Archive for July, 2010

Once on a Roll, the Fda Continues Its Action Against Generics

Having hit the jackpot with Ranbaxy, the lobbyists for Big Pharma have continued their pressure on the FDA to shut down more of the competition against their drugs. When the original manufacturers are not able to find a way to extend the patent protection, their only way of defending their profit margins is to undermine the credibility of the generic imports. The usual lines of attack always focus on patient safety. All action taken is to ensure that lives are not put at risk by imports from “foreign” countries. As with another article on this site, I emphasise this does not affect you when you buy generic viagra online. There is no action taken or threatened by the FDA to affect the import of this vital, safe and effective drug into the US. In this case, the FDA has picked on another Indian generic manufacturer, Sun Pharmaceutical Industries Ltd. However, this time the problem has been identified in quality checks at a manufacturing plant in Detroit owned and operated by Sun Pharma. To give you an idea of the scale of this company’s operations, it currently holds FDA licenses to import 96 drugs into the US. It is a major player and its activities significantly affect the profitability of the local companies. Politically, the local manufacturers benefit every time the FDA can be persuaded to take action against a generic manufacturer. It adds credibility to their general propaganda that generics are unsafe. But, as with Ranbaxy, the FDA cannot be persuaded to say that Sun Pharma’s drugs are in any way unsafe. There is no order that they be withdrawn from the market or stopped from entering the US (or, in the case of the Detroit factory, leaving that factory). Supplies are uninterrupted. But yet another seed of doubt has been planted in the public’s mind. At a time when the US has been building better ties with India, it is odd to see the FDA engaging in such obvious protectionism with two major manufacturers from a single country as its target. Nevertheless, the damage is done to the individual companies’ reputations and to their stock value. They are being punished for being too successful in competing with US business. Fortunately, none of this has affected the manufacture or supply of generic viagra which continues to be a cheap alternative to the branded equivalents. It will require a more brave head of the FDA to challenge the supply of viagra.

Age is No Barrier When the Product Delivers the Goods

One of the more interesting questions for any pharmaceutical company is how to market their drug. In theory, it’s the easiest thing in the world to do. You have this great tablet. When people take it, the terrible disorder or disease is cured. All you have to do is tell everyone who might get this disorder or disease, and they will flock to buy these tablets when they get sick. Except not everyone thinks the same way. Let’s say you come up with this really great drug that works on the nitric oxide in the body. People who research plants, fruit and vegetables get interested because nitric oxide extends the life of cut flowers and the shelf-life of food in our stores. They discover that putting tiny amounts of this medication in the water for cut flowers gives a week and more of life before wilting sets in. Who would have thought it? Well, certainly not the medical researchers who designed the drug in the first place. Those of you reading this are, of course, way ahead of me. You all know that adding a pinch of the little blue pill to the water of your cut flowers wards off droop for up to a week. It’s not the cheapest way of keeping flowers fresh but, if it’s that important to you, the remedy is in your hands. So what has all this to do with this article’s theme? To answer that, we need to go back to the history of the viagra. The first application that came up for clinical testing was as a treatment for pulmonary arterial hypertension (PAH). The drug dilates arteries. If the main arteries in the chest and lungs are constricted, this limits the flow of oxygen around the body and bad things happen. When the side-effect of erections was noticed, the researchers put PAH on the back-burner and focussed on making money — an understandable decision that has paid the bills at Pfizer for the last ten years. But good ideas never go away. Now’s the time to meet Calvin Muteesa. This British boy has been taking viagra for 92% of this life. The daily dose is between four and six tablets. He started when he was three months old. He’s now thirty-three months old. The diagnosis of PAH was clear. His heart was struggling to pump the blood around his body. He could barely breathe. The effect of taking this “adult” drug was described by his parents as nothing short of miraculous. Within an hour, his blood pressure dropped and his breathing became more normal. Remember, the chemistry in the body works the same in arteries at strategic places all around the body. If a drug works to dilate the artery to relieve erectile dysfunction, it also works to relieve PAH. Quite what will happen to Calvin’s physical development is uncertain. Doctors will monitor him and adjust the dose if it seems necessary. So age is no barrier to the use of this drug. Viagra really does get the blood flowing where it should with all the desired results.

What Does the US Government Actually Say About Generics?

It is always pleasing to find a government agency with a specialized website. In this case, the FDA maintains a site devoted to generic drugs at http://www.fda.gov/cder/ogd/. There are over two-hundred-thirty staff whose task it is to ensure that the generic drugs approved are safe for consumers to use. Just to give you an idea of the scale of the operation, in 2004, there were 563 applications made to license the production of a generic drug. There were 880 applications made in 2007. In other words, a vast number of generic drugs come on to the market every year. They are in every way as safe and effective as the original branded version they now compete with. So generic viagra is identical to branded viagra except that it is cheaper. As a part of its function, the Office of Generic Drugs in the FDA monitors and researches the way in which the market works when generics enter. The supposed advantage is that any competition from a generic manufacturer will force the holder of the patent to drop its price. The consumer therefore benefits immediately. But its research shows that one generic manufacturer has very little effect on prices within the market. The FDA has a detailed analysis of the market from 1999 to 2004 and price is not significantly affected until a second generic manufacturer starts to sell into the market. The reason is simple. When the first generic competitor enters, even a small price reduction gives it a market edge. But when a second company appears, the two generic manufacturers compete with each other to set the price for a generic version of the original drug. The average result is half the original branded price. In fact, if you now look at the prices for generic viagra you will find it is often less than half the price of the branded version. The greater the quantity you buy, the better the price per tablet (plus the possibility of bonus tablets from some of the online pharmacies). This is a perfect working example of the research in action. It is also a perfect explanation for Big Pharma’s dislike of generic manufacturers. Once two generic manufacturers start competing with each other, the original manufacturer’s profit margin drops like a stone. It’s great for the consumer. Bad news for the stockholders.

Generics ? Still Controversial

The moment you use the word “generic” in the presence of someone employed by Big Pharma, there are reactions comparable to asking about contraceptives when visiting the Vatican. The reason is simple. The generic manufacturers are allowed to compete with the companies that went through the research and development phase after the patents have expired. All these “dangerous” companies need to do is to wait a few years and then copy all the original research. That means the product is bioequivalent and, under normal circumstances, the regulatory authorities in each country routinely licence the import of the copied drugs which are sold at a big discount. This affects the profits of Big Pharma. So, equally routinely, the lobbyists employed by Big Pharma discuss generic imports with their regulatory authorities, and sometimes those discussions lead to action. First, a word of reassurance. The action I am about to discuss does not affect your ability to buy generic viagra online. Although some thirty drugs are affected, they are treatments for rather different conditions. The FDA has issued two Warning Letters to Ranbaxy Laboratories Ltd, one of the world’s largest manufacturers of generic drugs based in India. These letters assert that Ranbaxy has not maintained proper manufacturing standards in two of its plants. Following the warnings, there is also an Import Alert that allows US customs officials to detain the finished drugs as they enter the US. These Warning Letters are somewhat controversial. There is no suggestion that the thirty drugs named on the list and manufactured in the identified plants are unsafe. There is no product recall and no warning to patients not to continue taking the drugs they already hold. Further, there is no suggestion that the other plants where different drugs are produced are unsafe in any way. This is, at best, a technical violation by the manufacturer. But the effect on Ranbaxy’s reputation has been quite chilling and its share price has fallen. To repeat, this does not affect the generic Viagra manufactured by Ranbaxy. The politics of free trade are always complicated. When the interests of significant local industrial players are involved, there is always going to be a temptation to be protectionist. In this instance, the decision of the FDA looks suspect because it has not required a recall. By its own admission, there is nothing wrong with the generic drugs manufactured by Ranbaxy. They can be safely consumed by existing patients. But the FDA is nevertheless authorising customs to stop imports of new supplies. I suspect that if the FDA had tried to interfere with the import of generic viagra, there would have been am outcry. As it is, there has been little comment outside the financial press discussing the effect on share price.

Smoking may result in Impotence!

Smoking a pack of cigarettes per day can increase the risk of impotence by up to 40 per cent, it has been claimed.


Researchers surveying men in Australia concluded that erectile problems increase in direct proportion to the amount of cigarettes smoked.


Those smoking less than 20 cigarettes were still 24 per cent more likely than non-smokers to join the ten per cent of men who suffer from erectile dysfunction.


“The good news is that quitting smoking greatly reduces the risk of circulatory problems such as impotence,” said Deborah Arnott, director of the Action on Smoking and Health (Ash) charity.


“Young men who want to avoid the embarrassment and distress of impotence can help themselves by quitting smoking before such problems arise.”


Australia’s Study of Health and Relationships also found that cardiovascular disease and old age increased the risk of impotence, but, as Chris Millett from Imperial College London said, such causes “can feel distant”.


Mr Millett hopes to provide a wake-up call to the third of men aged 20-24 who smoke in the UK.


“By highlighting this link between smoking and erectile problems we may be able to motivate these men to quit,” he said.


Translating the 9.1 per cent impotence ration to the UK population suggests that over 700,000 British men aged between 30 and 50 may suffer some form of impotency.


The Department of Health recently launched a high profile publicity campaign with posters aimed at highlighting the effect smoking has on sexual performance.

Premature Ejaculation Cure Through Herbs

Every man in this world desires to love his beloved and express his love to her in the most different way. But there might occur some problem that stops you in achieving this wonderful feeling. In contrast to it, it may become the cause of constant tension in the relationship you have with her. She might feel unsatisfied with the love you give to her and desires more from you.

More then any other disease premature ejaculation is the biggest sexual problems males suffer from. Premature ejaculation is a serious issue worldwide with over 40 % of males suffering from this problem. Premature ejaculation can be defined as the inability to control the early ejaculation of sperm in the process of sexual intercourse. In more precise definition it can be defined as the condition in which a male is not able to make a women achieve her orgasm in more then half the sexual encounter he has with her.

The cause of premature ejaculation can be both physical and psychological. If we talk about today’s era this is more often caused due to physiological aspect than to the physical aspect. This is stated so as most of the work done in today’s world has become more and more inclined towards the application of or mind rather than the physical activities. This leads to stress and tensions that are regarded as on of the major cause of disturbances in our physiology as compared to anatomy.

But you might be surprsised to know that ayurveda, the worlds most ancient medical science has herbs that are every effective in treating various diseases like premature ejaculation to the most optimum level to make your love life happy and youthful.

Below are few ayurvedic herbs that are widely used not only in treating but also in curing premature ejaculation. These are :-

· Ashwagandha (winter cherry, withinia somnifera) – an herb popularly known as Indian ginseng is an herb that has been used since centuries to cure problems of male health and also to increase his vigor. Ashwagandha has been the herb of choice for treating any kind of deformity in the body and also is very effective in treating a diseased body. Ashwagandha is used both as rasayana (rejuvenator) and Vaajikarna (aphrodisiac agent). It not only increases the physical stamina but also helps in enhancing the sexual life. Ashwagandha is said to increase the libido and is very helpful in treating diseases like impotence, erectile dysfunction and premature ejaculation. It is so wonderful herb that Maharishi Charka has mentioned this herb in very first chapter of charka Samhita.

· Kavach beej (cowhage, Mucana pruriens) – it would be worth saying that Kavach beej are one of the best sex stimulant this world has. Kavach beej is popularly known as cowhage as it is found growing wild in Indian subcontinent and also in warmer countries like South America and Africa. Its properties make it as the best herb that helps in treating sexual problems. Kavach beej or Mucana pruriens is a part of almost every herbal Viagra available this time round the globe. It helps in treating premature ejaculation by increasing the stamina in males. It is also helpful in treating the problems of impotence. It is very beneficial in increasing and improving the sperm count. This also helps in enhancing the sexual vigor and ignites the desire to indulge in sexual affairs.

· Salab mishri (early purple orchid, orchis mascula) – salab mishri or saleb is widely used herb in ayurvedic medicine that deals in aphrodisiac purpose. It is one of the best herbs that has wonderful effect on our body. It not only increases the sexual stamina but also enhances the performance of the body. It increases the blood circulation to the penis and testes making it bigger and harder. It is a well known fact that harder the penis betters the performance. It will surely make your lady love to achieve the peck of your love intensity and it will also make you happy. Salab mishri or early purple orchid is also very helpful in increasing the sperm count and also improves the quality of the sperms. Salab mishri is a terrestrial plant that is highly recommended in sexual problem.

Difference Between Generic Medicines and Brand-name Medicines

There are many brands of prescription medicines on the market that are similar in every way, except price. This is because there are originator brands as well as generic brands of medicines. Medicines will often have more than one name:

• a generic name, which is the active ingredient of the medicine

• a brand name, which is the trade

name the manufacturer gives to the medicine.

The generic name is the official medical name for the active ingredient of the medicine. The brand name is chosen by the manufacturer, usually on the basis that it can be recognised, pronounced and remembered by health professionals and members of the public. An example would be Viagra – this is the well-known brand name given by Pfizer to the generic medicine sildenafil. (Brand names are capitalised; generic names are not.) About 10-12 years after a new medicine is introduced, the patent (exclusive rights) runs out, and then other drug manufacturers are allowed to produce it. These are often cheaper than the original brand, and may be sold under the generic name or new brand names.

A generic medicine is typically 20% to 80% less expensive than the brand-name original. In addition, the availability of lower-priced generic medicines brings down the price of originator drugs through market competition, producing even further savings to patients. The use of generic medicines saves European patients and healthcare systems an estimated _13 billion each year and also plays an important role in the developing world by providing cheaper treatments to many millions of people. Allowing effective competition between generic medicines and patent-expired original brands is crucial to lowering pharmaceutical costs and stimulating innovation. However, this said, there are many troubling issues surrounding generic medicines due to the easy access to an abundance of illegal generics on the internet breaking the patent ownership and the unregulated companies that produce and supply them.

While generic medicines should be approved equivalent versions of trusted medicines, providing the same quality, safety and efficacy as the original, this is often not the case. A generic drug should undergo strict scrutiny before it is licensed and given market approval by national medicines authorities. In short, generic medicines should comply with the same strict standards of quality, safety and efficacy as original pharmaceutical products. The lucrative business of selling generic drugs such as Viagra on the internet has led to the establishment of many small backyard operations in developing countries, operating with low overhead and labour costs and no regulatory oversight.. Where there is currently one western company “Pfizer” making the original, branded Viagra, there are literally over a hundred companies making generic versions The lack of an independent monitory organization means that there is a high probability that the treatment will not work or could even prove detrimental to one’s health.

This information has been brought to you by Firstmed.co.uk, an online clinic specializing in men’s health matters, including impotence treatment . If you wish to discuss any of the above issues in more detail, do not hesitate to contact info@firstmed.co.uk or call +44 (0)870 199 5287

Impotence at the Tour De France

Professional cycling is chaotic and edgy, thrilling and petty, and often dysfunctional. With recent reports that the erectile dysfunction treatment, Viagra, may improve performance on the mountain stages, there may be yet another drug scandal poised to hit future races.

Running from Saturday July 7th to Sunday July 29th 2007, the Tour de France is made up of a prologue and 20 stages and covers a total distance of 3,550 kilometres. All over Europe, and indeed the world, people marvel at the dedication, endurance, athleticism and pain thresholds the riders displayed over the three weeks. However, the world of professional cycling is rife with drug scandals. A sad fact that has led many to doubt whether or not the physical feats they see in a bike race are real.

Doping has been a problem in cycling for a long time (it actually dates back to the early days of the last century when cocaine was used as a stimulant). Here are just some of the scandals that have hit headlines in recent years.

• The pre-race favorite to win this year’s Tour, Alexandre Vinokourov, was kicked out of the competition after testing positive for blood doping

• The race leader, Michael Rasmussen, was kicked out of the Tour de France by his Rabobank team, during the 2007 race.

• The winner of the 2006 Tour, Floyd Landis, tested positive for performance enhancers and is awaiting an arbitration decision on his case.

• The winner of the 1999-2005 Tours, Lance Armstrong, never tested positive but a recently published book nonetheless claims he took performance enhancers (an allegation Armstrong vehemently and litigiously denies).

• The winner of the 1998 Tour, Marco Pantani, is dead of a cocaine overdose.

• The winner of the 1997 Tour, Jan Ullrich, retired this year after being banned from last year’s race in the Operacion Puerto doping scandal.

• The winner of the 1996 Tour, Bjarne Riis, recently confessed that he won the race while on EPO and other performance enhancers.

In a strange twist there may be one more substance that officials will have to test for. New studies suggest that a dose of viagra will help more cyclists to climb that summit with more success.

The relationship between cycling and impotence has long been a dubious one. There is plenty of anecdotal and clinical evidence to suggest that cycling causes numbness and discomfort in the genital region, but whether or not that equates to long-term impotence is unknown. As there has been no qualified or scientifically acceptable studies carried out the jury’s still out on the subject. However, the relationship between impotence and cycling has taken on a somewhat ironic twist.

Following reports that Viagra may improve breathing in low oxygen situations, it seems that cyclists may opt to take erectile dysfunction treatments regardless of whether or not they suffer from ED in order to improve their performance.

Erectile Dysfunction medications work by dilating blood vessels, and this effect might be the reason for the improvements in athlete’s performance in high altitude settings. By the same method that the drug improves circulation to the penis it can also pump blood through the lungs more efficiently.

Considering the world of professional cycling has been dogged by dope scandals, whether or not this will add a new dimension to drug testing is as yet unknown.

There Was Something Important I Had to Tell You

I know it was important because I tied this knot. I always tie a knot when I need to remind myself to remember something. I know it has something to do with generic viagra but it’s not the obvious – that there is no difference between the generic and the branded viagra. They are bioequivalent. Everyone knows that. Even though the generic sometimes comes as a slightly different shade of blue (or not even blue at all), all pills for the treatment of erectile dysfunction supplied through reputable online pharmacies have the same effect. Wait, it’s starting to come back to me now. There is a difference. When you buy the branded tablet from your local drugstore, you are guaranteed to get the written set of directions approved by the FDA. When you buy through the internet, there may be instructions, but they need not contain all the information required by the FDA. Right. We’re on a roll now. Those wonderful scientist types working at the FDA have been getting all worried about Transient Global Amnesia (TGA). Now, here’s the thing. A tiny percentage of people who take viagra find they can’t remember everything that happens in the hours following. So you might take the tablet in the restaurant and wake up the next morning not being able to remember the drive home (or anything else for that matter). This could be dangerous to your health if you can’t remember what you said to your partner at a critical moment during the evening (or how your car came to have that bent fender). So, the next time you read all the small print in those helpful instructions (something you do all the time when you have nothing better to do), you’re going to see a new warning about TGA. It’s going to be very reassuring and the FDA will be right. Only a very small number of people who take viagra, whether branded or generic, will experience this forgetfulness. And quite what you’re supposed to remember to do when you find yourself forgetting is unclear. But, assuming you remember you forgot something, it’s called TGA and it’s nothing to worry about. Just remember to take a lower dosage tablet next time and all will be fine.

Buying Online Allows Some Men to Avoid Restrictions

Drug manufacturers routinely lobby governments and the result is that both tend to say the same kind of things. On the question of whether people should be allowed to buy drugs without a prescription, both raise the question of public safety. Most medications are powerful and, unless patients are checked out before use, there can be unfortunate side-effects or, in the worst cases, serious injury from the use of the drug. When asked to comment on the rise of online pharmacies that will sell drugs without a prescription, the public safety issue is repeated. It’s bad if people can evade the measures put in place to protect them. Worse, there’s no guarantee that the online pharmacy will supply the right drug. And, in fairness, it’s always a good idea for people to consult their local healthcare provider before using any drug, and people should only buy online from pharmacies that come highly recommended (as in those reached through this site). All of which brings me to a case that’s making headlines on the inside pages of newspapers in Brooklyn. We’re interested in the activities of Elvis Elano. The Christian name gives away his age with his birth coming at the height of the King’s fame. Anyway, this forty-something man has been carrying on an affair with a fifty-something woman. He was determined to ensure his performance was never less than perfect so he relied on the little blue bill. There was just one problem. He could not afford to have suspicious plain brown packages arriving at his home address. So his mistress was more than happy to co-operate, allowing him to use her address for delivery purposes. So far, this all looks like a routine case of adultery except that there’s one small fact omitted from the description that converts this into a rather different situation. Elvis is not married. He’s a sexually experienced man who routinely bought his viagra online, knowing that he sometimes had problems. But the nature and extent of Elvis’ problems have grown in dramatic ways. He’s a Catholic priest, now suspended from his work in the diocese and the Catholic hospital where he also acts as a counselor and confessor. He’s accused of being predatory. The woman was going through a divorce and was looking for spiritual guidance from the priest. It’s alleged he said their meeting was not an accident, that a relationship with him had been ordained by God. This potentially coercive seduction technique found a willing party and, for seven months, the viagra worked its magic. Now, the knives are out and multi-million dollars of damages are being claimed from the priest and the diocese for failing to supervise him. All of which brings us back to the point that, if he had been forced to go to his own physician to get a prescription for the viagra, questions would have been asked about the vow of celibacy. Because he could buy viagra online, he avoided one of the methods for detecting inappropriate use. Not quite what the pharmaceutical companies would have had in mind, but it does fit their public safety concerns.

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