[JHeath]

http://thenewsdispatch.com/main.asp?Sectio...amp;TM=63576.24

Deborah Sederberg
The News-Dispatch

Sunday, February 10, 2008


‘HELP IS HERE’ BUS IS HERE
MICHIGAN CITY - The Help is Here Express bus tour will be at St. Anthony Memorial 10 a.m. to 2 p.m. Wednesday, Feb. 13.

The bus brings uninsured and financially struggling patients information on programs that provide prescription medications for free or nearly free.

The tour is part of a nationwide effort sponsored by America's pharmaceutical research companies to raise awareness of patient assistance programs.

For more information on chronic diseases see the Web site, www.fightchronicdisease.org.

For more information about the Partnership for Prescription Assistance, see the Web site, www.pparx.org.
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MICHIGAN CITY - St. Anthony Memorial is looking for a few healthy volunteers who would be willing to participate in clinical trials for certain medications.

Clinical trials are common at teaching centers but not so in the local 150-bed acute care hospital.

The trials will examine medications on the market for years. Researchers will conduct testing required when a brand-name drug's patent expires and the drug then is brought to market as a generic.

"It is important to understand that we won't be doing any first-to-man trials," said Trish Weber, hospital vice president in charge of the project. That means the trials are not the first human studies.

The Food and Drug Administration requires the same testing required before the drug first appeared under its brand name.

Dr. Maurice Ndukwu who will serve as medical director and chief investigator of the research center, explained the process using Tylenol as an example. Before acetaminophen could be marketed as the generic, the FDA required the same testing that had been required for Tylenol.

Bringing generics to market is right in line with the mission of the Sisters of St. Francis Health Care, the parent company of St. Anthony Memorial, Weber said.

"Assisting with bringing more affordable medication to the market is a service to our patients, really to everyone," Weber said.

"It can cost $150 for one inhaler, and if a patient cannot afford the medication, he might decide to take less than the doctor prescribes. Or the patient may not refill the prescription when the medication runs out.

"We end up seeing those folks in the emergency room with symptoms they likely would not be experiencing if they had taken their medications correctly."

Marlena Lagina-Kleine, a hospital spokeswoman, said volunteers will be screened for health issues.

Some trials will call for participants of a certain age, for just women or just men. The research will look at the body's absorption of the medication and at the rate at which it metabolizes it.

Scientists will look for a bioequivalence, Ndukwu said. In the study, two drugs with identical active ingredients are evaluated to determine their equality in the body. In bioavailability studies, the drugs are evaluated to determine their absorption properties in the body.

"Researchers want to be sure the medication is available," Ndukwu said.

A clinical trial management company called Symbio, based in Port Jefferson, N.Y., has joined St. Anthony in a research partnership for the clinical trials, Weber said.

Study participants will be paid and fed and in some trials, they spend the night in the hospital. The research unit will be equipped with WiFi as well as other conveniences for participants.

For now, hospital officials are looking for healthy adults, males and females age 18 and older. "Wouldn't it be wonderful to know we played a role in bringing affordable medications to market?" Weber said.

Contact Deborah Sederberg at dsederberg@ thenewsdispatch.com.

[JHeath]

From the same link...

‘HELP IS HERE’ BUS IS HERE
MICHIGAN CITY - The Help is Here Express bus tour will be at St. Anthony Memorial 10 a.m. to 2 p.m. Wednesday, Feb. 13.

The bus brings uninsured and financially struggling patients information on programs that provide prescription medications for free or nearly free.

The tour is part of a nationwide effort sponsored by America's pharmaceutical research companies to raise awareness of patient assistance programs.

For more information on chronic diseases see the Web site, www.fightchronicdisease.org.

For more information about the Partnership for Prescription Assistance, see the Web site, www.pparx.org.
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