Viagra for Women Will Take Up to Three Years To Arrive in Mexico
Published in El Universal
(Mexico) on 20 August 2015
by Carlos Loret de Mola (link to original)
(Mexico) on 20 August 2015
by Carlos Loret de Mola (link to original)
Translated from
by Cydney Seigerman.
Edited by Danielle Tezcan.
The United States announced what seemed like one of those fundamental changes in the well-being of the population: a pill to increase sexual desire in women.
It's called Addyi. It was immediately nicknamed pink Viagra and female Viagra, alluding to the legendary blue pill for men who, for years, have been winning the war against erectile dysfunction.
However, it seems like there are many differences between the two "Viagras," and that the nickname is unfair.
The male version emerged from the research of the well-known pharmaceutical giant, Pfizer. The female version was initially developed by Boehringer, but after the pill's early failure (it was rejected twice for marginal effectiveness), the company sold the product to Sprout Labs, who were famous for making miracle products.
The male version had a superior initial effectiveness, reaching about 90 percent. The female version only managed to increase sexual desire to have one additional sexual relation a month, on average, in the 2400 women who tried the pill as part of the study.
Why, then, was Addyi approved by the prestigious U.S. Food and Drug Administration, which leads the way worldwide concerning what medicines can be sold and which ones cannot?
An extraordinary journalistic piece titled "F.D.A. Approves Addyi, a Libido Pill for Women" by Andre Pollack in The New York Times details that it seems like political factors have more to do with the release of the pink Viagra into the market than medical factors did.
Pollack explains that Sprout Labs used more of a political strategy than a scientific one. Sprout convinced various women's organizations to return to the gender debate: Why don't women have the right to their Viagra when men do? The pressure of political correctness seems to have been effective.
Specialists in the sector believe that the approval by the FDA was unusual, to the extent that the FDA put a series of restrictive measures on the use of the drug. It is recommended for women who have not reached menopause, have a prescription and are enrolled in a monitoring program.
Yesterday, I interviewed Mikel Arriola, the head of COFEPRIS, on Radio Fórmula. COFEPRIS is like the FDA for Mexico and has the authority to decide when to start selling this singular pill that promises to increase the female libido.
Arriola calculates that COFEPRIS will delay the arrival of pink Viagra to Mexico for two or three years, at best, and only if it meets certain requirements:
The first requirement is that a study is done with thousands of Mexican women in order to know how they will react to the pill.
The second is that information is gathered from the United States in order to know the pill's effect on American women, who already have access to the drug, and in order to evaluate the risk level in an open population compared in a study.
And the third requirement is that a group of Mexican experts is brought together to give the pill its guarantee and approval.
It's called Addyi. It was immediately nicknamed pink Viagra and female Viagra, alluding to the legendary blue pill for men who, for years, have been winning the war against erectile dysfunction.
However, it seems like there are many differences between the two "Viagras," and that the nickname is unfair.
The male version emerged from the research of the well-known pharmaceutical giant, Pfizer. The female version was initially developed by Boehringer, but after the pill's early failure (it was rejected twice for marginal effectiveness), the company sold the product to Sprout Labs, who were famous for making miracle products.
The male version had a superior initial effectiveness, reaching about 90 percent. The female version only managed to increase sexual desire to have one additional sexual relation a month, on average, in the 2400 women who tried the pill as part of the study.
Why, then, was Addyi approved by the prestigious U.S. Food and Drug Administration, which leads the way worldwide concerning what medicines can be sold and which ones cannot?
An extraordinary journalistic piece titled "F.D.A. Approves Addyi, a Libido Pill for Women" by Andre Pollack in The New York Times details that it seems like political factors have more to do with the release of the pink Viagra into the market than medical factors did.
Pollack explains that Sprout Labs used more of a political strategy than a scientific one. Sprout convinced various women's organizations to return to the gender debate: Why don't women have the right to their Viagra when men do? The pressure of political correctness seems to have been effective.
Specialists in the sector believe that the approval by the FDA was unusual, to the extent that the FDA put a series of restrictive measures on the use of the drug. It is recommended for women who have not reached menopause, have a prescription and are enrolled in a monitoring program.
Yesterday, I interviewed Mikel Arriola, the head of COFEPRIS, on Radio Fórmula. COFEPRIS is like the FDA for Mexico and has the authority to decide when to start selling this singular pill that promises to increase the female libido.
Arriola calculates that COFEPRIS will delay the arrival of pink Viagra to Mexico for two or three years, at best, and only if it meets certain requirements:
The first requirement is that a study is done with thousands of Mexican women in order to know how they will react to the pill.
The second is that information is gathered from the United States in order to know the pill's effect on American women, who already have access to the drug, and in order to evaluate the risk level in an open population compared in a study.
And the third requirement is that a group of Mexican experts is brought together to give the pill its guarantee and approval.
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