Tuesday, October 9, 2007

Traditional Medicine Congress Website

Comment period for Traditional Medicine Model Extended

Traditional Medicines Congress

The comment period for a draft concept paper on a new model for the regulation of traditional medicines in the United States has been extended to June 30, 2006.

The draft document, “A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components,” was released by the Traditional Medicines (TM) Congress, made up of nine national organizations,* last November. At least 70 comments have been received to date, but the TM Congress recently received requests to extend the comment period from a number of practicing herbalists.

“From its inception the TM Congress has intended to have as broad a circle of inclusion in the process as possible. This review stage of the work to date, where the feedback by interested individuals and organizations is essential to building support for the model,” commented Bryn Clark, Dipl.O.M., Board Chair of the NCCAOM, which is part of the TM Congress. “We encourage everyone with interest in preserving access to the Oriental medicine material medica to read the draft and provide comments to let us know how it can be improved.”

Three key areas of confusion that were apparent in the initial review process are now being clarified:


The TM Congress is not suggesting that herbs that are now marketed as dietary supplements under the Dietary Supplement Health & Education Act be required to be sold as traditional medicines. Instead, the vision of the TM Congress is to create an optional new category. As envisioned, products in this new category could be labeled with their traditional uses (including medicinal uses) so long as such products conform with traditional criteria such as dose and preparation.

The TM Congress is not attempting to influence the practice of medicine or the scope of practice of any therapeutic discipline. The TM Congress drafted its regulatory model to differentiate between products that are offered for retail sale and traditional medicines that are provided directly to a patient, for example, by an acupuncturist or an herbalist. The primary focus of the model is on the first of these, and attention has been given to the need to ensure that practitioners maintain direct control over traditional medicines that they produce for their patients.

The TM Congress takes no position for or against license requirements for practitioners. Licensing for health care practitioners of every discipline is regulated on a state-by-state basis. The TM Congress has expressed neither support for nor opposition to expanding licensure requirements for any of the practitioners that use herbs in their practices, as this issue is outside of the scope of the Congress’ purpose.

A Proposed Regulatory Model for Traditional Medicines is posted online at http://www.ahpa.org/05_1129_TMCongress_ProposedModel.pdf. Comments should be emailed to TMCongressFeedback@pobox.com.

* Acupuncture and Oriental Medicine Alliance (AOMA); American Association of Naturopathic Physicians (AANP); American Association of Oriental Medicine (AAOM); American Herbalists Guild (AHG); American Herbal Products Association (AHPA); Council of Colleges of Acupuncture and Oriental Medicine (CCAOM); Medicinal Herb Consortium (MHC); National Ayurvedic Medical Association (NAMA); and National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM).

The National Certification Commission for Acupuncture and Oriental Medicine (www.nccaom.org) was established in 1982 and is incorporated as a non-profit organization under Section 501(c)(6) of the Internal Revenue code. Over 17,000 Diplomates are currently certified through NCCAOM, which is a member of the National Organization for Competency Assurance and which is accredited by the National Commission for Certifying Agencies (NCCA).


Monday, October 8, 2007

Merck and HVTN Halt Trials of HIV Vaccine Candidate V520 Due to Disappointing Preliminary Results

Last Friday, September 21, Merck and the National Institutes of Allergy and Infectious Disease Health HIV Vaccine Trials Network (HVTN) announced that they were discontinuing development of the HIV vaccine candidate V520, also known as MRKAd5, due to study data showing that it did not lower the risk of infection or disease progression.

Among the several HIV vaccine candidates under development, some are preventive vaccines intended to keep people from becoming infected with the virus, while others are therapeutic vaccines designed to stimulate the body's immune response to the virus and lessen disease progression in people after they become infected.

V520, a trivalent vaccine containing three recombinant HIV genes carried by an adenovirus vector, was being studied as both a preventive and a therapeutic candidate, and it was one of the furthest along in clinical trials. The international STEP study, begun in 2004, enrolled 3000 HIV negative individuals who were considered at high risk for infection, including gay men in San Francisco and female sex workers.

A review of preliminary data from the Phase II trial led the study's Data Safety and Monitoring Board (DSMB) to recommend that the trial not proceed due to lack of efficacy. After about 1 year of follow-up, volunteers who received 1 dose of V520 did not appear to be at less risk of infection than those who received a placebo injection. In both arms, about 3% became infected, and response rates did not improve significantly among those who received a second booster injection in what was intended to be a 3-shot series.

V520 also did not appear to promote stronger immune responses in people who were newly infected, since viral load rose to comparable levels among those who received the active vaccine and the placebo. The disappointing data were unexpected, since V520 appeared to stimulate a robust immune response against HIV in earlier studies.

Although no new subjects will be vaccinated, researchers plan to continue follow-up of participants already enrolled in the STEP study. Another V520 trial in South African, known as Phambili, is on hold while the DSMB reviews early data.

Below are excerpts from announcements from HVTN and Merck concerning the recent developments:

NIAID Statement: Immunizations Are Discontinued in Two HIV Vaccine Trials

An independent Data and Safety Monitoring Board (DSMB) met this week to review interim data from a large, international HIV vaccine clinical trial known as the STEP study - also referred to as the HVTN 502 or Merck V520-023 study. The clinical trial, which began enrolling volunteers in December 2004, is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the pharmaceutical company Merck & Co. Inc., which also developed and supplied the candidate vaccine. Based on a review of interim data, the DSMB concluded that the vaccine cannot be shown in this trial to prevent HIV infection or affect the course of the disease in those who become infected with HIV as a result of their own behaviors that expose them to the virus. Therefore, Merck and NIAID instructed all study sites to cease administering the investigational vaccine but continue scheduled follow-up visits with all volunteers until the data can be more thoroughly evaluated and a course of action is developed.

The STEP study, which enrolled 3,000 participants, was conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN) and Merck. Volunteers were enrolled at sites in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico, and the United States. The Phase IIb "test-of-concept" study was designed to test Merck's candidate HIV vaccine, the MRKAd5 trivalent vaccine, which aimed to stimulate production of immune system T cells that can kill HIV-infected cells. The goal of the study was to determine if the vaccine could prevent HIV infection, reduce the amount of HIV in those who do become infected, or both.

Based on its first evaluation of interim efficacy data, the DSMB found 24 cases of HIV infection among the 741 volunteers who received at least one dose of the investigational vaccine compared with 21 cases of HIV infection among the 762 volunteers who were vaccinated with placebo. In volunteers who received at least two vaccinations, the DSMB found 19 cases of HIV infection among the 672 volunteers who received the investigational vaccine and 11 instances of HIV infection among the 691 volunteers who received the placebo. The trial partners will fully evaluate the trial data, provide additional instructions to the STEP trial sites, and provide a detailed scientific analysis of the study results in the near future.

The same Merck candidate HIV vaccine is also being tested in South Africa by the HVTN and the South African AIDS Vaccine Initiative in a separate NIAID-sponsored clinical trial known as HVTN 503 or the "Phambili" study. This study was initiated in February 2007 and has enrolled 799 individuals. Immunizations and enrollment in the Phambili study have now been paused. This allows the independent DSMB that oversees the Phambili trial to review all available HVTN 503 and STEP interim findings to determine next steps. In contrast to the STEP study where the interim analysis was almost exclusively based on results in volunteers who were men who have sex with men, the Phambili study has primarily enrolled heterosexuals at high risk for HIV.

The study investigators at each site for both the STEP (HVTN 502/ Merck V520-023) and Phambili (HVTN 503) vaccine trials have been informed of the decision to cease immunizations and are contacting study volunteers to inform them of the developments.

For additional information about the HVTN 502 and HVTN 503 trials, see http://www3.niaid.nih.gov/news/QA/step_qa.htm.

Merck Statement: Vaccination and Enrollment Are Discontinued in Phase II Trials of Merck's Investigational HIV Vaccine Candidate

Interim Analysis of STEP Study Shows Vaccine was not Effective

WHITEHOUSE STATION, N.J., and Seattle, Sept. 21, 2007 - Vaccination in a phase II clinical trial of Merck & Co., Inc.'s investigational HIV vaccine (V520) is being discontinued because the vaccine was not effective. The announcement was made today by the co-sponsors of this clinical trial, Merck & Co., Inc., and the HIV Vaccine Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health.

The trial, called STEP, was an international phase II "test of concept" trial in uninfected volunteers at high risk for acquiring HIV infection. The independent Data Safety Monitoring Board (DSMB) for STEP reviewed safety data and results of an interim efficacy analysis of the study, and recommended that vaccination be discontinued because the STEP trial will not meet its efficacy endpoints. Study investigators have been instructed to discontinue vaccinating volunteers in this study and to monitor them in accordance with the study protocol. Enrollment and vaccination in a second Phase II trial of this vaccine being conducted by the HVTN in South Africa called Phambili, and two additional Phase I trials, have been discontinued. The DSMB for the Phambili trial will evaluate the available data.

The Merck vaccine candidate is a mixture of three components, each made with a weakened version of a common virus (adenovirus type 5), that serves as a carrier, or delivery vector, along with three synthetically produced HIV genes known as gag, pol and nef.

The STEP study (HVTN 502, Merck V520 Protocol 023) was a multicenter, randomized, double-blind, placebo-controlled phase II test-of-concept clinical trial. The trial enrolled 3,000 HIV-negative volunteers from diverse backgrounds between 18 and 45 years of age at high risk of HIV infection.

The study evaluated two primary efficacy endpoints: whether the vaccine prevented HIV infection and whether the vaccine reduced the amount of virus in those who developed infection. As planned, an interim efficacy analysis was conducted in the approximately 1,500 volunteers expected to have the best response to the vaccine because they had low levels of pre-existing immunity to adenovirus 5.

The vaccine did not prevent infection: in volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed in the 741 volunteers who received vaccine and 21 cases of HIV infection were observed in the 762 participants in the placebo group. In the subgroup who had received at least two vaccinations and who were HIV negative for at least the first 12 weeks of the trial, 19 cases of HIV infection were observed in the 672 volunteers who received vaccine and 11 cases were observed in the 691 volunteers who received placebo. In addition, the vaccine did not reduce the amount of virus in the bloodstream of those who became infected; HIV RNA levels approximately 8 to 12 weeks after diagnosis of infection were similar in the vaccine and the placebo arms. The geometric means of the HIV RNA levels in the blood of infected individuals, the standard measure of ongoing HIV replication, were approximately 40,000 copies/mL in the vaccine group and approximately 37,000 copies/mL in the placebo group. Additional analyses will be conducted on the entire study population and will be shared with the scientific community.

Study volunteers were followed for approximately 13 months. Overall adverse event rates were generally similar among the two groups, except for a higher rate of local injection-site related reactions in the vaccine group.

"We share in the disappointment of the research and HIV communities today. Sadly, developing an effective AIDS vaccine remains one of the most challenging tasks facing modern medicine," said Peter S. Kim, PhD, president, Merck Research Laboratories. "Merck's 20-year HIV research program has led to improved scientific understanding of HIV and to true breakthrough medicines. We are committed to studying the data closely and sharing it with the scientific community to inform the on-going search for an effective HIV vaccine."

"HVTN is a global network of scientists, staff and community members whose mission is to speed the rapid development of a safe and effective preventative HIV vaccine," said Larry Corey, M.D., principal investigator of the HVTN. "This trial was the first test of concept trial that provided us information on this vaccine more quickly and efficiently than with a traditional Phase III design.

While we are very disappointed that this vaccine candidate did not demonstrate protection, the data from this trial will provide critical insights into this disease and future vaccine development."

"This is a huge disappointment for all of us who have been involved in the search for an HIV vaccine," said Glenda Gray, MD, principal investigator of the HVTN sponsored Phambili trial. "HIV is ravaging our communities, and all the scientists, participants and communities involved in HIV vaccine studies have been affected by this epidemic. The scientific community must continue the race to find a vaccine to help secure an HIV free generation for the future."

The Merck adenovirus-based vaccine used a cell-mediated immune response approach; it was hypothesized that the HIV genes in the vaccine would stimulate the body to generate an HIV-specific immune response through the body's own CD8 T-cells, which become programmed to recognize and kill HIV infected cells.

Adenoviruses are among the causes of common cold; the type 5 adenovirus used in this investigational vaccine had been modified so that it was unable to replicate and could not cause a cold. Also, because the vaccine did not contain live HIV and contained only three HIV genes, volunteers could not become infected with HIV from the vaccination. This vaccine had previously been tested in several smaller clinical trials and was found to be generally well tolerated and capable of inducing significant levels of HIV-specific cell-mediated immune responses.

STEP included multiple clinical trial sites in North and South America, the Caribbean and Australia, where HIV subtype B, the subtype of HIV from which the HIV genes included in the vaccine, is predominant. Half the study participants received three doses of the vaccine over six months, while the other half were given three doses of a placebo. The first volunteer enrolled in the study in December 2004, and enrollment was completed in March 2007.

The second phase II trial of this vaccine candidate, the Phambili trial, (HVTN 503, Merck V520 Protocol 026) was begun in 2007 in South Africa by the HVTN to explore whether Merck's vaccine would be effective at preventing infection, reducing viral levels, or both, from HIV subtype C, which is more common in southern Africa.



NIAID. Immunizations Are Discontinued in Two HIV Vaccine Trials. Press release. September 21, 2007.

Merck & Co. Vaccination and Enrollment Are Discontinued in Phase II Trials of Merck's Investigational HIV Vaccine Candidate. Press release. September 21, 2007.


Predictive Value of Viral Load Testing Questioned

September 30, 2006 (AIDSmeds)—While the value of viral load testing is pretty much undisputed with respect to monitoring HIV-positive people while on treatment, a recent study by a nationwide team of HIV researchers strongly challenges conventional thinking about viral load as a measure of disease progression in those who aren't yet on therapy and questions the value of using viral load to determine when treatment should be started. The study, published in the September 27th issue of the Journal of the American Medical Association (JAMA), indicates that viral load is much less reliable as a tool for determining the rate at which an HIV-positive person will lose CD4 (T4) cells than previously thought.

Ten years ago, a monumental paper published in Science by John Mellors, MD, of the University of Pittsburgh and his colleagues, concluded that an HIV-positive patient's viral load is an excellent predictor of how quickly he or she will progress to AIDS if the infection is left untreated. Soon after these findings were published, HIV experts and healthcare providers all over the world embraced the idea of using viral load, in conjunction with CD4 cell counts, to monitor their patients' health and to figure out when to initiate treatment.

A simple analogy is often used to illustrate how viral load and CD4 count testing are supposed to work together. Viral load and CD4 cell counts are like a train rushing along a set of railroad tracks. Up ahead is a cliff. This cliff represents AIDS. The CD4 cell count tells us how far the train is from the cliff, whereas the viral load tells us how fast we are moving towards it.

The new research, headed by Benigno Rodríguez, MD, and Michael Lederman, MD, of Case Western Reserve University in Cleveland, doesn't debate the decade-old research concluding that average viral loads may predict average CD4 cell count declines in large cohorts of patients. What Dr. Rodríquez's group argues is that viral load is a relatively poor predictor of disease progression in individual patients. Based on the observed variability in viral loads and disease progression rates seen in individual patients, they say, depletion of CD4 cells is not solely driven by high HIV replication in the body.

"The results of this nationwide study may have profound implications in our understanding of how HIV causes disease and in our approach to the management of HIV-infected patients," says Dr. Rodriguez. "We hope that this study will provide impetus for a more thorough understanding of the mechanisms of HIV-induced damage to the immune system and for the design of strategies to block those mechanisms."

In the study, Dr. Rodríguez and his colleagues report the results of analyses involving two large cohorts of 2,800 HIV-positive people who were not receiving treatment for HIV. The first cohort consisted of patients enrolled in one of four sites of the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), the San Francisco Men's Health Study (SFMHS), and the Research in Access to Care for the Homeless Cohort (REACH). The second cohort, which the investigators used to validate their findings in the first group, included participants in the Multicenter AIDS Cohort Study (MACS) – the same group of patients that was used by Dr. Mellors' group back in 1996.

As expected, there was significant variation in the rate of CD4 cell loss within the cohort. Dr. Rodríguez's group then tried to determine if this CD4 cell loss could be accounted for on the basis of each patient's first recorded viral load measurement, in an attempt to reproduce more closely the situation that a healthcare provider would encounter in the "real world," where a patient presents with an initial set of laboratory results and the doctor must try to predict how quickly that person's CD4 cell count will reach the danger level at which treatment for HIV becomes most critical.

Using sophisticated statistical models, the researchers found that only 4% to 6% of an individual patient's CD4 cell loss rate was explained by his or her initial viral load. Moreover, the results were remarkably similar when the analyses were reproduced separately in each of the two cohorts, and changed only minimally when the investigators considered the possible effect of errors in the measurement of the CD4 cell count and the viral load.

These results, Dr. Rodríguez says, are at odds with current thinking that the rate of CD4 cell loss in a given HIV-positive person can be accurately predicted by his or her viral load.

In a September 29th Science news article by Jon Cohen regarding the JAMA report, Dr. Mellors said that he doesn't buy the conclusion of the study. "We don't agree with the paper at all," he was quoted as saying. "[Viral load] is the most powerful predictor of time to AIDS and death." Dr. Mellors suggested that the JAMA paper's results may reflect that CD4 measurements vary a great deal in different labs. Dr. Mellors also said that viral loads should continue to play an essential role in determining when to start people on treatment.

Dr. Rodríguez's group is sticking to its guns and concludes that CD4 cell loss in HIV-positive people cannot be thought of as a mere consequence of the amount of virus circulating in the blood. These new findings, they say, hint at more complex scenarios of disease progression, and point to the possibility of indirect processes through which HIV can induce damage to the immune system.


Absolute CD4 Cell Count and CD4 Percentage Independently Predict HIV Disease Progression By Liz Highleyman

Absolute CD4 cell count is the most commonly monitored measure of immune function in people with HIV. According to current U.S. federal HIV treatment guidelines , antiretroviral therapy should be considered when a person's CD4 count falls below 350 cells/mm3, while a level below 200 cells/mm3 indicates a diagnosis of AIDS.

However, CD4 cell percentage may also play a role in guiding decisions about treatment, according to a study published in the February 1, 2007 issue of the /Journal of Infectious Diseases/. (A CD4 percentage of about 40% is considered normal.)

In the present study, researchers sought to characterize the predictive utility of CD4 percentage. They performed an observational study of participants in the Collaborations in HIV Outcomes Research/US (CHORUS) cohort who started their first HAART regimen between 1997 and 2004 and received at least 30 days of therapy.


*•* The analysis included 1891 participants with a median age of 38
years; 89% were men, 72% were white, and 18% were African-American

*•* Before starting HAART, the mean baseline CD4 cell count was 240
cells/mm3, the mean CD4 percentage was 16%, and 29% had progressed
to AIDS.

*•* After a follow-up period of 55 months (IQR 23-83 months), 468
subjects (25%) experienced disease progression, defined as a new
AIDS-defining event or death.

*•* In a multivariable analysis including age, race, sex, HIV RNA
level, prior antiretroviral therapy, probable route of infection,
prior AIDS-defining events, absolute CD4 count, and CD4 percentage,
the following factors independently predicted disease progression:

- prior antiretroviral therapy (P < 0.0001);
- injection drug use (P = 0.04);
- lower baseline absolute CD4 cell count (P = 0.002);
- lower baseline CD4 cell percentage (P = 0.002).

*Conclusion *

In conclusion the authors wrote, "[CD4 percentage] at initiation of the first HAART regimen predicted disease progression independent of absolute CD4 [count]."

In their discussion, the researchers noted that while both absolute CD4 cell count and CD4 percentage predicted disease progression, the 2 measures did not always correspond.

That is, some patients with relatively high absolute CD4 counts but low CD4 percentages experienced more disease progression than subjects with low CD4 cell counts but high CD4 percentages. For example, a patient with a baseline absolute CD4 count of 350 cells/mm3 but a CD4 percentage of 14% was at higher risk of disease progression than one with an absolute CD4 count of 200 cells/mm3 but a CD4 percentage of 28%. Moreover, individuals with the same absolute CD4 counts had a variable risk of progression depending on their CD4 percentages.

Thus, the authors said, CD4 percentage may be used as an additional factor to help determine the optimal timing of HAART. These results suggest that some patients with low CD4 percentages may benefit from starting HAART earlier, even if their absolute CD4 counts are not yet at the recommended threshold for initiating therapy.


*T Hulgan, B E Shepard, S P Raffanti, and others. Absolute Count and Percentage of CD4+ Lymphocytes Are Independent Predictors of Disease Progression in HIV-Infected Persons Initiating Highly Active Antiretroviral Therapy. /Journal of Infectious Diseases/ 195(3): 425-431. February 1, 2007.

Most Patients with Highly Drug-resistant HIV Treated with an Incompletely Suppressive Regimen Maintain Durable Immunological and Virological Responses

Despite the recent approval of several new antiretroviral agents, some treatment-experienced patients with highly drug-resistant HIV have no option but to continue to receive an incompletely suppressive regimen.

Researchers at the University of Michigan Health System in Ann Arbor conducted a study to assess long-term immunological and virological responses to incompletely suppressive regimens, to investigate risks for immunological or virological failure, and to look for the occurrence of new drug-resistance mutations.

The investigators enrolled antiretroviral treatment-experienced HIV patients with a genotype sensitivity score
They determined the proportion of patients treated with incompletely suppressive regimens who developed immunological failure (defined as a 25% reduction in CD4 cell count from the baseline level) and virological failure (defined as a 0.5-log10 or greater increase in the viral load from the baseline level).

Cox proportional hazards analysis was used to investigate variables associated with immunological or virological failure.


• At baseline, 47 patients with 89 months median duration of prior antiretroviral therapy, a median CD4 cell count of 277 cells/mm3, and a median viral load of 19,728 copies/mL had multiple HIV mutations: a median of 5 nucleoside reverse-transcriptase inhibitor (NRTI) mutations, 1 non-nucleoside reverse-transcriptase inhibitor (NNRTI) mutation, and 6 protease inhibitor (PI) mutations.

• The median genotype sensitivity score at baseline was 0.

• After 48 months using an incompletely suppressive regimen, 43% experienced immunological failure and 22% experienced virological failure.

• New drug-resistance mutations were identified in 27 patients with sequential HIV genotypes available.

• New NRTI mutations occurred in 63.0% of patients, and new PI mutations occurred in 52.6% of protease inhibitor recipients.

• No deaths occurred.

• 8.5% of patients experienced a new AIDS-defining event.

• None of the studied variables were associated with immunological or virological failure, including age > 50 years, baseline HIV RNA > 100,000 copies/mL, baseline CD4 cell count < 200 cells/mm3, or inclusion of 3TC [Epivir] in the regimen.


Based on these results, the study authors concluded, "Most patients with highly drug-resistant HIV infection who were treated with an incompletely suppressive regimen maintain durable immunologic and virologic responses."

However, they added that, "New drug-resistant mutations occur frequently."


T Gandhi, V Nagappan, S Cinti, and others. Long-term immunologic and virologic responses in patients with highly resistant HIV infection who are treated with an incompletely suppressive antiretroviral regimen. Clinical Infectious Diseases 45(8): 1085-1092. October 15, 2007.


Friday, October 5, 2007

Artemisia annua: herbal use vs isolated active

The species of wormwood known as Artemisia annua has been used in Traditional Chinese Medicine for the treatment of fevers and malaria for many centuries. The active antimalarial compound known as artemisinin was isolated by Chinese researchers in the early 1970s. Since then research has focussed on artemisinin and its semi-synthetic derivatives such as artemether and artesunate. These drugs have become established as safe and effective antimalarial drugs which have particular value in the treatment of chloroquine-resistant parasites. However, a group of German scientists (1) have focussed their research effort on the use of the whole herb, particularly when taken as an infusion with boiling water. The motivation behind this research is to understand the value of the traditional use of Artemisia annua for the treatment of malaria, because this application could readily be adopted in poor countries such as in Africa where the semi-synthetic drugs are relatively expensive.

Artemisia annua can be cultivated with relative ease and there are new hybrids than can yield up to 1% artemisinin. One of the questions which needed to be answered was whether an infusion of the herb can deliver significant quantities of artemisinin into the bloodstream. Fourteen healthy male volunteers received 1 liter of tea prepared from 9g of Artemisia annua leaves. Blood samples were taken and artemisinin was measured by HPLC. Significant quantities of the phytochemical were found in the plasma. Artemisinin was absorbed faster from the herbal tea than from oral solid dosage forms, but its bioavailability was similar. The 1 liter of tea (from 9g of Artemisia annua) contained 94.5mg of artemisinin, which is approximately one-fifth of the usually recommended daily dose. The authors concluded that artemisinin plasma concentrations after intake as an herbal tea are sufficient for clinical effects, but insufficient to recommend such preparations as equivalent substitutes for modern artemisinin-based drugs in malaria therapy.

The same research team also investigated the clinical efficacy of an Artemisia annua tea in the treatment of subacute malaria in Africa. (2) In an uncontrolled study, 48 patients received the tea for 4 days (5g dried leaves infused in 1 liter of hot water). After the treatment, 92% of patients had no detectable parasites in their bloodstream and there were significant improvements in subjective symptoms in 70% of the treated patients.


One of the questions I am sometimes asked is whether the traditional galenical fluid extract of Artemisia annua can be used to provide clinically significant doses of artemisinin. The above pharmacokinetic study would support that this is the case. Interestingly, the pilot trial of the Artemisia annua tea preparation in malaria suggests that there could well be a synergistic advantage in using the tea or the galenical prepared from the whole herb, rather than the isolated compound artemisinin or its derivatives. The tea used in the pilot trial only delivered at best 10% of the normal therapeutic dose of artemisinin, but resulted in a substantial clinical effect.

These findings have particular relevance to the recently suggested use of Artemisia annua, or more specifically artemisinin, as an anticancer agent. This development is based on the finding that cancer cells have a much higher concentration of iron than normal cells. (It is thought that artemisinin interacts with iron to generate reactive oxygen species (free radicals) which kill the malaria parasite.) Tests on cancer cell lines have established that artemisinin is also selectively toxic to cancer cells, presumably because their higher iron levels result in cytotoxic effects following free radical generation after contact with artemisinin. (3-5)


1. Rath K, Taxis K, Walz G et al. Pharmacokinetic study of artemisinin after oral intake of a traditional preparation of Artemisia annua L. (annual wormwood). Am J Trop Med Hyg 2004; 70(2): 128-132

2. Miller M, Heide L. Malaria in Afrika: Wie hilfreich sind Arzneipflanzen? Z Phytother 2001; 22:77-81

3. Chen HH, Zhou HJ, Fang X. Inhibition of human cancer cell line growth and human umbilical vein endothelial cell angiogenesis by artemisinin derivatives in vitro. Pharmacol Res 2003; 48(3):231-236

4. Efferth T, Dunstan H, Sauerbrey A et al. The anti-malarial artesunate is also active against cancer. Int J Oncol 2001; 18(4):767-773

5. Woerdenbag HJ, Moskal TA, Pras N et al. Cytotoxicity of artemisinin-related endoperoxides to Ehrlich ascites tumor cells. J Nat Prod 1993; 56(6): 849-856

Bibliography for "Artemisia annua: herbal use vs isolated active"
Kerry Bone "Artemisia annua: herbal use vs isolated active". Townsend Letter for Doctors and Patients. April 2005. FindArticles.com. 05 Oct. 2007. http://findarticles.com/p/articles/mi_m0ISW/is_261/ai_n13654022

COPYRIGHT 2005 The Townsend Letter Group
COPYRIGHT 2005 Gale Group

LookSmart's FindArticles - Artemisia annua: herbal use vs isolated active

Townsend Letter for Doctors and Patients, April, 2005, by Kerry Bone

Officials say drug caused Nigeria polio

By MARIA CHENG, AP Medical Writer Fri Oct 5, 3:55 PM ET

LONDON - A polio outbreak in Nigeria was caused by the vaccine designed to stop it, international health officials say, leaving at least 69 children paralyzed.

It is a frightening paradox in a part of the world that already distrusts western vaccines, making it even tougher to stamp out age-old diseases.

The outbreak was caused by the live polio virus that is used in vaccines given orally — the preferred method in developing countries because it is cheaper and doesn't require medical training to dispense.

"This vaccine is the most effective tool we have against the virus, but it's like fighting fire with fire," said Olen Kew, a virologist at the U.S. Centers for Disease Control and Prevention.

The CDC and the World Health Organization announced the cause of the polio outbreak last week, even though they knew about it last year.

Outbreaks caused by the oral vaccine's live virus have happened before. But the continuing Nigerian outbreak is the biggest ever caused by the vaccine. It also follows a nearly yearlong boycott of the vaccine in Africa's most populous country because of unfounded fears the vaccine was a Western plot to sterilize Muslims.

Officials now worry that the latest vaccine-caused Nigerian outbreak could trigger another vaccine scare.

Experts say such outbreaks only happen when too few children are vaccinated. In northern Nigeria, only about 39 percent of children are fully protected against polio.

The oral polio vaccine contains a weakened version of polio virus. Children who have been vaccinated excrete the virus, and in unsanitary conditions it can end up in the water supply, spreading to unvaccinated children.

In rare instances, as the virus passes through unimmunized children, it can mutate into a form that is dangerous enough to spark new outbreaks.

In 2001, officials reported that 22 children were paralyzed from polio in the Dominican Republic and Haiti in this way. Subsequent vaccine-caused polio outbreaks have occurred in the Philippines, Madagascar, China and Indonesia.

In the West, the polio vaccine is given as a shot and uses an inactivated virus, but that method is more expensive and requires training.

In Nigeria, the outbreak comes "in the wake of all the other problems they've had in," said Dr. Donald A. Henderson, who led WHO's smallpox eradication campaign in the 1970s.

In 2003, politicians in northern Nigeria canceled vaccination campaigns for nearly a year, claiming the vaccine was a Western plot to sterilize Muslims. That led to an explosion of polio, and the virus jumped to about two dozen countries.

Now, health officials' decision to keep quiet about the cause of the outbreak for so long may look suspicious.

Dr. David Heymann, WHO's top polio official, said that because the organization considered the outbreak to be a problem for scientists and not something that would change global vaccination practices, they thought it was was unnecessary to immediately share publicly.

CDC's Kew added: "The people who are against immunization may seize on anything that could strengthen their position, even if it's scientifically untenable."

Rumors are still rife among Nigerians that the vaccine is unsafe, and several religious leaders continue to lecture on its dangers. Another mass vaccine boycott could lead to further polio spread, derailing long-standing eradication efforts for good.

Nigerian health officials contacted by The Associated Press declined to comment on the situation.

"Convincing the Nigerians to take even more of this vaccine will be a tough sell," said Dr. Samuel Katz, an infectious diseases specialist at Duke University and co-inventor of the measles vaccine.

More than 10 billion polio doses have been given to children worldwide, and the vaccine has been credited with cutting polio incidence by more than 99 percent since 1988. Far more children are paralyzed by the wild polio virus than the virus spread by the oral vaccine. But no vaccine is risk-free.

WHO said that changing the vaccination strategy is unnecessary. "It would be nice if we had a more stable oral polio vaccine, but that's not the way it is today," Heymann said. "We will continue working the way we have been working because we don't want children to be paralyzed anywhere."

From Yahoo News

Wednesday, October 3, 2007

Improving Breastfeeding Practices on a Broad Scale at the Community Level: Success Stories From Africa and Latin America

Victoria J. Quinn, PhD, Agnès B. Guyon, MD, MPH, Joan W. Schubert, MPH, Maryanne Stone-Jiménez, MS, IBCLC, Michael D. Hainsworth, MPH, and Luann H. Martin, MA

Published in the Journal of Human Lactation (Vol. 21, No. 3, pps. 345-354), this article examines the strategies and successes of large-scale community-level, communication-centred programmes designed to improve breastfeeding practices in Bolivia, Ghana, and Madagascar. The case study illustrates the way in which sizeable improvements in optimal breastfeeding can be achieved at scale and within a relatively rapid time frame using a multi-faceted, communication-focused approach, tailored specifically to meet the demands of each specific country in which the approach was implemented. In short, the resource explores how and why focusing on breastfeeding practices on a large-scale level - and using communication strategies to do so - is "feasible and should be a central component of any child survival strategy."

For the full article...go

Not All Herbs Are Dangerous: Chinese Herbs Show Promise for Those With HIV

Since 1987, National Cancer Institute has worked with the Chinese Academy of Sciences to study Chinese medicinal herbs with anti-HIV activity. Over 1000 Chinese traditional medicines were screened using different extraction forms. Of this number, more than 140 herbs showed HIV- inhibition activity. Among them, more than 20 herbs showed significant anti-HIV activity. Baicalin, which was isolated from scutellaria bacicalensis georgi inhibited HIV reverse transcriptase; baicalin and baicalein are active components of Chinese traditional medicine. Researchers have performed molecular modeling using these compounds and discovered additional potential for inhibiting HIV-reverse transcriptase with these ancient herbs.


Tuesday, October 2, 2007

Korean Red Ginseng Slows Depletion of CD4 T Cells in Human Immunodeficiency Virus Type 1-Infected Patients

Heungsup Sung,1 Sang-Moo Kang,2 Moo-Song Lee,3 Tai Gyu Kim,4 and Young-Keol Cho1*
Department of Microbiology1 and Preventive Medicine,3 University of Ulsan College of Medicine, Seoul 138-040,
Korea, Department of Microbiology and Immunology, Emory Vaccine Center, Emory University School
of Medicine, Atlanta, Georgia 30322,2 and Department of Microbiology, College of Medicine,
The Catholic University of Korea, Seoul 137-701, Korea4
Received 27 December 2004/Returned for modification 13 January 2005/Accepted 7 February 2005

Long-term intake of Korean red ginseng (KRG) delayed disease progression in human immunodeficency virus type 1-infected patients. Additionally, KRG intake significantly slowed the decrease in CD4 T cells even when influence of HLA class I was statistically eliminated. Researchers also observed significant correlation between KRG intake and a decrease in serum soluble CD8 antigen level. These data show that KRG intake independently and significantly affected the slow depletion of CD4 T cells irrespective of HLA class I. Korean Ginseng not only maintained CD4 T-cell counts in HIV patients over a 6 year period, but also reduced viral resistance to AZT.

To read the full study, please enter the blog entry title into a google search engine or contact CAMI for a link to access it.

1071-412X/05/$08.000 doi:10.1128/CDLI.12.4.497–501.2005
Copyright © 2005, American Society for Microbiology. All

High HIV Rates for Nigerian Women and Babies

September 25, 2007

Approximately 70 percent of people living with HIV/AIDS in Borno State, a northeastern state in Nigeria, are women and infants, according to Borno’s governor, Ali Modu Sheriff.

"Currently in Borno state…60 percent of people living with HIV/AIDS in the state are women [and] 10 percent [are] infants," he said.

Speaking at an AIDS awareness event, Sheriff said that recent research has shown that more women are contracting the virus than men, and that women are becoming infected through both casual relationships and intercourse with their husbands.

Last week, an official at the Planned Parenthood Federation of Nigeria urged religious leaders in the country to rethink their views on condom use, saying that their refusal to accept them is adding to the spread of HIV.

View Article.

Herbal Medicines in Early Drug Development for the Treatment of HIV Infections and AIDS

A new review study investigated the effects of herbal medicine in patients with HIV and AIDS and found some benefit.

Researchers from Beijing University of Chinese Medicine in China systematically assessed the beneficial and harmful effects of herbal medicines in people with HIV infection and AIDS.

Based on a Cochrane review and updated searches, they identified the available evidence on herbal medicines compared with placebo or antiretroviral drugs in patients with HIV infection, HIV-related disease or AIDS.

Ten randomized controlled trials, involving 571 individuals with HIV infection or AIDS, met the inclusion criteria.

The authors noted that some herbal medicines, such as IGM-1, seem to be effective in symptom improvement, but generally no significant effect on antiviral or immunity enhancement among reviewed herbs was seen.

The authors reported that combined treatment of Chinese herbal medicine, SH and antiretroviral agents showed increased antiviral benefit compared with antiretrovirals alone.

The study authors concluded that there may be beneficial effects from some of the tested herbs but more evidence from larger studies is needed to support this evidence in the future.

For more information on integrative treatment options for HIV/AIDS, please visit Natural Standard's Medical Conditions and Comparative Effectiveness databases.

To comment on this story, please click HERE to enter the Natural Standard blog.


1) Liu J. The use of herbal medicines in early drug development for the treatment of HIV infections and AIDS. Expert Opin Investig Drugs. 2007 Sep;16(9):1355-64. VIEW ABSTRACT.

2) Natural Standard Research Collaboration: The Authority on Integrative Medicine.www.naturalstandard.com. Copyright © 2007.