Tamiflu, Roche and the Cochrane Collaboration

April 10, 2014 7:59 AM

Ben Goldacre, The Guardian: "Today we found out that Tamiflu doesn't work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia."

The Telegraph: 'The review, authored by Oxford University, claims that Roche, the drug’s Swiss manufacturer, gave a “false impression” of its effectiveness and accuses the company of “sloppy science”.'

BBC News: 'The UK has spent £473m on Tamiflu, which is stockpiled by governments globally to prepare for flu pandemics.'

Reuters: 'The United States has spent more than $1.3 billion buying a strategic reserve of antivirals including Tamiflu...'

The Guardian: 'He and the rest of the Cochrane team asked Roche for the full, unpublished trials data. Roche said they could have it if they signed a confidentiality agreement, but they refused. They updated their review in 2009, omitting data they could not be sure of and concluded that the drug may work no better than aspirin.'

Previously on MetaFilter (May 2011).

posted by Wordshore (78 comments total)

Thanks so much, Roche, for giving the anti-vax loons ammunition. You stupid, stupid greedy fucks.
posted by five fresh fish at 8:02 AM on April 10, 2014 [46 favorites]

Tamiflu light sends Roche scurrying!
posted by barnacles at 8:06 AM on April 10, 2014 [14 favorites]

In case anyone is confused, Tamiflu is not a vaccine.
posted by grouse at 8:07 AM on April 10, 2014 [42 favorites]

So they're going to pull it, remarket and repatent it as Placebix? Or would it be Homeophlu?
posted by tilde at 8:10 AM on April 10, 2014 [11 favorites]

Tamiflu is not a vaccine, but anti-vaxxers use any sort of fuck-up by pharmaceutical makers as ammunition.
posted by LindsayIrene at 8:15 AM on April 10, 2014 [19 favorites]

To be fair, Tamiflu doesn't have the same potential Reye's Syndrome concerns as aspirin. And the one time I took it when I had the flu (real flu, diagnosed via nasal swab) I felt right as rain 72 hours later, as opposed to when I DIDN'T and was down. But anecdotes are not data, and hiding information is enough to pull the drug from the market until they figure out what the fuck, frankly.
posted by KathrynT at 8:22 AM on April 10, 2014 [4 favorites]

That's a big story, and a big talking point for (Ben and others') fight for trials-transparency.
posted by the quidnunc kid at 8:25 AM on April 10, 2014 [2 favorites]

Within the next two days Facebook and Momblogs will be swamped with claims that MMR/DPT/etc are bad because Roche lied about this injection. There will be endless howls of "Big Pharma is eeeevil!" — and they'll be absolutely correct.

And next year we'll see vax rates drop below the ~85% rate required for herd immunity, and a few years later we'll see a whopping huge MMR/DPT epidemic.

Some people at Roche need to be jailed for this.
posted by five fresh fish at 8:27 AM on April 10, 2014 [23 favorites]

So they're going to pull it, remarket and repatent it as Placebix? Or would it be Homeophlu?

Thing is, it's not nothing; it does have effects. They're just mostly bad. (Increased vomiting! What, you want your anti-flu drug to reduce it? Pfft.)
posted by Sys Rq at 8:28 AM on April 10, 2014 [1 favorite]

The report doesn't claim Tamiflu is ineffective, just that is a lot less effective than Roche made it out to be. As a first line defense against a pandemic it wouldn't help much.

What's interesting is that the report apparently doesn't point a finger at Roche for anything other than withholding data. The impression I get is that they don't think that Roche lied about anything, just that they screwed up their analysis.
posted by Tell Me No Lies at 8:33 AM on April 10, 2014

I got into a stupid fight with a friend of a friend (on facebook, of course) about vaccination, and one of his points was that Big Pharma is evil and untrustworthy and so why should we believe them and give them money?

Thanks, Roche. Thanks a lot, you greedy assholes.

On preview: If they didn't lie about their results, I'm not sure anyone should take comfort that instead they screwed up the analysis and then hid that.
posted by rtha at 8:35 AM on April 10, 2014 [3 favorites]

In case anyone is confused, Tamiflu is not a vaccine.

And what's more, its existence is an excuse for people not to bother with the annual flu shot.
posted by ocschwar at 8:38 AM on April 10, 2014 [5 favorites]

We need more scientists like Ben Goldacre, and more coordination among them like the Cochrane Collaboration. This is how civilization is supposed to work, as opposed to how it actually does.
posted by George_Spiggott at 8:46 AM on April 10, 2014 [18 favorites]

Tell Me No Lies: "What's interesting is that the report apparently doesn't point a finger at Roche for anything other than withholding data. The impression I get is that they don't think that Roche lied about anything, just that they screwed up their analysis"

I suspect discretion may be the better part of valour when calling out an organisation with deep pockets, a bad attitude and a legion of lawyers.
posted by Jakey at 8:47 AM on April 10, 2014 [2 favorites]

Also, imagine if a similarly purposeful global network of finance and economics professionals and academics in the public interest existed.
posted by George_Spiggott at 8:50 AM on April 10, 2014 [1 favorite]

The report doesn't claim Tamiflu is ineffective, just that is a lot less effective than Roche made it out to be.

This CBC article quotes one of the co-authors:

"There is no good evidence that the drug [Tamiflu] saves lives," Doshi said in an interview. "There is no good evidence that it reduces hospitalizations, no good evidence that it reduces the risk of complications, no evidence that the drug will interrupt the spread of the virus, that's person to person transmission — some of the major reasons why the drug was stockpiled."

And then goes on to note that:

Tamiflu treatment also increased the risk of vomiting in adults and children.

And that the studies which do show some positive effect are likely pretty loaded.

So the take-away that I'm now going to be hearing from my alt-medicine friends is that if homeopathy is a placebo, then at least it's doing less damage than Roche medicines, because it's at least not making them throw up.

And to all of the people who are saying "but Tamiflu is not a vaccine", here's the argument I am going to be trying to debunk in several conversations in the near future:

• Roche lied (really hard to dispute that deliberately hiding data isn't)
• Roche is big pharma, and it's likely that other big pharma companies have similarly lied (and we can go to all sorts of SSRI vs placebo or whatever else studies that at least suggest similar behavior)
• Vaccines are huge business for big pharma.

So far, I have no evidence to dispute any of these statements, so when they make the final leap, how do I say "but... but... this time it really is different!"?

This really needs some hardcore criminal prosecution, and huge civil pentalties, because this isn't just damaging public health budgets, it's damaging the practice of medicine.
posted by straw at 8:52 AM on April 10, 2014 [27 favorites]

This is exactly why basic medical research should be the province of government, with all studies published to the public. Pharma companies should be manufacturing and delivery organs only.
posted by feckless fecal fear mongering at 8:54 AM on April 10, 2014 [19 favorites]

This is, we've known this for years. Or at least something roughly like this story. Tamiflu etc. were known to be not greatly effective, and only decreased sickness length by a small amount. But there was some use in giving them to severely sick patients - the very young, the very old, the frail - because if illness was shortened even by a day, that might save their lives. But there were demands for the government to do something, anything. Doomsdayers - and some people of other sensible disposition - stockpiled these drugs, tossing them back like candy at the first sign of a sniffle, claiming they "worked".

You know what works against pandemic influenza? Surveillance. Research. Vaccination if we've got the first two right. Quarantine if the first three fail.
posted by outlier at 8:55 AM on April 10, 2014 [11 favorites]

AND it made me so dizzy i couldn't even read. it took me five days to feel better because you take tamiflu twice a day and every time i took it, within in 20 min, i need to just lie down. so i couldn't work from home and had to take a lot of time off of work.

i called the dr because i was so concerned with the dizziness. they said it's a side effect of tamiflu.

That's pretty common. You don't want to take Tamiflu casually or for no reason.
posted by outlier at 8:56 AM on April 10, 2014

So far, I have no evidence to dispute any of these statements, so when they make the final leap, how do I say "but... but... this time it really is different!"?

Off the top of my head:
Why believe the studies that showed Tamiflu was ineffective, but not believe the studies that show vaccines are safe? You either believe both or neither since they're both claims made by the same scientists.
posted by EndsOfInvention at 8:57 AM on April 10, 2014 [17 favorites]

This is exactly why basic medical research should be the province of government, with all studies published to the public.

Yeah, 'cause governments have consistently proven themselves much more trustworthy than corporations throughout history. And they have guns.
posted by ZenMasterThis at 8:58 AM on April 10, 2014 [1 favorite]

RIP Welcome trust as an active, non-profit culture player in Pharmaceutical science; all went downhill there after the mid-80's when it was fattened up to be sold to glaxo.
posted by lalochezia at 8:59 AM on April 10, 2014

Another earlier Ben Goldacre piece : It's a scandal drug trial results are still being withheld
posted by jeffburdges at 8:59 AM on April 10, 2014 [2 favorites]

Roche lied (really hard to dispute that deliberately hiding data isn't)
Roche is big pharma, and it's likely that other big pharma companies have similarly lied (and we can go to all sorts of SSRI vs placebo or whatever else studies that at least suggest similar behavior)
Vaccines are huge business for big pharma.

Let me help you with that third one.

Vaccines are NOT a huge business for big pharma. Almost all of them are off patent now, so margins are low. Vaccines are, however, a major interest for academia, specifically schools of public health, and governments, all 193 of them. Those are the entities monitoring the effectiveness and safety of vaccines. And it's worth noting that it's academia that blew the whistle on tamiflu.
posted by ocschwar at 9:00 AM on April 10, 2014 [47 favorites]

Vaccines are huge business for big pharma.

Actually, by and large vaccines are shitty business. A new vaccine can earn you big bucks, of course, but most of the vaccines for widespread childhood diseases are long since out of patent protection and the profit margins are tiny. Big Pharma would stand to make a lot more money out of convincing people they were ineffective and selling them new drugs to treat the ensuing rise in sick children.
posted by yoink at 9:01 AM on April 10, 2014 [25 favorites]

Thanks, yoink and ocschwar, I need to refresh myself on the dollar amounts involved, because that's the sole argument I have.

EndsOfInvention: In practice, this means that the alt-medicine users become more willing to discount all arguments from "the same scientists", or put those arguments on equal footing with the housewife from Topeka on a random Internet forum.
posted by straw at 9:04 AM on April 10, 2014

I remember a lot of uproar about this article published during the Avian Flu pandemic of 2005 when the US Government decided to stockpile Tamiflu. Here are some snippets from the article that might shed some light on this current scandal.

[Donald] Rumsfeld served as Gilead (Research)'s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.
...

Rumsfeld isn't the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead's board, has sold more than $7 million worth of Gilead since the beginning of 2005.

...
"I don't know of any biotech company that's so politically well-connected," says analyst Andrew McDonald of Think Equity Partners in San Francisco.
posted by any major dude at 9:05 AM on April 10, 2014 [8 favorites]

Big Pharma would stand to make a lot more money out of convincing people they were ineffective and selling them new drugs to treat the ensuing rise in sick children.

So you're saying that Jenny McCarthy is probably on the Pfizer payroll, then?
posted by a fiendish thingy at 9:05 AM on April 10, 2014 [3 favorites]

Yeah, 'cause governments have consistently proven themselves much more trustworthy than corporations throughout history. And they have guns.

Haven't they though? I'm seriously asking. How many governments have been as amoral as corporations?

I've seen very little corporate activity that is actually in the entire public's interest.
posted by srboisvert at 9:05 AM on April 10, 2014 [3 favorites]

How many governments have been as amoral as corporations?

I don't know, but vote #1 quidnunc kid and I promise to try my hardest.
posted by the quidnunc kid at 9:11 AM on April 10, 2014 [9 favorites]

Governments are at least nominally operating in the public interest. Here in the US at least, by law corporate officers have a fiduciary duty to operate corporations for the financial benefit of shareholders regardless of the external cost of those profits. If it profits the shareholders to withhold data to get an ineffective drug approved, then the corporation is legally obligated to do so.
posted by fogovonslack at 9:13 AM on April 10, 2014

Yeah, 'cause governments have consistently proven themselves much more trustworthy than corporations throughout history. And they have guns.

You don't have to rely on governments to verify the efficacy of vaccines. Just count the number of kids with polio in your neighborhood, and then ask you grandparents about theirs.
posted by CheeseDigestsAll at 9:13 AM on April 10, 2014 [12 favorites]

How many governments have been as amoral as corporations?

Might I step in and point out that this argument is moot?

Governments are terrible at providing stable long term funding for basic medical research. Every time there';s a budget standoff, those outfits are the first to face furloughs and the like, and their scientists start to look elsewhere for work.
posted by ocschwar at 9:15 AM on April 10, 2014 [1 favorite]

If it profits the shareholders to withhold data to get an ineffective drug approved, then the corporation is legally obligated to do so.

If this is completely true, then ... oh, I don't know. I just don't know how to finish that sentence.
posted by Wordshore at 9:18 AM on April 10, 2014 [1 favorite]

Yeah, 'cause governments have consistently proven themselves much more trustworthy than corporations throughout history. And they have guns.

The thing is, government-funded research works differently than corporate research - the incentives for researchers are really different, as are the publication standards. There's certainly some incentive to produce interesting/dramatic results, and there's certainly incentive to play fast and loose with research subjects, but the disincentives for those, the monitoring bodies at the federal, state and university level and the whole culture of this type of research is much better than in the corporate world. Plus the scientists who prefer the much, much less well-compensated world of government-funded research are generally people who have some serious commitment to the meaning and use of their research. (Good people end up going over to industry because they need to ie support their families, I'm not saying that all industry researchers are terrible.)

I actually observe this from the inside because I work around government-funded medical researchers, and while it has made me more skeptical of "And Science Has Proved This Large Far Reaching Conclusion Beyond All Doubt Based On A Single R01"-type claims and reporting, it has not shaken my faith in the vast majority of individual researchers.
posted by Frowner at 9:19 AM on April 10, 2014 [11 favorites]

I suspect discretion may be the better part of valour when calling out an organisation with deep pockets, a bad attitude and a legion of lawyers.

True. And to be fair the Cochrane Collaboration's big thing is getting research results made public, so they have no interest in picking a fight beyond this.

thanks Roche. i probably would've recovered faster if NOT for tamiflu. ugh.

According to the Cochrane analysis you probably recovered 10% faster (6.3 days instead of 7 days) with Tamiflu. Certainly not worth the money and side effects given what else is out there.
posted by Tell Me No Lies at 9:20 AM on April 10, 2014

Governments are terrible at providing stable long term funding for basic medical research. Every time there';s a budget standoff, those outfits are the first to face furloughs and the like, and their scientists start to look elsewhere for work.

And yet 97% of all climate scientists are lying like dirty dirty dogs about climate change in order to tap that sweet, sweet, government money. The tiny handful of honest ones are all working for selfless, benign job-creators like ExxonMobil. It's true, I saw it on Fox & Friends.
posted by George_Spiggott at 9:25 AM on April 10, 2014 [10 favorites]

Ben Goldacre is an international treasure.
posted by rebent at 9:34 AM on April 10, 2014 [4 favorites]

Here in the US at least, by law corporate officers have a fiduciary duty to operate corporations for the financial benefit of shareholders regardless of the external cost of those profits

That is often said, but it turns out not to be the case (although it has become so widespread a belief as to be self-fulfilling.)
posted by Major Clanger at 9:36 AM on April 10, 2014 [6 favorites]

Given the variation in flu strain virulence how in the world could you even measure that the medicine actually did anything?
posted by bukvich at 9:44 AM on April 10, 2014

Also: the last time I went to the doctor with the flu a couple years ago he didn't give me tamiflu. He said to stay in bed and drink plenty of water.
posted by bukvich at 9:47 AM on April 10, 2014

Time to sell off my Roche shares, then.
posted by Renoroc at 9:49 AM on April 10, 2014

Given the variation in flu strain virulence how in the world could you even measure that the medicine actually did anything?

Isn't that the reason one seeks a statistically significant, randomized sample?
posted by yoink at 9:49 AM on April 10, 2014 [2 favorites]

Time to sell off my Roche shares, then.

Time was yesterday, really.
posted by Rock Steady at 9:58 AM on April 10, 2014 [5 favorites]

feckless fecal fear mongering: "This is exactly why basic medical research should be the province of government, with all studies published to the public. Pharma companies should be manufacturing and delivery organs only."

I think that may be too dramatic of a step to justify.

However, moving trials and reporting to be 100% the responsibility of the government? Absolutely.

It's an obvious and glaring conflict of interest for the manufacturer to be running and guiding drug trials. We don't let auto manufacturers crash-test their own cars, and we shouldn't let drug makers run their own clinical trials.
posted by schmod at 9:59 AM on April 10, 2014 [2 favorites]

However, moving trials and reporting to be 100% the responsibility of the government? Absolutely.

That model is not working so well for the USDA anymore. Or the SEC, for that matter. Revolving doors and regulatory capture are a massive problem and it's actually getting worse. I'd say something about what will happen if the Dems lose the Senate at the mid-terms, but frankly the Dems ain't all that, either. They need money to run too.
posted by George_Spiggott at 10:07 AM on April 10, 2014 [1 favorite]

Here is the Cochrane review itself that all of this is based on

Reading through it, the review basically works by taking all the data provided by Roche, excluding data associated with various kinds of gaps in documentation or reporting, and then doing their own independent statistical tests on what is left. Looking through their various justifications for exclusion, a lot of them could be much more easily explained by the lack of an established framework for sharing data in this way along with Cochrane's - understandable - categorical refusal to negotiate on creating one and they also don't seem to explain why they seem to use different statistical tests, which is itself a pretty big red flag. I'd be very interested to see a technical reply to the review by Roche if anyone finds one while we wait for the grownups in the FDA and the NHS to look through all of this.

I guess what I'm saying is that the review could be entirely right but, because of limitations that aren't necessarily their fault or even Roche's exactly, it makes a very weak case.
posted by Blasdelb at 10:07 AM on April 10, 2014 [2 favorites]

I you can't trust Corporations and you can't trust Government, who you gonna trust? Ghostbusters?

Can you expect Ben Goldacre and the Cochrane Collaboration to do everything? And how much money are you personally providing to support them?
posted by oneswellfoop at 10:14 AM on April 10, 2014

five fresh fish: "Within the next two days Facebook and Momblogs will be swamped with claims that MMR/DPT/etc are bad because Roche lied about this injection. There will be endless howls of "Big Pharma is eeeevil!" — and they'll be absolutely correct.

And next year we'll see vax rates drop below the ~85% rate required for herd immunity, and a few years later we'll see a whopping huge MMR/DPT epidemic. "

Britain already went through an MMR epidemic last year. It ended after a steady ad campaign by the government encouraging parents to vaccinate their children.

You counter stupidity by educating people and reminding them of the consequences.

When that doesn't work, the stupidity will no doubt lift once a few idiot parents prove to the rest that refusing to vaccinate one's own children is selfish and fatal.
posted by zarq at 10:15 AM on April 10, 2014

Here in the US at least, by law corporate officers have a fiduciary duty to operate corporations for the financial benefit of shareholders regardless of the external cost of those profits

However, corporate officers are not obliged to instruct professionals working for the company to violate their professional ethical obligations.
posted by ocschwar at 10:15 AM on April 10, 2014 [1 favorite]

What we need is more multi-national corporations in the health care business.
posted by Catchfire at 10:15 AM on April 10, 2014

...corporate officers are not obliged to instruct professionals working for the company to violate their professional ethical obligations.

You're not from America, are you?
posted by oneswellfoop at 10:17 AM on April 10, 2014

I did not say it doesn't happen. I said corporate officers don't get to justify it with "my duty is to my shareholders."

That duty does not mean you can demand a newly hired engineer divulge trade secrets from his last job.

Or that a scientist engage in fudging. For instance.
posted by ocschwar at 10:20 AM on April 10, 2014 [1 favorite]

"What we need is more multi-national corporations in the health care business."

I get that you're being sarcastic here but this is actually something we would all benefit a hell of a lot from. At the moment we have way to few corporate entities that are way too big to operate effectively jumping on leads for cool new exorbitantly profitable shit, generally forgetting about it and letting it rot, buying up any mildly profitable companies doing solid but unexciting work to roll the dice some more with their patents, generally forgetting about those bets too soon afterwards, and inching forward on the occasional gamble they don't fuck up that also happens to pay off. We really do need more companies and more competition so the incompetent CEOs at the top of all of the mess can look shitty by comparison.
posted by Blasdelb at 10:24 AM on April 10, 2014 [6 favorites]

Also, make sure to watch for what Derek Lowe ends up having to say about all of this at In The Pipline
posted by Blasdelb at 10:27 AM on April 10, 2014 [1 favorite]

Haven't we always known that the profit motive does not mix well with healthcare? Yes, we can keep trying to regulate and structure and reform and plead and generally fight a losing fight. Or we acknowledge that when you have an overwhelming force that is simply not aligned with your objectives by its nature, maybe its time to design a system where the motivating force is not fundamentally uncontrollable. There are very good reasons why we don't want to turn over the judiciary or law enforcement wholly to the private sector. The costs, complexity, and always-catchup-mode make that an untenable proposition. I say its time to acknowledge the obvious, that there are areas of societal needs that should not be subject to the primacy of the profit motive, and have medicine join the judiciary as off limits.

There is no reason why we can't have government funded research directly and in collaboration with academia, and a government driven healthcare system. You can still have some private capital at the margins, but not in the drivers seat. Nothing is perfect, but that's not the argument for keeping a worse system in place, anymore than an imperfect judiciary or problems with law enforcement are an argument to turn those over to the private sector for an immeasurably worse outcome.
posted by VikingSword at 10:45 AM on April 10, 2014 [5 favorites]

I think the private sector can work very well in the production of commodity medical supply like palliatives and medical consumables. But it utterly fails as a linchpin of serious public health policy and epidemiological response: the capitalist model absolutely sucks as a way of producing and maintaining a vaccine supply for example, and it knows it. It's really not either/or, we just need to do a lot better job of being in charge and stop letting ourselves be held hostage.
posted by George_Spiggott at 11:02 AM on April 10, 2014 [6 favorites]

"What's interesting is that the report apparently doesn't point a finger at Roche for anything other than withholding data. The impression I get is that they don't think that Roche lied about anything, just that they screwed up their analysis."

Roche indeed hasn't been caught lying about anything. What has been shared with Chocrane is different from what has been shared with regulators, Chocrane is using a fundamentally different format for analyzing the data that they don't even try make a technical case for being better, and for a lot of the things Chochrane is faulting Roche for not sharing Roche does indeed have more than plausibly honest reasons for not sharing of varying levels of legitness.

While the way the media covers science seems to treat scientific papers as if they were the units that truth comes in, that is even less true for this review than usual. It doesn't really have anything to say about the efficacy of Tamiflu directly other than that it is difficult to support with the data Roche has made publicly available according to their analysis. It does have interesting things to say about the non-intuitively complicated business of exactly what should be publicly available and how, but all of that seems to have gotten lost in the reporting.
posted by Blasdelb at 11:04 AM on April 10, 2014 [3 favorites]

>Time to sell off my Roche shares, then.

Time was yesterday, really.

Actually the time was . . . well, whenever you feel like it, it seems. The market does not appear to care about this.
posted by Tell Me No Lies at 11:08 AM on April 10, 2014 [1 favorite]

ZenMasterThis: "Governments are terrible at providing stable long term funding for basic medical research. Every time there';s a budget standoff, those outfits are the first to face furloughs and the like, and their scientists start to look elsewhere for work."

Ha hahahaha...

I have a friend who works for one of the larger biotech/pharma firms in the world and it's like every other month she's complaining about more and more people are being let go. And this is a "successful" company. So acting as if budget cuts are going to put more people out of work than the private market is a bit silly, as if the pressures in the private market are completely unbowing to the vicious hand of the market.... I'm sure the situation is same at many other pharma and biotech companies as well.
posted by symbioid at 12:18 PM on April 10, 2014 [2 favorites]

The real question is whether those $Bs would have been better spent on things like research into more effective flu vaccines, which is very much needed.

This seems like an awful lot of stonewalling by Roche, even if it is a typical amount of stonewalling for the pharma industry. It's kind of like the backscatter airport scanner of medicine, right?
posted by RobotVoodooPower at 12:22 PM on April 10, 2014 [1 favorite]

Aren't corporations even worse at "providing stable long term funding for basic medical research", ocschwar? Isn't that research done by corporations mostly paid for with government money too?

I'm against the agency that does the approval actually being the agency that does the research funding, much less the research itself. Any such conflict will lead to dangerous drugs being approved to further someone's career. Just like corporate lobbying leeds to dangerous drugs being approved now.

It's fine doing all the research on the government dime, and in the public interest, so long as we keep the agencies separate, ala NIH v FDA. We could do more drug development in university labs or non-profit corporations by making government funding available. We could make the patents usable freely by anyone actually doing the manufacturing in the U.S., so the generic drug makers could exploit the research, but charge royalties when used abroad.
posted by jeffburdges at 12:36 PM on April 10, 2014 [1 favorite]

That's kind of what I was thinking, jeffburdges.

Government funds the research, separate arms'-length agencies supervise trials and (dis)approve the drugs for use.

The governments then hold the patents, and licence them out to whoever wants to manufacture the actual drugs, charging licence fees to do so.

Bam. Billions of dollars go straight to research instead of marketing, drug prices go down, research into 'unprofitable' drugs goes up--because the gov't can just contract a manufacturer to produce vaccines or whatever.

Also I would like a pony.
posted by feckless fecal fear mongering at 12:45 PM on April 10, 2014 [5 favorites]

"I think the private sector can work very well in the production of commodity medical supply like palliatives and medical consumables. But it utterly fails as a linchpin of serious public health policy and epidemiological response: the capitalist model absolutely sucks as a way of producing and maintaining a vaccine supply for example, and it knows it. It's really not either/or, we just need to do a lot better job of being in charge and stop letting ourselves be held hostage."

On the contrary, the extraordinary effectiveness and humanity of the vaccine industry is really a very strong argument for capitalist models having a place in experimental medicine. To be sure, this has been in large part due to extraordinary acts of human kindness but the vaccine supply has been safe, effective, affordable, and reliably produced every year for three generations now with constant innovation in new vaccines. The last actually real scandal in the industry was 60 years ago and was really the fault of academics.

We do actually have a real comparison to make though, where at the end of WWII both the US and Soviet Union invested large amounts of money in vaccine research. While the fully socialized model had a lot of strengths, for example the effort to eradicate smallpox and the order of the bifurcated needle was largely Soviet lead and the Soviet Union had some seriously impressive monitoring mechanisms to keep track of strains, there is a reason almost all of the vaccines we have today came out of the Western model.
posted by Blasdelb at 12:58 PM on April 10, 2014 [2 favorites]

I personally prefer the patents be freely usable so long as manufacturing occurs inside the country that funds the research because patents are inherently anti-free market. In practice, an agency controlling the patent will play favorites. And it encourages maintaining the production infrastructure. I'm fine with the nation that funds the research demanding royalties from foreign producers. Yeah, my pony has a sparkly tail too.
posted by jeffburdges at 1:02 PM on April 10, 2014

"Given the variation in flu strain virulence how in the world could you even measure that the medicine actually did anything?"

By carefully ensuring that a final analysis is sampling from multiple serotypes, flu seasons, and sites on both hemispheres; which is something Roche would have undoubtedly needed to do in their analysis for the FDA and that the Cochrane review says it does for at least flu seasons and sites, but is non-specific as to how well.
posted by Blasdelb at 1:10 PM on April 10, 2014

I'm loving this wild conspiracy theory that anti-vaccine conspiracy theorists secretly work for the pharmaceutical industry or similar :   If the anti-vaccine folks keep vaccination rates low enough to worry the NIH, etc. then governments must buy treatment up drugs like Tamiflu. And if vaccination rates remain high enough to avert epidemics, then said drugs need not even be particularly effective. Just sacrifice a few vaccine sales to compel millions of sales that could almost be placebos. And check out Russell Blaylock's connections with the radical right-wing. It's perfect! lol
posted by jeffburdges at 1:12 PM on April 10, 2014 [1 favorite]

Some people at Roche need to be jailed for this.

And every damn penny they made be paid back to be used for flu vaccine research.

Except for a couple million spent on free childhood vaccines for poor kids.

Yeah. That works for me.
posted by BlueHorse at 2:26 PM on April 10, 2014 [1 favorite]

I'm curious what the charge would be.
posted by Tell Me No Lies at 2:58 PM on April 10, 2014

Particularly when at this point its not at all entirely clear if anything illegal, or even wrong, has happened.
posted by Blasdelb at 3:32 PM on April 10, 2014

In case anyone is confused

Have you met the anti-vaxers?
posted by Halloween Jack at 7:38 PM on April 10, 2014

So, I spent a couple of hours at work today reading this Cochrane review, because that's the kind of thing I do at work. If you're wondering, Cochrane reviews, on average, are around 80-120 pages. This one? 560ish. So these are just initial impressions...

Basically, in terms of just treating the disease, oseltamivir (Tamiflu), works exactly like we thought it did. It'll reduce the duration of flu symptoms by an average of 10%ish (a little over half a day), when given to otherwise healthy people (i.e. not immunocompromised people) who are suspected to have the flu (so, a mix of people who actually have the flu and people who just look a whole lot like they have the flu). There's a slightly greater chance that you'll puke if you take Tamiflu than you would have if you had the flu and didn't take it. On the other hand, if you have the flu and take Tamiflu, you're less likely to get diarrhea than if you had skipped the drug. So, six of one?...

The real issues that come up concern secondary infections and disease transmission. First, secondary infections: getting the flu puts people at massively increased risk of getting bacterial pneumonia as a secondary infection. The limited data presented before this review said that Tamiflu reduced that risk. It turns out that, well, maybe not, mostly because it turns out that the researchers never actually defined what counted as pneumonia, so really, who knows? Secondly, disease transmission: a few trials looked at viral load and viral shedding, and it looked like Tamiflu reduced those, at least in people with one of the two major circulating strains of influenza, influenza A (which includes H1N1). Now, it turns out that isn't true. These two factors, though, were the arguments for governments making stockpiles of the drug in case of pandemics. Governments don't want big piles of drugs to make you feel better 16 hours faster; they want big piles of drugs to keep you from making everyone in your household and neighborhood sick, and to keep you from needing even more medical care. And... well... Tamiflu can't do that. Or at least, we still don't know for sure if it can.

And my conclusion from all of this is yeah, Roche hid data in order to make Tamiflu look like it was something valuable in a pandemic. And while it can help people feel better faster, it isn't helpful in an epidemiological sense in a pandemic. It won't slow the spread of disease, or make treating the disease and it's complications any cheaper on a population level. So it was gross in a stealing-money-from-the-goverment way. Nothing I've read would keep me from taking it, though, in terms of my own physical safety.
posted by amelioration at 7:55 PM on April 10, 2014 [13 favorites]

CheeseDigestsAll: "You don't have to rely on governments to verify the efficacy of vaccines. Just count the number of kids with polio in your neighborhood, and then ask you grandparents about theirs."

Or you know, Smallpox.
posted by Mitheral at 8:03 PM on April 10, 2014 [1 favorite]

Withholding pharmaceutical data is the least ethical thing you can do without actually breaking the law.

You have to ask hundreds, if not thousands of often seriously ill people to gamble with their health. They'll do it, maybe because they hope that this new medicine will cure them, maybe because they're desperate for money, or maybe because they want to help with finding a cure (I work with some terminally ill cancer patients, many of them take part in trials that they understand won't cure them, but they're willing to put themselves through a battery of invasive tests and unpleasant side effects in the hope that someday, their disease won't kill someone else). The risks of experimenting on humans are very real too. It's a really big deal to ask someone to participate in your study.

But assume you manage to get the number of patients you need, either by relying on their goodwill or their desperation to overwhelm the risks and the side effects and the time and the effort and the inconvenience of participating. Then you decide to throw that data away, the data that you relied on human volunteers to obtain. Why do you do it? Obviously it's so you can turn a profit on a useless drug. I can't express how evil it is. Especially as in doing so you're deceiving the world that your medicine is effective when actually it isn't, and it probably has horrible side effects, and billions of dollars of public money have been wasted, and people may have died who could have been treated properly. It leaves me unspeakably angry.

Fuck these guys. Fuck them to hell.
posted by Ned G at 3:49 AM on April 11, 2014 [5 favorites]

There is a nice, balanced review here, at Science Based Medicine:
New evidence, same conclusion: Tamiflu only modestly useful for influenza


Jefferson and associates argue their findings provide evidence that stockpiling of this drug should end. One question is how generalizable the current evidence base is to a pandemic situation, and how much we’re prepared to invest (to stockpile) given the limited beneficial effects shown as a treatment. The second question is the role of Tamiflu in the seriously ill, and in those at greater risk of flu-related complications and death. What the news coverage and the authors seem to be ignoring is that Tamiflu is demonstrably and meaningfully effective at preventing the spread of the infection. At the same time, there’s some real world evidence (albeit with limitations) that suggests that oseltamivir may provide a slight survival advantage in the very ill. Tamiflu is also well tolerated and has a generally good side effect profile. Overall, this new study reinforces what’s been argued by science-based medicine for years: Antivirals like Tamiflu don’t replace vaccination. It offers little benefit in the routine treatment of influenza in the otherwise-well individual, but may have a role in those with other medical conditions, or when used to prevent influenza’s spread.
posted by cacofonie at 5:55 AM on April 11, 2014 [1 favorite]

Bad Pharma is worth a read to realise that Pharma companies engage in these practices pretty much any time they think they can get away with it. I'd be all for nationalisation of pharma companies, especially considering a lot of the drugs taken to market by pharma these days are actually got by buying them from universities and other smaller research organisations.
posted by Cannon Fodder at 6:28 AM on April 11, 2014 [1 favorite]

You know, I know it's been mentioned upthread about the illogic of throwing out all government because it's prone to regulatory capture, but has anyone actually done any sort of logical proof showing how asinine this is? Because I feel like there is a very real and important thing to be done with this.
posted by symbioid at 7:41 AM on April 11, 2014

You know, I know it's been mentioned upthread about the illogic of throwing out all government because it's prone to regulatory capture, but has anyone actually done any sort of logical proof showing how asinine this is?

Why, yes. We ran that experiment. Welcome to the world before the FDA. Welcome to the actual snakeoil. Welcome to "medicine" that killed and maimed legions, and rarely, if ever, cured. Welcome to money running absolutely everything when it came to health.

Yes, government regulation (oh, how the right hates the very idea!) brought at least a semblance of order and the first real progress to the practice of medicine on a societal scale. And of course, the right will continue to distort that record and simple facts, by pointing to totalitarian regimes like the Soviets as examples of why government running more medicine is worse than our regulatory capture corporatocracy. Supposedly there is "a" reason why there were fewer medical breakthroughs in the Soviet Union compared to the West. That one sole solitary ("a") reason, is of course, for the right, "government control". But saying that the idea that the profit motive should be taken out of medicine (except at the margins) will end up as it did under the Soviets is as silly as claiming that the removal of the profit motive from the judiciary and law enforcement in the West would end up like the judiciary and law enforcement in the Soviet Union. We did that in the West, and didn't end up with a Soviet style judiciary and law enforcement. Those - and healthcare - were more a reflection of the Soviet Union, than a reflection of how it would or did actually work in the West. Not to mention, of course, that there is a whole bunch of a long, long stretch of middle ground between the totalitarian system and the laissez faire corporatocracy of the U.S. (Socialism!!!UNO!! being equated with totalitarian communism is of course a right wing trope, in order to prevent the examination of a system that demonstrably works much better than the absolute rule of capital we have today).

Bottom line, we can and should do better, and the profit motive should be removed as the driver of healthcare (it is still fine at the margins - the size of that margin subject to experimentation). Whether we have the political space to do so, is of course an entirely different question.
posted by VikingSword at 10:31 AM on April 11, 2014 [1 favorite]