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.
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The untold Side of the movie "Dallas Buyers Club"
The movie Dallas Buyers Club brings attention to a little-recognized part of the AIDS activist movement: ....
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Exhorbitant Price New Hepatitis C Drug
Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™...
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Six Promising HIV Drugs in the Pipeline (2013-2014)
What new HIV medications do we have to look forward to over the next few years? How will these newer drugs improve upon the older ones? To shed some light on these questions....
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What Can We Look Forward to in HIV Cure Research
TheBodyPRO.com's Nelson Vergel sat down with leading HIV cure research activist Richard Jefferys for an update on current important aspects, and controversies, in HIV cure research....
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What Supplements Can I take with HIV medications?
Is it ok to supplement with Creatine (Cell-Tech), and Protein (Nitro-Tech) along with Glutamine...
Sunday, May 21, 2006
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.
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
ugs
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.
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.
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.
Thursday, April 27, 2006
Hope for those with no options
For those of you trying to get on two active drugs....
You can get TMC 114 in expanded access. It is taking about 3 weeks to get it if the doctor knows the process. No T cell limit but your doctor has to prove that you have multi drug resistance. Three hours of paper work. Your doctor does not get paid for that time. Many doctors refused to be part of this system. To see who is listed in your area, email info@veritasmedicine.com and read
http://clinicaltrials.gov/ct/show/NCT00245739?order=1
Remember: TMC 114 will probably be approved in a month or so. TMC 114 is a second generation protease, and not a replacement to Fuzeon. Some people may be thinking about taking this drug with Merck's integrase (info below) to get off Fuzeon. We really do not know much about how to compare a Fuzeon containing regimen with this one.
Never start a new agent on top of a failing regimen. This is called virtual monotherapy and only works for a little while. Read more here
http://salvagetherapies.org/announcements.htm
If you have multidrug resistance and very low T cells...like under 10, you can qualify for a single patient access program that requires a lot of work from your doctor. Most doctors do not know how to do it. Read the last link about that.
The Merck integrase study is now enrolling fast in phase III. This is a very promising drug (MRK518). They allow the use of TMC 114 in expanded access. Bad news: you have a 33% chance of placebo but they will give you the real thing in 16 weeks if your viral load is not undetectable then.
You can find out more about this here
http://benchmrk.com/secure/investigator_sites/sites.html
This product MAY be in expanded access by the end of the year if Merck enrolls the study fully by then.
Pfizer's oral entry inhibitor Maraviroc: we are waiting to hear from the company to see if this product is a go or no go for treatment experienced patients. We will not know until they unblind their study in August.
Email me if you have any questions since this can be very confusing.
You can read some people's testimonials at
http://salvagetherapies.org/testimonials.html
You can get TMC 114 in expanded access. It is taking about 3 weeks to get it if the doctor knows the process. No T cell limit but your doctor has to prove that you have multi drug resistance. Three hours of paper work. Your doctor does not get paid for that time. Many doctors refused to be part of this system. To see who is listed in your area, email info@veritasmedicine.com and read
http://clinicaltrials.gov/ct/show/NCT00245739?order=1
Remember: TMC 114 will probably be approved in a month or so. TMC 114 is a second generation protease, and not a replacement to Fuzeon. Some people may be thinking about taking this drug with Merck's integrase (info below) to get off Fuzeon. We really do not know much about how to compare a Fuzeon containing regimen with this one.
Never start a new agent on top of a failing regimen. This is called virtual monotherapy and only works for a little while. Read more here
http://salvagetherapies.org/announcements.htm
If you have multidrug resistance and very low T cells...like under 10, you can qualify for a single patient access program that requires a lot of work from your doctor. Most doctors do not know how to do it. Read the last link about that.
The Merck integrase study is now enrolling fast in phase III. This is a very promising drug (MRK518). They allow the use of TMC 114 in expanded access. Bad news: you have a 33% chance of placebo but they will give you the real thing in 16 weeks if your viral load is not undetectable then.
You can find out more about this here
http://benchmrk.com/secure/investigator_sites/sites.html
This product MAY be in expanded access by the end of the year if Merck enrolls the study fully by then.
Pfizer's oral entry inhibitor Maraviroc: we are waiting to hear from the company to see if this product is a go or no go for treatment experienced patients. We will not know until they unblind their study in August.
Email me if you have any questions since this can be very confusing.
You can read some people's testimonials at
http://salvagetherapies.org/testimonials.html
Tuesday, April 25, 2006
Consensus Statement on the Pricing of TMC114 /Darunavir
Consensus Statement on the Pricing of TMC114 /Darunavir
April 17, 2006
TMC114/darunavir will soon become Tibotec’s first licensed drug for the treatment of HIV disease. It is likely to be the first of several important anti-HIV drugs from Tibotec. To date, the HIV/AIDS community’s relations with Tibotec have been exemplary as the company has shown an exceptional willingness to invite and listen to input from people affected by HIV disease. Based on everything we know now, the licensure of TMC-114/darunavir will be a worthy addition to our anti-HIV armamentarium, especially for people who have developed resistance to the existing protease inhibitors.
This good news, however, does not exist in a vacuum. Instead, it will be played out against a background of growing national and international crises in the cost of health care. The cost of a typical anti-HIV regimen in United States has risen to $15,000 or more for initial therapy, while the cost of salvage therapy can easily reach three times that amount. This is just for cost of the drugs. These costs plus the cost of associated medical care must be supported for decades to come for every single person with HIV disease. Better drugs, like TMC114/darunavir, result in longer lives and thus even longer times on therapy. If the average duration of therapy is limited to no more than 50 years per person, the costs of HIV drugs over this period will easily exceed a trillion dollars in the US alone, not even counting future price increases. Add in a reasonable cost for the vast numbers needing therapy in developing nations and the overall cost of drug for treating HIV disease worldwide could easily equal the current US national debt. Clearly, the path we are on is not sustainable, at least not for anyone other than the pharmaceutical industry.
At a time when evidence of responsible citizenship is needed from the pharmaceutical industry, we have instead been treated to ever increasing prices with each new drug. Two recently approved protease inhibitors, Reyataz and Aptivus, leapfrogged each other in setting new pricing thresholds, quickly reaching a price nearly three times that charged for Crixivan when it offered the first real breakthrough in AIDS treatment in 1996. TMC114/darunavir is the next drug in line and all eyes will be on it the day its price is announced. Its net price must include the cost of a booster drug, Norvir from Abbott Labs, whose price was recently increased by 400% in another demonstration of reckless civic behavior by a pharmaceutical company. While Tibotec isn’t responsible for the price increases taken by others, it is responsible for the decision to use the Norvir booster. Tibotec now has two choices. It can either follow in the footsteps its predecessors, defying the needs of patients and taxpayers, or it can make a bold statement that shows that the industry will do its part to restrain the cost of healthcare. Make the wrong choice and all of the company’s efforts to maintain strong relationships with the government and the community will have been for naught. The cycle of ever increasing costs, and ever higher profits, will once again be validated. Is this the legacy that Tibotec wishes to create?
Since it was formed in 1998, the Fair Pricing Coalition has sought drug pricing that is cost neutral. We seek to avoid having each new drug push the cost of treatment upward. In the case of TMC114/darunavir, this leads to a very specific demand: we ask that the price charged for TMC114/darunavir should be less than or equal to the current price of Kaletra, which is presently the best selling protease inhibitor and the drug that TMC114/darunavir is most likely to replace in clinical practice. Since Tibotec has chosen to use a ritonavir booster to improve the bioavailability of TMC114/darunavir, the price must include its cost, just as the ritonavir booster is already included in the price of Kaletra.
We also expect substantial discounts over and above the minimum required by law for the AIDS Drug Assistance Program and other government payers. We trust that separate negotiations are underway with the appropriate representatives of those programs, but we hope to establish the baseline for those discussions with the pricing principles laid out here.
We urge the leadership of Tibotec Research, Tibotec Therapeutics, and parent companies Ortho and Johnson & Johnson to give this proposal the most serious possible consideration. We believe that the company will benefit greatly from agreeing to this request. It will establish the company both as a scientific leader and also as a civic leader. It will stand as evidence to the taxpayer and to the Congress that the pharmaceutical industry is capable of more than simply seeking the greatest possible profits without regard for the impact on society. Perhaps most importantly, it will be welcomed and appreciated by the people with HIV and the medical professionals who treat them. It will almost certainly generate positive press about a “new, more responsible attitude” by industry. And, we believe, it will encourage the fastest possible uptake of the drug into clinical practice. Tibotec is aware, no doubt, that recent Medicare Part D formulary guidance issued by the Centers for Medicaid and Medicare services, has changed the mechanism for adding newly FDA approved drugs in the six protected classes, including anti-retrovirals, as of April 17, 2006. Any drug approved by the FDA after April 17 must be approved for inclusion in the individual plan formulary by that plan's Pharmacy and Therapeutics (P & T) committee. Drugs included in a protected class will have a expedited approval time that can take up to 90 days or three months, but there is no guidance suggesting that newly approved drugs in the protected classes must automatically be added to the plan formulary. Each state will likely take price into account along with therapeutic value. Additionally the P& T committees will make decisions as to how to tier new drugs for co-payment amounts. Because of their price, most of the newer anti-retrovirals are tiered in the highest tiers making them unaffordable for many. Therefore, if Tibotec hopes to see a rapid inclusion in formularies, they must price it aggressively. How state authorities and the HIV affected public feel about the pricing of new drugs will contribute to the speed of this process. At the state level, price will almost certainly be a key consideration. Meeting the goal described here will make it possible for the activist community to support the fastest possible acceptance on the formularies.
The payers, Congress, patients and providers are greatly frustrated with the pricing practices of the pharmaceutical industry. While patients and payers are struggling year after year to raise the money needed to obtain access for a growing patient population, the pharmaceutical industry has shown virtually no restraint in its quest for profits and shareholder benefits. Its profitability ranks among the highest of all industries while the percentage of revenues devoted to research and development are at best average. The pharmaceutical industry speaks proudly of the need for a “free market economy” and the benefits of competition, but in fact it behaves more like a group of monopolies. It accepts little or no pressure on prices as a result of competition, the cornerstone of a market driven economy. In the US, the industry funds massive political lobbying to prevent government from negotiating prices for the largest national payers. Unlike other industries, in which high profits are usually the result of the consumers’ selection of outstanding products, the “buyers” of pharmaceutical products have little choice in the selection of products and product quality bears no relationship to the price charged. This coercive relationship between buyer and seller can no longer be tolerated. It must be challenged, whether through consumer protest, eventual price controls, or payer product selection, none of which are very attractive to industry. Make the right choice now and none of these approaches will be necessary.
We will follow-up this letter with continued discussions and one or more face to face meetings with Tibotec. The list of signers supporting this position will be updated weekly.
[list in formation]
Regards,
Nelson Vergel
powerusa dot org
"I learned that...no one is perfect but most people are good; that people can't be judged only by the worst or weakest moments; that harsh judgements can make hypocrites of us all; that a lot of life is just showing up and hanging on; that laughter is often the best, and sometimes the only response to pain." My Life by Bill Clinton
-----------------
Forwarded Message:
Subj: Request for Sign-On New HIV Drug Pricing Consensus Statement
Date: 4/19/2006 3:44:46 P.M. Central Standard Time
From: Leichou
Please help distribute widely, apologies for duplicates.
Pricing of pending new HIV drug critical to domestic treatment access,
Now is the time to impact the pricing decision by Tibotec,
Join the Fair Pricing Coalition's consensus statement
The new anti-HIV drug TMC114/darunavir made by Tibotec is expected to receive FDA approval this summer. This drug is particularly important because clinical trials have shown it to work against highly resistant strains of HIV. Access to this drug is a matter of life and death for many people, particularly long-term survivors.
As shown by recent pricing decisions by other HIV drug makers, the industry trend is to price new therapies at record high levels. The prices of the last two protease inhibitors, Reyataz from Bristol Myers Squibb and Aptivus from Boeringher Ingelheim, bring the price of protease inhibitors alone to well over $10,000 and the cost of a typical regimen in excess of $16.000. With drug prices like these, we may never be able to get adequate funding for ADAP and the Ryan White program.
The escalation in the price of prescriptions drugs MUST STOP NOW if there is ever to be a hope of bringing treatment to all in need.
We believe that we have a good chance of reversing the upward spiral of prices with this company and this drug, but only if we raise sufficient public pressure before the price is set. Please join us and our organizations to help make this a reality. Directly or indirectly, it affects every other battle over government funding for HIV.
Thank You,
Martin Delaney, for Project Inform
Lei Chou, for Community HIV/AIDS Mobilization Project
Lanny Cross
Mark Harrington, for the Treatment Action Group
Lynda Dee, for AIDS Action Baltimore
Dennis deLeon, for the Latino Commission on AIDS
Matt Sharp, for the Test Positive Aware Network
Bob Huff, for Gay Men’s Health Crisis (GMHC)
William E. Arnold, for Title II Community National AIDS Network
To sign on to this consensus statement, please send the following information to leichou@aol.com
Name:
Organization:
Address:
City:
State:
Zip:
Phone:
email:
Consensus Statement on the Pricing of TMC114 /Darunavir
April 17, 2006
TMC114/darunavir will soon become Tibotec’s first licensed drug for the treatment of HIV disease. It is likely to be the first of several important anti-HIV drugs from Tibotec. To date, the HIV/AIDS community’s relations with Tibotec have been exemplary as the company has shown an exceptional willingness to invite and listen to input from people affected by HIV disease. Based on everything we know now, the licensure of TMC-114/darunavir will be a worthy addition to our anti-HIV armamentarium, especially for people who have developed resistance to the existing protease inhibitors.
This good news, however, does not exist in a vacuum. Instead, it will be played out against a background of growing national and international crises in the cost of health care. The cost of a typical anti-HIV regimen in United States has risen to $15,000 or more for initial therapy, while the cost of salvage therapy can easily reach three times that amount. This is just for cost of the drugs. These costs plus the cost of associated medical care must be supported for decades to come for every single person with HIV disease. Better drugs, like TMC114/darunavir, result in longer lives and thus even longer times on therapy. If the average duration of therapy is limited to no more than 50 years per person, the costs of HIV drugs over this period will easily exceed a trillion dollars in the US alone, not even counting future price increases. Add in a reasonable cost for the vast numbers needing therapy in developing nations and the overall cost of drug for treating HIV disease worldwide could easily equal the current US national debt. Clearly, the path we are on is not sustainable, at least not for anyone other than the pharmaceutical industry.
At a time when evidence of responsible citizenship is needed from the pharmaceutical industry, we have instead been treated to ever increasing prices with each new drug. Two recently approved protease inhibitors, Reyataz and Aptivus, leapfrogged each other in setting new pricing thresholds, quickly reaching a price nearly three times that charged for Crixivan when it offered the first real breakthrough in AIDS treatment in 1996. TMC114/darunavir is the next drug in line and all eyes will be on it the day its price is announced. Its net price must include the cost of a booster drug, Norvir from Abbott Labs, whose price was recently increased by 400% in another demonstration of reckless civic behavior by a pharmaceutical company. While Tibotec isn’t responsible for the price increases taken by others, it is responsible for the decision to use the Norvir booster. Tibotec now has two choices. It can either follow in the footsteps its predecessors, defying the needs of patients and taxpayers, or it can make a bold statement that shows that the industry will do its part to restrain the cost of healthcare. Make the wrong choice and all of the company’s efforts to maintain strong relationships with the government and the community will have been for naught. The cycle of ever increasing costs, and ever higher profits, will once again be validated. Is this the legacy that Tibotec wishes to create?
Since it was formed in 1998, the Fair Pricing Coalition has sought drug pricing that is cost neutral. We seek to avoid having each new drug push the cost of treatment upward. In the case of TMC114/darunavir, this leads to a very specific demand: we ask that the price charged for TMC114/darunavir should be less than or equal to the current price of Kaletra, which is presently the best selling protease inhibitor and the drug that TMC114/darunavir is most likely to replace in clinical practice. Since Tibotec has chosen to use a ritonavir booster to improve the bioavailability of TMC114/darunavir, the price must include its cost, just as the ritonavir booster is already included in the price of Kaletra.
We also expect substantial discounts over and above the minimum required by law for the AIDS Drug Assistance Program and other government payers. We trust that separate negotiations are underway with the appropriate representatives of those programs, but we hope to establish the baseline for those discussions with the pricing principles laid out here.
We urge the leadership of Tibotec Research, Tibotec Therapeutics, and parent companies Ortho and Johnson & Johnson to give this proposal the most serious possible consideration. We believe that the company will benefit greatly from agreeing to this request. It will establish the company both as a scientific leader and also as a civic leader. It will stand as evidence to the taxpayer and to the Congress that the pharmaceutical industry is capable of more than simply seeking the greatest possible profits without regard for the impact on society. Perhaps most importantly, it will be welcomed and appreciated by the people with HIV and the medical professionals who treat them. It will almost certainly generate positive press about a “new, more responsible attitude” by industry. And, we believe, it will encourage the fastest possible uptake of the drug into clinical practice. Tibotec is aware, no doubt, that recent Medicare Part D formulary guidance issued by the Centers for Medicaid and Medicare services, has changed the mechanism for adding newly FDA approved drugs in the six protected classes, including anti-retrovirals, as of April 17, 2006. Any drug approved by the FDA after April 17 must be approved for inclusion in the individual plan formulary by that plan's Pharmacy and Therapeutics (P & T) committee. Drugs included in a protected class will have a expedited approval time that can take up to 90 days or three months, but there is no guidance suggesting that newly approved drugs in the protected classes must automatically be added to the plan formulary. Each state will likely take price into account along with therapeutic value. Additionally the P& T committees will make decisions as to how to tier new drugs for co-payment amounts. Because of their price, most of the newer anti-retrovirals are tiered in the highest tiers making them unaffordable for many. Therefore, if Tibotec hopes to see a rapid inclusion in formularies, they must price it aggressively. How state authorities and the HIV affected public feel about the pricing of new drugs will contribute to the speed of this process. At the state level, price will almost certainly be a key consideration. Meeting the goal described here will make it possible for the activist community to support the fastest possible acceptance on the formularies.
The payers, Congress, patients and providers are greatly frustrated with the pricing practices of the pharmaceutical industry. While patients and payers are struggling year after year to raise the money needed to obtain access for a growing patient population, the pharmaceutical industry has shown virtually no restraint in its quest for profits and shareholder benefits. Its profitability ranks among the highest of all industries while the percentage of revenues devoted to research and development are at best average. The pharmaceutical industry speaks proudly of the need for a “free market economy” and the benefits of competition, but in fact it behaves more like a group of monopolies. It accepts little or no pressure on prices as a result of competition, the cornerstone of a market driven economy. In the US, the industry funds massive political lobbying to prevent government from negotiating prices for the largest national payers. Unlike other industries, in which high profits are usually the result of the consumers’ selection of outstanding products, the “buyers” of pharmaceutical products have little choice in the selection of products and product quality bears no relationship to the price charged. This coercive relationship between buyer and seller can no longer be tolerated. It must be challenged, whether through consumer protest, eventual price controls, or payer product selection, none of which are very attractive to industry. Make the right choice now and none of these approaches will be necessary.
We will follow-up this letter with continued discussions and one or more face to face meetings with Tibotec. The list of signers supporting this position will be updated weekly.
April 17, 2006
TMC114/darunavir will soon become Tibotec’s first licensed drug for the treatment of HIV disease. It is likely to be the first of several important anti-HIV drugs from Tibotec. To date, the HIV/AIDS community’s relations with Tibotec have been exemplary as the company has shown an exceptional willingness to invite and listen to input from people affected by HIV disease. Based on everything we know now, the licensure of TMC-114/darunavir will be a worthy addition to our anti-HIV armamentarium, especially for people who have developed resistance to the existing protease inhibitors.
This good news, however, does not exist in a vacuum. Instead, it will be played out against a background of growing national and international crises in the cost of health care. The cost of a typical anti-HIV regimen in United States has risen to $15,000 or more for initial therapy, while the cost of salvage therapy can easily reach three times that amount. This is just for cost of the drugs. These costs plus the cost of associated medical care must be supported for decades to come for every single person with HIV disease. Better drugs, like TMC114/darunavir, result in longer lives and thus even longer times on therapy. If the average duration of therapy is limited to no more than 50 years per person, the costs of HIV drugs over this period will easily exceed a trillion dollars in the US alone, not even counting future price increases. Add in a reasonable cost for the vast numbers needing therapy in developing nations and the overall cost of drug for treating HIV disease worldwide could easily equal the current US national debt. Clearly, the path we are on is not sustainable, at least not for anyone other than the pharmaceutical industry.
At a time when evidence of responsible citizenship is needed from the pharmaceutical industry, we have instead been treated to ever increasing prices with each new drug. Two recently approved protease inhibitors, Reyataz and Aptivus, leapfrogged each other in setting new pricing thresholds, quickly reaching a price nearly three times that charged for Crixivan when it offered the first real breakthrough in AIDS treatment in 1996. TMC114/darunavir is the next drug in line and all eyes will be on it the day its price is announced. Its net price must include the cost of a booster drug, Norvir from Abbott Labs, whose price was recently increased by 400% in another demonstration of reckless civic behavior by a pharmaceutical company. While Tibotec isn’t responsible for the price increases taken by others, it is responsible for the decision to use the Norvir booster. Tibotec now has two choices. It can either follow in the footsteps its predecessors, defying the needs of patients and taxpayers, or it can make a bold statement that shows that the industry will do its part to restrain the cost of healthcare. Make the wrong choice and all of the company’s efforts to maintain strong relationships with the government and the community will have been for naught. The cycle of ever increasing costs, and ever higher profits, will once again be validated. Is this the legacy that Tibotec wishes to create?
Since it was formed in 1998, the Fair Pricing Coalition has sought drug pricing that is cost neutral. We seek to avoid having each new drug push the cost of treatment upward. In the case of TMC114/darunavir, this leads to a very specific demand: we ask that the price charged for TMC114/darunavir should be less than or equal to the current price of Kaletra, which is presently the best selling protease inhibitor and the drug that TMC114/darunavir is most likely to replace in clinical practice. Since Tibotec has chosen to use a ritonavir booster to improve the bioavailability of TMC114/darunavir, the price must include its cost, just as the ritonavir booster is already included in the price of Kaletra.
We also expect substantial discounts over and above the minimum required by law for the AIDS Drug Assistance Program and other government payers. We trust that separate negotiations are underway with the appropriate representatives of those programs, but we hope to establish the baseline for those discussions with the pricing principles laid out here.
We urge the leadership of Tibotec Research, Tibotec Therapeutics, and parent companies Ortho and Johnson & Johnson to give this proposal the most serious possible consideration. We believe that the company will benefit greatly from agreeing to this request. It will establish the company both as a scientific leader and also as a civic leader. It will stand as evidence to the taxpayer and to the Congress that the pharmaceutical industry is capable of more than simply seeking the greatest possible profits without regard for the impact on society. Perhaps most importantly, it will be welcomed and appreciated by the people with HIV and the medical professionals who treat them. It will almost certainly generate positive press about a “new, more responsible attitude” by industry. And, we believe, it will encourage the fastest possible uptake of the drug into clinical practice. Tibotec is aware, no doubt, that recent Medicare Part D formulary guidance issued by the Centers for Medicaid and Medicare services, has changed the mechanism for adding newly FDA approved drugs in the six protected classes, including anti-retrovirals, as of April 17, 2006. Any drug approved by the FDA after April 17 must be approved for inclusion in the individual plan formulary by that plan's Pharmacy and Therapeutics (P & T) committee. Drugs included in a protected class will have a expedited approval time that can take up to 90 days or three months, but there is no guidance suggesting that newly approved drugs in the protected classes must automatically be added to the plan formulary. Each state will likely take price into account along with therapeutic value. Additionally the P& T committees will make decisions as to how to tier new drugs for co-payment amounts. Because of their price, most of the newer anti-retrovirals are tiered in the highest tiers making them unaffordable for many. Therefore, if Tibotec hopes to see a rapid inclusion in formularies, they must price it aggressively. How state authorities and the HIV affected public feel about the pricing of new drugs will contribute to the speed of this process. At the state level, price will almost certainly be a key consideration. Meeting the goal described here will make it possible for the activist community to support the fastest possible acceptance on the formularies.
The payers, Congress, patients and providers are greatly frustrated with the pricing practices of the pharmaceutical industry. While patients and payers are struggling year after year to raise the money needed to obtain access for a growing patient population, the pharmaceutical industry has shown virtually no restraint in its quest for profits and shareholder benefits. Its profitability ranks among the highest of all industries while the percentage of revenues devoted to research and development are at best average. The pharmaceutical industry speaks proudly of the need for a “free market economy” and the benefits of competition, but in fact it behaves more like a group of monopolies. It accepts little or no pressure on prices as a result of competition, the cornerstone of a market driven economy. In the US, the industry funds massive political lobbying to prevent government from negotiating prices for the largest national payers. Unlike other industries, in which high profits are usually the result of the consumers’ selection of outstanding products, the “buyers” of pharmaceutical products have little choice in the selection of products and product quality bears no relationship to the price charged. This coercive relationship between buyer and seller can no longer be tolerated. It must be challenged, whether through consumer protest, eventual price controls, or payer product selection, none of which are very attractive to industry. Make the right choice now and none of these approaches will be necessary.
We will follow-up this letter with continued discussions and one or more face to face meetings with Tibotec. The list of signers supporting this position will be updated weekly.
[list in formation]
Regards,
Nelson Vergel
powerusa dot org
"I learned that...no one is perfect but most people are good; that people can't be judged only by the worst or weakest moments; that harsh judgements can make hypocrites of us all; that a lot of life is just showing up and hanging on; that laughter is often the best, and sometimes the only response to pain." My Life by Bill Clinton
-----------------
Forwarded Message:
Subj: Request for Sign-On New HIV Drug Pricing Consensus Statement
Date: 4/19/2006 3:44:46 P.M. Central Standard Time
From: Leichou
Please help distribute widely, apologies for duplicates.
Pricing of pending new HIV drug critical to domestic treatment access,
Now is the time to impact the pricing decision by Tibotec,
Join the Fair Pricing Coalition's consensus statement
The new anti-HIV drug TMC114/darunavir made by Tibotec is expected to receive FDA approval this summer. This drug is particularly important because clinical trials have shown it to work against highly resistant strains of HIV. Access to this drug is a matter of life and death for many people, particularly long-term survivors.
As shown by recent pricing decisions by other HIV drug makers, the industry trend is to price new therapies at record high levels. The prices of the last two protease inhibitors, Reyataz from Bristol Myers Squibb and Aptivus from Boeringher Ingelheim, bring the price of protease inhibitors alone to well over $10,000 and the cost of a typical regimen in excess of $16.000. With drug prices like these, we may never be able to get adequate funding for ADAP and the Ryan White program.
The escalation in the price of prescriptions drugs MUST STOP NOW if there is ever to be a hope of bringing treatment to all in need.
We believe that we have a good chance of reversing the upward spiral of prices with this company and this drug, but only if we raise sufficient public pressure before the price is set. Please join us and our organizations to help make this a reality. Directly or indirectly, it affects every other battle over government funding for HIV.
Thank You,
Martin Delaney, for Project Inform
Lei Chou, for Community HIV/AIDS Mobilization Project
Lanny Cross
Mark Harrington, for the Treatment Action Group
Lynda Dee, for AIDS Action Baltimore
Dennis deLeon, for the Latino Commission on AIDS
Matt Sharp, for the Test Positive Aware Network
Bob Huff, for Gay Men’s Health Crisis (GMHC)
William E. Arnold, for Title II Community National AIDS Network
To sign on to this consensus statement, please send the following information to leichou@aol.com
Name:
Organization:
Address:
City:
State:
Zip:
Phone:
email:
Consensus Statement on the Pricing of TMC114 /Darunavir
April 17, 2006
TMC114/darunavir will soon become Tibotec’s first licensed drug for the treatment of HIV disease. It is likely to be the first of several important anti-HIV drugs from Tibotec. To date, the HIV/AIDS community’s relations with Tibotec have been exemplary as the company has shown an exceptional willingness to invite and listen to input from people affected by HIV disease. Based on everything we know now, the licensure of TMC-114/darunavir will be a worthy addition to our anti-HIV armamentarium, especially for people who have developed resistance to the existing protease inhibitors.
This good news, however, does not exist in a vacuum. Instead, it will be played out against a background of growing national and international crises in the cost of health care. The cost of a typical anti-HIV regimen in United States has risen to $15,000 or more for initial therapy, while the cost of salvage therapy can easily reach three times that amount. This is just for cost of the drugs. These costs plus the cost of associated medical care must be supported for decades to come for every single person with HIV disease. Better drugs, like TMC114/darunavir, result in longer lives and thus even longer times on therapy. If the average duration of therapy is limited to no more than 50 years per person, the costs of HIV drugs over this period will easily exceed a trillion dollars in the US alone, not even counting future price increases. Add in a reasonable cost for the vast numbers needing therapy in developing nations and the overall cost of drug for treating HIV disease worldwide could easily equal the current US national debt. Clearly, the path we are on is not sustainable, at least not for anyone other than the pharmaceutical industry.
At a time when evidence of responsible citizenship is needed from the pharmaceutical industry, we have instead been treated to ever increasing prices with each new drug. Two recently approved protease inhibitors, Reyataz and Aptivus, leapfrogged each other in setting new pricing thresholds, quickly reaching a price nearly three times that charged for Crixivan when it offered the first real breakthrough in AIDS treatment in 1996. TMC114/darunavir is the next drug in line and all eyes will be on it the day its price is announced. Its net price must include the cost of a booster drug, Norvir from Abbott Labs, whose price was recently increased by 400% in another demonstration of reckless civic behavior by a pharmaceutical company. While Tibotec isn’t responsible for the price increases taken by others, it is responsible for the decision to use the Norvir booster. Tibotec now has two choices. It can either follow in the footsteps its predecessors, defying the needs of patients and taxpayers, or it can make a bold statement that shows that the industry will do its part to restrain the cost of healthcare. Make the wrong choice and all of the company’s efforts to maintain strong relationships with the government and the community will have been for naught. The cycle of ever increasing costs, and ever higher profits, will once again be validated. Is this the legacy that Tibotec wishes to create?
Since it was formed in 1998, the Fair Pricing Coalition has sought drug pricing that is cost neutral. We seek to avoid having each new drug push the cost of treatment upward. In the case of TMC114/darunavir, this leads to a very specific demand: we ask that the price charged for TMC114/darunavir should be less than or equal to the current price of Kaletra, which is presently the best selling protease inhibitor and the drug that TMC114/darunavir is most likely to replace in clinical practice. Since Tibotec has chosen to use a ritonavir booster to improve the bioavailability of TMC114/darunavir, the price must include its cost, just as the ritonavir booster is already included in the price of Kaletra.
We also expect substantial discounts over and above the minimum required by law for the AIDS Drug Assistance Program and other government payers. We trust that separate negotiations are underway with the appropriate representatives of those programs, but we hope to establish the baseline for those discussions with the pricing principles laid out here.
We urge the leadership of Tibotec Research, Tibotec Therapeutics, and parent companies Ortho and Johnson & Johnson to give this proposal the most serious possible consideration. We believe that the company will benefit greatly from agreeing to this request. It will establish the company both as a scientific leader and also as a civic leader. It will stand as evidence to the taxpayer and to the Congress that the pharmaceutical industry is capable of more than simply seeking the greatest possible profits without regard for the impact on society. Perhaps most importantly, it will be welcomed and appreciated by the people with HIV and the medical professionals who treat them. It will almost certainly generate positive press about a “new, more responsible attitude” by industry. And, we believe, it will encourage the fastest possible uptake of the drug into clinical practice. Tibotec is aware, no doubt, that recent Medicare Part D formulary guidance issued by the Centers for Medicaid and Medicare services, has changed the mechanism for adding newly FDA approved drugs in the six protected classes, including anti-retrovirals, as of April 17, 2006. Any drug approved by the FDA after April 17 must be approved for inclusion in the individual plan formulary by that plan's Pharmacy and Therapeutics (P & T) committee. Drugs included in a protected class will have a expedited approval time that can take up to 90 days or three months, but there is no guidance suggesting that newly approved drugs in the protected classes must automatically be added to the plan formulary. Each state will likely take price into account along with therapeutic value. Additionally the P& T committees will make decisions as to how to tier new drugs for co-payment amounts. Because of their price, most of the newer anti-retrovirals are tiered in the highest tiers making them unaffordable for many. Therefore, if Tibotec hopes to see a rapid inclusion in formularies, they must price it aggressively. How state authorities and the HIV affected public feel about the pricing of new drugs will contribute to the speed of this process. At the state level, price will almost certainly be a key consideration. Meeting the goal described here will make it possible for the activist community to support the fastest possible acceptance on the formularies.
The payers, Congress, patients and providers are greatly frustrated with the pricing practices of the pharmaceutical industry. While patients and payers are struggling year after year to raise the money needed to obtain access for a growing patient population, the pharmaceutical industry has shown virtually no restraint in its quest for profits and shareholder benefits. Its profitability ranks among the highest of all industries while the percentage of revenues devoted to research and development are at best average. The pharmaceutical industry speaks proudly of the need for a “free market economy” and the benefits of competition, but in fact it behaves more like a group of monopolies. It accepts little or no pressure on prices as a result of competition, the cornerstone of a market driven economy. In the US, the industry funds massive political lobbying to prevent government from negotiating prices for the largest national payers. Unlike other industries, in which high profits are usually the result of the consumers’ selection of outstanding products, the “buyers” of pharmaceutical products have little choice in the selection of products and product quality bears no relationship to the price charged. This coercive relationship between buyer and seller can no longer be tolerated. It must be challenged, whether through consumer protest, eventual price controls, or payer product selection, none of which are very attractive to industry. Make the right choice now and none of these approaches will be necessary.
We will follow-up this letter with continued discussions and one or more face to face meetings with Tibotec. The list of signers supporting this position will be updated weekly.
I have updated my web sites and internet discussion groups!
Lipodystrophy, Wasting, Hormones, Exercise, Nutritrion
www.medibolics.com
Therapies for people failing HIV treatments
www.salvagetherapies.org
Nelson Vergel's personal web site
www.nelsonvergel.com
Subscribe to the largest Internet discussion group by sending a blank email to
pozhealth-subscribe@yahoogroups.com
If you are taking Fuzeon or planning to, send a blank email to
FuzeonSupport-subscribe@yahoogroups.com
If you have failed most of your HIV medications and you want to talk to others going through the same challenge, send a blank email to
Salvagetherapies-subscribe@yahoogroups.com
www.medibolics.com
Therapies for people failing HIV treatments
www.salvagetherapies.org
Nelson Vergel's personal web site
www.nelsonvergel.com
Subscribe to the largest Internet discussion group by sending a blank email to
pozhealth-subscribe@yahoogroups.com
If you are taking Fuzeon or planning to, send a blank email to
FuzeonSupport-subscribe@yahoogroups.com
If you have failed most of your HIV medications and you want to talk to others going through the same challenge, send a blank email to
Salvagetherapies-subscribe@yahoogroups.com
Saturday, April 22, 2006
Interview with Dr Jon Kaiser about his supplement
By Nelson Vergel
Jon D. Kaiser, M.D., has been a leader in promoting the integration of natural immune system support with state of the art standard medical therapies for HIV. He is also the author of Healing HIV: How to rebuild your immune system (1999 HealthFirst Press). All of Dr. Kaiser's current treatment guidelines and current research activities can be followed at www.jonkaiser.com.
I felt compelled to ask Dr. Jon Kaiser to give us his input on micronutrient use for the management of mitochondrial toxicity. Differing with Dr. Walker from Germany, Dr. Kaiser in San Francisco has positive experience with the use of simple micronutrients available over the counter in the US.
NV: Thank you Dr. Kaiser for taking the time to answer these questions. Could you tell us about your protocol for mitochondrial toxicity? What supplements are you using and at what dose? What variables are you looking at?
JK: Nelson, first let me commend you on the questions you submitted. They are both probing and insightful. It is my belief that mitochondrial toxicity is a severe problem which potentially affects every HIV(+) patient taking a reverse transcriptase inhibitor (RTI) (i.e. D4T, AZT, DDI, abacavir, etc.).
As is commonly known, the mitochondria are the power plants inside every cell that produce the energy required for healthful functioning. The RTI class of medications significantly blocks a mitochondrial enzyme whose sole purpose is to assist the mitochondria in producing the building blocks necessary to produce this energy.
As this enzyme is poisoned, the ability of the mitochondria to break down the toxic waste products of normal energy metabolism diminishes. These toxic waste products are known as “free radicals” and they contain highly charged oxygen atoms which are poisonous to the cells. As this process progresses over time, the level of free radicals increases to dangerous levels.
NV: Is there anything that can be done to prevent or reverse the buildup of these toxic free radicals in the mitochondria?
JK: The level of vitamins and antioxidants we consume as part of a normal diet are only adequate for detoxifying free radicals in a system that is not under stress. Once you add HIV infection, plus the use of RTI antiviral drugs, to a person’s system, the level of toxic free radicals rises dramatically and begins to cause system-wide toxicity which can ultimately lead to neuropathy, pancreatitis, liver problems, fat atrophy, lactic acidosis, amongst others.
I have been testing different combinations of antioxidants for the past several years in an attempt to identify which ones most effectively reduce the incidence of mitochondrial toxicity. Fortunately, I believe I have found a combination that, not only reduces antiviral medication side effects, but also provides the immune system with enhanced levels of energy and vitality.
This combination of antioxidants includes high doses of NAC, alpha lipoic acid, and acetyl L-carnitine, supported by a base of B-complex, vitamin C, Calcium, Magnesium, Zinc, and Selenium. After experimenting with different formulas, I have been so pleased with the beneficial effects of the current formula that my previous recommendation to include coenzyme Q-10 in the program has been dropped without any apparent loss of benefit. Leaving out coenzyme Q-10 has however allowed the overall cost of the formula to be reduced.
The exact formula that I have been using with my patients during the past three years for preventing mitochondrial toxicity with excellent results can be viewed on my website at www.jonkaiser.com. The dosage is based on a person’s weight. HIV(+) patients who weigh greater than 145 lbs. should take twice the dosage of HIV(+) patients who weigh less than 145 lbs. I have found this weight cutoff to work the best.
It is my opinion that HIV(+) patients taking this formula of nutrients experience far fewer medications side effects including peripheral neuropathy, fat atrophy, pancreatitis, liver inflammation, etc. Furthermore, I often observe a CD4 count boost of approximately 15-20 percent within a few months after beginning this formula.
NV: In your opinion, can micronutrients possibly prevent neuropathy for someone starting "D" drugs?
JK: In my opinion, there is no doubt that the right combination of quality antioxidants can block this mitochondrial toxicity process. My opinion is based on the past three years of reviewing the latest research combined with my clinical experience in over 500 patients following my protocol.
NV: Is there a difference between vitamin brands and manufacturing standards?
JK: Without a doubt. As I began the process of manufacturing my formula for a clinical study, I learned a great deal about how vitamin supplements are produced. In essence, vitamin supplements can be produced cheaply, using inferior raw materials, mixing them with wax so they can be pressed into less expensive tablets that don’t break down easily in the gut, or they can be produced to extremely high quality, pharmaceutical-grade standards that use the highest quality raw materials possible.
NV: In addition, the antioxidants I mentioned above (NAC, alpha lipoic acid, and acetyl L-carnitine) are extremely sensitive to heat, light, and most importantly, exposure to air. Antioxidants react vigorously with oxygen. Therefore, if they are not protected from the air and kept in cold long term storage, they will degrade over time.
JK: I guarantee that the manufacturing of my formula by IHC Vitamins applies these pharmaceutical-grade standards to every batch. They use the highest quality raw materials, are mixed into quick dissolving capsules, are sealed into single dose convenient packets and are kept in cold storage until shipment. I have direct oversight of the quality control process and every batch is tested for potency by a nationally accredited reference laboratory.
These are the same nutrient packets currently being tested in my research studies. To view the study protocol visit www.jonkaiser.com and click on the research button.
NV: What is the monthly cost of your mitochondrial toxicity prevention formula?
JK: As I mentioned above, the recommended dose of my formula is based on a person’s weight and health status. HIV(+) patients who weigh greater than 145 lbs. should take a double-strength packet twice daily while those weighing less than 145 lbs. should take a single-strength packet twice daily.
The current cost to individuals for a month’s supply of single strength packets is $84.95 per month while the cost for a month’s supply of double strength packets is $142.95 per month. In my opinion, this program provides all the micronutrients an HIV(+) person needs to take for optimal immune system support.
Buyers clubs and non-profit organizations can order the vitamins for their members at a substantial discount (30% off) and I am working hard to get the cost down even further as quickly as possible without compromising the high quality standards.
NV: Are you looking at the effect on fat cells under the skin? If not, do you know anyone doing research on supplements that may prevent lipoatrophy?
JK: The proposed mechanism…that fat atrophy in the face and extremities is due to the buildup of reactive oxygen species (free radicals) in the fat cells…is plausible and substantiated by a significant amount of research to date. There may be other factors as well, but the buildup of free radicals in fat tissue will cause apoptosis (cell death) to fat cells as just as effectively as it causes it to other types of cells.
A study which has yet to be done is to give a large group of patients just beginning antiviral therapy high-dose antioxidants, compared to a second group that gets a placebo. They should then be followed for at least 3-5 years with close monitoring. In my opinion, the high-dose antioxidant group will have fewer side effects (including lipoatrophy) and will require less frequent changes to their antiviral therapy due to resistance.
NV: Have you observed any improvements in metabolic parameters, lipids, etc.?
I have yet to see a patient taking my micronutrient formula develop diabetes due to antiviral medications. Cholesterol and triglycerides are another story. Increases in these parameters is most probably not due to a mitochondrial toxicity mechanism.
NV: In your assessment of neuropathy, what tool did you use?
JK: I used a questionnaire called the NILAS, plus a physical exam assessing the effect on light touch, pain, and vibratory sense to measure the degree of peripheral neuropathy present. The NILAS is a linear scale from 0 to 100 that asks three questions and is scored based on the patient’s subjective responses.
NV: Do you think there may be a possibility for BMS to provide supplements that enable people to take D4T and DDI in the long term as part of their product? I remember when adefovir was provided with Carnitine when it was studied for HIV.
JK: Yes, it is the goal toward which I am fervently working. However, high quality research needs to be performed which supports any benefit claims before they will consider this proposal.
NV: . If you had unlimited funds for research, what would you study and why?
JK: That’s easy. First, I would design a large research study that gave patients beginning antiviral medication for the first time either my vitamin packets or a placebo packet to be taken twice daily with food. Then I would follow both groups for as long as possible (at least 3-5 years) and carefully observe the incidence of drug related side effects as well as immunologic parameters such as CD4 cells and how often the patients needed to switch their antiviral regimens due to drug failure. I’m pretty sure the vitamin group would show clear benefits in several areas.
Next, I would do a study in an under-developed area, such as Africa, to test whether a combination of high-dose micronutrients, plus a daily protein supplement, could slow the progression of HIV in patients not taking antiviral medication. The use of this type of nutritional support could stabilize a large percentage of the population until the availability of antiviral medications had increased. My experience leads me to believe that this type of intervention would work very well.
NV: Are there any other natural treatments that you believe make a big difference in the long term health and wellbeing of an HIV(+) individual?
JK: Yes. I check a body composition test (BIA) on my patients every six months and strive to keep their muscle mass in the 40-44 percent range for HIV(+) men and the 30-34 percent range for HIV(+) women. This helps maintain solid energy production by the body and optimally supports the immune system.
While I believe accomplishing this naturally utilizing protein supplements and resistance exercise is optimal, I often prescribe nandrolone, oxandrolone, and occasionally recombinant human growth hormone, if the situation warrants.
I also strongly encourage all HIV(+) individuals to get their free testosterone and DHEA-sulfate levels checked every six months as well. The optimal range for these depends on each individual’s needs, however a general rule of thumb is to keep these hormone levels within the upper half of the normal range. Both these hormones support energy production, mood, libido, and immune function.
By utilizing micronutrients and intelligent hormone supplementation, the immune system can be well supported, ultimately leading to less reliance on drugs and fewer HIV-related illnesses. The E-newsletter archives on my website (www.jonkaiser.com) provides in-depth articles on how to supplement each of these hormones to your greatest advantage (see issues 12/02 through 5/03).
NV: You have been a trendsetter in the HIV medical world. Do you think physicians would embrace the use of micronutrients as a pharmacological intervention for side effect management?
JK: Yes, I do. There would need to be one or two very compelling studies (which I hope to do) that attract other researchers who had an open mind to study the effects of high-dose micronutrients in HIV disease. Once other researchers become involved, I believe there would be a great deal of important data generated that would convince HIV treatment providers that micronutrients can provide real benefits.
Remember, HIV has always been a condition that has been able to break down barriers for patients needing to access new treatments. This is primarily because the scientific community is trying to improve the standard level of care which is presently unable to guarantee our patients long and healthful lives.
Thank you very much for allowing me to share this information with your readership.
NV: And thank you, Doctor.
Jon D. Kaiser, M.D., has been a leader in promoting the integration of natural immune system support with state of the art standard medical therapies for HIV. He is also the author of Healing HIV: How to rebuild your immune system (1999 HealthFirst Press). All of Dr. Kaiser's current treatment guidelines and current research activities can be followed at www.jonkaiser.com.
I felt compelled to ask Dr. Jon Kaiser to give us his input on micronutrient use for the management of mitochondrial toxicity. Differing with Dr. Walker from Germany, Dr. Kaiser in San Francisco has positive experience with the use of simple micronutrients available over the counter in the US.
NV: Thank you Dr. Kaiser for taking the time to answer these questions. Could you tell us about your protocol for mitochondrial toxicity? What supplements are you using and at what dose? What variables are you looking at?
JK: Nelson, first let me commend you on the questions you submitted. They are both probing and insightful. It is my belief that mitochondrial toxicity is a severe problem which potentially affects every HIV(+) patient taking a reverse transcriptase inhibitor (RTI) (i.e. D4T, AZT, DDI, abacavir, etc.).
As is commonly known, the mitochondria are the power plants inside every cell that produce the energy required for healthful functioning. The RTI class of medications significantly blocks a mitochondrial enzyme whose sole purpose is to assist the mitochondria in producing the building blocks necessary to produce this energy.
As this enzyme is poisoned, the ability of the mitochondria to break down the toxic waste products of normal energy metabolism diminishes. These toxic waste products are known as “free radicals” and they contain highly charged oxygen atoms which are poisonous to the cells. As this process progresses over time, the level of free radicals increases to dangerous levels.
NV: Is there anything that can be done to prevent or reverse the buildup of these toxic free radicals in the mitochondria?
JK: The level of vitamins and antioxidants we consume as part of a normal diet are only adequate for detoxifying free radicals in a system that is not under stress. Once you add HIV infection, plus the use of RTI antiviral drugs, to a person’s system, the level of toxic free radicals rises dramatically and begins to cause system-wide toxicity which can ultimately lead to neuropathy, pancreatitis, liver problems, fat atrophy, lactic acidosis, amongst others.
I have been testing different combinations of antioxidants for the past several years in an attempt to identify which ones most effectively reduce the incidence of mitochondrial toxicity. Fortunately, I believe I have found a combination that, not only reduces antiviral medication side effects, but also provides the immune system with enhanced levels of energy and vitality.
This combination of antioxidants includes high doses of NAC, alpha lipoic acid, and acetyl L-carnitine, supported by a base of B-complex, vitamin C, Calcium, Magnesium, Zinc, and Selenium. After experimenting with different formulas, I have been so pleased with the beneficial effects of the current formula that my previous recommendation to include coenzyme Q-10 in the program has been dropped without any apparent loss of benefit. Leaving out coenzyme Q-10 has however allowed the overall cost of the formula to be reduced.
The exact formula that I have been using with my patients during the past three years for preventing mitochondrial toxicity with excellent results can be viewed on my website at www.jonkaiser.com. The dosage is based on a person’s weight. HIV(+) patients who weigh greater than 145 lbs. should take twice the dosage of HIV(+) patients who weigh less than 145 lbs. I have found this weight cutoff to work the best.
It is my opinion that HIV(+) patients taking this formula of nutrients experience far fewer medications side effects including peripheral neuropathy, fat atrophy, pancreatitis, liver inflammation, etc. Furthermore, I often observe a CD4 count boost of approximately 15-20 percent within a few months after beginning this formula.
NV: In your opinion, can micronutrients possibly prevent neuropathy for someone starting "D" drugs?
JK: In my opinion, there is no doubt that the right combination of quality antioxidants can block this mitochondrial toxicity process. My opinion is based on the past three years of reviewing the latest research combined with my clinical experience in over 500 patients following my protocol.
NV: Is there a difference between vitamin brands and manufacturing standards?
JK: Without a doubt. As I began the process of manufacturing my formula for a clinical study, I learned a great deal about how vitamin supplements are produced. In essence, vitamin supplements can be produced cheaply, using inferior raw materials, mixing them with wax so they can be pressed into less expensive tablets that don’t break down easily in the gut, or they can be produced to extremely high quality, pharmaceutical-grade standards that use the highest quality raw materials possible.
NV: In addition, the antioxidants I mentioned above (NAC, alpha lipoic acid, and acetyl L-carnitine) are extremely sensitive to heat, light, and most importantly, exposure to air. Antioxidants react vigorously with oxygen. Therefore, if they are not protected from the air and kept in cold long term storage, they will degrade over time.
JK: I guarantee that the manufacturing of my formula by IHC Vitamins applies these pharmaceutical-grade standards to every batch. They use the highest quality raw materials, are mixed into quick dissolving capsules, are sealed into single dose convenient packets and are kept in cold storage until shipment. I have direct oversight of the quality control process and every batch is tested for potency by a nationally accredited reference laboratory.
These are the same nutrient packets currently being tested in my research studies. To view the study protocol visit www.jonkaiser.com and click on the research button.
NV: What is the monthly cost of your mitochondrial toxicity prevention formula?
JK: As I mentioned above, the recommended dose of my formula is based on a person’s weight and health status. HIV(+) patients who weigh greater than 145 lbs. should take a double-strength packet twice daily while those weighing less than 145 lbs. should take a single-strength packet twice daily.
The current cost to individuals for a month’s supply of single strength packets is $84.95 per month while the cost for a month’s supply of double strength packets is $142.95 per month. In my opinion, this program provides all the micronutrients an HIV(+) person needs to take for optimal immune system support.
Buyers clubs and non-profit organizations can order the vitamins for their members at a substantial discount (30% off) and I am working hard to get the cost down even further as quickly as possible without compromising the high quality standards.
NV: Are you looking at the effect on fat cells under the skin? If not, do you know anyone doing research on supplements that may prevent lipoatrophy?
JK: The proposed mechanism…that fat atrophy in the face and extremities is due to the buildup of reactive oxygen species (free radicals) in the fat cells…is plausible and substantiated by a significant amount of research to date. There may be other factors as well, but the buildup of free radicals in fat tissue will cause apoptosis (cell death) to fat cells as just as effectively as it causes it to other types of cells.
A study which has yet to be done is to give a large group of patients just beginning antiviral therapy high-dose antioxidants, compared to a second group that gets a placebo. They should then be followed for at least 3-5 years with close monitoring. In my opinion, the high-dose antioxidant group will have fewer side effects (including lipoatrophy) and will require less frequent changes to their antiviral therapy due to resistance.
NV: Have you observed any improvements in metabolic parameters, lipids, etc.?
I have yet to see a patient taking my micronutrient formula develop diabetes due to antiviral medications. Cholesterol and triglycerides are another story. Increases in these parameters is most probably not due to a mitochondrial toxicity mechanism.
NV: In your assessment of neuropathy, what tool did you use?
JK: I used a questionnaire called the NILAS, plus a physical exam assessing the effect on light touch, pain, and vibratory sense to measure the degree of peripheral neuropathy present. The NILAS is a linear scale from 0 to 100 that asks three questions and is scored based on the patient’s subjective responses.
NV: Do you think there may be a possibility for BMS to provide supplements that enable people to take D4T and DDI in the long term as part of their product? I remember when adefovir was provided with Carnitine when it was studied for HIV.
JK: Yes, it is the goal toward which I am fervently working. However, high quality research needs to be performed which supports any benefit claims before they will consider this proposal.
NV: . If you had unlimited funds for research, what would you study and why?
JK: That’s easy. First, I would design a large research study that gave patients beginning antiviral medication for the first time either my vitamin packets or a placebo packet to be taken twice daily with food. Then I would follow both groups for as long as possible (at least 3-5 years) and carefully observe the incidence of drug related side effects as well as immunologic parameters such as CD4 cells and how often the patients needed to switch their antiviral regimens due to drug failure. I’m pretty sure the vitamin group would show clear benefits in several areas.
Next, I would do a study in an under-developed area, such as Africa, to test whether a combination of high-dose micronutrients, plus a daily protein supplement, could slow the progression of HIV in patients not taking antiviral medication. The use of this type of nutritional support could stabilize a large percentage of the population until the availability of antiviral medications had increased. My experience leads me to believe that this type of intervention would work very well.
NV: Are there any other natural treatments that you believe make a big difference in the long term health and wellbeing of an HIV(+) individual?
JK: Yes. I check a body composition test (BIA) on my patients every six months and strive to keep their muscle mass in the 40-44 percent range for HIV(+) men and the 30-34 percent range for HIV(+) women. This helps maintain solid energy production by the body and optimally supports the immune system.
While I believe accomplishing this naturally utilizing protein supplements and resistance exercise is optimal, I often prescribe nandrolone, oxandrolone, and occasionally recombinant human growth hormone, if the situation warrants.
I also strongly encourage all HIV(+) individuals to get their free testosterone and DHEA-sulfate levels checked every six months as well. The optimal range for these depends on each individual’s needs, however a general rule of thumb is to keep these hormone levels within the upper half of the normal range. Both these hormones support energy production, mood, libido, and immune function.
By utilizing micronutrients and intelligent hormone supplementation, the immune system can be well supported, ultimately leading to less reliance on drugs and fewer HIV-related illnesses. The E-newsletter archives on my website (www.jonkaiser.com) provides in-depth articles on how to supplement each of these hormones to your greatest advantage (see issues 12/02 through 5/03).
NV: You have been a trendsetter in the HIV medical world. Do you think physicians would embrace the use of micronutrients as a pharmacological intervention for side effect management?
JK: Yes, I do. There would need to be one or two very compelling studies (which I hope to do) that attract other researchers who had an open mind to study the effects of high-dose micronutrients in HIV disease. Once other researchers become involved, I believe there would be a great deal of important data generated that would convince HIV treatment providers that micronutrients can provide real benefits.
Remember, HIV has always been a condition that has been able to break down barriers for patients needing to access new treatments. This is primarily because the scientific community is trying to improve the standard level of care which is presently unable to guarantee our patients long and healthful lives.
Thank you very much for allowing me to share this information with your readership.
NV: And thank you, Doctor.
Uridine- Nucleomaxx- A supplement that may help to reverse lipoatrophy- Interview with Dr Walker
I had the pleasure to meet Dr. Walker after his oral presentation on Uridine and mitchondrial toxicity at the Lipodystrophy Conference in Paris. I was very excited to see his in vitro data on how this supplement may protect liver cell mitochondria exposed to D4T (Zerit) and DDC (Hivid). He gladly agreed to be interviewed for our newsletter. I am looking forward to seeing more data on this exciting approach that may make it possible for many of us to take nucleosides without the long term mitochondrial toxicity related side effects.
Dr. Ulrich A. Walker underwent his medical school education at the University of Tübingen/Germany and at the University of Michigan (AnnArbor/ MI) and graduating in 1991. He recieved his specialization in Internal Medicine, Rheumatology and Allergology at the University of Freiburg/ Germany. He did postdoctoral studies (3 years) with focus on mitochondrial genetics and metabolism at the Neuromuscular Research Centre in Melbourne/ Australia and at Columbia University (NYC, NY). He has also been director of a research lab on mitochondrial genetics and metabolism since 1999 and is currently anAssociate professor in Internal Medicine at the University of Freiburg/Germany since 2003. Dr Ulrich has also been a consultant doctor and medical director of the HIV outpatient care unit at the University of Freiburg/Germany since 2000.
NV: Doctor Walker, What is Uridine?
UAW: Uridine is a particular "nucleoside" which is used by our body to produce DNA. Uridine is also required for many other metabolic pathways - for example uridine is needed to produce glycogen. Uridine is a natural substance in our body. Humans are normally able to produce uridine, but the ability to do so requires intact mitochondria.
NV: How does Uridine reduce mitochondrial toxicity caused by nucleosides?
UAW: Our current research supports the following concept: One class of anti-HIV drugs are the so called "nucleoside reverse transcriptase inhibitors" (NRTIs). As the name implies, the NRTIs are themselves nucleosides ("nukes"). The NRTIs are "bad nukes", as they are toxic to mitochondria. This is because they inhibit gamma polymerase, an enzyme that is essential for the replication of mitochondrial DNA. As a consequence, the levels of mitochondrial DNA in mitochondria decline. Mitochondrial DNA however is necessary for the proper function of the respiratory chain (this is were we "breathe internally," consume oxygen and make ATP as the energy for our body. Another consequence of respiratory chain dysfunction is that the body cannot make uridine and other natural nucleosides (the "good nukes").
Therefore, the NRTI-nucleosides ("the bad nukes") are more abundant in relation to the natural nucleosides ("the good nukes") at gamma polymerase. This excess of the bad nukes makes mitochondrial function even worse, because a vicious circle is closed. Uridine replenishes the good nukes and therefore abolishes this vicious circle.
NV: Your research shows that the dose use invitro studies was 200 micromoles. What does that translate to in a 150 Lb man?
UAW: We have shown full protection at a concentration of 200 µM but there were some indications of improvement starting at about 50 µM. Other researchers looked at the effect of zidovudine (AZT) on blood cells in vitro and in mice and have shown protection at 50 µM.
Uridine can be bought at the chemist but the costs there are prohibitive to be used long-term by anybody. NucleomaxX is a dietary supplement that comes in sachets to be dissolved in water, milk or juice. It contains Mitocnol, a sugar cane extract with high amounts (18%) of nucleosides. We have discovered, that a single sachet of NucleomaxX increases the dose to more than 100 µM (for example in myself (190 Lb) to 105 µM. Repeated doses increase the serum concentrations even more.
NV: Your research so far shows promising results in liver cells that have been exposed to D4T, DDC, AZT+3TC. Are you planning to conduct studies to see the effect on fat, muscle and nerve cells?
UAW: Several studies looking at liver, fat, peripheral nerves, lactate, anemia and leucopenia in humans have been approved or are currently submitted.
NV: Are you currently performing any in vivo studies? If so, what are the variables you are looking at?
UAW: Other than the studies in humans discussed above, we are currently looking at mice, measuring mitochondrial DNA and mitochondrial function in every relevant tissue. We have not yet finished our experiments but I can say that the mice drink NucleomaxX without any apparent problem and that high uridine serum levels are achieved.
NV: What is the human dose?
UAW: We don’t know for certain yet. The experience from our in vitro work and from a very limited number of HIV-patients suggests that uridine resets the mitochondrial clock, thus supporting an intermittent dosing schedule. NucleomaxX is recommended to be taken on three consecutive days on each month. 7.
NV: How can anyone order the product?
UAW: Please refer to the NucleomaxX website www.nucleomaxX.com.
NV: Your research shows that Uridine may not work for mitochondrial toxicity related to DDI. Could you tell us why?
UAW: Nucleosides can be divided into two chemical classes, namely the "pyrimidines" (such as stavudine, zidovudine, zalcitabine, lamivudine) and the "purines", such as DDI (didanosine). Uridine itself is also a pyrimidine and thus does not block vicious circles caused by purines at the mitochondrial gamma polymerase. 9. You mention that the use of supplements like carnitine , thiamine, riboflavin and Coenzyme Q-10 have shown disappointing results in protecting the mitochondria against nucleosides. The HIV positive community in the US is using these products a lot. Should we stop using them? What would the effect be in we combined these supplements with Uridine? Would they work synergistically?
We have tested the above-mentioned supplements in our system but did not find any benefit. You may continue these supplements if you like as they are not harmful. I just would not put too much hope (and money) into them. I have no information on synergism.
NV:. There was a concern that Uridine may affect blood levels of nucleosides. It seems that your in vitro studies show that Uridine may increase blood levels and enhance the antiviral effect of nucleosides. Could you elaborate?
UAW: The increase of uridine blood levels is a desired effect. Our in vitro work and work by others did not show a significant interaction with the anti-HIV efficacy of antiretrovirals, but I think this still needs a watchful eye.
NV: Even though Uridine improves mitochondrial function of liver cells exposed to DDC, it seemed that the mitochondrial DNA was not restored to baseline values. Does this have any significance?
UAW: Probably not. This is because mitochondria seem to work badly only when mitochondrial DNA drops below a certain threshold (about 20% of baseline). Therefore mitochondrial function in our experiments was fully restored despite the fact that the levels of mitochondrial DNA did not fully return to baseline.
NV: Could Uridine be used to prevent AZT induced anemia and leucopoenia?
UAW: Yes, studies in vitro and studies in mice have shown this.
NV: What are the potential side effects of Uridine?
UAW: The dose-limiting effect in Uridine studies so far was a mild diarrhea with excessive doses. The diarrhea stopped immediately when Uridine was discontinued. We have not yet observed this with NucleomaxX.
NV: You mentioned in Paris that the old studies of Uridine were done in IV formulations and that you have a more bioavailable oral formulation. Can you expand on this?
UAW: This is probably a misunderstanding because intravenous Uridine is more bioavailable than oral Uridine.
NV: Any plans for US studies?
UAW: One study will look at lipodystrophy under Stavudine and is currently being submitted.
NV: Thank you Doctor.
Dr. Ulrich A. Walker underwent his medical school education at the University of Tübingen/Germany and at the University of Michigan (AnnArbor/ MI) and graduating in 1991. He recieved his specialization in Internal Medicine, Rheumatology and Allergology at the University of Freiburg/ Germany. He did postdoctoral studies (3 years) with focus on mitochondrial genetics and metabolism at the Neuromuscular Research Centre in Melbourne/ Australia and at Columbia University (NYC, NY). He has also been director of a research lab on mitochondrial genetics and metabolism since 1999 and is currently anAssociate professor in Internal Medicine at the University of Freiburg/Germany since 2003. Dr Ulrich has also been a consultant doctor and medical director of the HIV outpatient care unit at the University of Freiburg/Germany since 2000.
NV: Doctor Walker, What is Uridine?
UAW: Uridine is a particular "nucleoside" which is used by our body to produce DNA. Uridine is also required for many other metabolic pathways - for example uridine is needed to produce glycogen. Uridine is a natural substance in our body. Humans are normally able to produce uridine, but the ability to do so requires intact mitochondria.
NV: How does Uridine reduce mitochondrial toxicity caused by nucleosides?
UAW: Our current research supports the following concept: One class of anti-HIV drugs are the so called "nucleoside reverse transcriptase inhibitors" (NRTIs). As the name implies, the NRTIs are themselves nucleosides ("nukes"). The NRTIs are "bad nukes", as they are toxic to mitochondria. This is because they inhibit gamma polymerase, an enzyme that is essential for the replication of mitochondrial DNA. As a consequence, the levels of mitochondrial DNA in mitochondria decline. Mitochondrial DNA however is necessary for the proper function of the respiratory chain (this is were we "breathe internally," consume oxygen and make ATP as the energy for our body. Another consequence of respiratory chain dysfunction is that the body cannot make uridine and other natural nucleosides (the "good nukes").
Therefore, the NRTI-nucleosides ("the bad nukes") are more abundant in relation to the natural nucleosides ("the good nukes") at gamma polymerase. This excess of the bad nukes makes mitochondrial function even worse, because a vicious circle is closed. Uridine replenishes the good nukes and therefore abolishes this vicious circle.
NV: Your research shows that the dose use invitro studies was 200 micromoles. What does that translate to in a 150 Lb man?
UAW: We have shown full protection at a concentration of 200 µM but there were some indications of improvement starting at about 50 µM. Other researchers looked at the effect of zidovudine (AZT) on blood cells in vitro and in mice and have shown protection at 50 µM.
Uridine can be bought at the chemist but the costs there are prohibitive to be used long-term by anybody. NucleomaxX is a dietary supplement that comes in sachets to be dissolved in water, milk or juice. It contains Mitocnol, a sugar cane extract with high amounts (18%) of nucleosides. We have discovered, that a single sachet of NucleomaxX increases the dose to more than 100 µM (for example in myself (190 Lb) to 105 µM. Repeated doses increase the serum concentrations even more.
NV: Your research so far shows promising results in liver cells that have been exposed to D4T, DDC, AZT+3TC. Are you planning to conduct studies to see the effect on fat, muscle and nerve cells?
UAW: Several studies looking at liver, fat, peripheral nerves, lactate, anemia and leucopenia in humans have been approved or are currently submitted.
NV: Are you currently performing any in vivo studies? If so, what are the variables you are looking at?
UAW: Other than the studies in humans discussed above, we are currently looking at mice, measuring mitochondrial DNA and mitochondrial function in every relevant tissue. We have not yet finished our experiments but I can say that the mice drink NucleomaxX without any apparent problem and that high uridine serum levels are achieved.
NV: What is the human dose?
UAW: We don’t know for certain yet. The experience from our in vitro work and from a very limited number of HIV-patients suggests that uridine resets the mitochondrial clock, thus supporting an intermittent dosing schedule. NucleomaxX is recommended to be taken on three consecutive days on each month. 7.
NV: How can anyone order the product?
UAW: Please refer to the NucleomaxX website www.nucleomaxX.com.
NV: Your research shows that Uridine may not work for mitochondrial toxicity related to DDI. Could you tell us why?
UAW: Nucleosides can be divided into two chemical classes, namely the "pyrimidines" (such as stavudine, zidovudine, zalcitabine, lamivudine) and the "purines", such as DDI (didanosine). Uridine itself is also a pyrimidine and thus does not block vicious circles caused by purines at the mitochondrial gamma polymerase. 9. You mention that the use of supplements like carnitine , thiamine, riboflavin and Coenzyme Q-10 have shown disappointing results in protecting the mitochondria against nucleosides. The HIV positive community in the US is using these products a lot. Should we stop using them? What would the effect be in we combined these supplements with Uridine? Would they work synergistically?
We have tested the above-mentioned supplements in our system but did not find any benefit. You may continue these supplements if you like as they are not harmful. I just would not put too much hope (and money) into them. I have no information on synergism.
NV:. There was a concern that Uridine may affect blood levels of nucleosides. It seems that your in vitro studies show that Uridine may increase blood levels and enhance the antiviral effect of nucleosides. Could you elaborate?
UAW: The increase of uridine blood levels is a desired effect. Our in vitro work and work by others did not show a significant interaction with the anti-HIV efficacy of antiretrovirals, but I think this still needs a watchful eye.
NV: Even though Uridine improves mitochondrial function of liver cells exposed to DDC, it seemed that the mitochondrial DNA was not restored to baseline values. Does this have any significance?
UAW: Probably not. This is because mitochondria seem to work badly only when mitochondrial DNA drops below a certain threshold (about 20% of baseline). Therefore mitochondrial function in our experiments was fully restored despite the fact that the levels of mitochondrial DNA did not fully return to baseline.
NV: Could Uridine be used to prevent AZT induced anemia and leucopoenia?
UAW: Yes, studies in vitro and studies in mice have shown this.
NV: What are the potential side effects of Uridine?
UAW: The dose-limiting effect in Uridine studies so far was a mild diarrhea with excessive doses. The diarrhea stopped immediately when Uridine was discontinued. We have not yet observed this with NucleomaxX.
NV: You mentioned in Paris that the old studies of Uridine were done in IV formulations and that you have a more bioavailable oral formulation. Can you expand on this?
UAW: This is probably a misunderstanding because intravenous Uridine is more bioavailable than oral Uridine.
NV: Any plans for US studies?
UAW: One study will look at lipodystrophy under Stavudine and is currently being submitted.
NV: Thank you Doctor.
Friday, April 21, 2006
The Chipmunk look that noone talks about
I have been seeing many HIV positive men with enlarged parotid glands in my 14 years of travels giving lectures around the country. I was also one of those men with moderate inflammation of the parotid glands. No one really knows what causes this disfiguring inflammation. It could be due to the HIV virus itself, inflammatory cytokines and too many CD8 cells produced by immune reconstitution, hormones, fat build up in the glands, etc. Some people have this problem along with facial wasting, which makes their faces look very abnormal. So even if you treat your facial wasting with facial fillers, this problem needs to be treated so that you can attain a more normal look that resembles what you normally would look like without the effects of HIV and its medications. The parotid gland is the largest of the salivary glands that produce saliva that is important in the digestion of food. The gland lies under the angle of the jaw just beneath the ear. I have been searching for a long time for an answer. Not a single HIV conference has had a presentation on this problem that may affect around 20 percent of men with HIV. It does not seem to affect as many women with HIV for unknown reasons. I had heard about radiation treatments in the past but they created severe side effects like burning of the salivary glands, salivary production problems, and eventual tooth decay. A few months ago my dear friend Dr. Ton y Mills from Los Angeles called me to tell me about the great results he had seen in his patients referred to Dr Patricia Gordon. I decided to call Dr. Gordon myself to talk to her about her experiences. Dr. Gordon did her undergrad at Harvard and her residency at UCLA. She is a radiation oncologist and practices at Century City Hospital in Los Angeles. A very pleasant and seemingly dedicated doctor, she immediately told me how happy she was with the excellent remission rates she had been seen in her patients. Most noticed complete resolution of the problem after a few sessions of low dose electron-based radiation. She stressed the fact that this protocol differs greatly from the ones used in the past that created greater side effects because of the nature of the radiation, Unlike the old method that used photons that penetrate the skin more deeply, she uses electrons that penetrate a very thin layer of tissue instead, so they do not cause the burning and salivary gland dysfunction seen in the past. She has had over 200 male patients referred to her practice (not one female has been referred). At baseline, all patients get a CT scan of their parotid gland area for assessment. They get a customized molded lead mask that only exposes the area to be treated. They then receive 16 sessions (once a day for five days a week, for five minutes each) on both sides of the face. She said that most patients see improvements after four sessions. However, she did not have before and after pictures to share with me. All procedures have been reimbursable by Medicare and insurance. I decided to get my parotid glands treated and I am happy to say that they got back to normal after 7 sessions. It has been 4 years now (March 2006) and they are still normal ! I had no significant side effects besides redness for a few days, no beard for a month (which I liked), and a temporary loss of normal saliva production. All returned to normal after a month or so. I am not sure, but I think I had a slight decrease in CD4 cells (around 20) but this is hard to tell unless someone performs a controlled study. My CD4 cells also returned baseline after two months. Dr. Gordon will publish a paper on her experiences soon. Her phone number is 310-201-6739. Her email is _pgordonmd@aol.com_ (mailto:pgordonmd@aol.com) .She is happy to talk to doctors or patients about this procedure. (http://www.facialwasting.org/pages/891053/index.htm)
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