Why Won’t Andrew Witty Take the Dive? (Updated 7/30/10)

AIDS: An epidemic without end. It’s mostly fallen off the front pages—who has time or money or compassion for a decades-old global health crisis when we’ve got our own global economic crisis?—except for every two years when the International AIDS Conference comes around. The one held in Vienna last week earned some ink, but the big news was an old story: The help once promised is not on the way.

Wealthy nations that donated many billions to create the Global AIDS Fund in 2001, pledging universal access to treatment by 2010, still owe billions. So two out of every three HIV patients—some 10 million—in most of Africa and much of Asia, Russia, Eastern Europe, and even Latin America still can’t afford drugs. Without them, they are doomed to terrible deaths.

As for the 5 million on the standard three-drug cocktails, a growing number are developing HIV resistance, and they need a second (or third or fourth or … ) combination of new drugs or old drugs or anything.

And what about the children? Only half of the 20 or so HIV drugs on the market are available to kids.

The inconvenient truth about AIDS is, the drugs cost a lot, and you have to take three at once for the rest of your life, and when the forever-mutating virus finds a way around your cocktail, you have to take three new drugs. In the US, the total lifetime cost of HIV drugs for one person averages about $750,000.

Yet almost miraculously, a global activist movement forged an uneasy coalition over the past decade with the UN, HIV drugmakers, generics shops, and the developing world (led by big-daddy donor the US) around the shining belief that every person with HIV had the right to effective treatment, no matter the price. But the will energizing that belief is flagging.

One possible bright spot in Vienna was the launch of the Medicines Patent Pool by UNITAID, an international drug-purchasing agency for HIV, malaria, and tuberculosis. Three leading HIV drugmakers—Merck, Gilead, and Tibotec—were said to show “considerable interest” in licensing their entire HIV portfolios to the pool, not excluding best-selling, state-of-the-art products like Merck’s novel Isentress, Gilead’s fixed-dose combo Truvada, and Tibotec’s resistance-busting Prezista. Bristol-Myers Squibb and Abbott were said to be warming to the pool, but ViiV Healthcare, an HIV joint-venture between GlaxoSmithKline and Pfizer intended to restore the British firm’s early leadership in the AIDS market, remains ice cold to the pool party.

The patent pool idea materialized for AIDS advocates as the most practical mechanism to spur investment in the large-scale development of generic versions of not only the best HIV drugs but—equally essential—new fixed-dose combinations and formulations that Gilead, Glaxo, and the rest, left to their own incentives, have shown no interest in producing. Yet only a tiny fraction of people in the developing world have access to these drugs—they’re second-class patients on suboptimal therapy, but beggars can’t be choosers, right?

Once the innovator company contributes its IP to the pool, which will be funded and run by UNITAID, copycat companies will manufacture and market the antiretrovirals at affordable prices. As generics competition heats up, drug costs will fall further. Currently, first-line triple-drug therapy using branded products costs between $600 and $1,000 in places like South Africa, while generic competition has cut older first-line treatment to $87. For second-line cocktails, in the absence of generics, the prices are 17 times more expensive. 

In return for their compassion, the branded firms will get 5 percent royalty on all sales—chump change for Big Pharma, but more than they are already making by not selling these new drugs, combinations, and formulations to millions of people who can’t pay for them anyway. Plus, with free patents in the pool, generics-makers won’t have to entangle the pharmas in wasteful lawsuits.

A patent pool may not be the perfect solution, as the HIV drugmakers’ fear of commitment, even after long, drawn-out discussions with UNITAID makes plain. But self-interests clash, and then a compromise is struck. Above all, Big Pharma is loath to give aid and ammunition to its enemy, the generics industry. Yet for the mountains of men, women, and children with untreated HIV who are sick, the status quo is a death sentence. That is the ultimatum driving UNITAID—and it appears that Merck, Gilead, and Tibotec get it. 

But Glaxo doesn’t. This snub may seem surprising, given CEO Andrew Witty’s conspicuous display of concern for neglected diseases and the health of the world’s poorest since he took the job two years ago. In his most earnest, caring, and new kind of pharma CEO mode, Witty won weeks of glowing headlines for his big speech at Harvard last year about how the industry had to become a catalyst for positive global change—and he proceeded to make a series of Glaxo pledges to the developing world, including “a more flexible approach to IP,” a 75 percent discount on drug prices, and the re-investment of 20 percent of sales in local infrastructures.

He liked the idea of a patent pool so much that he started his own—the Least Developed Country Patent Pool. “We need to make sure nothing gets in the way of access, least of all price,” he said, earnestly and caringly.

Yet the UNITAID pool? Not his cup of tea. “HIV isn’t a neglected disease,” Witty said, explaining that while his pool is intended for malaria and other diseases long underfunded R&D, HIV is positively humming with innovation. ViiV Healthcare alone has promised to turn out a new drug every year starting in 2012.

No doubt Glaxo and other HIV drugmakers have other issues with the UNITAID pool agreement: ViiV reportedly opposes the inclusion of the BRIC nations, with their fast-growing middle-class; opposes the administration of the patent pool by UNITAID; and opposes the creation of what may turn out to be an independent public/private R&D enterprise, with its competitive potential. About all this, an advocate is tempted to say, “Tell that to the people who are dying for want of your drugs.” 

Medecins sans Frontiers, Oxfam, and some 15 other public health nonprofits have been dogging Witty to get in the pool, with letter, petitions, and public statements. (Witty’s AIDS-is-not-a-neglected-disease dismissal could be parodied nicely on an activist T=shirt.) “He is wrong,” MSF immediately responded, arguing that innovations that meet the specific medical needs of the HIV populations of the least developed countries—cheap new fixed-dose combinations, say, and pediatric formulations—are being neglected by Big Pharma because the market for such products in rich nations is so small. Generic manufacturers—the logical innovators—are discouraged from investing in the development  because of the patents. If the Glaxos of the industry aren’t up for the emergency, shouldn’t they just get out of the way?

The top priorities for UNITAID’s HIV pool are a protease inhibitor for children and a new combination of Gilead’s Viread and an experimental Tibotec compound. These don’t require billion-dollar, decade-long, cutting-edge R&D prowess—a Chinese or Indian copycat shop can whip them up once free IP lowers the manufacturing bills. And as for Witty’s pledge of a 75 percent discount on drugs, MSF said that over the past decade most antiretrovirals became affordable in poor nations only when the price fell by at least 95 percent.

Otherwise, MSF and other advocates have applauded Witty for his new global health initiatives. What activist would be so cynical or paranoid as to believe that Witty got the jump on the patent pool idea to steal UNITAID’s thunder or to deflect fallout from his own rebuff? Still, on the very day when the British government publicized a big study exhorting drugmakers to join the UNITAID venture, Witty turned up in, of all places, a dusty village in rural Uganda. He went there to make AIDS pledges, including $80 million to develop pediatric HIV formulations. Life is full of crazy coincidences. 

But all the pledges and patent pools in the world won’t bend the curve of the plague without the overdue funding from US and other rich (or rich enough) nations. By 2030, there will be 500 million people with HIV in Africa, Asia, Eastern Europe, and Latin America who need the drugs.