Almost half of the most important global drugs (those approved in the United States, Europe and Japan) developed during 1975-1994 were of US origin, followed by the UK with 14%. Within the last decade, US companies developed 370 new medicines to fight such diseases as cancer, hypertension, heart disease, diabetes, Parkinson's, Alzheimer's, depression, arthritis and a host of other diseases - and that's just a preview of coming attractions.

With accelerating advances in science and technology, the industry has entered its most promising period for new drug development. Pharmaceutical companies are using new knowledge and techniques to understand and attack the root causes - rather than just the symptoms - of disease, and thus to revolutionize the way in which new drugs are discovered and developed.

"It is certainly true that the central activity of drug companies - applying science to the discovery of new medicines - is undergoing the most radical upheaval in the industry's 100-year old history," The Financial Times reported on June 1, 1999.

An increasing number of the advances in drug discovery and development are based on advances in genomics, which aims to establish the link between individual genes and disease. New technologies include:

• Molecular modelling, which allows scientists to actually design molecules on a computer screen;
  
• X-ray crystallography, which helps researchers determine the three-dimensional structure of a drug target so they can design molecules that will bind to it;
  
• High-throughput screening, which uses robotics or automated technology to screen more compounds in an hour than an army of researchers can screen in a month;
  
• Laser-capture microscopes, which act like molecular scalpels to capture individual cells on glass slides so they can be studied against possible drug targets;
  
• 'Laboratories on a chip', which hold hundreds of fragments of DNA in tiny individualized wells to quickly identify drug targets.

The new technologies will make it possible to anticipate and prevent disease rather than just react to disease symptoms; prevent, cure and treat more diseases than is possible with conventional therapies, and develop more precise and effective new medicines with fewer side effects.

A March 2000 survey by the Pharmaceutical Research and Manufacturers of America (PhRMA) found that US companies have 369 biotechnology medicines in development (ie either in human testing or pending at the Food and Drug Administration, awaiting approval). These medicines are to cure or treat more than 200 diseases, including 175 medicines in the pipeline for cancer. All told, US companies have more than 1,000 new medicines in development.

This reflects the huge and ever-growing investment that US companies are making in research and development. In 2000, these companies will invest $26.4 billion in R&D, a 10.1% increase over 1999. These expenditures include $22.4 billion spent within the United States by both US-owned and foreign-owned firms, plus an additional $4 billion spent abroad (mostly in Western Europe) by US-owned firms. Research-based companies have more than tripled their R&D expenditures during the past decade.

Over the past two decades, the percentage of sales these companies have allocated to R&D has increased from 11.9% in 1980 to an estimated 20.3% in 2000. Meanwhile, the average ratio of R&D to sales for all US industries is less than 4%. Based on corporate tax data compiled by Standard & Poor's Compustat, pharmaceutical manufacturers invest a higher percentage of sales in R&D than virtually any other industry, including high-tech industries such as electronics, aerospace, office equipment (including computers), and automobiles.

To develop a new drug is time-consuming, expensive and risky. It takes 12-15 years on average, costs about $500 million, and only one of every 5,000-10,000 new compounds discovered in the laboratory ever makes it to market as a new drug.

Contrary to what many believe, industry - not the US government - is the source of almost all of the new drugs approved in the US. A study of the 196 new drugs approved by the FDA during 1981-1990 showed that industry was the source of 181 of the drugs (92.4%), academia was the source of seven of the drugs (3.6%), and government was the source of two of the drugs (1%). Government and academic scientists lead the way in basic research about how diseases are caused and develop, while industry leads the way in translating that knowledge into new medicines to help and heal patients.

Prescription drugs save lives - and money. "Prescription drugs are more important therapeutically than ever," an editorial in the February 26, 1999 edition of the New York Times noted. "New drugs can save money overall by keeping patients out of the hospital." They also keep patients out of nursing homes, emergency rooms, doctors' offices - and on the job. In a 1993 study, for example, cancer patients whose immune systems were weakened by high-dose chemotherapy were helped by a new drug known as a colony-stimulating factor. The treatment saves $30,000 per patient in hospitalisation costs for bone-marrow transplants.

Pharmaceutical and biotechnology companies - ranging from older drug companies such as Bristol-Myers Squibb, Johnson & Johnson, Eli Lilly, Merck, and Pfizer to newer biotechnology companies such as Amgen, Biogen, Genentech, and Genzyme - have facilities all across the country, and indeed, all around the world. The industry employs almost 215,000 people in the US alone, including about 37,500 scientific and technical specialists. Of these, 29% hold PhDs, 4% are physicians, and 67% have a bachelor's or master's degree in science.

The scientists include Drs. Dale J Kempf and Daniel W Norbeck of Abbott Laboratories, who helped to discover and develop a powerful anti-AIDS drug; Dr. Perry Molinoff of Bristol-Myers Squibb, who is working on a new treatment for Alzheimer's disease; Dr. Michael Jackson of the Robert Wood Johnson Pharmaceutical Research Institute, who is sifting through millions of human gene fragments to develop a new pain medicine, and Dr. Kari Nadeau of Biogen, who is helping to develop a drug for lupus, an autoimmune disease that afflicts more than 130,000 Americans alone, most of them women.

"Hang on to your hats - great things are coming down the line," says Dr. Rachel Humphrey, who designs and manages cancer trails at Bayer Corporation.

Author
Alan F Holmer
President & CEO
Pharmaceutical Research & Manufacturers of America

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