Monday, June 30, 2008

Local C-Path leads project for drug-firm info sharing

[Source: Dale Quinn, arizona daily star] - For the first time, 17 major pharmaceutical companies have agreed to share information to fight major diseases such as Parkinson's and Alzheimer's, said the president of the Tucson-based non-profit institute that's leading a drug-safety consortium.

The companies still need to hammer out the legal details of such an agreement, and that could take until the fall, said Dr. Raymond Woosley, the president and CEO of the Critical Path Institute, known as C-Path.

"One of the reasons drugs have been failing, even though they've had millions of dollars of lab work … (is that) most of the time we don't understand the diseases well enough," Woosley said.

It's just one project C-Path is looking into with several pharmaceutical companies. Together they're exploring how genetic indicators can lead to more effective disease treatment and reduce risks patients face when taking new drugs.

The Predictive Safety Testing Consortium, which is the cooperative effort of the 17 pharmaceutical companies led by C-Path, recently yielded its first major results by producing data that could help detect kidney damage from new drugs faster.

The Food and Drug Administration and its European equivalent, the European Medicines Agency, have announced that they would accept data from animal tests identifying new renal "biomarkers," or proteins secreted by injured kidneys.

The current indicator of kidney damage is creatinine, which doesn't show up in tests until the kidneys have suffered significant damage, said Federico Goodsaid, an associate director in the FDA's Office of Clinical Pharmacology.

The seven new protein signals, or biomarkers, were confirmed in data from rat studies, and they show kidney damage much sooner than the current method does, Goodsaid said.

It's the first time a new method for detecting kidney damage has been developed in more than 100 years, Woosley said.

The drug companies can now move toward using the biomarkers for detecting kidney damage in humans, Woosley said.

The FDA is more likely to trust research when it comes from several drug companies, said J. Lyle Bootman, dean of the University of Arizona's College of Pharmacy.

"In the past, companies just did the tests individually, so the FDA was much more hesitant about approving them," Bootman said.

Goodsaid said one drug company would not likely have the resources or the necessary perspective to develop a new process for detecting kidney damage.

"What we're asking them to do is pool together knowledge," he said. "And above all, this is a step forward, because we're asking companies to look into what they already know and what they've already done, and then share that."

Some treatments, while beneficial to some people, can be ineffective, or even dangerous, to others. When the pharmaceutical companies share information through C-Path, Goodsaid and Woosley said, they can more quickly identify how effective treatments will be for certain people.

C-Path is working with the drug companies to find out who will respond to drugs that treat lung cancer, Woosley said. The research centers on the epidermal growth factor receptor — EGFR — and finding out how drug companies get information about the presence of that protein.

"If your lung cancer has EGFR, you've got a much better chance to respond to certain drugs," Woosley said.

Another C-Path project involves warfarin, a blood-thinning drug that if administered in the wrong dose can cause excessive bleeding or stroke.

Determining the proper dose of warfarin can be challenging for doctors, Woosley said. Giving a patient too much can cause him to bleed to death, but too little can lead to a stroke, he said.

C-Path is working with the University of Utah and the drug companies to develop a genetic test that will predict the proper dose of warfarin for a person, which Woosley estimated could prevent as many as 17,000 strokes every year, based on a study by the Brookings Institute.

The process doesn't end when the products hit the market, because people can have an adverse reaction to drugs that already have been approved, said Don Featherstone, the pharmacy division supervisor for Bashas' in Southern Arizona.

C-Path conducted a pilot program with Bashas' pharmacies and the FDA called Community Pharmacy Safety Network, allowing people to report potential side effects of drugs to the UA's poison control center.

Featherstone said Vioxx — a painkiller developed by Merck & Co. that was removed from the market because of its potential to increase risk of heart attack — is an example of such a drug.

C-Path wants to take the program to all pharmacies nationwide, but it currently lacks the funding, Woosley said.

Historically, treatments have been developed that battle the symptoms of disease, Woosley said. But it's an understanding of the underlying causes of disease that leads to the most effective treatments, he said.

When it comes to sharing information about Parkinson's and Alzheimer's, the drug companies won't discuss drug development, Woosley said.

But they have made a verbal agreement to pull together everything they know about the diseases, including drugs that have failed, he added.

● Contact reporter Dale Quinn at 573-4197 or

No comments: