Thursday, February 10, 2005

Unnecessary Epidemic - Methamphetamine Part 4

This is part four of the series which ran in the Oregonian newspaper last year. I have decided to publish the faces of Meth users to illustrate that these public policy discussions have human outcomes. These souls may be our fathers, mothers, daughters and/or sons.

If you would like to write your Congressman or Congresswoman, Senator, or the President regarding these issues please feel free. I will post easy links to facilitate correspondence.

Write your Representative here.

Write the President and U.S. Senators from here.

Promising fixes to the meth scourge, including a cold pill impervious to abuse, go unpursued as . . .

Shelved solutions

Wednesday, October 06, 2004

Eight years ago at a laboratory in Texas, Warner-Lambert Co. began testing a possible cure for the methamphetamine epidemic: a new and improved cold medicine that could not be turned into the illicit stimulant.

The company was worried that federal regulators would soon ban or restrict sales of pseudoephedrine, the main ingredient used to make meth and Warner-Lambert products such as Sudafed, Actifed and Benadryl.

Warner-Lambert's meth-proof alternative showed promise in animal testing, conducted at a university lab in Fort Worth. The company quickly applied for a patent. But that is where the product's development ended.

Former company officials said they saw little chance of making a profit on the product. Federal approval of a new drug, which includes lengthy human trials, costs as much as $800 million, according to industry estimates. Warner-Lambert's top-selling cold remedy, Sudafed, was grossing less than $100 million a year.

"It would be a long road and an expensive road," said Robert G. Flynn, a former research vice president at the company.

A cold pill that could not be used to make meth would offer huge public benefits if it replaced existing products. Past constrictions in the flow of meth ingredients have radically altered the trade, disrupting the supply of meth for as long as a year, The Oregonian's analysis of federal data shows.

Federal authorities never offered the pharmaceutical industry financial or other incentives to develop such a pill.

By the time Warner-Lambert had its patent, the threat of a ban on pseudoephedrine had receded. In 2000, Pfizer Inc. took over Warner-Lambert and did not pursue the new cold medicine.

Jay Kosminsky, a Pfizer spokesman, said Warner-Lambert's formula was not enough of an improvement over existing products to merit further research.

Instead, Pfizer tried mixing Sudafed with chemicals that would make it harder for meth traffickers to extract pseudoephedrine. The company chose ingredients already approved for human use, which made it possible to avoid the lengthy testing required for new drugs.

After seven years of research, the company abandoned that project as unworkable this past summer, Kosminsky said.

Warner-Lambert's new decongestant is a close chemical sibling of pseudoephedrine, the bulk of which is manufactured in nine overseas factories. Executives at two of the largest pseudoephedrine makers -- India's Emmellen Biotech and Malladi Drugs -- say they could supply the new chemical if the vast U.S. market demanded it.

"I can supply large quantities, in tons," said V.N. Gopalakrishnan, technical director at Malladi.

Fear of a ban

Pharmaceutical companies have known that cough and cold remedies could be misused ever since the federal government first threatened tighter regulations to deal with the meth problem.

"All manufacturers of these types of products are aware that these decongestant ingredients are related, on a technical, chemical basis, to more powerful abuse drugs," Robert N. Anderson, an attorney for Nyquil maker Richardson-Vicks, wrote to Congress in September 1987.

But Anderson said Vicks' research indicated that it would be impractical for meth cooks to extract ingredients from over-the-counter cold medicine because it "unnecessarily complicates the chemical process, and raises the cost dramatically."

In fact, meth cooks did find it economical to extract the ingredients. The U.S. Drug Enforcement Administration responded in the 1990s with more attempts to control meth ingredients.

James D. Cope, former president of the Consumer HealthCare Products Association, said he warned the trade group's members that the DEA would make pseudoephedrine a controlled substance unless they prevented their products from being misused.

Read the rest here.

No comments:

Post a Comment