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Comment by haberman | Hacker News Reader

In its report, the WHO team agreed that the concept of RISUG was intriguing. But they found fault with the homegrown production methods: Guha and his staff made the concoction themselves in his lab, and the WHO delegation found his facilities wanting by modern pharmaceutical manufacturing standards. Furthermore, they found that Guha’s studies did not meet “international regulatory requirements” for new drug approval—certain data was missing. The final recommendation: WHO should pass on RISUG.

Is this an example of why health care is so incredibly expensive in this country?

Do these "modern pharmaceutical manufacturing standards" actually buy us extra safety?

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  Do these "modern pharmaceutical manufacturing standards"
  actually buy us extra safety?

Yes, but we pay a price:

* Evaluations take a really long time. So it's hard to get the drugs into the hands of people.

* Development is now extremely expensive. That forces just about everyone except the largest drug mega-corporations out of the market.

* Drugs that would be a net benefit to the world sometimes never make it through the entire process because the ROI isn't good enough, or the associated side effects are deemed too harsh. (We would likely not have aspirin today if it hadn't been developed prior to the modern way of drug development... it has too many high-risk side effects)

On the plus side:

* The drugs you do get are generally far safer and better understood than they otherwise would be

* You can feel safe that each batch of the drug was made the same way, using the same process, and ends up having the same strength/effectiveness as every other batch of the same drug... even when made by a different company. (We take that for granted now... but it's actually a really big deal if you look at medication from a historical perspective.)

* We have far fewer snake-oil salesmen ripping people off for cures that are, at best, useless and at worst, cause the condition to get worse, or cause birth defects, or some other harm. If we do find the drug doing harm, it gets pulled off the market

"We also have far fewer snake-oil salesmen ripping people off for cures"

Yet we still have chiropractors and homeopathy.

Sadly, they get around all the regulation by not making specific medical claims. If they did, then regulation would come down on them like a ton of bricks (as it did to producers of Cherries at one point). It's the difference between saying "Product X will cure Y" (illegal unless it's gone through all the testing) and "Product X may promote health" (which is entirely legal). It doesn't make much sense.

Hold on - Chiropractors are in the same class as homeopathy? I thought Chiropractors (which, admittedly, I've never been to, but have heard many good things about - particularly when people need to get their back "adjusted") were in the same class as Acupuncturists - kind of easternish philosophy, but effective within their domain. Not so much focussed on increasing health, as enhancing comfort (or reducing pain) without drugs.

Not the case?

I would like to know the real answer on this, too. I have read from people who claim to have been on the industry's inside (went to school for it, etc). The claim is that there are a bunch of logical steps based on false premises/beliefs and that some of the work results in mid- to long-term damage to the body in exchange for short-term relief.

Edit: http://www.chirobase.org/05RB/CPSQ/02.html -- More information that looks like something I have read.

Edit2: http://www.chirobase.org/01General/controversy.html -- "NACM members publicly renounce the subluxation theory and other forms of chiropractic pseudomedicine." Interesting stuff. What I read: There is a portion of "chiropractic medicine" that is snake oil; how do I identify what is real? Are NACM members better informed?

I've been to a chiropractor before and it really does work, at least for the problem I was experiencing (which was some sort of simple alignment problem.) The guy basically just pushed on my spinal column in different directions and I could clearly feel things moving back into place. I definitely would not lump them in with the quackery that is homeopathy, as long as you stay within the bounds of "pushing bones into alignment" and stay away from things like "improve the chi flow throughout your chakra nodes" or some such nonsense.

Until you realize that your bones were 'out of alignment' because you have weak core muscles that you should build up instead. In fact, 'pushing spinal column bones into alignment' without any x-rays or further inspection sounds pretty dangerous to me. What if the chiropractor pushes it too far and strains something, causing me to return for another adjustment? Everyone I know who has tried a chiropractor ends up going back over and over again, like an addiction.

Meanwhile, I had some back pain and started doing pilates and it evaporated, because now my core can actually hold my backbone up.

/plural of anecdote is not data

I've seen a chiropractor and x-rays are a part of the procedure. You can't do medicine without seeing that there is a problem, correcting the problem, and then verifying that the problem is solved.

You can't do medicine without seeing that there is a problem, correcting the problem, and then verifying that the problem is solved.

No one is debating that. What we're debating is whether chiropractic is medicine.

If chiropracty works, it would be a surprise given the history. See http://en.wikipedia.org/wiki/Chiropractic_history for more details, but basically it was founded by a complete crackpot and there's no reason to believe it should work.

Further, many studies have found weak effects, no effects, and negative effects. When you see this kind of evidential pattern, it almost always means that the effect isn't real and we're just seeing experimental error. See http://en.wikipedia.org/wiki/Chiropractic#Evidential_basis

That said, the placebo effect for something like chiropracty or massage can be very strong - and the placebo effect is real! Giving someone a saline shot creates a stronger effect than giving them a sugar pill; I don't know where chiropracty exists on that spectrum.

Off topic -- Where is the 'Edit' button on http://en.wikipedia.org/wiki/Chiropractic#Evidential_basis ?

The article doesn't say it's locked, but I see no edit button.

I was trying to replace "Opinions differ as to the efficacy of chiropractic treatment" with "Opinions differ as to the ability of chiropractic treatment to produce an effect", because I have a grudge against overly complicated language.

What's already there is better. :(

Also, if you look to the top right corner of the page, there's a lock icon that shows the article is semi-protected. You can't edit it without logging in.

Why is replacing one word with 4 making it less complicated?

Because more people will understand the longer version than the shorter one. A wiki is not a computer program.

http://simple.wikipedia.org

My own anecdotal experience would leave me surprised if controlled studies found that modern chiropractic care had no useful effect at all. Over a three month period I watched one guy go from a hunch-backed nerdy appearance to a shoulders-back, upright, and confident posture. Chiropractors probably can't cure ulcers, but they probably can accelerate improvements in posture, which have payoffs in other areas (improved posture->reduced pain->less stress caused by pain->better quality of life).

PBS did a report on alternative medicine, including Chiropractic. They didn't have much good to say:

http://www.ncahf.org/news/saf.html

I agree they are in the same class with acupuncturists, in the "stuff that doesn't work"-class.

Actually the best current evidence is that acupuncture does bring real pain relief: http://www.umm.edu/news/releases/back_pain.htm

That said, most of its relieving effect is due to the placebo effect, and there is no evidence saying that it can do anything for you other than possibly reduce pain.

"The sham acupuncture studies were double-blinded, meaning neither the researchers nor the participants knew who was receiving the real or the sham treatment. When looking at those studies, the reviewers found the differences in pain ratings showed a significant difference between the real acupuncture and the sham acupuncture groups, indicating that the benefit was not just due to the placebo effect."

How did you get "most of its relieving effect is due to the placebo effect" from the article?

I concluded that from several articles that I read on the way to picking that was as best representing current thought on the effectiveness of acupuncture.

There is still debate on whether real or fake acupuncture is better. (Studies have come down on both sides of this issue.) However pretty much everyone who has tried to study the subject has found that both real and fake acupuncture have a definite impact on pain. Frequently both will outperform conventional medicine. For a random example see http://featuresblogs.chicagotribune.com/features_julieshealt....

From that I know that there is a readily measurable benefit to acupuncture, another readily measurable benefit to the placebo, and the difference between the two benefits is difficult to measure. Which leads me to conclude that most of the benefit from acupuncture is due to the placebo effect, and only (possibly) a little is because acupuncture itself is effective.

Two weeks ago I went to see a chiropractor. I was in so much pain I could barely walk, and my lower back wouldn't flex enough for me to stand up straight. She thought I probably had a pulled muscle. She stretched my legs and hips, twisted my spine a bit and showed me some stretches that I could do at home. I left feeling a bit sore, but otherwise fine. It took 20 minutes and cost me $60.

It might not be medicine, but it's not snake-oil either.

Like almost everything, testing suffers from diminishing returns. The difference between no testing and delta testing is often huge, but the difference between a lot and a lot plus delta is often pretty small. But each delta of testing you add costs the same amount in terms of the prices you listed.

The optimal thing to do would be to keep adding more testing until the benefits of the latest delta drop to equal their costs. However, all the economic research on this topic that I've read suggests that while we need some testing we're way over the optimal point. Its the same sort of research that lets you publish papers on how the optimal copyright length is 14 years.

The same sort of ratchet effects are involved in both places too. The only people who care passionately about copyright lengths are those who have copyrights that are about to expire. The people who could have benefited from a work going out of copyright are often only dimly aware of it. Likewise when the FDA approves a drug that causes problems its obvious and there are a lot of people complaining, but when they don't approve a drug that could have helped someone - or when drug developers are scared off - people aren't as aware of it.

It's difficult to assess the situation without having the WHO report or an inspection.

The long and short of it is YES. There are regulations regarding the quality and reproducibility of pharmaceutical manufacturing processes (the CMC - chemistry, manufacturing and controls portion of an IND/NDA) that go a long way to ensure the safety of patients here in the US. Yes, they can be expensive to comply with. But current Good Manufacturing Process (cGMP) regulations are a necessary component to not only protect patients, but also to ensure the validity of the clinical data collected. Without these controls, changes in formulation, lack of reproducible drug substance (Active pharmaceutical ingredients, or APIs), and finished drug products (including container-closure systems), there is no way to be sure what the patient is getting is equivalent to what was used to obtain approval (NDA/BLA/PMA/510k) or consistent across the marketplace. There was a big push to get manufacturing and studies done "on the cheap" in India, China, SouthAmerica, and Eastern Europe. But over the past few years, many companies have pulled back development in these areas (unless they were planning to launch products in these regions) due to lack of oversight and poor quality of production and study conduct at clinical sites. And rightly so. If the WHO conducted a thorough audit of his processes and found that they weren't up to par with the FDA or EMA(Europe's FDA) then we should all hope that any development in the US or Europe be conducted in accordance with OUR guidelines and regulations. The India trials could (and should) be used as a benchmark and built upon, but not relied upon out of hand without more diligence and reproducible results across multiple clinical studies (and in various ethnic populations, age groups, and other factors). The inventor has a duty to obtain results using the most controlled and reproducible manner possible. For all of our sakes.

I'm sure it's not as black and white as that. There's a certain level of safety requirements, and we could probably relax them with only a small percentage of people suffering or dying as a result. We could also raise them, and decrease that number. Etc, etc., it's all a numbers game, and I'm already boring myself with this argument.

Regulation costs account for 90% of bringing a drug to market, on average $1 billion and 10 years of clinical trials for each new drug [1]. Of course, a mere 10 years of clinical trial cannot catch all long-term side effects, and we would be safer if the FDA was more stringent. The flip side is that we would have fewer and more expensive health care options. For better or worse, our regulatory structure is heavily biased towards fewer deaths from approved treatments, very long clinical trials, and expensive health care.

In general, the word "agile" and the health industry have nothing to do with each other.

[1] yeah, yeah, citation needed. I pick facts up by listening to The Economist podcast on the way home, you go find a hyperlink.

This process may be a preferable alternative to condoms, but it does not stop the spread of STDs. From the WHOs perspective there's no obvious benefit.

I suspect this may be the real cause of their lack of interest.

This is presented as though it's an instance of regulatory capture - which it may be - but I don't think we really have enough information to draw that conclusion.

It's entirely possible that there was concern for contamination or the like in the methods used, which would be a fair concern. On the other hand, the current manufacturing methods don't strike me as sufficient reasoning to pass on the concept as a whole, if that's indeed what the final recommendation means, as the article seems to imply.

  > Do these "modern pharmaceutical manufacturing standards" actually buy us
  > extra safety?

They certainly buy us jobs for bureaucrats. Recently the FDA confiscated all of the birthing pools (related to the surge in popularity of water births). Apparently inflatable pools should be classified as 'medical devices.' To quote the FDA, "pregnacy is an illness and birth is a medical procedure."

Do you have a source for that quote?

* http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-f...

* http://blog.cuntastic.org/2011/05/27/interview-with-barbara-...

My thoughts exactly. All the objections seem to sidestep the revolution that this drug could be. If the science is there, but some more studies are needed, why didn't the WHO back better lab conditions and make a go for it?

Either they thought it was not a viable theory for a drug, or they were avoiding it for profit/political reasons.

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