Big Pharma and the FDA: Suppress the Science and Ban the Natural

[Pharaoh]

Big Pharma, suppress scienceIn 2005, the pharmaceutical company Biostratum, Inc. made a mistake -- they invested millions of dollars into developing a drug, only to discover that the active ingredient, pyridoxamine, was a common, naturally occurring substance that has been sold for decades at low cost.

Biostratum responded by asking the U.S. FDA to declare supplements containing pyridoxamine “adulterated,” and effectively ban anyone but Biostratum from selling pyridoxamine. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement.

The FDA’s comment on the decision specifically says, “To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

Apparently, they were not as concerned about fairness to consumers.

This is hardly the first time the FDA has attacked naturally occurring substances. The FDA has banned information about scientifically proven health benefits of cherries from appearing on Web sites. And for years, the FDA barred health claims about the benefits of omega-3 fats for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process.

In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about a profit-seeking corporation taking advantage of corruption in what is supposed to be a public health organization.



http://articles.mercola.com/sites/articles/archive/2009/06/23/Big-Pharma-and-the-FDA-Suppress-the-Science-and-Ban-the-Natural.aspx

[KT2000]

1. Sounds like the SCOTUS decision

for Bush. Corrupt to the core.
That is absolutely absurd that the FDA should get away with that.
That needs to go to court.

[godai]

2. Actually, this makes regulatory sense

A substance can't be both a drug and a dietary supplement. Once a substance is used to treat a disease, as is the case here, that substance will always be declared a drug by the FDA. One declared a drug, the same substance can't be in dietary supplements.

http://www.nephrogenex.com/NGX_Product.htm

[Wizard777]

3. Coke Syrup can be used to treat upset stomach. So Coke-a-Cola is now a drug and not a food?

Good luck on that one!

[nadinbrzezinski]

Is Coca Cola Corporation making that claim? NO

that is why.

Now Cheerios was making a medical claim, notice how fast those adds have ahem disappeared?

That said, there are MANY natural things out there that come from plants and have been used for well, ever. So in an ideal world we would have a balance found. Will not happen as long as there are huge profits to be made in a successful med.

That said if I ever need Lasix, give me the controlled dose, not the plant to make a tea from.

[Wizard777]

8. No the doctors and apothecary's made it for them.

Oh yeah, you might not be old enough to remember apothecary's.

[nadinbrzezinski]

10. Lasix was actually a tea

Why I mentioned it in that form

And yes I am old enough to have read of them in the history of medicine class

Or to actually have known BOTICAS in Mexico City... as well as Farmacias.

[crikkett]

18. we have one in our town. n/t

[Wizard777]

19. That's good. It's a dying art. Pharmco's finger prints are all over the murder weapon.

[nadinbrzezinski]

5. Is Coca Cola Corporation making that claim? NO

that is why.

Now Cheerios was making a medical claim, notice how fast those adds have ahem disappeared?

That said, there are MANY natural things out there that come from plants and have been used for well, ever. So in an ideal world we would have a balance found. Will not happen as long as there are huge profits to be made in a successful med.

That said if I ever need Lasix, give me the controlled dose, not the plant to make a tea from.

[godai]

6. Milk can be used to treat upset stomach.

You can come up with numerous trivial examples of foods that treat minor ailments. Dietary supplements and especially drugs, are a step above such foods and similar products.

[girl gone mad]

7. So if they can make this ruling for a vitamin B6 supplement..

(pyridoxamine), what's to prevent them from doing the same for any other vitamin or natural remedy?

[godai]

16. The law....FD&C Act

A 'drug' is defined in the law and, potentially, other vitamins or natural remedies could be reclassified as a drug, if they are found to be useful in treating a disease. This has been the law in the US since 1938. Dietary supplements have been around only since about 1992, thanks to Orrin Hatch and his dietary supplement maker friends in Utah. I feel that most dietary supplements are just a waste of money.

[Johonny]

11. I agree

I'm actually for the FDA to regulate more dietary supplements not less. On the other hand if a drug has been found to be generally safe to consume, it makes no since to ban it from dietary supplements. But that's a problem with having an agency that has the job of regulating the safety and effectiveness of food and drugs and then allowing some sub categories be beyond their regulatory power. The problems would be solved by allowing the FDA to do it's job it was created for and stop writing laws that restrict it's ability to do it.

[mopinko]

4. seems pretty available on the internets.

:shrug:

[arikara]

9. Is it any wonder health costs

are through the roof. Big pharma gets the FDA to allow them sole right to sell naturally occurring inexpensive products and make obscene profits doing so.

Corrupt filthy slimey bastards.

[truedelphi]

12. It is really insanity as far as I can tell.

Supplements containing B6 have been on the market for years, and now the major players make up these phony baloney excuses to help Big Pharma keep its profit margin intact!

[godai]

15. It's being studied, by a small co., to treat major conditions.

B6 is not candy....
Too much vitamin B6 can result in nerve damage to the arms and legs. This neuropathy is usually related to high intake of vitamin B6 from supplements, and is reversible when supplementation is stopped. According to the Institute of Medicine, "Several reports show sensory neuropathy at doses lower than 500 mg per day". As previously mentioned, the Food and Nutrition Board of the Institute of Medicine has established an upper tolerable intake level (UL) for vitamin B6 of 100 mg per day for all adults. "As intake increases above the UL, the risk of adverse effects increases."

http://ods.od.nih.gov/factsheets/vitaminb6.asp

-----------------------------------------------

http://www.nephrogenex.com/NGX_Company.htm

Pyridorin™ has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials, and has been awarded Fast Track status by the FDA. NephroGenex is initiating a new Phase 2b clinical trial (PYR-210) that is evaluating the safety and efficacy of Pyridorin™ in slowing the progression of overt nephropathy in patients with type 2 diabetes. This trial incorporates the latest discussion with the FDA regarding the use of an approvable surrogate marker that would be subsequently confirmed with hard clinical endpoints.

Diabetic kidney disease afflicts about 20% of all diabetics and is the major cause of end-stage renal disease (ESRD). There are an estimated 1.2 million diabetic overt nephropathy patients in the US, and approximately 5.1 million diabetic patients exhibiting signs of developing kidney disease. Pyridorin™ is one of only two drug candidates in advanced clinical trials for diabetic kidney disease.

NephroGenex is also studying the application of Pyridorin™ to specific types of acute renal failure where carbonyl and oxidative chemistries have been identified as causative factors in the onset and progression of this condition.

[truedelphi]

20. Look -- too much of anything is not candy

One can die, or seriously weaken themselves, by ingesting too much water.

Pound for pound, caffeine is the most effective drug on the market. Bad enough that Starbucks is charging $ 4 a pop, but according to your wonderful, industry friendly philosophy, things like coffee, that we use for whatever reasons, should have their use approved by the government.

Meanwhile the benzenes and formaldehydes that can kill us are liberally sprayed throughout households and hotel rooms, and hospital wards throughout the country. Because, I guess, the FDA really, really cares about you and me.

And also because most Americans believe that it is what we eat that is important - they dismiss what we breathe as being of equal importance.

So go ahead and worry your little head over whether or not the jar of vitamin protein powder in my household, which has every nutrient known to mankind including B6 and L Tryptophan, will kill me and my family members. While you spray Lysol and Glade and Febreeze all over everything despite those products perhaps being liable for the fast acting lung cancers and other pulmonary diseases that are becoming epidemic these days.

When we start getting an FDA that really allocates time and independent research for things like Monsanto's RoundUp, Lysol, Glade and Febreeze, then you can start whining about the KILLER B6! Until then, I am far more worried about the aerosol products that the FDA ignores, rather than the nutrients many of us have used for decades. I do however worry about the FDA's intent (For the good ol' profit motive) to take away every nutrient we use so that Big Pharma can profit.

[godai]

21. You'll need to change the law rather than rant at the FDA.

What the FDA did in this case is exactly what is required by law. When a substance (eg B6) is being studied under an IND (Investigational New Drug) it's obviously a drug and can't also be a dietary supplement.

My advice is to stop wasting your money on dietary supplements. Most are probably ineffective and they are all overpriced. It's just a different part of big pharma ripping you off.

Here's what you should know about B6: http://ods.od.nih.gov/factsheets/vitaminb6.asp


If you eat a normal diet, you don't have a B6 deficiency and don't need it as a dietary supplement.

BTW, I am part of the FDA. Obama's FDA is not out to get you.

[truedelphi]

22. I could tell by your posts that you are industry (or government) connected.

Certainly I could tell you never stepped foot in any of the Univ of Oregon's Linus Pauling's studies.

And whether you think that supplements are a good idea or not, I find them beneficial.

Just powered up after a long hot afternoon of being in the garden. My protein shake gave me some vitamin C to combat the high temperature, the chromium also turned off my desire for a big thick Root Beer float.

BTW the 32 oz cannister this stuff comes in cost $ 12 and will last me about six months. Best value I can think of in terms of the needed boast in my well being. (One root beer shake would have cost $ 1.79 for the root beer, and about $ 1 for the ice cream.)

[godai]

23. Personally, I wouldn't take Vit C + chromium

But, you're certainly free to do so...
Chromium 6, the cancer-causing compound that sparked the legal crusade by Erin Brockovich, can be toxic in tiny doses. Brown University scientists have uncovered the unlikely culprit: vitamin C. In new research, the Brown team shows that when vitamin C reacts with even low doses of chromium 6 inside human cells, it creates high levels of cancer-causing DNA damage and mutations. Even miniscule amounts of chromium 6 can cause cancer. Blame that do-gooder nutrient, vitamin C.

Brown University researchers have discovered that naturally occurring vitamin C reacts inside human lung cells with chromium 6, or hexavalent chromium, and causes massive DNA damage. Low doses of chromium 6, combined with vitamin C, produce up to 15 times as many chromosomal breaks and up to 10 times more mutations – forms of genetic damage that lead to cancer – compared with cells that lacked vitamin C altogether.




http://www.sciencedaily.com/releases/2007/03/070312151951.htm

[truedelphi]

24. Oh mi friggin' Christ almighty! Oh mi gawd!!

You are an example of what I find to be so outrageous!

Get a clue. There are different types of chromium.

I am so scared of government, when I realize the non-educated people employed in positions of power. (And by education, I don't mean degrees. I mean KNOWLEDGE!)

Actually as an indie reporter I talked with and interviewed with many heads of various agencies, so I should be left un-shocked when I realize that there is yet another dunder head out there!!

Chromium as per a Power protein shake is healthy.

Hexavalent chromium is deadly.

You really have me shaking in my boots if your education has not allowed you to know/understand/realize the differences. In fact, the differences are even covered in the film "Erin Brockavitch."

Shudder Shudder Shudder. It is apparent that you have not taken too many (if any!)organic chemistry classes!!

Obama = Economic disaster by way of Geithner and Bernanke.

And apparently Obama and people like you at the FDA will further a tremendous loss of our powers as consumers!! I should not at all be surprised about your having a position in the FDA, despite your being woefully under-educated about necessary chemical awareness!
(But then, your ability to hold a post in the FDA proves my point!)

[godai]

25. Sticks and stones...

Can you maybe lighten up a little bit? Probably not...

"Due to the questionable safety profile and the lack of definitive studies documenting the safety of chromium when taken in supplemental form, it's probably best not to waste your money this particular supplement. In addition, most studies have failed to show a significant positive effect on weight loss or blood sugar levels in the normal individual. This supplement should definitely be avoided in those who are pregnant or have a history of liver or kidney disease."

http://www.xomba.com/doctors_analysis_is_chromium_piconlinate_safe

[truedelphi]

26. Permanently on ignore

Though first, I have given you the coveted Nancy Balter award (She was considered the preeminent professional in terms of understanding gas additive MTBE - but on questioning did not even know that significant amounts of MTBE become formaldehyde when in the car's compression chamber. Sort of like saying you understand coffee but are unaware that it contains caffeine!)

[godai]

13. More a selling price issue

US has no prescription drug price controls. Other countries do. Declaring a substance a drug relates more to safety and effectiveness than health costs, although drug cos. abuse this process (not FDA's fault) to charge ridiculous prices in the US.

Drug cos. are really no different that the oil cos., out to maximize profits.

[SidDithers]

14. Mercola. Say no more... nt

Sid

[godai]

17. He's very anti-FDA

He criticizes many of the practices of mainstream medicine and the Food and Drug Administration (FDA), particularly vaccination and the frequent use of prescription drugs and surgery to treat diseases. Mercola has received two warnings from the FDA for marketing nutritional products in a manner which violated the Federal Food, Drug, and Cosmetic Act.<2><3> On the website, he also promotes and sells a variety of products. He is a member of the politically conservative Association of American Physicians and Surgeons, as well as several alternative medicine-related organizations.<4>

http://en.wikipedia.org/wiki/Joseph_Mercola