[Pharm-policy] NYTimes.com Article: The Scientist's Story

[Amy Kapczynski]

William Prusoff, who discovered d4T's usefulness against HIV, speaks on=20
today's NTY editorial page. It's mostly interesting reportage on the=20
history of the drug and the recent BMS announcement. But also raises that=20
all-too common figure that it takes $500 million or more to develop a new=20
drug. If anyone has a reasonable calculation of how much it cost BMS to=20
bring d4T to market (which has got to be way less than that), it might be=20
worth pointing this out in a letter to the Times, along with other=20
indications of just what is wrong with the $500 million figure...

Amy Kapczynski


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>The Scientist's Story
>
>
>By WILLIAM PRUSOFF
>
>NEW HAVEN =97 I once helped create a drug that could enable millions of
>people to lead better and longer lives. At Yale University's
>pharmacology laboratory, my late colleague Dr. Tai-shun Lin and I
>developed d4T, an antiretroviral drug that now forms part of a
>"cocktail" used by people with H.I.V. and AIDS. The patent was held
>by Yale, which licensed it to Bristol-Myers Squibb for development.
>At great expense, Bristol-Myers took d4T through the necessary
>trials, then brought the drug to market under the name Zerit.
>
>  More recently, it became apparent that the drug Dr. Lin and I had
>developed was not reaching millions of desperately suffering people
>because they lacked the money to purchase it. However, Yale did
>hold the patent. The medical aid group Doctors Without Borders
>learned this and approached the university late last month. At the
>same time, a group of law students at the university became
>interested in the issue. The campus newspaper published an article
>about it on March 2, mentioning my role in developing d4T. A New
>York Times reporter called, and I said I thought d4T should be
>either cheap or free in sub-Saharan Africa. I believe Dr. Lin, were
>he still here, would agree.
>
>  Within days, Bristol-Myers had announced that it would cut the
>cost of Zerit to 15 cents for a daily dose, or 1.5 percent of the
>cost to an American patient. This all happened so quickly. More
>than two-thirds of people with H.I.V. live in sub-Saharan Africa =97
>about 26 million people. The numbers seem too great to understand.
>But they are not. In a way, they are as easy to understand as 15
>cents. I suppose this has now occurred to Bristol-Myers Squibb.
>
>  What is a reasonable charge for d4T in industrialized countries,
>and to what extent can this charge be reduced in poorer nations? It
>is estimated that to bring a drug from conception to the
>marketplace costs from $500 million to $800 million. The investment
>by a university like Yale is probably less than 1 percent of this
>amount. The major expense is clinical studies required by the Food
>and Drug Administration. Millions may be spent on these studies =97
>only to have unacceptable toxicities occur and the compound dropped
>like a hot potato.
>
>  Those lost millions become part of the cost of successful drugs.
>The patent enables pharmaceutical firms to recoup such losses as
>well as the costs of clinical trials for successful drugs. If a
>patent did not exist, other companies that did not have the
>expenses of preclinical and clinical studies could obviously afford
>to sell these drugs at much reduced prices.
>
>  The d4T compound was first synthesized by Dr. J. P. Horwitz of the
>Detroit Cancer Center in 1966. He was also the first to synthesize
>AZT. These were designed to be anticancer drugs, but they were not
>sufficiently potent. When AZT was reported to be a potent inhibitor
>of H.I.V.-1, Dr. Lin and I decided to look at similar compounds.
>
>  AZT is an analogue of thymidine, which is an essential component
>of DNA. I had worked on thymidine compounds for 40 years. Dr. Lin
>and I proceeded to synthesize d4T by modifying the process
>developed by Dr. Horwitz. We found that d4T was not toxic to human
>cells in cell cultures. Bristol-Myers became interested in d4T and
>received from Yale an exclusive license for further study and
>development. The company sent a sample to the National Institutes
>of Health for evaluation of its potential inhibition of H.I.V.-1.
>The institutes were slow in responding, so Dr. Lin and I sent a
>sample to Raymond F. Schinazi of Emory University School of
>Medicine and the Veterans Administration Medical Center in Decatur,
>Ga. I had known him since he was a postdoctoral fellow in my
>laboratory. He found d4T to be very potent against H.I.V.-1, as the
>N.I.H. eventually did as well.
>
>  Thus Bristol-Myers decided to do the clinical studies required by
>the F.D.A. to determine d4T's safety and efficacy in humans.
>Positive results were achieved after treating more than 13,000
>patients, from Europe and the United States, infected with H.I.V.-
>1. Of course, d4T is not a cure, but it can help prolong a person's
>life and make that life better.
>
>  Now Bristol-Myers, encouraged by Yale, has begun the process of
>making d4T and its companion drug, Videx, available to millions of
>people for whom, just a week ago, these treatments seemed utterly
>remote. I imagine many of these suffering people thought they would
>die before seeing these drugs.
>
>  I am struck by all the steps that led us to today: the work of Dr.
>Horwitz on anticancer compounds, my own work and that of Dr. Lin,
>the timely tests performed by Dr. Schinazi, the inquiries made by
>Doctors Without Borders to Bristol-Myers, which then led to Yale
>and some Yale law students and the campus paper and then back to
>Bristol-Myers, whose executive vice president John L. McGoldrick
>said on March 14 that his company hoped to "energize a groundswell
>of action" to fight AIDS in Africa. I find it hard to see any
>pattern in all this, except perhaps that there is a moral urge
>among people that, however coincidentally, can sometimes bring
>results.
>
>William Prusoff is an emeritus professor and senior research
>scientist in the Department of Pharmacology at Yale University
>School of Medicine.
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>http://www.nytimes.com/2001/03/19/opinion/19PRUS.html?ex=3D986014782&ei=3D1=
&en=3Df16842f44e47f32b
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