New "Miracle" Sleep Drug Developed By Merck

Current issue of New Yorker delves into the history of Ambien *with bits of Halcion story* and discusses dark tale of bringing newly discovered drug to market, including sick story of how FDA is making things worse. Oh boy. 

Great article - well worth reading: 

http://www.newyorker.com/reporting/2013/12/09/131209fa_fact_parker

I wonder if "feel like you are being hunted by enemies" will show up on the bottle or product information sheet.

Something tells me that unsuspecting patients will have to find out the hard way.

I agree FG - but for me the good thing about the artiicle was the article itself. For once, it was written with intelligence and forethought about the whole mess of trying to manipulate the brain. I was really happy about this since The New Yorker has always been one of my favorite magazines. 

M.

When suvorexant is in the brain, orexin is less likely to reach orexin receptors. Instead of promoting general, stupefying brain inactivity, suvorexant aims at standing in the way of a keep-awake signal. This difference may or may not come to mean a lot to insomniacs, but Merck’s marketing is likely to encourage the perception that suvorexant ends the dance by turning off the music, whereas a drug like Ambien knocks the dancer senseless.

Can someone please tell me WTF this means? 

When suvorexant is in the brain, orexin is less likely to reach orexin receptors. Instead of promoting general, stupefying brain inactivity, suvorexant aims at standing in the way of a keep-awake signal. This difference may or may not come to mean a lot to insomniacs, but Merck’s marketing is likely to encourage the perception that suvorexant ends the dance by turning off the music, whereas a drug like Ambien knocks the dancer senseless.

 

 

 

Can someone please tell me WTF this means?

Instead of propping open the receptors like benzos do (so that more GABA enters the neuron), this stuff prevents the orexin from getting to the neuron. So it doesn't directly affect the receptors. Still, your brain will figure out that something isn't right and make adjustments accordingly. Just because it doesn't touch the receptors doesn't mean your brain won't adapt.

Very interesting article. Now, they come out with how bad Ambien and Lunesta are.....like we didn't already know that and they're trying to convince us that altering this new neurotransmitter is more effective and has no side effects. It's all so manipulative. I can't believe people continue to fall for this. I'm sure Big Pharma is going to make big bucks on this new drug. It was so upsetting to read that they test these drugs on innocent animals.....like dogs.

Thanks for posting this mplsgrl. 

I was stunned to see this article, and then I was really frightened. I was thinking, what if they are really promoting a "safe" new "cure" for insomnia? What if they glorify benzos and other mind altering drugs? I cried a couple of times with relief reading the article as I knew the author clearly has at least a questionable if not hostile attitude towards these so called chemical miracles.

If this ariticle is picked up and repeated, or quoted on the 'net, maybe, finally, some people would start to do their own research into this whole stupid thing.

M.

After reading all the comments here (and having seen this article myself a couple weeks ago), I must admit I have a somewhat different take on it.

I've been following this one for quite a while, and while I think there are likely to be downsides and problems no one has foreseen, I'm far more fascinated than alarmed.

"Following" is something of an understatement. I have a friend with severe, long-term problems (delayed sleep phase syndrome and apnea) who is so desperate to get his hands on this stuff that he decided he couldn't wait until Merck gets it to market so he paid a chinese lab to synthesize the molecule for him. I think he paid something like $1000 for the equivalent of 100 pills. Needless to say I think he's loony, and I'm fairly certain there are legal concerns (it's not a controlled substance but Merck clearly has a patent; I don't know what the legality of making a knockoff for one's own use is, but I imagine it's complicated at best).

Anyway, I do find it refreshing to see entirely new receptor targets, even if it doesn't pan out at all as a sleep drug there will doubtless be other interesting things learned in the process. Of course I take a dim view of how profit focused drug development is, but that doesn't stop me from feeling some child-like wonder every time someone discovers a new transmitter system. This is also a pretty rare case of a drug being designed from the ground up to have a structure that targets a specific ligand -- that's feeling like the future of molecular engineering to me.

Cynically, this drug can do a lot of 'good' without really being good at all. If it's marketed well, it will displace benzos and z-drugs in the marketplace. If it's safer and works better, then that's a win for consumers. Clearly consumers demand "sleep aids", and clearly benzos and z-drugs are neither effective long term nor safe. So, to me this drug could be some combination of  'ineffective' and 'dangerous' and still be an overall win for the marketplace. That sets a pretty low bar.

I was stunned to see this article' date=' and then I was really frightened. I was thinking, what if they are really promoting a "safe" new "cure" for insomnia? What if they glorify benzos and other mind altering drugs? I cried a couple of times with relief reading the article as I knew the author clearly has at least a questionable if not hostile attitude towards these so called chemical miracles.[/quote']

I find the author's viewpoint pretty reasonable as well. I don't have a problem with chemical miracles, I just think people need to be mindful of all the other things that come out whenever you open pandora's box. I think a tide is turning as far as the popular perception of psych drugs in general, and if we can reach a homeostasis where people have an overall awareness of the potential dangers of drugs before they fill a script, that's as far as I'd push it. Even knowing all the risks and downsides, for any given drug there's going to be some number of people willing to take the risk, and I believe that's their right. I think the way pharmaceutical companies (and huge corporations in general) behave is often wretched - but that's a systemic issue, and has nothing to do with drugs themselves.

 

edit: I guess the short version is that I'm still an optimist, even about psych drugs 

I don't share your optimism, Spengler.

My experience with pharmaceuticals and the history big Pharma has with marketing psych meds will keep me ever skeptical.

From my perspective I have no reason to believe much of what they are selling.

The idea that big Pharma will be forthright with all the information seems almost delusional to me.

I'll trust them when they earn it.  To date they haven't earned my trust and as it stands it isn't happening.

I don't share your optimism, Spengler.

 

My experience with pharmaceuticals and the history big Pharma has with marketing psych meds will keep me ever skeptical.

 

From my perspective I have no reason to believe much of what they are selling.

 

The idea that big Pharma will be forthright with all the information seems almost delusional to me.

 

I'll trust them when they earn it.  To date they haven't earned my trust and as it stands it isn't happening.

I couldn't agree more BeauBeau.  Nicely said.

I don't share your optimism, Spengler.

 

My experience with pharmaceuticals and the history big Pharma has with marketing psych meds will keep me ever skeptical.

 

From my perspective I have no reason to believe much of what they are selling.

 

The idea that big Pharma will be forthright with all the information seems almost delusional to me.

 

I'll trust them when they earn it.  To date they haven't earned my trust and as it stands it isn't happening.

With the FDA testing and approval requirements the way they are how are we to know if any of these new drugs are truly safe?

Benzos have been around for what, 50 years, and we still have doctors promoting them as harmless and handing them out like Halloween candy. I have seen more than a trivial number of lives destroyed and even a few suicides during my own 3 years of suffering so I know they are anything but safe.

At least if they develop something to replace them the benzo fiasco will likely be acknowledged for the barbaric thing that it can be. It won't do unsuspecting patients any good if these new drugs turn out to be more of the same but at least we will have some vindication and maybe people will start paying more attention in general.

Every new drug is hailed as a "miracle drug" with no addictive potential. 

And then the lawsuits start rolling in. 

They did it with Quaaludes, benzos, Oxycodone, Ambien, Talwin...and the list goes on.  In every case it turned out to be a mistake or flat-out lie.  If the public hasn't caught on by now, there's no hope. 

Oh, don't get me wrong. I don't trust any large corporation to have my best interests in mind, it's contrary to their purpose. I'm especially wary of pharma cos and other companies that make stuff which goes directly into my body (food conglomerates, for instance). But, I am optimistic about progress and increased understanding, and whether I like it or not pharmaceutical research has been responsible for a huge number of breakthroughs. Are many drugs terrible? Sure. Are there a lot of conditions which used to be fatal or intractable which can now be controlled or cured with drugs? Absolutely.

If you left it all up to me, I'd set up an independent authority to actually test the safety and effectiveness of novel molecules, so that the research could be divorced from the financial motivation, but I certainly wouldn't discourage molecular innovation.

In every case it turned out to be a mistake or flat-out lie.

Marketing noise is always self-serving, but I think this statement is pretty extreme. It's easy to make a case that antibiotics have been vastly overused in a way that's put us on the cusp of a bunch of scary problems, but I think it's pretty impossible to claim that overall they haven't drastically improved human existence. Today, hip replacement surgery is very common, and has a relatively low rate of severe complications. I read a paper about antibiotic use recently which concluded that without antibiotics, hip replacements would have a 25% mortality rate (and that's just one isolated procedure). Benzos have messed us all up pretty good, but they're also used in ERs on a daily basis to abort seizures and severe trauma reactions that would otherwise be fatal. We have increasingly selective cancer drugs that have taken things which used to kill in weeks and turned them into conditions that can be managed for years or decades in some cases.

So, if all that we get out of Orexin research is a single insomnia drug which becomes over-prescribed and causes problems, that will be regrettable -- but I don't think it's likely. Even if Merck is completely wrong about this particular drug, someone else will learn something they wouldn't have otherwise. I'm not a big fan of being the first person to try a new drug because it amounts to risky human research, but I don't know what the alternative is besides "stop making new drugs at all", and I definitely oppose that. Someone has to be first in line. My big problem with the paradigm is that 'informed consent' is often neither.

Spengler,

For once we agree!  You are the very person we want to be "first in line" when big Pharma tests it's new psychotropic drugs.  And I want to personally thank you for your commitment!  Let us know how it all works out!

It's laughable that you would use antibiotics, hip replacement, and cancer drugs to bolster your argument.  Try again.

Yeah, I fully support the research and development aspect of Big Pharma.  I just wish the marketing side was different.  It seems the public always acts as guinea pigs for meds that haven't been studied long-term in humans.  There should be a disclaimer that states, "we don't know what the long-term risks might be", but instead we get glitzy ads full of smiling couples and kids playing in the sun. 

Here's hoping this new sleeping med really is "the one".   

Spengler,

 

For once we agree!  You are the very person we want to be "first in line" when big Pharma tests it's new psychotropic drugs.  And I want to personally thank you for your commitment!  Let us know how it all works out!

 

It's laughable that you would use antibiotics, hip replacement, and cancer drugs to bolster your argument.  Try again.

I don't know what this is all about, Babyrex.  My problem with big Pharma is the deception.

They have a long history of deception with psych meds.  Fabrications and word games like chemical imbalances and discontinuation syndromes just to start.  Purposeful manipulation of data from trials to increase efficacy of the substance under examination up to and including outright omission of negative results.  The revolving door between the FDA panels doing the approving and the drug companies.  Sophisticated education techniques designed to distract and mislead prescribing physicians and their patients.

And then there is the justification and rationalisation for their existence as evidenced by Spengler's last post, which is of course hard to deny.

The idea that they've done so much to improve the human condition doesn't excuse the bad behavior.

Not giving us all the information as it exists without bias seems an awful lot like lying, to me.  In the business they are in, that is criminal.

As M pointed out in an earlier post, this article suggests that somebody is starting to pay attention.  Now, if only they would come right out and say it.   

What I don't understand is why drug comalnies are allowed to do their own research, and they only have to present two studies, and they can legally throw out all the studies that show increased likelihood of side effects. Or they only test the drug for nine weeks and it ends up being legally prescribed for long term use.

At least with 'risky human research', as Spengler says, these people are consenting to possibly experiencing the severe side effects of a new drug.

It's laughable that you would use antibiotics, hip replacement, and cancer drugs to bolster your argument.  Try again.

I don't have to; you don't agree with me, and that's fine. I'd appreciate it if you could disagree without making it so personal, though.

What I don't understand is why drug comalnies are allowed to do their own research, and they only have to present two studies, and they can legally throw out all the studies that show increased likelihood of side effects. Or they only test the drug for nine weeks and it ends up being legally prescribed for long term use.

Yes, exactly. I think that if we could solve these problems in a meaningful way, then we could all enjoy progress without feeling conflicted about it (or, worse, being damaged by it). I think there are a couple of european countries that have better paradigms in use, but unfortunately because it's a global industry, things have to change in a big way here before they can change in a big way globally.

edit: in the most perfect of worlds, I think that in addition to drug co's not making their own proof, the whole model of for-profit R&D would have to be tossed out or changed. There are too many problems there. Obvious cures for rare diseases may go overlooked because they aren't likely to be profitable. One of my friends from childhood works for a non-profit that does cancer drug research, and that world looks very different than for-profit pharma cos... but of course the amount of resources they have are tiny in comparison. It's tempting to say that this work should be done for the public good and therefore should be done by the state, but given the bloat and red tape that creeps in to large government agencies, that might just be trading one problem for another. Drugs designed by computer help this problem, but at some point you have to test it in vivo and in vitro, and that's expensive and morally problematic no matter how you slice it.

We should be careful not to throw the baby out with the bath water here. Millions of people have indisputably been helped (if not had their lives saved) by pharmaceutical drugs. Absolutely there are abuses going on and problems with the system. But shifting to a different "paradigm" sounds pretty drastic. Bottom line is that there should be stricter testing requirements, greater accountability when drugs prove to be bad (withdrawal from market), doctors need to be more cautious when prescribing, and we as patients need to be more discerning.

Lots of blame to go around but painting big pharma as evil carte blanche is wrong. My wife works in oncology and sees people cured by their products daily.

Drug development, from initial discovery of a promising target to the final medication, is an expensive, lengthy and incremental process. The ultimate goal is to identify a molecule with the desired effect in the human body and to establish its quality, safety and efficacy for treating patients. The latter requirements ensure that the approved medication improves patients' quality of life, not only by curing their illness, but also by making sure that the cure does not become the cause of other problems, namely side effects (Snodin, 2002). It also means that this is a particularly costly and prolonged process. At present, bringing a single new drug to market costs around US$800 million, an amount that doubles every five years. According to the US Food and Drug Administration (FDA), it takes, on average, 12 years for an experimental drug to progress from bench to market. Annually, the North American and European pharmaceutical industries invest more than US$20 billion to identify and develop new drugs, about 22% of which is spent on screening assays and toxicity testing (Michelson & Joho, 2000). In addition to costs, administrative hurdles have become problematic, which contributes to the high failure rate of new drug candidates. Of 5,000 compounds that enter pre-clinical testing, only five, on average, are tested in human trials, and only one of these five receives approval for therapeutic use (Fig 1). It is not surprising that, while development costs have increased, the absolute number of newly approved drugs has constantly decreased for several years. These trends—increasing costs for drug development and testing and greater scrutiny of the approval process—create a growing problem both for the drug industry and for patients who are desperately waiting for new drugs to treat their illnesses. It is therefore timely to consider how new technologies, namely functional genomics, proteomics and the related field of toxicogenomics, can help to speed up drug development and make it more efficient.

Spengler,

 

For once we agree!  You are the very person we want to be "first in line" when big Pharma tests it's new psychotropic drugs.  And I want to personally thank you for your commitment!  Let us know how it all works out!

 

It's laughable that you would use antibiotics, hip replacement, and cancer drugs to bolster your argument.  Try again.

This is an incredibly rude post. Personal attacks like this (against a moderator of all people) are sad.

And why exactly is it laughable to use antibiotics and cancer drugs as part of this argument?