McKinsey Never Told the FDA It Was Working for Opioid Makers While Also Working for the Agency

Ian MacDougall, reporting for ProPublica: Since 2008, McKinsey & Company has regularly advised the Food and Drug Administration's drug-regulation division, according to agency records. The consulting giant has had its hand in a range of important FDA projects, from revamping drug-approval processes to implementing new tools for monitoring the pharmaceutical industry. During that same decade-plus span, as emerged in 2019, McKinsey counted among its clients many of the country's biggest drug companies -- not least those responsible for making, distributing and selling the opioids that have ravaged communities across the United States, such as Purdue Pharma and Johnson & Johnson. At times, McKinsey consultants helped those drugmaker clients fend off costly FDA oversight -- even as McKinsey colleagues assigned to the FDA were working to bolster the agency's regulation of the pharmaceutical market. In one instance, for example, McKinsey consultants helped Purdue and other opioid producers push the FDA to water down a proposed opioid-safety program. The opioid producer ultimately succeeded in weakening the program, even as overdose deaths mounted nationwide.

Yet McKinsey, which is famously secretive about its clientele, never disclosed its pharmaceutical company clients to the FDA, according to the agency. This year ProPublica submitted a Freedom of Information Act request to the FDA seeking records showing that McKensey had disclosed possible conflicts of interest to the agency's drug-regulation division as part of contracts spanning more than a decade and worth tens of millions of dollars. The agency responded recently that "after a diligent search of our files, we were unable to locate any records responsive to your request." Federal procurement rules require U.S. government agencies to determine whether a contractor has any conflicts of interest. If serious enough, a conflict can disqualify the contractor from working on a given project. McKinsey's contracts with the FDA, which ProPublica obtained after filing a FOIA lawsuit, contained a standard provision obligating the firm to disclose to agency officials any possible organizational conflicts. One passage reads: "the Contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias."

So, like everybody?

[nospam007]

Nobody divulges other clients' data to a client, there's a law against it.

Re:

[XXongo]

I suspect that he was attempting sarcasm, and failed.

The background cluelessness on the internet is so high that it is usually impossible to tell "I am a complete idiot" posts from "I am pretending to be a complete idiot" posts.

Re:

[gweihir]

Nobody divulges other clients' data to a client, there's a law against it.

While that is true, a company with minimal ethics will disclose a conflict of interest, especially one as fundamental as this one. It has become amply clear that McKinesy is lacking that minimal ethics.

McKinsey Works for Everyone

[crow]

I was under the impression that McKinsey is hired by pretty much every big company out there from time to time. They're pretty much the go-to firm when an executive at a multi-billion dollar company identifies a problem, probably knows the solution, but wants some outside party to lay it out so that there's no personal risk. (That's not really fair to McKinsey, as they do a lot of really good work.)

So I would generally assume that McKinsey is working for all of my competitors if I hired them unless it was made clear that they weren't. But I would also expect that the team helping my company would be isolated from the teams working for my competitors, so it the conflict would be mitigated, which is probably how it worked in the story being reported.

Re:

[cbeaudry]

They also consult for governments, Federal, State or Provincial (depending on country), Municipalities, etc.

You are right on the one hand, but on the other, they have their hands in pretty much everyone and everything.
Its not such a bad thing to wonder if there are conflicts of interest.

There are also revolving doors possibilities, like this one : https://www.fiercepharma.com/p... [fiercepharma.com]

I agree, that it isnt proof of any wrong doing, but might be a sign to have better due diligence or visibility on activities by t

Re:

[Tailhook]

They also consult for governments

They also kick back some of their revenue to politicians. Here is their Open Secrets profile: oh look; 91.78% to Democrats.

Re:

[Anonymous Coward]

McKinsey is the last of the One-Firm Firms. Others included Arthur Anderson & Co. S.C. (which included Arthur Anderson (audit) and Anderson Consulting (now Accenture), and Hewitt Associates, LLC. I've worked for two of the three.

Organizational Goal is on being the best - not the biggest.
Ownership is private. Allowing for independence from shareholder "guidance".
Focus is on the client.
Don't do it unless you can bill for it. The word 'free' (as in 'feel free to...') is stripped from your lexicon.
Cultu

Re:McKinsey Works for Everyone

[DaTrueDave]

I don't think you're wrong, but, as part of their contract that requires them to divulge potential conflicts of interest, why didn't they just notify the FDA that they have separate teams that are working with Purdue and J&J? That would have satisfied the contract, and everyone already knows they have their fingers in everything everywhere, so there would have been no issue. No, they were hoping that this information would never come to light, and they wouldn't have to say anything about it. They'll still likely not face any sort of accountability for this.

Why does the gov hires consultants ?

[dargaud]

Don't they have in-house experts ? And if not, why ? And if they can't hire experts because they don't pay them enough, then they should pay them more. And ban them for working for consultants or drug companies after their stint with the gov. Everything else is a recipe for exploitation.

Re:Why does the gov hires consultants ?

[frank_adrian314159]

And if they can't hire experts because they don't pay them enough, then they should pay them more.

If you pay them enough, Congress will ask why the agency costs so much and asks for places to use private contractors instead, because private industry is always so much more efficient and obviously less expensive than those government bureaucrats (we all know they're not, but somehow the word never got to Congress). And so people who have experience in the agency get yanked, many leave, and where do they go to? In short, you get the government you pay for and Congress is cheap. So if you want this stuff to stop, quit demonizing government employees, stop listening to Congresspeople who worship private companies, and vote different.

Re:

[dargaud]

private industry is always so much more efficient and obviously less expensive

Maybe it's worth asking why then ? Is it because they are double dipping, working both for gov and private industries at the same time, with all the involved insider shenanigans ? Or is it because they only claim they know their stuff while they actually don't and nobody every verifies ?

Re: Why does the gov hires consultants ?

[getuid()]

private industry is always so much more efficient

The major purpose of a democracy is to be efficient and slow. For good reason. By design and intention. And no, I'm not trolling.

"Efficiency" is pretty much synonymous with "touches as few hands as necessary" and in a democracy, the idea is that everybody (i.e. many hands, all hands) gets a say in it, by definition. You know what else is efficient? A dictatorship.

So when an institution of a democratically elected government gives away power of policy to a private entity, that kind of undermines the democrat

Re: Why does the gov hires consultants ?

[getuid()]

*to be inefficient and slow...

(Sorry.)

Re:

[Thelasko]

Don't they have in-house experts ?

Organizations don't hire consultants because they are experts. They hire them because they have done consulting for other organizations. The FDA likely hired McKinsey because McKinsey said they had some intelligence about drug manufacturers. They never bothered to ask how they obtained that intelligence. Obviously it's because the drug manufacturers hired McKinsey themselves.

The entire business consultant industry works this way. It's massively messed up, but organizations keep hiring them.

Re:

[technosaurus]

They do hire experts, but they're usually kept busy shifting data between and amongst databases, keeping up with email and mandatory training, trying to spend end of year funds, applying for intergovernmental grants, etc... while barely-qualified contractors do most of the real work. Government positions are always going to be inefficient because we demand levels of accountability that would bankrupt a competitive business.

Re:

[Anonymous Coward]

So the FDA is compromised. Shouldn't that at least suggest that their guidance on the vaccines is questionable?

That has nothing to do with this topic. Go fuck yourself.

Re:

[XXongo]

Someone's been triggered. It's a valid point.

No, it's not. The article is about opoids. The comment was about vaccines. The reply "That has nothing to do with this topic" was accurate.

Re:Compromised FDA?

[oh_my_080980980]

The article talked about an instance where McKinsey advised the FDA to water down a proposed opioid-safety program. That happened.

Thus, it is a valid question to ask if the FDA's guidance on vaccines is also questionable.

Re:

[jacks smirking reven]

The FDA has published all the documents and study information regarding the CV19 vaccines approvals. If you are concerned about them being "compromised" and beleive that would cause them to approve something dangerous feel free to look over all the available documents and find where that took place. I'll get you started:

https://www.fda.gov/emergency-... [fda.gov]
https://www.fda.gov/media/1442... [fda.gov]
https://www.fda.gov/media/1521... [fda.gov]
https://www.fda.gov/media/1442... [fda.gov]

The whole idea of the private-development/public-approv

Re:

[oh_my_080980980]

Are you fucking kidding me! We're living through an Opioid addiction crisis which the FDA helped make!

Re:

[oh_my_080980980]

And here's the British Medical Journal questioning FDA's approval of covid-19 vaccines.

Does the FDA think these data justify the first full approval of a covid-19 vaccine? https://blogs.bmj.com/bmj/2021... [bmj.com]

Christ I'm in the wrong line of work

[RightwingNutjob]

Of course there's money in playing both sides: selling weapons to both Iran and Iraq in the 80s, representing both sides in a high stakes lawsuit, etc. I didn't think anyone had the balls to actually do it.

Re:

[oh_my_080980980]

Big Pharma does. And if they don't have big balls they have a drug that can give you big balls.

Re: Christ I'm in the wrong line of work

[RightwingNutjob]

...and a pill to take in case your balls are too big

Really, so the FDA pretends it doesn't know then

[guruevi]

Because we all knew during the 2019 election cycle that Pete Buttigieg worked for McKinsey as a 'consultant' as did a number of other high profile Democrats that were put in charge of major industries.

McKinsey themselves don't really hide the fact they are advising big pharma for decades on their website: https://www.mckinsey.com/indus... [mckinsey.com]

Re:

[Beerismydad]

This story is pretty close to the plot line of the latest season of Goliath on Netflix.

Big pharma? Evil? NO WAY!

[EmoryM]

Fact check: the makers of Fauci brand science juice have no profit motives and just want to keep us all safe. There was never an Opiod epidemic - it was COVID all along.