FDA Approved Pre-Exposure Prophylaxis Pills for HIV

As a retired FDA chemistry team leader formerly involved in the development of new drugs, any news on new therapies about ant-infective and HIV drugs excite me to the fullest. I have a feeling though that patient's compliance to this new drug will be very, very low. As a new drug it will be expensive, so unless medical insurance covers at least 80% of the cost, Truvada will probably not be a best seller. The news on Truvada as a Pre-Exposure Prophylaxis (PREP) pills for HIV was published recently in USA Today as follows:

Truvada drug trials signal 'turning point' in AIDS epidemic By Liz Szabo, A trio of new studies highlights the promise and challenges of preventing the spread of HIV, the virus that causes AIDS: Giving anti-AIDS drugs to healthy but high-risk patients can dramatically reduce the risk of infection.

Two studies from Africa in heterosexual patients found that the drugs reduced the rate of HIV infection by 62% to 75%, a success rate that's comparable to results from studies of gay men, according to research in today's New England Journal of Medicine.

A third study in African women at high risk of infection, however, was ended early after researchers saw the drugs had no effect on HIV rates, largely because fewer than 40% of study participants took their pills as instructed. Overall, though, the results bolster the notion of giving anti-AIDS drugs to healthy but high-risk people before they're exposed to HIV, says Myron Cohen, a professor at the University of North Carolina-Chapel Hill and co-author of an accompanying editorial.

The strategy, known as PREP, or pre-exposure prophylaxis, is one of several powerful new tools in preventing HIV infection, he says. An advisory panel to the Food and Drug Administration in May recommended approving the drug used in the studies, sold commercially as Truvada, for prevention. Truvada, which combines the drugs tenofovir and emtricitabine, is already approved to treat the disease. In two of the studies, patients were randomly assigned to take either a placebo or Truvada.

In the third study, patients were randomly assigned to take either a placebo, Truvada or tenofovir. In that study, both tenofovir and Truvada worked about equally well. "We're at some sort of turning point in the AIDS epidemic," says Cohen, who will speak later this month at AIDS 2012, an international conference in Washington, D.C., focusing on science and policy. "It's not a single thing going on. It's the culmination of what's happened for 30 years. Each of them is moving the political world to start thinking about an AIDS-free generation." About 34 million people have HIV/AIDS, including 1.1 million in the USA, according to the Centers for Disease Control and Prevention. About 50,000 Americans are newly infected with HIV each year.

A key challenge to using these drugs will be finding ways to motivate patients to take them properly, Cohen says. Researchers should find out, for example, whether women stopped taking the pills because of side effects or simply underestimated their risk of getting HIV. In the study of African women, about 3% of women became infected with HIV during the study, whether they took placebos or active drugs. Using pills to prevent HIV is itself controversial.

On one hand, the pills could help protect the healthy partners of HIV-positive patients, says Anthony Fauci of the National Institutes of Health. The pills could give people a way to protect themselves, even when their partners refuse to use condoms, a common problem in some countries. But doctors have to be careful to test patients for HIV before prescribing Truvada. If someone already has HIV and doesn't take the pills faithfully, that person could develop and spread a resistant form of the AIDS virus, Cohen says.

Even AIDS activists are divided on the issue, says Guido Silvestri, a professor at the Emory University School of Medicine. Some argue that the pills should be given to everyone at risk of HIV, especially those with high-risk lifestyles. Others worry that the pills could give people a false sense of security and lead them to stop using condoms, which reduce the risk not only of AIDS but of other sexually transmitted infections and pregnancy, Silvestri says.

Figure Skating Gala, Winter Olympics, 2010

Figure Skating is one of my favorite winter sports. In 2010 the Winter Olympic games was held in Vancouver, Canada. At that time, my wife and I had been traveling, so we were not able to see most of the scheduled events in television. When I saw this video in You Tube the other day, I was so delighted, I have to share it with you.

The US won gold in the men's single ( Evan Lysacek), and silver in ice dancing. In the women's single, the US highest representative was ranked fourth and in the Pairs Event, the US highest pair was only in 10th place. But if you enjoy figure skating, this video is a must. It is good way to spend time indoors, to stay away from the over 100 degrees Fahrenheit temperature engulfing us now here in Northern California.



Event Men's singles Evan Lysacek (Gold) United States (USA) Evgeni Plushenko( Silver)Russia (RUS) Daisuke Takahashi ( Bronze)Japan (JPN)

Women's singles Kim Yu-Na (Gold) South Korea (KOR) Mao Asada( Silver)Japan (JPN) Joannie Rochette( Bronze) Canada (CAN)

Pairs Gold(China) Shen Xue Zhao Hongbo

Silver (China) Pang Qing Tong Jian

Bronze *Germany Aliona Savchenko Robin Szolkowy

Ice dancing: Canada (CAN)(Gold) Tessa Virtue Scott Moir

Meryl Davis (US) (Silver) Charlie White

Oksana Domnina (Russia)( Bronze) Maxim Shabalin

One of the most entertaining number was from the Russian Pairs representatives(4th place).

FDA Approves First Ever HIV Home Test

Last week, the FDA approved OraQuick, the first ever fully-private, over-the-counter HIV test. The test, which relies on a mouth swab and delivers results in 20-40 minutes, should be available in some 30,000 stores by October, according to an executive at OraSure, the company that manufactures OraQuick.

The widespread availability of such a test is obviously great news. The Times notes that the chances of an HIV-positive person spreading the disease is up to 96% lower if they're on anti-viral medication, and, according to the Center for Disease Control and Prevention, 20 percent of the 1.2 million Americans infected with HIV don't know they have it, with some 50,000 new infections occur each year. OraSure will also host a "24-hour question line, and advertise to high-risk groups, including gay men, blacks and Hispanics."

Dr. Anthony S. Fauci, the longtime AIDS researcher and director of the National Institute of Allergy and Infectious Diseases, called the new test a "positive step forward" and one that could help bring the 30-year-old epidemic under control.

Dr. Robert Gallo, who headed the National Institutes of Health lab that developed the first American blood test for the virus in 1984, called the F.D.A. approval "wonderful because it will get more people into care."

The test is not perfect. Due in some part to user error, it's 99.98% accurate when the user does not have HIV but only 92% accurate when it comes to positive tests. As the Times points out commenter Brinmat corrected, "only about one person in 5,000 would get a false negative positive test" while "about one person in 12 could get a false positive negative." The FDA noted that any positive test should be followed-up with a test at a doctor's office.

And, of course, there's some trifling bullshit about age restrictions. The FDA only approved use those 17 and older, so anyone youngish looking will probably have to show ID, which puts a damper on some of the privacy benefits and might scare off teenagers. Still, though, OraQuick is major progress.

The Illusionist-A Dramatic Film

In the Victorian period, there is a famous illusionist named Eisenheim. During one of his acts, Eisenheim recognizes his young lover Dutches Von Teshcen. When they were young they were separated because Eisenheim was too poor for the Dutchess. During his show, Eisenheim calls for a volunteer and Sophie now the Dutchess accepts. Eisenheim recognizes her immediately however the same is not true for Sophie. Later, Eisenheim meets Sophie in a stagecoach telling her the truth about his identity. The Dutchess is thrilled, but is already engaged to the Emperor's son who unfortunately watched Eisenheim's show as well. br />
The emperor's son soon invites Eisenheim to perform at his palace where out of his spite of jealousy, Eisenheim starts a feud with the emperor's son. Later, Sophie and Eisenheim have an affair and suspecting of this, the emperor's son hired private investigator Uhl(who also saw the performance) to keep an eye on Eisenheim. Sophie soon confesses to the emperor's son that she was in love with Eisenheim and that she is leaving him. The emperor's son was both filled with rage, and drunk. In his drunkeness, he chased Sophie down an alley, where Sophie was seen riding her horse lying down. The next morning, Sophie's horse is found with a huge spot of blood on its neck, and no Sophie, a search party goes on comprised of Blood Hounds, Uhl, Eisenheim some detectives, and ultimately, the emperor's son.

Sophie is found dead with a stab wound to her neck, and a small red gem on her presence. Eisenheim instantly tells Uhl that the emperor's son murdered Sophie because without a bride, he could not take the throne in his deceased father's place. Uhl and Eisenheim become close friends, but then, Eisenheim is fired by his manager due to a lack of money brought in by his performances. Eisenheim then buys a theater, where he starts his new act, of resurrecting spirits from the dead.

First, he brings up the entity of a young man called Frankel, followed by many others including, Sophie's. By the order of the emperors son, Uhl is to arrest Eisenheim if he continues these acts. Uhl warns Eisenheim who announces to a band of spectators that the spirits were an illusion, and apoligized for any false hope. During his next performance, Eisenheim brings back Sophie and the emperor's son in disguise sets forth the task on Uhl to arrest Eisenheim, his best friend. When Uhl pronounces Eisenheim's crimes to a whole auditorium of spectators, Eisenheim stands up, and vanishes into thin air, and Uhl sets out to look for him.

Disneyland Amusement Park in the Philippines?

A couple of months ago, there was news on the Internet that Representative Carmelo Lazatin of the First District of Pampanga had sent a letter of invitation to Disneyland CEO to build a Disneyland near the former Clark Air Force Base in Pampanga. The problem is that a 60% Filipino ownership is required for a foreign company to operate legally in the Philippines as mandated in the Philippine Constitution.

Since a Disneyland Park in Pampanga will be a huge economic boost to the country, I am suggesting that Congress either abolish or amend the Constitution on the 60% Filipino ownership requirement or passed a law to give an exemption to Disneyland. Here's the news from Manila Bulletin Online.

Manila Bulletin Online via Yahoo! News reports that Pampanga first district Representrative Carmelo “Tarzan” Lazatin has written The Walt Disney Company chairman and chief executive officer Robert Iger requesting him to consider Clark for their next Walt Disney park.

The solon said Clark’s 4,400 hectare main zone and 27,600-hectare subzone will be “the best place for a new Disneyland,” according to the report. In his letter dated April 11, 2012, Lazatin reportedly said:

“Aside from the huge space it provides, the Clark Freeport Zone can be an attractive destination for Disneyland theme park because of the tax-free privileges given to locators. The airport will be making it easier for tourists to enjoy the amenities and entertainment Disneyland is famous for without the hassles of long travels. Together with our population of more than 90 million Filipinos, a Disneyland theme park in the Philippines could be a major income generating site for your company.”

In Asia, Disneyland theme parks are situated in Hong Kong, Tokyo (Japan), and Shanghai (China)

Netizens were quick to react on the matter. One commenter posted that it is not possible for Disneyland to happen because of the forty percent foreign ownership limit under the 1987 Philippine Constitution, unless Congress will amend or abolish such policy.

What’s do you think of my suggestion?