USING TOBACCO TO FIGHT CERVICAL CANCER - YEAH, RIGHT!

[Guest guest]

Tobacco may help fight cervical cancer

http://www.usatoday.com/news/health/2007-07-29-cervicalcancer_N.htm

While cervical vaccine research continues in Kentucky, Merck is trying

to find ways to give Indian women access to Gardasil, with the help of

international organizations. " Merck will make new vaccines, including

Gardasil, available at dramatically lower prices to developing world

countries, " spokeswoman Eskin said, declining to name a price.

By Ungar, The (Louisville) Courier-Journal

OWENSBORO, Ky. - Inside a small, temperature-controlled room in the

heart of tobacco country, researchers are doing work that could give a

life-saving purpose to a plant best known for causing cancer.

The aim of the work is to coax from tobacco plants a drug that could be

used to prevent cervical cancer in India, where four times as many women

get the disease and eight times as many die of it as in the United

States.

The vaccine would be somewhat similar to Merck & Co.'s Gardasil,

approved by the U.S. government last year to prevent strains of a

sexually transmitted disease that causes most cervical cancer. In fact,

the same University of Louisville researchers who helped invent

Gardasil, Dr. A. Jenson and Shin-je Ghim, are also working on

this new vaccine.

One big difference between the two vaccines is cost.

The tobacco-based vaccine still in the works would cost an estimated $3

for three doses, compared with $360 for three doses of Gardasil. This

would make it affordable for developing countries like India, where the

disease is the most common malignancy among women.

Jenson has traveled to India three times, and said those visits helped

inspire him to create an alternative to his earlier invention - which he

said is too expensive for a poor country, despite Merck's assurances

that prices will be lower in developing countries.

" It's important to me because it turned out to be something special in

medicine, " said Jenson, who developed Gardasil with Ghim and another

researcher when they worked together at town University. " And it's

not going to reach the people who need it most. "

Jenson and Ghim are also working with an Indian researcher, Dr. Partha

Basu, to test an experimental treatment for late-stage cervical cancer.

" Every year, 120,000 new cervical cancer cases are detected in India,

80% of whom are at such an advanced stage " that they can't be treated,

said Basu, head of the department of gynecologic oncology at

Chittaranjan National Cancer Institute in Kolkata (formerly Calcutta).

" Naturally, there are nearly 80,000 deaths from cervical cancer every

year. This may be an underestimate as many deaths go unreported. "

Ruthie Snyder of Mount Pleasant, Pa., said the Louisville researchers'

work is crucial to wiping out the disease that killed her oldest child,

Rayna Gowton, a 28-year-old mother of three.

Jenson treated Gowton when she was dying, and once brought her a

necklace and earrings from India set with stones symbolizing hope and

life. Jenson still keeps a picture of Gowton in his office, near his

high-powered microscope.

Snyder said Jenson's dedication to stamping out the disease abroad is

" amazing. " " It's not just in America that we are dealing with cervical

cancer, " she said. " It's around the world. "

International health crisis

India's plight reflects problems throughout the developing world, where

poverty, lack of screening and spotty access to health care lead to late

diagnoses and early death, said Palmer, an Owensboro-based

researcher working with Jenson and Ghim.

Palmer said he saw the devastation wrought by the disease while growing

up in Zimbabwe and South Africa. " I have seen how ordinary people

struggle so to remain healthy, and how there is just so little resource

for them to get access to basic, primary health care, let alone

treatment for cancer, " said Palmer, who works at the Owensboro Cancer

Research Program, a joint venture between U of L and the Owensboro

Medical Health System. " We could make a big difference. "

The researchers hope their efforts help all developing countries as well

as the poor in the United States, and said they are not troubled that it

may provide competition for Gardasil.

They began their work by identifying a vaccine target: a protein called

" L-2 " in the sexually transmitted human papilloma virus. To make the

vaccine, they create a synthetic gene that expresses the same protein in

plants, then insert that gene into a tobacco virus, which is used to

infect plants and " grow " the vaccine inexpensively. Six to 10 days

later, they begin the long process of separating out parts of the

tobacco until they are left with pure protein.

That protein is designed to induce antibodies that protect against at

least 13 HPV strains known to cause cervical cancer. It is different

than the protein used to make Gardasil, which targets two strains that

cause 70% of cervical cancer cases.

So far, Palmer said, the tobacco-based vaccine has only been tested in

five dogs, which were completely protected when researchers tried to

infect them with oral canine HPV. Palmer said he would like to begin the

first phase of human clinical trials before the end of 2008, most likely

in Owensboro. When development is further along, Basu said that Indian

scientists, doctors and funding agencies can discuss whether to do a

trial in his country.

While research continues in Kentucky, Merck is trying to find ways to

give Indian women access to Gardasil, with the help of international

organizations. " Merck will make new vaccines, including Gardasil,

available at dramatically lower prices to developing world countries, "

spokeswoman Eskin said, declining to name a price.

But Basu said he's not optimistic about Gardasil in his country because

of its price. Palmer speculated that the high cost might be partly

because of the fact that they performed extensive clinical trials.

" Theoretically speaking, HPV vaccine, with its 70% to 80% protection

against cervical cancer, can be the greatest boon to our women, " he

said. " Unfortunately, the cost of the currently available vaccine is

prohibitive and beyond the reach of even the well-to-do social class.

The vaccine that (Jenson) is working on has the cutting edge in terms of

price. "

Preventive growth

If the tobacco-based vaccine proves safe and effective and gets the

necessary U.S. government approvals, researchers hope to see it

manufactured in a for-profit subsidiary of the Owensboro health system

called Kentucky Bioprocessing, located behind a cornfield seven miles

from Palmer's office.

" The world's supply of HPV vaccine can be made in a facility like this

working year-round, " Palmer said as he walked through a greenhouse

complex where small tobacco plants were growing.

The company has a 30,000-square foot manufacturing and laboratory

building and five greenhouses with signs reading: " Contains Genetically

Engineered Organisms. " The tobacco would only be grown in greenhouses,

not in fields where it could potentially infect other plants.

During manufacturing, trucks would deliver infected plants to the main

building, where they would be " juiced, " with the liquid stored in a

large tank. In other rooms, the liquid would be processed and purified,

the protein extracted, and the vaccine put into bladder bags or vials.

Vaccine needed for clinical trials would be made in a room featuring a

small version of the large-scale setup.

Palmer said he expects the vaccine would eventually be bought by a

pharmaceutical company in a developing country - " An Indian company may

well be a logical one. "

But none of this is finalized yet. And there are other unknowns as well,

such as how the vaccine would be received in places like India.

Efforts by state legislatures to require American girls to be vaccinated

with Gardasil were controversial, with some opponents arguing that it

could encourage early sex and others questioning the vaccine's safety.

Reverberations from this fight may reach other countries, experts said,

and may be complicated by cultural issues and views about the United

States.

But researchers said such obstacles can be overcome.

" Hopefully, " Ghim said, " everybody will put their effort together to

immunize the women who need it. "