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/

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".

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.

As for Sun, who knows? In 2008 Ranbaxy managed to pawn off 64% of the company to Japan's Daiichi-Sankyo for $7 billion. Sun bought that stake in 2014 for $4 billion ... in Sun shares, i.e. a firesale price, at least compared to the original. And Ranbaxy has lots of plants outside India which to my knowledge and recent research can still ship to the US.

Although I'm not sure how many of those actually synthesize the raw stuff as these Indian plants did, then again Sun is probably best off with them shut down; that they didn't proactively deal with the Ranbaxy's cancer ... well, you can see why I'm nervous about that drug I'm taking.

Let me put in a word for Indian English: the usage of "promoters" for that class of businessmen is perfect.

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.

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 )

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-death...

[1] http://en.wikipedia.org/wiki/Big_Four_(audit_firms)

[2] http://en.wikipedia.org/wiki/Big_Three_%28credit_rating_agen...

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.

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.

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.

Lol, good intentions are worth absolutely nothing. Your misallocation of resources story isn't really helpful either, if you think the SEC made a great move in structuring financial instrument ratings - explain it.

People are bad, therefor we need a government made of people are bad, therefor we need a government made of people are bad...

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.

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.

Merely repeating the original experiment might simply repeat the design errors of the original experiment. For example what if I drop a feather a bunch of times and find a value for g (gravitational acceleration) of 3.4 m/s^2? If you drop a similar feather you'll probably get a similar value, but that doesn't make it right.

The real question is not replication, it's whether I've found an accurate value for g. In that respect, science is better advanced if you attempt to confirm this value by designing your own experiment to test it, by dropping something else (a rock, maybe) instead of a feather.

We're well beside the original point of this thread now, but the focus on replication is a bit of a pet peeve of mine.

edit: clarity

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.

My role was to develop the custom software that ran on laptops we gave to hospitals involved in the clinical trial. In the drug manufacturing world, anytime computer software is used in a clinical trial or in the tracking of drug production, you have to have the software validated.

Software validation is basically a process by which you hire an outside company to go over what your software does. Similar to an ISO certification. The folks & companies you hire are very clueless... They know enough buzz words to ask good questions but they often over look things.

Anyway, long story short, the whole process of just collecting data is riddled with security problems. None of this, as far as I know, is exposed to the public either. So if buggy software is, somehow, corrupting test results, there is not feedback loop to correct or discard the data. Companies like the one I worked for at the time, would throw out the data as a policy and start over. Hence, very expensive situation and very crucial to make sure your systems do the right thing the first time.

This was in the late 90s and in one situation I was in charge of some software that we were developing that was expected run past Y2K. Back then there was a lot of hoopla about the Y2K century roll over and what it would do to computer systems.

The company we hired validated our software for Y2K use cases but they often over looked basic things like data encryption, plain text storage of user passwords, etc...

I imagine the validation companies have gotten better over the years but in the end I learned that software validation is nothing more than a big CYA tactic. It's a paper trail to try and claim we did our due diligence if the shit were to hit the fan.

Somebody has to be first.

That said, is an interesting question.

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.

A major flaw I see in most medications studies is that the market prices for the experimental drug or placebo are not included in the study.

My hypothesis is that a placebo described as costing $1000 per dose will produce a greater effect than a placebo described as costing $10 per dose, even if the patients are not asked to pay that cost.

Could it be that those drugs that barely outperform a gratis placebo are only producing that effect because the act of charging more for them makes them better placebos?

If that's the case, the fraud would only be needed to eliminate evidence of harm to get approval for a bogus remedy. All the effectiveness would come from magnified placebo effect.

I think there was a study which compared different placebos and the more expensive ones showed better effects. So your hypothesis may be right.

If it's done according to the scientific method, then it can be called scientific research.

If not, it's just research.

Yet odds are that most of the people taking it (for any value of "it") have smartphones and could be prospectively matched with people not taking it (I'm an enemy of case-control studies for lots of reasons, but this may be an area where a well-designed one would work.)

The FDA won't approve a drug without at least two positive phase III trials (some exceptions for oncology and other fatal diseases).

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."

http://imgur.com/nZTnzb5

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 [...]."?

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/ and there's a decent bit of background on Pain Science https://www.painscience.com/articles/ebm-vs-sbm.php as well.

You do not test basic physical laws, you just look them up.

Downvoters: Please explain. I have no idea about what any of SBM or EBM is, and I hadn’t even heard about any of them before now. This is genuinely what I what to know when I encounter the terms.

For example, homeopathy states that a remedy becomes stronger the more dilute it becomes - i.e. the lower the dose, the stronger the effect. This defies the dose-response relationship between an active ingredient and its effect. Further, it states that even when no more of the active ingredient remains, it can still have an effect.

SBM would say homeopathy isn't worth studying because it has no plausibility based on what we know of medicine and physics.

EBM would say let's test it and see what we get.

The problem is that if you test the same thing enough times, or measure enough variables, and then discard the ones that don't meet your desired outcome, you can gather "evidence" for basically anything.

SBM would say weak evidence for a claim like homeopathy is meaningless, as the claim is extraordinary (it overturns physics), so you need stronger evidence than you might accept for a less exceptional claim. EBM doesn't make that judgment, it treats all evidence as equally valid.

There is a treatment for trauma (PTSD etc.) called EMDR (Eye Movement Desensitization and Reprocessing) which has over 20 years of statistical evidence backing up it's efficacy. To date, no-one really knows how it works (there are a few good theories, and hopefully modern neuroscience can help here).

Currently, it's "EBM". There is a huge amount of evidence to show it works, but no proven theory as to why.

It's not "SBM" yet, as there still isn't a demonstrable mechanism or theory that describes why it works.

homeopathy, antivaxers and scientoligists don't even have any evidence to show they work. They don't even count as "EBM".

SBM, despite the name, believes that using science to study medical treatments is often a waste of money regardless of whether a treatment is very effective or completely ineffective; their claim is that there will always be some studies that say the treatment works and other studies that say the treatment doesn't work, and spending more money will just yield more unreliable data. They therefore believe that the bulk of scientific resources should be dedicated to research reinforces society's prior beliefs, and that research on the efficacy of any given drug should be weighted based on society's prior beliefs. You can read more about this philosophy here:

http://www.sciencebasedmedicine.org/hello-world/

If it seems somewhat muddled and handwavy as to how exactly prior beliefs and evidence should be weighted, well, this is why I personally think of SBM as the 'white person stamp of approval' approach to medicine. But certainly they have a point that a lot of medical research is complete crap.

I also presume that there is a more important aspect. If society believes that homeopathy works and that vaccines cause autism, that would be good cause to conduct very rigorous, credible (and above all media-friendly) experiments testing those beliefs.

If society believes that eating too many eggs is bad for you, test it. If we believe drinking red wine is good for you, test it. If we believe reptilian aliens are using sodium fluoride in the water supply as an adjuvant for their mind control rays, test it.

I presume, without knowing, that this particular aspect of SBM is very much about countering all the junk science hucksters stowing away on the gravy train, just because no one bothers to grab their freeloading asses and throw them off. So when Dr. Selschupplementsondeside (who may or may not be inspired by an actual person) touts a miracle cure on his cable television show, you put that on your list for potential testing and start tracking the hype versus scientific credibility ratio. If too many people start believing without knowing, you need some experimental results.

We can't test everything, so focus on testing the unanswered questions. Test the home remedies and traditional cures. Debunk the junk science.

I mean a large part of medical research is basically appropriating plant medicine from indigenous cultures and then sending people to prison for using the same medicine in plant form. So yes, racism does play a large part in the medical system.

----

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.

Nor, honestly, does it support the "getting a drug approved is more dependent on how much money you want to spend than on whether it works" claim, or the "some drugs that may be effective are delayed for years and years".

Developing a drug is an incredibly complex operation. The FDA requires evidence that a drug will not kill people before it will approve it, which means that most drugs need to be tested in thousands of people. That requires outsourcing clinical trials to hospitals, which are then paid per patient to take on the extra work.

The original link cites corruption at the hospital level, which does seem like the weakest link in the system. The hospitals/doctors get paid based on getting patients through the trial protocol, or at least saying they did. Much of the cost born by pharmaceutical companies is actually auditing this process, to make sure it happens correctly.

Just yelling about the FDA will not change the corruption practices of a hospital in China.

If corruption stopped at the hospital there, then this wouldn't happen at the FDA:

> As David Ross, the FDA official in charge of reviewing Ketek’s safety, put it, “In January 2003, over reviewers’ protests, FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.”

Corruption goes beyond the hospital level and it extends into the FDA itself.

> As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted.

The redactions are not surprising to me. The FDA is a regulatory agency that deals with very sensitive and confidential information. They are not a criminal agency, and this isn't some district attorney asking for the information.

The testimony: """ After considering the fact that the investigation results were preliminary and we had not received formal recommendations about how to take the results into account in review of the application, and the fact that only in very rare cases do inspection results from individual sites lead to the exclusion of an entire large clinical trial, FDA decided to hold the Advisory Committee meeting as planned. The Agency made this decision, knowing that any advice from the Committee would have to be later taken into account in the context of additional information about the integrity of data from Study 3014. It is not unusual for more information to come to FDA for review after an Advisory Committee meeting is held about an application. The Advisory Committee voted that the safety and efficacy of the requested indications had been demonstrated, based on the information it was provided, including Study 3014, and limited international post-marketing data provided at the meeting. Although the Advisory Committee recommended approval, on January 23, 2003, (two weeks after the Advisory Committee meeting) FDA issued another approvable letter to the sponsor because of the remaining questions about the safety of Ketek. The letter specifically noted the unresolved data integrity issues associated with Study 3014 (issues confirmed in the final clinical inspection summary of the Agency's audits of the first three clinical trial sites) and the incomplete post- marketing safety data from foreign countries. FDA noted that the final decision regarding approval of each indication would be made after a review of the information and analyses requested in this letter. On March 3, 2003, during a closed session of the Advisory Committee convened to discuss other matters, FDA briefly explained that an approvable letter was issued because the Agency wanted to see more information about data from Europe and Latin America. With regard to Study 3014, FDA explained that there were unresolved inspectional issues. Third Cycle. The sponsor submitted a complete response to the approvable letter in October 2003. The October 2003 submission addressed issues of Study 3014 and included post- marketing reports for spontaneous adverse events for approximately four million prescriptions for patients in other countries where Ketek had already been approved. Upon completing the review of the sponsor's October submission, including the findings from the additional audits of clinical trial sites summarized in a March 2004 memorandum from the Division of Scientific Investigations, the Agency decided that it could not rely on Study 3014 to support approval of Ketek because of the systemic failure of the sponsor's monitoring of the clinical trial to detect clearly existing data integrity problems. Accordingly, Study 3014 was dropped for consideration in making the decision whether to approve Ketek. The Agency considered data from other clinical trials and the international post-marketing experience to conclude there was adequate evidence of safety. """

Yes the FDA is a regulatory agency. In my mind, it's similar to the IRS, SEC, or FBI. It ensures that specific people and organizations are complying with rules and regulations; in other words they enforce the law. Also I'm not sure how the agency has to hide whole bogus studies to protect confidential information. It's not like they can't redact sensitive portions (things like drug names and misconduct don't count) of it instead of just hiding the whole thing. Am I wrong?

Now, one could argue that all clinical and pre-clinical data used for the drug approval process should be public information. That is a very complicated argument (and I actually come down on the "public" side, but it would take a long time to explain).

http://www.washingtonpost.com/wp-dyn/articles/A9802-2004Sep9...

Basically the FDA ordered pharma companies bury the research showing that antidepressants were ineffective in children and could lead to suicide, because they were worried that parents would stop spending money on them.

As for the suicide risk, again, there is data to suggest that antidepressants can increase the risk of suicide. However, that data isn't cut and dry. Over the last few years the FDA has actually loosened it's warning since the data is in question. Note that the FDA required all of these drugs to have a black box warning stating the risk of suicide (the most strict warning any drug can have).

Producing and testing drugs does not result in a binary outcome (drug good/drug bad). What the FDA does is look at the risk/benefit and makes a decision on that. Frankly I think they do a pretty good job at it.

I'm all for allowing patents to access unproven medicines, but why should the companies be allowed to run billion dollar marketing campaigns saying that they work?

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.

Sure, but combine the lack of such equipment for most people with the fact that your experiments will have small n size (because of lack of pilot plant scale to do proper large batches of drugs) and the significance of the home trial drops to nil.

For preview google about the current issues around people 3d printing their own dental braces (or prosthetics).

Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands.

P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.

When the receiver fails, you silently lose the hypoglycemia alerts.

I've already ordered a pack of Wixels to setup these throughout the house, backyard, and at his preschool:

https://github.com/StephenBlackWasAlreadyTaken/wixel-DexDrip

If evidence helps, let's talk about Thalidomide. http://en.wikipedia.org/wiki/Thalidomide

Hacking doesn't always produce a positive result. Who is going to take responsibility for the negative results?

The article you linked about one drug in West Germany does not take into account the overall benefit to health of learning that information and allowing more beneficial drugs to also enter the market quickly.

You could quibble about the numbers but it's important to understand the principle before doing so.

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 - he sums it up perfectly.

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.

Fortunately it's a lot better than that. They have been inspecting them for a long time, but infrequently and preannounced, and even then caught some in the act. After the gross, top to bottom fraud of Ranbaxy, they started doing unannounced visits, which has resulted in every one of their plants in India being shut down: https://news.ycombinator.com/item?id=9043423

There's some overlap, right? http://geke.us/PharmaVenn.001.jpg

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.

>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?

So the usual handwavy appeal to "regulation" that is so common I'm comfortable implicitly reading it into the above criticism despite it not explicitly containing it is not enough.

I'm generally libertarian, but behind that libertarianism is not the belief that the government "can't do anything", but more the observation that a lot of people go through the following process:

    1. Identify a problem. Maybe. (Accuracy is optional at this stage.)
    2. Claim we need "regulation". No details given.
    3. Case closed!

Nope, it's a hard problem. It's a lot of hard problems, and people who just attack industry and handwave haven't even properly engaged with the problems, let alone solved anything. The fact that there is such widespread belief in the airy handwaves of "regulation" is itself a primary cause of things like this sort of dysfunction... it becomes a political attack to claim that the regulation has a problem because of course it's working, how can it not? It is literally inconceivable, and to emphasize, I mean, literally not expressible in the relevant neurons in people's brains. People treat it as an atomic entity that can not be further investigated, rather than as a complicated mechanism in a complicated system that requires systemic analysis, and the resulting possibility that on occasion, yes, the regulatory agents will be broken.

(From a positive perspective, my libertarianism comes from the observation that markets are freaking powerful and regulatory regimes, since they are created by people whose thinking is biased into an "us vs. markets" modality rather than the aforementioned "systemic analysis" often screw up, either by missing chances to harness the power of the market, or by fighting them in ineffective or inefficient (in the usual sense of the term, not EMH) ways. This blindness results in regulatory regimes that start from day one by first dropping their most powerful tool on the ground. Unsurprisingly, this often results in less effective regulation. We need regulation because not even I want to live in a raw market-dominated world, but nobody wins when it's done stupidly because of preconceived moralistic notions about markets, which are in many ways best conceived of and treated as natural forces rather than demonic embodiments of pure evil or something equally silly, and thus something best harnessed properly, not fought and pilloried. In this case, I'd suggest that a more market-comprehending regulatory regime would understand that transparency and openness are key to properly keeping the system functioning properly, and that the top priority the first time they received any information like this should have been getting word out to people. But, that's not part of how they think, because the idea that this could have been nipped in the bud much earlier by harnessing the power of information flows in a market simply isn't in their DNA. In all likelihood they wouldn't hardly have needed to do much of anything else, but instead the inevitable logic of a market-fearing regulator, through several steps I'm not explaining, leads to this sort of coverup with distressing frequency.)

I don't know what soylent is (beyond just searching it in google). Wikipedia says:

Soylent is a nutritional drink, intended to cover all human nutritional requirements for an adult so that it may serve as main or sole food

There should be a very obvious test for this right? I think a large-scale controlled study would likely show negative effects compared to a randomly sampled population consuming the nutritional equivalent in natural products. This is actually part of the problem - you'll never read about such a study. Why? Because there is no profit incentive for anyone to finance a large-scale study that proves soylent or hypothetical product X to be useless or harmful.

If soylent (or company X) finances a study of their product and the results are contrary to their expectations (assuming the researches are honest and do not engage in fraud) - they can simply shelve that material - and if eventually study i++ is successful they can publish that (without ever referencing any number of past unpublished studies).

The FDA is wasting my money and yours (if you are a US citizen), in a way that normally should address this imbalance of selective interest in research. That it does not - hardly surprises me.

Yes, definitely, but I'm pretty sure it won't happen, and such a solution should not be allowed to make such claims ("intended to cover all human nutritional requirements for an adult") without any data supporting it, or at least a clear indication of the risks people take on it. In any case, some data is needed before you sell this kind of stuff to the public.

Products like Soylent or Plumpynut are foods, not drugs. Replacing one's entire diet with Soylent is logically equivalent to choosing to eat a banana rather than an apple with your lunch today.

If you have kwashiorkor or beriberi or scurvy or pellagra, it is unlikely that you could be effectively treated with Soylent, because it is formulated to satisfy daily needs, rather than to correct a deficiency that may have taken many months to manifest symptoms. It is designed to be a complete food, using a recipe.

And if you watched the movie (it doesn't hurt all that much), you would know that only Soylent Green was made from people, rather than algae, as was claimed. The Soylent company sold other types of food products, and everyone ate mostly Soylent-brand foods, because they could not afford anything better. In the film, all the extras got most of their nutrition from Soylent Orange or Soylent Blue, or whatever those grubby-looking flakes were in the bins. Soylent Green always sold out early, and was in short supply.

Still... not the best naming decision. Most people haven't seen any more of the movie than the scene where Heston cries "You've gotta tell 'em. Soylent Green is people!"

Define "nutritional equivalent" and "natural products"?

Do you just want the same levels of carbs/fat/protein as Soylent has, or do you want to also get the same levels of iron, sodium, vitamins, etc.? The more demanding you make that condition, the closer you get to just replicating Soylent. ("We could replace this artificial ingredient with that natural one, but the natural one has less salt, so to make up for that we have to...")

And it hardly seems fair to compare Soylent against a natural equivalent of Soylent, which doesn't currently exist to my knowledge, instead of against people's actual real-life diets.

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.

> 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.

I just discussed this with my 81 year old father, who along with everyone else stood in line for the first polio vaccinations; that was the big fear for adults who'd survived the other things children are immunized for like measles, e.g. FDR lost almost all the use of his legs from it when he was 39 and counted himself lucky. I myself was born early enough that I got a lot of vaccinations as they first became available, and my parents, my mother a former RN, were very happy about this state of affairs.

Seriously, you might as well read Kippling's The Gods of the Copybook Headings in favor as anything else about this rank insanity. As well as gain a much more sympathetic view of the "less enlightened" of the world and history, as we arrogantly view them.

And if you want hard numbers to analyze the impact of lobbying, you're not going to get it, because lobbyists have lobbied against transparency laws. Anyhow, the impact is real such as with Merck and Gardasil. Further, it's not only laws that matter but court precedent and CDC policies.

But certainly you're right that many unbiased/disinterested people agree with pharma. It's definitely not an issue only related to profits.

Consider: Eating McDonalds could certainly be a prerequisite for admittance to McPreSchool, the worlds largest hypothetical private preschool system.

Consider also: your government operating as a corporation. Public health is a massive drain on government resources. Vaccines have VERY researched positive impact on public health. If government were a private corp then hell yes they would require vaccinations.

Punishment is supposed to be disincentive to crime. With no punishment, what's wrong with lying, cheating, stealing, and killing?

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).

Jeez - I thought you were joking, but nope :(

http://www.cnn.com/2014/04/02/justice/delaware-du-pont-rape-...

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.

Edit: Please see The Truth About Drug Companies, by Marcia Angell, M.D., formerly an editor of the New England Journal of Medicine.

Where do the funds for R&D come from? Getting academia to discover drugs is not a workable solution.

It's mostly the "D" part of the "R&D" that is expensive, and shapes the pharma industry. Some of this could be addressed by making clinical trials cheaper to operate and initialize, but it's always going to be quite expensive.

About 24% of new drugs are discovered in academia.[1] The remainder come from industry. I think offloading all discovery to academia, plus the "D" part of R&D would be something academia would struggle with.

[1]http://pipeline.corante.com/archives/2010/11/04/where_drugs_...

In any case, the current system isn't working. Incentives for fraud far outweigh those for improving public health. And there is virtually no accountability.

"Today, medical-journal editors estimate that 95 percent of the academic-medicine specialists who assess patented treatments have financial relationships with pharmaceutical companies, and even the prestigious NEJM [New England Journal of Medicine] gave up its search for objective reviewers in June 1992, announcing that it could find no reviewers that did not accept industry funds.

Source: https://theamericanscholar.org/flacking-for-big-pharma/#.VOD... [2011]

Very true, and there is very little done to reveal "Conflicts of Interests". Public Officials should be completely transparent (sources of income, past and present relationships, etc) if not I am afraid we cannot exclude corruption at any level.

Sure there is. If you sit on an FDA panel you need to declare all conflicts of interest. Panel members usually recuse themselves under those circumstances.

The tough part is that you can't stop folks from moving between industry and the FDA. Both organizations are looking for the best folks. It reminds me of doctors being paid for clinical trials. Of course it's always the top doctors getting paid because if you're a company, do you want the crappy doctors running your trial?

I don't care if you work for the pharma, but please don't keep posting demonstrably false comments shilling for the industry:

"Since the lion's share [of FDA user fees] can only go to expedite approvals, that area of the agency has grown while staffing and resources in other parts of the FDA have been relatively starved. As drugs enter the market faster, it becomes increasingly difficult for the FDA to perform its other functions -- including monitoring drug safety, ensuring manufacturing standards, and regulating marketing. [...]

Furthermore, the FDA is subject to industry pressures through its eighteen standing advisory committes, which consist of outside experts in various specialties, are charged with reviewing new drug applications and making recommendations to the agency about approval. The FDA almost always takes their advice. Many members of these committees have financial connections to interested companies. Although there are conflict of interest rules that prohibit participation in such cases, the agency regularly waives them on the unlikely grounds that someone's advice is indispensable. USA Today examined FDA hearing records in 2000 and found that 'at 92 percent of the meetings at least one member had a financial conflict of interest,' and 'at 55 percent of meetings, half or more of the FDA advisers had conflicts of interest.'

Members of FDA advisory committees are said to command unusually high consulting fees from drug companies. They are certainly in a position to do so. They probably don't even have to say, 'Pay me if you want your drugs approved.' According to the Washington Times reporter August Gribbin, 'One drug company executive who asked not to be identified referred to the advisory committee members' approaches for obtaining [consulting] work as 'shakedowns' because a company that refused to yield to such requests could doom products that cost tens of millions of dollars to develop.'" Source: The Truth About Drug Companies, p. 209

So yes, some folks who have conflicts of interest remain on the committees. I don't think it's something that can be avoided. The point is that the FDA is trying to address the issue and many folks who have strong conflicts of interest usually recuse themselves from those discussions.

Cite?

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). 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.

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.

How you extrapolate FDA regulations and faith in it to banking is a bit beyond me, because if you get diabetes the FDA is not insurance you can use to treat it.

You're no less risky with your money because the FDIC backs your bank account - in fact, you're more likely to leave it there with less risk.

I'm sorry for assuming you knew this, but as you say, it isn't simple for some.

The first will lead to correcting bad faith efforts and marketing in the drug companies... the second will lead to fixing the FDA.

It's odd, but not too surprising, that the only job you can actually get 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.

I would love to try however I don't feel i know enough about the available data to work out what would be required

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-supple...

- The FDA already has the power to regulate supplements, for the most part they just choose not to. So the idea that supplements just need FDA regulation like 'regular drugs' is largely fallacious.

- Why should supplements need clinical trials for marketing approval when that isn't the standard for other any other comparable drugs on the market? I.e. almost all drugs that were in use before the 50s are allowed to be marketed without any testing for safety or efficacy, and since almost all supplements have a much longer history of human use, why should they be treated differently?

The FDA has some power to regulate supplements, but the relatively light touch they use on them is not something the FDA chose independently, but a direct result of the limits on the scope of their power and the bases on which they may exercise it in the authorizing legislation, which Congress made very weak after a supplement-industry sponsored publicity campaign painting the effort to grant the FDA regulatory authority over supplements as an effort to "ban supplements".

No, the "natural supplements" industry has carved out for itself a huge exemption from most of the regulation that applies to drugs, on the one hand, or foodstuffs, on the other hand. See a group blog post on "Big Supp"[1] for more information about this. For years, that industry had a champion in Congress[2] who resisted more effective and rational regulation.

[1] http://www.sciencebasedmedicine.org/big-supp-resists-giving-...

[2] http://www.sciencebasedmedicine.org/fda-versus-big-supp-rep-...

The FDA's own website contradicts you here:

http://www.fda.gov/Food/DietarySupplements/

The FDA, on their own website, says it's their job to make sure that supplements are unadulterated and not mislabeled. If 80% of supplements are in fact completely fake, then I don't see how you're using the problems of the supplement industry to show how well the drug industry is regulated in comparison.

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.

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.