Women's Health Issues -2

Virtual doctor trains patients in 3D

This website helps women check their own health

The latest 3D web technology is being used to allow women to look out for problems such as osteoporosis, heart disease and breast lumps.

US-based Superscape have produced a 3D virtual reality browser which allows visitors to their site to watch, or even interact with informative presentations - viewing them from any angle. But the company has stressed that its technology cannot do away with the trip to a GP or specialist. Speaking to the BBC, Superscape's Ben Green said: "I don't think there is any threat of us at any point in the future getting a system that can replace the years and years of training that a doctor undergoes."

Personal details taken

The sections of the site devoted to heart disease and osteoporosis allow the visitor to enter personal health details - then see a 3D representation of the results, whether good or bad.

So a smoker who admits to having a poor diet and taking little exercise might see a heart artery pumping slowly because it is clogged with fatty deposits.

And someone who does not drink enough milk, or a young person who diets too much, might be depicted as a stooping figure because of the effects of osteoporosis.

The site aims to teach women how to carry out their own breast examinations, allowing viewing to take place from any angle.

Ben Green said: "The information we are conveying is already available to the general public through leaflets - this provides the ability for concerned people to check out some of the basics, and if they're still concerned after that, to go and see a doctor."

He is hopeful that the technology could eventually be used in hospitals to guide patients through exactly what is going to happen during their operation, and perhaps even to help train medical students.

Virtual reality has already been used to help doctors learn the skills of brain surgery by offering a 3D image of a patient's head which can be operated on with a "software scalpel".

Superscape are well known for their innovative 3D virtual reality software - in the past, they have produced 3D shopping malls, a virtual medieval garden and even a virtual graveyard.

Visitors to the site will have to download the browser and should be running at least a 133 MHz Pentium processor.

'Warrior Women' seek healing through art

CNN - May 1999

A unique group called Waking Dreams and Warrior Women has been exploring the healing effects of art. The group's focus is and has been on breast cancer, but the members feel art has the potential to help with all types of illnesses.

Dr. Bethe Anne DeLuca-Verley, a breast cancer survivor and a founder of the organization, was diagnosed with the disease two years ago when she was breast-feeding her third child. She was given a grim prognosis, underwent intensive chemotherapy and eventually had a mastectomy.

Verley said Waking Dreams and Warrior Women began last September during a discussion in her living room with physicians interested in the impact of art on healing. Also present was sculptor Christiane Corbat, who was already using art with heart and breast cancer patients to help the healing process. Corbat approached Verley about doing a body casting of her before and after her mastectomy, which she says "let me see myself outside myself."

Verley feels art creates "almost sacred space." When people are doing art they don't feel vulnerable as they might in a doctor's office -- they can discuss and explore illness, death and dying more comfortably.

The goal of Waking Dreams and Warrior Women is not to create an alternative to traditional treatment but to offer spiritual healing as well.

People seem drawn to the concept. Verley says the group is growing quickly. The nonprofit organization incorporated in February. While it is based in Rhode Island, it has board members across the country as well as international representatives. The group is filling a void in medicine, Verley says. Art therapy is complementary care that helps improve the quality of life, she says.

Brown University Medical School has given the group a grant to work with medical students to help them explore other aspects of healing.

The group also plans to go into schools to talk to students about school violence. Verley says they are considering helping the students do hand castings because "hands are so reflective of everything that we do." After the students decorate the hands, they can be connected to build a bridge sculpture showing how they are individuals, yet connected.

A Paleolithic figurine has become the symbol of Waking Dreams and Warrior Women. It is called Nuit and was used in Greece and Algeria more than 4,000 years ago to help people who were sick. Verley says though it was picked at random, when they learned its meaning, group members thought it very appropriate. According to history books, Nuit was considered the goddess of the soul, related to fertility and the gateway to dreams. "It gives testimony to the journey," says Verley.

Researchers say breast cancer drug Herceptin is working

Reuters - Philadelphia - April 13, 1999

The newly approved breast cancer drug Herceptin reduces deaths by more than 20 percent after just two years, researchers said Monday.

The drug, which homes in on cancer cells with a specific genetic mutation, decreased the death rate by 22.4 percent, Dr. Dennis Slamon of the University of California at Los Angeles told a meeting of the American Association for Cancer Research.

"In terms of survival with patients with metastatic breast cancer (cancer that has spread), this is the largest reduction with any therapy we've seen to date," Slamon told a news conference at the meeting.

Herceptin, made by South San Francisco-based biotechnology company Genentech Inc., works by blocking the HER-2/neu (human epidermal growth factor receptor-2) gene, which seems to promote the growth of cancer cells.

It is mutated in 25 to 30 percent of all breast cancers.

The drug is a monoclonal antibody, a genetically engineered version of the body's own system for flagging invaders or cancerous cells. Herceptin, also called trastuzumab, blocks HER-2's action and thus stops production of the protein, slowing down the cancer's growth.

The U.S. Food and Drug Administration (FDA) approved Herceptin last September after the drug's dramatic effects were shown. It cut the progression of the disease and, even though patients were followed for just a year, seemed to cut the death rate.

The one-year survival rate for patients who got Herceptin plus standard cancer chemotherapy was 78 percent versus 67 percent for women who got chemotherapy alone, a difference of 11 percent.

Now, after two years of following the patients, the researchers say the numbers are even more striking. "The data demonstrates an even greater impact on survival," Slamon said.

Women who got Herceptin had a 50 percent improvement in response rate -- defined as shrinking the tumor by 50 percent or more -- compared to women in the so-called control group, who got the best standard cancer drugs but not Herceptin.

And there were no significant side-effects. With cancer chemotherapy or radiation treatment, all growing cells can be affected, which is why patients lose hair and have digestive upsets as the insides of organs are damaged.

But Herceptin is designed to avoid this, and Slamon said it seemed to be doing so. "Cells that do not have the alteration are not affected by Herceptin," he said.

Dr. Drew Pardol of Johns Hopkins University in Baltimore said the results show that drugs that harness the body's immune defenses, like Herceptin, will be the wave of the future.

Slamon said the 22.4 percent increase in survival might have been even higher. "That difference was despite a bias against the drug," he said. After one year, women in the control group whose cancer got worse were given the chance to go on Herceptin. Sixty-five percent of them did. Of that group, many responded to Herceptin almost immediately.

Computer-aided mammography near approval

Tuesday May 12, 1998

NEW YORK -- An advisory panel of the US Food and Drug Administration (FDA) has unanimously recommended approval for a computer-based scanning device to detect abnormalities on mammograms. While the device is not yet approved by the FDA, the government agency often follows the advice of such expert panels.

The device, the M1000 ImageChecker System, was developed by R2 Technology, Inc., of Los Altos, California, and is meant to be used by radiologists who screen mammograms for signs of breast cancer.

"The evidence is convincing that the device finds lesions missed by an observer and should be of great benefit" to radiologists, said Dr. Brian S. Garra, a professor and vice chairman of radiology at the University of Vermont in Burlington, and a member of the FDA's Radiological Devices Panel.

However, there is still the concern that a radiologist may rely too heavily on the device, or change their diagnosis if it does not agree with the M1000 ImageChecker System, according to panel member Dr. James B. Smathers, director of medical physics at the University of California, Los Angeles.

Currently, the false negative rate -- or the percent of mammograms incorrectly considered to be free of abnormalities -- is 20%, resulting in about 36,000 women every year with missed or delayed diagnoses, according to the FDA's Dr. William Sacks.

"The contribution of M1000 is significant. It allows a 31% to 44% reduction in false negatives, with an increase in sensitivity from 80% to 86% to 89%." Such an increase could result in 11,000 to 16,000 women diagnosed earlier out of the estimated 36,000 missed, Sacks said.

Birth Control

Washington--February 13, 1999 - AP

It would be a powerful tool for women: a gel or cream they could apply just before sex to protect against AIDS or other sexual infections, without having to get the man to agree to a condom.

Scientists have spent years hunting such a "topical microbicide" with little luck so far, although they have some early candidates that might fight the AIDS virus.

But Penn State University researchers announced a surprise: an experimental microbicide that promises to protect against both HIV and a sexually transmitted virus that causes deadly cervical cancer.

Microbicide is plentiful and affordable

It is a common ingredient in shampoos and toothpastes, so researchers already know it is safe; it also is cheap.

Many chemicals are being tested for anti-HIV action. After all, the AIDS virus is spreading most rapidly in heterosexual women.

But Penn State microbiologist Mary Howett's discovery of the first chemical that also destroyed human papilloma virus, or HPV, has researchers intrigued. The National Institutes of Health cautiously hopes that first-stage testing of sodium dodecyl sulfate could begin in a small number of women later this year.

"We're excited about the broad-spectrum nature," said Dr. Penny Hitchcock, NIH's microbicide chief. The HPV protection is particularly intriguing because "it's been a lot harder for us to find anything that works with that."

"But we're cautious," she stressed, because researchers have lots of work -- including turning the ingredient into a usable vaginal gel -- before initial testing could begin.

Potential to prevent against cervical cancer

Human papilloma virus is a common sexually transmitted infection. About one in four women is estimated to have a strain of HPV.

Most HPV is symptomless, but some strains go on to cause cervical cancer that kills 5,000 American women and 250,000 women worldwide every year. (The global toll is so high because developing countries cannot afford Pap smears, tests that let most American women discover cervical abnormalities before they grow into actual cancer.)

"If you could eliminate (HPV), you could potentially prevent all those cancers," Howett explained.

Creating the right gel

Microbicides are gels or films that women would insert into the vagina before sex to protect against various sexually transmitted diseases. So far, none has panned out. A study just found that the popular spermicide nonoxynol-9, long thought the best hope for an anti-HIV gel, does not protect after all.

Scientists now are studying whether other spermicides or chemicals could work instead, and the NIH is spending millions to help.

One approach in early testing is an acid-buffer gel. Semen is very alkaline, raising the pH level of a woman's vagina enough to help acid-averse HIV infect more easily. The gel would maintain a vagina's natural acidity in hopes of killing HIV.

But until now, no experimental microbicides have blocked the tougher cervical cancer virus.

In the February journal Antimicrobial Agents and Chemotherapy, Howett reported that in test-tube studies, the ingredient SDS inactivated the AID and herpes viruses. Like other experimental microbicides, SDS is a detergent that dissolves the fatty coating that holds those viruses together.

The cervical cancer virus is coated with tightly packed proteins that mere detergents cannot dissolve. But SDS also is a "denaturing" agent -- and it picked those proteins apart.

After it worked in test tubes, Howett injected human cells with the cancer virus or with SDS-treated virus and then implanted those cells inside mice. The treated human cells grew normally with no evidence of HPV infection. The untreated cells grew into genital warts.

It will take years to prove whether SDS will work in the bedroom as well as the lab. Still, Howett calls SDS "a major step toward ... producing a practical, nontoxic, inexpensive, discreet product" to protect women's sexual health.

Insurers wary of new computer system to read Pap smears

AP - May 25, 1998

Executives at Neuromedical Systems Inc. thought they'd struck gold. The U.S. Food and Drug Administration had just approved Neuromedical's PapNet, a computer system that reads Pap smears and points out abnormal-looking cervical cells that human screeners might miss.

With 60 million Pap smears done each year in the United States, Neuromedical executives thought they had it made. It didn't turn how that way. Three years later, Neuromedical can't get insurance companies to reimburse laboratories that use its system, despite FDA approval and research showing that the computer catches diseased cells that humans reading the Pap smear miss. This company, based in Suffern, a suburb north of New York City, is not alone.

Fifty years after the Pap smear became the standard screen for cervical cancer, a new generation of tests and technologies is on the market. But like PapNet, most aren't covered by insurance and thus remain unknown by women and unused by their doctors. The products, insurers say, are more expensive than traditional Pap smears and drain resources that would be better spent educating women to start getting regular gynecological checkups. Makers of the tests, many doctors and Wall Street analysts say insurers are impeding the first improvements to the Pap since 1948.

The issue has touched off a high-stakes debate about the future of the Pap smear. Credited with cutting the number of cervical cancer deaths by 70 percent, the Pap smear has become one of the most respected and successful disease-fighting tools in history.

It is this familiarity with the traditional Pap smear, coupled with the lack of reimbursement, that makes it so difficult to get the new products accepted, say industry watchers and doctors, some of who have lobbied Congress for Medicare coverage of the new tests.

Even insurers admit the Pap smear is far from infallible. It misses problems about 20 percent of the time, according to the National Institutes of Health, usually because of poor cervical samples or difficulty reading the slides at the lab.

Named for Dr. George Papanicolaou, the pathologist who developed it, the Pap smear involves the physician scraping cells from the cervix, at the neck of the uterus, with a special spatula or brush. The cells are smeared onto a glass slide, sprayed with a fixative and sent to a lab, where a technician reads the slide under a microscope. It's been done that way since 1948.

But in the last five to 10 years, scientists have made major advances in cervical cancer research. With much of the code cracked, entrepreneurs began creating new products to improve the venerable Pap smear -- or even replace it.

Some, like PapNet and NeoPath Inc.'s AutoPap, use computers rather than human eyes to spot abnormal cells. Others, like ThinPrep by Cytyc Corp. and Prep by AutoCyte Inc., treat the cells with a liquid to remove blood and mucus that can hide cancerous changes. Still others, like Hybrid Capture by Digene Corp., read a woman's DNA to see if her abnormal cells are likely to progress into cancer.

On the horizon: vaccines against the human papilloma virus, which causes cervical cancer. Drug companies say the vaccine would be given to adolescent girls before they become sexually active. Until competition drives down costs, however, insurers insist it's more cost-effective to focus on getting women to doctors for regular Pap smears. Fully half of the 15,700 American women diagnosed with cervical cancer each year have never had a Pap smear, so they are out of reach of any technology, no matter how much better than the Pap.

Lack of reimbursement aside, all sides agree the conventional way of reading a Pap smear is on the verge of replacement.

Morning after' pill wins FDA approval

Washington-September 2, 1998

For the first time, a company won government permission Wednesday to advertise and sell regular contraceptive pills as "morning-after" pills to prevent pregnancy after unprotected sex.The technique, which uses regular birth control pills, has been sanctioned as safe and effective by federal officials for more than a year. But without anyone trying to sell it to women or their doctors, experts say it has hardly been used.

That could change as more women learn of the pills, which have been 75 percent effective at preventing pregnancy in tests when taken within three days of sex. By contrast, regular contraceptive pills are 99 percent effective, if taken properly.

"Physicians are kind of waiting to be asked. Since women don't know about it, they don't ask," said Dr. Felicia Stewart of the Kaiser Family Foundation, which surveyed doctors and patients about the pills last year.

The morning-after pills are different from RU-486, the French abortion pill, which ends a pregnancy several weeks after it has begun. The PREVEN kits, made by Gynetics Inc. of Somerville, N.J., will be available by prescription by the end of September. The company, which won Food and Drug Administration approval Wednesday, anticipates that women will seek them out after unprotected sex -- or keep them in their medicine cabinets just in case.

European women have used this technique for years, but most contraceptive makers here have resisted selling emergency birth control, citing litigation and political concerns. Gynetics plans to advertise on radio and in magazines that many women read such as Glamour, Soap Opera Digest and People. It also plans a direct mail campaign to doctors.

Until now, it's been complicated for women to correctly use the morning-after technique. It involves taking regular birth control pills, but from regular birth-control packets that contain several types of pills. Women thus had to sort through to choose the right ones. In contrast, the PREVEN kits will include only the four pills needed for emergency contraception. Each kit will sell for about $20 and also include a pregnancy test.

The morning-after pills do not work if a woman is already pregnant. A woman can become pregnant days after sex because sperm remain in the uterus for some time. The morning-after pills delay or prevent ovulation, meaning no egg enters the uterus to be fertilized. Experts believe the pills also alter the uterine lining, making it more difficult for an already fertilized egg to attach and develop into an embryo; however, this scenario is technically difficult to prove, the FDA says.

Anti-abortion groups, who have vigorously protested RU-486, are neutral on these pills, saying women should consult their doctors and decide for themselves whether the method might interfere with life after conception.

In any case, the FDA believes a woman is not pregnant until a fertilized egg attaches to the uterine wall. Anti-abortion groups believe that life begins when an egg is fertilized, and oppose any destruction of a fertilized egg.The FDA certified that morning-after pills were safe and effective in March 1997, and since then, groups have been working to spread the word.

A project in Seattle allowed pharmacists to prescribe the pills using guidelines established by doctors, allowing women to get them with one trip to a drugstore. In three months, more than 2,000 doses were dispensed.

Planned Parenthood is considering setting up a national hot line so women can talk with a health care provider and get a prescription called into a local pharmacy.

The method is effective 75 percent of the time, the FDA said. It consists of taking two oral contraceptive pills, containing ethinyl estradiol and levonorgestrel, within 72 hours of unprotected sex, and another two pills 12 hours later.

For every 100 women who have unprotected sex during the second or third week of their menstrual cycle, eight would normally become pregnant -- but only two would if they took the emergency birth control, according to studies. The emergency contraceptive's side effects are nausea and vomiting, sometimes severe, similar to those some women experience with regular contraceptives.