The FDA and health (Full Version)

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Bettawrekonize -> The FDA and health (9/10/2008 12:46:10 PM)

quote:


On October 17, 2005, the FDA sent warning letters to 29 companies that market cherries. In these letters, the FDA threatened these companies with legal action and told them they had to remove the scientific information on their websites that described the health benefits of the natural medicines found in cherries, such as the anthocyanins that reduce inflammation for arthritis sufferers. According to the warped FDA logic that now seems to be standard, when cherry growers post scientific information about the health benefits of their cherries, they magically transform their cherries into drugs and therefore, as drugs, they must have FDA approval in order to sell them in the United States.


http://www.naturalnews.com/019366.html

So, basically, using the FDA's logic, because vitamin C cures scurvy, vitamin C is now a drug subject to FDA approval. We might as well outlaw information documenting that apples, oranges, and every other fruit and vegetable that contains vitamin C is helpful at treating scurvy. I also have other related posts below.

quote:


A team of scientists funded by Telstra to investigate claimed links between cell phones and cancer has turned up probably the most significant finding of adverse health effects yet. When presented to 'Science' magazine for publication the study was rejected on the grounds that publication "would cause a panic". Three other prominent magazines including 'Nature' also later rejected the report, suggesting that they would not handle such important conclusions without the research being further confirmed.


Cancer center director warns of cell phone risks

It doesn't matter if these people think that a study would "cause a panic"? What's the worst thing that can happen, people will use cell phones less (and that would cause profit margins of cell phone companies to drop)? What's more important, the health of the American people or the profit margins of cell phone companies. As far as not handling such important conclusions without further research, there are two problems with that. If they kept on rejecting research based on this excuse, they can keep on saying, "we need further research before we publish this research" and they can use that as grounds not to ever publish any research no matter how much research there is on a subject matter. Secondly, the American people have a right to know the results of this research even if there is no further research on the subject. The journals are free to say, "while this research may suggest such and such, further research is still needed to draw any conclusions" and allow the American people to interpret the given research as they please, but what they should NOT do is ban the publication of research because they don't like the implications. That's not sciecne, it's nonsense. They should publish the research for what it shows and then, if more research is done, they could publish that research as well. The additonal research that is done in the future may or may not support the conclusions of this research, but it should still be published along with this research. If it supports the conclusions of this research, fine. If it doesn't, then the journals can say, "while past research may have supported such and such conclusions, current research does not" and allow the American people to figure out how to interpret the results of various research. What these journals should NEVER do (this is counter scientific) is ban research because they don't like the implications.


Red Yeast Rice and the FDA

According to the FDA's logic, because vitamin C cures scurvy, we might as well make it a regulated drug and ban all apples and oranges that contain vitamin C. From now on, we can only produce fruits and vegetables with no vitamin C.

This is absolutely ridiculous. Yes, fruits and vegetables have health benefits, and they have health benefits because of the chemicals that they are made out of. What we should NOT do is find which chemicals have which health benefits, label those chemicals "drugs regulated by the FDA" and then ban any fruits and vegetables that contain those chemicals (and force farmers to produce the same fruits and vegetables, only without those chemicals). Pretty soon I'll need a prescription to eat an apple that contains Vitamin C. The FDA is basically causing health problems by forcing people to eat fruits and vegetables without the normal chemicals that keep them healthy (ie: vitamin C) and then, when they get sick (ie: due to a lack of that chemical that they would normally be getting. IE: due to a vitamin C deficiency), they are requiring you to get an expensive prescription drug to alleviate the health problems that they caused in the first place.



DanJames -> RE: The FDA and health (9/10/2008 1:30:31 PM)

I'm not positive, but I think that the problem (if it can be called a problem) is that the amount of research that has to be done in order to get something "FDA approved" is radically cost inefficient unless you can make a good deal of money off of it. Basically, nobody is going to do the paperwork to get comments like "Cherries treat AIDS" or "An apple a day keeps the doctor away" approved by the FDA. The reason? You can't patent a cherry or an apple. The only way to make these kind of claims is if you are NOT selling cherries. Nobody is going to get fined or go to jail for saying that cherries treat inflammatory arthritis. You could advertise that they cure cancer and nobody can do anything about it. The problem is when you are selling them. You can sell cherries, you can claim they cure cancer, but you can't do both.
This was a similar kind of lawsuit against someone that was selling apricot seeds as a cancer cure. It doesn't matter how many people have had their cancer successfully treated by apricot seeds, you need to have the FDA's kind of research done to make the claims if you're planning on selling them. After you do the research, though you're out the money, and everybody else cashes in because you can't patent a fruit.



Bettawrekonize -> RE: The FDA and health (9/10/2008 1:41:55 PM)

The studies were already conducted and these studies show the health benefits of cherries. The problem is that the FDA is trying to ban anyone selling cherries from telling others about those health benefits.

quote:


Protection Act (HR4282). It is a bill that will allow organizations like cherry growers to tell the truth about their products, as long as that truth is based on sound science. It would allow cherry growers, for example, to reference the published scientific studies that report on the healing benefits of the phytochemicals found in cherries.


http://www.naturalnews.com/019366.html

Basically, this is a matter of freedom of speech.

quote:


...the FDA is now threatening cherry growers with raids to confiscate their cherries, haul them into court, and put them out of business for doing one simple thing that the FDA cannot stand to allow: The distribution of scientific information describing the health benefits of cherries.


http://www.naturalnews.com/019366.html

This is absolute tyranny right here. It's against academic freedom, open inquiry, and freedom of speech. People (including cherry growers and those selling cherries) have a right to distribute scientific information about the health benefits of cherries (or whatever fruits and vegetables).



Bettawrekonize -> RE: The FDA and health (9/10/2008 1:49:59 PM)

quote:

ORIGINAL: DanJames
I'm not positive, but I think that the problem (if it can be called a problem) is that the amount of research that has to be done in order to get something "FDA approved" is radically cost inefficient unless you can make a good deal of money off of it.
...
After you do the research, though you're out the money, and everybody else cashes in because you can't patent a fruit.


Studies have been done on the health benefits of cherries, Red Yeast Rice, etc.. (in America and other countries) without the help of big pharmaceutical corporations. Just because something isn't "FDA approved" doesn't mean it doesn't have health benefits. You and I can probably both agree that eating fruits and vegetables is good for us (and not eating any fruits and vegetables is really bad for us) regardless of "FDA" approval. I don't need the FDA to approve the benefits of every substance in an apple in order to know that apples are good for me. Studies have been done on the effects of cell phones and the brain without the help of pharmaceutical corporations. Just because pharmaceutical corporations don't back something up doesn't mean studies won't be done on something. Besides, many of the studies required to get a drug approved by the FDA are largely publicly funded (ie: by public universities) and the pharmaceutical corporations often end up with an exclusive patent when the (mostly tax funded) research is complete (and the pharmaceutical corporations often wind up exclusively reaping the benefits of the patents).

quote:


Drugs are expensive, say the pharmaceutical companies, because of the years of research and failed trials that go into making a successful drug. However, they neglect to mention that up to 50% of the research and development cost in the world is incurred by the public sector. Tremendous amounts of drug research is funded by university funding and government grants.

But when putting a figure to the R&D costs, pharmaceutical companies include these public sector costs as if they were their own. This inflates the stated expenditure associated with R&D per drug for a company and provides an artificial justification for extremely high prices. To burst another drug company bubble, I should include that these companies spend more on marketing and administration than on R&D. It basically goes without saying that the pharmaceutical industry has been one of the most profitable industries in the nation for several years straight.


http://www-tech.mit.edu/V123/N41/shef_colum.41c.html

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"That is, the drugs that were developed with government funding were 3 times as expensive as the drugs developed without government funding. In 1991, the most recent year of the study, drugs developed with federal funding were over 11 times more expensive than drugs developed without federal funding."
...
"For many drugs, the government has paid for most or all of the pre-clinical research, and it frequently funds the development of the drug all the way through FDA Phase II and Phase III trials. In these cases, which are many, the drug should not be priced as though the firm had borne all the risks and made all the investments."
...
The Orphan Drug Act has vastly increased the monopoly pricing power for many drugs, and it has created special challenges for drugs developed with public funds. The first firm to obtain FDA approval to market a drug that can qualify as an orphan is automatically granted marketing exclusivity, regardless of the company's role in the drug's development.


http://www.mercola.com/2001/aug/15/drug_war.htm



Bettawrekonize -> RE: The FDA and health (9/18/2008 10:27:32 PM)

Now a pharmaceutical corporation wants to outlaw vitamin B6 and make it a drug.

Health Freedom Warning: Drug Company Seeks to Outlaw Vitamin B6 to Protect Pharma Profits

quote:


The latest attack against vitamins comes from an FDA petition filed by Medicure Pharma, Inc., which has astonishingly asked the FDA to ban the sale of Vitamin B6!

Vitamin B6, of course, is a naturally-occurring nutrient found in numerous vegetables, nuts and whole grains. Its natural form is called pyridoxal 5'-phosphate or P5P for short. It's an essential nutrient for expectant mothers, growing children and anyone who wishes to be healthy. It's absolutely crucial for healthy blood cell function, and it's used in over 100 enzymatic reactions involving protein metabolism.


http://www.naturalnews.com/023514.html



Bettawrekonize -> RE: The FDA and health (9/19/2008 12:29:25 AM)

Sorry, I got the red yeast rice link wrong last time. Here is the correction
Red Yeast Rice and the FDA



Bettawrekonize -> RE: The FDA and health (10/1/2008 1:10:07 PM)

quote:


Mehta reports that representatives from the food and pharmaceutical industries say banning ads would violate the First Amendment. “In our system of jurisprudence we have a very high threshold that protects the right to free speech, whether it’s political or commercial,” Jim Davidson, attorney for the drug-company-funded Advertising Coalition, told the Associated Press.


# 23 FDA Complicit in Pushing Pharmaceutical Drugs

Interestingly, freedom of speech seems to apply when it comes to pharmaceutical corporations, but not when it comes to natural foods and dietary supplements.

quote:


A letter sent from scientists at the Environmental Working Group (EWG) to officials at the FDA and FTC uncovers EWG’s extensive review of Nursery Water’s claims that both misrepresent the position of the American Academy of Pediatrics, which states, “supplementary fluoride should not be provided during the first six months of life” (AAP 2005), and contradict the official position of the FDA, which states, “the health claim [for fluoride] is not intended for use on bottled water products specifically marketed for use by infants” (FDA 2006).1


It's ok for pharmaceutical corporations to make claims that the FDA doesn't even approve of and to misrepresent the FDA and the American Academy of Pediatrics and when this happens, the FDA is slow to act.

quote:


Meanwhile, Mehta reports that it’s not clear whether the FDA reviews most advertisements at all. The agency can direct drug companies to change their advertisements after they are released to the public if it finds they violate regulations, but does no screening before the release of ads that may be dangerously deceptive.


But when anyone selling cherries, natural foods, or dietary supplements even refers to a study indicating the health/medicinal benefits of such foods, the FDA is quick to say that freedom of speech does not apply.



Bettawrekonize -> RE: The FDA and health (10/8/2008 12:46:24 AM)

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WASHINGTON, April 23 — Disorganization, bureaucratic infighting and an inability to force drug makers to conduct needed safety tests have undercut efforts at the Food and Drug Administration to uncover drug dangers, government auditors say.

When drug safety specialists raise alarms about certain medicines, they sometimes feel that their recommendations fall "into a 'black hole' or 'abyss' " at the agency, according to a report to be released Monday by the Government Accountability Office, the auditing arm of Congress.

Top agency officials sometimes excluded drug safety specialists from presenting findings at public hearings, and tensions between officials who approve drugs and those who ensure that they are safe are common, the report said.

"F.D.A. lacks clear and effective processes for making decisions about, and providing management oversight of" issues involving the safety of popular medicines, the report states.
...
Last year, the agency created a drug safety oversight board and asked the Institute of Medicine to examine its drug safety practices. ... The accountability office said in its report that the agency's responses so far might help "but will not address all gaps."
...
The report comes after a series of drug withdrawals led agency critics and some on Capitol Hill to suggest that the agency was failing in its mission to protect the public from dangerous drugs. Since 2000, pharmaceutical companies have withdrawn 10 drugs after deaths and other injuries belatedly demonstrated that the medicines were unsafe.

Many critics have said that the agency should never have approved these drugs for sale in the first place.

Senator Charles E. Grassley, an Iowa Republican who is chairman of the Senate Finance Committee, said the accountability office's report showed that "the F.D.A.'s problems are systemic and cultural, not isolated or easily fixed."
...
When it approves new drugs for sale, the drug agency often requires manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects once they get into a broader market.

But the agency announced in March that two-thirds of these promised studies had not even been started, and hundreds of trials have been pending for years.

In many cases, pharmaceutical makers had guaranteed they would undertake the studies as a way to speed their drugs' approval.
...
Dr. Alastair Wood, associate dean of the Vanderbilt medical school, said the report demonstrated that the drug agency needed more authority and should create an independent department that evaluates the safety of medicines.

"It confirms that the current system needs fixing," Dr. Wood said.
...
Much of the drug agency's functions are financed by fees paid by drug makers, but the industry mostly opposed proposals that would have allowed the agency to use this money to determine whether already approved medicines cause unexpected injuries or deaths.


Congressional Investigators Are Critical of F.D.A.'s Efforts to Detect Drug Dangers
G.A.O. Report (pdf)

Sorry for copying and pasting a substantial amount of information, but I thought all of it was important.

First of all, if pharmaceutical corporations guaranteed that they will undertake studies in order to get a drug approved faster and they do not follow through with their guarantee, I think that the pharmaceutical corporation that broke its promise should no longer be allowed to profit from the drug (at least temporarily until they follow through with their guarantee) and there should be sanctions for them not following through with their guarantee. Secondly, I do not think that pharmaceutical corporations should be doing the studies, an independent third party should be (though pharmaceutical corporations are free to pay for the studies in order to get the drug approved faster).

Thirdly, I do not think that an "independent department" is a long run solution to this problem. The FDA itself is supposed to be an independent agency that's designed to protect the American people and in as much as the FDA is subject to corruption, so is any "independent" department. A better solution would be to make the FDA more directly accountable to the people (ie: FDA elected officials who are elected either by the people or by congress (because congress is elected by the people), they should have limited terms after which they must be re - elected, and if they are elected by congress they should be directly accountable to congress. Specific people with authority must be accountable for the actions of the FDA).

Fourthly, if much of the drug agency's functions are financed by fees paid by drug makers, the agency should certainly be allowed to use this money to determine whether already approved medicines can cause unexpected problems.



jkdjr25 -> RE: The FDA and health (10/8/2008 5:40:03 PM)

I think it has less to do with the FDA being tyrannical and more to do with giving medical advice when the one advising isn't a doctor. At least that's how I see it. One can point to the studies but they can't say that x is better than y if they aren't a doctor.



Bettawrekonize -> RE: The FDA and health (10/9/2008 11:34:50 AM)

quote:

ORIGINAL: jkdjr25
I think it has less to do with the FDA being tyrannical and more to do with giving medical advice when the one advising isn't a doctor. At least that's how I see it. One can point to the studies but they can't say that x is better than y if they aren't a doctor.


No where did I suggest that people should ignore the recommendations of doctors. The doctors themselves are free to look at the studies and use them to make determinations as well (and I encourage them to), indeed, the knowledge that doctors have comes from various studies. I am not suggesting that those selling dietary supplements or natural foods/herbs (some of which maybe doctors themselves) advise everyone about what to do in each and every situation, but I see no problem with them referencing studies and making general suggestions about what a supplement can help with (just like pharmaceutical drugs do). Why should pharmaceutical drugs be given such permission and not dietary supplements, in as much as a pharmaceutical drug makes claims based on studies they are giving, "medical advice when the one advising isn't a doctor."

"One can point to the studies but they can't say that x is better than y if they aren't a doctor."

So if a doctor suggests that cyanide is better at curing scurvy than vitamin C, all the studies indicate that cyanide does not cure scurvy and it's deadly and that vitamin C does cure scurvy and it's relatively harmless, and I point to hundreds of studies indicating this and the doctor references no studies supporting his position, are you willing to take the advice of a doctor over the studies I am showing you? Yes, this maybe an extreme example (no doctor will recommend cyanide for scurvy), but it still displays the point I'm trying to make. Doctors themselves get their knowledge from studies and I see no reason why people should not be allowed to distribute studies done on a supplement/food (why should pharmaceutical corporations have a monopoly on doing such a thing?). A doctor who isn't familiar with certain studies will be less likely to make informed decisions and it is important to make as many people as possible informed about as many studies as possible so that both patients and doctors can make more informed decisions together. The validity of an argument is independent of who makes the argument and whether or not a supplement/herb/food/drug/substance will help someone in a specific situation is independent of who recommends the supplement/drug/etc... The fact that someone is a doctor does not in itself make them right and someone can be right even if they're not a doctor.

Besides, it is many qualified scientists (post 5) who work for the FDA who are suggesting that there is considerable corruption within the FDA.



Bettawrekonize -> RE: The FDA and health (10/19/2008 7:38:26 PM)

I also find this podcast interesting. I don't know how valid what this person is saying is, but I think it's worth considering.

I also posted this elsewhere but I think it's worth mentioning here.

I don't think that intellectual property rights really helps research and development that much (though I do think it has a place for things that have very high fixed costs and low variable costs). Many advancements were made without the help of intellectual property rights. Universities, for example, fund all kinds of research that doesn't help us economically and that doesn't help our health (ie: research to figure out where each star in the sky is), we don't need intellectual property for that. Universities, for the most part, can advance medicine without the need for intellectual property getting in the way. I also think that intellectual property causes a lot of corruption. For instance, look at my Red Yeast rice and the FDA article under conspiracies and my FDA and Health article here. Chances are, Red yeast rice containing lovastatin wouldn't be illegal if competing products aren't subject to intellectual property rights (intellectual property rights give special interest groups with patents an economic incentive to have non patented competing products outlawed, not because those competing products are harmful to our health or the environment, but because they get in the way of the profit margins of those special interest groups' monopoly. Removing these intellectual property rights removes much of the incentive to have non patented competing products outlawed for economic reasons and it removes much of the incentive to have the FDA, "alter technical information or their conclusions in a FDA scientific document" (post 5) (this problem has probably been going on long before this survey revealed it and, chances are, it won't go away anytime soon even if the reality of it never makes it to the public. Chances are that a lot of corruption happens behind closed doors and hardly ever surfaces to the public. The best way to remove this kind of corruption is to remove the incentive for it and intellectual property rights give incentive for corruption) and it removes much of the incentives to have authorities and independent organizations lie about or suppress the true conclusions of studies or to suppress studies or the conduction and public distribution of studies on things that don't have patents. The best way to eliminate corruption is to remove the incentive for corruption. If there is incentive for corruption this increases the chances that corruption exists. Patents give special interest groups an incentive to act unethically because they can benefit from it. Another good example of this is DCA (read post 2). DCA is relatively harmless and chances are that the only reason the FDA put a stop to the sales of it in this situation is because one can't get a patent on it and special interest groups were afraid that it would interfere with the profit margins of competing drugs that don't have patents. After all, the FDA does approve drugs that are far more dangerous. Heck, smoking cigarettes is harmful and cigarettes hardly have any health or medicinal benefits associated with them, yet selling cigarettes and smoking is not illegal. Why? Because special interest groups who have incentive to keep these harmful products legal lobby to keep them legal. So it doesn't seem like the government is too concerned about our health when it comes to smoking, why should I believe they are concerned about our health when it comes to what drugs or dietary supplements to outlaw? If it's legal for people to decide to smoke, it should be legal for them to decide to take red yeast rice for their cholesterol or DCA to try and treat their terminal cancer after the doctors sent them home to die. As long as people are aware of the known health benefits and risks of using such a drug for the purpose they want to use it for, or if few studies have been conducted on it, they should know that and then it should be for them to weigh the benefits and risks involved with taking a drug or supplement that isn't wells studies for a particular purpose. Otherwise, if the government wants to outlaw red yeast rice containing lovastatin or DCA because they think it's best for us, despite the fact that red yeast rice and DCA are far less harmful than cigarettes and studies have shown red yeast rice to be safer and more effective than some legal drugs that lower cholesterol, then the government should be consistent about their concern for our health (instead, they consistently do that which is most profitable to special interest groups) and they should outlaw cigarettes. The reason they won't is because cigarettes benefit special interest groups and so it doesn't take much of a leap of faith to deduce that the government is not that interested in our health and that they are highly influenced by special interest groups and that the reason many non patentable drugs and supplements are outlawed is not because of possible negative health implications, but because of special interest groups who have to compete with those drugs and supplements. People know the harmful risks of cigarettes and they can choose to smoke and just like people can choose to smoke, they should also be able to choose to take red yeast rice or DCA to try and treat a health problem they think it might treat so long as they know the risks and ramifications (ie: drug interactions) involved or so long as they know that the risks and ramifications are unknown due to a lack of studies. Of course, the assistance of a doctor is highly recommended and in many cases their prescription should be required. Intellectual property rights also give those who benefit the most from it incentive to claim that society as a whole benefits more from it than its cost even if such property rights cost society more than they benefit it).

Another comment I wanted to add that I posted somewhere else (not on these forums).

One thing I think people should consider when taking these supplements (with respect to their effectiveness) is the fact that the FDA often does try to regulate which substances they may or may not contain. Often times the FDA would insist on removing certain substances from natural herbs (perhaps for the purpose of making them ineffective) and the removal of those substances may make them ineffective (ie: lovastain and red yeast rice).
...
Sometimes (as in the case of ephedra) the FDA may ban certain variants of an herb (and the variants they may ban are the effective ones). Sometimes certain effective herbs maybe banned altogether, leaving less effective ones for a particular purpose on the market (hence giving herbs in general a bad name because you can't get specific herbs that are good for specific things). So, in taking this stuff into consideration, one must also take into consideration what actions the FDA has had on the herb in order to make it ineffective. Of course, if studies have been done by universities on either altered herbs (because the FDA required that chemicals be removed) or on ineffective herbs (because the FDA banned the effective ones or the effective variants) one can expect that the studies will not fair well for the herbs. It's unclear what the motives of the FDA are, but what is clear is that the FDA can't be trusted, either because it has extremely bad judgment or because they have been influenced by corruption. Either way, their actions regulating various dietary supplements and herbs must be taken into consideration before labeling natural medicine (ie: herbs and dietary supplements) ineffective.

The point here is that, in evaluating the effectiveness of, say, Chinese medicine, or any other type of (say herbal) ancient medicine that has been around for thousands of years, one must consider how the actions of the FDA and/or other governmental bodies might influence the effectiveness of a treatment (ie: by banning certain substances within an herb or by banning certain variations of an herb or by banning the most effective natural treatments to a health problem). It's even possible that results may have been altered (post 5) for the purpose of portraying results that are more desirable to the profit margins of pharmaceutical corporations (if special interest groups have managed to fraudulently influence the results of the FDA, what makes you think they will be unable to influence the results of other groups who may conduct studies?). I'm not saying that you should also accept the notion that dietary supplements and herbal remedies work whole heartedly (even those that sell dietary supplements and herbs may have incentive to trick the consumer), I'm just saying that you should be skeptical of everyone including the FDA, pharmaceutical corporations, dietary supplement manufacturers, those who sell herbal remedies, and those who present studies to us. Incentive to deceive exists everywhere you turn and the FDA is no exception (the FDA is composed of humans who are just as prone to corruption as anyone else and the FDA is just as prone to corruption as any other organization). However, I think it's important to realize that those who have patents have greater incentive to deceive consumers (ie: by making their products look safer and more effective than they really are or by making competing products look more dangerous and less effective than they really are and having competing products banned) because patents allow people to sell a product way above cost.



Bettawrekonize -> RE: The FDA and health (10/19/2008 8:33:50 PM)

quote:


While Ephedra remains illegal, FDA approves the same chemical for OTC pharmaceutical sales
...
(NaturalNews) The FDA has approved a new pseudoephedrine-containing product, Zyrtec D, for over-the-counter sale to people over the age of 11. "The approval of this widely used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Dr. Andrea Leonard-Segal, director of the agency's Division of Nonprescription Clinical Evaluation.

"This double standard in chemical safety is typical of the pro-pharma FDA," explained consumer health advocate Mike Adams. "According to the FDA, all drugs are assumed safe until proven dangerous, but all herbs are assumed dangerous unless proven safe. This approach to consumer safety is backwards," Adams said. "It is the highly-concentrated drugs that pose the real danger to consumers. The plant compounds used in Chinese Medicine are remarkably safe and have been used for literally thousands of years in the safe and effective treatment of numerous health conditions."

Zyrtec-D is indicated for the treatment of upper respiratory allergies such as watery eyes, runny nose, sneezing, nasal congestion, or itching of the eyes, nose or throat. It reduces nasal swelling and relieves sinus congestion and pressure.


http://www.ephedra.nu/

Also found this interesting

http://www.consciouschoice.com/2002/cc1511/healthconscious1511.html



Bettawrekonize -> RE: The FDA and health (10/22/2008 11:38:01 AM)

I found this quote interesting

quote:


The question I should like to pose is this: if you are a biomedical scientist who fails to convince your peers of your views on a particular matter of legitimate scientific inquiry, is it acceptable that you take your minority views to the streets in order to drum up public and media support for your stance?


Will donations fund dichloroacetate (DCA) clinical trials?

I'm not exactly sure how to respond on that blog (ie: where do I sign up) and I seem to be banned/indefinitely suspended from uncommondescent (for no reason) so I can't respond there, so I figure I'll respond here.

The problem is that it seems that those making the decisions, at least in part (ie: over what gets funded and what does not), are not scientists and doctors, but rather, administrators, politicians, and those who stand to benefit from having substances that compete with their patented drugs banned.

According to the postcast in post 11, in February, the largest oncology group in the nation told the FDA to ditch those drugs (about 2 min and 50 seconds into the podcast) and the FDA ignored them. I wish he stated his sources, I looked everywhere and couldn't find them (google, his website, etc..., I would greatly appreciate it if someone else would help me find what he is referring to. I doubt he is lying, but sources would be nice).

Also, as I already showed here surveys seem to indicate that many scientists who work for the FDA don't seem to be happy with the FDA and the decisions they make (posts 7 and 5) and in the case of Vioxx, one of the FDA scientists, Dr. David Graham warned the FDA about the potential problems, and they just ignored him (this guy worked for the FDA for two decades), and this guy indicated to the public that there is plenty of corruption within the FDA and the FDA denied it and ignored him (then later, a survey came out indicating that many other scientists who work for the FDA feel the same way, as I have already linked to). The problem here seems to be that it's not scientists making the decisions, the decisions are being made by non - scientists (politicians, administrators, and those who stand to gain from the decisions), and the decisions are not based on science, they are based on profits. Many scientists who work for the FDA seem to be convinced that what the FDA is doing is wrong (this doesn't seem to be that much of a minority view among scientists), but it's not the scientists making the decisions, it's the administrators, politicians, and other special interest groups. So, absolutely, what these scientists should do is let the world know what's going on and take their, "views to the streets," and they certainly should not hide them from the public just because administrators, politicians, and special interest groups (and non scientists) want them to.

In a survey, "66%, roughly two out of three, of the FDA's front-line research scientists were either "not at all confident" or only "somewhat confident" in the agency's practices with regard to monitoring a drug's safety once past the approval process." and, in another survey, "nearly one fifth of respondents 'have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document'.... 61 per cent of respondents knew of cases where 'department of health and human services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.' "

When that many scientists who work for the FDA think such a thing, I want to hear what they have to say (and I think it's important for us to hear what they have to say). Absolutely, these scientists have every right to take their "views to the streets" despite the fact that administrators, politicians, and special interest groups do not want them to.



kernsfamily -> RE: The FDA and health (10/22/2008 12:15:02 PM)

quote:

I'm not positive, but I think that the problem (if it can be called a problem) is that the amount of research that has to be done in order to get something "FDA approved" is radically cost inefficient unless you can make a good deal of money off of it.


Very true.

I work for a veterinary pharmaceutical company. To get ONE product "FDA approved" (which is required for most everything we do), costs us hundreds of thousands of dollars. And, the process can take 3-4 YEARS.

And, not every product that goes through the process gets "approved"....but, it still costs regardless.



Bettawrekonize -> RE: The FDA and health (10/23/2008 11:12:57 AM)

Another example of a survey that illustrates how it is administrators, politicians, and special interest groups making the decisions, and not scientists.

Survey: FDA Scientists (2006)

Here is a selected quote from scientists who work for the FDA.

quote:


"Scientific discourse is strongly discouraged when it may jeopardize an approval. . . . Whenever safety or efficacy concerns are raised on scientific grounds . . . these concerns are not taken seriously."

"First class scientists are leaving the FDA, and recruiting new ones will be very difficult."

—selected FDA survey essay repsonses


This survey, like the others, also demonstrates that the view of these scientists isn't much of a minority view among FDA scientists. I encourage these scientists to speak up. When the administrators, politicians, and special interest groups ignore them, they should absolutely go to the public and take their, "views to the streets," even if it is against the will of the administrators, politicians, and special interest groups (and other non scientists).

quote:


In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA's scientific work, compromising the agency's ability to fulfill its mission of protecting public health and safety.
...
In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs. In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety.



Bettawrekonize -> RE: The FDA and health (10/23/2008 11:51:10 AM)

I also think people will find this interesting

A Report Card on Federal Agency Media Policies

It regards survey's done by ucsusa

Full report



PaleHawkWoman -> RE: The FDA and health (10/23/2008 5:20:21 PM)

Yeah, the FDA is the finest example of our government inaction.



Bettawrekonize -> RE: The FDA and health (10/24/2008 9:56:40 AM)

quote:

ORIGINAL: PaleHawkWoman
Yeah, the FDA is the finest example of our government inaction.


What's even more disturbing is the fact that you will probably never see this stuff on public television. More proof that our media is controlled by special interest groups. You would almost have to get everyone to demand that this stuff be on the news for it to make it on the news (I'm exaggerating a bit), but by the time you get enough people informed about it so that they could demand such a thing, something would be done about it by then (because they would demand that something be done about it instead) and the problem would be fixed. It shouldn't require so much for something to make it on the media. Whoever is responsible for making our media censor such information needs to have their influence over the media removed (and the people who work for the FDA who are responsible for banning red yeast rice containing lovastatin should be fired. They could have at least made it available with a doctors prescription) and we need to make sure that whoever is responsible for ensuring that this stuff never makes it to public television does not gain the same control over the internet (just 30 years ago or so, practically no one would have thought that special interest groups would have this much control over our media). I'm sure it wouldn't be that hard to get a doctor/scientist who is informed about this stuff, who takes my position, on television to talk about this stuff (and they are free to put an informed doctor who doesn't take my position on television as well. The FDA would try to have us believe that all/most scientists wouldn't take the position that red yeast rice containing lovastatin shouldn't be banned, but that's probably just the administrators pretending to speak on behalf of the scientists like they always do (at least according to the surveys)).

About media censorship.
Where Have All The Muckrakers Gone?



Bettawrekonize -> RE: The FDA and health (10/24/2008 2:00:24 PM)

I found this article very interesting.

quote:


Ocean Spray grapefruit juice products carry the American Heart Association's "heart-check" logo, signaling to consumers that grapefruit juice is "heart healthy." But when Ocean Spray tried to elaborate on that and other health claims on its Web site, the FDA threatened legal action.

The FDA's tenuous rationale was that by mentioning Ocean Spray's Web site on the label, the cooperative converted the site into a food label subject to regulation. Only health claims information specifically permitted by FDA regulation are allowed on labels.
...
The larger question is should the FDA censor information about food health claims? A study in this week's Journal of the American Medical Association is more strong evidence that information flow to consumers should be encouraged, not squelched and compressed into food packaging hieroglyphics.
...
Consumers would likely benefit from responsible and balanced information about health claims posted on the Internet or otherwise made available by food growers and processors.

Instead of being misled by the "heart-check" logo and enigmatic symbols, consumers should be able peruse food company Web sites that offer information on the latest research reports about diet and health. The FDA is wrong to assume that consumers need to be protected from this information.

Certainly the FDA could take action if the information presented by a company was demonstrably wrong or intentionally misleading. In the case of Ocean Spray, the FDA had some valid objections to some of the Web site material. But instead of a measured response, the FDA overreacted.
...
Food industry efforts may fare no better. But they certainly can't be any worse. And with the possibility of consumer, legal and regulatory backlash for false or misleading information, at least the food industry has incentives to get it right.


http://www.foxnews.com/story/0,2933,2125,00.html

I actually kinda agree with the last statement (only to some extent though). It seems like the FDA has little incentive not to be wrong because, when they're wrong, the FDA administrators don't lose sales or lose their jobs. If a manufacturer of a dietary supplement or a manufacturer of someone selling something in the open market is wrong, they tend to lose sales. The FDA should certainly not consider itself the ultimate and only authority on the what information gets distributed, as if they are somehow a more legitimate source of information than any other group of people (especially since other groups of people maybe more subject to legal action or loss of sales if they are wrong. What is the FDA subject to? They are not really accountable to congress or to voters so they would have the lowest incentive to be right).



Bettawrekonize -> RE: The FDA and health (10/25/2008 2:59:08 PM)

I found this interesting.

SHOULD YOU BE FORCED TO UNDERGO CHEMO?

I wonder what percentage of doctors (especially oncologists) undergo chemo if they get cancer? I heard somewhere (not sure if it's true) that the percentage of those who survive cancer (and the length of their life) with chemo isn't much different than the percentage of those who survive cancer without (btw, if this is true, why doesn't it ever make it to mainstream media?).

Chemotherapy or Alternative Medicine?



Bettawrekonize -> RE: The FDA and health (10/25/2008 3:11:46 PM)

I finally found some statistics on this

quote:


The great lack of trust is evident even amongst doctors. Polls and questionnaires show that three doctors out of four (75 per cent) would refuse any chemotherapy because of its ineffectiveness against the disease and its devastating effects on the entire human organism. This is what many doctors and scientists have to say about chemotherapy:
“The majority of the cancer patients in this country die because of chemotherapy, which does not cure breast, colon or lung cancer. This has been documented for over a decade and nevertheless doctors still utilize chemotherapy to fight these tumors.” (Allen Levin, MD, UCSF, “The Healing of Cancer”, Marcus Books, 1990).


75% OF THE PHYSICIANS REFUSES CHEMOTHERAPY THEMSELVES

I suspected that the reason I couldn't find these statistics (ie: why I had so much difficulty) is because the results would show that few doctors would undergo it (suggesting that special interest groups suppress these statistics). Turns out my suspicion was correct.

So why should doctors subject patients to chemo when they won't even subject themselves to it? If doctors don't seem to think that chemo is safe and effective for themselves, why should they think it's safe and effective for others? BTW, I wonder why I can't seem to find more recent statistics on this (that's not to say that they don't exist, but these statistics should be blasted all over the public media, I shouldn't have to dig through the internet for them)? Could it be because special interest groups know that doctors will refuse chemo but they do not want the public to know (so they suppress such info from the public)?

Same article

Seems like these special interest groups are gaining more and more control over the internet. People should always easily have up to date public access to the percentage of physics (especially oncologists) who refuse chemotherapy themselves. In fact, this should be the case for any health issue. This stuff should be all over the media. If a treatment isn't good enough for doctors, why should it be good enough for patients? I think the best way to determine the safety and effectiveness of a treatment is simply to know the percentage of doctors who undergo that treatment (especially doctors in relevant fields). Politicians, administrators, and special interest groups can much more easily silence the opinions of doctors that don't conform to the norm (and force them to pretend to agree with the medical establishment for the sake of keeping their job) when their lives don't depend on it, but when their lives are on the line is when you get their true opinions (and we need access to the true opinions of doctors).

quote:


In 2002, the Journal of the American Medical Association reported that in the previous year, the average oncologist had made $253,000 of which 75% was profit on chemotherapy drugs administered in his/her office. Yet, surveys of oncologists by the Los Angeles Times and the McGill Cancer Center in Montreal show that from 75% to 91% of ongologists would refuse chemotherapy as a treatment for themselves or their families. Why? Too toxic and not effective. Yet, 75% of cancer patients are urged to take chemo by their oncologists.


Amazon

There is a good chance that, when you go to see a doctor, you're not really getting the opinion of your doctor, but you're getting the opinion of administrators (ie: FDA administrators who ban safe and effective alternative medicine leaving only ineffective alternative medicine on the market to make alternative medicine look ineffective), politicians, and special interest groups who aren't diagnosing you based on what's best for you, but who are diagnosing you based on what's best for their profits. The doctor merely acts as an intimidated puppet.



Bettawrekonize -> RE: The FDA and health (10/26/2008 12:55:13 AM)

I found this interesting

Bush plans to screen whole US population for mental illness

quote:


But the Texas project, which promotes the use of newer, more expensive antidepressants and antipsychotic drugs, sparked off controversy when Allen Jones, an employee of the Pennsylvania Office of the Inspector General, revealed that key officials with influence over the medication plan in his state received money and perks from drug companies with a stake in the medication algorithm (15 May, p1153). He was sacked this week for speaking to the BMJ and the New York Times.


This is what happens to people who are honest and try to speak the truth. They lose their jobs. This behavior by special interest groups is unacceptable. The fact is that there is a lot of corruption that goes on and there is a lot of effort to suppress it from being exposed to the public (which is why you hardly ever hear about this in the public media, despite the fact that this should be blasted all over public television). Many people who are aware of the corruption are afraid of speaking out because they are afraid of losing their jobs. Allen Jones tried to be a good Samaritan and tell the people that there were conflicts of interest involved. What is his reward? He lost his job. The fact that he lost his job does not erase the corruption involved. These conflicts of interest still exist and they are not going away anytime soon.

quote:


The Texas project started in 1995 as an alliance of individuals from the pharmaceutical industry, the University of Texas, and the mental health and corrections systems of Texas. The project was funded by a Robert Wood Johnson grant—and by several drug companies.
...
Mr Jones told the BMJ that the same "political/pharmaceutical alliance" that generated the Texas project was behind the recommendations of the New Freedom Commission, which, according to his whistleblower report, were "poised to consolidate the TMAP effort into a comprehensive national policy to treat mental illness with expensive, patented medications of questionable benefit and deadly side effects, and to force private insurers to pick up more of the tab"


This goes back to my discussion on the incentive for corruption that patents induce.

quote:


Larry D Sasich, research associate with Public Citizen in Washington, DC, told the BMJ that studies in both the United States and Great Britain suggest that "using the older drugs first makes sense. There's nothing in the labeling of the newer atypical antipsychotic drugs that suggests they are superior in efficacy to haloperidol [an older "typical" antipsychotic]. There has to be an enormous amount of unnecessary expenditures for the newer drugs."


One thing people have to realize is that, even though this population screening may start with generic drugs, once this screening is in place, it would be much easier for the special interest groups who are lobbying for this screening to transition from generic drugs to the requirement of patented drugs (because they will be one step closer, and the transition could be subtle and might go unnoticed by mainstream media. After all, how often do you hear about this on public television? Heck, I don't even think the New York Times even published it). Those lobbying for this know this.



Bettawrekonize -> RE: The FDA and health (10/26/2008 9:33:48 PM)

I found this interesting

quote:


Even health care workers reject flu shots
60 percent opt not to get vaccinated despite promixity to virus

http://www.msnbc.msn.com/id/27214082/

If flu shots are so safe, why is it that so many health care workers refuse them?

quote:


DES MOINES, Iowa - Operating room nurse Pauline Taylor knows her refusal to get a flu shot is based on faulty logic.

But ever since she got sick after getting a shot a few years ago, she's sworn off the vaccine.

"I rarely get sick. The only thing I could narrow it down to is that I had gotten this shot," said Taylor, who works at University Hospitals and Clinics in Iowa City. "I know that it's not a live virus. It just seemed pretty coincidental."
...
"A lot of reasons we heard about people not wanting flu shots was all about them — it's my freedom, I don't want to get it, I get sick when I get it," Lammert said.


I wonder how well studies on flu shots reflect this. I think that the people who are refusing the shot are refusing it for good reason and if the studies do not reflect their testimonies, I find it suspect. DES MOINES claims she got sick only after getting the flu shot. Others claim they get sick after receiving flu shots. If officials reject the notion that they got sick from the flu shot, well, how can I know that people claiming to get sick from flu shots during studies aren't merely dismissed in a similar manner?

quote:


"Now, the culture has really changed to thinking about patients. This is what we do to protect our patients."


Sounds like social engineering.

If health care workers only take flu shots to protect their patients, then obviously they do not think the benefits of flu shots to themselves outweigh the (health/religious/etc...) risks/costs (to themselves). If the benefits of flu shots do not outweigh the risks/costs for health care workers, why should they outweigh the risks/costs for patients?

This also begs another question. Out of the 40 percent of health care workers who do accept flu shots, how many of them only accept flu shots because they are led to believe that for them to accept flu shots is best for their patients (and not for themselves)?

quote:


That's despite recommendations from the Centers for Disease Control and Prevention that all health care workers get vaccinated, from hospital volunteers to doctors.


Uhm... I wonder what percentage of those who stand to gain (economically speaking) from the mandatory administration of flu shots actually get flu shots themselves (and how many of them actually recommend their family members get flu shots). This is kinda irrelevant, but I remember when the do not call list first came out, it was all over the news that someone who was lobbying against the do not call list was actually on the list him/herself.



Bettawrekonize -> RE: The FDA and health (10/31/2008 9:31:39 PM)

I also found this interesting

quote:


Within this 800 page rule the FDA states, “We find that this final rule will have a significant economic impact on a substantial number of small entities…. Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business…. 140 very small [less than 20 employees] and 32 small dietary supplement manufacturers [less than 500 employees] will be at risk of going out of business…. costs per establishment are proportionally higher for very small than for large establishments….The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”


FDA Announces Plan To Eliminate Vitamin Companies

I don't think the FDA should artificially raise the price of vitamin supplements. People need treatments to cost less, not more, and there is no reason why the free market shouldn't be allowed to give people decent supplements at a decent price.

quote:


This FDA rule will directly raise the price of dietary supplements for all consumers. The FDA acknowledges this and says “We expect that the majority of these costs will be borne by consumers of dietary supplements, who will likely respond to the increase in prices by reducing consumption.”


quote:


It is noteworthy that fascist governments of the past have eliminated health freedom and health options as a necessary condition to enslave and brainwash a population.
...
Any company that can afford to comply with the costs and regulations of this new FDA rule can be targeted and eliminated at will by the FDA. In essence, the FDA is seeking to make the dietary supplement industry document every phase of production, including expensive testing at multiple points in the production process. Massive recordkeeping will be required, including all customer complaints and returns for any reason!...No doubt, the FDA will impose user fees as an additional charge so that FDA agents will have the funding required to enforce the regulations.
...
Consumer safety could readily be guaranteed by simply having all companies test their final products for purity and potency. Instead of this simple approach the FDA has gone to the extreme of burdening the dietary supplement industry with regulations in excess of the drug industry!


What's next, are the FDA going to control what chemicals an apple can contain. Because apples contain vitamin C, a substance that cures scurvy, is it ok for the FDA to demand that apples containing vitamin C be banned (because it has medicinal use)? But it's ok for the government to put a stop to good nutrition, but not to cigarettes.

http://www.newswithviews.com/Richards/byron36.htm



Bettawrekonize -> RE: The FDA and health (11/1/2008 9:40:25 PM)

quote:


FRIDAY, Oct. 31 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel agreed Friday that the agency had erred in August when it said that a chemical widely used in baby bottles and other plastic packaging for foods and beverages posed no health risks.

On Wednesday, a panel of toxicology experts said the FDA hadn't properly assessed the potential health risks posed by the chemical bisphenol A (BPA), which some studies have linked to cancer, diabetes, heart disease and developmental delays in children. The toxicologists said the FDA had relied too heavily on studies funded by the chemical industry to make its decision, and had failed to consider other studies that questioned the safety of BPA.


FDA Faulted for Stance on Chemical in Plastics

Review Reignites Questions Over BPA

I've actually been following this for some time now, but the evidence indicating that the FDA's permitted levels of BPA are plausibly harmful was so small that I didn't think much of it (it was an astronomically small quantity if memory serves me correctly). If memory serves me correctly, I still think that the permitted levels of BPA were too small to really cause any harm. One of the most compelling counterarguments I remember reading though (if memory serves me correctly) is that there was a good potential that levels of BPA far higher than the FDA's allowance could plausibly make its way into the food we eat (again, if memory serves me correctly, one of the biggest concerns had to do with canned foods). This, of course, is an enforcement issue, and not an issue of whether or not the laws in question serve the public good (it's a question of whether or not the laws in place are properly being enforced). As such, I didn't think much of it since it's not practical to be 100 percent sure that every law is being 100 percent enforced everywhere at all times (of course, that doesn't mean that we should make no effort to enforce (reasonable) laws. For example, if someone is harmed because of a breach of law, they should be able to successfully sue). Now since the issue resurfaced though, I think it's worth bringing up.

More thoughts on BPA

A Survey of Bisphenol A in U.S. Canned Foods

I guess my main concern would be to ensure that the levels of BPA in our food never exceed FDA limits.



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