Cynthia wrote:So two good studies would be okay with you, but the more than 35 peer-reviewed studies done on walnuts somehow don't qualify?

No, two studies isn't enough for me. Two studies as part of a filing with FDA showing animal toxicology, manufacturing quality, and human safety and efficacy.

What's an adequate dose to get an effect? A bran-nut muffin a day or two cups of walnuts?
What's too much? If I eat two cups of walnuts, will it cause headaches, nausea, diarrhea, constipation? (Just about every drug reports those, by the way)
Are walnuts from Wisconsin different from walnuts from California? Does processing them change efficacy? What about long-term storage? If they're kept in a 68-degree cabinet for six months, are they still effective?

I know Quaker went through a lot of effort to get their cholesterol claims on Cheerios and other oat products. These are just the same rules that everyone has to follow for disease-modifying or [i]symptom-treating[i] substances.

I'm starting to bump into the limits of my knowledge here -- my expertise in in the electronic submission of information to FDA and other agencies, not what goes into them.

But FDA's primary mission is public safety, and they have to hold everyone to the same standard.
This may be a claim that's legitimate, but they have to follow the process.

I actually understand the stated purpose of the FDA (though I sometimes think power, politics, and money get in the way of that purpose).

I just have a different view of how information should be made available.

If dozens of research studies show good results and thousands of newspapers, journals, and magazines publish those reports (who hasn't heard about Omega 3 fatty acids by this point), I don't see why a company with a product that has Omega 3 fatty acids should have to go to huge expense in order to be able to print on their website or their products that reports show that Omega 3 fatty acids are good for you.

So we just have different opinions on what constitutes a reasonable use of widely available information.

As for how much to consume, packages generally state a serving size (including calorie counts, which will, in the case of nuts, dissuade some from over indulging). However, just as one cannot stop people from abusing drugs, there is no guarantee that people won't get stupid with food, too.

Cynthia wrote: I don't see why a company with a product that has Omega 3 fatty acids should have to go to huge expense in order to be able to print on their website or their products that reports show that Omega 3 fatty acids are good for you.

But that's not what they said. They said walnuts would help prevent specific diseases.

leek wrote:

Cynthia wrote: I don't see why a company with a product that has Omega 3 fatty acids should have to go to huge expense in order to be able to print on their website or their products that reports show that Omega 3 fatty acids are good for you.

But that's not what they said. They said walnuts would help prevent specific diseases.

My point was that they were quoting widely published reports. We've already identified several times precisely what it was they said, so I didn't think it all had to be repeated again. My point is that they should not have to go to huge expense when all the information has already been made public.

Which raises the question in my mind -- why can the press publish all this information as each research report is released, but a company selling the thing being discussed in the reports can't publish it? Someone could just as easily OD on walnuts after reading about it in Newsweek as they could reading about it on the Diamond website. (Actually, greater danger, as the Diamond website doesn't get nearly the traffic the newspapers and magazines get.)

It's not secret information. It's not information they generated. It's not even information that has been limited to medical journals. It's information that has been published in thousands of popular magazines, newspapers, and health blogs all over the world. Why is it that the only people who can't publish the info are the people selling the thing being researched? It just doesn't make sense.

Cynthia wrote:

leek wrote:

Cynthia wrote: I don't see why a company with a product that has Omega 3 fatty acids should have to go to huge expense in order to be able to print on their website or their products that reports show that Omega 3 fatty acids are good for you.

But that's not what they said. They said walnuts would help prevent specific diseases.

My point was that they were quoting widely published reports. We've already identified several times precisely what it was they said, so I didn't think it all had to be repeated again. My point is that they should not have to go to huge expense when all the information has already been made public.

We do apparently need to keep going over what they said because you seem unable or willing to accept that your version of the facts is plain wrong.

"OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":
• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."
• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ...
• "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."
• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

That's the language from the website that the FDA quotes in its letter. I'm sure if Diamond limited their marketing to say that walnuts are a good source of Omega 3's the FDA wouldn't give it a second look. When they create marketing material that references inhibiting tumor growth (not directly in this case, but still)...that's what causes a problem. Seems to me, Diamond is trying to skirt the rules with the old "I'm not saying...I'm just saying".

jesteinf wrote:

"OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":
• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."
• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ...
• "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."
• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."

That's the language from the website that the FDA quotes in its letter. I'm sure if Diamond limited their marketing to say that walnuts are a good source of Omega 3's the FDA wouldn't give it a second look. When they create marketing material that references inhibiting tumor growth (not directly in this case, but still)...that's what causes a problem. Seems to me, Diamond is trying to skirt the rules with the old "I'm not saying...I'm just saying".

And ALL of that information has been printed in newspaper articles, magazine articles, health newsletters. My point is not the content of what they said, my point is that if it has been published all over the world, why can't the seller publish it on their site. Everyone who reads health and nutrition research would just nod and say, "Yes, that's right. Yes, I read that study."

The issue for me is NOT what they said. It's whether something that has been widely published in the press can be repeated by a company selling the product in question.

They can say whatever they want, but if they're going to make a health claim then the FDA would consider the product in question to be a drug and will regulate it as such. Diamond just needs to decide if they want to deal with that treatment. They decided they don't. If they want, I'm sure they can put a link on their website to any article they want and say "hey, look at all of the great things these publications have to say about our product". Obviously there's nothing wrong with that, but that's not what they were doing.

jesteinf wrote:They can say whatever they want, but if they're going to make a health claim then the FDA would consider the product in question to be a drug and will regulate it as such. Diamond just needs to decide if they want to deal with that treatment. They decided they don't. If they want, I'm sure they can put a link on their website to any article they want and say "hey, look at all of the great things these publications have to say about our product". Obviously there's nothing wrong with that, but that's not what they were doing.

I know that's what happens. What I'm saying is that I don't think that's right. Diamond isn't making any claims of their own. They are simply reporting on things that have already been widely published. I understand FDA policy. I don't agree with it.

Cynthia wrote:However, to point out that FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have, whatever the claims either has made, is hardly a departure from reason.

Dare I hope you have evidence to back up this claim? Not just "look here is one specific example of a drug that caused harm", or even 10 examples, but a tally of all known cases of both pharmecutical incidences and "nutritional substances" clearly backing up your statement:

"FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have"

or is this your opinion?

zoid wrote:

Cynthia wrote:However, to point out that FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have, whatever the claims either has made, is hardly a departure from reason.

Dare I hope you have evidence to back up this claim? Not just "look here is one specific example of a drug that caused harm", or even 10 examples, but a tally of all known cases of both pharmecutical incidences and "nutritional substances" clearly backing up your statement:

"FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have"

or is this your opinion?

Aside from having read reports on thousands of deaths per year from prescription drugs, plus the reports about drug recalls, plus the friends who have been hospitalized because of some FDA-approved drugs, any time one turns on the TV (which, granted, for me, is only when I'm visiting someone with a TV, but I never see TV without seeing these ads) there are ads about class-action lawsuits against the FDA for a wide range of seriously adverse drug reactions -- so I'd say it's not just an opinion.

For example, more than a decade ago, an article in the Journal of the AMA said about 28% of all hospitalizations were due to reactions to prescription drugs. And last year, Scientific American reported that deaths due to prescription drugs were rising dramatically.

Of course, it's not just prescription drugs. FDA-approved OTCs are a problem, too. Tylenol is one of the leading causes of liver failure.

From 2000-2009, the FDA itself (FDA's Adverse Event Reporting System) calculated deaths totaling 370,056 and "serious outcomes" (episodes requiring hospitalization and resulting in disabilities or other long-term problems) equaling 2,345,006 from prescription drugs. (Deaths due to FDA-approved OTC drugs are not included in their calculations.)

One of the problems is that, until relatively recently, the FDA did not permit any testing of drugs to be done on women, as hormone fluctuations made it harder for them to read the data. So most of the drugs on the market were never tested on women, and we're seeing the results of that now.

Now, this is not saying I don't think there should be people checking out the drugs we're going to be taking -- there needs to be oversight. But the FDA does not have a good enough track record to be allowed to legislate.

It's also why I'm a lot more interested in finding foods with Omega 3 fatty acids than I am in taking anything the FDA has approved.

Cynthia wrote:Aside from having read reports on thousands of deaths per year from prescription drugs, plus the reports about drug recalls, plus the friends who have been hospitalized because of some FDA-approved drugs, any time one turns on the TV (which, granted, for me, is only when I'm visiting someone with a TV, but I never see TV without seeing these ads) there are ads about class-action lawsuits against the FDA for a wide range of seriously adverse drug reactions -- so I'd say it's not just an opinion.

You have no statistics to back up your claim. This is the textbook definition of an opinion.
It's not the only position you've presented as fact either:

Cynthia wrote:The FDA has a pretty solid track record of trying to discourage anyone from choosing nutrition, vitamins, and alternative approaches to healing. They seem to have lost their way, as far as what their real goals are. It's more about protecting their power than about protecting our health.

zoid wrote:

Cynthia wrote:Aside from having read reports on thousands of deaths per year from prescription drugs, plus the reports about drug recalls, plus the friends who have been hospitalized because of some FDA-approved drugs, any time one turns on the TV (which, granted, for me, is only when I'm visiting someone with a TV, but I never see TV without seeing these ads) there are ads about class-action lawsuits against the FDA for a wide range of seriously adverse drug reactions -- so I'd say it's not just an opinion.

You have no statistics to back up your claim. This is the textbook definition of an opinion.
It's not the only position you've presented as fact either:

Cynthia wrote:The FDA has a pretty solid track record of trying to discourage anyone from choosing nutrition, vitamins, and alternative approaches to healing. They seem to have lost their way, as far as what their real goals are. It's more about protecting their power than about protecting our health.

If you don't recognize the numbers I supplied from the FDA Adverse Event Reporting System as statistics, then I'm not sure what would constitute statistics.

I wonder if this means General Mills decided it was worth submitting to an FDA review to be able to call Cheerios "heart healthy", or is their approach done in such a way as to prevent the FDA from coming after them?

What if Diamond said, "here are a bunch of links to studies that say that Omega 3 fatty acids are good for you...by the way, walnuts contain tons of Omega 3 fatty acids"? Would that keep the FDA at bay?

This all sounds like a giant pain in the butt, but to me it's an interesting pain in the butt to ponder

Read the Cheerios text carefully. They're "part" of a heart healthy diet. Soluable fiber from oats can "help" lower cholesterol. "Can lower"..."May reduce". I think the situation is different because Cheerios isn't claiming that our product has A therefore you will see result B. Just a guess though.

Cynthia wrote:For example, more than a decade ago, an article in the Journal of the AMA said about 28% of all hospitalizations were due to reactions to prescription drugs. And last year, Scientific American reported that deaths due to prescription drugs were rising dramatically.
...
From 2000-2009, the FDA itself (FDA's Adverse Event Reporting System) calculated deaths totaling 370,056 and "serious outcomes" (episodes requiring hospitalization and resulting in disabilities or other long-term problems) equaling 2,345,006 from prescription drugs. (Deaths due to FDA-approved OTC drugs are not included in their calculations.)

I'd be curious to know if that 28% figure is lower now. A decade is a long time to go by. Also, these 370,000 deaths and 2.3 million "serious outcomes"...how many were due to misdiagnosis, or drug interactions that weren't picked up by pharmacists, or other factors? Are those all due to faulty drugs slipping through the system? Not trying to be snarky, I'm genuinely trying to understand these stats that you're citing.

Cynthia: I think hospitals are really bad. Do you know how many people die in hospitals each year??? Clearly you are safer not being in a hospital compared to being in one.

I think you've misunderstood the data on prescription drugs and the role of the FDA in the process.

Cynthia wrote:If you don't recognize the numbers I supplied from the FDA Adverse Event Reporting System as statistics, then I'm not sure what would constitute statistics.

You did not simply claim that there have been adverse events from pharmaceuticals. You claimed "FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have".

Nothing you've posted backs that up.

jesteinf wrote:

Cynthia wrote:For example, more than a decade ago, an article in the Journal of the AMA said about 28% of all hospitalizations were due to reactions to prescription drugs. And last year, Scientific American reported that deaths due to prescription drugs were rising dramatically.
...
From 2000-2009, the FDA itself (FDA's Adverse Event Reporting System) calculated deaths totaling 370,056 and "serious outcomes" (episodes requiring hospitalization and resulting in disabilities or other long-term problems) equaling 2,345,006 from prescription drugs. (Deaths due to FDA-approved OTC drugs are not included in their calculations.)

I'd be curious to know if that 28% figure is lower now. A decade is a long time to go by. Also, these 370,000 deaths and 2.3 million "serious outcomes"...how many were due to misdiagnosis, or drug interactions that weren't picked up by pharmacists, or other factors? Are those all due to faulty drugs slipping through the system? Not trying to be snarky, I'm genuinely trying to understand these stats that you're citing.

Scientific American last year reported that the number has increased sharply.

I do believe that the FDA only tracks things that can be attributed to the drug itself, rather than to a misdiagnosis.

And Darren72 -- yes -- a tremendous number of people die each year in hospitals of things they caught while in hospitals. Hospitals are great places when you're in trouble medically, but one should never take for granted that one is "safe" because one is in a hospital. Take all the precautions you'd take if you were visiting a developing nation. So while I don't know that I'd say "bad" I'd definitely say not really safe. They are the only really good place to be if you need surgery, but if you can avoid surgery (say, but eating better), that's definitely a better option.

As for misunderstanding the data -- while that is possible, I am at least in the company of a lot of smart people, including a lot of doctors, who have issues with the FDA.

zoid wrote:

Cynthia wrote:If you don't recognize the numbers I supplied from the FDA Adverse Event Reporting System as statistics, then I'm not sure what would constitute statistics.

You did not simply claim that there have been adverse events from pharmaceuticals. You claimed "FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have".

Nothing you've posted backs that up.

I posted the statistics gathered by the FDA on how many people were hospitalized or who had died from FDA-approved drugs. Millions.

No one has been hospitalized from switching to brown rice or eating more fish.

If you are going to make the claim "FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have" then you need to provide reliable numbers for both categories and demonstrate that one group is greater than the other with statistical significance. The problem is that I very much doubt the work has been done to prove this point either way.

Just to be clear, you will note I have never said any of your claims are wrong. That's because I can't it back up, just like you cannot back up the original claim.

Cynthia,

I have in my hand an article titled "Incidence of Adverse Drug Reactions in Hospitalized Patients" published in JAMA in 1998. Is this the article that you are referring to?

According to this article, the incidence of adverse drug reactions is 15%. 2/3 of these people were already in the hospital when they had the adverse drug reaction. They estimate about 1.5 million adverse drug reactions among people not already in the hospital 1994. There were over 33 million total admissions that year. 1.5 divided by 33 is 4.5%. 4.5% is not close to 28%.

The number of adverse reactions is rising because.... mysteriously, the number of people taking drugs is rising.

One of the problems is that, until relatively recently, the FDA did not permit any testing of drugs to be done on women

Almost, but again, wrong. The ban was only for certain types of drug testing, it was lifted in 1993, and had only been in place for about 16 years. The ban had nothing to do with hormone fluctuations. It was for fear that drugs might harm a fetus if the woman got pregnant.

zoid wrote:If you are going to make the claim "FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have" then you need to provide reliable numbers for both categories and demonstrate that one group is greater than the other with statistical significance. The problem is that I very much doubt the work has been done to prove this point either way.

Just to be clear, you will note I have never said any of your claims are wrong. That's because I can't it back up, just like you cannot back up the original claim.

Zoid, nearly every claim she has made is wrong.

Saying that nutritional substances don't put people in the hospital has about as much intellectual content as saying that painting your fingernails pink won't put you in the hospital.

Khaopaat wrote:I wonder if this means General Mills decided it was worth submitting to an FDA review to be able to call Cheerios "heart healthy"

Actually, that did happen, except that it was Quaker Oats that blazed the trail to be able to make that claim on their oatmeal boxes. I was doing some work for them at the time and it was a very big deal to them to jump through all the hoops necessary with the FDA to be able to make that claim.

Darren72 wrote:Cynthia,

I have in my hand an article titled "Incidence of Adverse Drug Reactions in Hospitalized Patients" published in JAMA in 1998. Is this the article that you are referring to?

According to this article, the incidence of adverse drug reactions is 15%. 2/3 of these people were already in the hospital when they had the adverse drug reaction. They estimate about 1.5 million adverse drug reactions among people not already in the hospital 1994. There were over 33 million total admissions that year. 1.5 divided by 33 is 4.5%. 4.5% is not close to 28%.

The number of adverse reactions is rising because.... mysteriously, the number of people taking drugs is rising.

One of the problems is that, until relatively recently, the FDA did not permit any testing of drugs to be done on women

Almost, but again, wrong. The ban was only for certain types of drug testing, it was lifted in 1993, and had only been in place for about 16 years. The ban had nothing to do with hormone fluctuations. It was for fear that drugs might harm a fetus if the woman got pregnant.

The statistics I listed were, as noted, from 2000-2009 and were from the FDA -- so no, not from a JAMA article in 1998.

In the scheme of things, 1993 is "relatively recently." (The recent suspension of the FDA approval of feeding arsenic to chickens relates to something they approved in 1944 -- so a bit of history here.) However, it's nice to know that the doctors who suspected darker motives were wrong.

Darren72 wrote:

zoid wrote:If you are going to make the claim "FDA-approved drugs have put a lot more folks in the hospital than any nutritional substances have" then you need to provide reliable numbers for both categories and demonstrate that one group is greater than the other with statistical significance. The problem is that I very much doubt the work has been done to prove this point either way.

Just to be clear, you will note I have never said any of your claims are wrong. That's because I can't it back up, just like you cannot back up the original claim.

Zoid, nearly every claim she has made is wrong.

Saying that nutritional substances don't put people in the hospital has about as much intellectual content as saying that painting your fingernails pink won't put you in the hospital.

Of course it is is similar to saying "painting your fingernails pink won't put you in the hospital." That's the whole point. The FDA wasn't protecting people from drugs. It was keeping a company from quoting reports on nutritional benefits of a food substance.

Clearly, I'm not dealing with a lot of Libertarians here. All I'm trying to get across it that I think someone selling a food with health benefits should be able to quote reports that tell what those health benefits are. I'm not saying that is how it works, just that I think it should work that way.

I should probably also note, since this has gone so far off track, that my point is not to make it look like the FDA should be omniscient and have a 100% clean track record when it comes to approving drugs. That's not possible. I've stated at least one other place that we absolutely need someone checking drugs. The issue I was addressing is the FDA making nutritional information hard to come by. Let them make sure food isn't tainted. Let them rigorously test drugs. But also let people selling nutritious food quote reports on nutrition.

Cynthia wrote:The issue I was addressing is the FDA making nutritional information hard to come by. Let them make sure food isn't tainted. Let them rigorously test drugs. But also let people selling nutritious food quote reports on nutrition.

The FDA does permit sellers of nutritious food make health claims for their food--as long as they have clinical studies to back it up.

Similarly, the FDA does permit sellers of pharmaceutical drugs to make health claims for their drugs--as long as they have clinical studies to back it up.

It's a level playing field.

riddlemay wrote:

Cynthia wrote:The issue I was addressing is the FDA making nutritional information hard to come by. Let them make sure food isn't tainted. Let them rigorously test drugs. But also let people selling nutritious food quote reports on nutrition.

The FDA does permit sellers of nutritious food make health claims for their food--as long as they have clinical studies to back it up.

Similarly, the FDA does permit sellers of pharmaceutical drugs to make health claims for their drugs--as long as they have clinical studies to back it up.

It's a level playing field.

But the whole discussion was triggered by a situation where the FDA did not allow the seller of a nutritious food to make claims, even though the claims were backed up by peer-reviewed, clinical studies. So I'm not really sure what you're saying. Are you just leaving out the "if they go to the expense of jumping through the FDA's hoops"? (And can the playing field truly be said to be level when it costs so many millions to get the FDA to approve something? You'd never make it back selling walnuts.)

The whole point of the FDA is that they have a VERY high standard for the claims that can be made.

Nitroglycerin helps with some heart conditions, but if I try to start selling chewing gum with nitroglycerin with the claim that it's been shown to have beneficial heart effects they're gonna fall on me like piano.

The point is that there are many people who are willing to misrepresent the effects of their products. Because of that the FDA must have a very strict guidelines and they cannot make any exceptions.