By F. Brinley Bruton
NEW YORK, Aug 16 (Reuters) - About one in five people in the world's richest
nation are obese and overweight Americans would probably pay a king's ransom for
a pill that could help them look slimmer, feel better and live longer.
Finding the pot of gold at the end of that rainbow is a temptation that is
difficult for pharmaceutical makers to resist, even though the road to riches so
far has brought many of them disappointment.
They "thought there were a lot of people in America who would be very
desperate to get their hands on an anti-obesity drug, but they forgot that you
don't just take a pill and lose pounds. There is not a cure-all and panacea for
obesity," Morgan Stanley Dean Witter analyst James McKean said.
The latest stumble in the history of obesity drugs came in June when
Swiss-based Roche Holdings Ltd. warned of slowing second-quarter sales growth
for Xenical, its showcase medicine, only a year after its launch.
Some weight-control drugs that have hit the market carry the risk of
unpleasant or even dangerous side effects. Others have proven only partially
effective as they also involve harsh dietary regimes that patients do not follow
for long.
Another issue is that many doctors are reluctant to prescribe drugs to help
patients lose weight when dieting and exercise may be the best cure.
Even so, with billions of dollars in sales up for grabs from about 35
million obese Americans and tens of millions elsewhere, the company that
develops a safe, effective treatment to help people lose weight knows it will be
onto a winner.
In the United States, about 55 percent of the population is above the
recommended weight for their height, the National Institutes of Health (NIH)
says. The percent of Americans the NIH defines as obese went from 13 in 1991 to
about 20 in the mid-1990s.
With the extra weight comes increased risk of hypertension, or high blood
pressure, type 2 diabetes, coronary heart disease, stroke, gallbladder diseases,
osteoarthritis, respiratory problems and certain types of cancer. But even as
the number of overweight people grows, a clear winner has yet to emerge in the
race to develop safe and effective obesity treatments.
"There is just no easy cure for losing weight," said Neil Sweig,
pharmaceutical analyst for Ryan, Beck Co. in New York.
Knoll Pharmaceutical Co., part of the world's biggest chemical company,
Germany's BASF AG, has hit its share of obstacles in trying to tap the
anti-obesity market. It is now recovering from disappointing sales and
regulatory problems regarding its anti-obesity drug Meridia.
Sales for the drug, known as Reductil outside the United States, fell in
1999. Taking the drug could carry with it the risk of side effects such as
insomnia, rapid heartbeat and elevated blood pressure, according to data from
clinical trials sponsored by BASF Pharma, the company's pharmaceuticals arm.
After spending about $29 million in each of the past five years on
anti-obesity research, BASF said in April it was selling a research site in
Britain where it was conducting five anti-obesity studies.
"It doesn't mean that we are leaving the area, but we are certainly reducing
our involvement," Ulrich Grau, head of research and development at BASF Pharma,
said.
Roche Holding Ltd. had the most recent setback. On June 22, the Swiss drug
maker warned that its first-half revenues would be little changed from last year
because of lackluster sales for its showcase anti-obesity drug Xenical. Analysts
say possible side effects, such as diarrhea if a strict diet is not followed,
may mean that people are using it once and not returning.
Roche's experience with Xenical was disappointing after a year of heady
growth and great expectations for the drug, whose US launch was in April 1999,
according to analysts.
Before drugs like Xenical and Meridia can reach their potential, companies
say, the possibility of a pharmaceutical treatment for obesity would have to be
more widely accepted.
Many consumers still see obesity more as a cosmetic concern, not a health
issue. The view that some obese people could benefit from certain drugs -- going
beyond changes in exercise and eating habits -- must be embraced by the medical
profession and patients alike, they say. And that is an uphill struggle.
"Part of our challenge moving forward with Xenical is to 'medicalize' weight
management to physicians," Terence Hurley, a Roche spokesman, said. Before that
can happen, some medical experts say, questions about the effectiveness of
anti-obesity drugs must be resolved conclusively.
"None of the drugs that we have today work very well," said Robert Sherwin,
president of the American Diabetes Foundation and a professor at the Yale
University School of Medicine. He said drugs on the market are not very
effective "weight-reducing agents, and for most people only have small effect."
Some anti-obesity treatments have proved not only hard to stick to but
potentially dangerous.
Fen-phen was one to hit the headlines. The drug cocktail made by combining
either Pondimin (fenfluramine) or Redux (dexfenfluramine) with another diet
appetite suppressant called phentermine was widely prescribed to help people
lose weight.
But in 1997 American Home Products Corp., which made Redux and Pondimin,
recalled them after some of the 6 million Americans who had taken fen-phen
developed heart valve problems. The New Jersey-based drug maker eventually took
a pre-tax charge of $4.75 billion to cover settlements of claims in the United
States by former users of the diet pills.
Curiously, the fen-phen experience may actually have enticed drug companies
such as Roche and Knoll to compete for the anti-obesity market. Fen-phen was
"fabulously successful" for a time, said McKean of Morgan Stanley, and Roche
probably intended Xenical to fill the market space emptied by fen-phen.
While no new drugs to combat obesity are on the immediate horizon, research
efforts aimed at developing new ways to treat obesity are under way. In June and
July, two studies -- one by researchers from SmithKline Beecham and Cambridge
University in England, the other by researchers at Johns Hopkins University in
Baltimore -- signaled the discovery of compounds or proteins that led to
significant weight loss in mice.
But McKean said even these promising studies do not mean a new anti-obesity
treatment will reach the market any time soon. While a drug may help obese
rodents lose weight, there is no guarantee it will work on humans, he said, and
a breakthrough in this area is not very likely for at least another 18 months.
Knoll's Grau is even less optimistic. "We should expect major breakthroughs
in treatment in none of the drugs currently in development," he said. "I would
be surprised if we had anything come to the market in five to six years."
