Archive

Posts Tagged ‘Fda’

Jan
15

There’s something rather unfair about the very idea of an adverse side effect. You take a pill expecting it to cure your illness or disorder, and you suddenly discover you are allergic to it. Instead of instant happiness, you find major problems with your breathing, your skin may blister. Overall it can feel like a heart attack. Well, that’s the extreme version. The majority take drugs without anything adverse happening. Obviously, the FDA would not approve a drug if it produced health-threatening effects in any significant number of people. So don’t read this as one of those articles warning you of a dramatic loss of vision or an increased risk of suicide. We don’t go in for alarmism here. Nevertheless we do want to talk about those drugs were there’s evidence of an effect on sexual performance.

 

The best documented are the antidepressants. This is a difficult area of cause and effect. When men are depressed, they often feel less interested in sexual activity. If your libido drops, erectile dysfunction is one of the first consequences. The reason is a mind/body link. If you do not feel sexually stimulated by the situation, no erection appears. Many men also report erectile dysfunction when they take some of the standard antidepressants, but separating out the contribution of the drug as opposed to the loss of libido is difficult. In this case, the solution is not to add one of the three erectile dysfunction drugs to the mixture. If you are genuinely depressed, the new pill is not going to help you feel in the mood. You have to wait until your depression lifts. Then you can reduce the antidepressants and experiment with sex again.

 

The moral of this story is always to consult with your doctor if you are taking any drugs. It’s possible the erectile dysfunction is a side effect of the medication. If so, the doctor will either want to change the dosage or change you to a different drug. One of the big unanswered questions revolves around painkillers you take on a regular basis over long periods of time. Aspirin, for example, is useful in reducing the risk of heart attacks. Whenever you go into a home, the odds are you will find one of the over-the-counter painkillers or one of the anti-inflammatory drugs (NSAIDs). We all take these routinely if there’s a minor problem. A new report in the Journal of Urology suggests a risk to men who take a painkiller over long periods of time. Now let’s be clear. At present there’s no evidence any of the OTC painkillers or NSAIDs do cause erectile dysfunction. Some of the stronger opiate drugs have been linked to poor sexual performance. A lot more research is required.

 

Until this work is done, you should discuss your medication with your doctor. It may be that reducing the intake of painkillers may solve the problem. If not, you still need to check whether there will be a problem if you take Levitra given the underlying cause of the pain. This is not to suggest Levitra is in any way unsafe whether on its own or in combination with other drugs. But it always makes sense to ask for guidance before adding drugs together.

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Dec
21

The idea of a patent makes good commercial sense. You give an inventor a monopoly to sell the new product without anyone being allowed to copy it. So, as a consumer, you either pay the asking price or go without. With no competition, the inventor can keep the price high and earn back the R&D costs fast. Once into profit, there’s a bigger return on the money invested and, in turn, this encourages more investment in R&D. The more consistently creative and innovative the manufacturer, the more money it makes. Except, this is a way of gouging the consumer. Let’s say for argument’s sake that the manufacturer gets a ten year monopoly and, at the end of five years, it has recovered all its R&D costs. It now has five years in which it can continue to charge the same high prices without there being any competition in the market. So here’s the question? How much profit should an inventor be allowed to make?

At present, this is never discussed let alone defined in law. Manufacturers simply demand increasingly long period of protection without regard to the payback time. Let’s say the development of a particular drug was a lucky accident. The company was testing for one use but noticed the participants were discussing an interesting side effect. That’s how the erectile dysfunction drugs were discovered. No one was trying to develop this drug so the actual R&D costs after the accidental discovery were to cover a comprehensive clinical trial and the application to the FDA – a fraction of the usual costs. Yet a court has just given one of the manufacturers protection from a generic manufacturer until 2019. That’s twenty-three years of protection in total. No one can possibly suggest this is anything other than a decision to keep on gouging the consumers. To make a sexist point – this is a decision of Rebecca Beach Smith, a female judge who obviously doesn’t care that men are paying excessive prices to keep their sexual satisfaction levels high.

So was this an unusual case? Actually, this was a standard case of a manufacturer taking out a second patent on the same product some years after the first. Nothing like stretching out your gravy train. Except there was one interesting twist. The generic manufacturer waited until it arrived in court and then accused the attorneys representing the patent holder of “inequitable conduct”. To translate this into English, it accused the poor lawyers of being dishonest, deceitful and fraudulent. Strong accusations except it was too late to raise them. To investigate would require the patent case to be adjourned, possibly for months. The judge ruled this should have been raised long before the case came to trial.

This leaves the market for erectile dysfunction drugs without an immediate threat of a generic product competing for market share. So although only one manufacturer was involved, the other two manufacturers benefit. They have all agreed to keep their prices high. Only the internet offers any competition on price. The moral of this story is for you to buy Cialis online at the generic prices. That way, you get the full value of Cialis at the lowest possible price. You can feel good when sticking one in the eye of the patent system.

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Feb
17



Our nation is fat, on average the obesity levels of people in America is climbing each year but there could be come new diet pills on the way in 2010, 2011 or 2012. Some studies say that 2/3 of Americans are overweight, other say about half but what most can agree on is that our nation is out of control and at near “break scale” levels. People have always known about ways to reduce their weight with the basics like good diet and exercise but for most it is just not happening. The sedentary lifestyle combined with overeating is making our nation obese. But what doctors have argued about over recent years is if obesity is something to be classified as a disease. While some people could lose weight, there are also those that it just seems to be either far too difficult or near impossible. Yet the health of those who are not losing the weight is getting progressively worse.

Well there could be some new players in the never ending search for the ultimate diet pill. Contrave could be available in 2010 or early 2011. Empatic could be available in 2011 or sometime in 2012. These are specifically prescription diet pills that have been scientifically proven to help the obese. Two of such new drugs with the possibility of helping people lose weight are Empatic and Contrave. Each is being developed by Orexigen Therapeutics. Interestingly enough, each medication is actually a combination of other existing medications used for ailments other than weight loss. For Empatic the combinations are zonisamide and bupropion. Contrave is a combination of naltrexone and bupropion. Tests are showing remarkable weight loss and the benefit to risk ratio is looking rather favorable for each. In fact Contrave is expected to be submitted to the FDA as a drug to fight obesity in early 2010. If submitted, the FDA still needs to approve it but, so far things are falling into place for Contrave.

Empatic on the other hand it a little further behind in its research and development but the test results so far look promising. Some of the issues that could make the FDA reject them if submitted would be their side effects. All drugs have side effects on some level. If they are deemed to be too destructive then they will be discarded. Other issues would be if the FDA deemed them to be too ineffective, if they barely get the job done than there is not much of a reason that they would be passed. Without getting too technical, it is most likely that the passing or failing would fall on these two issues or a combination both.

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Oct
22

Promoted as the most potent authorized fat burners available, Phen375 is rapidly capturing a large number of happy customers. A significant claim if ever there was one still the observations and the fat loss figures speak on their own. Many consumers are saying about ten pounds of weight loss in the initial 2 weeks and over a interval of 6 weeks there are announcements of about 25 pounds burned by couple of individuals!

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The Phen375 evaluations suggest that you can have minor side effects say, enhance in the pulse rate on usage of this pill. Despite the fact side effects are restricted to few persons, one could take precautionary actions by taking Phen375 on a experiment basis to gain far more self assurance and check out the Phen375 evaluations to far more comprehend this supplement. Keep in mind that a nice balance within the dieting and the workout along with the intake of Phen375 will present you elevated bonuses.

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Mar
30

In the good old, bad old days before television, the world was a simpler place for parents. They could more easily control the flow of information to their children and, as a result, everyone grew up more innocent. Today, it’s almost impossible for parents to prevent their children from learning all about the world through the programs they watch and the adverts that appear every ten minutes. It can be quite a revelation for parents to watch some of the cartoon series offered to the young. There is a remarkably adult sensibility running through many of them, introducing some very sophisticated ideas about family relationships, life and death. But it’s the ads that offer the most comprehensive window into the contemporary world, particularly those marketing the range of modern drugs. If children are watching afternoon television, they can learn about the problems of insomnia and its cure, be reassured there are cures for cancers, and have the chance to ask parents what erectile dysfunction is.

The corporations that run television exist to make a profit. Given the importance of free speech in the US, it’s not for them to make judgements about the timing of adverts. That would be a form of censorship and that would never be permitted. So the pharmaceutical manufacturers hand over the money and run their ads. The sooner they establish brand awareness, the better their long-term chances of profitability. More importantly, they reinforce the message there is a drug to cure every major disease and disorder that plagues our age. If in doubt, take a pill. The government’s only gesture at regulation is to empower the FDA to monitor the content of ads. The aim is to ensure the descriptions of drugs is reasonably balanced. That’s why the majority of seconds in a forty-second slot is given over to a voice listing the adverse side effects that can affect those taking the drug. The images are enticing. The words can be chilling.

All this gives parents an interesting set of choices. There is no way they can prevent their children from watching tv. Trying to direct which programs they can watch is equally challenging. Indeed, denying access to some programs simply creates curiosity and invites the children to disobey. So, sooner rather than later, they can find themselves explaining what an erection is and why it might be distressing if “it” failed to function. At least the children can take away the reassurance that cialis in both forms represents a more or less guaranteed cure. The traditional form is taken as needed and has justified the nickname of the “weekend pill”. Unlike the competition, the effect of this drug lasts for thirty-six hours. But there is now a once-daily version. So long as the body retains a stable level of the drug in the blood stream, the man will be able to produce an erection on demand whenever the opportunity for sex presents itself. That’s why an increasing number of men around the world buy cialis and find erectile dysfunction stops being a problem. That’s why this drug is now the number 1 in many of the markets around the world.

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