Be the One

One Pill to Heal Them All. Those words -- apologies to J.R.R. Tolkien's "one ring to rule them all" -- kept going through my mind as I attended Wednesday's press conference spearheaded by acting Food and Drug Administration Commissioner Dr. Andrew von Eschenbach, at which the federal government announced its approval of Atripla, a new three-in-one AIDS medicine.

Gilead Sciences and Bristol-Myers Squibb have worked together to combine three medicines (Sustiva, Emtriva, and Viread) into one single pill. As noted, One Pill To Heal Them All. But, one might protest, isn't it overstating things to wax rhapsodic about a new medicine that merely combines existing medicines? Isn't Atripla, after all, just...another pill?

Well, the serious and senior government officials -- Medical Doctors all -- who are closest to the situation are vocal in proclaiming that Atripla is a big, big deal. Let's listen to them: First up was FDA chief von Eschenbach, who declared that the triune nature of Atripla represented "a new paradigm" of medicine, comparing the pill to the laptop computer -- all the parts and components squeezed into one cool and compact tool. And his deputy at the FDA, Dr. Murray Lumpkin, referred to the idea behind Atripla as "the holy grail" of medicine. These are health-and-safety regulators talking; they get paid to focus mostly on the downside of whatever it is that comes before them. So if von Eschenbach invokes Thomas "Paradigm Shift" Kuhn, of Structure of Scientific Revolutions fame, then maybe this is a big deal. And if Lumpkin can cite the Grail Legend, maybe Atripla is an even bigger deal, right up there with the greatest of medical breakthroughs.

The enormous value of Atripla becomes manifest when one considers the difficulty of keeping track of a complicated pill-taking regimen -- which is all the more difficult for the sick. The more "moving parts," as it were, in the course of treatment, the greater the risk of under-dosing or over-dosing. In addition, an increase in the number of discrete medicines in a specific programme also increases the danger of storage and delivery SNAFUs. As Lumpkin explained, "The number of pills to take is inversely proportional to good health outcomes." And of course, if one moves the problem to the Third World -- home to most AIDS victims -- where literacy levels are low and where the medical and transportation infrastructure is minimal-to-non-existent, then the lifesaving power of simplicity becomes even more palpable.

As von Eschenbach put it, "Compliance with treatment is as important as the treatment itself." If one can't take the medicine properly, for whatever reason, then the good effect of the medicine is lost. Indeed, the problem of mistreatment is worse than that; scientists know that if adherence to a prescribed regimen falls below 95 percent, not only will the medicine fail to help the patient, but the danger of adaptive mutation -- as the bug "learns" how to survive the medicine -- increases dramatically. That's what has happened as a result of sloppy administration of tuberculosis medicines; new and improved TB germs are on the loose, killing more than in many years. It would be an even greater tragedy if the HIV/AIDS virus were to get the same "opportunity." So the One Pill Paradigm is powerful, in and of itself. But the idea of the One Big Thing, which unifies many things, resonates throughout our entire culture, through the history of technological advancement. In fact, one way to measure progress is to measure the trend toward the simplification and unification of disparate strands of technology. The goal -- the grail, even -- is to get everything into one user-friendly package.

Paradoxically, perhaps the most obvious example of such a unifying merger of components comes from an area that's far away from lifesaving: the bullet cartridge. According to Wikipedia, the idea of the cartridge -- a charge of powder and a bullet in a paper tube -- first appeared in the 16th century. But the idea didn't take off till the mid-19th century, when the percussion cap was invented. It was the percussion cap that made the cartridge (that phrase was soon simplified down to "bullet") so lethally effective: thanks to cartridged bullets, the firearm could be loaded, discharged, and reloaded quickly, in any kind of weather, without the hassle of such trouble-prone parts as flints and powder pans.

Of course, the technical improvement of the bullet was just a part of the process of "cartridge-izing" other items, from food (in the form of cans and other packages -- think Spam) to film and audio tapes (cassettes) to electronics (integrated and solid-state circuitry). On a physically larger scale, author Brian Cudahy makes some ambitious claims for cargo containers, as seen in the title of his recent book: Box Boats: How Container Ships Changed the World.

The idea of Oneness has great power in other realms, too: Everyone, for example, wants a Universal Remote to control all their gadgets, even if sometimes the plan can go a bit haywire. And of course, everyone looks forward to the day when the telephone, the TV, and the computer are all made one, with one single simple line coming in to, and out of, the home.

There is one problem, of course. While it's important to think of the idea of holism, it's even more important actually to figure out how to achieve it. As we have seen, it took the better part of three centuries to turn the idea of the bullet-cartridge into the reality of the bullet-cartridge. And the same holds true for medicine; the One Pill Paradigm has been around for awhile, in the form of multivitamins, but when medicines get complicated, the manufacturing gets even more complicated.

So meet Dr. Taiyin Yang, the senior vice president for development and manufacturing at Gilead, who was present at von Eschenbach's press conference. She told me that it took more than 20 person-years -- 15 people working full time for a year-and-a-half -- to make the One Pill idea work. The key is "bi-layer compression" (which I can't explain any more than I can explain the innards of a laptop computer).

But I don't have to understand it, and neither do you. The point is that it works. And now that Pharma companies and the FDA have established a workable template for One Pill-izing complicated medicines, other combo products are likely to emerge.

Thanks to the miracle of science, and also the miracle of the free marketplace -- and the further miracle of a federal government that managed to approve Atripla in a mere three months -- a new lifesaving product is on the market, offering hope to millions.

I don't know if anyone will ever write a book about this "One-izing" process, but somebody should, because it's a huge story. It's a saga of hard work and vision, featuring more heroes than even Tolkien could dream of.