Norman doctor conducts clinical trials

The Norman Transcript
December 19, 2011
By Joy Hampton
Copyright © 2011, The Norman Transcript, Okla.

Meningitis can be serious, even fatal.

Not surprising then, that as a mother of four, Dr. Lisa Connery would want her children and all children vaccinated to protect them from this dangerous disease.

Connery has been in family practice in Norman for 20 years.

“I chose family practice because I love connecting with patients and their families on a long-term basis,” Connery said.

For eight years she was the medical director of Health for Friends. Connery has also been doing clinical trials for six or seven years as a principal investigator for Lynn Institute.

As a principal investigator, Connery conducts clinical trials on drugs that are in the final stages of Food and Drug Ad-ministration approval.

“The safety and efficacy has already been tested and proven,” she said.

But there are other factors besides safety and effectiveness that must be tested, such as do the medicines or vaccines work in conjunction with other medications, vaccines or in certain conditions.

Volunteers in clinical trials get many benefits.
“A number of my patients at Health for Friends found the clinical trials helpful because it was a way to get lab evaluations, tests, and medication for a number of health conditions all free of charge,” Connery said. “Patients are also compensated for time and travel.”

Connery is one of the physicians currently conducting nationwide clinical trials for a new meningitis vaccine. Also known as meningococcal disease type B, meningitis B is one of the more serious and common forms of the disease, but there is no vaccine currently on the market for type B meningitis.

“The current meningitis vaccine that is on the market, that all the kids are supposed to get before college, doesn’t cover type B,” Connery said.

Studies estimate as many as 40 percent of meningitis cases contracted by teens are type B.

Connery said a major drug company has developed a vaccine for type B. That vaccine is in the final stages of testing and is close to FDA approval. Tests indicate the vaccine is safe and effective. The clinical trial is testing whether the vaccine is equally effective when combined with the vaccines children and teens normally get at the same age.

“They just have to prove that you get the same response when taken with the other vaccines recommended for that age group,” Connery said.

Connery is actually conducting two studies with the vaccine. One is targeted for children ages 10 through 12 when kids get tetanus and other vaccinations. Participating in the study allows kids to get those routine vaccines for free.
Many of the participants will also get the meningitis type B vaccine being tested. A small portion will not get the new meningitis vaccine until after the study, however, for comparative reasons, but they can still receive the vaccine later.
Older teens receive the meningitis B vaccine in conjunction with the HPV vaccine, Gardasil, to compare results with adolescents who did not receive the investigational vaccine for meningitis B.

Patients also receive reimbursement for transportation and other related expenses.
“As a parent, I feel that these vaccines are not only safe, but extremely important to get,” Connery said.

All four of Connery’s children have had the vaccinations, including Gardasil, to protect their health.

“No significant adverse effects are linked to the Gardasil shot,” Connery said. “As a family doctor, I see young women 18, 19, and 20 years old that already have abnormal pap smears.”

Connery said getting the HPV vaccine can prevent the high risk of cancer associated with the virus.

The clinical trial is simple. After shots are administered, the patient comes back a month later and blood is drawn to check the immune response. Connery said a numbing cream is used so that there is little to no discomfort associated with the shots or the blood draws.

“The kids aren’t feeling the blood draws at all,” she said. “The don’t feel the needle sticks.”

While the study in Norman has had a good response, it’s part of a bigger investigation.

“This is not just something we’re doing here locally,” Connery said. “This is a world wide study that’s going on.”
Lynn Institute does clinical trials for many drug companies that need non-biased people to conduct the trials.
Connery also conducted trials for a new flu vaccine for the elderly.

“We got 157 in that study,” Connery said.

In the current study, Connery said there is still a need for children in the younger group, ages 10-12. Older teens may still be able to get into the study as well.

“They’re getting shots they need,” she said.

Parents who are interested in having their children participate in the clinical trials can call the Lynn Institute in Norman at 701-2828 or call Dr. Connery at 701-4079.