Judge strikes down FDA ban on ephedra

[Squatch]

http://www.msnbc.msn.com/id/7504443/

SALT LAKE CITY - A federal judge Thursday struck down the FDA ban on ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths.


The judge ruled in favor of a Utah company that challenged the Food and Drug Administration’s ban. Utah-based Nutraceutical claimed in its lawsuit that ephedra “has been safely consumed” for hundreds of years.

[FlashHarry]

1. Well... like many things, moderation is the key.

[sui generis]

2. moderation yes

that stuff still makes me jittery and bat shit crazy. I get the uncontrollable urge to polish metal. Very fast.

[fertilizeonarbusto]

3. You, jittery?

Scary thought...

[Roland99]

5. I was gonna wax my car this weekend.

PM me for directions.



;)

[Cha]

60. LOL! I sure ain't gonna

take any!

[chyjo]

4. Good

I lost 60 lbs on ephedra and never experienced any negative side effects. Neither have most people who have used it. I drink sometimes, but Alcohol is way way more harmful than ephedra. If they need to ban a legal drug they should start with that.

[doodadem]

14. More than good--great!

I've gained 20 pounds since they took ephedra off the market. Took it for several years, never had a problem. I'm still not "fat", but ephedra just kind of made my system normal. I've always been just this side of hypoglycemic, pass out if I don't eat, etc. etc. Ephedra seems to tone down the internal furnace, and never made me jittery.

[DemBeans]

21. this is *very* good news

I lost about 30 pounds with an ephedra-based pill, and I never had any negative side effects. The stuff really works - although the person I bought it from recommended I take a potassium supplement - it apparently does affect your potassium levels as an FYI to anyone who might take it again if it's reintroduced.

[chyjo]

25. Good Point

I think that goes for any thermogenic agent too. Whenever I used Ephedra I always drank a good amount of V8 to keep up my potassium.

[ender]

6. good... now only if the would...

look at GHB.

and yes, i mean that.

[BrainRants]

7. Correct me if I'm wrong, but isn't this another win for big Pharm?

Dozens of deaths? Damn the consumer and all that?

Just observin'

[Squatch]

9. It's not really produced by big pharma...unless you consider

Joe Weider big pharma.

[Ruby Romaine]

12. Weider CEO infor from Hoover's online-

is that a big Pharma salary?

Bruce J. Wood, Age 53
President, CEO, and Director, $456,676 salary, $579,979 bonus

btw-located in Utah
Orrin Hatch connection?

[Dogmudgeon]

34. That's chicken feed

Check out the packages they give the CEOs and CFOs of Merck, SmithKlineGlaxo, Astra-Zeneca, and the others.

Orrin Hatch connection? Maybe. A racist right-wing jackass also invented the transistor (Robert Shockley). Ephedra has similar effects on people no matter how they vote.

--p!

[bain_sidhe]

18. Nope. Big loss

**edited for formatting**

Ephedra-based weightloss products work better than the sh*t they sell for zillions of dollars. "Big Pharm" was behind the push to ban it in the first place. Ephedra has approximately 150 deaths linked to in in 20 years - most by people who misused it. OTOH, over the counter drugs like asprin cause almost 1000 deaths in one year

From NewsTarget (http://www.newstarget.com/001046.html):

There are 150 deaths apparently linked to ephedra. Over-the-counter pain medications kill 40,000 American each year by comparison. Prescription drugs kill another 100,000. Where is the FDA outcry on these drugs?

Second, there's the abuse issue. You can't possible be killed by ephedra unless you abuse it by taking too many pills at once in some sort of desparate weight loss attempt. Over-the-counter pain pills and prescription drugs, by comparison, kill people even when taken at the proper dosage So there's a tremendous difference in the risk of death with ephedra vs. prescription drugs, and yet the FDA chose to focus on ephedra.

From Dr. Murray (http://www.doctormurray.com/newsletter/2-8-2004.htm):

In the worst case scenario, over the last 20 years ephedra was linked to approximately 150 deaths (virtually all of which were related to excessive dosage or abuse). In contrast, approximately 2,000,000 people in the United States died from adverse drug reactions including over 140,000 deaths caused by aspirin and other NSAIDs.

Some people believe there was a wider purpose: From Common Ground (http://www.commongroundmag.com/2004/cg3103/ephedrawars3103.html):

Many see the FDA’s action to prohibit the sale of ephedra, or ma huang, as the opening salvo of an attack on all supplements — especially botanicals — and the landmark law that protects them, 1994’s Dietary Supplement Health and Education Act (DSHEA). They fear if the supplement act is overhauled or rescinded, millions of consumers may be denied access to what are overwhelmingly safe, effective, and inexpensive alternatives to prescription drugs.

I'm fairly up on this fight because I took ephedra for years. I took the "weight loss" dosage for about a year - and lost 60 pounds, and continued with a "maintenence" dosage for about three years after that, and kept it off until they banned it. I've only gained a few pounds back - but they're very unwelcome pounds, and I've only kept the amount so low by eating only one meal a day (I have a very low metabolism - even caffeine doesn't raise it much). Not only did I not have any ill effects, I also had far fewer sinus headaches than I used to get, and consequently, used far fewer sinus products and aspirin. Those have come back too.

I'm celebrating the judge's ruling.

:party: :woohoo: :party: :woohoo: :party: :woohoo: :party:

Hope it holds up!

:nonexistentworryicon: :nonexistentworryicon: :nonexistentworryicon: :nonexistentworryicon:

[housewolf]

8. I had an irregular heart beat while taking it

But wow, did I ever get a lot of stuff done ...

Hmmm... I think that people who use it ought to be regularly monitered by a physician.

[Eloriel]

50. And I think people who have side effects oughtn't freakin' take it

Doesn't it occur to you that irregular heartbeat is something NOT GOOD -- as in a little sign from your body that you're either sensitive to ephedra and oughtn't take it at all OR you're taking way too much? Why are you intent upon harming yourself? Forget weight loss -- see a shrink instead for your self-destructive streak.

/rant

I am delighted with this ruling, BUT --

It's imperative that individuals NOT abuse the herb. The weight loss aspect isn't even ephedra's main or best (or proper?) useage! I do find it listed for weight loss in my newer herbals, but not in my older ones (the ones I tend to trust the most).

[housewolf]

55. Wow, Eloriel...

I guess something I said pushed a button and set you off on some sort of ranting tangent!

I didn't realize my heartbeat was irregular until I happened to have a dr. appt for some other reason. I was't abusing the herb. I was taking half the daily suggested dosage. I wasn't, as you said, "intent on harming myself" - I was taking a nutritional supplement that I thought would be beneficial to me. The dr. was ready to send me for cardiac testing. I discontinued the use of ephedra and the problem went away.

Obviously I have a sensitivity to the herb and shouldn't take it. I haven't taken it since nor will I.

My point being that I was unaware of the potentially serious problem.

[Ganja Ninja]

10. Too bad the judge can't do the same about pot laws.

:argh:

[librechik]

29. you and I are fellow travellers

why not pot too?

(sigh)

[illflem]

11. Moderation is the key

if every substance that could cause death was to be banned water should be first on the list.

[Cha]

61. Yeah, too much

agua in the snout!

[Squatch]

13. Funny thing is how right at this moment, MSNBC has a story

on how water is bad for athletes AND the story on the repeal of the ban on ephedra (which is a diuretic).

Remind me not to rely on MSM to help me make decisions about my health.

[Zynx]

15. This stuff made me feel like I was going to die

Granted, the pounding chest was after I broke all my workout maxes wide open without really trying but still, I threw it in the garbage.

[prodigal_green]

28. Exactly

I tried it, I didn't like the way it made me feel so I stopped taking it. This is one drug that lets you know right away how you're going to react to it. You would have to push pretty hard and put up with a lot of discomfort for it to kill you. It's not like alcohol which masks its own effects (or your ability to make judgements about its effects).

How many people did Vioxx kill before the drug company took it off the market? (FDA wasn't going to ban it, hasn't banned similar drugs, just recommended a warning).

[Dogmudgeon]

36. Sounds like you got bad dosing advice

You start out low and titrate (adjust the dose) over a period of three days to one month, depending on your desired weight loss goal and medical situation.

Vioxx, incidentally, did not kill a whole lot of people (at least based on the information Merck has submitted under FDA order). I'm beginning to smell a rat in that whole scandal.

--p!

[prodigal_green]

43. I followed the directions

I just didn't tolerate it well. Some people don't. I don't think it should be banned by any means though. I know plenty of folks who have done really well on it.

You need to be a grownup about what you put in your body.

I don't feel so good the next day after drinking too much alcohol, so as a practice, I don't drink too much alcohol.

[HuckleB]

45. A lot of people don't tolerate it well.

Same with pseudoephedrine.

[RobinA]

58. Me Too, Regarding Vioxx

Seems to be a dearth of details. Tell me how many people died taking the recommended dosage.

[Trillo]

16. Good. Were there any fourth amendment issues in the decision?

I find the comments by people here of the physical symptoms ephedra causes to be curious. I took it as a weight loss supplement, oh, maybe a decade ago, and never found it to have much effect. Perhaps it made me a little less hungry, but I experienced no physical sensations such as tremors, no feelings of frenzied activity, no irregular heartbeat.

I guess I didn't abuse the recommended dosage level. Likely it affects some more than others.

Does taking ephedra result in false positives on so-called illegal drug tests? Perhaps that's the real reason for the ban.

[prodigal_green]

44. I think most people had bad reactions to ECA stacks

as in hydroxycut and xenadrine. ECA=ephedrine, caffeine, aspirin. They all work together to boost the effect. Some people could be having a bad reaction to the caffeine.

[Eloriel]

51. A lot of people abuse it -- thanks to some supplement mfgrs who

abuse it!! -- and some people are simply sensitive to it. I think it's contraindicated for things like high blood pressure, etc. and a lot of overweight people have that. Some may not even know it.

ALL herbs are good, IMO. Some are safe for almost everyone under normal circumstances (I'm thinking of those which are also foods, spices, etc.). But some aren't. ALL herbs should be treated with respect and taken responsibly by people. Unfortunately, some supplement manufacturers make that more difficult (tho I'm sure there are people who ignore the warnings and cautions they do publish).

[Zenlitened]

17. Great news. I tailored the dosage to my own needs...

... and shed that "stubborn 10 or 15" with no side effects. Since they banned it, I've steadily gained it back. This is a product that consumers CAN use responsibly -- it was wrong to ban it because a few people abused it.

[I see you]

19. Great News!

I use to take Ripped Fuel. It's a great weightloss supplement, and more people die each year from taking asprin than did with ephedra. IMO they only took it off the market because people were using it to make meth.

[leftofcool]

20. Fantastic!!!!!!!!! eom

[KittyWampus]

22. Ephedra Traditionally Was Used For SINUS CONGESTION

And a pox on the athletes who decided to abuse it.

[Kagemusha]

23. Self-deleted.

Censored for commentary deemed offensive due to excessive concern for black athletes.

[bain_sidhe]

24. read upthread... more people die from ASPRIN

in one year, than have died from ephedra in 20 years.

[Kagemusha]

26. Self-deleted.

[bain_sidhe]

27. Fine. Set up your "race card" straw man

I'm not buying it.

*edited to add:

and I have no interest in debating your ridiculous "point."

[Kagemusha]

30. Self-deleted.

[sled]

32. Agreed...

Probably "excessive", even if all 150 deaths, in the last 20 yrs. were all "black athletes". If that's the case, maybe a warning for "black athletes" to beware ephedra, or they'll have a one in some odd million chance of dying...maybe more, maybe less...who knows???

[earthboundmisfit]

31. Ephedra is also a pretty effective non-prescription antidepressant...

Yet another reason pharma companies wanted it off the shelves.

[HuckleB]

35. It might mask depression for a short period of time.

But its no anti-depressant, not unless you find a manic state to be an OK alternative, while knowing that you're not going to be able to maintain that state.

[Dogmudgeon]

38. It depends on the depression

It works well for many dysthymic patients, but it's not a good idea for bipolar patients. However, for those patients, well-supervised use of methylphenidate (Ritalin) or d-amphetamine (Adderall) is the better choice.

--p!

[HuckleB]

39. No.

You can't balance it, and you're not treating the underlying cause of the depression. That's really the bottom line. Ephedra might make someone "feel good" but I can think of a few thousand substances that would do that. I've gone round and round with people who try to use this to "treat" depression, as their lives spin ever more out of control. No one should be selling this as an anti-depressant without facing serious questioning.

[Dogmudgeon]

48. That spinning metaphor is more suited to "Psycho"

Your insistence that the "underlying cause" of depression must be treated is sound, but what do you choose as the "underlying cause"?

People have self-treated for millennia, and many use ephedra for weight loss, energy, and a few use it for depression. (And no, I don't self-treat depression with ephedra/ephedrine.) I don't recall seeing anyone selling it for that, but I know it had been used for the medical treatment of depression before the development of tricyclic antidepressants. These days, we have much better medication for depression, as well as hundreds of approaches for treating underlying causes.

The sad fact is that approximately 40% of the population of the USA has been shut out of the medical system, and many people who can afford treatment may be wary of "advances" like the anorectic (weight-loss med) sibutramine, a four-bucks-a-pop substitute for ephedra that works just like ephedra, only with more serious side-effects.

I don't know why you've gone round and round with ephedra issues, but my own experience of things "spinning out of control" comes mainly from having a chronic (but fortunately not fatal) illness -- and no insurance. If you're looking for underlying causes, that would be the best place to start. With better medical education and universal health care, self-care would take a healthier course, which would usually mean consulting with a physician for depression and/or obesity treatment.

--p!

[HuckleB]

54. Lack of insurance is one issue.

But that's seldom been the issue with people using Ephedra, in my experience. People have also used alcohol, coca, opium and hundreds of other self-defeating treatments for depression for thousands of years. That doesn't mean someone should recommend them as a treatment now.

Regardless of the underlying cause you choose to accept or not accept for depression, there is no even remotely widely accepted theory that connects a treatment like ephedra to the underlying cause. I have gone round and round, because what happens with people who treat with Ephedra is that they "feel great," meaning they actually end up feeling hypomanic and uninhibited to a degree that leads them to do things that often trigger greater bouts of depression later. It's not much different than having a few drinks, if you're discussing its use by people suffering from depression. Further, it usually interrupts their sleep cycle, which can lead to a deepened depression and on and on and on.

Depression is often fatal, by the way. And the likelihood of fatality increases when self-medication leads to more self-medication and down the road until one spins out of control.

[damntexdem]

33. Yeah, safely consumed for hundreds of years ...

by those whom it didn't kill.

[HuckleB]

37. FDA vs. Ephedra: Dietary Supplement Regulation Under DSHEA

http://leda.law.harvard.edu/leda/data/507/Jones.html

[HuckleB]

40. Report of Ephedra Working Group to NCCAM

http://nccam.nih.gov/health/alerts/ephedra/working-group.htm

Also...
NCCAM Consumer Advisory on Ephedra:
http://nccam.nih.gov/health/alerts/ephedra/consumeradvisory.htm

[Avalon Sparks]

41. I've taken it before...

In the form of "Metabolife". It was the best drug I've ever taken for alertness. Metabolife bottle said do not exceed 8 pills a day and the recommended dosage was 6 pills a day. One or two pills a day did it for me, especially on Monday's when I felt like falling asleep at my desk at work.

I've tried other pill forms of speed for various reasons - one being I like to stay up late at night and I usually only sleep 4 or 5 hours a nite - and ephedra is the ONLY speedy type of drug that didn't make me jittery and nervous and bitchy. Since they took it off the market I've been hating it. My friend and I found all the local mini-mart type gas stations that were still selling in under other brand names long after the ban - but even they have ran out.

I figured most of the people that died from it took too much. I agree with the moderation statement.

I hope and hope and hope it comes back because there is no substitute!

[AlienGirl]

53. Primatene and Bronk-Aid (OTC) tablets contain ephedrine

Ephedrine is the medical-grade refined alkaloid from ephedra. It's a good bronchodilator and decongestant.

Tucker

[Jack_DeLeon]

42. Good...

people should always have the choice on what they want to put in thier own bodies.

[Beaverhausen]

46. At the risk of sounding like Delay, should a judge be making this decision

The FDA decided it's unsafe. I think it's rather odd that a judge decides that they are wrong.

Oh wait...it isn't judicial activism if the judge decides FOR the republican donors.

I get it now.

[tabasco]

49. Government decisions are challenged all the time in court.

The government must show that it used a rational decion-making process with best available facts. In this case it didn't. The Bush FDA is a tool for the big drug companies. Good for the court for exposing the FDA's flawed decision process.

Is your trust in the government really that deep?

[Yo_Mama_Been_Loggin]

56. I thought of Tom Delay too

The fact that the judge and the company producing the stuff are from Utah leaves me a bit curious. Maybe I'm paranoid but theres at least the appearance of a conflict of interest.

[NorthernSpy]

47. herbal "medicine": a plague the FDA helped to create...

... with their onerous rules that keep safe and effective "prescription-only" drugs and devices out of the hands of the uninsured.

Ephedra is one of the herbs that uninsured asthmatics have commonly used for self-treatment. It's hardly ideal, but aside from a handful of weak, over-the-counter bronchodilators, herbal potions are the only "treatments" available to someone who cannot regularly afford to pay a doctor for that all-important permission slip -- the one that entitles you, presumably a responsible adult, to purchase real medicine.

Ephedra is not innocuous, but neither is the sort of regulation that puts the business interests of doctors ahead of the right of the individual to buy and use safe, proven medications.

[Eloriel]

52. Not quite

herbal "medicine" was around long before the FDA was, or even the USA, or even recorded history.

I think I agree with you other than that. :D

[Rose Siding]

57. kick

[left15]

59. now if they would only bring back PPA

thats what they used to use in Tavis D when it worked.

[HuckleB]

62. Why?

Should we just ignore safety issues altogether?