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The FDA buries evidence of fraud in medical trials. My students and I dug it up

552 points by tokenadult 12y ago

guylhem 12y ago
In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accepted in one member state (then you can sell it everywhere) or go to the EMA. That's moderate competition. It may works slightly better, but it's still limited by the number of countries and regulatory agencies. The only conclusion we should make from such stories is that there should be no public bodies susceptible to regulatory capture, but various independent organizations doing that. See that as adding redundancy - if one was found to cheat and lie, it wouldn't be too big to fail, and a competitor would be glad to update its rating on say the 40 generics whose bioequivalence ratings are based on cooked data. That's a bit like how I trust Michelin guides more than any government evaluation of restaurants. EDIT: I noticed a comment about financial ratings agencies. You realize there are only 3 big ones (Moody's, S&P, Finch) and that they have very strong ties to some governments, right? I predict they give you more quality that the FDA (because it's a legal monopoly), but less than what more competition could bring.
- voronoff 12y ago
  Because the financial ratings agencies have proved to be such a huge success?
  - Retric 12y ago
    US raiting agency's are setup to be corrupt as the seller pays the raiting agency so there going to look for the loosest respectable option. And the agency has little incentive to dig deep.
    - woodman 12y ago
      Setup by the SEC. The incentives are structured, by the government, in the most ridiculous way possible. Pointing at the failure of government mandated and monitored rating agencies as a failure in private enterprise is just stupid.
      - Retric 12y ago
        I think it's more nuanced than that. Private companies optimize for money, with the right incentives they work well, with poor incentives they become a pointless money sink. All too often you see the equivalent of “though the magic of the invisibly hand we will solve X.” But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets.
        woodman 12y ago
        > But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets. Well, that is true every system - including functions of government. It has nothing to do with privatization vs nationalization. The government mandates that certain financial instruments must be rated by a short list of companies that have been blessed to do so. So the government has limited competition among rating agencies, a laughable mistake in judgement. Then these companies only get paid by the folks trying to sell the instrument under review... another stupid move. Many government programs, presumably setup with the best intentions, have serious negative consequences because the moron behind it didn't think more than one step ahead. This happens in private industry as well, the difference being that there the market corrects for mistakes by mercilessly crushing fools. In government the fools live on, and their plans are slow to change because it is now law.
        Retric 12y ago
        'the moron behind it didn't think more than one step ahead' I think many and possibly most of these are based on regulatory capture where elected officials / regulators are ‘given incentives’ to look the other way. Lots of seemingly stupid decisions are completely reasonable from the person who made them. All it takes is for someone to be judged just on their little piece of what happens (how much do we spend on paper) and not judged based on how much their changes hurt the corporation/overall economy etc. And before you know it, we saved 1million in ink last year at the cost of 50 million in manpower.
  - nickff 12y ago
    Perhaps this proposed drug testing regime would be more comparable to auditing firms.[1] Arthur Andersen went under after it lost credibility in the eyes of shareholders, as a result of the Enron scandal. On the other hand, from everything I have read the ratings agencies were simply 'going through the motions', and cashing in on their government mandated service. No large investors trusted the ratings agency to begin with, the investors were all gaming the system, and the agencies were playing along to get a piece of the action.[2] [1] http://en.wikipedia.org/wiki/Big_Four_(audit_firms) http://en.wikipedia.org/wiki/Big_Four_(audit_firms) [2] http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agencies%29 http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agen...
- GauntletWizard 12y ago
  Regulatory capture is pretty much inevitable. In almost any field, the skills needed for government regulators to evaluate claims are interchangeable with the skills needed to work in the field. The only thing that will help is strong whistleblower protections, to allow the ethical members of a profession to call bullshit without fear of repercussion. (This won't work in banking, for obvious reasons :P )
  - narrator 12y ago
    How about the Singapore model? Pay government bureaucrats huge salaries and pensions so they don't have to structure their career around getting a private sector cash out after they retire from regulating.
    - jonlucc 12y ago
      I'd wonder where the regulators are going to learn the skills needed to regulate. Drug development is not quite like academic research.
- sjg007 12y ago
  Except the major drugs are brought to both markets usually and largely made by multinationals. Many drugs get approval in Europe first before they are tested in the US.
  - ekianjo 12y ago
    Most drugs go first on the American Market, because that's the most profitable one by far. Any source for your claim ?
    - chrisbennet 12y ago
      I worked for a client that was trying to develop a medical device (stents). I was told it was cheaper and faster to get approval in Europe.
      - ekianjo 12y ago
        Medical devices are not drugs. They do not follow the same regulations. And in Europe the medical device registration can be very fast depending on the type of medical device (they have standard classifications for fast review, and some are self-certification type of registration). You should never make a parallel between medical devices and drugs because those are just two very different markets. And unless you have a better source for your first point, I stand by my position that the US gets most of the approval first, worldwide. And most of the large pharma industries are American.
- refurb 12y ago
  The EMA isn't that much better. Just do a google search for Mediator a diet drug only sold in the EU. There were multiple signs that the drug causes heart damage. It took years and years for it to eventually be pulled.[1] [1]http://news.yahoo.com/france-drugmaker-trial-suspected-deaths-135830398.html http://news.yahoo.com/france-drugmaker-trial-suspected-death...
user_name2 12y ago
Maybe we aught to stop allowing corporations to run our media and arbitrarily censoring facts they don't like.
powera 12y ago
I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-a-hopeful-drug-thats-out-of-reach/?_r=0 http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.
- erkkie 12y ago
  Most likely self-experimenting and community based "trials" are gonna be much more prevalent in the coming years, due to bio hacking opening up. Gonna be even trickier to regulate and navigate.
  - ekianjo 12y ago
    Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.
    - erkkie 12y ago
      > Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. You might've misread me as condoning this, not at all, but I think it's inevitably gonna happen and in fact already is, if you dig around a little bit (all kinds of life extension forums out there, not to mention the current nootropics trends). You don't have to agree with or like things to see them coming you know. > Plus, the public does not have access to the synthesis or new materials You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well.
      - 12y ago
CodeWriter23 12y ago
The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.
- themartorana 12y ago
  And more importantly, given that no one is ever held responsible. No one goes to jail. Again. Punishment is supposed to be disincentive to crime. With no punishment, what's wrong with lying, cheating, stealing, and killing?
  - littletimmy 12y ago
    The issue here is slightly different. As the law works, there is absolutely a lot wrong with lying, cheating, stealing and killing if you are poor or black. White billionare? Nope. You can literally rape your toddler daughter and go free because the judge feels you would "not fare well in prison." (DuPont heir). Large corporation? Lol. The attorney general will argue on your behalf instead of bringing a case against you. (JP Morgan).
    - vijayr 12y ago
      not fare well in prison Jeez - I thought you were joking, but nope :( http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-case/ http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-...
- marincounty 12y ago
  Maybe as a condition of hire, the appicliant, if hired by the FDA, couldn't seek future employment in any aspect of the Pharmacutical industry? I belonged to a union that flat out told apprentices that they were forbidden from going through the program and opening up a non-union shop. I've always wondered about the legality of putting conditions on a job? I know the formentioned union still has the clause in it's bylaws, and it's a union in a huge city.
hurin 12y ago
Pharmaceuticals is a ridiculous industry, public health and scientific merit are on the lowest rungs of their list of priorities.
- ekianjo 12y ago
  To be honest I can't think of many industries which place public health scientific merit at their top priorities either. You could say the same thing about the food and beverages industries, and Soylent too if you care about mentioning stuff that makes HN tick often.
  - logn 12y ago
    I can't think of many industries pushing for laws to force you to ingest their product. Eating McDonald's is not a prerequisite for admittance to pre-school.
    - ericd 12y ago
      Are you trying to imply that vaccines being mandatory is the result of lobbying and not just because it's an extremely important tragedy of the commons problem?
      - logn 12y ago
        I'm pointing out that pharma can either be treated like every other company and held to similar standards or they can act like scientists if they want mandated use of their products. And yes, pharma does lobby for laws to mandate vaccinations. edit: obviously lobbying is not 100% responsible for all vaccinations laws, but it's partly so and increasing.
        jamestnz 12y ago
        Fine, but obviously it's not only the vaccine manufacturers who are pushing for things like mandatory vaccinations for public school enrolment (except where unable, e.g. immunocompromised children unable to tolerate the vaccination itself). It's also, y'know, people with an interest in promoting public health, people who understand the concept of herd immunity, and people who have a reasonably tuned sense of social responsibility. So, sure: Big Bharma employs lobbying as part of their business strategies. This is both unsurprising and irrelevant to the overall societal benefit of high immunisation rates. > edit: obviously lobbying is not 100% responsible for all vaccinations laws, but it's partly so and increasing But how can you tell that the number of vaccination laws passed due to lobbying is increasing? Or possibly you just meant that lobbying dollars are increasing. But higher dollar values alone would tell us nothing about the relative success of that lobbying in getting laws passed. For example, perhaps the laws were going to be passed regardless, and the increased spend is illusory, being attributable to a general trend of increased lobbying spend in US big-business, inflation, or other factors. In an environment where lobbying is the norm, I think gauging the "effectiveness" of lobbying spend, especially for something which lots of people generally seem to support anyway, is a hard problem.
pasbesoin 12y ago
To clarify: I'm not calling for less regulation from the FDA. Far from it. Rather, I'm pointing out that in the follow instance where more regulation is being called for, a major influence is again Big Pharma and the motivation is, to my eyes and reading, not primarily consumer protection. ---- There is also the other "half" of this FDA saga. "Supplements" and herbal treatments are a mixed bag, and there are fraudulent manufacturers and suppliers in this market as well. However, there are repeated pushes to get the FDA to more or less outlaw all of them and/or to regulate this marketplace out of existence. I'm someone who, along with more than a bit of grief from pharmaceutical industry products, has actually found some significant results in the "natural" marketplace. I've had to be careful, and I've had to find manufacturers who actually deliver what they say. But the idea of one of these knee jerk, "ban 'em all" reactions taking these items away from me, scares me in no small measure. The FDA appears no longer to be an effective regulator; it has become ever more an economic and political tool of the most moneyed private interests. (Where a focused Big Pharma far outweighs the broader field of smaller supplement providers, for example.) To be somewhat repetitive, I don't want to discount the significant problems with the "supplements" marketplace. But I have been able to achieve results with it that I have not found in the pharmaceutical marketplace. I am unwilling to cede this territory to the pharmaceutical companies, as they seek to have it shut down -- for their own economic self-interest, rather than the public interest.
- fapjacks 12y ago
  I am in a similar situation, using a product which the FDA has declared unfit for human consumption based on anecdote. The FDA has stolen my mail a few times, despite the substance not being controlled or otherwise illegal. The FDA has a really bizarre set of priorities, and "protecting consumers" is somewhere either at the bottom or just not even on the list at all.
harkyns_castle 12y ago
I feel like we're so deep in the mire now, of this kind of corruption and control by wealthy people/interests/entities, it'll be tough, if not impossible, to dig out of. Being a fairly selfish person, that's not for my own self interest. Its a recipe for disaster. We need a massive overhaul. Edit: Lobbying and the ability for a fiat currency to control decisions, and revolving door setups, seems like the obvious first step to me. But the people that can make that happen are the people that benefit from it currently. Bring on a new planet, without those types of people.
- colechristensen 12y ago
  It is only with a false view of the past that today can be seen as more corrupt than any point in history. Of course there is an ebb and flow of where the corruption lies, and to what extent it takes hold. People tend to forget that we're living in the safest, most transparent, most free point in the whole of human history. We've been digging ourselves out of a pit of corruption for ten thousand years, don't let yourself be fooled into thinking things are terrible by focusing on a few things that have gotten worse over a decade or two. Big picture: things are and have been getting massively better continuously. You should be celebrating that such corruption can so easily come to light instead of decrying doom that it has been discovered.
  - FeeTinesAMady 12y ago
    Celebrating that is a recipe for resting on your laurels and allowing it to continue. There is nothing to celebrate here. You should be mad as hell and doing something about it.
  - meric 12y ago
    I was trying to think of an argument to disagree with you with but you're right. From the times of Woodrow Wilson's reign to John Edgar Hoover and Nixon to the NSA, there's never really been a time in the past hundred years some part of the government wasn't corrupt and power hungry. And probably even before 1900 too with slavery and subduing of the Indian tribes. The freest least corrupt point in USA government's history is probably July 2, 1776.
DigitalSea 12y ago
Both honestly and sadly, I think nobody is actually legitimately surprised by this. The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable. If anyone hasn't seen John Oliver's latest video, it's on the whole marketing to doctors thing and touches upon the pharmaceutical industry and I highly recommend watching it: https://www.youtube.com/watch?v=YQZ2UeOTO3I https://www.youtube.com/watch?v=YQZ2UeOTO3I - he sums it up perfectly.
- refurb 12y ago
  The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable. But this isn't about the pharmaceutical industry, it's about the FDA. The FDA is clearly catching these companies doing wrong, so why are they covering it up? And if you think the FDA and the pharmaceutical industry are in bed with each other, I would have to disagree (coming from the industry). The company I used to work for would never mess with the FDA since you could be shutdown in an instant. To be honest, I think a lot of the FDA failings come from a lack of resources. Most of the drugs people take in the US and EU are made in places like India and China. The FDA is just starting to think about inspecting those plants. They just don't have enough inspectors to make sure each and every manufacturer is doing things by the book.
  - hurin 12y ago
    > (as someone coming from the industry) What do these particular failings referred to in the article have to do with the FDA's lack of resources? From what I can see all you are doing is trying to change the subject of discussion away from the industry.
    - Intermernet 12y ago
      I personally think @refurb asked exactly the right question (whether he's from the industry or not). >The FDA is clearly catching these companies doing wrong, so why are they covering it up? This deserves more research. Don't get distracted by "big pharma", ask why the FDA aren't doing anything about the wrong-doing they're uncovering. Occam's razor cuts towards lack of funding. Next question: Who is in charge of FDA funding? How can this be changed?
Alex3917 12y ago
Tokenadult, Out of curiosity, given that you've said in your previous comments that you believe medical questions are best answered with 'science-based medicine', which is a philosophy that explicitly rejects evidence-based medicine: do you believe that the FDA covering up scientific fraud is bad, or do you agree with the FDA's argument that it's justified? Also, do you still believe that "It's an exaggeration (contradicted by thoughtful comments by drug industry researchers who have already posted replies in this thread) to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general [...]."?
- austinz 12y ago
  Question (not being sarcastic): what's the difference between 'science-based medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but the former just redirects to the latter.
  - wanion 12y ago
    Science Based Medicine is a movement to improve Evidence Based Medicine with a stronger focus on scientifically rigorous evidence. It's not in opposition to EBM. To quote the SBM blog's about page: "Good science is the best and only way to determine which treatments and products are truly safe and effective. That idea is already formalized in a movement known as evidence-based medicine (EBM). EBM is a vital and positive influence on the practice of medicine, but it has limitations and problems in practice: it often overemphasizes the value of evidence from clinical trials alone, with some unintended consequences, such as taxpayer dollars spent on “more research” of questionable value. The idea of SBM is not to compete with EBM, but a call to enhance it with a broader view: to answer the question “what works?” we must give more importance to our cumulative scientific knowledge from all relevant disciplines." You can find the original Science Based Medicine announcement on their blog http://www.sciencebasedmedicine.org/hello-world/ http://www.sciencebasedmedicine.org/hello-world/ and there's a decent bit of background on Pain Science https://www.painscience.com/articles/ebm-vs-sbm.php https://www.painscience.com/articles/ebm-vs-sbm.php as well.
    - 12y ago
zipfle 12y ago
I find it really interesting to juxtapose this situation with the current furor over Brian Williams' not actually having been in a helicopter he said he was in. It's odd, but not too surprising, that the only job you can actually get fired from for lying is "propaganda mouthpiece."
- bgun 12y ago
  the only job you can actually get _publicly shamed and publicly_ fired from for lying is "propaganda mouthpiece." Someone being fired for lying, and someone you heard about getting fired for lying, are very different things.
graeme 12y ago
How much of this could be solved by replication? Some sort of rule where we say, formally, not to take any study seriously unless it's been replicated? On the one hand, it's very bad that the FDA has covered this up. But on the other hand, there was science before the FDA. I may be interpreting the article wrong, but it seems as though the FDA is merely failing to prevent bad science. Presumably, journals that cited these experiments didn't replicate that and knew they weren't replicated. Is science too complex and expensive to replicate these days? If so, is it even still science? (Those are actual questions, not rhetorical ones. I don't know the answers here). Edit: For some reason, at present my comment seems to be the top comment. I don't want to detract from the story itself. The actual issues at the FDA raised by the article deserve discussion.
- Scaevolus 12y ago
  Clinical trials are very expensive to run. The only people financially interested in running them are the pharmaceutical companies trying to make new products available. Replication is hard enough to achieve in hard sciences where replicating a study might cost tens of thousands of dollars. Finding the money to replicate or refute a clinical trial for millions of dollars is very difficult.
  - graeme 12y ago
    So can we still call it science, or not? And if not, what do we call it?
    - chris_va 12y ago
      Well, technically they are replicating the study over 50+ different hospitals until they reach some confidence interval on the safety data. If you get fraud in a small fraction of them, it should not (and if you read the actual testimony, does not) impact the net result.
      - static_noise 12y ago
        If you need 50 experiments to actually show that the effect exists, then even a small fraction of fraudulent experiments can heavily skew the result when looking at confidence intervals. Think of selfhealing as a coin toss with 50/50 chance and a medication increasing this chance: a) Medication increases healing chances to 80% -> Only few experiments needed. b) Medication increases healing chances to 55% -> Many experiments needed to prove that the effect exists. c) Medication is not effective but 5% fraud is introduced so that data shows 55% healing chances -> The same as in b) but with only "a little" fraud involoved.
molyss 12y ago
I'm just wondering something probably very stupid. Shouldn't an FOIA request turn back all information that the article claims the FDA is refusing to give away ? Looking at the FDA FOIA exemption list (http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm or http://www.foia.gov/faq.html#exemptions http://www.foia.gov/faq.html#exemptions), there's none that seems to match a drug name, a lab's name, a detail on a mistake or even communication between ab and FDA. The only things that I would think apply would be internal FDA comm, and patient names. None of the things I cited sound like : - national security threats - internal rules - breaking federal law - trade secrets, commercial or financial info - inter/intra agency comm - personal privacy (if we exclude patient names) - law enforcement info - supervision of financial institutions (that's an interesting exception to see BTW) - geological info on wells (totally off topic, but I'm kind of curious about this one). It looks like the author si as baffled by the assumption that misconduct fall into the "commercial info" exception... Really scary also is the whole orange book thing. I thought generics were actually the exact same molecule, as in "we've done a mass spectrometry of the stuff, and it's the same shit, only cheaper". It looks it's not at all the case... Reading the wikipedia talks on generic drugs, it looks like there was confusion there as well (http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book). As of today, there's only one reference to the word molecule in the wikipedia article ("[...] most small molecule drugs are accepted as bioequivalent if[...]), which doesn't seem to address the confusion. Assuming (and it's a pretty big assumption) that insurances really want you to get better, it would then look like the should tell you _not_ to use generics, rather than pushing you to. Argument could be made that you only depend on them for a limited time. I guess the same argument could be made for public healthcare systems (like France), in the sense that you're less expensive dead on generics than alive on the real stuff, but I sound a bit cynical, even to myself.
- zerocrates 12y ago
  Generally, generics are required to have the same active ingredient as the brand-name, in addition to showing bioequivalence.
  - 12y ago
CodyBZ 12y ago
Statins are the most widely prescribed drug on earth. The drug company's report that myopathy occurs in 1% of the population. Field reports show that number is around 20%. One in five people statin intolerant due to muscle disorders. Its common knowledge these drugs can cause serious muscle problems, yet most doctors are unaware. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/ "It is impossible to discern the true incidence of mild muscle complaints because these problems typically are not examined in pharmaceutical sponsored trials and because of study design. In HPS, for example, subjects were not randomized to simvastatin or placebo until they had successfully tolerated simvastatin 40 mg for a 5 week introductory period (17), and most trials report muscle symptoms only when CK values exceeded 10 times upper limits of normal."
tracker1 12y ago
Simple, take away patent protections from the drug companies for derivative works... Then make all unredacted documents regarding FDA trials once a medication is approved for use available publicly... The first will lead to correcting bad faith efforts and marketing in the drug companies... the second will lead to fixing the FDA.
MichaelGG 12y ago
A related and very interesting story is this article[1] on Ranbaxy. Basically this company was corrupt and fraudulent from the top down. Falsifying data, copying competitor information as their own, etc. Or encouraging internationally traveling employees to privately import medicines to India for them. Or asking doctors on staff to write prescriptions for everyone in the office to boost sales figures. The FDA applied light bans, only on individual manufacturing sites, allowing the company to continue to push out product from other sites. Including making a bunch of pills with glass fragments in it. The FDA eventually fined them $500M, and the company has since been bought by Sun Pharma, the largest in India. Zero indication that the systemic corruption, fraud, poor quality, etc. have had real change. 1: http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/
- hga 12y ago
  A bit more happened, last year the FDA started making unannounced visits to their production plants in India. When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. This Google search will provide a lot of info, https://www.google.com/search?q=Ranbaxy+flies https://www.google.com/search?q=Ranbaxy+flies that's "flies" as in those disease spreading insects. One of the articles had a picture of a man unloading dung from a cart with a Ranbaxy plant in the not too distant background.... I pay attention to this because I take a lifesaving maintenance medicine that my medical plan currently sources from Sun :-(. Since that and another important drug I take went generic over the last few years, my doctor has been very happy with my reporting that to me, they seem to be bioequivalent. He's in a field when generics of one class of drugs, the anti-convulsants, are notorious for not being easily substituteble with brand name. Ah, a bit more on that fabulous Fortune article: their First World drug mules were being asked to deliver First World brand name manufactured drugs so that Ranbaxy could falsify equivalence tests. One US executive left the company after the 2nd "wow, these guys are so good their data matches the brand names's point to point" "coincidence".
  - refurb 12y ago
    When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. I'm not sure if they are shutdown, but the FDA has banned imports into the US from everyone of the Ranbaxy plants. Sun Pharma is in a bad situation with this since they can't sell into the US market from their new acquisition.
SixSigma 12y ago
The juxtaposition of adverts for "earn money participating in medical trials" at the top of the page made me smile. http://imgur.com/nZTnzb5 http://imgur.com/nZTnzb5
known 12y ago
Can't you cross check with https://en.wikipedia.org/wiki/European_Medicines_Agency https://en.wikipedia.org/wiki/European_Medicines_Agency ?
known 12y ago
I normally cross-check with https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research_and_Quality https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research...
nodefortytwo 12y ago
Could this type of investigation be done automatically. pulling data from FDA and cross referencing against medical journals and FDA redacted docs. I would love to try however I don't feel i know enough about the available data to work out what would be required
tokenadult 12y ago
I post a fair number of stories about regulation of medical treatments here on Hacker News. I see this one has attracted a lot of reader interest. The comments already posted as I post this comment point out that once someone sets up a regulatory program, the incentives become powerful to figure out ways to cheat the regulators. And, as usual, scientific research is hard (another topic I post a lot about here), and researchers all operate under incentives to publish interesting and hopeful results rather than acknowledge that their research program didn't show what the researchers hoped to show. The submitted article identifies a specific problem in how the FDA doesn't publish identifying details of studies that its own inspectors discovered to have problems. Biomedical researchers, then, don't know which previous study findings are flawed, even though the FDA detected flaws, and much time and effort is wasted trying to pursue research results that don't reflect reality. That has to change. Meanwhile, there is a different pattern of regulation for some products that consumers in the United States take regularly as they seek better health, namely "natural supplements." For natural supplements, the regulatory problem is far worse, because those products can go on the market with no research done on safety or effectiveness at all, and without even any guarantee that the product contains the labeled active ingredient,[1] a plain violation of the warranty of merchantability in the Uniform Commercial Code. So the better trade-off for the consumer here is to amend existing law so that as drugs go through clinical trials, disclosure and peer review of FDA inspection findings during the trials is a condition for marketing approval. If manufacturers can't deal with that kind of regulation, tough. But it's only fair that natural supplement products, a multi-billion-dollar industry, should be regulated the same way. (To answer a question asked in another comment, already well answered overnight in my time zone, yes, "science-based medicine" includes "evidence-based medicine," that is clinical trials, as a subset of practices that include also consideration of fundamental principles of science and statistical understanding of prior plausibility before interpreting clinical trial results. If a sample size is small enough, many implausible treatments can look like successes in a clinical trial, especially for subjective, patient-self-reported symptoms, but we shouldn't call such treatments effective until they have been replicated in larger samples and verified with independently gathered "hard endpoint" data about clinical signs.) [1] "Searching for the supplement in your supplement" http://www.sciencebasedmedicine.org/searching-for-the-supplement-in-your-supplement/ http://www.sciencebasedmedicine.org/searching-for-the-supple...
vaadu 12y ago
The authors better be careful or the next contact they have with government documents is notice of an IRS audit.
parallelist 12y ago
Talk about this kind of journalism out of context (why you don’t trust a particular study, for instance) and you’ll be called a quack or conspiracy theorist.
edkennedy 12y ago
Time to split into a Food Dept. and Drug Dept. and reform them from the ground up to be health based rather than corporately based.
thisIsNotMikey 12y ago
The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?
- acdha 12y ago
  How many consumers are capable of evaluating drug safety and have time to do so? This is a real problem requiring time from a limited number of highly skilled professionals and easy proposed solutions are naive.
  - thisIsNotMikey 12y ago
    The consumers directly don't. But as a consumer I don't know how to evaluate an automobile, a smart-phone, or other products. But there is a market that provides the relevant data to consumers. Before I buy a car, I check out USNews, or Edmunds; before I buy any product I check out the relevant resources. Because of the way the FDA is structured, not much non-FDA research and reviews are being done. Lol. I didn't propose a solution.
    - acdha 12y ago
      … and those markets have a long history of being gamed despite enjoying much larger numbers of people who can check the work. The drug market is huge and extremely lucrative which ensures that any successfully started review service would be under attack from multiple fronts – lawsuits, attempts to hire people away or buy influence, setting up “competing” groups which try to sound legitimate but exist only to attack the other group’s claims, etc. Read the history of what happened with say the financial ratings companies during the 2000s for one side (regulatory capture) and the tobacco or fossil fuel industry for the dirty tricks version. There's no reason to think that wouldn't keep happening, all of which dramatically increases the cost and likelihood of failure.
- 12y ago
tangerine_beet 12y ago
This article really brings home the truth of how helpless we are in the face of corrupt government bodies like the FDA. You can just picture von Eschenbach and his group reading the piece, and then calculating whether a response is going to be needed: Maybe it will all blow over if we just stay quiet? What can one do as a citizen to fight this kind of corruption?

552 points by tokenadult 12y ago

In healthcare, there are many skeletons in the closet - and many closets. This FDA story is sad, but not surprising. The article seems to suggest the European equivalent (the EMA) is way better. Maybe it did behave better on this case, but as a rule of thumb, I strongly doubt it is much better. The only advantage Europe has is how it works: if you want to bring a drug to the market, you either have it to get it accepted in one member state (then you can sell it everywhere) or go to the EMA. That's moderate competition. It may works slightly better, but it's still limited by the number of countries and regulatory agencies. The only conclusion we should make from such stories is that there should be no public bodies susceptible to regulatory capture, but various independent organizations doing that. See that as adding redundancy - if one was found to cheat and lie, it wouldn't be too big to fail, and a competitor would be glad to update its rating on say the 40 generics whose bioequivalence ratings are based on cooked data. That's a bit like how I trust Michelin guides more than any government evaluation of restaurants. EDIT: I noticed a comment about financial ratings agencies. You realize there are only 3 big ones (Moody's, S&P, Finch) and that they have very strong ties to some governments, right? I predict they give you more quality that the FDA (because it's a legal monopoly), but less than what more competition could bring.

voronoff 12y ago
Because the financial ratings agencies have proved to be such a huge success?
- Retric 12y ago
  US raiting agency's are setup to be corrupt as the seller pays the raiting agency so there going to look for the loosest respectable option. And the agency has little incentive to dig deep.
  - woodman 12y ago
    Setup by the SEC. The incentives are structured, by the government, in the most ridiculous way possible. Pointing at the failure of government mandated and monitored rating agencies as a failure in private enterprise is just stupid.
    - Retric 12y ago
      I think it's more nuanced than that. Private companies optimize for money, with the right incentives they work well, with poor incentives they become a pointless money sink. All too often you see the equivalent of “though the magic of the invisibly hand we will solve X.” But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets.
      - woodman 12y ago
        > But, without the proper incentives simply privatizing or reducing regulations are going to do little but line someone’s pockets. Well, that is true every system - including functions of government. It has nothing to do with privatization vs nationalization. The government mandates that certain financial instruments must be rated by a short list of companies that have been blessed to do so. So the government has limited competition among rating agencies, a laughable mistake in judgement. Then these companies only get paid by the folks trying to sell the instrument under review... another stupid move. Many government programs, presumably setup with the best intentions, have serious negative consequences because the moron behind it didn't think more than one step ahead. This happens in private industry as well, the difference being that there the market corrects for mistakes by mercilessly crushing fools. In government the fools live on, and their plans are slow to change because it is now law.
        Retric 12y ago
        'the moron behind it didn't think more than one step ahead' I think many and possibly most of these are based on regulatory capture where elected officials / regulators are ‘given incentives’ to look the other way. Lots of seemingly stupid decisions are completely reasonable from the person who made them. All it takes is for someone to be judged just on their little piece of what happens (how much do we spend on paper) and not judged based on how much their changes hurt the corporation/overall economy etc. And before you know it, we saved 1million in ink last year at the cost of 50 million in manpower.
- nickff 12y ago
  Perhaps this proposed drug testing regime would be more comparable to auditing firms.[1] Arthur Andersen went under after it lost credibility in the eyes of shareholders, as a result of the Enron scandal. On the other hand, from everything I have read the ratings agencies were simply 'going through the motions', and cashing in on their government mandated service. No large investors trusted the ratings agency to begin with, the investors were all gaming the system, and the agencies were playing along to get a piece of the action.[2] [1] http://en.wikipedia.org/wiki/Big_Four_(audit_firms) http://en.wikipedia.org/wiki/Big_Four_(audit_firms) [2] http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agencies%29 http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agen...
GauntletWizard 12y ago
Regulatory capture is pretty much inevitable. In almost any field, the skills needed for government regulators to evaluate claims are interchangeable with the skills needed to work in the field. The only thing that will help is strong whistleblower protections, to allow the ethical members of a profession to call bullshit without fear of repercussion. (This won't work in banking, for obvious reasons :P )
- narrator 12y ago
  How about the Singapore model? Pay government bureaucrats huge salaries and pensions so they don't have to structure their career around getting a private sector cash out after they retire from regulating.
  - jonlucc 12y ago
    I'd wonder where the regulators are going to learn the skills needed to regulate. Drug development is not quite like academic research.
sjg007 12y ago
Except the major drugs are brought to both markets usually and largely made by multinationals. Many drugs get approval in Europe first before they are tested in the US.
- ekianjo 12y ago
  Most drugs go first on the American Market, because that's the most profitable one by far. Any source for your claim ?
  - chrisbennet 12y ago
    I worked for a client that was trying to develop a medical device (stents). I was told it was cheaper and faster to get approval in Europe.
    - ekianjo 12y ago
      Medical devices are not drugs. They do not follow the same regulations. And in Europe the medical device registration can be very fast depending on the type of medical device (they have standard classifications for fast review, and some are self-certification type of registration). You should never make a parallel between medical devices and drugs because those are just two very different markets. And unless you have a better source for your first point, I stand by my position that the US gets most of the approval first, worldwide. And most of the large pharma industries are American.
refurb 12y ago
The EMA isn't that much better. Just do a google search for Mediator a diet drug only sold in the EU. There were multiple signs that the drug causes heart damage. It took years and years for it to eventually be pulled.[1] [1]http://news.yahoo.com/france-drugmaker-trial-suspected-deaths-135830398.html http://news.yahoo.com/france-drugmaker-trial-suspected-death...

user_name2 12y ago

Maybe we aught to stop allowing corporations to run our media and arbitrarily censoring facts they don't like.

powera 12y ago

I think we have to face that the FDA is incompetent and corrupt. Getting a drug approved is more dependent on how much money you want to spend than on whether it works. Some drugs that may be effective are delayed for years and years ( http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-a-hopeful-drug-thats-out-of-reach/?_r=0 http://well.blogs.nytimes.com/2015/02/05/for-a-l-s-patients-... ) while other drugs that don't work are approved as being effective.

erkkie 12y ago
Most likely self-experimenting and community based "trials" are gonna be much more prevalent in the coming years, due to bio hacking opening up. Gonna be even trickier to regulate and navigate.
- ekianjo 12y ago
  Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. Plus, the public does not have access to the synthesis or new materials, and I doubt that people would actually inject themselves with drugs that have never been tested on animals in the first place.
  - erkkie 12y ago
    > Oh really ? Is that Science, in a non-controlled environment, no supervision of health care professionals ? I doubt anything like that is going to happen any time soon. You might've misread me as condoning this, not at all, but I think it's inevitably gonna happen and in fact already is, if you dig around a little bit (all kinds of life extension forums out there, not to mention the current nootropics trends). You don't have to agree with or like things to see them coming you know. > Plus, the public does not have access to the synthesis or new materials You wouldn't believe how much is possible to do in a home lab and dna/rna based techniques are becoming more and more accessible as well.
    - 12y ago

CodeWriter23 12y ago

The misconduct itself is not surprising, given that all drug studies required for drug approval are performed by the company seeking the approval. The cover-ups are also not surprising, given that industry insiders go back and forth between jobs in Industry, and running the FDA.

themartorana 12y ago
And more importantly, given that no one is ever held responsible. No one goes to jail. Again. Punishment is supposed to be disincentive to crime. With no punishment, what's wrong with lying, cheating, stealing, and killing?
- littletimmy 12y ago
  The issue here is slightly different. As the law works, there is absolutely a lot wrong with lying, cheating, stealing and killing if you are poor or black. White billionare? Nope. You can literally rape your toddler daughter and go free because the judge feels you would "not fare well in prison." (DuPont heir). Large corporation? Lol. The attorney general will argue on your behalf instead of bringing a case against you. (JP Morgan).
  - vijayr 12y ago
    not fare well in prison Jeez - I thought you were joking, but nope :( http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-case/ http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-...
marincounty 12y ago
Maybe as a condition of hire, the appicliant, if hired by the FDA, couldn't seek future employment in any aspect of the Pharmacutical industry? I belonged to a union that flat out told apprentices that they were forbidden from going through the program and opening up a non-union shop. I've always wondered about the legality of putting conditions on a job? I know the formentioned union still has the clause in it's bylaws, and it's a union in a huge city.

hurin 12y ago

Pharmaceuticals is a ridiculous industry, public health and scientific merit are on the lowest rungs of their list of priorities.

ekianjo 12y ago
To be honest I can't think of many industries which place public health scientific merit at their top priorities either. You could say the same thing about the food and beverages industries, and Soylent too if you care about mentioning stuff that makes HN tick often.
- logn 12y ago
  I can't think of many industries pushing for laws to force you to ingest their product. Eating McDonald's is not a prerequisite for admittance to pre-school.
  - ericd 12y ago
    Are you trying to imply that vaccines being mandatory is the result of lobbying and not just because it's an extremely important tragedy of the commons problem?
    - logn 12y ago
      I'm pointing out that pharma can either be treated like every other company and held to similar standards or they can act like scientists if they want mandated use of their products. And yes, pharma does lobby for laws to mandate vaccinations. edit: obviously lobbying is not 100% responsible for all vaccinations laws, but it's partly so and increasing.
      - jamestnz 12y ago
        Fine, but obviously it's not only the vaccine manufacturers who are pushing for things like mandatory vaccinations for public school enrolment (except where unable, e.g. immunocompromised children unable to tolerate the vaccination itself). It's also, y'know, people with an interest in promoting public health, people who understand the concept of herd immunity, and people who have a reasonably tuned sense of social responsibility. So, sure: Big Bharma employs lobbying as part of their business strategies. This is both unsurprising and irrelevant to the overall societal benefit of high immunisation rates. > edit: obviously lobbying is not 100% responsible for all vaccinations laws, but it's partly so and increasing But how can you tell that the number of vaccination laws passed due to lobbying is increasing? Or possibly you just meant that lobbying dollars are increasing. But higher dollar values alone would tell us nothing about the relative success of that lobbying in getting laws passed. For example, perhaps the laws were going to be passed regardless, and the increased spend is illusory, being attributable to a general trend of increased lobbying spend in US big-business, inflation, or other factors. In an environment where lobbying is the norm, I think gauging the "effectiveness" of lobbying spend, especially for something which lots of people generally seem to support anyway, is a hard problem.

pasbesoin 12y ago

To clarify: I'm not calling for less regulation from the FDA. Far from it. Rather, I'm pointing out that in the follow instance where more regulation is being called for, a major influence is again Big Pharma and the motivation is, to my eyes and reading, not primarily consumer protection. ---- There is also the other "half" of this FDA saga. "Supplements" and herbal treatments are a mixed bag, and there are fraudulent manufacturers and suppliers in this market as well. However, there are repeated pushes to get the FDA to more or less outlaw all of them and/or to regulate this marketplace out of existence. I'm someone who, along with more than a bit of grief from pharmaceutical industry products, has actually found some significant results in the "natural" marketplace. I've had to be careful, and I've had to find manufacturers who actually deliver what they say. But the idea of one of these knee jerk, "ban 'em all" reactions taking these items away from me, scares me in no small measure. The FDA appears no longer to be an effective regulator; it has become ever more an economic and political tool of the most moneyed private interests. (Where a focused Big Pharma far outweighs the broader field of smaller supplement providers, for example.) To be somewhat repetitive, I don't want to discount the significant problems with the "supplements" marketplace. But I have been able to achieve results with it that I have not found in the pharmaceutical marketplace. I am unwilling to cede this territory to the pharmaceutical companies, as they seek to have it shut down -- for their own economic self-interest, rather than the public interest.

fapjacks 12y ago
I am in a similar situation, using a product which the FDA has declared unfit for human consumption based on anecdote. The FDA has stolen my mail a few times, despite the substance not being controlled or otherwise illegal. The FDA has a really bizarre set of priorities, and "protecting consumers" is somewhere either at the bottom or just not even on the list at all.

harkyns_castle 12y ago

I feel like we're so deep in the mire now, of this kind of corruption and control by wealthy people/interests/entities, it'll be tough, if not impossible, to dig out of. Being a fairly selfish person, that's not for my own self interest. Its a recipe for disaster. We need a massive overhaul. Edit: Lobbying and the ability for a fiat currency to control decisions, and revolving door setups, seems like the obvious first step to me. But the people that can make that happen are the people that benefit from it currently. Bring on a new planet, without those types of people.

colechristensen 12y ago
It is only with a false view of the past that today can be seen as more corrupt than any point in history. Of course there is an ebb and flow of where the corruption lies, and to what extent it takes hold. People tend to forget that we're living in the safest, most transparent, most free point in the whole of human history. We've been digging ourselves out of a pit of corruption for ten thousand years, don't let yourself be fooled into thinking things are terrible by focusing on a few things that have gotten worse over a decade or two. Big picture: things are and have been getting massively better continuously. You should be celebrating that such corruption can so easily come to light instead of decrying doom that it has been discovered.
- FeeTinesAMady 12y ago
  Celebrating that is a recipe for resting on your laurels and allowing it to continue. There is nothing to celebrate here. You should be mad as hell and doing something about it.
- meric 12y ago
  I was trying to think of an argument to disagree with you with but you're right. From the times of Woodrow Wilson's reign to John Edgar Hoover and Nixon to the NSA, there's never really been a time in the past hundred years some part of the government wasn't corrupt and power hungry. And probably even before 1900 too with slavery and subduing of the Indian tribes. The freest least corrupt point in USA government's history is probably July 2, 1776.

DigitalSea 12y ago

Both honestly and sadly, I think nobody is actually legitimately surprised by this. The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable. If anyone hasn't seen John Oliver's latest video, it's on the whole marketing to doctors thing and touches upon the pharmaceutical industry and I highly recommend watching it: https://www.youtube.com/watch?v=YQZ2UeOTO3I https://www.youtube.com/watch?v=YQZ2UeOTO3I - he sums it up perfectly.

refurb 12y ago
The pharmaceutical industry is a profit machine that will do anything to ensure that it remains profitable. But this isn't about the pharmaceutical industry, it's about the FDA. The FDA is clearly catching these companies doing wrong, so why are they covering it up? And if you think the FDA and the pharmaceutical industry are in bed with each other, I would have to disagree (coming from the industry). The company I used to work for would never mess with the FDA since you could be shutdown in an instant. To be honest, I think a lot of the FDA failings come from a lack of resources. Most of the drugs people take in the US and EU are made in places like India and China. The FDA is just starting to think about inspecting those plants. They just don't have enough inspectors to make sure each and every manufacturer is doing things by the book.
- hurin 12y ago
  > (as someone coming from the industry) What do these particular failings referred to in the article have to do with the FDA's lack of resources? From what I can see all you are doing is trying to change the subject of discussion away from the industry.
  - Intermernet 12y ago
    I personally think @refurb asked exactly the right question (whether he's from the industry or not). >The FDA is clearly catching these companies doing wrong, so why are they covering it up? This deserves more research. Don't get distracted by "big pharma", ask why the FDA aren't doing anything about the wrong-doing they're uncovering. Occam's razor cuts towards lack of funding. Next question: Who is in charge of FDA funding? How can this be changed?

Alex3917 12y ago

Tokenadult, Out of curiosity, given that you've said in your previous comments that you believe medical questions are best answered with 'science-based medicine', which is a philosophy that explicitly rejects evidence-based medicine: do you believe that the FDA covering up scientific fraud is bad, or do you agree with the FDA's argument that it's justified? Also, do you still believe that "It's an exaggeration (contradicted by thoughtful comments by drug industry researchers who have already posted replies in this thread) to say that the enterprises that develop new drugs for prescribed medical treatment are corrupt in general [...]."?

austinz 12y ago
Question (not being sarcastic): what's the difference between 'science-based medicine' and 'evidence-based medicine'? I did a quick Wikipedia search, but the former just redirects to the latter.
- wanion 12y ago
  Science Based Medicine is a movement to improve Evidence Based Medicine with a stronger focus on scientifically rigorous evidence. It's not in opposition to EBM. To quote the SBM blog's about page: "Good science is the best and only way to determine which treatments and products are truly safe and effective. That idea is already formalized in a movement known as evidence-based medicine (EBM). EBM is a vital and positive influence on the practice of medicine, but it has limitations and problems in practice: it often overemphasizes the value of evidence from clinical trials alone, with some unintended consequences, such as taxpayer dollars spent on “more research” of questionable value. The idea of SBM is not to compete with EBM, but a call to enhance it with a broader view: to answer the question “what works?” we must give more importance to our cumulative scientific knowledge from all relevant disciplines." You can find the original Science Based Medicine announcement on their blog http://www.sciencebasedmedicine.org/hello-world/ http://www.sciencebasedmedicine.org/hello-world/ and there's a decent bit of background on Pain Science https://www.painscience.com/articles/ebm-vs-sbm.php https://www.painscience.com/articles/ebm-vs-sbm.php as well.
  - 12y ago

zipfle 12y ago

I find it really interesting to juxtapose this situation with the current furor over Brian Williams' not actually having been in a helicopter he said he was in. It's odd, but not too surprising, that the only job you can actually get fired from for lying is "propaganda mouthpiece."

bgun 12y ago
the only job you can actually get _publicly shamed and publicly_ fired from for lying is "propaganda mouthpiece." Someone being fired for lying, and someone you heard about getting fired for lying, are very different things.

graeme 12y ago

How much of this could be solved by replication? Some sort of rule where we say, formally, not to take any study seriously unless it's been replicated? On the one hand, it's very bad that the FDA has covered this up. But on the other hand, there was science before the FDA. I may be interpreting the article wrong, but it seems as though the FDA is merely failing to prevent bad science. Presumably, journals that cited these experiments didn't replicate that and knew they weren't replicated. Is science too complex and expensive to replicate these days? If so, is it even still science? (Those are actual questions, not rhetorical ones. I don't know the answers here). Edit: For some reason, at present my comment seems to be the top comment. I don't want to detract from the story itself. The actual issues at the FDA raised by the article deserve discussion.

Scaevolus 12y ago
Clinical trials are very expensive to run. The only people financially interested in running them are the pharmaceutical companies trying to make new products available. Replication is hard enough to achieve in hard sciences where replicating a study might cost tens of thousands of dollars. Finding the money to replicate or refute a clinical trial for millions of dollars is very difficult.
- graeme 12y ago
  So can we still call it science, or not? And if not, what do we call it?
  - chris_va 12y ago
    Well, technically they are replicating the study over 50+ different hospitals until they reach some confidence interval on the safety data. If you get fraud in a small fraction of them, it should not (and if you read the actual testimony, does not) impact the net result.
    - static_noise 12y ago
      If you need 50 experiments to actually show that the effect exists, then even a small fraction of fraudulent experiments can heavily skew the result when looking at confidence intervals. Think of selfhealing as a coin toss with 50/50 chance and a medication increasing this chance: a) Medication increases healing chances to 80% -> Only few experiments needed. b) Medication increases healing chances to 55% -> Many experiments needed to prove that the effect exists. c) Medication is not effective but 5% fraud is introduced so that data shows 55% healing chances -> The same as in b) but with only "a little" fraud involoved.

molyss 12y ago

I'm just wondering something probably very stupid. Shouldn't an FOIA request turn back all information that the article claims the FDA is refusing to give away ? Looking at the FDA FOIA exemption list (http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm http://www.fda.gov/RegulatoryInformation/FOI/ucm390370.htm or http://www.foia.gov/faq.html#exemptions http://www.foia.gov/faq.html#exemptions), there's none that seems to match a drug name, a lab's name, a detail on a mistake or even communication between ab and FDA. The only things that I would think apply would be internal FDA comm, and patient names. None of the things I cited sound like : - national security threats - internal rules - breaking federal law - trade secrets, commercial or financial info - inter/intra agency comm - personal privacy (if we exclude patient names) - law enforcement info - supervision of financial institutions (that's an interesting exception to see BTW) - geological info on wells (totally off topic, but I'm kind of curious about this one). It looks like the author si as baffled by the assumption that misconduct fall into the "commercial info" exception... Really scary also is the whole orange book thing. I thought generics were actually the exact same molecule, as in "we've done a mass spectrometry of the stuff, and it's the same shit, only cheaper". It looks it's not at all the case... Reading the wikipedia talks on generic drugs, it looks like there was confusion there as well (http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book http://en.wikipedia.org/wiki/Talk%3AGeneric_drug#Orange_book). As of today, there's only one reference to the word molecule in the wikipedia article ("[...] most small molecule drugs are accepted as bioequivalent if[...]), which doesn't seem to address the confusion. Assuming (and it's a pretty big assumption) that insurances really want you to get better, it would then look like the should tell you _not_ to use generics, rather than pushing you to. Argument could be made that you only depend on them for a limited time. I guess the same argument could be made for public healthcare systems (like France), in the sense that you're less expensive dead on generics than alive on the real stuff, but I sound a bit cynical, even to myself.

zerocrates 12y ago
Generally, generics are required to have the same active ingredient as the brand-name, in addition to showing bioequivalence.
- 12y ago

CodyBZ 12y ago

Statins are the most widely prescribed drug on earth. The drug company's report that myopathy occurs in 1% of the population. Field reports show that number is around 20%. One in five people statin intolerant due to muscle disorders. Its common knowledge these drugs can cause serious muscle problems, yet most doctors are unaware. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3463373/ "It is impossible to discern the true incidence of mild muscle complaints because these problems typically are not examined in pharmaceutical sponsored trials and because of study design. In HPS, for example, subjects were not randomized to simvastatin or placebo until they had successfully tolerated simvastatin 40 mg for a 5 week introductory period (17), and most trials report muscle symptoms only when CK values exceeded 10 times upper limits of normal."

tracker1 12y ago

Simple, take away patent protections from the drug companies for derivative works... Then make all unredacted documents regarding FDA trials once a medication is approved for use available publicly... The first will lead to correcting bad faith efforts and marketing in the drug companies... the second will lead to fixing the FDA.

MichaelGG 12y ago

A related and very interesting story is this article[1] on Ranbaxy. Basically this company was corrupt and fraudulent from the top down. Falsifying data, copying competitor information as their own, etc. Or encouraging internationally traveling employees to privately import medicines to India for them. Or asking doctors on staff to write prescriptions for everyone in the office to boost sales figures. The FDA applied light bans, only on individual manufacturing sites, allowing the company to continue to push out product from other sites. Including making a bunch of pills with glass fragments in it. The FDA eventually fined them $500M, and the company has since been bought by Sun Pharma, the largest in India. Zero indication that the systemic corruption, fraud, poor quality, etc. have had real change. 1: http://fortune.com/2013/05/15/dirty-medicine/ http://fortune.com/2013/05/15/dirty-medicine/

hga 12y ago
A bit more happened, last year the FDA started making unannounced visits to their production plants in India. When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. This Google search will provide a lot of info, https://www.google.com/search?q=Ranbaxy+flies https://www.google.com/search?q=Ranbaxy+flies that's "flies" as in those disease spreading insects. One of the articles had a picture of a man unloading dung from a cart with a Ranbaxy plant in the not too distant background.... I pay attention to this because I take a lifesaving maintenance medicine that my medical plan currently sources from Sun :-(. Since that and another important drug I take went generic over the last few years, my doctor has been very happy with my reporting that to me, they seem to be bioequivalent. He's in a field when generics of one class of drugs, the anti-convulsants, are notorious for not being easily substituteble with brand name. Ah, a bit more on that fabulous Fortune article: their First World drug mules were being asked to deliver First World brand name manufactured drugs so that Ranbaxy could falsify equivalence tests. One US executive left the company after the 2nd "wow, these guys are so good their data matches the brand names's point to point" "coincidence".
- refurb 12y ago
  When I checked on this about a month ago, it appeared that every Ranbaxy plant in India had been shut down. I'm not sure if they are shutdown, but the FDA has banned imports into the US from everyone of the Ranbaxy plants. Sun Pharma is in a bad situation with this since they can't sell into the US market from their new acquisition.

SixSigma 12y ago

The juxtaposition of adverts for "earn money participating in medical trials" at the top of the page made me smile. http://imgur.com/nZTnzb5 http://imgur.com/nZTnzb5

known 12y ago

Can't you cross check with https://en.wikipedia.org/wiki/European_Medicines_Agency https://en.wikipedia.org/wiki/European_Medicines_Agency ?

known 12y ago

I normally cross-check with https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research_and_Quality https://en.wikipedia.org/wiki/Agency_for_Healthcare_Research...

nodefortytwo 12y ago

Could this type of investigation be done automatically. pulling data from FDA and cross referencing against medical journals and FDA redacted docs. I would love to try however I don't feel i know enough about the available data to work out what would be required

tokenadult 12y ago

I post a fair number of stories about regulation of medical treatments here on Hacker News. I see this one has attracted a lot of reader interest. The comments already posted as I post this comment point out that once someone sets up a regulatory program, the incentives become powerful to figure out ways to cheat the regulators. And, as usual, scientific research is hard (another topic I post a lot about here), and researchers all operate under incentives to publish interesting and hopeful results rather than acknowledge that their research program didn't show what the researchers hoped to show. The submitted article identifies a specific problem in how the FDA doesn't publish identifying details of studies that its own inspectors discovered to have problems. Biomedical researchers, then, don't know which previous study findings are flawed, even though the FDA detected flaws, and much time and effort is wasted trying to pursue research results that don't reflect reality. That has to change. Meanwhile, there is a different pattern of regulation for some products that consumers in the United States take regularly as they seek better health, namely "natural supplements." For natural supplements, the regulatory problem is far worse, because those products can go on the market with no research done on safety or effectiveness at all, and without even any guarantee that the product contains the labeled active ingredient,[1] a plain violation of the warranty of merchantability in the Uniform Commercial Code. So the better trade-off for the consumer here is to amend existing law so that as drugs go through clinical trials, disclosure and peer review of FDA inspection findings during the trials is a condition for marketing approval. If manufacturers can't deal with that kind of regulation, tough. But it's only fair that natural supplement products, a multi-billion-dollar industry, should be regulated the same way. (To answer a question asked in another comment, already well answered overnight in my time zone, yes, "science-based medicine" includes "evidence-based medicine," that is clinical trials, as a subset of practices that include also consideration of fundamental principles of science and statistical understanding of prior plausibility before interpreting clinical trial results. If a sample size is small enough, many implausible treatments can look like successes in a clinical trial, especially for subjective, patient-self-reported symptoms, but we shouldn't call such treatments effective until they have been replicated in larger samples and verified with independently gathered "hard endpoint" data about clinical signs.) [1] "Searching for the supplement in your supplement" http://www.sciencebasedmedicine.org/searching-for-the-supplement-in-your-supplement/ http://www.sciencebasedmedicine.org/searching-for-the-supple...

vaadu 12y ago

The authors better be careful or the next contact they have with government documents is notice of an IRS audit.

parallelist 12y ago

Talk about this kind of journalism out of context (why you don’t trust a particular study, for instance) and you’ll be called a quack or conspiracy theorist.

edkennedy 12y ago

Time to split into a Food Dept. and Drug Dept. and reform them from the ground up to be health based rather than corporately based.

thisIsNotMikey 12y ago

The problem with the FDA is it usurps liability from the manufacturer and responsibility from the consumer. Most Americans will grant more time to a free app review, than to a nutrition label. We have a false sense of security that food and drugs are FDA "approved." This same problem exists in banking because of the FDIC. How many people know what's on their bank's balance sheets?

acdha 12y ago
How many consumers are capable of evaluating drug safety and have time to do so? This is a real problem requiring time from a limited number of highly skilled professionals and easy proposed solutions are naive.
- thisIsNotMikey 12y ago
  The consumers directly don't. But as a consumer I don't know how to evaluate an automobile, a smart-phone, or other products. But there is a market that provides the relevant data to consumers. Before I buy a car, I check out USNews, or Edmunds; before I buy any product I check out the relevant resources. Because of the way the FDA is structured, not much non-FDA research and reviews are being done. Lol. I didn't propose a solution.
  - acdha 12y ago
    … and those markets have a long history of being gamed despite enjoying much larger numbers of people who can check the work. The drug market is huge and extremely lucrative which ensures that any successfully started review service would be under attack from multiple fronts – lawsuits, attempts to hire people away or buy influence, setting up “competing” groups which try to sound legitimate but exist only to attack the other group’s claims, etc. Read the history of what happened with say the financial ratings companies during the 2000s for one side (regulatory capture) and the tobacco or fossil fuel industry for the dirty tricks version. There's no reason to think that wouldn't keep happening, all of which dramatically increases the cost and likelihood of failure.
12y ago

tangerine_beet 12y ago

This article really brings home the truth of how helpless we are in the face of corrupt government bodies like the FDA. You can just picture von Eschenbach and his group reading the piece, and then calculating whether a response is going to be needed: Maybe it will all blow over if we just stay quiet? What can one do as a citizen to fight this kind of corruption?