Sunday, May 21, 2006

Fort Lauderdale and Miami Lectures in June


JUNE 6

6:00 PM

Free Dinner

Artserve Auditorium located at 1350 EAST SUNRISE BLVD. Fort Lauderdale (Broward County Library Building right next to the auto dealers & Holiday Park)

Topics:

How to qualify for a free wellness program in Ft Lauderdale,
Upcoming new HIV medications and Clinical Trials,
Exercise, body composition and HIV,
The effects of Alcohol and party drugs on HIV Meds
Latest on HIV Prevention


RSVP by emailing djjimmyp@aol.com

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JUNE 8

6 PM

Free dinner
Bellissimo Italian Restaurant. 1672 E Oakland Park Blvd. Ft.Lauderdale, Fl 33334 954-565-1042

TOPICS:

Emerging Drugs and Issues in HIV. How to best manage side effects. Latest lipodystrophy data.

RSVP by emailing jihme@careresource.org
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JUNE 7

MIAMI

6:00 p.m.
TEXAS de Brazil Restaurant
11401 NW 12 th St
Suite 514
Miami , Florida
RSVP to Raul Medina at (305) 585-5256.


Nelson Vergel will be the speaker for all lectures.

Wednesday, May 03, 2006

WallStreet Journal's article on Salvage Therapy


As AIDS Drugs Fail Thousands, 'Salvage' Is Key

By MARILYN CHASE
May 3, 2006; Page B1
http://online.wsj.com/article/SB114660908687541895.html


Steve Kovacev, a sinewy 52-year-old from Truro, Mass., has run the Boston Marathon and sailed in the Transpacific Yacht Race from Los Angeles to Honolulu. Neither event comes close to his current competition: a race for his life.

Mr. Kovacev has AIDS. He has used all the drugs available to fight HIV, the virus that causes the disease, but now almost all regimens have lost strength, and his virus is on the upswing. His plight places him in an unenviable class: the estimated 40,000 U.S. AIDS patients whose illness isn't responding to treatment. As a last-ditch effort, some of these people -- Mr. Kovacev included -- are turning to a regimen known among AIDS patients and doctors as salvage therapy.


In general, salvage therapy refers to any treatment devised by a doctor to save a patient when all other options have failed. There isn't a single recipe for salvage. Some AIDS physicians return to older drugs to wring out a last drop of efficacy, while others bid for access to experimental agents in a desperate attempt to bring the spiraling virus under control.

Today there are about one million people living with HIV in the U.S., with about 40,000 new infections a year. In 2004, the most recent year for which statistics are available, 15,798 people died from AIDS, down sharply, thanks to new AIDS drugs, from 51,000 in 1995. Hepatitis and drug toxicity contribute to deaths among HIV patients. Because of salvage therapy, most patients with drug-resistant virus are, for now, hanging on.

Even with optimal treatment, Daniel Kuritzkes, associate professor of medicine at Harvard Medical School, says, "we've only changed the slope of the disease progression, not halted it altogether, and eventually they do run out of options."

Nearly two dozen AIDS treatments are currently on the market. But as the epidemic turns 25, many long-term patients have been driven by the mutating virus to keep switching regimens until all have failed. Of the 40,000 patients who aren't responding to even the latest high-power medication, "20,000 are in dire need," says Houston AIDS-treatment activist (and AIDS patient) Nelson Vergel. "I call them the invisibles, because they are too tired and too sick to fight for their rights."

Mr. Kovacev believes he contracted HIV in the early 1980s from his partner, who died in 1990. In 1996, illness forced him to begin antiviral cocktail treatment for AIDS. He "got very sick last fall and went on a new regimen -- one of the last available," combining the injectable drug Fuzeon with two antiviral pills, says his doctor, Stephen Boswell of the Fenway Community Health Clinic in Boston.

Over the years, Mr. Kovacev has survived bouts of an intestinal parasite that left him wasted, a virus that nearly blinded him, and painful neuropathy that required morphine. But he rallied to run the 2006 Boston Marathon last month as an unregistered disabled runner. He finished the race -- his 13th marathon -- in six hours and 41 minutes.

Dr. Boswell cites Mr. Kovacev's "voracious will to live" and athleticism for his survival. Mr. Kovacev swears by nutrition and Dr. Boswell's vigilance in tailoring 10 successive AIDS cocktails.

Mr. Kovacev hates the term "salvage therapy." "Salvage sounds like you're dredging a shipwreck," he says.

Mr. Vergel seems resigned to the term. "Salvage isn't a science. Salvage is an art," says the Houston activist, who has taken all 22 approved AIDS drug products.

Many patients now in salvage have, like Messrs. Kovacev and Vergel, lived with HIV for over two decades. Some like Mr. Vergel took the first antiviral, AZT, approved in 1987, and swapped in each new product until protease inhibitors in 1996 heralded the era of modern drug cocktails.


AIDS patient Steve Kovacev as he competed in the 1997 Boston Marathon.
At San Francisco General Hospital, physician Steven Deeks is studying 300 salvage patients, many of whom started on AIDS drugs in the early 1990s. Many considered aggressive switching as the best practice at the time, and the patients quickly switched to each new product like DDI and 3TC.

By the 1996 debut of protease-inhibitor drugs, which are now anchors of modern cocktail therapy, such patients "already had high-level resistance," Dr. Deeks says. It now appears that rapid switching of single drugs had fueled the development of resistant virus.

Dr. Deeks, an associate professor of medicine at the University of California at San Francisco, warns that people on cocktails who still swap in the latest new drug one at a time are perpetuating the problem. "We need to stop switching so aggressively," he says. "We need to hold still until we have a number of new families of drugs."

Salvage therapy is "a huge issue," says Harvard Medical School Professor Jerome Groopman. "You've got these patients who did well and you're excited for them. Then you get back with them and they have 12 mutations. You're desperately searching. They're hanging on by a thread."

Dr. Deeks urges resurrecting old drugs like AZT or 3TC as stopgaps to stabilize patients until two or three novel drugs can be combined in an all-new cocktail.

Once doctors get access to two or three novel drugs, they can concoct the first all-new cocktail many patients have had in several years. Raining multiple blows on HIV gives a chance even patients with multidrug-resistant virus can lower the level of HIV in the blood to the limits of detection, Harvard's Dr. Kuritzkes says.

Experimental drugs furthest along in the new product pipeline include: the new protease inhibitor TMC114 from Johnson & Johnson's Tibotec unit; new integrate inhibitors from Merck & Co. and Gilead Sciences Inc.; new entry inhibitor drugs that block the CCR5 co-receptor from Pfizer Inc. and Schering-Plough Corp.; and Tan ox Inc.'s IV monoclonal antibody to block the virus's entry through the CD4 receptor on human immune cells.

"I'm excited," Mr. Vergel says. But he adds, "I want people to wait. Don't blow your options by adding [one drug] to a failing regimen."

For those who can wait, Mr. Vergel says the new drug pipeline may yield products this summer and next spring. "I am just concerned that so many patients who need help now may not see the good days coming ahead," he says.

Appeals Court Rules that Terminally Ill Patients Have 'Fundamental Right' to Experimental Drugs


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From a Washington Legal Foundation (WLF) press release:

Appeals Court Rules that Terminally Ill Patients Have 'Fundamental Right' to Experimental Drugs



(Abigail Alliance v. Eschenbach)

WASHINGTON, May 2, 2006-In a major victory for the Washington Legal Foundation (WLF), the U.S. Court of Appeals for the District of Columbia Circuit ruled today that terminally ill patients have a “fundamental right” – protected by the U.S. Constitution – to access to experimental drugs that have not yet been fully approved by the Food and Drug Administration (FDA). The decision caps a three-year WLF effort to establish such a right. Because of FDA’s refusal to recognize such a right, WLF filed suit in 2003 on behalf of itself and the Abigail Alliance for Better Access to Developmental Drugs, a patients-rights group.

The appeals court held 2-1 that once FDA has determined, after Phase I trials, that a potentially life-saving investigational new drug is sufficiently safe for expanded human trials, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available to the patient. The court held that the Fifth Amendment’s Due Process Clause encompasses a right, recognized throughout American history, of all individuals facing terminal illnesses to make fundamental decisions regarding whether to seek or not to seek medical treatment. The court said that if FDA wishes to prevent such patients from gaining access to investigational drugs that have completed Phase I trials, it bears the burden of demonstrating that its restrictions are “narrowly tailored” to serve a compelling governmental interest. Commenting on the Court’s decision, WLF Chief Counsel Richard Samp said:

Under FDA regulations, the vast majority of patients with life-threatening illnesses do not have access to promising new medications during the years of clinical testing and review required by FDA. The drugs remain unavailable even though there is evidence that they are safe and effective and even though patients have no alternative to the drugs other than to wait for their own deaths. We are hopeful that today’s decision will reverse that policy.

Unless FDA appeals, the case now returns to the district court, where FDA will have an opportunity to demonstrate that it has a “compelling interest” in restricting the constitutional rights of terminally ill patients. WLF is hopeful that it can work with FDA to develop a new policy that takes into account FDA’s legitimate concerns while also respecting the rights of those in need of access to potentially life-saving medications.

Richard A. Samp, counsel for WLF in the Abigail Alliance case, is available for comment at (202) 588-0302. A copy of WLF’s brief is available at its website, www.wlf.org.

Tuesday, May 02, 2006

Are salvage patients beyond help?


I just found out about the death of Gary Bischop, one of the first patients that I was able to help in the past two months to convince his doctor to advocate for his access of TMC 114 and TMC 125. Gary wrote me a nice testimonial in salvagetherapies.org about his ordeal and how full of hope he was. In it he said: "Thankfully, I don’t have to face the dim prospect of monotherapy again. Nelson informed me and the ATAC discussion group about a process called Emergency Investigational New Drug (EIND) access. So I approached my doctor with this idea. He was hesitant at first, but finally he did apply for the EIND in the beginning of March 2006 and within a week and a half we had permission from Tibotec, the FDA, and my medical Center’s Internal Review Board to proceed with the EIND. That means I will receive my TWO new drugs by the end of this month, March 2006. There is hope after all. Thank you Nelson and Barry for all of your help".
He died a few days after he finally got the combination of investigational agents. I cried just thinking about this terrible loss. Could it have been prevented if he had got the drugs sooner? Could he still be with us? Why has hardly any activist out there help me spread the word about single patient treatment IND access for desperate patients? My mind is full of questions and it is a painful mistery that I hope to have an answer to eventually.

I have so far only been able to help fewer than 10 patients to get this combination of drugs outside a protocol setting. They all found out about this possibility after reading a press release that I wrote that only thebody.com was kind enough to publish (see http://salvagetherapies.org/announcements.htm). TheBody.com and ACRIA.org were the only groups kind enough to post information about this salvage access program. No other AIDS service organization that I contacted supported spreading the word about this potentially life saving program. This is a mistery that I still do not understand.

I have been afraid to write these words. But I have already been isolated and demonized by many of my fellow activists for being too aggressive about the way we should work on salvage access, specially now that there are so many possibilities to help people with drugs in phase III and expanded access.

Many activists think that all salvage patients are dead or beyond help. I wonder what world they live in.

Salvage patients are too tired and too busy trying to stay alive to have any time to get involved with activism, so their voices are never heard. They are silent, invisible, and a great inconvenience for AIDS groups and researchers. Next time you write a check for an AIDS organization, ask them what they are doing to help those who are in dire need for new drug access.

I donot believe in hell and heaven. But right now I am fantasizing with the idea of Gary sitting somewhere, looking down, and getting ready to wake some people up to help this cause. He was a true fighter and one who will be with me in my heart until not a single patient dies after running out of options for HIV. Too bad we coud not help him sooner. I am sorry Gary, and I hope that wherever you are now, you have no pain and no sorrow, but light and hope for the world you left behind.

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