 8:11 AM writes...

#16 Drug_Hunter.....yes, our travel budgets are a mess. What's typically done is that one fills out a Sponsored Travel form 348 and whomever is inviting you pays all of the bills, through NIH. There was a big kerfluffle over this mode of travel last year, but Francis Collins did a good job of defusing Congress' concerns, IMHO. Lesson learned - don't use it too often.

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25. CMCguy on June 23, 2011 9:47 AM writes...

#20 MIMD I am not sure can apply that rule of thumb as presupposes ethical standards and behavior by Journalist to present information in unbiased manner and although don't wish to paint all with the same brush (just like in done with Pharma) that no longer seems to be the predominate mode of most in print (and less so on TV).

It's funny that #24 talks about defusing Congress' concerns as when it comes to COI/ethics the gap between what is allowed/done by elected officials verses rules/laws applied to others are typically in stark contrast. Again may be over stereotyping however there is great hypocrisy directed by some in Congress toward Pharma that appears silent when it comes to internal workings of the government.

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26. Jonathan on June 23, 2011 11:38 AM writes...

@11 - the restrictions I'm talking about apply to all federal employees, whether they be in the department of defense or DoE or where ever. But it's not like NIH doesn't work with industry. If that were the case we wouldn't have any of the next-gen sequencing platforms (or any of the new technologies coming down the pike like nanopores).

@20 - that's the same maxim we live by. "Would you want to read about this on the front page of the Washington Post?"

@14 there are differences between what applies to federal employees and grantees.

@25 yes, but then you'd have to wait a long time before Congress cottoned on to the incoherence between what they say and what they do.

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27. Anonymous on June 27, 2011 11:02 AM writes...

There are two problems here. First, we have the issue of government restrictions on interactions between government workers (including NIH staff) and the private sector. As Jonathan says, these restrictions apply to all Federal employees. I think travel used to be less of an issue, though. My impression is that is became much more restricted, especially for scientists, during the GWB administration.

Then there is the problem of conflict of interest rules on *NIH-funded* scientists, such as those who put their names on the contractor-written textbook. As I see it, most of those issues should be policed by the home institutions of those researchers. After all, having articles ghostwritten should come under academic integrity. Curiously, though, many academic institutions have shown a decided lack of interest in enforcing reasonable rules where well-funded researchers are concerned.

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