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Controversial Cancer Preventive Comes Up for FDA Approval: Vaccine Protects Women From Cervical Disease, but Some Say It's Unneeded.

Posted on: Wednesday, 7 June 2006, 12:00 CDT

By Kathleen Parrish, The Morning Call, Allentown, Pa.

Jun. 7--Lauren Boulay can always tell when her father has had to deliver a diagnosis of cervical cancer to one of his patients.

His broad shoulders slump as he shuffles through the front door of their stately home, he doesn't have much to say at dinner, and his eyes hold a sadness she can't quite dispel with lighthearted chatter about her day in middle school.

"It's hard on him," said 12-year-old Lauren of her father, Dr. Richard Boulay, chief of gynecologic oncology at Lehigh Valley Hospital-Cedar Crest.

That's why she's decided to receive Gardasil, a new vaccine against cervical cancer, the second most common cancer in the world, if it's approved by the Food and Drug Administration on Thursday.

"This would help me in the future in case I had a problem," said Lauren, a seventh-grader at Salisbury Middle School who plays soccer and is a flutist in the band.

More than 300,000 women die each year from cervical cancer, including 3,700 in the United States. It's less of a problem in this country because of early detection through Pap tests, but it's the No. 2 cause of cancer deaths in developing countries.

The vaccine, developed by Merck & Co., neutralizes two strains of the human papillomavirus, the most common sexually transmitted disease in the country and one that is contracted by more than 80 percent of all women.

While the immune system generally clears the infection in a year or two, HPV causes 70 percent of all cervical cancer.

"Most women don't even know they have it because it has no symptoms," said Dr. Doug Lowy of the National Cancer Institute, whose research led to development of the vaccine. "It's extraordinarily common. It's the unusual person who will not be infected."

Gardisil is big news because it's the first vaccine to prevent a cancer, a medical advance that will not only save lives but millions of dollars in health care costs.

"It's a huge breakthrough," said Dr. Boulay. "It's going to change women's health care."

But the vaccine is not without controversy. Conservative Christian groups worry it will give young women carte blanche to have premarital sex and foist another vaccine on public schoolchildren.

Because HPV is transmitted through sexual contact, the vaccine is most effective if administered to girls between the ages of 9 and 13 or before they become sexually active.

Linda Klepacki, analyst for sexual health with Focus on the Family, said the conservative group supports widespread distribution of the vaccine but is against making it mandatory for entrance to public schools. That's a decision a child's parents should make, Klepacki said.

"This is a sexually transmitted disease, and because it's sexually transmitted it can be prevented by abstaining from sex until marriage," she said.

But that's no guarantee a woman won't get infected because her husband, who may have had other sexual partners before the wedding, could pass along the virus, Boulay said.

"If I never again have to tell a child that his or her mother is dying of cervix cancer, I will be the happiest guy around," he said. "If you don't want to have your kid vaccinated, don't. It's up to you, but don't tell me I can't have my kid vaccinated."

Once the FDA approves Gardasil as expected, the American Academy of Immunology Practices will recommend whether it should become a routine vaccine for adolescent girls. Whether it becomes a mandatory addition to the slate of childhood vaccinations is a decision left to state legislatures.

Richard McGarvey, spokesman for the state Department of Health, said Pennsylvania could add Gardisil to its list of required vaccines by changing school immunization regulations, a process that would require public hearings.

"It's way too early to tell where all that will go," he said. "Certainly, when you're talking about a vaccine aimed toward sexually transmitted diseases, that can always lead to some controversy."

But it's happened before. In 2002, the state required inoculation of all school-age children for hepatitis B, which can be transmitted through sexual contact and causes liver cancer.

"It's a similar situation," said Barbara Stader, director of the Allentown Bureau of Health. "Any way we can prevent cancer through a very easy means, like a vaccine, we should go for it."

Gardasil blocks against four strains of HPV, two that cause the majority of cervical cancer cases and two responsible for 90 percent of genital warts in both men and women.

There are roughly 1 million cases of genital warts a year in the United States, and an estimated 32 million cases occur worldwide. In addition, the results of roughly 4.7 million Pap tests nationwide require follow-up care, and at least 3 million of those are caused by a type of HPV.

The vaccine is 100 percent effective in blocking the two most common causes of cervical cancer, but it's not foolproof. There are other types of human papillomavirus that cause cancer.

That's why it's important for women to continue getting regular Pap smears, said Dr. Marie Savard, a Montgomery County internist who is a nationally known women's health expert. The tests detect abnormal cell growth on the cervix -- caused by HPV infections -- and are recommended annually for women over 30.

"This is unbelievably exciting news," she said of the cervical cancer vaccine, but Pap tests should still be a part of routine gynecological exams. That's because the vaccine "only reduces risk from the two most virulent strains."

The vaccine will, however, reduce the number of Pap tests that result in false positives. "It will eliminate some of that unnecessary scare and worry," Savard said.

The Pap test was developed in the 1940s and is responsible for the sharp decline in the number of women dying from cervical cancer. Before the test, cervical cancer was the No. 1 cause of cancer deaths in women in the United States. Now it is No. 8.

The National Cancer Institute's Lowy said trials of the vaccine indicate it's effective for up to four years.

"Up to that time, protection is excellent," he said. "Although there's every reason to hope protection will last longer than that, but there's no data. If protection were to wane after a four-year period, presumably you would get boosters, but that would add to the cost of the vaccine."

In testing, the vaccine caused no side effects, Lowy added.

"From a scientific point of view, the vaccine seems very safe," he said. "But once the vaccine is approved and you're giving millions of doses, there could be side effects you hadn't seen."

New Jersey-based Merck is hoping Gardasil will rejuvenate flagging stock prices after the company had to withdraw the painkiller Vioxx, which was linked to heart attacks in some patients.

GlaxoSmithKline also developed a cervical cancer vaccine, called Cervarix, and is expected to seek FDA approval later this year. GlaxoSmithKline's vaccine includes protection against two strains of cancer-causing HPVs but doesn't block genital warts, as Merck's does.

Merck spokeswoman Kelley Dougherty said the company hasn't assigned a cost to the vaccination, which consists of three shots over six months, but health care analysts have put the price at $300 to $500.

Merck's trial of the vaccine included more than 27,000 women and men from 33 countries, including a small sample at Lehigh Valley Hospital, who participated in the final phase of the study, said Dana Wentzel, director of clinical research at LVH.

None of the participants in the study who received Gardasil, as opposed to a placebo shot, developed cervical cancer or precancerous lesions.

"The impact on the community is huge," said Wentzel. "Most women don't know they have a problem until they have an abnormal Pap."

That was the case with Kellie Csrenko, 29, of Allentown after results from a Pap test two years ago showed abnormal cells, and a subsequent biopsy revealed precancerous growth. She was pregnant with her daughter and hadn't had an annual gynecological exam in three years. The precancer was caught just in time, Csrenko said.

Later, she asked Boulay, her oncologist, what would have happened if it wasn't detected. "He said, 'You would have been fighting for your life in two years,' " Csrenko said.

It's no surprise, then, that she plans to have her now 14-month-old daughter vaccinated when she's older. "If it can prevent her from going through this, it's a good thing," she said. "I think it should be be part of the vaccines for all females. It's not going to hurt them."

kathleen.parrish@mcall.com

610-820-6627

What: Gardasil, a cervical cancer vaccine from Merck & Co. Expected to get approval from the Food and Drug Administration on Thursday.

What it does: Neutralizes two strains of the human papillomavirus, a sexually transmitted infection that causes 70 percent of all cervical cancer cases.

Who should get it: Girls ages 9-13, before they become sexually active.

Source: Merck & Co.

CERVICAL CANCER VACCINE

Click here to find out more!

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Source: The Morning Call, Allentown, Pennsylvania

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