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Immunotherapy is still bleeding edge stuff with much of it not out of trials yet. It probably hasn't impacted survival numbers yet.

The FDA has been fast-tracking immunotherapy drugs. Pembrolizumab and Ipilimumab have been approved and credited with the remarkable remission in Jimmy Carter.

A couple of minutes spent with Google suggests that, contrary to my knee-jerk reaction, these would probably not be subject to regulation (see section three of this. Wording for the product blurb, in conjunction with that fda document, suggest that they're thought this through :-)

There are serious ethical concerns with giving a placebo where giving no treatment is substantially worse. You'd basically be condemning them to a death if you did that. That's why, in these kinds of circumstances, the experimental treatment is compared to the current accepted standard of treatment.

This kind of treatment has been in the experimental phases since at least 2011, and has undergone clinical trials;

http://ascopubs.org/doi/abs/10...

http://ascopubs.org/doi/abs/10...

And I believe this link, from 2011, is a press release announcing the approval of the trial discussed in this particular story. I'm not 100% sure, but the names and terminology match up...

http://www.fda.gov/NewsEvents/...

=Smidge=

Criminal litigation or civil lawsuits alone don't solve the problem. There are lots of criminals looking to capitalize on short-term opportunity, then close up shop before Lady Justice brings the pain. We need regulators who can actively sniff out fraudulent activity.

Otherwise, any fly-by-night company looking to make a quick profit will be happy to sell counterfeit Copper Clad Aluminum data cables, which can easily catch and spread fire, or cheap batteries that are also more fire prone, or toys with lead paint, or counterfeit medicines, and so on. It's like the snake oil salesmen of yore...by the time the townsmen realize they were sold an empty promise, the salesman has already packed the wagon and moved onto the next town.

Lawsuits only work on the Walmarts, business who aren't going away anytime soon.

Absent other regulations, it's up to the federal trade commission, similar state-level bodies, and disgruntled customers filing lawsuits to keep companies from using deceptive advertising.

Where the FTC and state regulators don't act, it's up to consumers to sue or their advocates such as the press or Consumer's Union to shame them into honesty.

So, will we be seeing regulatory action soon, or will the land sharks be filing class-action suits, or will this be just a case of public shaming?

Or, will nothing happen at all?

The FDA can regulate here and work with the Department of Justice to enforce in this case as this is a cosmetic that is "misbranded".
http://www.fda.gov/Cosmetics/G...

Article implies the FDA has no jurisdiction over this based on that they don't test cosmetics by default, but they do regulate based on it being a "misbranded" cosmetic product.
  http://www.fda.gov/Cosmetics/G...

I call bullshit. Cite your source, here's mine.

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

See section S2.

Tell the FDA to stop requiring the same drug to be re-approved by each vendor in a very expensive and years-long process and instead switch to the presumption that THE DRUG ITSELF

They already do this; it's called the Abbreviated New Drug Application. This process was created as a result of an act of Congress, so if you have a problem with it, talk to Congress.

It was a further government encroachment and step to even further government meddling that keeps making things worse, and would only exacerbate the core problem created by our "friends" in places like the UK and Canada who do it.

lolWUT??? Every corporation in the world that negotiates prices is an efficient enterprise, but when a government agency does it, it's "meddling in the free market"? What the fuck kind of idiocy is this? Do you honestly expect people to be stupid enough to believe that if foreign governments were as stupid as we are in drug pricing policy, that the pharma companies would lower our prices? Do you honestly expect people to be stupid enough to believe that the prices charged have ANY relation to R&D costs? Have you seen the Pfizer, Novartis or Roche P&Ls?

Thanks - and it looks like these have not been banned yet

You may have missed the following text from the same page:

If a product....is intended not only for cleansing but also to cure, treat, or prevent disease...it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers.

From the FDA announcement:

Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE).

Having classified these products as drugs, the FDA does have jurisdiction. The ruling was proposed in 2013, subjected to public review, subjected to congressional review and finalized last week.

Weak antibacterial properties will leave populations of higher resistance bacteria in your 'kitchen colony'.

If that were the actual motivation for banning anti-microbial agents, they wouldn't be banning iodine or phenol.

We were a lot dirtier (in many ways) in the 1960s, it hasn't harmed us (I can see the flame comments already building under this!) and may have been of benefit to our immune systems.

(1) In the 1960's, antibacterial soaps were already half the soap market in the US.

(2) Antibacterial soaps came into widespread use because there was good scientific evidence that they did reduce the incidence of bacterial skin infections. citation.

(3) People generally use antibacterial soaps not out of germ-phobia, but in order to reduce body odor, something that they are actually moderately effective for.

(4) Although science has recognized the importance of microbiomes and exposure to pathogens, little is known about how to translate those results into medical choices. In fact, there is probably a lot of individual variation, with some people benefiting from antimicrobials and others being harmed by them.

(5) The FDA's decision is based on a risk/benefit tradeoff to human health. First, as the FDA itself states, there is little compelling evidence of either risk or benefit, so their decision is based on the principle "it might be dangerous and we know of no health benefit, therefore we ban it". Second, many products have benefits other than health benefits that the FDA simply isn't entitled to, or even qualified to, evaluate or judge.

Overall, you're using the same Orwellian reasoning that the FDA is using; the FDA decision is not rooted in sound science, but in guesswork, speculation, and preferences.

What the FDA could have done instead is required manufacturers of antibacterial soaps to label their products better.

The press, being the idiots that they are, don't realize that the FDA doesn't have jurisdiction over "soap." The FDA isn't helping by trying to broaden their reach.

Their order says "The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed."

That is not soap. In fact, the FDA says it has no jurisdiction over soap, which is confusing because on various webpages they say "Soap," and they do so in the title of said order as well.

Here's the FDA's explanation of Soap:

http://www.fda.gov/Cosmetics/G...

Here's the part that's relevant.

"Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission disclaimer icon (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC. "

Tap water regulations are usually very strict.

Unless you live in Flint Michigan...

But once you bottle the water it becomes food, and food can contain pretty much anything.

Not even remotely true but thanks for trying. While there is (unfortunately) a lot of wiggle room, food production, marketing, and sales is actually pretty heavily regulated by the FDA and USDA among others.

An other thing is she was a commercial user, not all commercial users are allowed to update their computer's software due to support contracts, it might even be a violation of Federal Regulations such as an FDA 501(K) facility.

Ordinarily, FDA will not need to review software patches before a device manufacturer puts them in place. FDA views most software patches as design changes that manufacturers can make without prior discussion with FDA. ......For example, manufacturers need to seek FDA's approval or clearance before installing a software patch if it would change who it’s for, what it does, or how it works (a change in the indication for use), and/or it would make the device less safe and effective.

Eyeglasses are considered to be medical devices, although they are exempted from certain regulations.

Here's a list https://www.accessdata.fda.gov...

A blood pressure monitor is a class II medical device, according to the FDA: http://www.fda.gov/MedicalDevi... Seems like the app creators could be in some pretty hot water if their device doesn't work and they didn't get certification from the FDA to distribute it...

Well, if you audit your food you will be disgusted...
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/sanitationtransportation/ucm056174.htm
If that's too long, CBS made a little photo tour
http://www.cbsnews.com/pictures/11-revolting-things-government-lets-in-your-food/
and then there is water, no simple chart from the EPA on that...
http://www.epa.gov/dwreginfo/drinking-water-rule-quick-reference-guides.

We got to the point that you have to roll your own BIOS. So we have already lost, for if we go to all that trouble, we will have the only secure machine, as far as we know... and what will we hook it to?

Being anti GMO is every bit as nonsensical as being an anti-vaxer.

That which can be asserted without evidence can be dismissed without evidence.

Goodie! Fresh meat! You wanted evidence? You can't handle the evidence, And my little chachalaca, I will definitely expect more thasn a one sentence off the cuff dismissal

Heeeeere we GO! Wif cytaytions

In 1998, Andrew Wakefield published a fraudulent paper in thte Medical Journal "The Lancet"

https://en.wikipedia.org/wiki/...

The paper had 13 co-authers who ended up repudiating the possibility that MMR vaccines could cause autism.

So what happened Oh yes, we'll go into this, yes we will.. As it turns out, this staretd a little time before, when teh good Richard Barr, a lawyer, met up with the Good Andrew Wakefield. This was a marriage made in heaven. https://en.wikipedia.org/wiki/...

As well, teh Good Andrew Wakefield recieved 55,000 pounds from other lawyers who were looking for evidence to use in lawsuits agains MMR manufacturers. But don't worry, it must have been on teh up and up because Wakefield kept this a secret from his co-authors. https://en.wikipedia.org/wiki/...

Turns out that the Good Andrew Wakefield and his lawyer buddy had big plans to make a lot of money. https://en.wikipedia.org/wiki/...

Eventually, after investigations of manipulation of data, a General medical council investigation and eventual full retraction of the paper by the Lancet,

And in 2010 https://en.wikipedia.org/wiki/...

Just in case you aren't reading the citations, and I don't believe you will: 28 January 2010, the GMC ruled against Wakefield on all issues, stating that he had "failed in his duties as a responsible consultant",[13] acted against the interests of his patients,[13] and "dishonestly and irresponsibly" in his controversial research.[14] On 24 May 2010 he was struck off the United Kingdom medical register. It was the harshest sanction that the GMC could impose, and effectively ended his career as a doctor. In announcing the ruling, the GMC said that Wakefield had "brought the medical profession into disrepute," and no sanction short of erasing his name from the register was appropriate for the "serious and wide-ranging findings" of misconduct

Here's a pdf of their findings https://web.archive.org/web/20...

Now I betchya you are just about sick and tired of Wikipedia citations aintchya? http://www.fda.gov/BiologicsBl...

Maybe it's a conspiracy. But they removed the deadly autism causing agent from vaccines, that the good Andrew Wakefield said was a cause, and, and, and, didn't change a thing. It might have appeard that it went up, but considering that autism speaks seems to be moving toward a world where everyone is autistic, that data is fuzzy at best, IMO http://www.sciencedaily.com/re...

There's all of about zero credible scientific data against it.

You want credible evidence GMO is bad? Go to home depot and buy a bottle of roundup. Read the warning label.

Until someone can explain with a straight face how Roundup r

Amalgam fillings are a mix of mercury and silver, tin and copper. More or less the same stuff as the solder put on circuit boards.

http://www.fda.gov/MedicalDevi...

That was replaced by plastic or acrylic fillings which are hardened using UV light, but get soft due to exposure with alcohol.

And these fish aren't isolated to these fish-farms, some will get out and breed with other fish.

The salmon approved by the FDA can only be produced where there is no way for them to get out and breed with wild fish.

Under the approval, AquAdvantage Salmon are subject to stringent conditions to prevent the possibility of escape into the wild. The salmon cannot be raised in ocean net pens: instead, the approval allows for them to be grown only at two specific land-based facilities: one in Canada, where the breeding stock are kept, and Panama, where the fish for market will be grown out using eggs from the Canada facility.

You must not have any product marketing experience. If my product is labeled differently from yours, from a marketing perspective (which is based on the psychology of people when they are buying things) one is better than the other. Back before the USDA Certified Organic program existed marketers were putting the word "organic" on everything because it didn't mean anything legally (so they weren't lying) and it increased the perceived value of a product (thus increasing sales volumes or sales price). Marketing team are always looking for the next buzzword, as well as looking for the next term to avoid because they have the opposite effect on perceived value. Natural is another term that doesn't have a legal definition and so is getting slapped on everything despite meaning precisely nothing.

Due to all of the fear mongering about GM products by Big Organic et al., labeling your product as GM means to most consumers that it is unsafe. Nothing is stopping anyone from labeling their product as containing GM, and the FDA released 2 guidances to industry at the same time as the GM salmon announcement to address voluntary GM free labeling.

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

The difference between these salmon, and the newly revised food labeling rules come down to justification. Mandatory labeling requires justification. It is the government compelling speech, and that power cannot be abused on a whim. "I'd simply like to know" is too low of a bar, and that is the only really valid reason I've seen put forward in support of a GM-status label. With the nutritional labels, on the other hand, there is definitive health and nutrition concern being addressed. Public health and safety is a sufficiently high bar, and that is the basis for the nutritional guide labeling revisions recently pushed out.

The FDA is a food safety organization that is part of the federal government. They can oversee voluntary labeling plans to ensure that they are accurate and safe, but they cannot impose new labeling requirements based on a popular vote. That is why they are proposing new rules to address the desire of a subset of consumers to know the GM status of their food. Furthermore, they must (by law) consider the cost/benefit of any new regulation. There is a cost associated with labeling, and it is higher than most realize. Since there is no health and safety benefit to GM labeling, the cost/benefit is entirely one sided. If you want to voluntarily increase the cost of your product to cover certifications and labels, they can support you, but they cannot force your competitors to do the same without a good reason, which in this case there isn't.

You must not have any product marketing experience. If my product is labeled differently from yours, from a marketing perspective (which is based on the psychology of people when they are buying things) one is better than the other. Back before the USDA Certified Organic program existed marketers were putting the word "organic" on everything because it didn't mean anything legally (so they weren't lying) and it increased the perceived value of a product (thus increasing sales volumes or sales price). Marketing team are always looking for the next buzzword, as well as looking for the next term to avoid because they have the opposite effect on perceived value. Natural is another term that doesn't have a legal definition and so is getting slapped on everything despite meaning precisely nothing.

Due to all of the fear mongering about GM products by Big Organic et al., labeling your product as GM means to most consumers that it is unsafe. Nothing is stopping anyone from labeling their product as containing GM, and the FDA released 2 guidances to industry at the same time as the GM salmon announcement to address voluntary GM free labeling.

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

The difference between these salmon, and the newly revised food labeling rules come down to justification. Mandatory labeling requires justification. It is the government compelling speech, and that power cannot be abused on a whim. "I'd simply like to know" is too low of a bar, and that is the only really valid reason I've seen put forward in support of a GM-status label. With the nutritional labels, on the other hand, there is definitive health and nutrition concern being addressed. Public health and safety is a sufficiently high bar, and that is the basis for the nutritional guide labeling revisions recently pushed out.

The FDA is a food safety organization that is part of the federal government. They can oversee voluntary labeling plans to ensure that they are accurate and safe, but they cannot impose new labeling requirements based on a popular vote. That is why they are proposing new rules to address the desire of a subset of consumers to know the GM status of their food. Furthermore, they must (by law) consider the cost/benefit of any new regulation. There is a cost associated with labeling, and it is higher than most realize. Since there is no health and safety benefit to GM labeling, the cost/benefit is entirely one sided. If you want to voluntarily increase the cost of your product to cover certifications and labels, they can support you, but they cannot force your competitors to do the same without a good reason, which in this case there isn't.

Good advice. The FDA also released 2 Draft Guidance For Industry documents at the same time aimed at establishing voluntary labels for GM status. One for salmon and the other for plant derived products. http://www.fda.gov/Food/Guidan... http://www.fda.gov/Food/Guidan...

Good advice. The FDA also released 2 Draft Guidance For Industry documents at the same time aimed at establishing voluntary labels for GM status. One for salmon and the other for plant derived products. http://www.fda.gov/Food/Guidan... http://www.fda.gov/Food/Guidan...

"Based on the common definitions of "alternative medicine", your statement is false"

No, I think you're confusing "alternative medicine" with "natural medicine". I know full well that something like willow contains salicylate, which is one of the main ingredients of aspirin. When such plants and herbs pass through peer-review clinical trials and the proper dosing is determined, they are determined to be medicine, even though they contain natural ingredients. I think you'd be hard pressed to find someone who thinks aspirin or opium is an "alternative medicine", even though both are derived from plants.

"However, you missed my point that "homeopathic" is often a meaningless term used more as a marketing gimmick than anything else"

I didn't miss the point. The FDA has set guidelines that a product must follow in order for it to be labeled as homeopathic.

http://www.fda.gov/ICECI/Compl...

As an area that I am very close to, I decided to sum up my comments in a single post rather than scatter replies to many of the uninformed, hyperbolic statements already made on this issue.

The FDA is not lazy or incompetent on this topic. I have personally worked with the people there who are driving this topic. There is a guidance document that was put through the draft/final review cycle on a fast track for FDA work (about 15 months between the two phases, which often takes 2-4 years).
http://www.fda.gov/downloads/m...
They also held a workshop on the topic, and have been reaching out and supporting communications on this issue in many venues.
http://www.fda.gov/MedicalDevi...

The FDA rarely is prescriptive on *how* a function should be performed. They regulate far too many types of devices used in all different kinds of situations. Their regulations need to stand for decades, so guidance documents are how they address issues that are more rapidly changing. The FDA is all about risk management, and directs manufacturers to perform risk management, document their results and submit it for review. How strongly the reviewers push back when guidance isn't followed indicates how strongly the FDA is concerned with an issue. I have been contacted more than once by companies who are getting questions on cybersecurity in their FDA submissions. If you are building a higher-risk networked medical device, you will need to follow the guidance document and produce your data or expect your approval to be delayed while you answer their questions (and thus, have to produce the data).

Having worked in the industry for many years, I really don't subscribe to the general theory that medical device companies are money greedy corporate fat cats who care only about profit at the expense of patient care. Everyone I have worked with has family members and friends who end up using these devices. I think the reluctance to embrace security in these devices is much more of a disbelief that anyone would try to actively harm a patient. I tend to use the examples of devices as vulnerable pivots to get at data in the hospital that can be monetized as my means to turn thinking in this domain.

Another challenge is that every hospital is different. Even the hospitals don't have standards that they generally use for the interconnection of devices. I have been encouraging hospital-based groups to work on the prescriptive standards so device manufactures have something to build against that they know will be salable in the end. Add to that the fact that 80% of device companies have 50 employees or less, and there is the challenge of teaching every one what they need to know.

By the way, the EHRs that these devices are being connected to aren't classified as medical devices, and are not regulated by the FDA. Despite the fact that the medical device definition includes software used to "diagnose disease."

Billy Rios is a great guy, and has done great service in this area. But the press tends to take comments in this space out of context. They love to find a line that makes it sound like the sky is falling.

As an area that I am very close to, I decided to sum up my comments in a single post rather than scatter replies to many of the uninformed, hyperbolic statements already made on this issue.

The FDA is not lazy or incompetent on this topic. I have personally worked with the people there who are driving this topic. There is a guidance document that was put through the draft/final review cycle on a fast track for FDA work (about 15 months between the two phases, which often takes 2-4 years).
http://www.fda.gov/downloads/m...
They also held a workshop on the topic, and have been reaching out and supporting communications on this issue in many venues.
http://www.fda.gov/MedicalDevi...

The FDA rarely is prescriptive on *how* a function should be performed. They regulate far too many types of devices used in all different kinds of situations. Their regulations need to stand for decades, so guidance documents are how they address issues that are more rapidly changing. The FDA is all about risk management, and directs manufacturers to perform risk management, document their results and submit it for review. How strongly the reviewers push back when guidance isn't followed indicates how strongly the FDA is concerned with an issue. I have been contacted more than once by companies who are getting questions on cybersecurity in their FDA submissions. If you are building a higher-risk networked medical device, you will need to follow the guidance document and produce your data or expect your approval to be delayed while you answer their questions (and thus, have to produce the data).

Having worked in the industry for many years, I really don't subscribe to the general theory that medical device companies are money greedy corporate fat cats who care only about profit at the expense of patient care. Everyone I have worked with has family members and friends who end up using these devices. I think the reluctance to embrace security in these devices is much more of a disbelief that anyone would try to actively harm a patient. I tend to use the examples of devices as vulnerable pivots to get at data in the hospital that can be monetized as my means to turn thinking in this domain.

Another challenge is that every hospital is different. Even the hospitals don't have standards that they generally use for the interconnection of devices. I have been encouraging hospital-based groups to work on the prescriptive standards so device manufactures have something to build against that they know will be salable in the end. Add to that the fact that 80% of device companies have 50 employees or less, and there is the challenge of teaching every one what they need to know.

By the way, the EHRs that these devices are being connected to aren't classified as medical devices, and are not regulated by the FDA. Despite the fact that the medical device definition includes software used to "diagnose disease."

Billy Rios is a great guy, and has done great service in this area. But the press tends to take comments in this space out of context. They love to find a line that makes it sound like the sky is falling.

Here's a few more links for you:

http://www.realclearscience.co...

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

Notice for example that Spinach is permitted up to 1mg of mammalian excrement (read: cow shit) per pound as per fda regulations. Tomatoes are permitted up to ten fly eggs per 500 grams, or five fly eggs and one maggot, or two maggots. Wheat is permitted up to 9mg of rat shit per kilogram. Ground oregano (a common additive in salads and salad dressings) can have up to 1250 insect fragments per 10 grams, in addition to 5 rodent hairs per 10 grams.

Meanwhile there are no allowed defects for meat, other than the meat product is allowed to be 65% of some other substance, aka fillers, such as cornstarch, or the "pink slime". While that's bad IMO from a food quality perspective, it isn't unhealthy. Unlike with plants, meat is easy to avoid contaminants because the slaughter and processing occurs in a very clean environment. I know because I once did routine IT work at a food distributor that had a meat plant. I've seen how clean the environment has to be if they want to comply with FDA regulations and ISO standards. It's just not possible to achieve that for veggies however as they inevitably have to be grown and harvested outside.

Have a nice day.

FDA:

Is HFCS less safe than other sweeteners?

FDA receives many inquiries asking about the safety of HFCS, often referring to studies about how humans metabolize fructose or fructose-containing sweeteners. These studies are based on the observation that there are some differences between how we metabolize fructose and other simple sugars.

We are not aware of any evidence, including the studies mentioned above, that there is a difference in safety between foods containing HFCS 42 or HFCS 55 and foods containing similar amounts of other nutritive sweeteners with approximately equal glucose and fructose content, such as sucrose, honey, or other traditional sweeteners. The 2010 Dietary Guidelines for Americans recommend that everyone limit consumption of all added sugars, including HFCS and sucrose.

American Heart Association:

The American Heart Association (AHA) recommends limiting the amount of added sugars you consume to no more than half of your daily discretionary calories allowance. For most American women, that's no more than 100 calories per day, or about 6 teaspoons of sugar. For men, it's 150 calories per day, or about 9 teaspoons. The AHA recommendations focus on all added sugars, without singling out any particular types such as high-fructose corn syrup.

(FYI -- that daily limit for sugar for men is approximately one 12-oz. can of soda. It's less for women. And that assumes you don't consume ANY added sugars in anything else you eat that day, which is nearly impossible if you consume any processed foods.)

Review article supported by the American Medical Association:

Because the composition of HFCS and sucrose is so similar, particularly on absorption by the body, it appears unlikely that HFCS contributes more to obesity or other conditions than sucrose does. . . . At the present time, there is insufficient evidence to ban or otherwise restrict use of HFCS or other fructose-containing sweeteners in the food supply or to require the use of warning labels on products containing HFCS. Nevertheless, dietary advice to limit consumption of all added caloric sweeteners, including HFCS, is warranted.

You can find plenty more things like this if you look, because there are dozens of studies that back up such a position. After decades of looking, we so far have only a handful of studies measuring significant differences with HFCS metabolism. That doesn't mean we shouldn't keep looking... but it's important to see those Princeton findings in context.

This is why my remedy, if elected, for this situation would be to strip the FDA of all powers to regulate the market for drugs. Let it have proposed new drugs tested for safety and efficacy, as it does now, but let its findings be advisory only. Doctors, patients and insurance companies would generally follow its recommendations as a "gold standard," but absent any power to prevent consumers from shopping around on the world market for cheaper subscription fills and absent any power to enforce sweetheart deals with pharma, the free market would bring the US prices of medications into line with worldwide prices.

Right. And when someone takes something that's labelled "aspirin" but actually contains rat poison--because, after all, under your scheme, this would be entirely legal and there'd be no way to prevent it from occurring--and dies as a result, yeah, the market will correct that problem.

You think something like this can't happen? Think again.

You are not allowed to sell a generic equivalent unless you can prove it is as effective as the nongeneric version. In order to prove it is as effective as the nongeneric version, you need to do trials that compare it to the nongeneric version.

This is not correct. From the FDA:

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

The generic drug manufacturer needs only to prove that their version is equivalent to the original (details also spelled out at the above link.)

There's no such thing as "exclusive rights" on a drug that's off patent.

Yeah, there is, in the U.S. at least. The FDA's Unapproved Drug Initiative, among other things, grants pharmaceutical manufacturers the exclusive right to sell the drugs they test under the program. It's the reason that colchicine, which had been around for hundreds of years and was cheap and common prior to the program, is no longer available as a generic. Another screwed-up situation is that of albuterol, which was also cheap and widely available. In that case, mandated changes to the drug's delivery system to remove CFCs (even though using CFCs was otherwise legal in this application) allowed manufacturers to patent new delivery systems, and albuterol is no longer available as a generic even though the drug itself is not patented.

In both cases, it was administrative action by the FDA that was solely responsible for forcing drastically increased drug prices on people.

It is not legal in many cases. http://www.fda.gov/AboutFDA/Tr...
Though I suspect this particular drug would fall under the exceptions.

The snag though is that there is a relatively short period during which this drug is used (100 pills or so?). Importing drugs is difficult and so is more practical if you have an ongoing use of the drug such as for a chronic condition.

hampton creek is no innocent victim here either.

fda warning the company about misleading claims on product labels: http://www.fda.gov/ICECI/Enfor...

So all these companies are "screwed" as you put it?

They never heard of the Elixir sulfanilamide incident.

Neither had I. The first result from a quick search makes for some chilling reading.

Thanks for that--I think.

Citation required. "Often" is a bit of hyperbole. Maybe a lot of hyperbole. Manufacturers of pills have quality control systems that verify the output of their pill mills, and if they aren't right the entire batch is dumped.

Or maybe it's not a lot of hyperbole. Maybe drug companies don't actually take as much care as you think they do. Maybe you're just making unfounded assumptions because they make you feel better.

The truth is that there isn't a recall every time a defective drug is found; and there is no reason to believe that every defect is detected. The drug manufacturers do not take the care that you think they do; at best, some of them do.

The FDA "document" you linked is an FDA docket SUBMITTAL by known conspiracy nut Mark Gold. If you go here: http://www.fda.gov/ohrms/DOCKE... and read the findings from the relevant bodies, you will see that most (if not all) of them dismiss his (And Betty Martini's) claims out of hand.

He also has NO medical background and professes to be an expert in holistic healing. http://americanloons.blogspot....

If you want to take nutritional advice from people with no medical background, be my guest.

And seriously, Monsanto suppressed reports that aspartame is bad? Monsanto is in the business of GMO produce, like corn for high fructose corn syrup. I seriously doubt they would want to suppress a report that shows their competitor's product is bad for you. Do you even read what you write?

How about this: http://www.fda.gov/ohrms/docke... from the F.D.A. so apparently they changed their mind.

How about you wake up and smell the flowers, aspartame is bad for people and studies and research that prove it has been suppressed by Monsanto.

They already do undergo testing. You can read about it on the FDA's website.

The studies that are being done have overwhelmingly shown that GMO crops are not harmful. Also, it's not something that's being done and monopolized by corporations either. I suggest you read up about Golden Rice which was engineered to help deal with Vitamin A deficiency in impoverished nations that was killing or debilitating millions of people every year.

From the FDA's web site (emphasis mine):

Food and food ingredients derived from GE plants must adhere to the same safety requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act that apply to food and food ingredients derived from traditionally bred plants .

The developer produces a safety assessment , which includes the identification of distinguishing attributes of new genetic traits, whether any new material in food made from the GE plant could be toxic or allergenic when eaten, and a comparison of the levels of nutrients in the GE plant to traditionally bred plants.

FDA scientists evaluate the safety assessment and also review relevant data and information that are publicly available in published scientific literature and the agency's own records.

In my book that qualifies as a statement from the company of "trust us." There's no independent verification. Since GMOs are held to the same standard as traditionally bred plants, no standard either really.

> Selling "medicine" under false pretenses is 100% of the reason why the FDA exists.

Not really. From fda.gov:
FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs

Now, I hear your inner pedant trying to argue that adulterating and misbranding is false pretenses. But it is definitely not the same kind of false pretenses as homeopathy where the contents are fully disclosed, they just don't do what is claimed.

Citation required. I want to see these "studies." They don't exist. Many of these ingredients have been grandfathered in. The assumption being that since no one has provably dropped dead from having eaten them that they do not cause harm. The term is GRAS, Generally Recognized As Safe. An increasing body of these GRAS ingredients have come under suspicion as of late, some provably show to cause harm.

Regarding GMOs, Monsanto and co. prevent ANYONE from testing their seeds. Farmers are contractually obligated put them into the dirt or destroy/return them. Researches are not allowed access. Government bodies do not require independent testing. They are allowed to vouch that their products are safe and we're just supposed to trust them. A common genetic modification is to cause the plant to produce its own pesticide. Specifically Bt-toxin a neat little compound that works by eating holes in the digestive track. Even if we're not immediately dropping dead by this stuff, we're ingesting some pretty f'ed up stuff. GI inflammation continues to receive interest as a contributor to a significant number of health problems. Are these GMO plants contributing? Difficult to tell since there's no mandate for independent safety studies.

It is strangely coincidental that we are experiencing unprecedented health problems, unheard of allergies, whose timeline track rather closely with the inclusion of these so-called GRAS ingredients and GMO crops. I am far too cynical to believe that the calorie companies have my best interest at heart over their own profit. I also seem to recall the tobacco industry telling us similar tales. I will not take their word for it. These ingredients and plant modifications should be subject to same rigor as medications have to prove their safety.

We don't really have to. The FDA already has:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=101.22
Right at the top. (a)(1).

No, it is not true.

But once again you misstate the story.

The FDA did not declare walnuts to be a drug.
The FDA -did- send a warning letter to Diamond Foods warning them that they were overselling their product, and crossing a legal line in doing so.

The FDA warning stated Diamond Foods was effectively marketing its walnuts AS a drug due to the claims it was making in its marketing in its attempt to sell the walnuts. That is a far different thing from declaring all walnuts to be a drug. Companies frequently make claims about the benefits of their products, including food companies. But there is a limit to what is allowed, and Diamond Foods went beyond it.

Among their claims were that their walnuts could "inhibit tumor growth", "reduce incidence of breast cancer", that they could "treat major depression", and "reduce chance of stroke".

Diamond Foods was overselling their product by making several false or unsubstantiated medical claims, to the extent that they crossed into territory properly defined as "marketing a drug for medical treatment purposes".

And as a result Diamond Foods settled with the FDA and corrected its packaging and marketing.

Link to the actual warning letter: http://www.fda.gov/iceci/enfor...

FDA has decided a lot of things, many of which turned out not to be true. According to the FDA, Walnuts are a drug (yes it is true).

No it's not true. The FDA forced a walnut distributor to remove some unsubstantiated health claims from the packaging of their products: http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm. People making false claims about the health benefits of their products (e.g. selling grain alcohol mixed with an emetic as cure-all) was the whole reason the FDA was created.

Walnuts are not classified as a drug, but if you claim they cure cancer without a good double blind study to back you up, you will be called on your bullshit. This is a good thing and is an example of a government agency exercising it's regulatory authority within the appropriate ambit. There are plenty of other real government conspiracies both covert and flagrant to worry about without inventing more.

The main reason they put it out is that it helps reduce their costs.

If you read the FDA advice at http://www.fda.gov/RegulatoryI... and at http://www.fda.gov/MedicalDevi...

The key piece of advice is If manufacturers chose to use OTS software in their devices and vulnerabilities in OTS software can affect the safety and effectiveness of their networked devices, they have to act to keep their devices safe and effective.

Locking their devices away behind firewalls is great, but you should also provide copies of the above documentation to the vendor and ask them how they act to "keep their devices safe and effective". Make sure your legal staff are involved in asking the question, and see how quickly their advice changes.

Oh - and if you want bonus points in this - make sure that your purchasing people are across this issue and the question is asked during all procurement exercises, and that the contracts and specifications stipulate that the vendors are accountable for doing so.

The main reason they put it out is that it helps reduce their costs.

If you read the FDA advice at http://www.fda.gov/RegulatoryI... and at http://www.fda.gov/MedicalDevi...

The key piece of advice is If manufacturers chose to use OTS software in their devices and vulnerabilities in OTS software can affect the safety and effectiveness of their networked devices, they have to act to keep their devices safe and effective.

Locking their devices away behind firewalls is great, but you should also provide copies of the above documentation to the vendor and ask them how they act to "keep their devices safe and effective". Make sure your legal staff are involved in asking the question, and see how quickly their advice changes.

Oh - and if you want bonus points in this - make sure that your purchasing people are across this issue and the question is asked during all procurement exercises, and that the contracts and specifications stipulate that the vendors are accountable for doing so.