Story URL: http://news.medill.northwestern.edu/washington/news.aspx?id=138449
Story Retrieval Date: 12/5/2009 8:41:04 PM CST

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Docs cringe at the thought of painkillers taken off the market

by Melissa Suran
Aug 19, 2009


WASHINGTON – Michael Jackson was addicted to them. Jamie Lee Curtis admitted she was addicted too. So did Cindy McCain. And about four million other Americans are also addicted – to painkillers.

In July, an advisory panel recommended to the FDA the ban of the painkillers Vicodin and Percocet. A month later, the one thing the experts still haven’t recommended is an alternative.

Some wonder if the ban is imposed, whether popular over-the-counter pain medications could be next on the list.

Vicodin and Percocet are made with an ingredient called acetaminophen, which is the generic form of Tylenol, and opioids, which are extracted from opium. Both ingredients help reduce pain –  but opiods can be very addictive.

For many people, Vicodin and Percocet are essential to helping deal with pain resulting from injury, surgery or even cancer.

Dr. Paul Christo, a pain specialist at the Johns Hopkins University School of Medicine, said the number of people living with chronic pain is gargantuan.

“About 100 million people currently live with pain in the U.S.,” Christo said. “I think removing pain medications off the market is not the answer and it will expand the epidemic of poor pain control in this country.”

Christo believes that painkiller addiction is blown out of proportion.

“Patients are at risk for abuse with opiods and some do become addicted, but I don’t think it’s as high as the public thinks,” he said.

Even with patients who may have had past addictions to drugs or alcohol, Christo said there are ways to monitor problems effectively.

“I may still prescribe the opiods they need but I will also require that they …engage in counseling or collaborate with an addiction medicine specialist to help prevent relapses,” he said.

Even if someone has no history of addiction, “when anyone starts using an opioid, there is some risk of addiction. The prevalence of any addiction in the population is approximately 10 percent,” Christo said.

Even more than concerns about addiction, experts question the effect of opiod/acetaminophen compounds – commonly found in painkillers – on the liver.

According to a 2008 study released by Indiana University, acetaminophen overdosing is a leading cause of liver failure.

As a result, some doctors have mixed feelings about the possible ban.

“[Vicodin] is a morphine compound,” said Dr. David Perry, the director of the Pharmacology Graduate Program at George Washington University. “Plus, the presence of acetaminophen is toxic in high doses.”

That’s why even too much Tylenol can ruin your liver. And Tylenol isn’t the only common over-the-counter medication that contains acetaminophen – so do certain cold medicines and sleep aids.

“We think of Tylenol being benign and it’s definitely not,” Perry said. “[But] take a couple of Tylenol a day and you’ll be fine.”

A Tylenol representative also commented on the product’s safety.

“When taken at recommended doses, the product is safe and effective,” she said, also mentioning that more than 150 clinical studies have supported more than 50 years of clinical use. “When taken in overdoses, serious liver damage can occur.”

On June 30, another FDA advisory panel recommended reducing a single adult dose of any acetaminophen from 1,000 milligrams to 650 milligrams – and making Tylenol available by prescription only.

But Perry is guessing that the FDA will back off on the issue of a ban.

“I don’t see a good product on the market right now that would fulfill that niche of mild to moderate pain control in a tablet that you can take orally and at home,” Perry said.

There are some options, although they don’t work for everyone.

Ibuprofen is known to help with acute pain relief, but it’s hard on the stomach for some patients. Same thing goes for medications like Aleve and aspirin. Still, they do work for many people. Another possible option is Oxycodone, an opioid excluding acetaminophen. The problem is that it’s very addictive.

“The FDA can tell companies what not to sell, but not what to make,” Perry said.

Spokeswoman DeAnna DuBose of Abbott Laboratories, the Illinois-based pharmaceutical company that produces Vicodin, said it’s still too early to know whether the FDA will ban the popular medications.

“The combination pain medication of acetaminophen and hydrocodone [which composes Vicodin] has been available for more than 30 years,” DuBose said. “The FDA will take the panel recommendation under advisement, but whatever decision they make, they make and Abbott will respond accordingly.”

There is one other controversial painkiller – but it has its own problems.

With all this talk of the ban and what’s good for you and what’s not, many people are becoming increasingly concerned with the issue of legalizing medicinal marijuana. The problem with marijuana is not its addictiveness, Perry said, but the taboo that casts a shadow over it.

“There is so much tied up into the social policy issue, it comes with a lot of baggage,” he said.

“Medical marijuana may be effective in controlling pain and inflammation, but its use needs more structure, monitoring and safety education to ensure that patients use it properly rather than for non-medicinal purposes,” Christo added.

But getting rid of Vicodin and Percocet could be a gateway to getting rid of more vital medications.

Perry warned that anything could be toxic – even so-called natural products. He said that not many people know that aspirin is a natural product that comes from willow bark.

“Ancient humans chewed willow bark and figured out that it helps pain,” he said. “Of course, a lot of them died trying it out.”

Even too much vitamin C can be toxic.

“The only difference between a medicine and a poison is the dose,” Perry said.

The FDA declined to comment.