How Are New Drugs Approved?
- Author John Scott
- Published July 30, 2009
- Word count 544
Once a pharmaceutical company has a potential product, it has to go through a series of clinical trials that are designed to prove the drug does what it’s supposed to do safely. Armed with that evidence, the pharmaceutical company heads for the FDA and argues the case for approval. If the FDA agrees, the drug is licensed for the given purpose. Once released into the wild, doctors report back if there are adverse side effects and the pharmaceutical company decides whether the drug has any other possible uses. In this, the medical profession has a key role because although the FDA only gives approval for a narrow use, doctors can and do prescribe drugs "off-label", i.e. for quite different purposes, if they think the drug may have some other benefit for the patients. This leads to a grey area of medical practice where drugs are used without any government supervision or authority. But it is an important testing ground for new ideas.
In May 2009, the FDA gave its approval for a new use of tadalafil, the generic name for the 36-hour wonder drug. It always has had great potential because it achieves its effect as a treatment for erectile dysfunction by dilating the arteries leading into the penis. The system of blood vessels passes throughout the body and, if not properly dilated can cause difficulties anywhere. One such difficulty is called pulmonary arterial hypertension (PAH), a relatively uncommon condition that causes high blood pressure in the lungs. The pharmaceutical company, Eli Lilly, confirmed its effectiveness in treating PAH in a second set of clinical trials. Those participating in the randomized, double-blind trial were allocated tadalafil and a placebo. Over a period of sixteen weeks, they were encouraged to attempt exercise. At the end of the four month period, all were challenged to walk for six minutes. Those using tadalafil were able to walk an average of thirty-three meters further than those on a placebo. There was also clear evidence that the general physical condition of the participants had improved during the trial although a few suffered from the usual side effects of nasal congestion, nausea and headaches. These effects were relatively mild and passed quite quickly as participants built up tolerance.
In its form as cialis, the same side effects can affect a very small percentage of the men and those few consider the occasional headache a small price to pay for restoration of their sexual activity. Staying with the spirit of experimentation, there are also ongoing trial to determine whether the use of tadalafil gives an unfair advantage to top class athletes. There is strong evidence that the dilation of arteries not only improves the flow of blood around the body, but also increases the carriage of oxygen to the muscles. An increasing number of players who go through a drug testing regime have shown up positive for this drug. The trials are due to report later this year on whether the drug gives an unfair advantage and should be banned. Ironically, the idea that cialis turns all men in sexual athletes is great marketing copy and may, in part, be responsible for the surge in sales that has made cialis the top selling brand in many markets around the world.
With over 10 years working as a professional journalist John Scott has contributed many interesting materials to [http://www.36hour-strong.com/articles/how-are-new-drugs-approved.html](http://www.36hour-strong.com/articles/how-are-new-drugs-approved.html) that many users around the globe regard as a benchmark for professional writing.
Article source: https://articlebiz.comRate article
Article comments
There are no posted comments.
Related articles
- UNPACKING THE HIDDEN EFFRECTS OF SEXUAL MEMORIES ON MENTAL HEALTH
- Invisible After 40: The Erasure of Queer Women in Mainstream Media
- Advancing Sexual and Reproductive Health and Rights: A Crucial Global Imperative
- Discover Sexual Health Products for erection, volume, ejaculation, and satisfaction
- How AI Has Revolutionized the Adult Industry
- AmputeeAmber: Shattering Stereotypes and Redefining Beauty in the Online Sex Work Industry
- Unveiling the Technology Behind Adult Toys: Innovation Meets Pleasure
- The Effects of Cam Sex on Human Erotic Interaction
- Overcoming the Causes of Not Too Hard Erections
- How does a Christian learn how to no longer be in subjection to the cravings and desires of their flesh?
- Will We Ever Stop Fighting Over God, Sex, and Kids?
- Something about a homosexual in Bangladesh
- Understanding the relationship between structural violence and the lives of Black lesbians
- Masturbation Benefits - What are the benefits of masturbation?
- THE INTOLERANCE OF MALAYSIAN GOVERNMENT ON LGBT COMMUNITY: RIGHT OR WRONG?
- Tips for Satisfying Couples To Reach Peak Orgasm
- LGBT Statistics: How many people are gay, lesbian, bisexual and transgender?
- Why is N.O. So Important for Erection Quality (EQ) and Sexual Performance?
- Do You Really Know About Bisexuality? – Break the Rumors
- 5 Ways For Men to Improve Sexual Performance
- The Benefits of Having Sex More Often
- How to Keep Your Sex Life Healthy?
- Sexless Marriage Reasons and Remedies
- Sexuality of Violence and Other Human Predations – Part 2
- 5 Simple and Successful Methods to Overcome Erectile Dysfunction
- Sex love and hard times
- https://articlebiz.com/submitArticle
- Discover How Losing Weight Helps Improve Your Sex Life
- Here’s why you need to get a tantric massage
- Exercises that Stimulate Libido and Boost Sex Drive