Cipla launches HIV/AIDS treatment kit at Rs 158

via IBN Live

New Delhi: Drug major Cipla on Tuesday said it has launched 'Qvir', a four-drug kit priced at Rs 158 per kit to be used for treating HIV/AIDS. The kit consists of two tablets packaged together in one strip which represents a single day's treatment, Cipla said in a statement.

Commenting on the introduction Cipla Chairman and Managing Director YK Hamied said: "While we are committed to making drugs affordable and accessible, we also endeavour to have more options for HIV infected patients, which are potent, effective, patient-friendly and easy to take".

As the tablets are packaged together in one strip, the patient does not have to remember which tablet he took, and cannot mistakenly take two of the same tablet, the company said.

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Big pharma is cut out by India's plan to bring medicine to masses

via The Independent, by Nikhil Kumar

India is planning a multibillion-dollar push to bring free medicines to the hundreds of millions of its citizens who, despite the country's economic revival, still languish without access to the very basics of health care.

The $5bn initiative, which is slated to be rolled out by the end of this year, will offer 348 essential drugs to patients across the country. In a blow to the West's big pharmaceutical firms, the planned scheme will largely cut out branded drugs, opting instead for cheaper generic alternatives.

News of the plan comes as the Congress-led administration in Delhi attempts to shore up public support after a raft of corruption scandals and crushing electoral losses in state polls. A recent report confirming a slowdown in economic growth has only served to sharpen criticism of the government.

Now, Delhi is plotting a multi-billion dollar health-care drive, using its network of government-funded hospitals and clinics to deliver free drugs across a country where, despite the much-vaunted boom of recent years, more than two million young children die every year from preventable infections, according to Unicef.

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HIV Drug Trial in South Africa Draws Concerns

via allafrica.com, by Anso Thom

AIDS activists and researchers are at loggerheads over the planned South African trial of a lower dose version of the controversial antiretroviral stavudine, which has in the past been responsible for debilitating side-effects in HIV patients.

The main adverse effect is peripheral neuropathy, which can be corrected by reducing dosage.

The symptoms of peripheral neuropathy include burning, stiffness, prickling, tingling, and numbness or a loss of feeling in the toes and soles of the feet. Sometimes the nerves in the fingers, hands, and wrists are also affected.

Stavudine is also one of the most likely ARVs to cause lipodystrophy, and for this reason it is no longer considered an appropriate treatment for most patients in developed countries and is no longer recommended by the World Health Organisation.

However, due to its low price, it is still widely used in the developing world.

Lipodystrophy is the redistribution of fat in the body, which manifests as excess, or lack of, fat in various regions of the body. People can have sunken cheeks and/or "humps" on the back or back of the neck (also referred to as buffalo hump).

In the one camp, the Treatment Action Campaign, Medecins Sans Frontieres (Doctors without borders) and the Treatment Action Group have serious concerns about the proposed trial.

They are concerned that stavudine is more toxic than tenofovir (the drug which replaced stavudine in the government treatment programme), making it an inferior treatment.

Patients' poor tolerance means that they are more likely to not adhere to treatment and will have to be switched to more expensive second-line treatment when they fail first line treatment.

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Reuters: India Should Tax Air Tickets to Pay for AIDS Drugs - U.N.

via Reuters.com, by Nita Bhalla

Millions of the world's poorest people could have easier access to life-saving drugs if India introduces an air ticket tax to help fund purchases of cheap medicines for HIV/AIDS, malaria and tuberculosis, a senior U.N. official said.

UNITAID, a U.N. agency which negotiates for cheap medicines from pharmaceutical manufacturers to treat deadly diseases, is lobbying countries such as India to join its air ticket levy initiative which began in 2006.

Under the program, countries put a nominal amount on the cost of air tickets which funds UNITAID to buy drugs for patients in the developing world. Ten countries have imposed the levy, generating $200 million annually for cheap medicine.

"What we want in India is a similar system by which a very small contribution which is painless to the traveler can be applied to large numbers of travelers," UNITAID Executive Director Denis Broun told AlertNet in an interview.

"Since air traffic is very high in India, the small amount of levy makes a huge difference to the amount of drugs that we can purchase and the number of poor who can benefit from them."

HIV/AIDS, malaria and tuberculosis kill 4.4 million people each year, UNITAID says. Approximately 14.2 million people are in need of anti-retroviral drugs globally, yet more than half cannot afford them.

India's airlines are reeling under a debt load of $20 billion and lost $2 billion last year, as high fuel prices, a weakening rupee and competition kept fares low and costs high.

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The Impact Generic Drugs Have on the Cost of HIV Treatment

via Huffington Post, by Dean Baker

Drugs are cheap. Patent monopolies are expensive. These are simple facts that everyone should know but for some reason few do.

The point here is simple; the vast majority of drugs are cheap to produce. Chain drug stores sell hundreds of generic drugs for $5-$7 per prescription. They can do this profitably because few drugs require expensive chemicals or manufacturing processes.

However, many brand drugs sell for hundreds or even thousands of dollars per prescription. This is due to the fact that drug companies have patent monopolies on these drugs. The government will arrest anyone who produces these drugs without the permission of the patent holder. Since drugs can be essential for people's health and/or life, if they can find a way to pay any price demanded by the drug companies, they will.

The higher prices due to patent monopolies are the reason that many people have difficulty paying for drugs. If all drugs were sold in a free market as generics, paying for drugs would not be a serious issue except for the very poor.

Of course, patent protection is the way in which drug companies finance their research. It costs a lot of money to research new drugs and then test them to establish their safety and effectiveness and bring them through the Food and Drug Administration's approval process.
However, there are more efficient mechanisms than patent monopolies to finance drug research. Vermont Senator Bernie Sanders is proposing one such mechanism, a prize system, be adopted to support research on AIDS drugs.

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The Impact 'The Affordable Care Act' Will Have on HIV Treatment and Care

via HuffPost Chicago, by Gregory Trotter

For the 1.2 million Americans living with HIV, the Affordable Care Act will be utterly life-changing. For some, it will be life-saving.

Just ask Will Wilson, 58, who was diagnosed with "full-blown AIDS" in 2002.
"It will basically mean freedom," said Wilson, a Chicago resident and an advocate for the Illinois Alliance for Sound AIDS Policy.

For the first time, Wilson will be able to purchase private insurance without fear of being rejected for his preexisting condition. The former graphic designer will be able to aggressively re-enter the job market without risking his continuous access to lifesaving HIV drugs that cost him $3,000 a month.

He'll have options he's never had.

This week, the Supreme Court has heard oral arguments on the constitutionality of the Affordable Care Act, specifically the legality of the individual mandate provision and the expansion of Medicaid. It is slated to rule in June on what is widely considered to be the most important Supreme Court case in decades. Many people living with HIV/AIDS and other preexisting conditions will be hoping and praying that the court rules in favor of health care reform.

In January, the AIDS Foundation of Chicago (AFC) signed on to a legal brief -- along with 130 other HIV/AIDS organizations throughout the country -- asserting that the Affordable Care Act is, in fact, constitutional. It's also necessary to stopping the AIDS epidemic in the United States.

"The list of supporters for our brief urging the court to uphold the ACA continues to grow because of the law's enormous potential to impact the domestic AIDS epidemic," said Scott Schoettes, HIV Project Director for Lambda Legal, the legal firm that submitted the brief.

About 24 percent of people living with HIV are uninsured, according to data from the U.S. Department of Health and Human Services. The majority of people living with HIV depend on Medicaid and Medicare for medical treatment.

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High HIV Prevalence Calls for Stronger Commitment Towards Treatment and Care in Thailand

via Press Tv Bangkok, by Sonia Labboun

The concern is that the disease is increasingly affecting youngsters; about 25% of the total diagnosed patients are in the working group aged between 30-34 years old.

Experts say that schools and universities lack the means to give a proper education about the dangers of HIV and how the disease is transmitted, making this group age an ideal focal for its spread.

In a move to show the government's commitment to combat the disease, the National Health Security Office has announced a subsequent budget of nearly $100 million for HIV care and treatment and is already planning to increase the amount to almost $114 million for 2013.

In a major blow to global pharmaceutical firms, Thailand issued licenses for cheap HIV drugs between 2006 and 2008, a move that has angered industries from the US, Germany and Switzerland who until recently had the monopoly in HIV treatments.

Recently The world bank has pointed out at the fiscal burden of HIV, they say it shouldn't be considered only as a health problem, but also as an economic problem because of the huge costs in treating patients, highlighting as well the importance of effective prevention in order to lessen future costs.

In early 1990s, Thailand has overcome predictions that four million of the 65 million population could become infected by 2000 thanks to successful Aids education and prevention campaign that the current government wishes to revive.

The government is concerned that even though a cheap alternative for HIV treatments is available, the number of new infections is still rising. Experts blame it on poor education at schools and lack of prevention campaign in the media; deficiencies which the current government has promised to take action on."

Check out a video here.

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The Influence of India's New Ruling on HIV/AIDS Pharmaceuticals

via Reuters.com, by Kaustubh Kulkarni and Henry Foy

"India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say."

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.
"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

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Bristol-Myers Squibb, Gilead Sciences in licensing deal to produce new combination HIV pill

via The Washington Post, by Assoicated Press

Drugmaker Bristol-Myers Squibb Co. will develop a once-a-day pill to treat the HIV virus that combines its popular Reyataz with an experimental drug from Gilead Sciences Inc., the companies said Wednesday.

Under the licensing deal, Bristol-Myers will formulate, manufacture and sell the pill. It will include Reyataz, a popular drug in the class called protease inhibitors, and Gilead’s cobicistat, which is designed to boost blood levels of some HIV drugs. It works by blocking an enzyme that breaks down drugs in the body.

Gilead currently is doing mid- and late-stage human tests using the two drugs together to treat newly diagnosed HIV patients.

The two companies already have a joint venture selling the three-drug combination pill Atripla, the top-selling HIV pill in the U.S., with more than $3 billion in global sales last year. It includes Sustiva, made by Bristol-Myers, and Gilead’s Viread and Emtriva.

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Treatment alone will not win war against HIV

via Cape Argus, by Sipokazi Fokazi

If South Africa is to win the battle against HIV/Aids it cannot rely solely on treatment, and must explore prevention strategies that would target those most at risk, including women and children, a Cape Town scientist and HIV researcher has cautioned.

Professor Linda-Gail Bekker, head of the Desmond Tutu HIV Centre, at UCT, said although the effect of HIV treatment was starting to show with the number of deaths beginning to even out, the country would not win the battle with treatment alone.

Bekker was speaking during a meeting hosted by the Microbicide Media and Communication Initiative, an advocacy group that gathers research in microbicides by a range of organisations.

She warned that reliance on treatment would at some stage become unaffordable and unsustainable.

Finance continued to be a problem for many countries, and paying for antiretroviral drugs was becoming expensive.

“Given the financial difficulties, countries will somehow have to come up with plans on how to bring infection levels down.”

The focus needed to be on strategies that achieved behavioural change.

One of the most important things for South Africa was knowing its epidemic – who was most at risk, who was passing HIV to whom, and where the epidemic was concentrated.

UNAids information was that four population groups remained at risk: men who had sex with men, commercial sex workers, prisoners, and intravenous drug users.

In South Africa, young women and pregnant women could be added to that list.

Bekker suggested targeting, directing and tailoring prevention interventions to reduce infection rates.

“You need to know where most of your infections are occurring, and then to work out how best to intervene. I believe it has been a mistake to think one size fits all,” she said.

One area in which South Africa could start shutting the door was in the mother-to-child transmission of HIV.

“We need to wipe out paediatric infection.”

South Africa could not afford to allow transmission of the virus from mother to child.

“If we don’t prevent this, those children will need treatment for the rest of their lives and it will be expensive for the country. We can bring our mother-to-child HIVinfection rate to below 1 percent.”

Researchers had made great strides in HIV prevention studies, particularly in the field of microbicides.

Bekker said it was important that prevention packages be tailored to population groups that were most at risk.

Such strategies would have to take into account biomedical, behavioural and structural components.

“We are in a very exciting period where a whole range of biomedical technologies are showing partial but significant efficacy. Combinations of these prevention technologies in the future will give people options.”

Among the most promising interventions being researched by the Desmond Tutu HIV Centre and its partners was a rectal microbicide, for those practising anal sex. The proposed study would be carried out here and in other places around the world.


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Obama Pushes More Competition on Biologic Drugs

via The New York Times, by Andrew Pollack

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology.

Tucked into the president’s deficit reduction plan released on Monday was a proposal to reduce the market exclusivity offered to brand-name biologic drugs to seven years, down from the 12 incorporated in the 2010 federal health care legislation.

That would allow so-called generic versions of such drugs to reach the market sooner, saving an estimated $3.5 billion in federal health spending over 10 years, or a little over one-tenth of 1 percent of the $3 trillion the president’s deficit reduction plan is supposed to save in a decade.

Biologic drugs are proteins made in living cells, like Avastin and Herceptin for cancer and Enbrel and Humira for rheumatoid arthritis. Such drugs can cost tens of thousands of dollars a year and are not subject to the same rapid onset of generic competition as drugs made in chemical factories, like Lipitor and Prozac.
The issue was a thorny one during the debate in Congress over the health care legislation.

The biotechnology industry argued it needed 12 years of freedom from lower priced competition to recoup research and development costs. Any less, it argued, would retard innovation. The generic industry, as well as many insurers and employers who pay health care bills, said a much shorter period would suffice.

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A Trade Barrier to Defeating AIDS

Via the New York Times, by Tina Rosenberg.

Earlier this month, [the Medicines Patent Pool, a new organization trying to make AIDS drugs better, cheaper and available sooner to people who need them in poor countries] received its first donation of rights from a pharmaceutical manufacturer, Gilead Sciences.   It is an important step  — but the terms Gilead negotiated are also confirmation of a dangerous new trend: middle income countries as a target market for drug makers.  In the past, pharmaceutical companies have lowered prices in these countries to increase sales.  The new strategy is to treat people in Egypt, Paraguay, Turkmenistan or China — middle-income countries, all — as if they or their governments could pay hundreds or even thousands of dollars a year each for AIDS drugs.   This low-volume high-profit strategy might make  business sense.   But in terms of the war against AIDS, it means surrender.

In the world’s most impoverished countries, AIDS drugs are cheap.   It wasn’t always that way.  Until well into the Clinton administration, the United States government pressured even the poorest countries shamelessly if they tried to bring down the prices of medicine.   Even newly democratic, AIDS-ravaged South Africa became the object of an all-out assault by the Clinton administration to get the country to repeal a law allowing it to break medical patents, a step that was perfectly legal under world trade rules.  Washington was not interested in the health consequences.   (A U.S. trade negotiator who worked on South Africa at the time told me that he had been unaware that AIDS was a major problem there.)    Public outrage over South Africa ended Washington’s pressure on poor countries.   In 2000, President Clinton issued an executive order pledging that sub-Saharan African countries would not face trade sanctions for laws promoting access to AIDS medicines.

The order continues to be largely respected, and the group of countries who are generally able to get access to the cheapest drugs has grown to include the poorest countries from around the world — Afghanistan, Tajikistan, Bangladesh, Burma.    Gilead’s agreement with the Medicines Patent Pool covers these countries.

But countries just above this cutoff line are on their own.  “There are countries that are considered to be “middle income” that will never be able to afford the high prices charged by innovative pharma companies,” said reader A. Grant of New York.  These nations are also losing the discounts that major manufacturers of AIDS drugs used to offer them.  According to Médecins Sans Frontières, which tracks drug prices, prominent manufacturers of AIDS drugs have stopped offering discounts to middle-income countries, or now require that countries negotiate those discounts one by one.

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