Should A CRO Invest In Drugs It Tests?
4 CommentsBy Ed Silverman // July 2nd, 2007 // 12:26 pm
Here’s a scenario for you: PPD, a big clinical research organization, is the second-biggest investor in Accentia BioPharma and also runs trials for the little company’s sinus drug. If approved, PPD stands to reap 14 percent of the royalties. The arrangement, however, is being criticized as a conflict of interest, especially since Accentia was cash-strapped. PPD wouldn’t comment, but here’s what others told The St. Petersburg Times:
Francis O’Donnell, Accentia’s ceo: “Their execution has been flawless, and their counsel has been invaluable to us…There are enough checks and balances built into the system. The chances of mischief are de minimis.”
Ron Wooten, president of NovaQuest, a PPD rival: “You manage that conflict by having fire walls around all information and strict confidentiality across all functions. Nobody on my staff talks to operations about there being higher stakes in a program when we have an investment. That never happens.”
“Protocol violations are much more common than data suggest, ” says Brett Bishop, executive director of clinical operations at Covance, another CRO, referring to errors in the conduct and reporting of clinical trials. “They have an underestimated impact on drug development. They are not readily detectable. And conventional measures to prevent them are ineffective.”
“We assume CROs have a financial interest in the compounds they’re testing,” says the FDA’s senior adviser for clinical science, David LePay, who adds that the agency rarely finds fraud in trials and suggests this is proof that the system is working. “We only find it in 1 to 2 percent of inspections.”
“The FDA does not have the resources to inspect all clinical trial sites or even a major fraction of them, ” said David Ross, a former FDA medical reviewer who disclosed the Ketek antibiotic scandal, which involved fraudulent testing. “And if you don’t look for fraud, you won’t find it.”
“CROs stay in business by hitting the numbers, ” says Art Caplan, who heads the Center for BioEthics at the University of Pennsylvania. When a trial monitor has a financial interest in a study’s outcome, such as PPD does with Accentia: “That’s a big ethical no-no, ” he says. “They should never be reviewing anything in which they have a direct financial interest.”
You can read the full story here. Drugmakers, of course, run clinical trials and have vested interests in outcomes. That doesn’t mean there aren’t conflicts. The issue raised here, however, suggests more oversight is needed.
What do you think? Is this a conflict of interest?
- Yes (78%, 53 Votes)
- No (22%, 15 Votes)
Total Voters: 68
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Reality
I can see why people might see this as a conflict, but I voted “no” for the reason stated in the 2nd-to-last sentence of the post: if a CRO doesn’t run the trial, who does? The drug company, which also has serious financial interests in the outcome. I do think they should have to disclose such relations, though.
However, there are details in the article that I DO find troubling: it sounds like PPD basically saved Accentia financially. So having PPD run their trials strikes me a little as “pay for play.”
Hank
If this isn’t “conflict of interest,” then there is no such thing. Re: Reality’s question, The privatization of trials is relatively recent historically. Prior to that, academic medical centers or the NIH units did much of them. Of course (as we’ve learned), those contexts are no firewall against COIs either, but probably slightly less easy to act on them.
I’ve heard enough “war stories” about CRO-based fraud, but the reality is we have very little idea of how often, or not, it happens, as some of those quoted point out.
Reality
Well, it’s not that there’s no COI, but I think that whoever runs a trial, be they a CRO, pharma, or the NIH, they all want to see a trial succeed. Even if a CRO has no financial gain (other than another contract), they want the trial to succeed. Do some want to see it succeed because there may be financial gain? Sure. But many want to see it succeed because of the questions it will answer, which is why scientific fraud occurs outside of pharma.
On that subject, and as Hank alluded to, there are other COIs beyond money. There are publications, grants, prestige, tenure, and, oh, I don’t know, money for your IVUS lab. I must say, I’m increasingly annoyed at the number of journal editors/editorialists who consistently pooh-pooh, or completely deny the existence of serious, nonfinancial COIs in academic medicine.
In the dozen or so symposia I’ve been to over the last few years in which COI was discussed, which included editors from Annals, Lancet, and other top-tier journals, only one person has acknowledged that academic COI is an issue, and I can tell you and it wasn’t one of the (sanctimonious) editors. Indeed, one editor was questioned if authors need to disclose pharma ties and money, why do they not also need to disclose that their grant funding (and salary), advancement, etc. are dependent on the conduct/outcome of such trials. Her glib reply was, “I think everyone knows that.” I found that to be an unacceptable answer both in its condescending tone, but also because the most egregious scientific fraud and misconduct in recent history (e.g., South Korea stem cell) have been academic fraud, not pharma fraud.
I’ve said it many times before, money is but one potential COI, and I think a relatively weak one. For the academicians of the world, prestige/ego is their currency, not dollars, and I would argue a much more powerful motivator and potential source of corruption.
Sal Giorgianni, PharmD
I voted that it is a COI because it is. If the drug fails they get paid-x if the drug is approved and does well in the market they get paid-y. However, the more important matter is HOW THE COI IS HANDLED. There are always COIs, Harvard and Columbia University Academicians have them, Government has them, Journalists have them,
It is the level of integrity and transparency in which the research is conducted, reported and interpurted that matters the most.
We are foolish to believe that COIs - let alone the perception of COI under any given scenario - can be eliminate. Time and time again, case and case again that has been shown to be inpracticable. Wise, transparent and watchful Management of COIs is the best solution.