Comment by Dave Nichols on June 11, 2009 at 10:08am

A very fair set of questions and ones I'm not capable of answering very effectively. My primary concern involves the claims made of these products by their manufacturers. A quick example I pulled up for Natrol Black Cohosh says "Black Cohosh Extract is Clinically Shown to Relieve Hot Flashes, Night Sweats and Mood Changes", which includes a fine-print postscript to the fact that "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

Now, it is easy to argue that the claims made there ("Relieve Hot Flashes, Night Sweats and Mood Changes") don't explicitly assert that he product can "diagnose, treat, cure or prevent any disease". Semantics, really, and specifically worded to add authority of the product's claims without needing to pass the legal hurdles of actually submitting to FDA approval. The problem is that 'legit' drugs have to go through a very-thorough FDA testing process in order to be legally available. When a consumer reads 'clinically tested', there is an assumption that this means the product too went through a legit, official set of tests. All Natrol claims (on the website at least, as far as I could find) is that "Natrol undergoes regular quality audits by its licensing and certif...", agencies which are not named or referenced in the same FAQ. There is no reference to exactly what clinical tests this product was subjected to or how the consumer can be assured that such tests were reasonable and thorough.

There is no doubt that the FDA has many, many flaws and that it is often a hinderance to quickly making good medical solutions available, and I'm not one to argue that the government needs to step in to verify every single claim made in every case. However, there has to be some oversight here. I'd suggest that no claim can be made for a product to have been 'clinically shown' unless the clinical tests (and those who conduct them) are fully vetted and verified in some meaningful way. Yes, research and testing can produce most any desired end point, but we have to have some manner of filter here. There are likely many dangerous and damaging alternative medicines on the shelves today that have never been properly tested, especially for deadly interactions with other medications, and this seems likely to become a greater problem as more and more alternative solutions become available quickly while avoiding the safer but much slower process of proper approval. As we live longer and encounter new and strange conditions as human animals, people are increasingly likely to look to any 'solution' which promises to help in any way. Alternative medicine may not be a religion, but it sure smells like one when it comes to requiring faith and commitment despite lack of (or in spite of contradictory) evidence.

Thanks for the questions, wish I had better answers!

Comment by Dave Nichols on June 11, 2009 at 10:11am

I should clarify that I'm not in any way claiming that Natrol (or its Black Cohosh) can't deliver on the claims, or that Natrol itself is committing fraud here. My point is that, just like the mythical Jesus, there is really no evidence available which provides any concerned skeptic reason to believe, and I'm of the opinion that health, like spirituality, is too important to be 'faith-based'.

Comment by Misty: Baytheist Living! on June 11, 2009 at 10:55am

Meh.. I don't trust the FDA anymore than I do alternative healing stuff. FDA is a case of the fox guarding the hen house, and the alternative healers are poachers of hope or literal cons.

When the FDA makes more money for people being healthy than they do for them being ill, I might change my tune. Seems a bit counter productive until then.
Talk to your doctor. Do your own research... the truth is out there!

Comment by Dave Nichols on June 11, 2009 at 11:55am

Misty: I'm confused by what you mean when you say 'When the FDA makes more money for people being healthy than they do for them being ill, I might change my tune'. The FDA is a government agency which does not 'make money'. There are certainly some concerns (largely in principle with little actual proof of any specific wrongdoing) of conflict of interest with the User Fees making up a significant chunk of the agency's budget, and the ways in which those fees are spent, but the FDA has been grossly underfunded given the enormous amount of oversight that is expected. Could you explain your thoughts on this a bit more? Thanks!

Comment by Dave G on June 11, 2009 at 12:01pm

No big surprise here. And the homeopathic snake-oil salesmen will either ignore this, or claim that it was faked up by 'Big Pharma'.

Comment by Misty: Baytheist Living! on June 11, 2009 at 2:29pm

Dave-
Pretty much everything you put in links :) Thanks for saving me the trouble.. oh, except for the underfunded part. Hmm.. Lemme read up on that and I might retract my statement.

I've traveled the world and can say first hand that America has the absolute worst health system I've ever encountered. From the ground up, a change needs to be made. The ground just happens to be the FDA.

Reading the 'underfunded' bit now. I'll get back to you.

Comment by Misty: Baytheist Living! on June 11, 2009 at 2:51pm

Dave-
Obviously you can see the time stamp on this and deduce that I haven't spent hours researching the subject, so I won't lie and say that I have.
In the few short moments that google and I had, this is what I've found:
-The FDA is horribly understaffed.
-It received emergency funding in the last year.
-It's been involved in Avandia, Nexium (heh. Which I used to take while diving!) Align-life, and varius generic-drug scandals.

Now, it seems to me that even a non-profit that's desperate for money will sink to a whole new level of lows to get it. A broke company is probably more vulnerable to taking cash under the table than a rich one.

My statements weren't based off of any pharma-conspiracy.. just out of first person experience with American food and drugs vs. other place's food and drugs.
I assumed that if the people in charge of approving medication made money off of it in any way, they were probably biased or contaminated.
Now I've seen that not only does the company make money off of some approved medication, but it's money it desperately needs.

I'm not reassured.

Like I said, I didn't do a whole lot of homework on the subject, so I'm not answering from any area of expertise. I'm just using some basic logic here and a few google sites to back this up.
FDA=compromised.
Big Pharmaceuticals=evil
Alternative Healing=crazy/predatory.
Me=going abroad for health care :)

Comment by Dave Nichols on June 11, 2009 at 3:08pm

I'm still confused, I suppose. The FDA is not a company, it is a US government agency, paid for by a combination of taxpayer money (60-70%) and the 'user fees' (30-40%), which pharma companies pay to get the FDA to get their drugs tested and (hopefully) approved faster (the alternative assumedly is that the FDA with less money can only test and approve so many at a time, so the user fees allow them to hire more and use more resources to accomodate more drug requests). There is no 'profit' at all, and the folks at the FDA are on the government payroll.

I'm with you that these fees smack of a conflict of interest (given that the money is needed, as you said, and that budgets tend to grow, meaning the FDA wants to take on more approval tests and therefore gather more user fees, etc), but the alternative here seems even worse (no oversight whatsoever). I'm not denying that the FDA doesn't get embroiled in controversies (what large government agency can avoid them?), or that there isn't corruption within the agency (again, what large agency is devoid of corruption?), but I'm not at all following how the FDA is 'compromised' to the point that they cannot offer any reasonable oversight.

What are other nations doing to ensure drug safety that is better than FDA-like government agencies?

Comment by Misty: Baytheist Living! on June 11, 2009 at 3:39pm

Sorry about the use of the word company. I did mean agency (I promise) I'm not trying to seem thoughtless and using offhand remarks, I'm just trying to do a few things at once here, plus a bit of research and still answer you in a timely fashion.
My best argument here is going to seem just as flimsy as my use of the word company instead of agency. I don't know the name for the word of the like-body in Thai, so I'll just say the 'Thai-Agency' instead of being a good debater and looking it up.
The Thai-Agency approves way more 'herbal' remedies as being efficient mirrors to their pharmaceutical counterparts than America does. They also approve more 'risky' medicines. Coupled with clear warnings and training, this allow doctors and patients more choice. My own personal experience was in the realm of sleep aids and allergy medicines. I'm a low risk addictive personality (oddly enough:)) and was allowed to dose myself herbal sleep aids and generic or non-generic Valium as I saw fit. Whether it was placebo effect or not, I can't honestly say, but one worked as well as the other for me. I was also prescribed and monitored Reducil, (Then given an open prescription for it without monitoring) which is weight loss drug I took because as a diver I go through periods of burning 4000+ calories a day when working the boats to burning about 1800 calories a day when writing articles. My body got used to demanding lots of food, whether or not I actually needed it. These pills helped me make the transitions back and forth much easier. I'm an a very fit adult of normal height, weight and blood pressure, but when I asked about a refill on this in the U.S, I found out it was considered a class three drug! My diet pills, which had no side effects of mood changes, risk of overdose or hypertension are basically illegal in the U.S because of blood pressure problems that MIGHT manifest in folks that already have blood pressure problems (and shouldn't be prescribed them to begin with) I can see this drug being a HUGE weapon in the fight against obesity! Why it isn't more available in the U.S is beyond me. Non addictive, no problems.. I'm just.. frustrated. That's the word. Frustrated.
I've seen a bit of the same thing in Vietnam when it comes to health care. Drugs and laser methods that are just now being approved in America have had long standing in south east Asia. The one day yeast infection pill had been available over the counter in Thailand and Vietnam forever.. same with the birth control pill and antibiotics. Pharmacists are actually educated and see you before counting out medicine. They take a huge load off of doctors and generally have more time to spend with customers, so the product you get is better for you individually..
Thailand's FDA like agency also did something else I really liked, though my side of the story might be a little sideways since I was living there at the time that the news broke..(and it isn't exactly an unbiased news networked country.)
There was a drug or drug cocktail used to treat HIV and AIDS. For the longest time it was being bought from France and Germany (I think) at prices that the typical Thai household could not afford. The Thai Agency, with permission from their government and king broke the trademark on the drug and started to distribute it a reachable cost to the typical population. In a press conference they said that their people's health came before the intellectual integrity of a providing country or business.
Like I said, this is a lot of first hand experience and even first hand experience that I'm not exactly stable on... but you wanted to know why I thought the way I did, so I'm telling you so. In no way am I saying that my opinion won't change or couldn't change, especially with further information on the subject, but based on what I know now, that's why I made the statement I did.

Comment by Reggie on June 11, 2009 at 7:26pm

Modern society is very sophisticated and we can't all be experts on everything. I would like to see tighter government regulation on these snake oil products. Some of these are obviously a sham to most people but other products do a better job of blurring the line. Tricky wordplay that is legally on the up and up but dishonestly implies something else in the minds of unwary consumers is just one way to give an air of legitimacy. Another way to achieve this is to share space with legitimate medicines in pharmacies, getting equal prominence on displays and shelves that influence perception of these items by the public.

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