In 1981, when Pharm Exec published its first issue,
the pharmaceutical world was a very different place: There was no direct-to-consumer advertising, no map of the genome, no
high-speed screening of millions of compounds. The process of marketing and selling drugs was discreet and nearly invisible
to the public; and sales forces, by today's standards, were minuscule. The first biotechs had just launched; and the Bayh-Dole
Act, passed the year before, had begun to lay the groundwork for the explosion of research-driven university spin-off companies
that transformed the face of research in the 1990s. The AIDS epidemic was months away from being detected and identified.
Tagamet was the best-selling drug, having toppled Valium, which had topped the sales rankings since 1969. There was not a
single pure-play pharmaceutical company in the top 100 of the Fortune 500 (Procter & Gamble clocked in at 24 and American
Home Products, later to become Wyeth, was 92).
Flash forward 25 years and the picture is drastically different. After a wave of consolidation, the biggest pharma companies
are true giants. On the 2005 Fortune 500 list (which, of course covers American companies only) Pfizer is 24, P&G 26, Johnson
& Johnson 30, Merck 84, Bristol-Myers Squibb 93, and Abbott 100. Prescription drug sales are predicted to hit between $640
and $650 billion, according to IMS Health. In numerous disease categories, breakthrough products are making life better for
patients. AIDS, though still incurable, can nearly be halted in its tracks in many cases. Deaths from heart disease continue
on a downward trend, while the cancer rate, for the first time, fails to keep pace with the growth of the population. Drugs
based on proteins—from enzymes to monoclonal antibodies and beyond—are transforming the treatment of cancer, rheumatoid arthritis,
and other diseases; while biomarkers, nanotechnology, the mapping of disease pathways, "smart" drugs, and other new technologies
move ever closer to the clinic. And the industry has become global on an unprecedented level.
The changes of the past 25 years haven't taken place without controversy or pain. The once nearly invisible process of pharma
marketing is now front-page news—bad news, too often. Drug safety is a political football. The rate of drug development remains
too slow, while patent expirations threaten to drain the revenue needed to support it. Pharma now communicates directly with
patients, but that has proven a mixed blessing. The federal government (now the largest purchaser of drugs) has been using
the threat of criminal prosecutions to force companies into the regulation-by-contract of Corporate Integrity Agreements;
and the states and European governments seem to be lining up with the feds.
How did we get from there to here? In this special anniversary issue, we attempt to provide at least part of the answer. In
the pages that follow, you'll find a timeline of the past 25 years—a reminder for anyone who needs one of how fast the pace
of change has been. Albert Wertheimer of Temple University argues the case that popular opinion is wrong, and that the pace
of improvement in the clinical value of drugs is accelerating, not slowing. We take a brief photo tour of Kendall Square in
Cambridge, one of the epicenters of the biotech revolution, and finally we hear from close to 45 industry leaders on what
the past 25 years has meant to them—and to you.
On behalf of the Pharm Exec staff, we thank you for the opportunity to serve the industry for the past 25 years. We're looking forward to tomorrow's
news, tomorrow's triumphs, and tomorrow's challenges.