Monday, August 3, 2009

Fort Worth firm testing swine flu vaccine on volunteers:

12:00 AM CDT on Sunday, August 2, 2009 Fort Worth Star-Telegram

FORT WORTH – When Angela Witkamp heard that a local research company would soon be testing a swine flu vaccine, she had no reservations about signing up her two young daughters for a clinical trial.

"Any vaccination you get, there are side effects," Witkamp said. "But the benefits of getting the vaccination definitely outweigh them. There are people dying from the swine flu.

"Some of my friends call us guinea pigs, but they are not fully informed. The vaccination that they will be studying will be the same that anyone can get at the health department [when it is approved]."

Witkamp and her girls, Baylee, 3, and Emmie, 5, are among thousands of people rolling up their sleeves for science as drug companies, doctors and government officials work to get a safe and effective swine flu vaccine on the market by October.
In June, the World Health Organization declared a global pandemic of H1N1, or the swine flu, which has killed more than 300 and sickened more than 43,000 in the U.S. In Texas, 5,373 cases have been reported, with 357 confirmed in Dallas County and 210 in Tarrant County, according to the Texas Department of State Health Services.
Officials expect to see those numbers rise when school starts, which is why large-scale clinical trials are being conducted worldwide.

In Fort Worth, Benchmark Research is conducting clinical trials for several drug companies, testing to see patients' reactions to the experimental vaccine and whether it produces an immune response to the H1N1 virus. Benchmark, which is paying patients $200 to $600, depending on the study and its protocol, will begin administering injections next week.

"What we are doing is private and independent," said Dr. William Seger, Benchmark's principal investigator, who also has a private medical practice next door. "These are private companies that are developing the flu vaccine, and they need to prove to the FDA that they are acceptable. They may be the one to help bring us a vaccine that is first to the market. We are going to need them all to produce the gazillion H1N1s that we are going to need worldwide."

Although studies are being conducted on all ages, Seger especially needs patients 6 months to 17 years old, the population that is most likely to come into contact with H1N1.

Good experiences

Sara Rix's sons, Tyler, 8, and Nathan, 6, are among those participating in a clinical trial. The boys have participated in previous trials at Benchmark for other flu studies and meningitis.

"I have had good experiences in the past," said Rix, 38, a part-time preschool teacher. "I think it is beneficial, not only for the general public, but for my children. I want them to be protected. ... There are parents out there who do not vaccinate their kids at all. To me, I just don't understand that. It is like getting in a car; you want to wear a seat belt."
Tyler – a third-grader in the Lake Worth school district, which had closed down this year because of the swine flu – said he isn't afraid to get the shot.

"I know once I get the shot, I won't get that virus," Tyler said. "The shot is good."
Seger said patients who qualify for a study will be examined, have their blood drawn and receive the vaccine. For several months, they will record their temperatures, aches and pains and if there are any side effects.

In subsequent visits, their blood will be checked to see whether their immune system is building up antibodies against the H1N1 virus. The data are continuously being sent to the drug companies.

Risks involved

Seger acknowledges that there are always risks and said patients are informed that serious injury, or even death, is a possibility. In 1976, more than 500 Americans ended up with a rare neurodegenerative condition called Guillain-Barre syndrome during a mass vaccination campaign for the swine flu. Twenty-five people died.

Seger pointed out, however, that science and medicine have come a long way and that flu vaccines have been used safely for decades. He stressed that, while there is a push to get the vaccine on the market quickly, corners are not being cut.

Fort Worth Star-Telegram

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