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One of the worst things you can do is to just too little of such things. It means it's not enough to kill the bacteria, just enough for it to live through it and form immunity to it.

You either use it to kill this generation, knowing the next generation will be less in number but probably immune, or you use it en-masse *with other antibiotics* so that nothing can evolve to survive against all of them quickly enough.

Spraying huge amounts (and that is a huge amount - way more than enough to contaminate your entire house and cause you health problems, for instance - generally antibiotics are measured in mg, not cc) of a single antibiotic at a time is basically the best way ever to render it useless permanently worldwide in as short a time as possible.

It's not huge quantities, no, but it doesn't need to be... it works on the microscopic scale where dumping hundreds of thousands of tons of it onto actively harvested crops is stupid. There's literally enough antibiotics left in our urine after sewage treatment to affect the ocean life, what the hell do you think dumping thousands of tons of it into just open nature is going to do?

P.S. About 8m kilos of antimicrobials, including antibotiocs, active ingredient a year is used on US livestock. (Source: 2017 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals). This one idea alone accounts for 5.5% of that use across the entire nation.

That number recently dropped in 2017 to under 5.5m,. Guess why. Because the FDA are supposed to be trying to combat antibiotic resistance.

https://www.fda.gov/AnimalVete...

There was an FDA medical recall a few months ago, which is a far bigger problem in practice. That too is expected to be fixed with a software 'update'.

Here you go. It's for contaminated water, but closest I could find.

No-one claims they're 100% safe. Not the government, not medics, and not the manufacturers. They specifically warn of a bunch of risks, on package inserts that look like this: https://www.fda.gov/downloads/...

And they're given a liability carve-out because they're at risk of strategic lawsuits designed to shut them down, orchestrated by a coalition of the dumb and the fuckers.

https://www.fda.gov/newsevents...

Also:
Safety and efficacy concerns: There are no homeopathic drug products marketed in the United States that are FDA-approved. This means that FDA has not evaluated them for safety or effectiveness. Thus, such products may not meet modern standards for safety, effectiveness, and quality.Mar 21, 2018

I agree that assuming "not synthetic = safer" is a fallacy. But in this particular case, Apeel's coating is extracted from fruits that are already Generally Recognized as Safe (GRAS) by national food regulators.

Also, if someone gets sick shortly after lunch, they are likely to blame lunch; it's more likely causd by breakfast several hours before. Here's a chart from the FDA showing typical onset times for various bacteria. Rarely would one get sick within an hour. More likely the cause would be YESTERDAY'S dinner.

https://www.fda.gov/food/resou...

Ok... decades old drug, these guys are taking advantage of a government-mandated monopoly (patent) that turned into a natural monopoly - US patent exclusivity is seven years. FDA needs to create a process to automatically institute a fast-track for generic competition in cases like this where a drug's price is increased by over a defined threshold (100%?). The resources required to staff such fast tracking should be recoverable in reduced cost to Medicare/Medicaid/etc. Let the Pharmacy Benefit Managers pitch in, for that matter... they are supposed to be all about managing the price of drugs. This is a simple way to do it.

No need to ban GMO. Just clearly label it. No one will buy it, and the frankenfarmers will go out of business.

We should also label all irradiated food, and all those atomic farmers will go out of business! https://www.fda.gov/food/resou...

Labels on foods without any scientific basis do nothing but scare ignorant people.

But seriously, I don't think "juice" means what you think it does. It's even more inaccurate than calling non-dairy products "milk".

Not possible to make it less accurate than calling it milk. Milk is a very specific thing derived solely from secretions by mammals used to feed their young. There is no product derived from plants that matches the chemical composition, nutritional profile, taste, mouth-feel, or cooking characteristics. That's not to say the veggie based products are bad or shouldn't be used. They just aren't even close to being milk in the technical sense or the legal sense.

You can squeeze soybeans or nuts all you want; you'll get neither juice nor milk. Non-dairy "milks" are generally made of highly processed, ground-up seeds mixed with thickening agents and large volumes of water.

"Soy milk" is a stable emulsion if you want to get technical about it. But we don't have a great word in common parlance for stable emulsions and we do have a good word for plant derived drinks - albeit an already corrupted one as you point out. So unless you want to invent a term (which I'm fine with), juice is as close to accurate as we have available. Given that we already describe lots of drinks that really barely fit the description of juice as juice (see fruit "juice" with just 5% or less plant derived actual juice) we're not really misleading anyone in a new way. You are correct that technically it is not juice but it's far closer to juice than it is to milk.

Where do you think does it improve over the current practice:
https://www.fda.gov/NewsEvents...

Improvement over previous practice:

The FDA lacks compassion, of course.

If it is the same shit following the US food pyramid, full of grains, carbs and low fat, I can guess they're likely NOT going to get that pleasant of an outcome.

The food pyramid was made by the USDA who's job is to promote agricultural commodities. The had their finger all of the scale during its creation. One of my favorite cheats is that fortified food are allowed, but vitamins are not. This was used to justify crazy amounts of milk and grains. If the food guideline had come from the FDA it would have looked much different.

The FDA did eventually approve thalidomide for treatment of myeloma and leprosy.

Our systems were more efficient before the existing government intrusions.

Our healthcare costs are doubling as are our education costs etc as a result of feedback subsidies.

Where in the government offers money to help people buy something, the market responds by raising prices, the government responds by increasing subsidies, and the market responds by increasing prices again... over and over.

It happened with the US housing market, our education, and our healthcare.

large portions of the US population are economically illiterate. This is not unusual, economic illiteracy is actually very common throughout the world and last I checked europeans score worse than Americans on it.

The point is that people don't understand basic economic concepts and so don't understand why given courses of action are obviously stupid.

To prove that it is government mismanagement and incompetence... We have a medical baking soda shortage in the US.

https://www.nytimes.com/2017/0...

To be very clear here, this is a shortage of sodium bicarbinate mixed with distilled water. It is impossible for the US to have a shortage of this substance and yet we do.

Why? The FDA pharma regulations make it almost impossible for US suppliers to make drugs. It is very hard to be a pharma company in the US. Which is why we have so few pharma companies and why it is so common for new pharma companies to go bankrupt. The FDA kills them.

Drugs in the US are dramatically more expensive in the US than outside not because of evil corporations but because Americans cannot import foreign drugs and domestic suppliers are crushed with crippling regulations.

Again... the regulations are so crippling that we have shortages of baking soda.

here is a list of drug shortages in the US:
https://www.accessdata.fda.gov...

This is what our government has done. These drugs are not expensive because of companies. Absent government regulation we'd have more domestic producers and/or would import from out of the country. It is the government that prevents both effective domestic production and foreign import.

And that is just ONE example of how they fuck it up.

It goes on and on and on and on.

https://www.healwithfood.org/a...
https://www.fda.gov/Food/Foodb...

PPB of acrylamide
Brewed coffee: 5-10
Gerber Tender Harvest Organic Sweet Potatoes: 121
Arby's french fries: 252
Lamb Weston Inland Valley Fajita Fries (baked): 1325
Pepperidge Farm Dark Pump Pumpernickel (not toasted): 34
Pepperidge Farm Dark Pump Pumpernickel (toasted): 364 <-- better not use your toaster
General Mills Cheerios: 266
Blue Diamond Roasted Salted Almonds: 236
Hershey's Cocoa: 909
Nabisco Chocolate Teddy Grahams: 199
Starbucks Coffee Colombia (brewed): 7
Starbucks Coffee Lite Note (brewed): 11
Keebler Rumbly Grahams Cinnamon: 334

Holy crap, see how much toasting your bread adds?! California should place warning on toasters. Turns your food into a cancer causing poison. But really, Gerber baby food has 12-24x more.

While FDA approved, https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm596531.htm, the UCH-L1 and GFAP markers may be of less diagnostic value in the presence of concomitant orthopedic injury, https://www.ncbi.nlm.nih.gov/pubmed/27841729.

Because when I hear "regulated like the tobacco industry", I immediately think of regulations which will be, at best, an annoyance to the established players (ie. Facebook) but devastating to any potential small businesses that could one day be competitive with the big guys. This is exactly the way the tobacco industry has been regulated--the Democrats are a bunch of useful idiots to Big Tobacco, happily instituting whatever regulation seems like a good way to "stick it" to smokers and tobacco companies without the slightest consideration of the long-term consequences or economic effects. Let's look at some examples:

The FDA bans flavored cigarettes, supposedly to keep kids from trying cigarettes, yet for some reason doesn't ban menthol, which is the number 1 flavor that people try when they start smoking. But I guess we can't do anything that might hurt our buddies in Big Tobacco, eh? The actual effect is to put small, niche tobacco firms out of business--less competition for Big Tobacco.

All the ridiculous scare mongering over vaping, because even though it's obviously safer than smoking, it might not be totally 100% safe, and we can't allow anything to be sold that hasn't been proven to be completely 100% safe. Why isn't this standard applied to alcohol or tobacco? Oh, right, I forgot, we can't do anything that might hurt our big corporate friends. Better ban vaping now!

What's that? People got sick of the obscene taxes on cigarettes and switched to rolling their own from loose tobacco. That's a good thing, right? less money in the pockets of big tobacco companies, wasn't that the whole reason we made these regulations? Oh, I'm sorry, I forgot we really made these regulations so Big Tobacco wouldn't have to compete. We better hike takes on loose tobacco by more that 2000%!

The bottom line is that if you want Facebook (or anything, for that matter) to go away, please, for the love of God, do not regulate it like we have regulated tobacco. The tobacco regulations we've made thus far have been nothing but neatly wrapped gifts to big tobacco conglomerates, sold as "onerous rules and regulations" to a public that won't bother thinking about them for five seconds and will support it as long as it has the superficial appearance of "sticking it" to big tobacco companies.

Chinese manufacturers adulterated foods with melamine

I was glad to see that at least they draw the line at profiting from poisoning infant formula. But that is a different issue from the one of unsolved pet deaths attributed to chinese made jerky treats. I'm sure that being "skilled at scaling quality requirements downward" has something to do with that. What is worse is that it is impossible to avoid Chinese food products as their spices are imported and used as ingredients.

The problem is American companies demand lower cost, and press down on the quality. That lets them get low, low prices.

Long term planning for the public interest, or anything other than the next quarterly report, is not their concern. In theory, that is the job of elected representatives and appointed regulators to provide necessary oversight and forcibly drag the Job Creators kicking and screaming to where they give even the slightest shit about the welfare of the country. I say in theory, because the reality is adversarial authoritarian regimes who do not share our civil liberties being catapulted into 'global manufacturing superpower' status, as an example.

Because China is such a global manufacturing superpower, they have the economic basis to do all of this stuff now, instead of generations down the line.

And the Waltons and Bezos of the world are all better off for it. Instead of having used tariffs and access to our markets to incentivize democratic reform and environmental regulation early on, now we'll gladly sell them the tools they need to suppress and censor their population in a digital age. It is our corporations that must now capitulate, unmasking journalists and dissidents if they want to do business there. While it is good that there is hope that in the next decade they may not have to worry as much when the wind changes direction, there is still a larger picture to look at.

Sucrose, glucose, and fructose are the sugars that the FDA actually considers sugar.

That's not a citation, that's just assertion. So I'll do the work for you:

According to this the term "no sugar added" may only be used if no sugar was added using the definition of sugar found here, which states "sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose)."

Trehalose is a disaccharide, so...

Sucrose, glucose, and fructose are the sugars that the FDA actually considers sugar.

That's not a citation, that's just assertion. So I'll do the work for you:

According to this the term "no sugar added" may only be used if no sugar was added using the definition of sugar found here, which states "sugars shall be defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose)."

Trehalose is a disaccharide, so...

Wockhardt has FDA approval for a generic. I am not sure if Wockhardt would enter the market because of this. All they have to do is make it and sell it to lower the price.

You can find information like this at Drugs@FDA, with the lovely link https://www.accessdata.fda.gov.... If you search for NIACOR and then look under the result for therapeutic equivalents, you find the approved Wockhardt product has been approved as Application No. 081134 since 1992.

The FDA doesn't have legal authority to regulate or certify supplements

And the supplement industry spends lots of money to ensure it stays that way. I wonder why?

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm153239.htm
https://www.consumer.ftc.gov/articles/0261-dietary-supplements#supplementssafe?
https://www.marketwatch.com/story/dietary-supplements-a-37-billion-a-year-boondoggle-2016-01-22
https://www.webmd.com/diet/features/truth-behind-top-10-dietary-supplements#1

Now of course I'm not saying all dietary supplements are fraudulent. I'm just saying its not always easy to tell which ones are fraudulent and which ones are not since they aren't regulated by anything beyond the amount of dollars they can convince you to spend.

And of course that's not even considering that many of the not-technically-fraudulent ones may simply be doing little or nothing for you and are effectively just an expensive placebo.

And even then many of the ones that might be theoretically useful are only beneficial if you have a bad diet to start with and actually need to supplement whatever chemicals your body isn't getting enough of -- but you claim to be eating well so that also shouldn't apply to you. For example if you're getting sufficient vitamin C and you take a vitamin C tablet.. its basically just going to go straight from your mouth to your bladder and out again without doing you any good whatsoever (but also no real bad in that case.. too much of some vitamins and minerals are as bad or worse than not enough so even more things to be careful of!)

The bleach solution is per FDA requirements more dilute than lots of tap water.

I found this very hard to believe, so I looked it up. The FDA limit is either 100 or 200 ppm (46c1 and 46c2). Drinking water's limit is 4 ppm.

The FDA Advisory Committee materials and presentations are here, for those interested.

Note that this is for a very specific genetic cause of blindness, where a mutation in a gene for an enzyme results in effective loss of that specific enzyme. The drug is a retroviral vector encoding only the missing gene. Other causes of blindness, genetic or otherwise, wouldn't benefit from this treatment.

Pretty amazing, and a long time coming for gene therapy, since Jesse Gelsinger's death prompted a long close look at using adenoviral vectors for gene therapy.

It operates in backup mode with 67 beats per minute. FDA has details.

. . . refuses to call the "burger" safe for consumption.

To wit, the ingredient of soy leghemoglobin:

"arguments presented [by its creators] ... do not establish the safety of soy leghemolgobin for consumption.”

Interestingly enough, Impossible Foods asked the FDA to STOP the approval process on their cultured meat substitute.

"Anyone attempting to use 915 MHz microwave to sterilize food while retaining the food's texture and taste will have to pay royalties to the following patents"

Those patents aren't for using 915mhz.

"Hundreds of 2450 and 915 MHz systems between 10 to 200 kW heating capacities are used in the food industry for precooking bacons (e.g., used in Subways restaurants), tempering deep frozen meats when making meat patties, and precooking many other foods products [2, 3, 4, 5]. Commercial systems performing microwave pasteurization and/or sterilization of foods are currently available in Europe (e.g. TOP’s Foods); however, the use of microwaves in USA to produce shelf stable low acid (pH>4.6) foods requires FDA acceptance."

https://labs.wsu.edu/microwave...

https://www.fda.gov/Food/FoodS...

Fixed link https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064932.htm

the term 2x4 has no units specifically attached. Also, the 1.5" by 3.5" is within rounding error. Food products get away with a similar rounding advantage: they just make the serving size small enough to round down to zero in the health-conscious categories (see link) https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm064932.htm/

In fact, both the glue and the sticker are edible. Here.

The FDA provides information about their standards. For example, To date, the FDA has set specific lead levels for a variety of foods. We set a guidance level for candy likely to be consumed frequently by small children (100 ppb). Assuming lead exposure decreases I.Q. and assuming I.Q. has some bearing on quality of life, children born in the U.S. after 1980 have benefited greatly from the reduction in enviromental lead.

You mean six months. Assuming the drug actually works that is. The delays come in proving it works.

I guess you never heard of sulfanilamide

Nor Thalidomide. From 1962:
http://www.washingtonpost.com/...
https://en.wikipedia.org/wiki/...

I guess you never heard of sulfanilamide

That's pretty rich, given that government guidelines have been saying for years that saturated fat is bad:

Saturated fat can increase the risk of developing cardiovascular disease.

The worst part isn't even that they falsely identified saturated fats as bad, but that for years governments told people to eat a low-fat, high-carb diet, which is pretty much a prescription for weight gain and diabetes.

This is another confirmation that the standard American diet puts most people in a situation of not being able to lose stored body fat due to insulin levels being too high in a chronic fashion for large scale fat metabolism to occur. This is why there is an obesity problem and a type 2 diabetes problem in this country.

This is due to the fact that Ancel Keys cherry picked his research data and gave the government the conclusion that saturated fat causes heart disease and to avoid heart disease you need to eat a high carb low fat diet. This advice in retrospect is upside down and backwards to what a heart healthy diet or weight loss actually requires to achieve, that is without excessive exercise (anyone can lose weight by burning 10,000 calories per day, but most people are not physically conditioned to do that and to do that much caloric burn on a daily basis is not practical.)

This is not a big revelation to those of us who have been practicing ketogenic diets, but it is a nice confidence click that we have been doing the right thing all this time despite being criticized for it by the big sugar shills or the clueless doctors who don't know about ketogenic diets.

That's pretty rich, given that government guidelines have been saying for years that saturated fat is bad:

Saturated fat can increase the risk of developing cardiovascular disease.

The worst part isn't even that they falsely identified saturated fats as bad, but that for years governments told people to eat a low-fat, high-carb diet, which is pretty much a prescription for weight gain and diabetes.

Considering this new research (not by experts, but singular, one controversial expert shill) is complete bunk, it might have been good thing to advise people to do what is good for them.

That's pretty rich, given that government guidelines have been saying for years that saturated fat is bad:

Saturated fat can increase the risk of developing cardiovascular disease.

The worst part isn't even that they falsely identified saturated fats as bad, but that for years governments told people to eat a low-fat, high-carb diet, which is pretty much a prescription for weight gain and diabetes.

>

If you want to know the risks of aspartame (spoiler alert: there are none unless you've been diagnosed with phenylketonuria), consult legitimate scientific bodies, like the NHS or Health Canada.

Links supporting that statement: Health Canada, UK NHS or UK Food Standards Agency, FDA.

The whole point being that dosage is critical in all of these cases.

"Formaldehyde is also produced naturally in the human body. It is essential for the production of some basic biological materials, such as certain amino acids. Amino acids are necessary for important life processes as they are the building blocks of proteins in the body."

It's normal but unnecessary for laypeople to be afraid of cell phones, just like it's normal but unnecessary for them to fear formaldehyde in small amounts. Now, as for that guy whose job it is to adjust active microwave relays...

I am a father of 8, and I have plenty of anecdotal evidence that Hyland's teething tablets are effective, and I want to continue to use them for my baby. From what I have read, the effective ingredient in them is probably the belladonna rather than the homeopathic ingredients, but I am not aware of any alternatives, and as near as I can tell the FDA refuses to actually release their data, which doesn't sound much like science to me. Maybe that has changed.

I think I've found the data here: Laboratory Analysis of Homeopathic Teething Tablets. I think the last table at the bottom of the page is the one of interest--it seems to list the levels of Belladonna in tested Hyland's teething tablets. I don't know how much is okay, from what I can tell, the table seems to indicate that while most of the tablets tested had less than 0.1 nanograms (being listed as "Below Limit of Quantification", with the lowest quantification given being 0.1 nanograms), one bottle had six tablets over 10 nanograms, including one at 53.4 nanograms. It seems to me that this is probably at least 500 times the usual amount.

It's misleading to say that Hyland's won't recall their product - they quit selling in the US months ago thanks to the FDA's pressure.

Yes, although this is clarified later in the submission: "Still, the company discontinued distribution in the U.S."

There was a flap several years ago where Hyland's was yanked off of the market because of alleged inconsistent levels of ingredients and that was supposed to have been corrected or the FDA would never have let them back on the market.

Perhaps Hyland's raised their standards for a while, then let them slip again?

I hope you find something else that works for you.

In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...

September 30, 2016

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Reference to adverse event reports here. Multitudes of reports reference events of seizures by infants.

January 27, 2017

Laboratory Analysis of Homeopathic Teething Tablets

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.

This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."

So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?

In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...

September 30, 2016

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Reference to adverse event reports here. Multitudes of reports reference events of seizures by infants.

January 27, 2017

Laboratory Analysis of Homeopathic Teething Tablets

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.

This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."

So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?

In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...

September 30, 2016

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Reference to adverse event reports here. Multitudes of reports reference events of seizures by infants.

January 27, 2017

Laboratory Analysis of Homeopathic Teething Tablets

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.

This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."

So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?

In the forest of anti-FDA and/or pro-homeopathic comments above, I was curious, so as far as I can determine, this is the FDA timeline for this...

September 30, 2016

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.

Reference to adverse event reports here. Multitudes of reports reference events of seizures by infants.

January 27, 2017

Laboratory Analysis of Homeopathic Teething Tablets

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. FDA analysis found the levels of atropine and scopolamine in some of the CVS tablets and the levels of scopolamine in some of the Hyland’s tablets far exceeded the amount stated on the products’ labels.

This is despite Standard Homeopathic Corporation (the manufacturer of Hyland brand Teething Tablets) insistent claims in voluntary reports that "Manufacture and processing occurred within established procedures to ensure product quality."

So you are the administrator of the FDA and are sitting on the pile of adverse event reports and have this completed laboratory testing report.... What would you do?

That proves the only way homeopathy might have some effect is when the acting product is still present in the final pills. Which is generally not the case.

More specifically, the FDA is saying certain homeopathic products have *too* much active ingredient because the manufacturer of that product uses unregulated, substandard dilution processes...

Even "modern-drug" manufacturers have problems like dillution to the proper amount of active/inactive ingredients as evidence by the McNeil/Tylenol recall of 2010. Speculation is that this appears to be a problem similar to the 2010 recall of teething tablets.

It just seem to my that Standard Homeopathic Corp / Hyland is bitching more than normal this time even in the face of mounting adverse event reports to the FDA since the voluntary recall back 2010. FWIW, most of the multitude of reports are infant seizures so it's hard to blame the FDA for not just sitting on this information (if they got caught sitting on this pile of paper, I'm sure all hell would break loose)...

That proves the only way homeopathy might have some effect is when the acting product is still present in the final pills. Which is generally not the case.

More specifically, the FDA is saying certain homeopathic products have *too* much active ingredient because the manufacturer of that product uses unregulated, substandard dilution processes...

Even "modern-drug" manufacturers have problems like dillution to the proper amount of active/inactive ingredients as evidence by the McNeil/Tylenol recall of 2010. Speculation is that this appears to be a problem similar to the 2010 recall of teething tablets.

It just seem to my that Standard Homeopathic Corp / Hyland is bitching more than normal this time even in the face of mounting adverse event reports to the FDA since the voluntary recall back 2010. FWIW, most of the multitude of reports are infant seizures so it's hard to blame the FDA for not just sitting on this information (if they got caught sitting on this pile of paper, I'm sure all hell would break loose)...

That proves the only way homeopathy might have some effect is when the acting product is still present in the final pills. Which is generally not the case.

More specifically, the FDA is saying certain homeopathic products have *too* much active ingredient because the manufacturer of that product uses unregulated, substandard dilution processes...

Even "modern-drug" manufacturers have problems like dillution to the proper amount of active/inactive ingredients as evidence by the McNeil/Tylenol recall of 2010. Speculation is that this appears to be a problem similar to the 2010 recall of teething tablets.

It just seem to my that Standard Homeopathic Corp / Hyland is bitching more than normal this time even in the face of mounting adverse event reports to the FDA since the voluntary recall back 2010. FWIW, most of the multitude of reports are infant seizures so it's hard to blame the FDA for not just sitting on this information (if they got caught sitting on this pile of paper, I'm sure all hell would break loose)...

Ok but admit that, given a choice, when your kid goes into anaphylaxis, you're not going to reach for the generic.

So when your kid goes into anaphylaxis and you're given the choice of injecting 1mg of epinephrine or 1mg of epinephrine, you'll go with what the TV advert tells you to do? No, I will definitely reach for the generic.

There is zero evidence that generic drugs lack quality. In fact the FDA's own website has a handy pictorial guide where the key picture is the one that says "Generic = Brand".

Actually there are plenty of studies which show all you're doing is giving money away so next time you're having an anephylactic shock just hand me your $600. I'll treat you with the same care a Mylan drug would and I get some spare spending money.

the patent lasts like 5 or 10 or 20 years (I don't know)

Uh, it's 20 years, sometimes including an additional exclusivity period of up to 5 years (or apparently up to 10 years for certain antibiotics) offered by the FDA in some situations such that competitors' products will not be approved during that time. The exclusivity period isn't guaranteed to run consecutive to the patent period, although the drug companies obviously attempt to engineer it that way if possible.

I just thought that was worth clarifying. Like, "I'm don't recall if Joe was two or four or eight feet tall [and it turns out he might've been as much as twelve feet tall]"... that's not something you should hand-wave away. Yes, it's a complicated situation, but the government-created barriers to entry here (of which drug patents are just a tiny piece) are significant. We do need some barriers, obviously, along with some method of incentivization, but given the high or wildly fluctuating prices of some generics when there doesn't appear to be much of a marginal cost involved (I'm not necessarily saying that's the case with the epi-pens), the system as a whole does not appear to be functioning terribly well.

the patent lasts like 5 or 10 or 20 years (I don't know)

Uh, it's 20 years, sometimes including an additional exclusivity period of up to 5 years (or apparently up to 10 years for certain antibiotics) offered by the FDA in some situations such that competitors' products will not be approved during that time. The exclusivity period isn't guaranteed to run consecutive to the patent period, although the drug companies obviously attempt to engineer it that way if possible.

I just thought that was worth clarifying. Like, "I'm don't recall if Joe was two or four or eight feet tall [and it turns out he might've been as much as twelve feet tall]"... that's not something you should hand-wave away. Yes, it's a complicated situation, but the government-created barriers to entry here (of which drug patents are just a tiny piece) are significant. We do need some barriers, obviously, along with some method of incentivization, but given the high or wildly fluctuating prices of some generics when there doesn't appear to be much of a marginal cost involved (I'm not necessarily saying that's the case with the epi-pens), the system as a whole does not appear to be functioning terribly well.