Drug Companies "Block" Cheap Medicine

Their actions cost EU healthcare providers 3bn euros ($3.9bn; £2.5bn) in savings between 2000 and 2007, it said. It added that drug firms used legal action and multiple patents to stop rivals getting to market.Drug firms said the "perfectly lawful" measures were justified to protect investment in research and development.

Market access

Generic drug companies - which sell cheaper versions of drugs once the patent has expired - have long complained that it is difficult to get their drugs to market in Europe. The Commission said that innovators filed multiple applications to stop generic drugs getting to market - in one case, there were 1,300 patents for a single drug.

The report found that owners of original drugs often intervened in national approval procedures for generic medicines. There were nearly 700 cases of reported patent litigation and more than 200 settlements between brand name drug companies and generic companies. More than 10% of these settlements limited the entry of the generic drug to the market.

Fine threat

"Market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed, at significant cost to healthcare systems, consumers and taxpayers," said Competition Commissioner Neelie Kroes. "It is still early days but the Commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached," she added.The Commission could impose large fines on drug companies if they have engaged in unfair practices. In 2005, AstraZeneca was fined 60m euros for blocking cheaper rivals to Losec, its heartburn and ulcer pill.

Pressure mounts

Drug firms use "perfectly lawful practices - such as patent portfolios, patent litigation and the release of improved medicines," the European Federation of Pharmaceutical Industries and Associations (EFPIA) said.

"These [practices] are essential for innovators to protect their huge investment in R&D [research and development]," it said, adding that the 17% of turnover industry spent on R&D exceeds any other sector in Europe. The EFPIA - which said the Commission's report missed the opportunity to tackle the real issues facing the industry - called for a more competitive market for generic drugs, pointing out that Europeans pay more for generic drugs than US citizens.

In response to claims that the delayed or blocked sale of generic drugs was pushing up healthcare costs, the EFPIA said: "A single member state, the Netherlands, achieved greater savings - up to 400m euros - in one year, on only 33 medicines, simply by promoting greater price competition between generics."

The Commission report increases the pressure on the global pharmaceuticals industry.

Barack Obama, the US President-elect, is also expected to try to cut costs as part of the reform of healthcare coverage in the US.

Women More Susceptible to HIV/AIDS than Originally Thought

A new study has found that HIV appears to attack normal, healthy genital tissue in women and does not require breaks in the skin to infiltrate cells, offering new perspectives on how the virus is spread, researchers said on Tuesday, Reuters reports. Thomas Hope, a study author from Northwestern University's Feinberg School of Medicine, said that scientists have had little detailed understanding of how HIV is transmitted sexually in women and that it was "previously thought there had to be a break in [genital tissue] somehow" for women to contract the virus. He added that the study's findings show that "[n]ormal skin is vulnerable."

For the study, researchers in a partnership between Northwestern and Tulane University introduced HIV -- which carried fluorescent, light-activated tracers, a new method developed to better see how the virus worked -- to newly removed vaginal tissue taken from hysterectomy surgeries. A microscope was used to observe the virus as it penetrated the outer lining of the female genital tract -- also called the squamous epithelium -- and found that HIV was able to move quickly past the skin barrier to reach immune cells. The process also was observed in nonhuman primates, according to Reuters. In addition, the results of the study suggest that HIV focuses on areas of the genital tissue where skin cells recently had been shed, Hope said (Steenhuysen, Reuters, 12/16). Hope said the results are "an important and unexpected result -- we have a new understanding of how HIV can invade the female vaginal tract." He added, "We urgently need new prevention strategies or therapeutics to block the entry of HIV through a woman's genital skin" (BBC News, 12/17).

According to Reuters, researchers in the past have assumed that HIV sought out breaks in the skin -- like a herpes sore -- to gain access to immune system cells deeper in tissue, and some thought the normal lining of the vaginal tract could work as a barrier to transmission during sexual intercourse. Reuters reports that the study "casts doubt" on the theory that HIV transmission requires a break in the skin or that the virus gains access through the cervical canal's single layer of skin cells. The findings also "might explain why some prevention efforts" -- such as diaphragms or herpes treatment -- have "failed," Reuters reports (Reuters, 12/16).

Lisa Power from the Terrence Higgins Trust in the United Kingdom said the results are an "important finding" but "sadly, not surprising" because it has been "long known that it is easier for a man to transmit HIV sexually to a woman than for a woman to transmit it to a man." She added that the study "helps us understand why" and "will help in developing better prevention mechanisms -- but until then, it's more clear than ever that a condom is a vital part of safer sex." The British not-for-profit organization AVERT said that the study "serves to strengthen" the argument for condom use during heterosexual intercourse and "will hopefully give weight to the need for safer heterosexual sex to be advocated further by governments and practitioners worldwide" (BBC News, 12/17). According to Hope, the findings emphasize the importance of methods to prevent transmission, such as a vaccine and condom use. He said, "People need to remember that they are vulnerable. The sad part is if people just used a condom, we wouldn't have this problem" (Reuters, 12/16).

Ryan White Funding Delays

Errors in a public notice last week in New Orleans have forced city officials to delay the start of the 2009 process for distributing an expected $5 million in Ryan White Program funding for local HIV/AIDS agencies, the New Orleans Times-Picayune reports. The announcement of the delay comes after Fran Lawless -- who serves as director of Mayor Ray Nagin's Office of Health Care Policy -- in October testified before the city council's Housing and Human Needs Committee that 2008 funding distribution was delayed by six months and that service providers went without funding from March to October.

According to the Times-Picayune, City Council member Arnie Fielkow called on officials to begin the application process for 2009 earlier in the year. In an effort to meet this request, officials listed a public request for proposals in the Times-Picayune on Dec. 8, 9 and 10, which set the deadline for picking up applications as Dec. 5 -- a date that had already past. The deadline for submission also was listed incorrectly in the electronic notice sent directly to the service providers, which left many of them confused, according to the Times-Picayune. Carlos Butler -- Health Policy office manager and the contact who was listed in the public notice -- said that the request for proposals was canceled and referred questions to Lawless and a Nagin spokesperson, who did not respond to requests for comment, the Times-Picayune reports.

Several agencies that receive funding to provide assistance to more than 4,000 people living with HIV/AIDS in the city complained in October that they would be unable to operate if their funding continued to face delays as it had in 2008, according to the Times-Picayune. Doug Morgan, who administers Ryan White Program funding for the federal Health Resources and Service Administration, said, "Our hope is that some of the issues they faced in [2008] will not be repeated in [2009]." He added, "I'm unhappy to learn the initial draft of the (requests for proposal) had glitches in it. It sounds like they're close to repeating some of the timelines they had last year, and that makes me a little nervous."

A new notice appeared Tuesday in the Times-Picayune and the deadline for submitting requests was listed as Jan. 9. The notice also will appear Wednesday and Thursday in the newspaper. Dave Munroe of In This Together -- a not-for-profit agency serving 225 patients that was forced to shut down over the summer because of the delay in funding and reopened in October -- said that the agency will not apply for 2009 funding because of "continuing issues of truthfulness, transparency and professionalism" at the city level (Hammer, New Orleans Times-Picayune, 12/17).

In the event that funding runs out, and you require alternatives, please visit www.aids-drugs-online.com

Generics Really Do Measure up to Brand Name Drugs

Brand-name drugs for treating cardiovascular disease don't appear to be clinically superior to generic versions, say U.S. researchers who reviewed studies comparing the drugs.

Some doctors and patients have expressed concerns that the drugs may not be equivalent in their effects, although generic drugs are chemically equivalent in terms of active ingredients, the study's authors said.

In Wednesday's issue of the Journal of the American Medical Association, Dr. Aaron Kesselheim of Brigham and Women's Hospital and Harvard Medical School in Boston and his colleagues combined the results of 30 studies done since 1984 that compared nine subclasses of cardiovascular medications, 81 per cent of which were randomized controlled trials.

"The studies in our sample concluded that generic and brand-name cardiovascular drugs are similar in nearly all clinical outcomes," the researchers concluded.

Brand-name prescription drugs are sold at high prices after approval by the U.S. Food and Drug Administration and while under patent protection, the study's authors said. Brand-name cardiovascular drugs may cost as much as a few dollars per pill while generics may be as little as a few cents a pill, Kesselheim added.

"If a patient is prescribed a generic drug because that's what's appropriate for their condition, then they should feel confident taking that drug. And physicians themselves should also feel confident prescribing generic drugs where appropriate," Kesselheim said in a telephone interview.

The review of randomized clinical trials found clinical equivalence in:

* 7 of 7 trials for beta-blockers.
* 10 of 11 trials of diuretics.
* 5 of 7 trials for calcium-channel blockers.
* 3 of 3 trials for antiplatelet agents.
* 2 of 2 trials of statins.
* A single trial for angiotensin-converting enzyme or ACE inhibitors.
* A single trial for alpha-blockers.

Cost questions

Of 43 editorials and commentaries reviewed, 23 or 53 per cent expressed a negative view of the interchangeability of generic drugs compared with 12 (28 per cent) that encouraged substitution of generic drugs, with the remaining eight not reaching a conclusion, Kesselheim and his colleagues said.

As for why, commentaries may be more likely to highlight doctors' concerns based on anecdotal experience, and the conclusion of the editorial writers could be skewed by financial relationships, the team said in noting that nearly half of the editorials and commentaries did not identify sources of funding.

Generic medications account for 65 per cent of all prescriptions dispensed in the U.S. and less than 21 per cent of money spent on prescriptions, according to IMS Health, a company that tracks prescription drug sales.

"The contention that brand-name medicines drive up the cost of health care is fatally flawed," Ken Johnson, senior vice-president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents brand-name drug makers, said in a statement released in response to the study.

"Without today's innovative brand-name drugs to legally copy, there would be no generic drug industry," he said.

The study's authors reported no financial disclosures.
With files from Reuters

Global Financial Crisis Could Adversely Effect AIDS Funding

The current global financial crisis could harm HIV/AIDS funding and increase the factors that make people vulnerable to the disease, UNAIDS Executive Director Peter Piot said on Tuesday during an event at the Center for Strategic and International Studies, CQ HealthBeat reports. According to Piot, as rising food and energy costs drive more people into poverty worldwide, the factors that drive the spread of HIV also could increase. "That must have an impact on the spread of HIV, although it's not so clear," he said, adding that it is certain that low-income countries will be more affected by and vulnerable to the financial crisis when it comes to providing HIV/AIDS treatment. For example, 100% of the cost to provide 50,000 HIV-positive people in Rwanda with antiretroviral drugs at the end of last year was paid by donors -- such as the Global Fund To Fight AIDS, Tuberculosis and Malaria and the President's Emergency Plan for AIDS Relief -- according to Piot. He added that Brazil receives no donor funding to provide similar treatment services to its HIV-positive citizens.

Countries likely will not feel the effects of the financial crisis on HIV/AIDS "in the next six or 12 months because of commitments that have been made in better times," Piot said, adding that he wonders if it will be possible to continue enrolling 700,000 to one million people in drug treatment programs over the next few years. "If not, deaths will go up again, deaths from AIDS, no doubt about it," he said, adding, "We estimate that even if (funding) continues at the same level, deaths will go up to about three million per year by 2011."

Piot also praised the Bush administration and Congress for continuing PEPFAR, which he said is an "unprecedented program that has saved millions of lives." Piot added, "It is quite rare in international development that you can count so easily, you can measure, the impact of actions, and yet this has been the case when it comes to what PEPFAR has done, and it's unprecedented in international development." In addition, Piot commended President Bush and Secretary of State Condoleezza Rice for their comments at the recent White House summit on international development about how the U.S. should not reduce aid. "I hope that the next president will follow along the same lines," Piot said.

Jennifer Kates -- vice president and director of HIV policy at the Kaiser Family Foundation -- said it is difficult to assess how the financial crisis will affect future funding levels. "How the financial crisis plays into that, we still don't know," she said.

Piot will leave his position at UNAIDS at the end of the year to head the new Institute for Global Health at Imperial College London (Vadala, CQ HealthBeat, 10/28).

Recession proof your medicine cabinet today by switching to generic AIDS drugs. Visit www.aids-drugs-online.com

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

www.aids-drugs-online.com

Rising HIV Prevalence Among MSM in Hong Kong

The senior medical director of Hong Kong's Centre for Health Protection, Raymond Ho Lei-ming, on Tuesday warned residents that HIV prevalence in the region is increasing among men who have sex with men, Hong Kong's Standard reports (Chui, The Standard, 9/17).

According to Ho, a study released last year found that HIV prevalence among MSM in Hong Kong is about 4%, up from a 1% HIV prevalence rate in previous years. Ho said prevalence among MSM in the region could top 30% by 2020 if current trends continue. According to Ho, sex parties and low condom use have been attributed to the increased number of cases. "If we don't do anything, we are looking at a worst-case scenario," Ho said (Benitez, South China Morning Post, 9/17). He called for people at risk of HIV infection to get tested and for greater condom use and other HIV prevention measures (Standard, 9/17).

Loretta Wong Wai-kwan, the CEO of AIDS Concern, a volunteer organization offering HIV/AIDS support and prevention programs in Hong Kong, said that the number of HIV/AIDS clinics in Hong Kong has remained stagnant over the past decade. She added, "How do the existing human resources or facilities cope with the increasing case load?" (South China Morning Post, 9/17).

http://www.aids-drugs-online.com

Doctor's advice on Viraday - Taken from thebody.com

How long they live with Viraday? Apr 10, 2007 The patient found CD4 at 8 and viral load at 350,000 started treatment by taking medicine of "Viraday" (Cipla company). By continuing the treatment how long the patient can live? What are the cautions to be taken by the patient? Response from Dr. Pierone Viraday is a combination of Viread, Emtriva, and Sustiva, the same components which are in Atripla. This combination agent leads to an undetectable viral load and increases in CD4+ lymphocyte counts in the great majority of patients. AIDS is a chronic, manageable disease for people who have access to potent combination therapy like this. The expectation is that individuals on successful treatment for HIV infection and AIDS will have a normal or near normal lifespan. The precautions for this medication would mainly be for the Sustiva component of this medication which produces neuro-cognitive adverse events more than half of the time, but these effects tend to dissipate after the first several weeks. Viread can produce kidney problems, but not commonly, and usually in patients who already have kidney problems or are on other medications with kidney toxicity. I hope that this information helps and best of luck!

The Bronx to Test Everyone for HIV/AIDS

The New York City Department of Health and Mental Hygiene on Friday will begin a three-year effort to test every adult living in the Bronx -- which has the highest rate of HIV/AIDS-related deaths in the city -- for HIV, the New York Times reports. According to the Times, the campaign will initially work to make voluntary testing routine in emergency rooms and storefront clinics, where city officials say that state consent procedures deter physicians from offering the tests. City Health Commissioner Thomas Frieden said that routine testing "would mean if you came into the emergency room for asthma or a broken leg, we test everyone for HIV, if they're willing."

Although Manhattan has the highest incidence of HIV/AIDS cases in the city, the Bronx, which has a lower-income population, reports more deaths from the disease. Public health officials say the high mortality rate is associated with people not getting tested until it is too late to effectively treat the virus. According to city officials, 40% of the borough's 830,000 people ages 18 to 64 have undergone HIV testing in the past year, and half of the remainder, about 250,000, have never been tested. The campaign intends to first test this group at 40 designated sites, including clinics, community centers, churches and emergency rooms. Monica Sweeney, an assistant health commissioner for HIV prevention, said the city has not set aside money specifically for the program, but that it would absorb the $12 cost of each test.

The Times reports that several HIV/AIDS experts have described the effort as the most aggressive in the country. Donna Futterman -- director of Montefiore Medical Center's Adolescent AIDS Program in the Bronx, which helped New York City develop the program -- said, "What's new here is that we are implementing it on this large a level," adding, "The Bronx has 1.3 million people. It's bigger than most cities, bigger than Boston, bigger than Washington. We're talking about a significant urban population." Frieden -- who has enlisted the support of Bronx elected officials, health care providers and clergy members -- said the health department chose the Bronx because it has good relationships with clinics and hospitals there. City officials also said that Bronx residents already are more likely to be tested than adults in other boroughs.

However, Frieden said the efforts come after years of lobbying to overhaul strict state regulations -- which have changed little since HIV/AIDS was first discovered in the 1980s -- that require patients to give written permission for testing after being counseled on the process. According to Frieden, New York's consent law is one of the strictest in the country; CDC recommends that written consent and pretest counseling requirements be dropped.

Futterman said that she hopes that making HIV testing routine by including the test as part of a patient's blood work will change the mentality surrounding the test and spur state legislators to ease consent rules. "Everything in AIDS has changed except the old testing paradigm," she said, adding, "Old school was that you had to tell them everything that could happen. That starts to seem cruel. If you go for cancer diagnosis, they don't make the doctor say what you're going to do if your mammogram is positive."

According to the Times, under the new initiative, hospital administrators in the Bronx have agreed to test in emergency departments, where physicians have felt the requirement interferes with more immediate health needs, but still follow state consent laws. Futterman said she has carefully constructed a script for physicians that follows state law but condenses what is typically a 20-minute counseling and consent process into five minutes. She added that using the process has helped her increase the proportion of her patients being tested to between 20% and 25%, up from 10%.

In an attempt to make HIV testing less intimidating, the city also will issue public service announcements and information on its 311 hotline. It also is posting tear-off sheets with addresses of testing centers in places like check-cashing stores, where residents can discreetly slip them into pockets. Sweeney said, "It's not about one group doing it, it's about everybody doing it." Community organizations, universities, churches and politicians are going to have all their constituents that come to them for other services, they're going to use it as an opportunity to say, 'Get your HIV test'" (Hartocollis, New York Times, 6/26).

The Quality Standards for Generic Drugs

Are Discount Drugs of Inferior Quality?

"Most people believe that if something costs more, it has to be better quality..."says Gary Buehler, Director of FDA's Office of Generic Drugs. "In the case of generics (discount drugs), this is not true. The standards for quality are the same for brand name and generic products." (1)

When a brand name product has a generic competitor, this simply means that the brand name product has been around long enough for its patent to expire, which then allows generics (copy discount drugs) to be made. Most often generics will be the discount drugs found in these markets, and almost always they will be less expensive prescription drugs when compared to their brand name counterparts.

Despite their lower price, manufacturers of generic prescription drugs are required to meet rigorous quality standards before they can sell their generic 'discount drugs'. Pharmacies who source high quality generic products only from pharmaceutical manufacturers that comply with these strict international regulatory standards are providing quality alternatives to the branded equivalent. The quality standards of the lower cost generic products available are as high as they are for the most expensive original brand name drugs .

While the active ingredients in generic prescription drugs are the same as the active ingredients in their brand name counterparts, there may be differences in their appearance. (For example, the shape or the colour of a tablet.)

Sometimes different non-active ingredients may used to produce the final product. (For example, the non-active base in creams or diluents in nasal sprays.) However, the active ingredients, which give a drug its intended effect, are the same in generic prescription drugs and their brand name counterparts. None of these differences should alter the clinical effect of any approved generic discount drug.

The Current Use of Generic Prescription Drugs

The U.S. drug regulatory authority, the FDA, has approved more than 7000 generic discount drugs for use in the U.S. The approval process that all of these generic prescriptions drugs have completed is extremely intensive and multi-faceted. It covers quality, performance and labelling. Also, while these generics will inevitably become the country's discount drugs, the manufacturing facilities where they are to be made, are required by the FDA to be as good as those used to manufacture brand name drugs. This standard applies no matter where in the world the manufacturing facility is located.

Almost half of the prescriptions filled in 2002 in the U.S. were for generic drugs (1), these being the discount drugs of the country. This strong and growing demand for generic prescription drugs is testimony to their widespread acceptance by the health authorities, health professionals, and patients.

Pharmacies source high quality generic products only from pharmaceutical manufacturers that comply with strict international manufacturing standards. This means that any generic product supplied to a customer has complied with robust internationally accepted quality standards.


Some of the generic products sourced from internationally approved pharmaceutical manufacturers from India. The key companies that supply Indian generic pharmaceuticals are:

• Dr Reddy's Laboratories Limited

• Cipla Limited

The links provided will take you to the respective company websites which have information to show that their manufacturing facilities have been inspected to meet the robust standards of the FDA as well as other internationally recognised regulatory authorities.

Some Technical Facts About The Generic Drug Approval Process

In the U.S and most developed countries generic drugs must show that they:

• Contain the same active ingredients as the brand name drug (inactive ingredients may vary)

• Are identical in strength, dosage, form, and route of administration

• Are used for the same condition(s)

• Are bio-equivalent (that is, they are available to the same extent in the body when taken or administered)

• Meet the same batch requirements for identity, strength, purity, and quality

• Are manufactured under the same strict standards of the FDA's good manufacturing practice as required for brand name products. (1)

Useful Links

To read more about the FDA standards for generic drugs click on the following links. http://www.fda.gov/opacom/factsheets/justthefacts/18generic.html
http://www.fda.gov/cder/about/whatwedo/testtube-17.pdf

WHO Director-General Chan Calls on Member States To Make Antiretrovirals, Other Medications More Affordable

World Health Organization Director-General Margaret Chan on Monday at a meeting of WHO's Intergovernmental Working Group on public health in Geneva called on developed countries to make antiretroviral drugs and other medications more affordable for developing countries, the AP/Tacoma News Tribune reports. WHO's 193 member states by the end of the week hope to develop a strategy on drug development, patenting and pricing, according to the AP/News Tribune.

Chan at the meeting said she is aware that the "price of medicines and other products can be prohibitive, effectively blocking access to care," but she added that innovation is needed. "Resistance develops and drugs fail, creating an urgent need for second- and third-line medicines," Chan said, adding, "We have seen this problem most acutely with HIV/AIDS. We are seeing it again with the spread of extensively drug-resistant tuberculosis, which is far more costly and difficult to treat" (Klapper, AP/Tacoma News Tribune, 11/5).

Chan said, "The challenge is to work on multiple fronts: to meet the immediate need for equitable access to quality, affordable medicines, while also, at the same time, working to stimulate innovation." She added that the global health community "cannot allow the costs of health care to drive impoverished households even deeper into poverty."

Working Group
According to AFP/Yahoo! News, the working group was set up last year after a WHO-commissioned report called on pharmaceutical companies to reduce prices of drugs sold in developing countries. Some companies have said they already have reduced prices, and the International Federation of Pharmaceutical Manufacturers and Associations has said that drug price and patent issues fall under World Trade Organization jurisdiction and not WHO.

According to U.S. documents obtained by the lobby group Knowledge Ecology International, the U.S. urged countries attending the weeklong meeting to respect existing WTO commitments and not extend WHO's mandate. The U.S. "would like you to make sure you are aware of the potentially negative trade and intellectual property implications that could arise from this initiative" at WHO, the document said. James Love, director of KEI, said the U.S. and European Union are playing a "cynical game" in attempting to break the consensus toward making drugs more affordable (AFP/Yahoo! News, 11/5).

Related Opinion Pieces
Two newspapers on Tuesday published opinion pieces in response to the WHO meeting. Summaries appear below.

* Franklin Cudjoe, Wall Street Journal: Inadequate infrastructure, not price, is the "chief obstacle blocking access of high-quality medicine" in developing countries, Cudjoe, executive director of the Imani Center for Policy and Education, writes in a Journal opinion piece. "If the West is any guide, better health systems come with economic development and higher standards of living," both of which are "frequently stifled" in developing countries by "destructive policies and home-grown corruption," Cudjoe writes. "Let's hope the WHO won't succumb to the misconception that compulsory license can cure Africa's health problems," Cudjoe writes, concluding that "economic development remains the continent's best hope for eradicating the diseases of poverty" (Cudjoe, Wall Street Journal, 11/6).

* Jeremiah Norris, Taipei Times: WHO member states "need to knock this treaty on the head ... before the WHO does lasting damage to global public health," Norris, director of the Center for Science in Public Policy at the Hudson Institute, writes in a Times opinion piece. According to Norris, WHO "aims to weaken intellectual property further and to bring research and development under the control of governments and international bodies," adding that "past evidence shows that nationalizing any business stifles innovation and that it would hinder future efforts to create drugs" for developing countries (Norris, Taipei Times, 11/4).

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at AIDS Drugs Online))

AIDS Vaccine

Merck's Experimental AIDS Vaccine Fails

By LINDA A. JOHNSON – Sep 22, 2007

TRENTON, N.J. (AP) — In a disappointing setback, a promising experimental AIDS vaccine failed to work in a large international test, leading the developer to halt the study. Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the study, which was partly funded by the National Institutes of Health.

It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.

"It's very disappointing news," said Keith Gottesdiener, head of Merck's clinical infectious disease and vaccine research group. "A major effort to develop a vaccine for HIV really did not deliver on the promise."

Michael Zwick, an HIV researcher at Scripps Research Institute, said the vaccine's failure is unfortunate. But he said it's too soon to know if other vaccines using the same strategy would also fail.

"It's par for the course in the HIV field," he said of the Merck result.

The volunteers in the experiment were all free of HIV at the start. But they were at high risk for getting the virus: Most were homosexual men or female sex workers. They were all repeatedly counseled about how to reduce their risk of HIV infections, including use of condoms, according to Merck.

In a statement, the NIH said a data safety monitoring board, reviewing interim results, found the vaccine did not prevent HIV infection. Nor did it limit severity of the disease "in those who become infected with HIV as a result of their own behaviors that exposed them to the virus" — another goal of the study.

Merck's was the first major test of a new strategy to prevent HIV infection. The first wave of attempts to develop a vaccine tried to stimulate antibodies against the virus, but that hasn't worked so far.

The new effort — an approach that Gottesdiener said is being tried in most other current research — is aimed at making the body produce more of a crucial immune cell called killer T cells. The goal is to simultaneously "train" those cells, like an army, to quickly recognize and destroy the AIDS virus when it enters cells in the bloodstream.

Zwick said some researchers still are working on vaccines to neutralize the AIDS virus. He thinks ultimately what's needed is one that combines that approach with a way to stimulate and train killer T cells.

Merck and the HIV Vaccine Trials Network, an international collaboration of researchers and institutions funded by the NIH, co-sponsored the study. The experiment, called STEP, began in December 2004 and had enrolled 3,000 volunteers in Australia, Brazil, Canada, the Dominican Republic, Haiti, Jamaica, Peru, Puerto Rico and the United States.

The results announced Friday involved volunteers who researchers thought would benefit most because they had never been exposed to the particular cold virus used in the vaccine.

Wall Street, on a generally upbeat day, showed little reaction to the news, with Merck shares rising 44 cents to $51.82.

Analyst Steve Brozak of WBB Securities said the vaccine was considered the most promising candidate both by Wall Street and the science community. He said a vaccine is the only financially feasible way to fight the AIDS epidemic in poor countries and that the company that comes up with the first successful shot would have "a license to print money."

"You're talking about a Carl Sagan kind of number — billions and billions" of dollars, he said.

The Merck vaccine, known only as V520, also was being tested in a similar study in South Africa and in two smaller studies, which also were halted.

The Merck vaccine failure is a "deep disappointment and a scientific setback for the AIDS vaccine field," the AIDS Vaccine Advocacy Coalition said in a statement. However, the nonprofit group added that "while this is a disappointment, it is in no way the end of the search for an AIDS vaccine."

((Considering that the vaccine has failed, there are still several viable and inexpensive treatment options available at www.aids-drugs-online.com))

Cipla launches 3-in-1 AIDS drug in India

Cipla has launched an innovative combination of 3 HIV/AIDS drugs, Viraday that needs to be taken just once a day for effective treatment.

The three anti-HIV drugs efavirenz 600 mg, tenofovir 300 mg and emtricitabine 200mg comprise the drug Viraday. Viraday, one tablet of which alone effectively treats a HIV infected person, eliminates the need for 3 separate medicines. This drug has some advantages like, it is less burdensome and it can be taken along with tuberculosis medicines, which could not be done previously.

This combination drug, that was previously available only in the U.S. and European countries, was first launched in India by Cipla on Thursday. In the U.S. and Europe this combination drug costs Rs. 52,800 a month, whereas Cipla will make it accessible at just Rs. 5,200 per month. This combination drug is less toxic than when the drugs are taken separately.

This breakthrough would improve the adherence-how faithfully patients stick to the course of treatment advised by the doctor. “This is a vital issue in HIV treatment to prevent the infection from reaching the advanced stage of AIDS,” said senior consultant in Internal Medicine at Indraprastha Apollo Hospital, Dr Nalin Nag. He said, “Viraday is very patient friendly, as it requires just one pill a day and freedom from the severe side effect of many other anti HIV drugs.”

The innovative treatment kits and the 3-in-1 pills introduced by Cipla will promote adherence and ease of use. Viraday is the most remarkable accomplishment of Cipla.

Cipla has brought down the price of HIV/AIDS drugs in international market. It supplies HIV/AIDS drugs to majority of African, South Asian, Latin American and several other developing countries.

Source-Medindia
GYT

Find Viraday available at www.aids-drugs-online.com