Readers’ Corner: It’s a Drug When Big Pharma Wants It to Be a Drug

A medication at the center of a recent court ruling turns out to be a completely natural substance.

Earlier this month we reported on a court decision about free speech issues surrounding the promotion of off-label uses of an FDA-approved drug called Xyrem.

Jonathan V. Wright, MD, writes:

Re your December 4 article on Xyrem, I thought you would be interested to know that Xyrem is actually not a patent medicine (“drug”). It is entirely identical to the natural substance gamma-hydroxybutyric acid (GHB). In the US, it was once used as a sedative. In Europe, it is still used safely as a sedative during childbirth. In the US, by contrast, it was categorized as a Schedule I controlled substance (like heroin) by act of Congress in 2000, principally on the grounds that it had been used for date rape. Alcohol, also associated with date rape, was not included in the same act.

As a controlled substance, GHB cannot be compounded by a compounding pharmacy. It can, however, be sold as Xyrem. Because it is federally approved, it is able to be manufactured by only one company, is sold retail by only one pharmacy, costs (as of 2011) $1,750 per prescription—and is covered by insurance.

Thank you, Dr. Wright. Clearly a “drug” is anything the pharmaceutical industry wants it to be, and the federal government is their willing accomplice.


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21 comments

    1. yeah, it borders on criminality in my opinion… Congress is the enabler of big (insert corporation here)’s attack on the health and prosperity of the American People…They (it) enacts laws insuring corporate profits at the expense of the health of Americans = sociopathic behavior…so whats new from congress for sure!
      Peace, truth, justice, freedom,prosperity and the REAL american way..in-spite of those who would have it otherwise.

  2. I always wondered where GHB went…I was watching back in the late ’90s as that phony, Big Pharma-induced hysteria was taking over the debate about the sleep aid GHB in the U.S. and a ‘date rape’ dog and pony show was traveling state-by-state convincing legislatures to act against this natural substance found in hamburger. Word was some pharmaceutical company was waiting to launch an approved use for narcolepsy. Never heard what happened after that.
    Before the dog and pony show came to my state, I warned my assemblyperson about it and asked to be notified if/when any bills on the matter came up in the state assembly. The assemblyperson’s staff dropped the ball and never told me. (This was before communication over the Internet was to become as functional as it is now.) I heard about the assembly bill too late, and communicated with my state senator about it, to no avail. The state senate shortly thereafter enacted the new law, having already fallen for the lie promulgated by some pro-Pharma expert’s testimony. And then the feds followed suit with their Schedule I classification.
    Just ridiculous. All for a substance found in hamburger.

  4. Good grief. We are really getting the shaft from the big pharma outfits. Is there to be no end to what they are doing to us? Guess we had better do a lot of research and learn all we can about good things for us before there is a blackout of information by those money grubbing big pharma guys.
    Question: Is this GHB found in any particular food item? And the Congress deems it okay to call a natural ingredient a drug and let the drug company charge an outrageous price per prescription.

    1. Yes. MSM. Methyl-Sulfano-Methane. Research it. My experience was that it stopped my allergies in their tracks, and I was taking it for joint pain. If you consider using it, consider building up to the dosage you decide upon. Also, one person reported to me that she needed considerably more than the amount stated. FYI only, I am not prescribing. You are the laboratory, you are the experiment, you are the researcher.

  6. This is so bizarre! Don’t know whether to laugh or cry. Bless Jonathan Wright for bringing this latest piece of insanity to public awareness. I still possess my copy of his video “The Big B-Vitamin Bust” when his clinic was raided by FDA with guns and flak jackets in the 80’s. Government in cahoots with Big Pharma just keeps on doing this crazy stuff. I’m encouraged however that Burzynski has defeated them court.

  7. And we wonder why health care costs are soaring. The pharmaceutical companies have way too much power — I become more and more convinced they are controlling the testing companies also — way too much difference in blood work.

  8. How do these left-wing whackos expect you to uphold Big Pharma’s monopoly status if you don’t keep passing laws that will generate money for them from the bottom up? I swear, some people just don’t get it. $1,750 a prescription sounds like it will be very good for the GDP.
    Keep on making the rich richer. We can always use a little more inequality.

  9. So GHB which can be made for less than $20 quart at home and is considered a date rape drug can be sold by drug companies $1,750. and it OK. The republican should be looking at eliminating the FDA as a good start to eliminate waste.

  10. question: How much of this drug is actually being paid for by insurance companies?? Shouldn’t they be informed of this usage. Or are they?

    1. I’ve often wondered that–why don’t insurance companies see the benefits of nutritional medicine. I don’t know why they don’t fund their own studies–like GTF chromium with Diabetes. I can only conclude that they are, in some way, in on the scam.

      1. It doesn’t always work that way. Though it is natural, it is only found in very small quantities in food. Since it also has to cross the blood brain barrier, achieving a therapeutic dose from food is nearly impossible.

  11. My husband discovered the same kind a “baloney” with quinine, another natural substance. Because a pharmaceutical company decided to corner the market on this – they created a synthetic quinine – Quinequel – or something like that. -and dug up some records between 1960 and whenever they got their product “approved” and quinine disapproved to show that a handful of people died from taking quinine. They charge an arm an a leg for it when prescribed, because it is illegal for a doctor to prescribe quinine, it is illegal to sell it here in the US etc. etc. All because some company decided to corner the market to sell their synthetic stuff. What a crock.

  12. Ha-ha… What?? $1750 per prescription? This is ridiculous fraud: GHB by itself is dirt cheap. It’s direct precursor, γ-Butyrolactone goes by $600 per 20 Kg at Sigma-Aldrich that is highly OVER-priced: http://www.sigmaaldrich.com/catalog/product/aldrich/b103608?lang=en&region=US
    What they do to manufacture GHB is just treat the lactone with alkaline; that’s it! A few bucks per kilo of GHB…
    We need to be better educated to reduce our rates of being duped on everyday basis…

  13. Its ridiculous that Big Pharma is getting a monopoly over a natural substance and charging an exorbitant price. Its the medical-industrial complex trying to control our health again!

  14. The drug companies don’t want you to die. That’s a loss of profit. What they want is for you to be sick forever, and need their drug to stay alive. Mucho profit ! Of course, part of the scheme is to outlaw all natural alternative remedies so your only choice is their outrageously priced prescriptions. Why do the insurance companies go for this? Hey, what’s it to them? They just raise your premiums to cover the costs. How do you beat this system? Simply die. That’ll teach ’em.

  16. Anything related to monopoly is a guaranteed evil, in this case the government’s over-regulation created this situation. Try start a company of your own to make this a legal drug, try go through all those procedures by yourself, without help from lawyers, see how that’s going to take. $1750 is for the time-cost, paid to those lawyers/lobbyist who benefits from these lengthy procedures.

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