Published Sunday, October 31, 1999
Common cold may be too big, too unprofitable to fight
Judy Foreman / Boston Globe
Next time your throat is so raw you can't swallow and your nose is so stuffed you can't breathe, think about this:
Antiviral drugs for the common cold have passed various stages of human testing. But the manufacturers have decided that the drugs simply aren't profitable enough to bring to market. Thanks a lot, guys.
You would think that with 61 million cases of the common cold each year in this country alone, the sheer enormity of the market would goad drug companies into an all-out attack on cold viruses. And some companies are still pushing to finish studies to get their antiviral cold remedies to market.
But two other drug firms, Boehringer Ingelheim and Bayer, have dropped their drugs faster than you can say what Boehringer did in May: "In order to optimize the use of human and financial resources, some projects have been reassigned lower priorities where, despite showing promise of considerable therapeutic progress, the prospects for success in terms of clinical development, potential indications or later production were rated as less significant."
In other words, your suffering is not worth their investment.
It is not a new sentiment. For decades, the common cold was seen as a hopeless cause. For one thing, there are about 200 viruses that cause colds. That makes it tough to figure out which virus is at fault and which drugs might help.
For another, colds rarely kill anybody, which means that drugs must be very safe to justify taking them.
Still, the idea of making a drug that did not just relieve symptoms, but actually attacked the virus itself is obviously appealing.
After years of work, a number of scientists, among them Timothy Springer, a molecular biologist at the Harvard-affiliated Center for Blood Research in Boston, figured out how.
They developed a kind of biological catcher's mitt to snag viruses after they enter the nose but before they get into cells lining nasal passages. It's a decoy molecule called soluble ICAM-1 (intercellular adhesion molecule-1).
Last May, Dr. Ronald Turner, director of pediatric infectious diseases at the Medical University of South Carolina, showed that the drug worked in people.
In a published study of 177 people, his team put drops of cold viruses into volunteers' noses. Either before this exposure or soon afterward, volunteers were given a placebo or Boehringer's version of the ICAM-1 drug, tremacamra.
The results showed that it reduced cold symptoms by 50 percent and reduced nasal secretions, as well. But when the study came out, Boehringer shelved the drug, which Turner says was "obviously a disappointment to us."
Indeed, why a company would drop a drug at this point "does seem odd," says Dr. Ken McIntosh, an infectious-disease specialist at Children's Hospital in Boston.
But Bayer has done likewise. Human safety tests of its ICAM-1 drug "were successful," says Jeffrey Greve, a molecular biologist who heads the company's molecular technology unit in Berkeley, Calif. Nonetheless, its ICAM-1 will go no further unless the company finds a "commercial partner" to develop the drug. It boils down, Greve says, to "a money issue."
ICAM drugs are made by genetic engineering, an expensive technology that in other products can cost as much as $1,000 a dose.
So are we destined to continue to suffer long, snuffly winters? This year, probably, but perhaps not forever.
At a recent conference on antimicrobial agents, ViroPharma Inc. of Exton, Pa., reported encouraging results with its drug called pleconaril, a so-called capsid binding agent being tested against viral meningitis as well as cold viruses.
Cold viruses come cloaked in an outer shell, which they must shed before replicating. Pleconaril seems to prevent this shedding, stopping the virus in its tracks.
In double-blind, placebo-controlled studies involving more than 1,000 patients, pleconaril reduced the duration of cold symptoms by 3« days. The company expects to seek federal approval of the drug (initially, for meningitis) early next year, says spokeswoman Kori Beer.
Meanwhile, researchers at Agouron Pharmaceuticals in San Diego are pursuing a drug that still goes by its numerical name, AG7088, and which works like the protease inhibitors used for HIV. Agouron's drug blocks an enzyme that's needed for the cold virus to chop up its proteins into usable segments.
So far, the Agouron drug, a nasal spray, has been tested in several hundred people, and seems to be active against about 50 strains of cold viruses. It is now being tested in hundreds more people, says spokeswoman Joy Schmitt.
Outside the mainstream pharmaceutical establishment, researchers at Gel Tech LLC in Woodland Hills, Calif., have begun marketing a nasal spray called Zicam, which retails for $10 to $13. It is marketed as a homeopathic remedy, which the U.S. Food and Drug Administration does not approve or disapprove, and only loosely tracks.
The product has been in the works since 1995, says one of its creators, physiologist Charles Hensley. It is a form of ionized zinc that may work by binding to the same tiny part of a cold virus that the ICAM decoy molecule latches onto.
Hensley says Zicam reduces the duration of cold symptoms from nine days to 1«, but the problem is there is only Gel Tech's word to go by because there are no published independent studies that confirm his statements.
-- Judy Foreman is health columnist for the Boston Globe. |