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Pill for Aids

Healthy gay men who took an anti-AIDS pill every day were well protected against contracting H.I.V. in a study suggesting that a new weapon against the epidemic has emerged.

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Paul Sakuma/Associated Press

Truvada, a combination of antiretroviral drugs made by Gilead Sciences, costs around $13,000 a year in the United States.

Related

• An AIDS Advance, Hiding in the Open (November 28, 2010)

• U.N. Reports Decrease in New H.I.V. Infections (November 24, 2010)

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In the study, published Tuesday by theNew England Journal of Medicine, researchers found that the men taking Truvada, a common combination of two antiretroviral drugs, were 44 percent less likely to get infected with the virus that causes AIDS than an equal number taking a placebo.

But when only the men whose blood tests showed that they had taken their pill faithfully every day were considered, the pill was more than 90 percent effective, said Dr.Anthony S. Fauci, head of the infectious diseases division of the National Institutes of Health, which paid for the study along with the Bill and Melinda Gates Foundation.

“That’s huge,” Dr. Fauci said. “That says it all for me.”

The large study, nicknamed iPrEx, included nearly 2,500 men and was coordinated by the Gladstone Institutes of the University of California, San Francisco.

The results are the best news in the AIDS field in years, even better than this summer’s revelation that a vaginal microbicide protected 39 percent of all the women testing it and 54 percent of those who used it faithfully.

Also, Truvada, a combination of tenofovir and emtricitabine that prevents the virus from replicating, is available by prescription in many countries right now, while the microbicide gel is made in only small amounts for clinical trials.

The protection, known as pre-exposure prophylaxis, is also the first new form available to men, especially men who cannot use condoms because they sell sex, are in danger of prison rape, are under pressure from partners or lose their inhibitions when drunk or high.

It “does not involve getting permission from the other partner, and that’s important,” said Phill Wilson, president of the Black AIDS Institute, which focuses on the epidemic among blacks.

Michel Sidibé, the head of the United Nations agency that fights AIDS, called it “a breakthrough that will accelerate the prevention revolution.”

AIDS experts and the researchers issued several caveats about the study’s limitations, emphasizing that it looked only at gay men and Truvada. More studies, now under way, are needed to see whether the results can be duplicated, whether other antiretroviral drugs will work and whether they will protect heterosexual men and women, prostitutes and drug users who share needles.

There is no medical reason to think the pill would not work in other groups, since it attacks the virus in the blood, not in the vaginal wall as a microbicide does. Pre-exposure prophylaxis became possible only in recent years as newer, less-toxic antiretroviral drugs were developed.

Some scientists fear that putting more people on the drugs will speed the evolution of drug-resistant strains, though that did not occur in the study.

Because Truvada is available now, some clinicians already prescribe it for prophylaxis, Dr. Fauci said, but whether doing so becomes official policy will depend on discussions by theCenters for Disease Control and Prevention, the Food and Drug Administration, medical societies and others, which could take months.

Although the C.D.C. would prefer that doctors wait for further studies, more will probably prescribe the drugs now that this study is out, said Dr. Kevin Fenton, chief of the agency’s AIDS division, so the C.D.C. will soon release suggested guidelines.

The agency will suggest that the drug be prescribed only with close medical supervision and used only with other safe-sex practices.

“The results are encouraging, but it’s not time for gay men to throw away their condoms,” Dr. Fenton said.

AIDS advocacy groups were very excited by the results.

“If you comply with it, this works really well,” said Chris Collins, policy director of amfAR, the Foundation for AIDS Research. “This is too big to walk away from.”

Mitchell Warren, executive director of AVAC, an organization that lobbies for AIDS prevention, called the study “a great day for the fight against AIDS” and said gay men and others at risk needed to be consulted on the next steps.

In the study, 2,499 men in six countries — Brazil, Ecuador, Peru, South Africa, Thailand and the United States — were randomly assigned to take either Truvada or a placebo and were followed for up to three years. For ethical reasons, they were also given condoms, treatment for venereal diseases and advice on safe sex. There were 64 infections in the placebo group and 36 in the group that took Truvada, a 44 percent risk reduction.

Two in the Truvada group turned out to have been infected before the study began. When the remaining 34 were tested, only 3 had any drug in their blood — suggesting that the other 31 had not taken their pills.

Different regimens, like taking the pills not daily but only when sex is anticipated, also need testing.

Also, many men in the study failed to take all of their pills, and some clearly lied about it. For example, some who claimed to take them 50 percent or 90 percent of the time had little or no drug in their bloodstreams.

The pills caused no major side effects, though men who began to show signs of liver problems were taken off them quickly. Some men stopped taking the pills because they disliked relatively minor side effects like nausea and headaches. Also, some stopped bothering once they suspected that they might be taking a placebo.

“People have their own reasons,” Mr. Collins said. “People don’t take their Lipitor every day either.”

A major question now is who will pay for the drug.

In the United States, Truvada, made by Gilead Sciences, costs $12,000 to $14,000 a year. In very poor countries, generic versions cost as little as 40 cents a pill.

Globally, only about 5 million of the 33 million people infected with the AIDS virus are on antiretroviral drugs, and in an era of tight foreign-aid budgets, that number is not expected to rise quickly.

Hundreds of millions of Africans, Eastern Europeans and Asians are at risk and could benefit from prophylaxis, but that would cost tens of billions of dollars.

In this country, insurers and Medicare normally pay for the drugs, and the Ryan White Act covers the cost for the poor, but none of these payers yet have policies on supplying the drugs to healthy people.

No participant in the study developed resistance to tenofovir. Three were found to have strains resistant to emtricitabine, but investigators believe that all three were infected before the study began at levels low enough to have been missed by their first H.I.V. tests.

Another concern was that the participants would become so fearless that they would stop using condoms, but the opposite effect was seen — they used condoms more often and had fewer sex partners. But that can also be a result of simply being enrolled in a study and getting a steady diet of advice on safe sex and free condoms, the investigators said.

Other trials of pre-exposure prophylaxis have about 20,000 volunteers enrolled around the world. Their results are expected over the next two years.

A version of this article appeared in print on November 24, 2010, on 

keeping track,, IH

Pell Grant restored to Prisoners seeking education

Other exciting news that you may have heard is that
Julie Weiss told me that Sen. Sheldon Whitehouse of Rhode Island will
introduce legislation to repeal the Pell Grant ban on prisoners.
Finally, Jon Marc Taylor who wrote his doctoral thesis on Pell Grants
and prisoners told me in a phone conversation that two staffers from
Julie's group will visit him in prison to receive as much info as
possible about the issue. Charlie and Pauline

Back to School: A Guide to Continuing Your Education after Prison

Some inmates are able to pursue educational goals during a period of
incarceration, but few leave prison feeling that they have fully met
their educational needs. In the recent national Serious and Violent
Offender Program evaluation, 94% of adult male inmates interviewed as
they approached release identified education as a personal reentry
need. Inmates facing release from prison want to know how they can
either continue or begin to access adult education, post secondary
education, and/or occupationally specific education and training
programs. But there are some challenges in moving from knowing you
need it to knowing how to get it!

In 2008 the John Jay College of Criminal Justice Prisoner Reentry
Institute, with funding from the U.S. Department of Education,
developed a planning and information guide for inmates nearing
release. In 2010, the Department of Education updated the guide to
reflect the most recent information on federal student financial aid.
Back to School includes topics ranging from setting personal
educational goals and committing to a long term plan of educational
development, to knowing exactly where to go and what to ask for to
find, access, and pay for an educational program.

This 64 page document is in the public domain and can be downloaded
and reproduced from the web site of John Jay College at
(http://www.jjay.cuny.edu/BacktoSchoolSummer2010Revision.pdf ). Free
copies are available in limited quantities from the Department of
Education’s materials distribution center, EDPubs. (Visit EDPubs at
www.EDPubs.gov, call 1-877-4EDPUBS, or write to ED Pubs; P.O. Box
22207; Alexandria, VA 22304 and request item number ED005088P.)
 

Constitution Day September 2010

So you think you know the Constitution..lol

http://www.constitutionfacts.com/?page=quiz.cfm

“The Constitution, on this hypothesis, is a mere thing of wax in the hands of the Judiciary, which they may twist and shape into any form they please.”



— Thomas Jefferson
hmm TJ had his visionary glasses on that day

http://www.constitutionfacts.com/?section=constitution&page=readTheConstitution.cfm

and I QUOTE..
POWER FORBIDDEN TO CONGRESS


Section 9. [1] The Migration or Importation of such Persons as any of the States now existing shall think proper to admit, shall not be prohibited by the Congress prior to the Year one thousand eight hundred and eight, but a tax or duty may be imposed on such Importation, not exceeding ten dollars for each Person.



[2] The privilege of the Writ of Habeas Corpus shall not be suspended, unless when in Cases of Rebellion or Invasion the public Safety may require it.



[3] No Bill of Attainder or ex post facto Law shall be passed.



[4] No Capitation, or other direct, Tax shall be laid, unless in Proportion to the Census or Enumeration herein before directed to be taken. (Note: See the Sixteenth Amendment.)



[5] No Tax or Duty shall be laid on Articles exported from any State.



[6] No Preference shall be given by any Regulation of Commerce or Revenue to the Ports of one State over those of another: nor shall Vessels bound to, or from, one State, be obliged to enter, clear, or pay Duties in another.



[7] No Money shall be drawn from the Treasury, but in Consequence of Appropriations made by Law; and a regular Statement and Account of the Receipts and Expenditures of all public Money shall be published from time to time.



[8] No Title of Nobility shall be granted by the United States: And no Person holding any Office of Profit or Trust under them, shall, without the Consent of the Congress, accept of any present, Emolument, Office, or Title, of any kind whatever, from any King, Prince, or foreign State.

Section 10. [1] No State shall enter into any Treaty, Alliance, or Confederation; grant Letters of Marque and Reprisal; coin Money; emit Bills of Credit; make any Thing but gold and silver Coin a Tender in Payment of Debts; pass any Bill of Attainder, ex post facto Law, or Law impairing the Obligation of Contracts, or grant any Title of Nobility.



[2] No State shall, without the Consent of the Congress, lay any Imposts or Duties on Imports or Exports, except what may be absolutely necessary for executing its inspection Laws: and the net Produce of all Duties and Imposts, laid by any State on Imports or Exports, shall be for the Use of the Treasury of the United States; and all such Laws shall be subject to the Revision and Controul of the Congress.



[3] No State shall, without the Consent of Congress, lay any duty of Tonnage, keep Troops, or Ships of War in time of Peace, enter into any Agreement or Compact with another State, or with a foreign Power, or engage in War, unless actually invaded, or in such imminent Danger as will not admit of delay.

Monroe Doctrine Review by James Monroe

James Monroe's seventh annual message to Congress on December 2, 1823. The European powers, according to Monroe, were obligated to respect the Western Hemisphere as the United States' sphere of interest.



President James Monroe’s 1823 annual message to Congress contained the Monroe Doctrine, which warned European powers not to interfere in the affairs of the Western Hemisphere.


Understandably, the United States has always taken a particular interest in its closest neighbors – the nations of the Western Hemisphere. Equally understandably, expressions of this concern have not always been favorably regarded by other American nations.


The Monroe Doctrine is the best known U.S. policy toward the Western Hemisphere. Buried in a routine annual message delivered to Congress by President James Monroe in December 1823, the doctrine warns European nations that the United States would not tolerate further colonization or puppet monarchs. The doctrine was conceived to meet major concerns of the moment, but it soon became a watchword of U.S. policy in the Western Hemisphere.


The Monroe Doctrine was invoked in 1865 when the U.S. government exerted diplomatic and military pressure in support of the Mexican President Benito Juárez. This support enabled Juárez to lead a successful revolt against the Emperor Maximilian, who had been placed on the throne by the French government.






Almost 40 years later, in 1904, European creditors of a number of Latin American countries threatened armed intervention to collect debts. President Theodore Roosevelt promptly proclaimed the right of the United States to exercise an “international police power” to curb such “chronic wrongdoing.” As a result, U. S. Marines were sent into Santo Domingo in 1904, Nicaragua in 1911, and Haiti in 1915, ostensibly to keep the Europeans out. Other Latin American nations viewed these interventions with misgiving, and relations between the “great Colossus of the North” and its southern neighbors remained strained for many years.






In 1962, the Monroe Doctrine was invoked symbolically when the Soviet Union began to build missile-launching sites in Cuba. With the support of the Organization of American States, President John F. Kennedy threw a naval and air quarantine around the island. After several tense days, the Soviet Union agreed to withdraw the missiles and dismantle the sites. Subsequently, the United States dismantled several of its obsolete air and missile bases in Turkey.






(Information excerpted from Milestone Documents [Washington, DC: The National Archives and Records Administration, 1995] pp. 26–29.)




recently brought to my attention.. history fans..