Showing posts with label HIV Drugs. Show all posts
Showing posts with label HIV Drugs. Show all posts

Sunday, January 30, 2011

Luc Montagnier, Nobel Prize Winner, Takes Homeopathy Seriously

Posted: January 30, 2011 11:49 AM


Dr. Luc Montagnier, the French virologist who won the Nobel Prize in 2008 for discovering the AIDS virus, has surprised the scientific community with his strong support for homeopathic medicine.
In a remarkable interview published in Science magazine of December 24, 2010, (1) Professor Luc Montagnier, has expressed support for the often maligned and misunderstood medical specialty of homeopathic medicine. Although homeopathy has persisted for 200+ years throughout the world and has been the leading alternative treatment method used by physicians in Europe, (2) most conventional physicians and scientists have expressed skepticism about its efficacy due to the extremely small doses of medicines used.

Most clinical research conducted on homeopathic medicines that has been published in peer-review journals have shown positive clinical results,(3, 4) especially in the treatment of respiratory allergies (5, 6), influenza, (7) fibromyalgia, (8, 9) rheumatoid arthritis, (10) childhood diarrhea, (11) post-surgical abdominal surgery recovery, (12) attention deficit disorder, (13) and reduction in the side effects of conventional cancer treatments. (14) In addition to clinical trials, several hundred basic science studies have confirmed the biological activity of homeopathic medicines. One type of basic science trials, called in vitro studies, found 67 experiments (1/3 of them replications) and nearly 3/4 of all replications were positive. (15, 16)

In addition to the wide variety of basic science evidence and clinical research, further evidence for homeopathy resides in the fact that they gained widespread popularity in the U.S. and Europe during the 19th century due to the impressive results people experienced in the treatment of epidemics that raged during that time, including cholera, typhoid, yellow fever, scarlet fever, and influenza.
Montagnier, who is also founder and president of the World Foundation for AIDS Research and Prevention, asserted, "I can't say that homeopathy is right in everything. What I can say now is that the high dilutions (used in homeopathy) are right. High dilutions of something are not nothing. They are water structures which mimic the original molecules."

Here, Montagnier is making reference to his experimental research that confirms one of the controversial features of homeopathic medicine that uses doses of substances that undergo sequential dilution with vigorous shaking in-between each dilution. Although it is common for modern-day scientists to assume that none of the original molecules remain in solution, Montagnier's research (and other of many of his colleagues) has verified that electromagnetic signals of the original medicine remains in the water and has dramatic biological effects.

Montagnier has just taken a new position at Jiaotong University in Shanghai, China (this university is often referred to as "China's MIT"), where he will work in a new institute bearing his name. This work focuses on a new scientific movement at the crossroads of physics, biology, and medicine: the phenomenon of electromagnetic waves produced by DNA in water. He and his team will study both the theoretical basis and the possible applications in medicine.

Montagnier's new research is investigating the electromagnetic waves that he says emanate from the highly diluted DNA of various pathogens. Montagnier asserts, "What we have found is that DNA produces structural changes in water, which persist at very high dilutions, and which lead to resonant electromagnetic signals that we can measure. Not all DNA produces signals that we can detect with our device. The high-intensity signals come from bacterial and viral DNA."

Montagnier affirms that these new observations will lead to novel treatments for many common chronic diseases, including but not limited to autism, Alzheimer's disease, Parkinson's disease, and multiple sclerosis.

Montagnier first wrote about his findings in 2009, (17) and then, in mid-2010, he spoke at a prestigious meeting of fellow Nobelists where he expressed interest in homeopathy and the implications of this system of medicine. (18)

French retirement laws do not allow Montagnier, who is 78 years of age, to work at a public institute, thereby limiting access to research funding. Montagnier acknowledges that getting research funds from Big Pharma and certain other conventional research funding agencies is unlikely due to the atmosphere of antagonism to homeopathy and natural treatment options.

Support from Another Nobel Prize winner

Montagnier's new research evokes memories one of the most sensational stories in French science, often referred to as the 'Benveniste affair.' A highly respected immunologist Dr. Jacques Benveniste., who died in 2004, conducted a study which was replicated in three other university laboratories and that was published in Nature (19). Benveniste and other researchers used extremely diluted doses of substances that created an effect on a type of white blood cell called basophils.

Although Benveniste's work was supposedly debunked, (20) Montagnier considers Benveniste a "modern Galileo" who was far ahead of his day and time and who was attacked for investigating a medical and scientific subject that orthodoxy had mistakenly overlooked and even demonized.
In addition to Benveniste and Montagnier is the weighty opinion of Brian Josephson, Ph.D., who, like Montagnier, is a Nobel Prize-winning scientist.

Responding to an article on homeopathy in New Scientist, Josephson wrote:
Regarding your comments on claims made for homeopathy: criticisms centered around the vanishingly small number of solute molecules present in a solution after it has been repeatedly diluted are beside the point, since advocates of homeopathic remedies attribute their effects not to molecules present in the water, but to modifications of the water's structure.
Simple-minded analysis may suggest that water, being a fluid, cannot have a structure of the kind that such a picture would demand. But cases such as that of liquid crystals, which while flowing like an ordinary fluid can maintain an ordered structure over macroscopic distances, show the limitations of such ways of thinking. There have not, to the best of my knowledge, been any refutations of homeopathy that remain valid after this particular point is taken into account.

A related topic is the phenomenon, claimed by Jacques Benveniste's colleague Yolène Thomas and by others to be well established experimentally, known as "memory of water." If valid, this would be of greater significance than homeopathy itself, and it attests to the limited vision of the modern scientific community that, far from hastening to test such claims, the only response has been to dismiss them out of hand. (21)
Following his comments Josephson, who is an emeritus professor of Cambridge University in England, was asked by New Scientist editors how he became an advocate of unconventional ideas. He responded:
I went to a conference where the French immunologist Jacques Benveniste was talking for the first time about his discovery that water has a 'memory' of compounds that were once dissolved in it -- which might explain how homeopathy works. His findings provoked irrationally strong reactions from scientists, and I was struck by how badly he was treated. (22)
Josephson went on to describe how many scientists today suffer from "pathological disbelief;" that is, they maintain an unscientific attitude that is embodied by the statement "even if it were true I wouldn't believe it."
Even more recently, Josephson wryly responded to the chronic ignorance of homeopathy by its skeptics saying, "The idea that water can have a memory can be readily refuted by any one of a number of easily understood, invalid arguments."

In the new interview in Science, Montagnier also expressed real concern about the unscientific atmosphere that presently exists on certain unconventional subjects such as homeopathy, "I am told that some people have reproduced Benveniste's results, but they are afraid to publish it because of the intellectual terror from people who don't understand it."

Montagnier concluded the interview when asked if he is concerned that he is drifting into pseudoscience, he replied adamantly: "No, because it's not pseudoscience. It's not quackery. These are real phenomena which deserve further study."

The Misinformation That Skeptics Spread

It is remarkable enough that many skeptics of homeopathy actually say that there is "no research" that has shows that homeopathic medicines work. Such statements are clearly false, and yet, such assertions are common on the Internet and even in some peer-review articles. Just a little bit of searching can uncover many high quality studies that have been published in highly respected medical and scientific journals, including the Lancet, BMJ, Pediatrics, Pediatric Infectious Disease Journal, Chest and many others. Although some of these same journals have also published research with negative results to homeopathy, there is simply much more research that shows a positive rather than negative effect.

Misstatements and misinformation on homeopathy are predictable because this system of medicine provides a viable and significant threat to economic interests in medicine, let alone to the very philosophy and worldview of biomedicine. It is therefore not surprising that the British Medical Association had the sheer audacity to refer to homeopathy as "witchcraft." It is quite predictable that when one goes on a witch hunt, one inevitable finds "witches," especially when there are certain benefits to demonizing a potential competitor (homeopathy plays a much larger and more competitive role in Europe than it does in the USA).

Skeptics of homeopathy also have long asserted that homeopathic medicines have "nothing" in them because they are diluted too much. However, new research conducted at the respected Indian Institutes of Technology has confirmed the presence of "nanoparticles" of the starting materials even at extremely high dilutions. Researchers have demonstrated by Transmission Electron Microscopy (TEM), electron diffraction and chemical analysis by Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES), the presence of physical entities in these extreme dilutions. (24) In the light of this research, it can now be asserted that anyone who says or suggests that there is "nothing" in homeopathic medicines is either simply uninformed or is not being honest.

Because the researchers received confirmation of the existence of nanoparticles at two different homeopathic high potencies (30C and 200C) and because they tested four different medicines (Zincum met./zinc; Aurum met. /gold; Stannum met./tin; and Cuprum met./copper), the researchers concluded that this study provides "concrete evidence."

Although skeptics of homeopathy may assume that homeopathic doses are still too small to have any biological action, such assumptions have also been proven wrong. The multi-disciplinary field of small dose effects is called "hormesis," and approximately 1,000 studies from a wide variety of scientific specialties have confirmed significant and sometimes substantial biological effects from extremely small doses of certain substances on certain biological systems.

A special issue of the peer-review journal, Human and Experimental Toxicology (July 2010), devoted itself to the interface between hormesis and homeopathy. (25) The articles in this issue verify the power of homeopathic doses of various substances.

In closing, it should be noted that skepticism of any subject is important to the evolution of science and medicine. However, as noted above by Nobelist Brian Josephson, many scientists have a "pathological disbelief" in certain subjects that ultimately create an unhealthy and unscientific attitude blocks real truth and real science. Skepticism is at its best when its advocates do not try to cut off research or close down conversation of a subject but instead explore possible new (or old) ways to understand and verify strange but compelling phenomena. We all have this challenge as we explore and evaluate the biological and clinical effects of homeopathic medicines.

REFERENCES:
(1) Enserink M, Newsmaker Interview: Luc Montagnier, French Nobelist Escapes "Intellectual Terror" to Pursue Radical Ideas in China. Science 24 December 2010: Vol. 330 no. 6012 p. 1732. DOI: 10.1126/science.330.6012.1732
(2) Ullman D. Homeopathic Medicine: Europe's #1 Alternative for Doctors. http://www.huffingtonpost.com/dana-ullman/homeopathic-medicine-euro_b_402490.html
(3) Linde L, Clausius N, Ramirez G, et al., "Are the Clinical Effects of Homoeopathy Placebo Effects? A Meta-analysis of Placebo-Controlled Trials," Lancet, September 20, 1997, 350:834-843.
(4) Lüdtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. Journal of Clinical Epidemiology. October 2008. doi: 10.1016/j.jclinepi.2008.06/015.
(5) Taylor, MA, Reilly, D, Llewellyn-Jones, RH, et al., Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial Series, BMJ, August 19, 2000, 321:471-476.
(6) Ullman, D, Frass, M. A Review of Homeopathic Research in the Treatment of Respiratory Allergies. Alternative Medicine Review. 2010:15,1:48-58. http://www.thorne.com/altmedrev/.fulltext/15/1/48.pdf
(7) Vickers AJ. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane Reviews. 2009.
(8) Bell IR, Lewis II DA, Brooks AJ, et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo, Rheumatology. 2004:1111-5.
(9) Fisher P, Greenwood A, Huskisson EC, et al., "Effect of Homoeopathic Treatment on Fibrositis (Primary Fibromyalgia)," BMJ, 299(August 5, 1989):365-6.
(10) Jonas, WB, Linde, Klaus, and Ramirez, Gilbert, "Homeopathy and Rheumatic Disease," Rheumatic Disease Clinics of North America, February 2000,1:117-123.
(11) Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D, Homeopathy for Childhood Diarrhea: Combined Results and Metaanalysis from Three Randomized, Controlled Clinical Trials, Pediatr Infect Dis J, 2003;22:229-34.
(12) Barnes, J, Resch, KL, Ernst, E, "Homeopathy for Post-Operative Ileus: A Meta-Analysis," Journal of Clinical Gastroenterology, 1997, 25: 628-633.
(13) M, Thurneysen A. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur J Pediatr. 2005 Dec;164(12):758-67. Epub 2005 Jul 27.
(14) Kassab S, Cummings M, Berkovitz S, van Haselen R, Fisher P. Homeopathic medicines for adverse effects of cancer treatments. Cochrane Database of Systematic Reviews 2009, Issue 2.
(15) Witt CM, Bluth M, Albrecht H, Weisshuhn TE, Baumgartner S, Willich SN. The in vitro evidence for an effect of high homeopathic potencies--a systematic review of the literature. Complement Ther Med. 2007 Jun;15(2):128-38. Epub 2007 Mar 28.
(16) Endler PC, Thieves K, Reich C, Matthiessen P, Bonamin L, Scherr C, Baumgartner S. Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10-23: a bibliometric study. Homeopathy, 2010; 99: 25-36.
(17) Luc Montagnier, Jamal Aissa, Stéphane Ferris, Jean-Luc Montagnier, Claude Lavallee, Electromagnetic Signals Are Produced by Aqueous Nanostructures Derived from Bacterial DNA Sequences. Interdiscip Sci Comput Life Sci (2009) 1: 81-90.
http://www.springerlink.com/content/0557v31188m3766x/fulltext.pdf
(18) Nobel laureate gives homeopathy a boost. The Australian. July 5, 2010. http://www.theaustralian.com.au/news/health-science/nobel-laureate-gives-homeopathy-a-boost/story-e6frg8y6-1225887772305
(19) Davenas E, Beauvais F, Amara J, et al. (June 1988). "Human basophil degranulation triggered by very dilute antiserum against IgE". Nature 333 (6176): 816-8.
(20) Maddox J (June 1988). "Can a Greek tragedy be avoided?". Nature 333 (6176): 795-7.
(21) Josephson, B. D., Letter, New Scientist, November 1, 1997.
(22) George A. Lone Voices special: Take nobody's word for it. New Scientist. December 9, 2006.
(23) Personal communication. Brian Josephson to Dana Ullman. January 5, 2011.
(24) Chikramane PS, Suresh AK, Bellare JR, and Govind S. Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective. Homeopathy. Volume 99, Issue 4, October 2010, 231-242.
(25) Human and Experimental Toxicology, July 2010: http://het.sagepub.com/content/vol29/issue7/
To access free copies of these articles, see: http://www.siomi.it/siomifile/siomi_pdf/BELLE_newsletter.pdf

Tuesday, November 2, 2010

Pastor: "Jesus Was HIV-Positive"

Pastor Xola Skosana x390 (fair, no credit) | ADVOCATE.COM

A pastor in South Africa has shocked churchgoers with a series of sermons claiming Jesus was HIV-positive.


"Today I will start with a three-part sermon on: Jesus was HIV-positive," Xola Skosana said in a recent Sunday service in Cape Town, in a move intended to fight the stigma surrounding the virus.

Read more on Skosana's service on HIVPlusMag.com.

While some are outraged at South African Pastor's Xola Skosana's words because they portray Jesus Christ as possibly being sexually promiscuous, the pastor told followers that Jesus frequently put himself in the position of the poor or sick population.

Skosana also said he used the example to illustrate the stigma that HIV/AIDS still has on South Africans and people around the world.

"Of course, there's no scientific evidence that Jesus had the HI virus in his bloodstream," the pastor said according to the BBC. "The best gift we can give to people who are HIV-positive is to help de-stigmatise Aids and create an environment where they know God is not against them, he's not ashamed of them."

Watch House of Numbers to learn more about HIV and AIDS. 

Source: http://advocate.com/News/Daily_News/2010/11/01/Sermon_Jesus_Was_HIV_Positive/
Source: http://hivplusmag.com/NewsStory.asp?id=22044&sd=11/01/2010

Thursday, September 2, 2010

AIDS Quest to Kill `Sleeping' Virus Enlists Merck Cancer Drug

HIV AIDS Cocktail Medications
The 30-year-long search for a cure for AIDS, the world’s deadliest viral infection, may get a renewed boost from an unlikely source: a little-used Merck & Co. cancer drug.

Researchers at the University of North Carolina in Chapel Hill plan to test Merck’s drug, Zolinza, next year in about 20 people infected with HIV, the AIDS virus. The goal is to determine if Zolinza, or a medicine like it, can force HIV out of cells where it can reside, concealed from attack by potent antiviral treatments, said David Margolis, a professor of medicine who’s leading the research.

While AIDS drug cocktails can eliminate more than 99 percent of virus from an infected person, the treatment isn’t a cure because a remnant of the virus remains hidden in certain cells. For years, scientists have sought a simple way to drive the remaining virus into the bloodstream where the drugs can clear them from the body. Zolinza, approved in 2006 for use against a rare type of blood cancer, may work by blocking an enzyme that helps the virus avoid detection.

“It’s really all about trying to move the field ahead,” Margolis said in a telephone interview. “We don’t expect to cure anybody, but we expect to really show whether it can work the way we think it does in people -- or not.”

Zolinza earned Whitehouse Station, New Jersey-based Merck $15 million in 2008, the last year it disclosed sales of the drug, for treating a malignancy of white blood cells that affects the skin. In a laboratory test published last year, Margolis used the medicine to coax HIV out of hiding in cells taken from infected patients. Now he wants to replicate the result inside the body. Success would show he’s on the right track to finding a cure.

Mysterious Illness 

“There is a good chance that it will cause some activation of latently infected cells,” said Robert Siliciano, a professor of medicine at Johns Hopkins University in Baltimore who first identified the cells in which HIV hides out, and isn’t involved in the Zolinza trial. “Nobody knows if it will work, but it’s important to try.”

AIDS was first observed as a mysterious illness among gay men in the U.S. in 1981, the same year Margolis started medical school at Harvard University in Boston. Since then it’s killed more than 25 million people, mostly in Africa.

Medicines developed over the past 20 years by companies including GlaxoSmithKline Plc and Bristol-Myers Squibb Co. control HIV without purging it from the body. Combination regimens can drive virus levels down so low that patients can live healthy lives. But since a small amount of the virus can remain hidden, the infection can re-emerge and endanger patients if treatments are ended.
“We’re never going to cure anybody unless we go for this latent pool,” Siliciano said. In May he received $360,000 from the New York-based Foundation for AIDS Research to identify drugs approved for other diseases that may work against latent HIV, just as Margolis is doing.

Increasing Investments 

The costs of treating HIV rise every year as more people become infected, and because people need to stay on medication to keep HIV at bay. President Barack Obama in February requested $14.1 billion for the treatment and care of AIDS patients in the U.S. next year, 6.8 percent more than the $13.2 billion in the 2010 federal budget, according to a report by the Kaiser Family Foundation, a Menlo Park, California-based nonprofit health research group.

Governments, companies and foundations are increasing their investments in cure research, spurred by treatment costs, advances in science and the failure of researchers to develop a vaccine. The U.S. National Institutes of Health last month offered $8.5 million a year for five years for research projects aimed at finding a cure. The Foundation for AIDS Research in May gave $1 million to four research groups in Sweden and the U.S. for the same purpose.

‘Hopeless Problem’ 

“It’s gone from being a hopeless problem to one that people think we should devote a big effort to,” Siliciano said. “I used to be very pessimistic about the likelihood of finding a cure. I guess I’m less so.”

Gilead Sciences Inc., the world’s biggest maker of AIDS medicines, started work on finding a cure in 2009 and wants to test an experimental drug in monkeys next year. Johnson & Johnson’s Tibotec unit, which also started looking for a cure last year, is screening thousands of compounds and plans to design experiments in rodents and monkeys that would allow it to test the most promising candidates.
“We should not and cannot continue to accept that HIV is a long-term chronic illness that commits patients to lifelong treatment with associated toxicities,” said Sharon Lewin, head of infectious diseases at the Alfred Hospital in Melbourne. “In the absence of an effective vaccine, we must seriously pursue the possibility of cure,” Lewin said in a speech at the International AIDS Conference in Vienna last month.

Scientists are exploring two main ways of clearing viral reservoirs. The first involves reducing them to such low levels they can be corralled by the immune system, allowing patients to go off medications without the virus rebounding. The second strategy involves making patients resistant to HIV infection by giving them a genetic mutation that makes it impossible for the virus to enter cells.

Lasting Damage 

The Zolinza trial is part of the first effort. Margolis said his work was inspired by the failure of a Dutch study a decade ago. The scientists tried to flush out HIV using antibodies, proteins made naturally by the body to fight infection, to activate all the cells that typically host latent virus. The treatment over-stimulated the subjects’ immune systems, causing lasting damage to some patients.
“Pretty much since that time I’ve been looking at selectively purging the virus without activating the cell,” Margolis said.

He published a paper in the journal Lancet in 2005 showing that Depakote, an approved treatment for bipolar disorder made by Abbott Laboratories, reduced the number of infected resting cells by as much as 84 percent when combined with Roche Holding AG’s AIDS drug Fuzeon, in a study involving four patients. Subsequent research by Margolis and others contradicted those findings.

“David deserves a lot of credit for moving the field with those initial studies,” Daria Hazuda, Merck’s worldwide antiviral franchise head, said in a telephone interview.

Viral Kickstart 

Now Margolis is trying again with Zolinza. Like Depakote, Zolinza targets an enzyme called histone deacetylase, or HDAC, that helps HIV go to sleep in cells by interfering with its ability to replicate. By blocking HDAC, Zolinza would reactivate the virus, kickstarting reproduction.

From there, nature would take its course: HIV would exit and kill its host cell, and enter the bloodstream in search of new cells to infect. Anti-AIDS drugs would prevent it from doing so, and with nowhere left to go, the virus would die after several hours.

Margolis and his colleagues plan to give about 20 patients a few doses of Zolinza, then measure whether it’s had any effect on the amount of virus the immune cells are producing. That will tell them whether they’ve succeeded in disturbing the reservoir.

Zolinza, also known as SAHA, may not be suitable as a cure for AIDS because of its potential to cause genetic mutations that lead to cancer, Margolis said. The U.S. Food and Drug Administration accepts that risk when the drug is being used in patients who already have cancer. It probably won’t tolerate the risk for use in other diseases, Margolis said.

‘Getting a Tan’ 

The FDA has approved the trial “because we will so severely limit the exposure to SAHA that the risk of inducing cancer is felt to be negligible, like getting on a plane and taking a flight to New York, or lying on the beach and getting a tan,” he said.

Margolis plans to apply to the NIH for funding “in the next few weeks.” If the trial succeeds or fails early, it may cost less than $500,000. A longer trial may cost as much as $1.5 million over three years, he said.

Merck supports the study, and is continuing its own research on other drugs that it might be able to combine with HDAC inhibitors, Hazuda said.

“Everybody has now come to the conclusion that it’s going to take a combination of different approaches,” Hazuda said. “Because there are HDAC inhibitors that are already licensed to treat other diseases, they may provide at least an anchor upon which to build a first-generation regimen.

Collateral Damage 

Gilead is also experimenting with about a dozen families of its own HDAC inhibitors, said Romas Geleziunas, the company’s director of biology. The aim is to select one to test in monkeys as early as next year. The challenge is identifying a drug that’s powerful enough to activate HIV and not so powerful it causes collateral damage, he said in a telephone interview.

Geleziunas said he has “no idea” what the research project might mean for Gilead commercially.
“We’re all just trying to get our heads around the science, and trying to prove that in animal models these things have even a slight hope of working,” he said. “I really have no idea where this is going to go.”

Tibotec isn’t limiting itself to HDAC inhibitors, said Bruce Malcolm, the Beerse, Belgium-based company’s senior director of HIV research and early development.

“We’re casting a wide net,” Malcolm said in a telephone interview. “We’ll go about looking for anything and everything that proves useful, especially since we feel in the end it will probably be some combination of compounds that will be put together that will lead to the best efficacy and minimal toxicity.”

Berlin Patient

The second strategy has scientists looking for clues from the only person known to have been cured of HIV. The man, who researchers call “the Berlin patient,” was a leukemia sufferer who received a bone marrow transplant from a donor resistant to HIV in 2006. The donor’s cells lacked a protein on the surface called CCR5 that the virus needs to latch on. Without it, the virus can’t get a grip on the cell and infection is averted.

Sangamo Biosciences Inc., a biotechnology company based in Richmond, California, started two trials last year aimed at achieving the same result in a simpler way. Its approach uses a cold-causing virus as a Trojan horse to smuggle a CCR5-deleting gene into the body. The company said in November that one trial subject who had stopped taking AIDS drugs had undetectable levels of HIV one month later, though the virus was detectable after six weeks.

‘Before I Die’ 

Some scientists are skeptical a cure will be ever achieved, given HIV’s ability to integrate itself into the DNA of cells.

“We’ve never eradicated an integrated virus,” said David Cooper, director of Australia’s National Centre in HIV Epidemiology and Clinical Research. “That doesn’t mean we can’t do it, but it would be the first. At the end of the day, a vaccine is the best approach.”

Margolis is more optimistic.

“I’m 51,” says Margolis. “I’m not doing this because I think that I can’t succeed before I die.”
To contact the reporter on this story: Simeon Bennett in Singapore at sbennett9@bloomberg.net

Watch House of Numbers to learn more about AIDS drugs.  

Monday, July 19, 2010

HIV drug causes liver damage, admits FDA

Monday, July 19, 2010 by: David Gutierrez, staff writer

(NaturalNews) The HIV drug Videx (sold generically as didanosine) may cause fatal liver problems, the FDA has warned.

Since the drug's initial approval, the agency has received 42 adverse event reports linking Videx and its delayed release version Videx EC to a rare liver disorder known as non-cirrotic portal hypertension. In four of these cases, patients died from liver failure or severe bleeding. Only three patients were able to fully recover from the condition, and all of those needed a liver transplant. Patients had been undergoing treatment with the drug for anywhere from months to years.

Although it has not yet been proven that the drugs caused the liver disorder, the FDA noted that there is definitely an association between the two.

In non-cirrotic portal hypertension, blood flow through a major vein in the liver becomes constricted, causing blood to back up into the esophagus. Veins in the throat can become so enlarged that they rupture, leading to serious and potentially fatal bleeding.

Although the FDA stated that the benefits for HIV patients still outweigh the risks, it warned that Videx patients should be closely monitored for any signs of portal hypertension. Furthermore, it noted that "the decision to use this drug ... must be made on an individual basis between the treating physician and the patient."

Videx was first approved in 1991, and the delayed release version was approved in 2000. The drug is a type of antiretroviral drug known as a nucleoside analogue, and slows the proliferation of HIV to prolong the onset of AIDS and extend the life of patients.

It has previously been linked to other forms of liver damage, especially in combination with other antiretroviral drugs including hydroxyurea and ribavirin.

According to a spokesperson for manufacturer Bristol-Myers Squib, worldwide sales of the drug amounted to $71 million in 2009.

Sources for this story include: www.aboutlawsuits.com/hiv-drug-vide... online.wsj.com/article/BT-CO-20100129-714703.html?mod=WSJ_latestheadlines; www.medscape.com/viewarticle/716198.

Watch House of Numbers to learn more about HIV, AIDS and AIDS Drugs. 

Friday, April 23, 2010

Romania runs out of Aids drugs

The lives of people with HIV in Romania are being put at risk as the country runs out of drugs to keep them alive, say NGOs, while the government appears to blame the recession.


Activists have been afraid it would happen in the poorest countries of Asia or Africa. But it's happening in Europe instead. In Romania, HIV drugs are running out. People in the regions have been traveling to Bucharest to try to get their supplies, but the capital city's shelves are emptying and from this week, they will be turned away. As the Romanian Aids organisations put it, people with HIV are being sentenced to death.

Some people have had no drugs for over a month now. The reasons for the stock-outs are not entirely clear. Certainly Romania is hit by the recession, but, as an open letter from the EU HIV/Aids Civil Society Forum to the Romanian president, Traian Basescu, and his government said yesterday, other cash-hit European states have managed to keep the medicines available. It is a very serious situation for the 7,000 or so people with HIV in Romania. Antiretroviral drugs keep people alive and well, but those who start the drugs have to stay on the drugs, or the virus in their body will evolve into a drug-resistant strain. And then the drugs they were taking will not work any more. They will need other (more expensive) drugs instead. And for some, the Forum told the government in its letter, time is running out.

In particular those who as youngsters got infected in Romanian hospitals during their early childhood, between 1986 and 1992, are patients who received several drug regimens in the past, and some of them are already receiving their last treatment option. By interrupting their treatment, these people will be at great personal health risk, with the well-known public health implications on top.
The Forum - and the local NGOs - are urging the Romanian government to take steps to restore the drug supply. Money may be short, they say, but it is open to them to negotiate lower prices with the pharmaceutical industry, which they have not done. The letter also asks the government to call in the World Health Organisation for help and advice.

Depriving people of the drugs that will keep them alive is a clear breach, they say, of article 3 of the European Convention of Human Rights.

Two Romanian HIV/Aids NGOs, SENS POZITIV Association and ARAS - the Romanian Association Against AIDS, have set up a petition, here.

 ______________________________________________

Watch House of Numbers and see the Nagel Family talk about adopting their daughter from Romania, her HIV positive test, and the direction they chose to take regarding HIV treatment.

HIV/AIDS - Drug Pipeline Analysis and Market Forecasts to 2016

Published: Apr-2010   Report Code: GDHCPRT086
Report Format: Electronic PDF
 
 
GlobalData's report, “HIV/AIDS – Drug Pipeline Analysis and Market Forecasts to 2016” is an essential source of information and analysis on the global HIV/AIDS market. The report identifies the key trends shaping and driving the global HIV/AIDS market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global HIV/AIDS sector. GlobalData estimated the HIV/AIDS market was worth $12 billion in 2009. The global Human Immunodeficiency Virus (HIV) infection market will continue to grow between 2009 and 2016 at a slower rate due to a series of patent expiries during this period. The growth rate is likely to decline from 2012 onwards due to the impact of the patent expiry of key drugs. The market is characterized by a high unmet need of drugs which can cure the disease. Highly Active Antiretroviral Therapy (HAART) which requires patients to take different classes of drugs has however succeeded in achieving near zero levels of HIV in infected people. Increased uptake of HAART and increasing awareness (which leads to increased treatment seeking) will drive the market. The pipeline for HIV is strong and consists of more than 250 molecules currently in development for various disease segments.

Scope

  • The scope of the report includes:
  • Annualized global HIV/AIDS market revenues data from 2001 to 2009, forecast for seven years to 2016.
  • Geographies covered in this report are the United States (US), the United Kingdom (UK), Italy, Spain, Germany, France and Japan.
  • Pipeline analysis data providing a split across phases by mechanism of action, and the emerging trends. The key classes of mechanism of action include HIV vaccines, Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs), Protease Inhibitors (PIs), Multi-class Combination Products, Nucleoside Reverse Transcriptase Inhibitors (NRTIs), CCR5 receptor antagonists, HIV integrase inhibitors, Nucleoside analogues, Viral entry inhibitors, Maturation inhibitors and Fusion Inhibitors.
  • Analysis of the current and future market competition in the global HIV/AIDS market. The key market players covered Boehring Ingelheim, Achillion Pharmaceuticals, GlaxoSmithKline, Incyte and Pharmasset, Shire Pharmaceuticals and Tibotec Virco
  • Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
  • The key topics covered include a strategic competitor assessment, market characterization, unmet needs and implications for the future HIV/AIDS market.

Reasons to Buy

  • The report will enhance your decision making capability in a more rapid and time sensitive manner. It will allow you to:
  • Develop and design your in-licensing and out-licensing strategies through review of pipeline products and technologies and by identifying companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global HIV/AIDS market.
  • Drive revenues by understanding key trends, innovative products and technologies, market segments and companies likely to impact the global HIV/AIDS market in future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
  • What’s the next big thing in the global HIV/AIDS market landscape? – Identify, understand and capitalize.
Watch House of Numbers to see more on HIV Drugs. 
 

Tuesday, April 20, 2010

Gilead cuts 2010 sales outlook, shares fall

(Reuters) - Gilead Sciences Inc (GILD.O) posted disappointing quarterly sales for its core HIV drugs and cut its full-year forecast due to U.S. healthcare reform, sending its shares down more than 3 percent after-hours.

First-quarter sales of AIDS drug Truvada rose 11 percent to $657.8 million, while sales of Atripla, which combines Truvada with Bristol-Myers Squibb Co's (BMY.N) Sustiva into a single pill, rose 36 percent to $692.9 million.

However, analysts had expected even higher Truvada sales of $680 million and Atripla sales of $726 million, according to RBC Capital Markets.

The results followed news late on Monday that Gilead had terminated study of an experimental drug for hepatitis C because the drug was causing too much toxicity.

"Their hepatitis C program doesn't look like it's competitive and now you've got a little softness in their HIV revenue," Sanford Bernstein analyst Geoffrey Porges said, adding that investors may be "heading toward the end of their patience."

The company also lowered its outlook for 2010 sales by about $200 million to a range of $7.4 billion to $7.5 billion, citing the impact of recently passed healthcare reform. The new legislation calls on drugmakers to offer higher price rebates for government-funded health plans.

The biotech company posted a first-quarter net profit of $854.9 million, or 92 cents per share, compared with $589.1 million or 63 cents per share a year earlier.

Adjusting for acquisition expenses, restructuring costs and stock-based compensation, the company said it earned 99 cents a share for the quarter. Analysts had expected 96 cents a share, according to Thomson Reuters I/B/E/S.

Quarterly revenue rose 36 percent to $2.09 billion, while product sales rose 24 percent to $1.79 billion. Analysts had expected revenue of $2.07 billion.

Chief Financial Officer Robin Washington said on a conference call that international government pricing pressures and currency exchange rates could also affect sales.

"During the first quarter we have seen increased evidence of additional international government measures to reduce pharmaceutical expenditures including increased rebates, cancellations, and callbacks of price increases," she said.

Gilead said product sales for the quarter were reduced by $29.4 million due to the impact of U.S. healthcare reform legislation.

Royalty, contract and other revenue more than tripled to $297.8 million from $82.9 million. Gilead derives most of its royalty revenue from Roche Holding AG's (ROG.VX) sales of Tamiflu, which has seen strong demand because of the swine flu pandemic.

J&J said its experimental AIDS drug, known as TMC278, was found to be at least as effective as Bristol-Myers' Sustiva in tests the company plans to submit for regulatory approval in the third quarter. J&J is working with Gilead on a single pill that would combine TMC278 with Truvada.
The company said it expects to file for regulatory approval of the new fixed-dose regimen later this year.

Gilead shares, which closed at $45.07 on the Nasdaq, fell to $43.60 in after-hours trading.

(Additional reporting by Bill Berkrot; Editing by Andre Grenon, Richard Chang and Matthew Lewis)

Wednesday, April 14, 2010

City Endorses New Policy for Treatment of H.I.V.

Published: April 2, 2010 - By SABIN RUSSELL - NY Times 

In a major shift of H.I.V. treatment policy, San Francisco public health doctors have begun to advise patients to start taking antiviral medicines as soon as they are found to be infected, rather than waiting — sometimes years — for signs that their immune systems have started to fail. 

The new, controversial city guidelines, to be announced next week by the Department of Public Health, may be the most forceful anywhere in their endorsement of early treatment against H.I.V., the virus that causes AIDS.

Ever since combinations of antiviral drugs were found to slow progression of the disease in the mid-1990s, doctors and patients have wrestled with the question of when to begin a lifetime regimen of costly and sometimes toxic medicines. The answer remains in dispute, but public health leaders here are now making a case for a change.

Behind the policy switch is mounting evidence that patients who start early are more likely to live longer, and less likely to suffer a variety of ailments — including heart disease, kidney failure and cancer — that plague long-term survivors. Studies suggest that in the early years of infection, when a patient may show few signs of immune system failure, the virus is in fact causing permanent damage that becomes evident later.

For instance, in older patients who finally start taking the drugs, the effects of chronic inflammation take their toll.

“The impact on health risk is comparable to that of diabetes,” said Dr. Steven G. Deeks, a researcher at the University of California, San Francisco. “Their immune system may look like that of someone 30 years older.”

Dr. Diane V. Havlir, chief of the H.I.V./AIDS division at San Francisco General Hospital, said the new policy was already in effect for her patients. Although a decision whether or not to take the medicine rests with the patient, all those testing positive for H.I.V. will be offered combination therapy, with advice to pursue it.
“The history of H.I.V. disease has always been about change,” she said. “We pride ourselves on working quickly with new data.”

At the public hospital’s H.I.V. clinic, a 30-year-old man is mulling advice from Dr. C. Bradley Hare to start on antiviral drugs. He was infected four years ago, but his T-cell count, a measure of infection-fighting white blood cells, is 735, comparable to that of an uninfected, healthy adult. He is buff and athletic and feels good.

The man has decided to keep waiting. “Once you start the drugs, you can’t stop,” he said. “You know how they say, ‘If it ain’t broke, don’t fix it?’ ”

Dr. Hare has been following research on early treatment, and for the last several years he has asked his patients to think about it. Now, he is recommending it outright. He said most of his patients did not have serious problems with drug side effects. “A lot of times they have a sense of relief when they start the meds,” he said.

The turning point in San Francisco’s thinking may have been a study in The New England Journal of Medicine on April 1, 2009, that compared death rates among thousands of North American H.I.V. patients. Dr. Mari Kitahata, an epidemiologist at the University of Washington, and her team of researchers found that patients who put off therapy until their immune system showed signs of damage had a nearly twofold greater risk of dying — from any cause — than those who started treatment when their T-cell counts were above 500.

There is another motivation prompting the change. Reducing the level of virus in the population of infected people may reduce the spread of the disease.

“I do anticipate it will drive down the rates of new infections,” Dr. Mitchell H. Katz, San Francisco director of public health, said. “It’s a nice, secondary benefit of this new policy.”

Dr. Katz said that despite cuts in health budgets, a policy to add to the number of H.I.V. patients taking expensive drugs made economic sense. “H.I.V. medications have been continually proven to be cost effective,” he said, “and in this case, it is also the right thing to do.”

The program is being carried out without a clear picture of its cost to city and state health agencies. Antiviral drugs can cost $12,000 a year, consuming $350 million of the budget of California AIDS Drug Assistance Plan.

Dr. Michelle Roland, chief of the state’s Office of AIDS, said she and her counterparts across the country were working with the Centers for Disease Control and Prevention to estimate the added cost of early treatment.

In San Francisco, up to 2,000 people know they are H.I.V. positive, have healthy T-cell counts and are not yet on treatment, according to the city. Cost estimates are complicated by unknowns, like the number of patients choosing to participate, how close they were to needing treatment under the previous system and whether they had private insurance.

When the first combinations of AIDS drugs came out in 1996, the thinking was “hit early, and hit hard.” But as patients battled nasty side effects, like diarrhea and disfiguring shifts in body fat, therapy was deferred until T-cell counts fell as low as 200.

Today, with safer drugs, quick viral suppression is back in fashion.

“The field is moving, inexorably, to earlier and earlier therapy,” said Dr. Anthony Fauci, director of the National Institutes for Allergy and Infectious Diseases. He called San Francisco’s decision “an important step in that direction.”
But the proposal is highly controversial, even in San Francisco. “It’s just too risky,” said Dr. Jay Levy, the U.C.S.F. virologist who was among the first to identify the cause of AIDS. The new drugs may be less toxic, Dr. Levy said, but no one knows the effects of taking them for decades.

San Francisco’s decision follows a split vote in December by a 38-member federal panel on treatment guidelines. Only half of the H.I.V. experts gathered by the Department of Health and Human Services favored starting drugs in patients with healthy levels of more than 500 T-cells.

One panel member, James D. Neaton of the University of Minnesota School of Public Health, contends that a rigorous, randomized clinical trial is needed to show whether early intervention works. The risks of early treatment — giving powerful drugs to people at low risk of disease — - could outweigh the “modest predicted benefit,” Dr. Neaton wrote in an e-mail message. “That is why we do randomized trials.”

In 2009, the University of Minnesota began a study to find that proof. Results are expected in 2015.
Dr. Lisa C. Capaldini, who runs an AIDS practice in the Castro district, also has strong reservations. “H.I.V. behaves differently in different people,” she said.

Although Dr. Capaldini recognizes that today’s drugs are a vast improvement over earlier therapies, the program, she said “is not ready for prime time.”

But the changes make sense to Dr. Stephen Follansbee, director of H.I.V. Services for Kaiser Permanente in San Francisco, who oversees a program that covers 2,100 people with the virus.
“The idea of living in happy symbiosis with this virus is delusional,” Dr. Follansbee said. “If you have a fire in one part of the house, but not in the living room, you don’t wait for it to reach the living room before you call the fire department.”


Tuesday, March 23, 2010

Made Up Phenomenon: Can 'super bananas' tackle HIV?

Monday, 22 March 2010

The Donal MacIntyre team investigates reports that a substance in bananas called "BanLec" could be as effective as some anti-HIV drugs.
Reporter Bob Howard's suspicions about the truth of these reports were confirmed when he spoke to Professor David Markovitz from the University of Michigan whose research into bananas was being cited.
Donal MacIntyre was broadcast on BBC Radio 5 live on Sunday 21 March 2010.


Bananas prevent HIV infection (on scienceblog.com)

Chemicals found in bananas are better at preventing HIV than two current syntheticanti-HIV Drugs