Posted on 06/22/2005 11:44:55 PM PDT by DuckFan4ever
Cold medicine manufacturers, in an abrupt change, are reformulating their products in a way that likely will cripple home meth labs, which account for 35 percent of illegal meth production.
Drug companies are rushing to replace their pseudoephedrine-based products with the decongestant phenylephrine, which can not be made into methamphetamine. The new cold medicine is expected to dominate the U.S. marketplace within the next two years.
Previous industry opposition has vanished in the face of growing political recognition of the meth epidemic and the drug's devastating impact.
Officials at Pfizer, the leading U.S. maker of pseudoephedrine products, told The Oregonian that the company expects to convert half its lineup of Sudafed, Actifed and other products to phenylephrine by January. The company plans to stop actively promoting its pseudoephedrine-based products, some of which it will keep for pharmacy use.
Pfizer officials said they would now support federal legislation to confine the sale of pseudoephedrine products to pharmacies, as Oregon and other states have done. The company will endorse such legislation on the condition that it pre-empts state pseudoephedrine rules.
"Given the patchwork quilt of state regulations now in place, the time has come for a single national standard for moving all pseudoephedrine behind the counter," Gordon Knapp, president of Pfizer Consumer Healthcare North America, said through a spokesman.
Sen. Jim Talent, R-Mo., who is sponsoring national legislation with Sen. Dianne Feinstein, D-Calif., said he expects the bill to cause meth-proof cold products to eclipse sales of those that contain pseudoephedrine.
"It's already pushing manufacturers in that direction," Talent said. "They see the handwriting on the wall."
"There's really no reason, when we understand the science of it, that they couldn't do it," Talent said. "They just really haven't had the incentive to do it."
Boehringer Ingelheim of Germany, the world's largest producer of phenylephrine, told The Oregonian that the company is ramping up capacity to be able to replace the entire U.S. supply of pseudoephedrine by 2006.
The rapid switch to phenylephrine is significant because it could dramatically reduce global demand for pseudoephedrine and ephedrine, the two chemicals without which the most potent form of meth cannot be made.
The United States imported roughly half of the 1,500 tons of ephedrine and pseudoephedrine manufactured for export in 2003.
A dramatic shrinking of the U.S. market could force the nine major overseas factories where the chemicals originate to shift to phenylephrine. Already, one of India's biggest pseudoephedrine producers, Malladi Drugs, has begun manufacturing phenylephrine.
Boehringer Ingelheim first developed phenylephrine as an active ingredient for eyedrops in 1949. Later, it became used as a decongestant in the United States and Europe.
Boehringer officials say that because the phenylephrine molecule lacks a component known as a methyl group -- the defining feature that methamphetamine, ephedrine and pseudoephedrine have in common -- it cannot be converted to meth.
Pfizer officials say it is theoretically possible for someone to alter the phenylephrine molecule for meth production, but it would be exceedingly complicated, expensive and nearly impossible for anyone to do outside of a commercial laboratory.
Few studies have been done to compare the effectiveness of phenylephrine versus pseudoephedrine as a cold medicine ingredient.
Industry experts say consumer perceptions of the drug and its availability may play a bigger factor than any clinical comparisons with pseudoephedrine.
A study released earlier this month by Information Resources Inc., a national market research firm, found that Oklahoma's sales of pseudoephedrine products fell 16 percent after the state confined sales of the cold medicine to pharmacy counters.
"Companies are going to just stop producing it eventually," Gerald Kress, CEO of Surveillance Data Inc., a Pennsylvania-based market research firm that serves the pharmaceutical industry.
Chris Vance, director of sales and marketing at Boehringer Ingelheim's facility in Petersburg, Va., said nearly every company that manufactures pseudoephedrine products has expressed an interest in converting to phenylephrine.
Already, the company has tripled its shipments of phenylephrine from Germany to the United States since last year. It will begin installing new machinery to manufacture phenylephrine in Virginia later this year.
"What these guys are doing is fighting to keep their shelf space and fighting to keep something in front of the consumer," Vance said.
A major factor forcing the switch is that roughly 30 states are now contemplating or have enacted legislation that would restrict sales of pseudoephedrine, either by confining such products to pharmacies or by requiring identification from customers.
It started with Oklahoma, which in April 2004 confined sales of pseudoephedrine products to pharmacies. Oregon and other states followed. In December, Pfizer announced it would be the first to offer phenylephrine-based Sudafed PE in addition to its traditional, pseudoephedrine-based version.
As more drug companies followed, major grocery and drugstore chains began announcing that they would voluntarily place their pseudoephedrine products behind the pharmacy counter, even in states that did not require it. Twelve national grocery and drugstore chains -- including CVS, Walgreens, Kmart and Target -- have now done so.
Most such chains have already introduced or will introduce phenylephrine versions of their generic cold medicines in the near future, according to Perrigo, the main supplier of such generic store brands.
"It's their intention to begin moving pseudoephedrine behind the counter, and they would like to have the equivalent phenylephrine reformulations out as quickly as possible," said Ernie Schenk, manager of investor relations for Perrigo.
"Over the next six months, you'll see everyone moving that way," Schenk said.
According to Feinstein, co-author of the pseudoephedrine legislation, such industry moves have cleared away obstacles to federal action.
"The passage of tough laws in the states, voluntary actions by major retailers and the proven effectiveness of new cold medications without pseudoephedrine has created the best opportunity in years for passing tough, effective anti-meth legislation," Feinstein said through a spokesman.
In the past, drug executives have opposed retail restrictions on the sale of products containing pseudoephedrine. But the arrival of new products containing phenylephrine has changed the landscape radically.
Pfizer spokesman Jay Kosminsky said the company has dropped its opposition to keeping pseudoephedrine behind the pharmacy counter partly because retail restrictions have succeeded in reducing the number of meth labs in some states.
But another factor is that Sudafed PE and similar phenylephrine-based products are selling surprisingly well. A nationwide behind-the-counter law would accelerate the trend toward phenylephrine among other companies, he said.
"Most people are just going to take what's available on the shelf and that will be effective for them," Kosminsky said. "Phenylephrine will grow when Congress actually creates incentives."
If that happens, he added, "there would be a lot less pseudoephedrine out there for people to get their hands on."
Pfizer's support for a federal behind-the-counter law has a condition: It must pre-empt states from enacting such rules.
Officials with the National Association of Chain Drug Stores and the Consumer HealthCare Products Association take the same position.
Barring state legislation is strongly opposed by anti-meth activists in states such as Oregon, which is now debating even more stringent restrictions such as an outright ban on pseudoephedrine or requiring a doctor's prescription for pseudoephedrine products.
But passage of the Feinstein-Talent bill would ensure that pseudoephedrine products are behind the pharmacy counter in every state -- including ones that have not traditionally experienced problems with meth production.
Industry officials also said they don't want the legislation to take full effect until 2007, giving drug manufacturers time to gain approval from the U.S. Food and Drug Administration for their new products containing phenylephrine.
Most over-the-counter medicines containing pseudoephedrine, such as those in combination with acetaminophen or aspirin, can be switched quickly because phenylephrine is already recognized as a safe and effective decongestant by the FDA.
But a few popular products fall under special FDA provisions that require companies to go through a three-year-long new drug application if they wish to add phenylephrine.
These are products containing pseudoephedrine in combination with ibuprofen, Naproxen and Loratadine -- commonly marketed as Advil Cold and Sinus, Alleve Cold and Sinus, and Claritin-D.
Talent said his staff is now talking with industry groups about the possibility of faster FDA approval for such products if companies wish to switch to phenylephrine.
The international problem
Lawmakers acknowledge that limiting access to pseudoephedrine products will only address the 35 percent of U.S. meth that is manufactured by small-scale producers. The other 65 percent is made by "superlabs" operated by Mexican drug traffickers.
But members of Congress are also showing new interest in legislation that would target the international traffic in pseudoephedrine. A comprehensive anti-meth package is being developed in the House.
The idea of passing such a broad meth bill gained steam last week when House members tacked on an additional $54 million to combat local and international meth trafficking. Rep. Frank Wolf, R-Va., said he was encouraged by the intense interest in meth funding during floor debate. He now expects more anti-meth legislation to start moving soon.
"We're going to see if we can come up with something fairly dramatic to deal with this issue," said Wolf, chairman of the House Appropriations subcommittee that handles Justice and State department budgets.
Steve Suo: 503-221-8288; stevesuo@news.oregonian.com
The pervasiveness of the meth problem just amazes me. In just a couple of years or so, we have gone from rarely hearing of such a thing, to seeing raids on labs on an almost daily basis. Just another sign of the continued corrosion of our culture, I'm afraid.
Crank has been a problem for over 20 years now. It's only been the last 5 years that the MSM has brought it to your attention.
I was skeptical at first, but from what I've heard it's made a real dent in the meth problem around here, and that's all for the good. I watched an eye-opening documentary about the effects of meth on a small town on one of the subscription channels a while back (I can't remember which one), and that was one scary program.
It's also only been in the last 7-10 years that people got on the internet and learned how easy the stuff is to brew up. Unfortunately, this has lead to a large number of house and apartment explosions, which is what got the MSM interested.
Well, not easily. But it can be made into phenylethylamine (C6H5-CH2-NH-CH3), the precurser of many interesting substances, from mescaline to MDA. Never underestimate human ingenuity.
I've heard stories of these @$$holes making meth in hotel rooms also. They should be given good long sentences for endangering others so much.
Georgia now requires pharmacies to put any cold pills containing ingredients that could be used by meth labs behind the counter. There is a limit how many you can buy and I think you have to show identification. I never use this stuff. I prefer holistic products like zicam which works great by the way.
Is the new stuff as good as the old stuff? I can see myself stocking up before the new stuff ends up in Sudafed Sinus/Allergy.
"Is the new stuff as good as the old stuff?"
In my opinion, no.
They look the same (both small, round, red pills) and cost about the same (the new stuff is a little bit cheaper);
Dosage: old stuff = 2 pills per 4-6 hours
new stuff = 1 pill per 4-6 hours
Dream on. They'll just come up with more "creative" methods and more toxic ingredients to achieve the same results. Eventually the WOD will be stepped up to prevent ordinary citizens from obtaining such common household items as bleach and aspirin because somebody might invent a way to use them to manufacture meth, or some equally "evil" substance.
The most depressing "Cops" shows show the effects of meth and inhalents. "Huffing" houses. It's death in fast, slow motion.
The problem with your idea is that ephedrine hydrochloride or pseudoephedrine hydrochloride is *the* critical ingredient for making meth. The only other chemicals you can make it from are phenylacetone and methylamine, which are highly regulated, highly restricted (forget about finding it in a local store) and pretty much unavailable to the common thief. There *isn't* anything else to make meth with.
Some idiots have even created meth labs in the trunks of cars and in the cargo bays of vans and SUVs. One was recently found on the grounds of a nursery school. Several have been found in high school parking lots.
Even if you don't support the war on drugs, this is something that has to be taken out of play. Phosphine gas, a fatal nerve agent and fumigant that is colorless and odorless, can be produced when someone cooks their meth too long. This can actually kill more people than the potential explosion when someone makes a mistake. If pseudoephedrine and ephedrine are taken off the market, there simply is no easy way to make meth any more. Meth labs/idiot bombs/amateur poison gas factories will pretty much disappear in the US.
All pointless. Probably sincere intentions but absolutely pointless.
I use the throat spray myself and it works great. Even common nose drops can cause this sort of reaction.
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