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).

Drug Access | Boehringer, Gilead Freeze Antiretroviral Prices for Some U.S. Agencies

[Jun 05, 2008]

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports. Gilead will freeze the prices on its antiretrovirals Viread, Truvada and Emtriva for the U.S. Public Health Service, the Federal Supply Service and state AIDS Drug Assistance Programs, according to company spokesperson Amy Flood. The price freeze will be effective through Dec. 31, 2010, according to AHF. The wholesale acquisition cost is $552 monthly for Viread, $329 monthly for Emtriva and $840 monthly for Truvada, Flood said. She added that government purchasers generally receive partial rebates from the prices. "We share your concern regarding antiretroviral cost pressures faced by government payers, particularly during times of limited budget access and flat funding," Gregg Alton, senior vice president and general counsel at Gilead, said in a letter to AHF.

Boehringer will freeze the price of its antiretroviral Aptivus for ADAPs through May 1, 2009, according to AHF. The price freeze became effective May 1, according to a Boehringer letter to AHF. Boehringer spokesperson Judith von Gordon did not return calls for comment, Bloomberg reports.

"We urge the other drug companies to follow [Boehringer's] and Gilead's lead and to freeze price increases that create an unnecessary burden on an already overburdened public health system and keep lifesaving drugs out of reach for those who need them," AHF President Michael Weinstein said. AHF called on companies to freeze their prices because of issues government agencies have had in increasing access to antiretrovirals (Lauerman, Bloomberg, 6/3). Reponses from Abbott Laboratories, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, Roche and Johnson & Johnson subsidiary Tibotec Therapeutics "reiterated the companies' commitment to increasing access but made no specific pledge with regard to" price freezes, according to an AHF release (AHF release, 6/3).

For access to low cost generics, please visit:
www.aids-drugs-online.com

All it takes is one

Kaiser Daily HIV/AIDS Report

Science & Medicine | Most HIV Cases Traced to Transmission of Single Virus, Study Finds

[May 22, 2008]

Most HIV cases can be traced to the transmission of a single virus, according to a study published online Monday in the Proceedings of the National Academies of Science, the Birmingham News reports. According to researcher George Shaw, a professor at the University of Alabama-Birmingham, the findings are surprising and could have an impact on HIV/AIDS vaccine development.

For the study, Shaw and colleagues analyzed blood samples from 102 people who had recently contracted HIV. The study was funded by NIH's National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation. The researchers genetically analyzed the samples and were able to count generations of HIV. They found that 76% of the cases could be traced back to a single virus. The remaining 24% could be traced to two to five viruses, according to Shaw. Shaw noted that in the "vast majority" of cases, a single virus has "gone across the sexual mucosa, and that virus has infected a cell." He added, "That cell then makes a lot of virus. Now you just have a firestorm of HIV replication in the next couple weeks. Very quickly the person is populated by millions of viruses." According to Shaw, the findings help explain why it usually takes several exposures for a person to contract HIV, why transmission of the virus is so inefficient and why condoms help prevent HIV transmission.

The findings are significant because they indicate that if researchers are "trying to develop a vaccine or microbicide or whatever to prevent [HIV] infection, the only thing it has to do is prevent the transmission of a single virus," Shaw said. He added, "That should be possible. All you have to do is provide some additional block to what already is an efficient process." The findings "provide light on what was previously a very cloudy area of HIV infection," Shaw said, adding, "It puts acute and early transmission of HIV-1 in very sharp focus."

Most other sexually transmitted infections -- such as gonorrhea and syphilis -- "invade the body en masse," according to the News. "They just all come across 10, 20, 100, 200 bacteria or spirochetes," Shaw said. Several research centers worldwide were involved in the project, including Duke University, the University of California-San Francisco, the University of Cape Town in South Africa, the University of Massachusetts-Amherst, the University of North Carolina-Chapel Hill, the University of Maryland, the University of Rochester, and the Los Alamos National Laboratory and the Santa Fe Institute in New Mexico (Parks, Birmingham News, 5/20).

The study is available online (.pdf).

Source: Kaiser Daily HIV/AIDS Report

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

FDA Approved AIDS Drugs

For those seeking treatment options, below is a listing of medications available in the USA. Please note that this list is not 100% complete, and does not include all possible available or recently approved medications. Also, it is possible to buy some of these medicines as generics and as such they would have different names.

• Agenerase (amprenavir) - Protease inhibitor.
• Aptivus® (tipranavir) - Protease inhibitor.
• Atripla; Three pills in one; combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).
• Combivir -combination of Retrovir (300mg) and Epivir (150mg) - together in the same tablet for convenience.
• Crixivan (indinavir) - protease inhibitor.
• Emtriva [ emtricitabine (FTC).
• Epivir (3tc / lamivudine) - nucleoside analog reverse transcriptase inhibitor
• Epzicom ( a combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs in the same pill; 600mg of Ziagen (abacavir) and 300mg of Epivir (3TC).
• Fortovase (saquinavir) - protease inhibitor.
• Fuzeon (enfuvirtide) - Fusion inhibitor.
• Isentress (raltegravir) Integrase Inhibitor.
• Invirase (saquinavir) - protease inhibitor.
• Kaletra (lopinavir) - protease inhibitor.
• Lexiva (Fosamprenavir) - Protease Inhibitor approved 10/20/03
  Formerly known as GW-433908 or VX-175
  Improved version of Agenerase ( amprenavir); supposed to be fewer pills per day and fewer GI Side effects.
• Norvir (ritonavir) - protease inhibitor.
• PREZISTA (darunavir) tablets. - protease inhibitor;
  used when other protease inhibitors don't work any more.
• Rescriptor (delavirdine) - non nucleoside analog reverse transcriptase inhibitor.
• Retrovir, AZT (zidovudine) - nucleoside analog reverse transcriptase inhibitor.
• Reyataz (atazanavir; BMS-232632) - protease inhibitor.
• Sustiva (efavirenz) - non nucleoside analog reverse transcriptase.
• Trizivir (3 non nucleosides in one tablet ; abacavir + zidovudine + lamivudine.
• Truvada (Emtricitabine + Tenofovir DF )
  Combination of 2 nucleoside reverse transcriptase inhibitor (NRTI's in one pill).
• Videx (ddl / didanosine) nucleoside analog reverse transcriptase inhibitor.
• Viracept (nelfinavir) - protease inhibitor.
• Viramune (nevirapine) - non nucleoside analog Reverse transcriptase inhibitor.
• Viread (tenofovir disoproxil fumarate) Nucleotide Reverse transcriptase inhibitor ( Adenosine Class).
• Zerit (d4t / stavudine) - nucleoside analog reverse transcriptase inhibitor.
• Ziagen (abacavir) - nucleoside analog reverse transcriptase inhibitor.

AIDS-Drugs-Online.com

New AIDS Drugs

According to Avert, an international AIDS charity, more than half a million people with AIDS have died in the United States. Since 1989, there have been at least 39,000 new AIDS diagnoses each year. Prevalence of the disease peaked in the United States in 1993, then showed a decline. The most dramatic drops in both cases and deaths began in 1996, with the widespread use of the combination antiretroviral therapy, or “drug cocktails.” While almost one million people have been diagnosed with AIDS, only an estimated 550,394 have died. The number of deaths among people with AIDS has remained stable since 1999. The drug cocktails have contributed significantly to this, but now, two new drug innovations could be the next big things in HIV and AIDS treatment. If they are as affective as researchers hope, those rates will not only remain stable -- they’ll go down.

NEW WEAPONS: The introduction of the drug cocktails made a major impact on the number of deaths from AIDS. Researchers hope two new classes of HIV and AIDS drugs could be the new "drug cocktails" of the 21st century. There are nearly 30 drugs in four different classes. The four existing classes of HIV and AIDS antiretroviral drugs each targeting the HIV virus in one of four different ways. With the introduction of two new drugs -- each representing a new class of HIV and AIDS drugs -- there will be a total of six different classes of drugs available. Doctors say the drugs should be used in combination with existing drugs to combat the disease in multiple ways.

ISENTRESS (raltegravir), manufactured by Merck, is the first medicine to be approved in the new integrase inhibitors class of antiretroviral drugs. ISENTRESS works by inhibiting the insertion of HIV DNA into human DNA by the integrase enzyme. Doing so limits the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process, but ISENTRESS is the only drug that inhibits the integrase enzyme.

SELZENTRY (maraviroc), manufactured by Pfizer, is the first approved medicine in the CCR5 antagonists, which block the CCR5 co-receptor -- the virus' predominant entry route into T-cells. HIV enters cells in the blood by attaching itself to structures on the surface of the cell called receptors. SELZENTRY blocks a specific receptor called CCR5 that CCR5-tropic HIV-1 uses to enter T-cells in your blood.

Neither drug reduces the risk of transmitting HIV to others. HIV is spread through sexual contact, sharing needles or being exposed to an infected person's blood. Manufacturers caution the drugs will not cure HIV infection, but may slow the progression.

These medicines will likely be available first at AIDS-Drugs-Online.com

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).