Patent protection means you get to charge whatever the market will bear. In this case, it bears a 935% increase in the price tag.
Xyrem is the brand name for sodium oxybate. Sodium oxybate is the sodium salt of γ-hydroxybutyric acid, or GHB—the “date rape drug.” It’s an old drug—even older than aspirin—and it’s FDA-approved for the treatment of excessive daytime sleepiness caused by narcolepsy.
Basically, the very qualities that make it ideal for drugging young women in bars also allows narcoleptic patients to get a deep night’s sleep in order to encourage daytime wakefulness. If its approval can be extended to other patients who have trouble sleeping, the sky will be the limit on how successful this drug can be for its manufacturer, Jazz Pharmaceuticals.
According to “Narcolepsy Blues,” a recent article from Grant’s Interest Rate Observer, Xyrem generated a second-quarter sales growth this year of 43%, despite the fact that between 2006 and 2013, Jazz raised the price of Xyrem by 935%. A year’s worth of the medicine now costs $65,146; its gross profit margins are close to 100%—far better than 60% of the other drugs made by Jazz.
In 2002, Xyrem was granted seven years’ market exclusivity under the FDA orphan drug program: there were no similar drugs to treat cases of excessive daytime sleepiness and cataplexy caused by narcolepsy. Even though GHB is classified as a Schedule 1 drug, which “has no currently accepted medical use in treatment in the United States” and may not be marketed or prescribed, Xyrem (the sodium salt of GHB) is listed as a Schedule 3 drug, which has a currently accepted medical use and may be prescribed. There is no reason for this distinction except as a means to give Jazz greater sales.
How can they do this? Patents are granted by the patent and trademark office. They can be granted anywhere along the development lifeline of a drug and can encompass a wide range of claims. Patents can last up to up to twenty years. On the other hand, market exclusivity is granted by the FDA upon its approval of a drug. These are exclusive marketing rights, and can run from 180 days to seven years. Drugs can have patent exclusivity, market exclusivity, both, or none. It all depends on what criteria they fit.
Now, five years after its Orphan Drug Act market exclusivity expired, Xyrem still faces no competition. Even though other companies have filed applications for generic versions of the drug—not to mention different formulations of the drug—Jazz has also managed to get a patent on how they distribute the drug, since it is a controlled substance. This is facing legal challenges, but until it is resolved, Jazz maintains its monopoly, selling the drug at ludicrously high prices—and reaping a financial bonanza.
Another example is Sovaldi, a drug developed by Gilead Sciences to treat hepatitis C; which can cost up to $84,000 for a single course of treatment. Not all high prices are because of greed alone: the invention of a new drug—which includes the R&D costs of all the molecules that fail the process, not to mention the drug approval process itself—costs, according some estimates, between an average of $1.2 billion to as much as $5 billion.
The monopoly on certain drugs, and high R&D costs that the FDA’s approval process virtually ensures, may be keeping many beneficial treatments off the market. The great pity of it all is that FDA approval doesn’t guarantee, or even promise, drug safety. Each year there are, on average, 526,527 adverse events for FDA-approved drugs—275,421 of which have “serious outcomes,” including death.
So much for the FDA being “the consumer watchdog for safe and effective drugs”!
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Second Verse:
Replace the FDA & CDC.
They may have been watchdogs at inception, but times have changed.
They are paid by the drugs companies.
How can this be impartial?
Profit margin compared to butyrolactone (dehydrated GHB):
$65K retail for 1 year of Xyrem at 99+% purity.
$20 (wholesale) for 1 year (1 gallon) of butyrolactone at 99.97% purity.
That’s a gross margin of 99.6%.
If we assume that it takes $100 to convert it to the sodium salt,
$100 to package it and label it,
$100 to ship it,
$100 to pay out dividends, and
$100 to maintain lobbying with Congress to keep their monopoly,
that’s only a 99% margin.
It’s a miracle they can stay in business.
Yet another example of what is wrong with current US drug laws & regulations (Sched 1 vs Sched 3). Probably due to the fact that regulatory agencies have been infiltrated by former execs of the very companies they’re supposed to oversee. Also, a testament to greed.
Is it going to take a Class Action Suit against the FDA for contributing to Sexual Assault Nation wide?
Although police and the FDA like to state that GHB is THE date-rape drug, and routinely attribute all the amnestic effects of Rhohypnol to GHB, this is a gross exaggeration. Contrary to this myth, GHB does not induce amnesia. Any more than sleep does. With Rohypnol, drugged individuals can lose a half-hour of memory. With GHB, drugged individuals remember everything normally until they fall asleep. So they are perfectly capable of testifying to the circumstances that led up to any assault that took place while asleep. This is not what date-rapist predators want.
The real crime here is against the elderly. GHB is the only FDA-approved sleep drug that actually enhances sleep architecture instead of further damaging it. GHB deepens stage-3 and stage-4 phases of sleep, which is not only the part of sleep most compromised in older ages, but also the phase of sleep when growth hormone is released and healing is most efficient. For growth hormone enhancement, periodic use is best. Once-weekly doses of butyrolactone (dehydrated GHB, which rapidly converts to GHB in the blood stream) would cost seniors $50/year allowing for a fifteen-fold markup for distributors. The health savings would be phenomenal, to them, and to the health-care (disease-management) system. This hidden cost is a crime against humanity.
the FDA and USDA need to be eliminated from the USA, period. They are a danger to our population of the USA.
I think the FDA must have filled their prescription for the stupidity virus drug!
There are those who prefer a Rx for what ails them + those who know Nature has a solution for everything – melatonin, valerian and so much more in this case…
GREEDY, greedy, GREEDY!!!!
That seems fair to me,that’s why they spend so much on R&D.
So not fair for those who use it for what it is intended for. Please do the
right thing.
I’ve recently been very affected by this topic. My sleep has been so bad for well over the past decade that I was recently experiencing diarrhea and extreme loss of appetite after being awoken too soon. I am only able to sleep with earplugs in and I also need to use earmuff headphones. When my ears started hurting from the earplugs and earmuffs, I basically couldn’t sleep at all. I was genuinely ready to die and went several days without eating or having the desire to eat. My body was literally shutting down due to lack of sleep. I gradually was able to start sleeping again but since my sleep has only gotten worse over time it seems quite likely to me that this will lead to my death.
Since Xyrem is so insanely expensive and hard to get prescribed, I was even going to try to make GHB myself but due to how easy and inexpensive it is to make the pre-cursors have also been banned. Those heartless monsters at Jazz should be ashamed of themselves.
Binaural beats or isochronic tones are available and will absolutely bolw your mind when it comes to relieving pain and getting and staying asleep. I have personaly gotten the best sleep of my life using them. You can get them off you tube or buy a audio rife machine program for your computer from some one like bztronics.com or
It is unfortunate that so many people are subject to unscrupulous drugging in their unattended drinks. Young women as especially prone to the malicious dating game that some young men have invented by drugging unsuspecting victims. All too often I have seen the reports of sexual assault victims who do not even know what happened or who did this heinous act to them while they were unconscious typically on college campuses. These kinds of insidious drugs are easily available and too-often distributed unlawfully among people who think it’s “fun” to take advantage of innocent young girls and women.
That’s why I do not take prescription drugs unless there is a clear reason for them. Unfortunately, most people are not aware of the problems with drugs. They believe the FDA has their interests at heart. If it’s FDA approved, it must be safe. So goes the sentiment. It’s up to those of us who are paying attention to do what we can to reign in a number of federal agencies, including the FDA. Presently, there are stronger ties between the corporate world and government than between the people and government. Hopefully, we can get back to a government of, by, and for the people. There’s much work to be done.
HAVE YOU EVER READ THE SIDE EFFECTS ON MOST OF THE PRESCRIPTION DRUGS. THEY INCLUDE THE WORDS ” MAY CAUSE DEATH.”
My daughter takes this medicine for her Narcolepsy. It is so very sad that there is only one place to get this medication and the cost is astronomical! Because it is an orphan drug they can charge whatever they want to. How unfair and it isn’t due to new technology.