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Placebos Are Getting More Effective

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http://www.wired.com/medtech/drugs/magazin..._placebo_effect

Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn't introduced a truly new product in three years, and its stock price was plummeting.

In interviews with the press, Edward Scolnick, Merck's research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company's reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. "To remain dominant in the future," he told Forbes, "we need to dominate the central nervous system."

His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive's dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people's health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson's disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn's disease, an intestinal ailment, citing an "unusually high" response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body's innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.

And people say the financial industry is built on sand......

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http://www.wired.com/medtech/drugs/magazin..._placebo_effect

....except, the whole point is they are tested. This is as opposed to people who claim vaccines are not real or assert blind claims. If only the city had been tested in a double blind study, perhaps it would not have been caught, but the chances would be higher.

Merck could always release it as a homeopathic remedy.

Times will be getting harder though. There will not be easily found, easily produced treatments that will produce effective medicines. The easy ones have been found and there will be an aspect of diminishing returns, this is market maturity.

And people say the financial industry is built on sand......

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When the epitan/melanotan/clinuvel first came out; the placebo trials showed a problem with sexual dysfunction in the placebo group. Somehow they had picked up that the drug was supposed to cause increased libido and inverted it creating a problem that was statistically significant. So it can work both ways.

Edit: I blame the internet

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Oddly enough, I went to a talk last night by a geneticist who was giving numerous examples of placebos being almost as effective as drugs, often just 1 or 2 percent less effective, and who gave a wonderful talk on the power of the Human Mind to cure itself/the body.

http://www.drdavidhamilton.com/

It is true.

Typically this example is with homeopathy, the main example of a placebo available on the market. People have examples of them seemingly working, as indeed they do with any placebo. However, if something is seriously wrong, then try something else as well.

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It is true.

Typically this example is with homeopathy, the main example of a placebo available on the market. People have examples of them seemingly working, as indeed they do with any placebo. However, if something is seriously wrong, then try something else as well.

The key word is seemingly.

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When the epitan/melanotan/clinuvel first came out; the placebo trials showed a problem with sexual dysfunction in the placebo group. Somehow they had picked up that the drug was supposed to cause increased libido and inverted it creating a problem that was statistically significant. So it can work both ways.

Edit: I blame the internet

Greeting Three Pint Princess 2,

Can you share where you got this information from? This is quite an interesting anecdote.

Thanks,

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Greeting Three Pint Princess 2,

Can you share where you got this information from? This is quite an interesting anecdote.

Thanks,

The first result for epitan placebo trials sexual, is http://www.housepricecrash.co.uk/forum/ind...view=getnewpost

If you need it for a paper I can spend some time digging through their trials, although with the name change they went through I would probably

end up asking them directly for all previous papers.

To help if you are searching, there was a comparison on the trial (this is before they went for the unlikely to be commercially viable clause in the EU, which would work the same on the FDA most likely as it should where rare conditions

don't have the return but could encourage companies to invest by relaxing the laws and making it possible for them to develop drugs to treat 10 thousand people but costing 1 million per person, in my opinion")

It showed Placebo and statistically significant then mapped that against the trial results for the key areas, resulting in the Placebo group having a higher incidence of lowered arousal, along with sexual dysfunction

That was followed up by a paper which cited it, again this is around 8 years ago.

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The first result for epitan placebo trials sexual, is http://www.housepricecrash.co.uk/forum/ind...view=getnewpost

If you need it for a paper I can spend some time digging through their trials, although with the name change they went through I would probably

end up asking them directly for all previous papers.

epitan's drug never had sexual effects (unlike their drug's cousin melanotan II). Maybe the test subjects were confusing melanotan-1 with melanotan II?

Where might one be able to go "digging through their trials"?

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epitan's drug never had sexual effects (unlike their drug's cousin melanotan II). Maybe the test subjects were confusing melanotan-1 with melanotan II?

Where might one be able to go "digging through their trials"?

Epitan is the company name , the same drug melanotan and melanotan II which I'm not sure was a name ?? could have been under Clinuvel.

I should probably say I invested in Epitan through the AU stock market when they were only listed there.

Edit: i'm probably going to ignore someone called "melanotan" Joined: Today, 12:02 AM Posts: 2

Being confident in the prior research I did, I'll leave my posts as they are.

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Epitan is the company name , the same drug melanotan and melanotan II which I'm not sure was a name ?? could have been under Clinuvel.

I should probably say I invested in Epitan through the AU stock market when they were only listed there.

Edit: i'm probably going to ignore someone called "melanotan" Joined: Today, 12:02 AM Posts: 2

Being confident in the prior research I did, I'll leave my posts as they are.

I joined to ask you this question. melanotan-1 ≠ melanotan II. Two very different (though quite related) creatures, one with sexual effects (melanotan II) and one without (melanotan-1) both with pigmentation effects.

One gets the impression that you're making statements based upon non-publicly accessible information.

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I joined to ask you this question. melanotan-1 ≠ melanotan II. Two very different (though quite related) creatures, one with sexual effects (melanotan II) and one without (melanotan-1) both with pigmentation effects.

One gets the impression that you're making statements based upon non-publicly accessible information.

Page last updated at 23:02 GMT, Thursday, 27 August 2009 00:02 UK

English turn to booze on holiday

Drinking in the sunshine

Drinking and socialising is a key part of most summer holidays

English holidaymakers are turning to drink on their breaks with the average adult consuming eight alcoholic drinks a day, a survey suggests.

_46278387_004867829-1.jpg

That equates to 80 drinks over the course of the average holiday, or well over 200 units of alcohol.

More than a quarter said they ended up drinking three times more than normal.

But 70% of the 3,500 adults questioned by the Department of Health said they plan to make September the "new January" by cutting back

http://news.bbc.co.uk/1/hi/health/8225029.stm

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I wonder if people are becoming generally more suggestible? :ph34r:

Actually, that is the wrong way to look at it. Geneticists and Quantum Theorists are actually coming together and are beginning to understand the power of the Human Mind & Body to heal itself.

If you read the latest research into this area there are some truly startling things going on regarding injuries and illness and the Human Mind's ability to overcome them.

What is rubbished today may well become common knowledge tomorrow.

I suggest you look up research into metaphysics, DNA, genetics and quantum theory.

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I wonder if people are becoming generally more suggestible? :ph34r:

I think more people are 'aware' of these drugs and their effects. Anti-depressants feature heavily in American TV shows and films and are often pushed as being somehow normal and acceptable.

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really placebo versus drugs test should add a third patient group where no drug and no placebo is given- i.e. the patient is given nothing at all, as it is quite possible that time is what is healling patients in both placebo and drugs cases- someone once said that the job of a doctor is to keep the patient ammused while the disease heals themselves - not sure who that was but I have a feeling it may have been voltaire?

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Actually, that is the wrong way to look at it. Geneticists and Quantum Theorists are actually coming together and are beginning to understand the power of the Human Mind & Body to heal itself.

If you read the latest research into this area there are some truly startling things going on regarding injuries and illness and the Human Mind's ability to overcome them.

What is rubbished today may well become common knowledge tomorrow.

I suggest you look up research into metaphysics, DNA, genetics and quantum theory.

Suggestibility means simply that there is correlation between external suggestion (for example that the placebo is effective) and subsequent manifest confirmation of the suggestion. Like many other psychological attributions, it is essentially a statistical phenomenon, currently lacking a scientific causal explanation.

Why and how that correlation occurs entails a deeper level of analysis, looking inside the black box of the mind/body interface if you like, and the research areas that you mention are of course highly relevant.

Our comments are quite compatible, neither is "wrong", they simply address different layers of the same complex phenomenon.

I thank you for your well-intentioned guidance towards the deeper investigations, in return I suggest you look up a couple of good books on critical thinking and the philosophy of science.

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really placebo versus drugs test should add a third patient group where no drug and no placebo is given- i.e. the patient is given nothing at all, as it is quite possible that time is what is healling patients in both placebo and drugs cases- someone once said that the job of a doctor is to keep the patient ammused while the disease heals themselves - not sure who that was but I have a feeling it may have been voltaire?

There should be a fourth group who are just given a hug and some encouraging words.

Think this may be the most effective remedy of all......

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There should be a fourth group who are just given a hug and some encouraging words.

Think this may be the most effective remedy of all......

Oddly enough, at the above mentioned talk I was at the other night the speaker talked at length about the positive chemical changes that go on in the brain and body when people hug or are hugged.

Scientists now know that a hug stimulates creation of oxytocin - the love hormone - in the brain and that this then sweeps throughout the body. Latest research is that oxytocin is hugely beneficial to human health.

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In the original report most of the drugs mentioned were for psychiatric diseases that don't have a physical test to diagnose them or a physical test to determine if the subject is actually cured.

It may be that the subjects chosen for the trials of the new drugs had fluctuating symptoms or that the tool used to determine if the drugs were effective were flawed.

How does one test a new drug for a psych illness that isn't backed up by a physical test? They would have used a symptom inventory or similar.

My guess would be that for these psychiatric diseases, better tests are needed to determine if a drug was effective. Until there are physical test that show the reason for the psychiatric disease (i.e physical meaures) then this problem may often occur.

For depression serotonin levels were touted and then became controversial. Parkinson's disease is also argued about.

I doubt if the "placebo" effect has much of a bearing here. Could be wrong though but there isn't enough data to determine that.

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