What will be in the 2018?

August 27th, 2008

I am constantly amused by futurologists. This is, as the name suggests, the willingness of experts to predict what will happen in the future by applying probabilities and other scientific methods. Usually marketing uses their work too much. This April sees the publication of a new report by PharmiWeb (2002) Ltd. It sets out to predict which current or future products will be significant contributors to the market to treat sleep disorders over the next ten years - an ambitious timescale for anyone without a reliable crystal ball. This is actually a market in transition. In April last year, ambien lost its patent protection in the United States. Although a generic version sold under the name of zolpidem (tartrate) will be launched, Ambien is almost certain to maintain its brand dominance because the world market is predicted to grow. Indeed, the most recent data on the number of prescriptions for ambien continues a trend of upward demand. To understand the market, we need to factor in two other factor.

This fact point requires clarification. Never one to skimp, the medical profession has identified some eighty different sleep disorders. Such exuberance is extraordinary to describe a condition in which people cannot get to sleep or sleep for very long. On the basis of current medical research, it is estimated that some 200m people around the world may be affected by sleep disorders. If that is the case, pharmaceutical companies working in the sleep field have only just begun to scratch the surface of the total market. But, of course, that is only insomnia. When we get started on the other disorders, we include narcolepsy (involuntary sleep), sleep apnoea (brief periods when you stop breathing while asleep), bruxism (grinding your teeth while asleep), night terrors, and so on. As the public become more aware of the range of these disorders and of the existing and pending treatments, demand should continue to grow. For the insomnia market, the focus remains on the existing medications with the fewest side effects, i.e. the benzodiazepines and nonbenzodiazepine hypnotics such as ambien. But even that market is likely to continue growing because:

  • more countries are loosing their advertising rules to allow the direct marketing of prescription medications to the general public;
  • more pharmacies are coming online and they are likely to boost the market because no prescription is required; and
  • new technologies will allow new products to emerge.

As it stands, ambien is the brand to beat for insomnia. Which new medications will emerge to treat the other sleep disorders is difficult to predict.

What is cognitive behavioural therapy?

August 25th, 2008

One of the approaches is CBT. This is a broad-based method intended to allow anyone to change the way they behave. In the case of ED, it aims to build sexual comfort with your partner. This may be the first time you have tried to be intimate or you may wish to recapture the intimacy of your early relationship. Either way, the therapy focuses on improving your sexual skills and teaches you a number of different exercises to practice so that you can improve your general level of sexual performance. Once erections have begun to return, the use of Viagra, Cialis and Levitra will continue the trend.

The difficulty of achieving erections may be purely psychological or secondary to a physical cause. In the same words, the first resulting failures undermine confidence and produce a self-fulfilling prophecy, i.e. you become so afraid that your erection will fail that it does fail. You gain these problems when you’re trying to prolong sexual plesure. They are having so much pleasure, they want it to go on longer. To achieve this result, they have to reduce the level of arousal. When carried too far, the loss of arousal results in the loss of the erection. If this is not controlled, it can lead to the loss of erection occurring earlier and earlier until the man has difficulty in getting an erection at all and, through fear of embarrassment, begins to avoids sexual intimacy.

All this reasons lead to the statment, that clinical research shows that most men push for intercourse as soon as they get an erection. The point of this therapy is to teach you that you can enjoy sexual activity without having an erection. Pleasure continues and that pleasure is not conditional on rushing straight into intercourse and orgasm. If you and your partner know that intercourse is not allowed, you need not feel under so much pressure. You can experiment and find out what activities are most stimulating in co-operative sexual activity with your partner. Indeed, you will probably find intimacy more interesting if your partner is more actively involved. Listening and talking with her, learning about her needs should help you to see intercourse not as an end in itself but as part of a wider activity of generating mutual pleasure.

It is a fact that more men are prepared to come for sexual counselling than for any other kind of therapy. Yet many are actually resistant to change. They have a fixed criterion for measuring success, believing that they lack masculinity if their performance is not perfect. For these purposes, perfection is defined as a state achieved by a man without regard to his partner’s wishes or needs. If it was good for him, it must have been good for her. This means the counsellor has to get the man to understand that sex is about more than his penis. It should be about giving and sharing pleasure with the woman as an active partner. Rebuilding the idea of sexual intimacy overcomes the fixed performance criterion. So the counsellor addresses the anxieties, inhibitions, anger and guilt that may be blocking real emotional feelings, and aims to replace them with thoughts, images, sensations and fantasies that can underpin a successful sexual relationships. In this, both parties have to take responsibility for their sexuality and sexual needs.

Therapists are trained to deal with a wide range of problems including sex. They are very goal-oriented people and hence their attempts almost always lead to the good results. Once you have been started on the track to learn better sexual habits, you can begin to take Viagra, Cialis or Levitra as a reinforcement to maintain progress. But, in this, you should take the advice of your therapist.

The Mayo Clinic on weight.

August 14th, 2008

The bad news on obesity in the United States continues to roll in with about one third of adult Americans now considered obese. Against this continuous drip feed of research data showing the scale of the emerging medical crisis, it is all the more strange that the Food and Drug Administration continues to resist approving medications such as Acomplia. It would be easy to understand this reluctance if there were already three or four major medications on the market that would help to combat the epidemic spread of obesity. But this is not the case.

Acomplia would substantially add to the campaign to prevent or reduce the incidence of obesity. If this were to happen, the numbers of people suffering high blood pressure, diabetes and heart disease would be significantly reduced in the population at large. In turn, there would be less pressure to build new hospitals, staff them and equip them with the equipment and medications to treat all these conditions. This would save vast amounts of money both in insurance payments and public expenditure.

So what is the latest news? New research from the Mayo Clinic shows that more than half of American adults considered be within the normal range of BMI, i.e. between 18 and 24, actually have high body fat percentages - more than 20% for men and 30% for women. Thin people also had symptoms suggesting emerging metabolic problems and heart disorders. It is therefore clear that simply having a low body weight does not reduce the risks of heart disease or type 2 diabetes if your cholesterol levels are high. Body weight is not as good a guide to risk as lipid levels, i.e. even though thin, you can still have excessive fat. The BMI is a crude measure because it does not distinguish between body fat and lean muscle.

Given that the findings from the clinical trials show Acomplia as not only effective in reducing body weight, but also in improving the level of lipids in the blood (particularly helpful among those who already have diabetes), this latest data from the Mayo Clinic puts the decision of the FDA into more stark terms. Sanofi-Aventis will be referring Acomplia back to the FDA within the year. It will be interesting to see what its reaction is this time around.

Then, somewhat inappropriately on April Fool’s Day, the Mayo Clinic also announced that researchers have been carefully studying the stools of children up to the age of seven years. This is part of a more wide-ranging project using both animal testing and human subjects to study bacteria called gut microbiota which live in our intestines and help to regulate body weight by extracting calories from what we eat and storing them for later use. Thin children do not have the same bacteria in their stools as overweight children. Similarly, laboratory mice which lack gut microbiota are always thinner than mice that have these bacteria. The researchers therefore speculate that changing the population size of these bacteria in your gut could be the key to changing your body weight “naturally”.

This is a fascinating new avenue for researchers to explore and a very different approach than that taken by Acomplia which works on the cannabinoid system in the brain. The only reason we are not cheering from the announcement of this proposed treatment is the time taken to work through the process to develop a medication. It must adjust only the levels of these bacteria. There must be several more years of clinical trials to establish safety in human participants. And that just leaves the highly politicised FDA approval system still to negotiate.

In the meantime, the United States is left to fight an emerging obesity crisis without the benefit of medications like Acomplia which has been used successfully in Europe in combination with reduced calorie diets and physical exercise to reduce body weight and maintain that reduction for a year and more. Just makes me glad to be a European. Wait though, anyone can buy Acomplia online wherever they live. Must be a moral in that somewhere.