ARV Drought

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Left Field by Patricia Nell Warren

Drug shortages threaten the promise of the “end of aids.”

As I write this, the International AIDS Conference is going on in Washington, D.C. Anthony Fauci got up to the mike and proclaimed, “We want to get to the end of AIDS.” From there he launched into the familiar rhetoric about getting more millions of the world’s people onto ARV drugs. “No promises, no dates, but we know it can happen,” Fauci added. The act rings hollow in view of the growing shortages of drugs, including ARVs.

Blogging for the Huffington Post, Glenn D. Braunstein, MD, chairman of the Department of Medicine at Cedars-Sinai, put forth some reasons for the shortages: “Drug shortages occur, manufacturers report [according to the Food and Drug Administration’s Web site], because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs. If a company is the only supplier of a drug, it legally must notify the FDA six months before it anticipates a shortage of the medication. Still, the law lacks teeth. If a company fails to inform the FDA of a looming shortage, it faces no legal consequences. In late October, however, President Obama signed an executive order directing the FDA to speed up reviews of new manufacturing facilities and to get manufacturers to report shortages earlier.”

But the problem is more complicated than that. According to a recent Reuters report, “Health officials blame the shortages on industry consolidation that has left only a handful of generic manufacturers of these drugs, even as the number of drugs going off patent is growing. Some drugmakers have been plagued by manufacturing problems that have shut down multiple plants or production lines, while others have stopped producing a treatment when profit margins erode too far.…The number of drug shortages has escalated in recent years, jumping from 56 in 2006 to 250 last year, according to U.S. Food and Drug Administration figures.”

How is this possible—especially with AIDS drugs, in view of the stated urgency to “end AIDS”?

If one goes to Google and searches under “drug shortages,” dozens of links to horror stories come up. For example, in Russia a few years ago, HIV drugs were so scarce that only around fifty percent of people needing treatment were actually getting it. Yet the Russian government is legally required to make drugs available for everyone needing them, and has budgeted $32 million for this purpose. Outraged patient activists started using Google to expose the problem, and the Russian government finally woke up and made more drugs available.

Drug shortages have been building for at least a decade, especially in Africa. Often, there, the cause of shortage is government corruption and ramshackle distribution systems. Avert has commented at length about the festering situation in Zimbabwe: “In 2002 the government declared the treatment shortage as a national emergency, allowing Zimbabwe to produce and purchase generic AIDS drugs locally under international law, and thereby reducing their cost.…There have been huge improvements recently with a 50 percent increase between 2009 and 2010….However, the challenges in accessing treatment are still very apparent, particularly among children in need of ARVs, of which only 32 percent have access. According to the latest WHO guidelines (2010) 59 percent of
HIV positive patients in need of treatment are receiving it….An article published in 2006 even reported that government officials…intercepted drugs for their own use that were actually meant for public hospitals. One study found that Zimbabweans on the government free ARV programme are often expected to pay bribes for drugs and services that are supposed to be free under the programme.….Women and children who live in rural areas reportedly find it very difficult to obtain ARVs.”

In South Africa, shortages of nevirapine threaten the treatment of HIV-positive women that is supposedly so vital to “ending AIDS.” In July 2012, blogging for Robben Island, the official blog of the Center for African Affairs and Global Peace, Khan Kikkawa wrote of the dilemma facing S.A. policymakers who aim at improving child health by increasing breastfeeding. He stated: “HIV is a looming demon in this debate.…If this declaration is implemented at the national level, there are not sufficient nevirapine supplies available in the public sector.”

Uganda is often cited as a flagship African country where HIV treatment has been highly successful. Yet here, too, government corruption drives ARV scarcity. AllAfrica recently wrote: “While people living with HIV/AIDS were grappling with shortage of anti-retroviral drugs last year, [funds] meant for buying the drugs was lying idle in the government coffers, findings of an audit report have revealed. According to the latest Auditor General’s report released last week, the health ministry had received $24m from Global Fund to procure HIV/AIDS drugs.…Out of this amount, only (about 15.4%) was spent on procurement of ARVs and paying the program coordinator’s salary.” Notice that the program coordinator got paid before patients were taken care of.

In the far east, India and even China join the ranks of countries experiencing drug drought. In New Delhi recently, the Deccan Herald reported, “Hundreds of HIV/AIDS patients, including children, receiving anti-HIV medicine from government outlets found themselves in a precarious position a few months ago after the outlets went out of stock for first and second line drugs increasing the risks for the HIV positives.”

Here in the U.S., where most people are accustomed to having piles of everything imaginable available in every store, there are shortages as well. According to The Lancet, in March 2012, “US drug shortages could continue for years.” Lancet writer Sharmila Devi explains, “The shortages have led to delays in surgery and cancer treatments, left patients in pain, and forced hospitals to prescribe less effective treatment, said a review by the Associated Press late last year. At least fifteen deaths in fifteen months were blamed on the shortages, according to data compiled by the Institute for Safe Medication Practices, a patient safety group, and the true number might be higher because many deaths and injuries caused by shortages go unreported.” Among the drugs in short supply in the U.S…is Doxil, used to treat Kaposi’s sarcoma.

In the wake of scarcity comes another growing threat: counterfeit drugs, including fake ARVs. Several African countries, including Kenya, Nigeria, and Uganda, found fake ARV drugs for sale in pharmacies. Right here in the U.S., earlier this year, a counterfeit version of Serostim was being sold in at least seven states.

Last but not least, patent termination can be a cause of drug scarcity. In 2005–6, GlaxoSmithKline’s Retrovir (brand name of AZT) went off patent. Given the drug’s popularity, especially in combination with 3TC for developing countries that participated in PEPFAR, one would think that arrangements could be made for supply to continue seamlessly through generics. Yet, starting in 2005, countries like Zambia were reporting that AZT was hard to get. GlaxoSmithKline denied that there were shortages. But as recently as this year, Panama was finding AZT and 3TC scarce, with a drama this spring where 400 bottles of tablets were rushed into the country for treatment of children. Yet Panamanian healthcare providers told the media that they still saw an ongoing shortage ahead.

How odd that these persistent shortages are occurring, in spite of the fact that the pharmaceutical industry’s profits continue to be awesome. One would think that Big Pharma could stay on top of supply and demand. Unless, of course, they are no more competent than the banks and mortgage lenders whose corruption and bumbling have pushed the planet to the brink of economic ruin.

Back at the International AIDS Conference in Washington, D.C., Secretary of State Hillary Clinton is beating the drums for more money for more ARV drugs for developing countries. In spite of the life-and-death budget wars going on between Democrats and Republicans, the Obama administration has expanded the international program for providing ARV treatment. Vaccine development is little mentioned now—policy is aimed at pipelining as many drugs into patients as possible. But, given the graft and disorganization that rules in some areas, we have to wonder how these drugs will get to many people…and whether some of this taxpayer money is being spent in vain.

Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at [email protected]

Copyright © 2012 by Patricia Nell Warren. All rights reserved.

August 2012