Posted on 05/28/2012 3:18:06 AM PDT by yoe
Today on the U.S. Senate floor, Sen. Rand Paul introduced an amendment to the Food and Drug Administration User Fee Reauthorization bill, which would curb the Food and Drug Associations overreach and abuse of power. Sen. Paul's amendment, No. 2143, would disarm the FDA, put an end to raids on natural food stores and Amish farmers, and stop FDA censorship of truthful claims of dietary supplements.
[snip] "Mr.President, today I'm offering an amendment to the FDA. I'm troubled by images of armed agents raiding Amish farms and preventing them selling milk directly from the cow. I think we have bigger problems in our country than sending armed FDA agents into peaceful farmers' land and telling them they can't sell milk directly from the cow.
My amendment has three parts. First, it attempts to stop the FDA's overzealous regulations of vitamins, food and supplements by codifying the first amendment prohibition on prior restraint. What do I mean by that?
(Excerpt) Read more at paul.senate.gov ...
Now that’s a breath of fresh air!
Disarming the FDA only received 15 votes.
” Now that’s a breath of fresh air! “
It’s a step in the right direction, but it’s a retail approach to a problem that needs wholesale solutions —
All Federal Agencies should be abolished, and then the ones with true ‘necessary and proper’ (and Constitutional) functions can be re-established with strict limits to their power, and controls with oversight - and mission statements clearly written to preclude ‘mission creep’...
Could he do that to the EPA too?
What is needed is a SIMPLE way to report bad drug side effects. As a person who has had to many brushes with the side effect riddled crap, trying to report it is near impossible. And don’t rely on your doctor to do it, they don’t even read your health history, much less your drug reaction list.
Why are drugs with a 50% side effect failure rate allowed to be manufactured? That is an F in any one’s book!
Ugh, this one needs to go down in flames. I would hate to go back to the days where anyone could sell anything, caveat emptor, and injured people had no recourse. No safety standards for food products... no safety and efficacy testing of drugs... snake oil salesmen being able to make any scientifically baseless claim about their wares, while selling bottles of poison... NO, THANKS!
The Constitution mandates that the Federal government provide for the general welfare of its citizens. The FDA is a large part of that effort. There are plenty of federal agencies that don’t meet any Constitutional requirement—why doesn’t Rand Paul go after them?
Why are drugs with a 50% side effect failure rate allowed to be manufactured? That is an F in any one’s book!
All drugs have side effects. It sounds like you're one of the unlucky people who has a particular genetic makeup that causes you to be particularly susceptible to side effects. In any case, you can report drug side effects here. There are links to forms right on the website.
Nightmare to try to do so, have tried it. Yes I am that 2-5% who react badly to most of the newer drugs.
And I can’t get my doctors to stop prescribing the stupid things. So I just send them back to the pharmacist marked ALLERGIC, and cancel prescription! And add to my VERY long list of drug reactions.
Last one was Zetia...it was written off a cholesterol report taken during a Vertigo and Meniere’s attack when food and water tasted like cardboard....It hits all 4 of my auto immunes for just it’s common side effects. I don’t like spending hours hugging the toilet puking my guts up because of 1 pill or having my pain level go from 3 to puke level in less than an hour. And yes I can react that fast to some of them. Others takes weeks.
They are all supposed to be ‘flagged’ in my pharmacist computer, some how it never works. Good thing I pick up our meds, and not my husband, because he’d bring the dang things home, where I won’t.
As I read the bill, it strengthens the need to prove willful and knowing intent to cause harm AND it disarms the agency. It allows an oat cereal to state that studies show oat fiber can reduce cholesterol or that prune juice can be laxative. That is not wholesale allowing of snake oil. Oat fiber or prune juice will not kill or even injure you and if you want to drink raw milk, that is not the purview of government. Yes, the individual drinking the milk _could_ become ill, but they aren’t going to cause an epidemic. Millions of us have ingested clean milk direct from a bulk tank or from a cow and lived to tell the tale. I am one of those.
And, as I understand it, it did not pass.
OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.
Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.
A government bureaucracy is not eliminating threats by regulating around the edges of the problem. They appear to go after relatively innocent practices while not being able to address the serious problems.
I have found that if I speak up quickly, I can get the MD to prescribe a different drug. If you know what does work, that helps the MD to make better prescription decisions. I had to go to the emergency room last year; I told every single person that saw me that I did NOT want narcotics, and no one tried to give me any.
If your interpretation of the “general welfare” clause is correct then there are no constitutional limits on what the federal government can do.
You don’t have my non-listening internist..and as we are both Medicare and Tricare Life, it is extremely hard to find doctors to take us as new patients. Or I would have changed doctors 3 years ago. He listens to my husband, and ignores me. He faxes in the RX’s no matter what I say. So I stop them at the pharmacist counter.
And no, I am not a hypochondriac, I have a huge file folder with all the test to back up the results. That is one thing I found out the hard way, make them give you copies of ALL test.
Since Oct I’ve had 3 trips to the ER, 2 to the Minor Med, 1 UN-necessary ear surgery, which left me with less hearing than I had before, and pain in the opposite ear for life. Can’t sue, you have to sign waivers. And you are told it is the only way to cure Vertigo and Meniere’s. BULL no cure, made it worse.
On top of all the Uro trips and test for false UT test results at the internist. Been one Heck of a wild ride since last July.
As things are, the FDA only steps in when the claims are not supported by solid published scientific studies. And the language of the claims is limited: my box of Quaker Oats says that "3 grams of soluble fiber...may reduce the risk of heart disease" (emphasis mine). Without those limitations, we'd see all kinds of fantastic, scientifically unsupported claims made about various foods.
As for drinking raw milk without ever getting ill from it, that is just a matter of chance. The reason for the heavy regulation of raw milk in the ~20 states that even allow its sale is that, relative to the amount consumed, raw milk is associated with more food poisoning outbreaks than any other food product.
OTOH, the fine print on many drugs is difficult to read and requires a medical dictionary to decipher. Drugs, devices and treatments are regularly passed by the FDA that later turn out to have debilitating and life threatening side effects. Recourse is expensive and class actions only benefit the attorneys. There is no real protection because of FDA.
The nature of clinical trials means that adverse effects that occur at a rate of ~1/1000 or less probably won't be picked up during a clinical trial. For that reason, a fourth clinical trial is conducted after drug/device approval, which is meant to catch those rarer adverse effects. Plus, there are reporting mechanisms that alert the FDA to the need for specific investigations. Another consideration would be the risk/benefit ratio. The FDA isn't perfect, but it is still the best mechanism we have for ensuring that the benefits of any drug/device sufficiently outweigh its risks. I hate to think what would happen if we didn't have the FDA acting as a central regulatory agency for these things. Trying to prove that a drug is harmful would be nearly impossible without having accessible data on side effects and so forth. Trying to prove that a drug does or doesn't have the claimed effect would also be nearly impossible without scientific data. The Libertarian notion that such adverse effects would be adequately addressed by the free market may be romantic, but it never actually happened (which is why the FDA was created). You only have to look at China to see what happens in an unregulated environment.
Normal food production and processing inspections miss many instances where numbers of individuals are sickened, permanently harmed or killed by pathogens. These are failures of the food inspection process that are not addressed in this bill.
Are those failures the fault of the inspectors who check whether the farm/factory/stores/restaurants are storing and processing food products in accordance with the scientifically developed regulations? Or are those failures the fault of farmers/manufacturers/grocers/restaurateurs who flout the regulations and basically ignore food safety? The regulations are written to reflect the latest scientific information on food safety. The USDA and FDA inspectors can only do so much to ensure that the regulations are being followed. And then, when they are trying to ensure basic food safety, they're accused of "attacking innocent practices."
I've been to several American Society of Microbiology meetings. After going to those meetings and seeing presentations discussing various challenges of food safety, I've come to realize that it takes a HUGE effort to provide a safe food supply. A single small mistake anywhere within the production/distribution chain can negate the efforts of everyone else involved in that particular chain, which could be hundreds of individuals. Food safety is not a trivial matter!
“Ugh, this one needs to go down in flames. I would hate to go back to the days where anyone could sell anything, caveat emptor, and injured people had no recourse.”
The present “solution” to these concerns leads us to a government first presumes the power to tell me what I can and cannot ingest thus violating one of my may unalienable rights.
Second, it leads to a government that is willing to kill people who are selling unapproved vitamins or raw milk. Well, government doesn’t really intend to kill them, but during raids by machine-gun equipped SWAT troops, accidents can happen.
Third, it protects commercial interests who are favored by that same gun-wielding bureaucracy via regulatory capture.
Fourth, it leads to false claims of harmless substances when the bureaucracy that enforces its monopoly on competence tells us that there is nothing to worry about, we should just move on with our lives, when in fact a real hazard exists.
See for example: FDA claims no need to test Pacific fish for radioactivity.
http://www.adn.com/2011/04/16/1813982/fda-claims-no-need-to-test-pacific.html#ixzz1JlrzUS7x
Sixth: this bureaucracy becomes self-serving. Companies that work within the system and are cooperative with it get protection. For example, the CDC estimates that in 2011 contaminated food caused approximately 47.8 million illnesses, over 127,800 hospital admissions and over 3,000 deaths.
But we don’t send a SWAT squad to Jack in the Box when contaminated beef causes several deaths, we send a team of biologists. Had that same number of people died after eating organic beef from an organic farmer in Arkansas, the SWAT raid would have been broadcast live.
see: Spending Big at the Ag Department
http://www.zerohedge.com/contributed/2012-05-27/spending-big-ag-department
Now certainly the public health is an important issue. However, government is only force and as George Washington observed, like fire in that it was a wonderful servant but a terrible master. The present structure of protecting the public costs a lot of lives and part of the media-government collusion is to protect government from the public seeing how much damage it does in the process of protecting us.
One solution is for government to set standards based on sound science and prudent practices but to limit its power to simply requiring labeling as to how well a product complies with the standard. We don’t have to threaten people with machine guns (and risk actually killing them) in order to stop their ability to sell to the public.
Even with my proposal we all must realize there are limits to government, another fact that government bureaucrats just cannot understand. This fact is proved by crack addicts every day.
To a gun-wielding bureaucrat every power of government is there for him to use and his budget only gets bigger when he can use those powers. Government only can grow at the expense of our liberty and prosperity. Our government is way too large and way too expensive as it is.
Let me add that the case of the deaths from contaminated beef at Jack in the Box is a great example of how product liability claims have a far greater effect on corporate behavior than the regulators, who were doing their job at the very moment the beef was being contaminated.
I am not arguing against food or drug safety. I know several producers, a former veterinarian meat inspector and a couple of registered food scientists who work in quality control. I have relatives who are medical clinicians and scientists working for pharmaceutical companies.
The fault(s) are shared. Unfortunately, any regulatory scheme only deals with things after the fact, after the contamination has been discovered, either by the QA person or after an outbreak.Notifying the public during or after an outbreak is preferable to no notification at all, but can only work to close down the source after the fact. Further injury may be prevented, but injury has still occurred.
I believe that the push from the public for local sources and basic foods(not processed) has come about because of a distrust of large conglomerate producers and processors. Everyone understands the economics of scale,however, there are many steps in the chain of production and processing that appear vulnerable to contamination, regardless of an FDA.
If I understand you correctly, drugs, supplements, devices and treatment protocols are approved prior to large scale real world *testing* via distribution to the public (Stage Four). This perhaps needs to be rethought. I have taken one undergraduate course in microbiology, over 50 years ago, but I do remember that even there, there was a time lag between culturing and getting the results. Perhaps that has changed w/technology. However, it does appear that much of this regulation depends upon reacting after the fact. Certainly, this can be improved upon.
It has been over 35 years since I consumed bulk tank milk. My family drank it for 4 years or so, until the rules changed. We checked out each producer with local vets, with other dairy farmers and other consumers. We visually inspected the premises. We brought out own sterilized containers. I was aware, as are all such consumers, of the inherent dangers. The responsibility was mine. As I recall, there was never a hint of food-borne illness back then from responsible producers.
Accidents happen, even with a massive regulatory bureaucracy. Arming these bureaucrats seems excessive. I see no problem with the law requiring proof of willful intent and disarming of the regulatory inspectors/enforcers.
Life is full of risks. Everyone needs to be responsible. Armed intimidation stops no outbreak, no side effect nor defective device. Much of the regulatory process appears to be theater. I still must be a savvy consumer. I will not purchase those huge tubes of ground beef from huge processors. In my kitchen, I assume chicken is contaminated before cooking. I do not consume raw eggs, although, growing up in the 40s and 50s, everyone occasionally did so. People ate steak tartare regularly, as well.No one ever feared fresh greens until well after this regulatory agency came into existence. I do not purchase or consume drugs with extensive black box warnings. I have done so in the past and was less than satisfied with my clinician’s response to my adverse experiences. I examine all information available on supplements and have still had adverse, individualistic reactions. I do not expect some massive bureaucracy to keep me safe. I do not presume that a gun in the hands of people who want to limit the average citizen’s access to firearms will keep anyone safe.
You can eat whatever you want--if you want to eat raw nightshade berries picked fresh from your garden, you can do so. The FDA and USDA, however, will prevent you from selling them as a health food. Their job is to make sure that food products offered for sale meet a certain level of safety requirements.
Second, it leads to a government that is willing to kill people who are selling unapproved vitamins or raw milk. Well, government doesn’t really intend to kill them, but during raids by machine-gun equipped SWAT troops, accidents can happen.
Wow, talk about hyperbole.
Although I can't say I see anything wrong with sending someone who intentially sells unsafe contaminated products in wilful disregard of safety and health regulations to prison.
Third, it protects commercial interests who are favored by that same gun-wielding bureaucracy via regulatory capture.
Huh? Do you mean those commercial interests like the local farmers and ranchers who comply with local, state, and federal laws and sell their products at local farms and markets? Is there any reason they *shouldn't* be protected?
Fourth, it leads to false claims of harmless substances when the bureaucracy that enforces its monopoly on competence tells us that there is nothing to worry about, we should just move on with our lives, when in fact a real hazard exists.
Please tell me, what is the "real hazard"? Am I to presume, because of the nature of the articles you linked, that the scientific assessment that it is not necessary to test west coast fish for radioactive contamination from a plant several thousands of miles away somehow adds up to a "real hazard" being ignored?
Sixth: this bureaucracy becomes self-serving. Companies that work within the system and are cooperative with it get protection. For example, the CDC estimates that in 2011 contaminated food caused approximately 47.8 million illnesses, over 127,800 hospital admissions and over 3,000 deaths.
So, companies that practice Good Manufacturing Processes to ensure that their products are safe to consume are "protected" by the system (by which I assume you mean they aren't being shut down)? Why is that a problem? With so many foodborne illnesses, it doesn't make sense to argue for more lax standards.
One solution is for government to set standards based on sound science and prudent practices but to limit its power to simply requiring labeling as to how well a product complies with the standard. We don’t have to threaten people with machine guns (and risk actually killing them) in order to stop their ability to sell to the public.
The people making the regulations *are* scientists, working with the most comprehensive and current scientific data available. I don't see a problem with it. OTOH, restricting regulatory authority to simply requiring labeling of products while allowing anyone to sell anything won't protect anyone. So what if half the dairy cattle at that farm have tuberculosis and the other half carry E. coli H157O7--the raw milk they're selling at their unrefrigerated roadside stand is clearly labeled "Raw milk--may contain pathogens", so it's okay! And no one can sue them, either, since their label meets legal requirements! Oy.
Some of these 'scientists' are working for competing pharma's. $$$$$$$$
That is incorrect. Pharmaceutical companies devote a lot of resources to documenting and reporting adverse events.
This is an area for which they can have a drug pulled from the market for inadequate reporting.
If you have any complaints a company's phone service is trained on forwarding anything that sounds like a complaint to their vigilance group. Those folks are skilled at listening, reporting and follow-up. So your point about being difficult to report an adverse event is not accurate.
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