Attention turns to drug development process

New incentives are recommended to spur companies to tackle the big health problems facing an aging society.

By Susan J. Landers — Posted Nov. 14, 2005

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Washington -- The pharmaceutical industry has its problems.

Too many new drugs in the development pipeline are copies of existing drugs and the quest for blockbuster drugs is on a collision course with a growing trend toward individualized medicine, which favors drugs that provide targeted help to fewer people.

However, even as drug development costs spiral upward and drug safety issues are frequently on the front pages of the nation's newspapers, more and more drugs continue to be consumed and the cost to the nation's health care system continues to mount, said Joseph P. Newhouse, PhD, professor of health policy and management at Harvard University.

Dr. Newhouse was moderating an Oct. 24 discussion on pharmaceuticals in the 21st century at the Institute of Medicine's annual meeting.

In tackling the problems, several speakers suggested changes in trial design and more attractive incentives to drug development manufacturers.

Alastair J.J. Wood, MD, associate dean and professor of medicine at Vanderbilt University Medical Center in Tennessee, noted that while numerous beta blockers and nonsteroidal anti-inflammatory analgesics are available, there are no drugs to prevent Alzheimer's disease or arthritis.

Dr. Wood, who has served on Food and Drug Administration advisory committees and was among those considered to head the agency in 2002, proposed a new, incentive-based system for drug approvals.

This strategy would allow for surrogate endpoints to demonstrate a drug's effectiveness. He suggested that an endpoint to measure a drug's usefulness on beta-amyloid, for example, might serve as a surrogate endpoint for an Alzheimer's drug.

The strategy could overcome the impediment presented by the time it takes to determine a drug's effect on mortality rates, he said. The time needed to reach a solid endpoint on a disease like Alzheimer's could take more years than a company can balance against patent-protected rights to market the drug.

A promise of continued market exclusivity in exchange for continued testing could also serve as a carrot to drugmakers, Dr. Wood suggested.

He also recommended granting only limited exclusivity to a drug company that develops a "me-too" drug unless studies show a clinical advantage over other drugs in the same class.

The need is also great for long-term safety data, he noted.

As an example of exclusivity at work, Dr. Wood pointed to the Best Pharmaceuticals for Children Act that allows manufacturers to maintain patent protection of a drug tested in children. As a result, many drugs now, for the first time, have safety and dosing information for children.

A storm of trouble

The IOM meeting was also sprinkled with vignettes from recent drug development history that ranged from the near-fabled success of Gleevec for the treatment of chronic myeloid leukemia to the downfall of a vaccine for rotavirus that was linked to bowel obstruction in infants.

Currently, the drug development enterprise finds itself at the center of a "perfect storm" of patient lawsuits, pricing pressures, imported drugs and animal activists, said Tadataka Yamada, MD, chair for research and development at GlaxoSmithKline.

The length of time to develop a drug, at 10 to 15 years, and the cost, at $1.5 billion, has led the industry to seek ways to cut corners without compromising quality, he said. The linking of genetic variants to disease is one way to speed up the process.

Clinical trials conducted in other countries can also cut development costs, said Dr. Yamada. The same quality trial can be conducted abroad by American-trained academicians at much lower expense, he said.

The tremendous size increase of the major pharmaceutical companies as they merge and absorb other firms may also have cut into the industry's entrepreneurial spirit, he said.

But large size and a variety of drugs in development also can be helpful to carry the company if one product fails, he added.

Louis Galambos, PhD, professor of history at Johns Hopkins University, asked whether the nation is choosing to weaken its pharmaceutical industry by ignoring its medical enterprise system created after World War II.

An example of this is the lack of improvement in the field of vaccine development -- a problem society is ignoring, he said. "Such systems don't last forever."

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