HIV/AIDS Medication Prices Remain High in US

How can we fight AIDS abroad while denying treatment at home?

This past May, the Bill Clinton Foundation managed to greatly reduce prices of medication in the developing world, but in the same month HIV/AIDS activists protested pharmaceutical giant Gilead for its unwillingness to drop prices for low-income Americans.

Simultaneously, scientists in the US and Africa began historic vaccination research that, if successful, could prevent and treat HIV/AIDS as well as make expensive AIDS medications obsolete.

These seemingly separate events are linked to the ongoing debate surrounding the right to access effective methods of HIV/AIDS treatment and prevention.

Lowering the Cost of Medication Abroad
On May 17, The Bill Clinton Foundation announced that it had successfully negotiated price reductions of antiretroviral (ARV) drug regimens used to treat HIV/AIDS. The partnership of the Clinton Health Access Initiative (CHAI), UNITAID, and UK's Department for International Development (DFID) has worked together in the past to successfully reduce prices. Since 2008 the organizations have yielded prescription savings of over $600 million worldwide. The latest price reductions were offered by eight Indian pharmaceutical companies that will allow modern ARVs to be sold at lower prices in developing nations.

"Over 70 countries and 70% of the HIV-infected population have access to the prices my Foundation negotiated; so these new price reductions...will provide millions of people with increased access to better, cheaper and more convenient first and second-line drug regimens," said President Clinton.

Most significantly, the negotiations resulted in a price reduction of crucial first-line medicines containing tenofovir (TDF) and efavirenz (EFV). In 2008, patients in developing countries would pay US$400 per year for treatment with TDF and EFV. The World Health Organization recommends TDF as a first line treatment option, because the virus is less likely to develop resistance to the drug and it has fewer side effects. However, hardly any patients in the developing world can afford this historically expensive drug. After the Clinton negotiations, TDF based regimens are now available for US $159, a price reduction of 60% from 2008.

CHAI states that the demand of TDF will continue to grow (from 1 million patients in 2010 to 4.2 patients in 2013) as it becomes cheaper and more available in developing nations. The organization also expects that the price of a TDF regimen will drop below the price of medicines containing zidovudine (AZT). Even with the price reductions, TDF is still 20% more expensive than less safe AZT regimens.

"The British Government's support to the Clinton Health Access Initiative is helping to provide life-saving HIV treatment in countries that have been devastated by the epidemic," The UK's International Development Secretary Andrew Mitchell continued, "by working with the private sector to drive down the cost of lifesaving drugs."

In order to reduce prices, CHAI worked directly with suppliers. The DFID as well as the Bill and Melinda Gates Foundation provided financial support to suppliers to improve manufacturing efficiency. Also, UNITAID supported the purchase of newer ARV medicines in developing countries. Philippe Douste-Blazy, Chair of UNITAID's Executive Board commented, "By stimulating greater availability of better medicines and price reductions, UNITAID's partnership with CHAI will facilitate the work of the Global Fund, PEPFAR and countries themselves and ultimately improve aid effectiveness by making the money go further." This method of public and private sector cooperation has yet to be successfully used to drop HIV/AIDS medication prices on a large scale in the United States.

Price of Health Stateside
While efforts to lower prices of AIDS treatment options in developing countries is both admirable and necessary, the Clinton Foundation's recent negotiations begs the question, who is negotiating lower prices in the United States? American pharmaceutical companies, such as Gilead, continue to keep prices high. This places the burden on the government-funded AIDS Drug Assistance Program (ADAP) to supply expensive medications to the thousands who cannot afford it. As of May 5, nearly 7,900 low-income patients have been placed on ADAP waiting lists.

Gilead held its annual meeting at the Westin San Francisco Airport Hotel on May 12, 2011. The meeting was disrupted by members of the AIDS Health Foundation (AHF) who protested outside the building as well as entered the building to question CEO John Martin. The AHF's primary concern was the high prices of Gilead's AIDS medication Atripla despite increasing profit margins for the company and its executives. In 2010 Gilead's profit margin was 36.5% and Martin received a bonus of US$ 57 million.

Atripla is an example of a tenofovir (TDF) based treatment. Atripla is Gilead's top-selling AIDS drug and costs patients of $10,000 per year. In 2010 Atripla sales amounted to $2.9 billion. Atripla accounts for 20% of ADAP expenditures. In a time of crisis for the ADAP, Gilead refuses to reduce prices for low-income American patients.

Earlier in the year, Martin was interviewed by CNBC. He was asked to respond to a protest held by AHF, although Gilead was not the target of criticism at this particular moment. In January 2010, AHF demanded that Merck Research Laboratories reduce the price of its key HIV/AIDS drug, Isentress. At the time of AHF's protest, Isentress was the highest priced first line treatment on the market. Similar to AHF's most recent protest of Gilead, the high price of Isentress was putting unnecessary financial stress on the ADAP. In the context of AHF's complaints, the CNBC reporter asked Martin how he balanced business and access to affordable HIV/AIDS medication. Martin replied,

"You have to have very good judgment. You need to make sure you do responsible pricing. The various groups involved with HIV provide a lot of value, not only providing feedback on pricing, but also feedback on the design of studies, access in not only the United States, but also access around the world. You may be aware that for access around the world we have an innovative tier pricing formula...to make sure price is not a barrier to access anywhere in the world."

According to the AHF press release announcing the May 2011 Gilead protest, "Atripla is sold 'at cost' for $600 per year in developing countries, Gilead can lower the price significantly and still make a huge profit, yet it has not."

Although it is crucial that we continue to reduce medication costs in developing countries to avoid an AIDS epidemic among extreme poverty, we cannot forget the American reality of impoverished people living with HIV/AIDS in our own cities and towns.

A Vaccine Approach
Recent preventative and therapeutic HIV/AIDS vaccine research may provide an important alternative to over-priced medications.

Two promising vaccinations began trials this month in Kenya. Both vaccines, Ad35/Ad26 and Ad35/GSK Protein, were tested in the US and Europe and are now being tested on patients in Nairobi. In past trials of HIV/AIDS vaccines in Kenya, scientists found it difficult to enlist volunteers. This time however, Kenyans are amongst the most willing populations to participate in these trials. High turnouts have been attributed to self-sacrifice for humankind, but another reason may be this vaccine has proven to be more effective than those previously tested in Kenya are.

If these trials go well, Kenya will be among the first countries to access a successful vaccine and will also receive increased recognition and funds for future HIV/AIDS research. This is important considering Kenya is suffering from one of the world's harshest AIDS epidemics. Although UNAIDS declared the situation "stable" in its 2010 report, in 2009 1.5 million Kenyans were living with HIV and 80,000 died of AIDS related illnesses.

Another vaccine is being developed at the University of Maryland. Funded by the National Institutes of Health and the Gates Foundation, the vaccine aims to neutralize "many different strains of HIV." A vaccine that could prevent multiple types of the disease would have an enormous impact in ending HIV/AIDS epidemics globally. Most preventative vaccines in development, including the two being tested in Kenya, only prevent one strain.

Also this month, The University of Limpopo in South Africa began trials for a therapeutic vaccination that would slow the degeneration of patients with HIV. Unlike preventative vaccines, therapeutic vaccines treat people living with HIV/AIDS. The patients undergoing therapeutic vaccine trials continue to take their ARV drug regimen and scientists measure what benefits, if any, the vaccine provides to patient's health that ARV medication does not.

In developing countries where many of the HIV-infected population cannot afford medication, the possibility of a therapeutic vaccine is much welcomed news. A vaccination would be a one or two-time cost, while medications cost thousands of dollars per-patient per-year.

In the US some are hesitant to replace effective ARV drug therapies with a new approach. If pharmaceuticals continue to be sold at high prices in the US, faith and funding should be placed in vaccines in order to provide patients and government health programs like ADAP with cost-effective means of prevention and treatment.