Cervical Cancer: Endangered Species - Pharmaceutical Executive

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Cervical Cancer: Endangered Species
Preventive care is more efficient than treating disease after the fact. Now this paradigm takes hold in cancer.


Pharmaceutical Executive


It is in this way that the competitive landscape is shaping up. "They're going to be competing very sharply with each other," says Digene's Rasmussen. "GSK is behind, but it will be out there soon. I think you'll find they are doing some education out there, but that it's going to quickly get into a lot of competition—and not just unbranded disease education.

Gardasil and Ceravix can't compete against one another in their primary and most important indications—preventing the cancer-causing HPV types 16 and 18—because they have the same efficacy. Instead, the war for market share will be waged on the back of other benefits.

It's not yet clear whether Gardasil's ability to treat genital warts will remain an outstanding positive for the company. Certainly, it opens up a wider market for Merck by enabling the potential for male vaccination. However, that can come at a price, given the sensitivity of some conservative groups.

"Vaccines for hepatitis B, another often sexually transmitted disease, only gained widespread public acceptance in the US as a cancer vaccine preventing liver cancer," says Rovini. "Gardasil may have more trouble here since it does not just prevent cancer but also genital warts, an STD."

Perhaps because of that, Barr points to the other benefits of targeting HPV types 6 and 11 for genital warts, like saving the US system money. After all, these HPV types often pass for pre-cancerous cells. Each year, 150,000 women are told, after a PAP smear, that they may have pre-cancerous cervical cells and must undergo additional testing, when in reality they were infected with the HPV types that do not cause cancer.

Barr also notes the ability to prevent recurrent respiratory papillomatosis, a condition that occurs when pregnant mothers with genital warts give birth, resulting in newborns' with sizeable tumors in their throats, which are just "total disaster cases," says Barr.

On the other hand, GSK's studies show their vaccine provides cross protection against other oncogenic HPV types 45 and 31, which are less agressive but still cause about 10 percent of cervical cancers.

The company has also begun building its body of data to show long-term effectiveness—a big question mark facing both vaccine makers, given the potential need to develop booster shots. Recently, GSK published a study in the Lancet that showed Ceravix maintained protection for the 4.5 year study period without any sign of waning. Dubin credits the use of an adjuvant called ASO4, instead of the standard adjuvant alum that is used in most vaccines, including Gardasil.

"It was very encouraging that by using adjuvant, it would be possible to have longer-term protection," says Dubin.

THE CHALLENGE OF MASS INOCULATION




Now that the science is in order, Merck and GSK face several important challenges in conditioning the market.

The court of public opinion There is some pushback against the HPV vaccines from religious-based organizations, which are concerned that these vaccines promote promiscuity. But how prevalent is that criticism?

The court of public opinion There is some pushback against the HPV vaccines from religious-based organizations, which are concerned that these vaccines promote promiscuity. But how prevalent is that criticism?

"My sense is that it's not a widespread opposition, just a few vocal opponents," says Duke University Medical Center's Evan Myers, MD. "They are arguing that if a teenage girl knows she got the HPV vaccine, that it is somehow going to remove a barrier against her having intercourse. That argument assumes a.) teenagers make rational decisions, b.) drugs and alcohol are never involved in adolescent sex, and c.) there's widespread knowledge of the consequences of HPV—and most kids don't know anything about HPV."


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