Federal Enactment of the 2008 Genetic Information Nondiscrimination Act (GINA) As Law Appears Imminent

“Although nearly 40 states have had individual forms of the legislation in place, with the federal passage of GINA, the message would be unambiguous: the misuse of genetic information resulting in discrimination in employment or health insurance is against the law in all U.S. states.”

“After installing compromises and ‘minor’ changes, including a ‘firewall’ separating the potential liabilities insurers and employers could face, the US Senate last week unanimously passed the Genetic Information Nondiscrimination Act [‘GINA’].

The bill, which seeks to protect individuals’ genetic information from being misused by insurers and employers, now moves to the House, where it is also expected to pass, and then to the White House, where President Bush is expected to sign it into law.

According to American Society of Human Genetics Executive VP Joann Boughman, the Senate version of the bill adopts language appearing in the House bill (HR 493) designed to ‘limit, but not completely prevent,’ employees from suing their employer for being denied insurance based on genetic information obtained by a payor.

The bill exempts employers from liabilities if the employer ‘inadvertently’ garners genetic information through a company-sponsored wellness program, or must request such information in order to monitor biological effects of toxic substances in the workplace. The bill’s language also specifies that ‘an employer, employment agency, labor organization, or joint labor-management committee shall not be considered to be in violation … [for the] use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee or member, including a manifested disease, disorder, or pathological condition that has or may have a genetic basis.’

Industry observers have long said that the lack of legal protections for people’s genetic information deters them from participating in clinical trials for gene-based therapies and tests, which in turn hampers advances in the genetics field.

In an NIH-funded study of families newly -diagnosed with a hereditary cancer syndrome named hereditary non-polyposis colorectal cancer, researchers found that participants consistently asked how their involvement in the study would impact their and their families’ insurance. During the study, ‘it was clear that there was an overwhelming concern, and in some cases, a palpable anxiety about the impact of genetic testing on health insurance,’ Donald Hadley, an associate investigator and a genetic counselor with the National Human Genome Research Institute, said in a 2004 testimony to the HHS Secretary’s Advisory Committee on Genetics, Health, and Society.

‘These concerns dominate our informed consent process and recur session after session with an intensity that opened our eyes to the level of concern that the public feels about genetic discrimination,’ Hadley said in his testimony.

With the expected passage of GINA, academic genetic researchers, diagnostics firms, and pharmacogenomics companies can better assure clinical trial participants that their genetic data will not be used to make insurance or employment decisions, and that they have recourse under the law if their genetic information is abused in such a manner.

GINA is expected to go back to the House of Representatives where it will be aligned with the Senate version of the bill and voted on again. Because GINA has already passed in the House twice with ‘considerable support,’ it is not expected to encounter any problems when the lower chamber votes on it, which can happen as early as this week.

Once it clears the House, GINA is expected to be signed into law ‘in short order,’ Kurt Bardella, press secretary for GINA sponsor Sen. Snowe, told Pharmacogenomics Reporter sister publication GenomeWeb Daily News last week.

In a recent address to the National Institutes of Health, President George Bush said he is willing to sign the bill into law if it passes Congress.

GINA’s Long Haul

Since last summer, after GINA cleared the House the first time by a vote of 420 to 3, the bill has had many detractors. The bill’s main opponent was Senator Coburn, who placed a hold on GINA, citing concern that the bill could potentially increase lawsuits against employers.

Mainly, Coburn wanted the bill to include a ‘firewall’ that would prohibit employees from being able to sue their employers if an insurer denied coverage based on genetic information.

Then in March, in a surprising move, the House passed GINA by a vote of 264 – 148 as part of the Paul Wellstone Mental Health and Addiction Equity Act of 2007 (H.R. 1424), which would require health insurers to cover mental health and substance abuse-related disorders under group health plans.

Attaching GINA to that bill appeared to invite more detractors to the expanded legislation. When the Wellstone bill passed in the House, 11 senators, including Coburn, sent a letter to Democratic leaders in Congress raising concerns about GINA’s ability to ‘maintain current law distinctions between employee benefit disputes … and disputes about civil rights in the employment context.’

Some of GINA’s other detractors, including the US Chamber of Commerce, the National Association of Manufacturers, and the National Retail Federation, shared the Senators’ concerns. These groups, which formed the Genetic Information Non-Discrimination in Employment Coalition, remained optimistic that the group may be appeased with ‘minor technical fixes’ to GINA, according to Michael Eastman, executive director of labor policy at the US Chamber of Commerce.

With GINA’s passage in the Senate, it seems those ‘minor fixes’ are now in place.

Senator Coburn’s office did not return requests for comment on GINA’s passage prior to deadline.

Employer Exemptions

Although the bill would make it unlawful for an employer to obtain genetic information from an employee or a family member in order to make employment decisions, the employer is not held liable for a number of scenarios.

For example, an employer would not be breaking the law if he “inadvertently requests or requires family medical history of the employee or family member of the employee” through a employee-provided wellness program; if the employee provides prior, knowing, voluntary, and written authorization; if the employee and the doctor receive individually identifiable information concerning the results of such services; and if the employer receives genetic information regarding these services in ‘aggregate terms that do not disclose the identity of specific employees.’

The employer is also exempt if genetic information is requested to comply with medical leave laws; if an employer purchases documents that are commercially and publicly available that include family medical history; or where the information involved is to be used for genetic monitoring of the biological effects of toxic substances in the workplace. In the last instance, the employer is required to provide written notice of the genetic monitoring on an employee.

Genetic Alliance President Sharon Terry described the compromise as a product of a “great conversation” between all parties involved and the engagement of the genetics community. She also suggested that the sudden advancement in consumer genetic testing businesses over the past year, and greater discussion in the media about the uses and ethics of such tests, could have helped push the bipartisan effort to pass GINA.

Grassroots Instruction

Expecting GINA to be signed into law, its supporters are now focused on educating physicians and patients regarding their rights.

‘Our challenge now is to make sure that doctors and patients are aware of these new protections so that fear of discrimination never again stands in the way of a decision to take a genetic test that could save a life,’ Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University.

The pending passage of the bill also was lauded by the Personalized Medicine Coalition, a collection of industry, academic, payor, and other partners. The PMC lauded two of its members, IBM and Eli Lilly, for adding genetic nondiscrimination to their employment policies in advance of GINA’s passage.

‘GINA closes important gaps in the current patchwork of federal and state protections against the misuse of genetic information,’ the PMC said in a statement. ‘Current federal statutes for protecting medical information, including the Health Insurance Portability and Accountability Act, do not prohibit insurers from requiring genetic testing or from denying coverage based on genetic information; and while the Americans with Disabilities Act protects individuals with symptomatic genetic disabilities, it is not clear if it explicitly covers discrimination based on unexpressed genetic susceptibility to disease.’

In the ASHG‘s view, the promulgation of a national genetic anti-discrimination law will help clear up the confusing patchwork of state laws that have emerged.

‘Although nearly 40 states have had individual forms of the legislation in place, with the federal passage of GINA the message would be unambiguous: the misuse of genetic information resulting in discrimination in employment or health insurance is against the law in all US states,’ the ASHG said in a statement.”

[Quoted Source: “Senate Unanimously Passes GINA, Though With‘Compromises’; Now Faces Sympathetic House,” by Turna Ray, Pharmacogenomics Reporter, April 30, 2008.]

Comment: For additional GINA and genetic discrimination information, please refer to the following: (i) “Genetic Information Nondiscrimination Act: 2007-2008,” National Human Genome Research Institute, National Institutes of Health, April 24, 2008; (ii) “Senate Gives GINA Critical Boost Toward Becoming Law,” National Human Genome Research Institute, National Institutes of Health, April 24, 2008; (iii) “Genetic Discrimination” Overview, National Human Genome Research Institute, National Institutes of Health, April 28, 2008; and (iv) “State Genetic Privacy Laws,” National Conference of State Legislatures, January 2008.


“Life Must Be Measured in Its Beauty, Not Its Length”

The title quote above was spoken by Elana Waldman, who is the inspirational ovarian cancer survivor highlighted and honored by H*O*P*E* this week. Simply put, Elana Waldman is an outstanding advocate for cancer research. She educated and inspired luncheon guests at the 2007 Israel Cancer Research Fund (ICRF) Women of Action Luncheon held in Toronto, Canada on April 19, 2007. During her talk, Elana provided an account of her illness and discussed her decision to be the first person in Canada to try an unconventional chemotherapy protocol. “I’m young,” Elana says, “my daughter is young, and the numbers are stacked against me. You do whatever you have to do to get the most time possible.” “Cancer,” Elana says, “has given me a clearer understanding of what life is about.”

As you will see from the excerpt of her April 2007 speech and the video below, “Elana’s courageous battle with ovarian cancer will touch your heart. Elana’s appreciation for everyday miracles will open your eyes. Elana’s determination to help others will inspire you …”

“…I was diagnosed 20 months ago on August 19, 2005. Time is running.

On September 23, 2005, after extensive surgery, I was told the cancer was stage 3c despite my doctor’s earlier belief that it was not that advanced. The diagnosis meant that I needed chemotherapy and only had a 30% chance of surviving 5 years from that point. At 32 years old, while trying to build my family and with a 2 year old daughter, this news was devastating.

When I was told the statistics though, I guess I couldn’t wrap my head around them because I never thought I would die. No one I knew had ever died from cancer. My own mother had fought and beat the disease twice. I knew I had a tough road ahead of me but I always focused on the light at the end of the tunnel and just did what I had to do to get better. It was hard but many others had done it before me and I knew I could and had to do it for my family…..

My cancer has returned. When I was told this time, the news hit me like a Mack truck. The numbers for a recurrence are even worse than for an original diagnosis and my chances for survival are small. I understood the numbers this time and the implications for me and my family. The diagnosis shook me to my core and I had a huge reality check. I have cancer, a potentially fatal disease. This is not something that regular medication can treat and I am now literally fighting for my life, everyday. I have given up my career to focus on my health and my family. I want to enjoy as much time as I can while I feel strong and healthy. I want to be a spokesperson for ovarian cancer for a long time but more importantly I want to see my daughter grow up and I want to grow old with my husband.

These simple goals in life that I now set for myself are in jeopardy so I have truly learned to enjoy all the everyday miracles that I do have – my daughter’s smile, my husband’s kiss, my mother’s laugh. I am more than this disease and I do not want to let it take away everything else that makes me the person that I am. I am asking you to help me continue to enjoy these miracles. Your donations and your generosity allow our scientists to do cutting edge research which will hopefully lead to a cure for cancer. Your support for ICRF directly benefits people who are battling cancer and on all their behalves, I say thank you.”

[Quoted Sources: Israel Cancer Research Fund Newsletter – Issue #5, Summer 2007; “Like Getting Hit By a Mack Truck: One Woman’s Fight With Cancer,” Chaim Steinmetz – Happiness Warrior Blog, April 25, 2007.

Jewish Women Change Their Destinies by Testing for Genetic Mutation

“One in 40 Ashkenazi Jews – compared to one in 500 in the general population – carries a mutation that gives women a 50 percent to 85 percent chance of getting breast cancer by the time they are 80. The genetic mutation, discovered in 1994, also increases the likelihood of melanoma and ovarian, prostate or pancreatic cancer. While within the general population about 5 percent of cancers can be attributed to a hereditary syndrome, in the Jewish community, that number is closer to 30 percent. ”

“Erika Taylor didn’t want to know whether she had the breast cancer gene.

‘My thinking was I would never get a prophylactic mastectomy,’ Taylor, 44, said of the idea of removing her breasts as a preventive measure. ‘I just thought it was horrible thing to do to myself, and if I was unwilling to do that, why bother finding out?’

Her grandmother died of breast cancer at 56, and her mother battled and beat the disease in her 30s. Taylor, who is single and the mother of a 14-year-old boy, always suspected cancer was in her future, but taking steps to confirm that was not something she wanted to do. Until she got her own diagnosis.

A routine mammogram last November revealed early stage noninvasive cancer cells in Taylor’s milk ducts, making information about her genetic status vital for determining her treatment.

All of a sudden, the idea of ‘I would never do such a thing’ goes out the window,’ she said. ‘It’s astonishing how quickly you go, ‘OK, OK, what do I need to do? I’ll do it.” Taylor’s mother tested first, and when she was identified as a carrier of the BRCA 2 genetic mutation common in Ashkenazi Jews, Taylor tested next. In January, she found out she, too, carries the gene that makes it likely that even if she were to rid herself of her diagnosed cancer, it would probably recur.

Like a growing number of women, Taylor faced both the gift and the terror of knowledge.

One in 40 Ashkenazi Jews – compared to one in 500 in the general population – carries a mutation that gives women a 50 percent to 85 percent chance of getting breast cancer by the time they are 80. The genetic mutation, discovered in 1994, also increases the likelihood of melanoma and ovarian, prostate or pancreatic cancer. While within the general population about 5 percent of cancers can be attributed to a hereditary syndrome, in the Jewish community, that number is closer to 30 percent.

The good news is that knowledge about how the mutation causes cancer is opening scientific doors to more effective, targeted treatment for those already diagnosed. And people who have the genetic mutation can take preventative measures to drastically reduce their breast and ovarian cancer risk.

Surgery – removal of the breasts and ovaries – reduces the risk of breast cancer by 90 percent, to well below the 13 percent odds of getting breast cancer in the general population. But less-drastic measures, such as drug therapy, removal of just the ovaries and careful screening to catch and cure the cancer at an early stage, can also save lives. Genetic information also helps women feel empowered to take control of other factors that raise risk, such as smoking, alcohol consumption and obesity.

‘The use of genetic information to understand a person’s risk for diseases like cancer is clearly reaping huge benefits,’ said Dr. William Audeh, a medical oncologist with an emphasis on hereditary risk at Cedars-Sinai Medical Center‘s Samuel Oschin Comprehensive Cancer Institute. ‘It’s gone from being a somewhat frightening piece of information that gave people concerns to a hugely important piece of information that empowers people to either take preventative steps that can save their lives or to accurately target therapy if one develops cancer. There is a general understanding that genetic information for cancer is going to be critical for taking the best care of people.’

Knowing she had the genetic mutation sent Taylor, editor of the trade publication, Pool and Spa magazine, into a tailspin of research and soul-searching. Treatment for DCIS (ductal carcinoma in situ) usually consists of removal of the tumor and perhaps radiation. But Taylor’s genetic status put her in a different risk category, and after hearing from four different doctors that her cancer, even if cured, would return, she opted for a double mastectomy and reconstruction. Her surgery is scheduled for May.

Taking the test

While Taylor confirmed her genetic status after a cancer diagnosis, experts encourage people to test before cancer strikes. For Ashkenazi Jews, having just one relative who has had premenopausal breast cancer warrants getting tested, according to geneticists. (For non-Jews, testing is indicated if there are two relatives.) Any history of male breast cancer or any ovarian cancer in the family also raises a red flag, as do multiple cases of melanoma or pancreatic cancer. And women who themselves have early onset breast cancer should be tested, so they can tailor their treatment and inform other family members.

In the last five years, the number of people testing for the BRCA mutation has increased by 50 percent every year, according to Myriad Genetics, which patented the blood test for BRCA about 12 years ago. About 70,000 people tested last year. Myriad recently launched an East Coast direct-marketing campaign for the test.

Of the estimated 600,000 people who carry the gene in the United States, only about 20,000 have been identified. Of those 600,000 carriers, about 150,000 are Jewish, mostly Ashkenazi. Other ethnic groups, such as French Canadians and Filipinas, also have a genetic predisposition, as do some Latina subpopulations – some of which have been traced back to having Jewish genes.

Only about 15 percent of people who test come out with positive results, though the percentage is somewhat higher among Jews. But even a negative result is not entirely reassuring, since it indicates only that the specific mutations were not found. Other as-yet-undiscovered mutations, or other genes, could also cause a heavy incidence of cancer in a family, according to Dr. Ora Gordon, director of the GenRISK adult genetics program at Cedars.

Gordon encourages anyone being tested to see a genetic counselor to get the results properly interpreted and to understand their options if they find out they are carriers.

‘When learning about this for the first time, very frequently people say to themselves, If I’m not going to have surgery, I shouldn’t get this test.” Gordon said. ‘But that would be a tremendous loss in terms of potential reassurance for people who are not carriers and for identifying people who might have a whole variety of other options that might provide very substantial risk reduction.’

Prophylactic bilateral mastectomy – or having both breasts removed before any sign of cancer – seems to be growing in popularity as an option in the United States, though hard statistics are just now being compiled.

One recent study of women with the BRCA mutation and a cancer diagnosis put the rate of mastectomy at 50 percent in the United States, the highest by far of anywhere in the world. In Israel, that number is 2 percent, Gordon said.

In Los Angeles in particular, the numbers seem to be especially high.

Gordon estimates that 65 percent to 70 percent of BRCA-positive women in Cedars’ cancer programs opt for the surgery, some immediately, some after a few years of surveillance. ‘The quantity and quality of medical options makes the surgery more attractive in big cities, and Los Angeles has a high tolerance for breast surgery,’ Gordon said. She is spearheading a study about decision-making among BRCA-positive women at Cedars’ Gilda Radner early detection program, which screens genetically high-risk women for ovarian cancer.

Gordon understands that a woman’s decision about treatment is intertwined with her relationship status, her self-image and how many family members she saw battle or succumb to cancer.

Surgery or surveillance?

‘The decision to take off your breasts is really hard. It’s a part of your body that is associated with your outward appearance, and it’s a part of who you are. It’s a part of your sex life,’ said Joi Morris, who was 41 when she learned she carried the same genetic mutation that gave her mother and grandmother breast cancer at a young age.

Morris remembers a day, not long after she found out, when she really confronted the issue as her sons, then 7 and 10, played at the beach.

‘My kids were in the water and jumping and playing and having a fabulous time, and I looked down at my breasts in my swimming suit and thought, “Oh my God, what would it be like to not have these?'” ‘It’s a seesaw of emotions,’ she said, because at the same time, ‘you wake up every morning, and you know you are at risk, and you wonder if there is something in there you can’t find.’

Morris initially opted for close surveillance – a regimen of regular mammograms, manual exams, ultrasounds and breast MRIs – the most sensitive, noninvasive screening available, used only for high-risk patients. Her first MRI revealed a lump close to her chest wall.

‘I panicked. There is no other way to put it. That lump turned out to be benign, but the whole process was so stressful for me and hard on my family. I just decided if this lump is not cancer, the next one could be,’ Morris said.

She had a prophylactic bilateral mastectomy, with immediate reconstruction. As it turned out, her surgery wasn’t prophylactic at all – pathology revealed pre-cancerous cells scattered throughout both breasts.

Early in the process, Morris turned for support and information to FORCE: Facing Our Risk for Cancer Empowered, an organization that advocates for people at high genetic risk for breast and ovarian cancer.

Today, she is an outreach coordinator for FORCE, helping link women through face-to-face groups and one-on-one pairings as they face life-altering decisions.

‘It was very hard getting those results,’ said Lisa Stein, a 43-year-old mother of two, who found out she has the gene last year. ‘I was trying to prepare for being positive, but I don’t think you ever can. After I got the results, I really struggled. I was feeling raw for a while, crying easily knowing that it was going to be life-changing.’

Stein’s mother died of breast cancer at 57, and her grandmother died of ovarian cancer, but she didn’t test until her older sister, Lauren Rothman, tested positive.

Rothman opted for a mastectomy, but Stein chose to keep her breasts.

‘I think I knew instinctively that I was not going to have a double mastectomy. That felt too radical to me,’ Stein said. ‘I didn’t feel psychologically prepared or that it was necessary. I don’t feel like cancer is imminent; I feel like I have a few years to take it in and think about it and prepare, so I’ve put that decision on hold.’

She goes in for screening every few months, and she said the anxiety of waiting for those results has been manageable.

Both Rothman and Stein had their ovaries removed, however, which doctors are now recommending for women who test positive and who are finished having children or who are over age 35. Removing ovaries not only reduces the risk of ovarian cancer – which is notoriously hard to catch early and thus has a high mortality rate – but it reduces the risk of breast cancer by 50 percent. Stein also went on Tamoxifen, a drug taken by breast cancer survivors to reduce the risk of recurrence and which reduces risk by 50 percent in BRCA-positive women. The birth control pill, which stops the ovaries from cycling, can also reduce the risk of ovarian cancer but requires more vigilant screening for breast cancer.

Both ovary removal and Tamoxifen push women into menopause, with all its emotional, sexual and physiological ramifications.

‘I think of myself as a healthy person but not like I used to – it’s kind of tainted,’ Stein said. ‘It’s an identity issue. I still think of myself as youthful, but suddenly, I’m dealing with instant menopause, and that doesn’t sit well with me. But I’m dealing with it.’

Stein and Rothman provide support for each other, despite the different routes they’ve taken.

‘I came to reality very quickly – and the reality was I wanted to see my children grow up, and I didn’t want cancer, and I didn’t want chemotherapy. I wanted the rest of my life,’ Rothman said. Her daughters were 3 and 5 years old when she had surgery.

Rothman, a program director for Hadassah of Southern California, traveled to New Orleans for her breast procedure – two surgeries and tatoooing – at a small clinic that specializes in natural-tissue reconstruction, where a solid flap of fat is removed from the belly and inserted into the shell of the breast after tissue has been removed. The surgery offers a more natural result than silicone implants, though it is longer and more involved.

‘This procedure has provided me with a new outlook on life. It has taken a huge weight off my shoulder,’ Rothman said. ‘I no longer go into mammograms thinking, “Is this the year I’m going to get cancer like mom?'”

And she loves her new body – she got not only a breast lift but a bonus tummy tuck, too.

Advances in reconstructive techniques mean that women have several options for maintaining a body they can feel proud of.

Decades ago, radical mastectomies removed all the tissue and muscle of the chest wall. Today, the muscle is not removed, and reconstructive surgery, usually at the time of mastectomy, can leave intact the women’s natural skin, but in most cases the nipples and areola are removed. A silicone implant, or, as in Rothman’s case, fat from the abdomen, fills the pocket from which breast tissue was removed. Nipples and areola are tattooed on, or some surgeons use a new technique that leaves a woman’s own nipple and areola intact. Doctors try to bury scars in the fold beneath the breast, though that is not always possible.

But even the most beautifully done reconstructions leave a woman with scars and no sensation in her breasts.

‘When women come to see me, my approach is to listen to them and find out where they are in life and how they relate to their own breasts,’ said Dr. Kristi Funk, a breast surgeon and director of patient education at Cedars’ Brandman Breast Center. ‘Women have different feelings about sexuality and what roles breasts play, and that makes a big difference.’

Funk also finds out about the woman’s relationship status, and how she has been affected by a family history of cancer.

More information, better treatment

Family histories can be deceptive, however. Some families don’t know their medical histories, because they were lost due to the Holocaust or immigration.

The gene also can hide out in male members of a family.

A BRCA 1 gene mutation raises the risk of male breast cancer to 6 percent, and there is no increased risk for other cancers. BRCA 2 mutation also increases the risk for melanoma, prostate and pancreatic cancer. Still, men who carry the gene are likely never to get any cancer, although they have a 50 percent chance of passing the gene to children. Families with few females may never discern any cancer history.

Dora Cohen (not her real name) suspects it was her father who passed the BRCA 1 gene mutation to her. Last year, she was diagnosed with DCIS, a noninvasive cancer, which was treated with a lumpectomy and radiation. Of the many oncologists she saw, only one recommended that as an Ashkenazi woman in her 40s, she probably should have genetic testing.

In the last six months, Dora has had her ovaries, uterus and breasts removed.

Her daughter, Diane (not her real name), who is 27 and has been married for two years, doesn’t want to get tested yet.

‘I see what my mom is going through,’ Diane said. ‘I want to have kids, and I’m not in a place where I would take those measures [mastectomy and removal of the ovaries]. Knowing I’m positive and having that pressure on me would be something very difficult to live with.’

She and her husband of two years have pushed up their plans for children, and she worries that a positive test could jeopardize her medical insurance, especially because she is self-employed.

Federal and California law provide fairly good protection against genetic discrimination from insurers, stipulating that a genetic predisposition cannot be considered a pre-existing condition. But individual policies are not as well protected as group policies.

Still, genetics experts say much of the fear is overblown. They point out that there has been little litigation involving genetic discrimination, and that the insurance industry is open to the reality that genetic testing can lead to better and more cost-effective treatment. Most insurers cover genetic testing, and some genetic counseling – a rapidly growing field.

‘The genetics community has been struggling to help people understand the importance of talking to someone who knows the nuances of genetic testing,’ said Heather Shappell, a genetic counselor and founder of Informed Medical Decisions, which offers over-the-phone genetic counseling.

‘Genetic tests do not always yield a yes-or-no answer,’ Shappell said, ‘and often doctors aren’t sure how to read the results and guide patients through their decisions.’

In August, Aetna extended full coverage for Shappell’s phone-counseling services to its 14 million policyholders.

What geneticists are looking for is an error in the sequencing of the BRCA gene.

All people carry two genes, BRCA 1 and BRCA 2, which prevent cancer by repairing damaged cells. A mutation damages the genes’ repair function, which leads to uncontrolled growth and causes cells to become cancerous.

About 95 percent of Ashkenazi Jews who have the mutation have one of three errors, which means the mutation is easier to find and the test costs much less – about $400, as compared to $3,000 for a test that analyzes the entire gene.

As researchers learn more about how BRCA mutations cause cancer, they are developing targeted treatments.

A clinical trial with sites at Cedars and City of Hope uses a drug called a PARP-inhibitor to shut down the cell’s backup repair function. Normal cells are not affected, because the primary repair pathway is still functioning. But cancerous cells are left with no functioning repair system, so those cells die. Because normal cells are not affected, there are few major side effects.

‘We have a promising situation where you have a treatment which is completely targeted to cancer and leaves the normal cells alone. And that is very different from treatments like chemotherapy, where there is toxicity to every cell,’ said Audeh of Cedars.

Another study in Israel has found that women with ovarian cancer who are BRCA positive respond better to chemotherapy and have a higher survival rate than women who are not carriers, according to Jeff Weitzel at City of Hope. Weitzel, an investigator in the PARP-inhibitor trial, is also working on a study that manipulates hormones to reduce breast density, which makes surveillance through mammography and ultrasound more effective.

In February, the Jerusalem Post reported that doctors for an Orthodox woman undergoing in-vitro fertilization at Hadassah Hospital were able to identify and screen out embryos that had inherited her BRCA mutation. [Jerusalem Post Feb. 2008 article abstract]

A gift of life?

But while such progressive procedures have been generally well received in Israel, there is still social reluctance to test for the gene, especially in traditional circles, where families fear a genetic flaw could hurt the marriageability of their kids.

Debra Nussbaum Stepen, a Los Angeles therapist who now lives in Israel, is trying to break those perceptions. She works as a therapist at a clinic for hereditary breast and ovarian cancer, and she volunteers for Bracha, a Hebrew-language Web site for BRCA carriers.

The name of the site – bracha means blessing and is a play on BRCA – connotes that knowing one’s genetic makeup is a blessing that can save one’s life.

It is a lesson Stepen learned personally.

Her father had several kinds of cancer, including breast cancer, and before he died at 77, Debra urged him to get genetic testing. She was 51 and had never had cancer when she found out she carried the gene.

‘My doctor told me my breasts were ticking time bombs, and I couldn’t go to bed at night knowing that and thinking today am I going to get cancer?’ said Stepen, who has three stepchildren and a new stepgranddaughter.

She observed her father’s first yahrzeit in New Orleans, where she was undergoing the third and last part of a double mastectomy and reconstruction.

‘I said to my husband, in my father’s death he gave me the gift of life,’ Stepen said.

It takes time to reach this comfort level. As Erika Taylor prepares for her surgery in a few weeks, she worries about the ‘gift’ she may give to her son. She and her mom have talked about how irrational that guilt is.

‘I can say to my mom, “You didn’t know. It’s OK. It’s not your fault,’” she said. ‘But when it comes to me and my son, I think how could I have done this to my son. I am in abject horror that I might have passed this on to him. I know it’s irrational, but the whole idea fills me with grief.’

At the same time, she has hope.

‘My grandmother died from breast cancer at 56. My mother almost died of this disease. And I’m not going to even come close to dying,’ Taylor said. ‘My hope for my son, if he has this, is that he may not have to have any medical intervention at all. Maybe they can repair this mutation. The idea that there is trajectory moving in the right direction gives me some comfort and hope.’”

[Quoted Source: “Jewish women change their destinies by testing for genetic mutation,” by Julie Gruenbaum Fax (Jewish Journal of Greater Los Angeles), Texas Jewish Post, April 24, 2008 (emphasis added)]

Comment: For additional information relating to hereditary breast and ovarian cancer with respect to all women (Jewish and Non-Jewish), refer to the following: (i) FORCE: Facing Our Risk of Cancer Empowered; (ii) National Breast and Ovarian Cancer Coalition; (iii) “Clinical Considerations,” Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility Recommendation Statement, U.S. Preventive Services Task Force (USPSTF), Agency for Healthcare Research & Quality (AHRQ), U.S. Department of Health & Human Services, September 2005; (iv) “Genetics” hyperlinked materials, H*O*P*E* Blog homepage.

Macmillan Cancer Support Launches On-Line Personalized Assessment For Risk of Inherited Breast or Ovarian Cancer

With so many women concerned about the possibility of inherited breast or ovarian cancer, Macmillan Cancer Support launched “OPERA” (On-line Personal Education and Risk Assessment) – the first United Kingdom on-line interactive software program which gives personalized information regarding a woman’s risk with respect to hereditary breast and ovarian cancer. Macmillan Cancer Support is based in London, England and merged with Cancerbackup in April 2008.

Dr Andrea Pithers, Genetic Information Project Manager at Macmillan Cancer Support, says: “By simply typing in some details of your family medical history, OPERA can provide personalised information and advice on whether there might be an inherited genetic link and where to go for further information and support.”

Upon the OPERA launch, Mike Richards, the United Kingdom Government’s National Cancer Director said: “This is an important resource for all those who have concerns over breast and ovarian cancer in their family. For many it will provide reassurance that the risk is not as high as they feared. For others it will provide the information which prompts them to see their GP [General Practitioner] and get tested for the BRCA gene or to be referred appropriately for further genetic assessment.”

Jan Buckle discovered that she inherited a BRCA gene mutation after her sister died of breast cancer and her mother was diagnosed with the same disease. She had her ovaries removed and a double mastectomy with reconstructive surgery as a preventative measure against developing cancer herself. When asked to comment about OPERA, Jan said: “OPERA will be very useful for families like mine, and those who are worried that inherited breast and ovarian cancer runs in their family. It was really important for me to know the risks and to find out if I had the gene so I could make informed decisions on how to prevent breast and ovarian cancer occurring. Knowing your risk from inherited breast or ovarian cancer and getting good advice on what to do is much better than burying your head in the sand and just hoping that you don’t get breast cancer. I urge anyone who has any concerns to go on-line and try OPERA out for themselves.”

For additional resources regarding hereditary breast and ovarian cancer, click on the “Genetics” caption tab located at the top of the H*O*P*E* homepage.

OPERA Genetic Breast/Ovarian Cancer Risk Assessment Tool

[Source: “Macmillan Cancer Support launch on-line personalised assessment for risk of inherited breast or ovarian cancer,” Macmillian Cancer Support Press Release dated April 23, 2008.]

Avastin/Tarceva Combination May Be No More Effective Than Avastin Monotherapy

The purpose of this single arm, multicenter Phase II clinical trial was to assess the activity and tolerability of the combination of bevacizumab (Avastin®) and erlotinib (Tarceva®) in patients with recurrent ovarian, primary peritoneal or fallopian tube cancer. Eligible patients received two or fewer prior chemotherapy regimens for recurrent or refractory disease and no prior anti-VEGF or anti-EGFR drugs. Between July and October 2005, 13 patients were enrolled.

There were two major objective responses — one complete response of 16+ month duration and one partial response of 11 month duration, representing an overall response rate of 15%. Two patients had fatal gastrointestinal perforations, and therefore, the study was discontinued. The trial investigators concluded that there was no strong suggestion that the Avastin®/Tarceva® combination was superior to single agent Avastin®, and noted that the rate of gastrointestinal perforation was of concern. The investigators believe that identification of risk factors for gastrointestinal perforation will be important with respect to the use of Avastin in the treatment of ovarian cancer.

[Source: “Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: A trial of the Chicago, PMH, and California Phase II consortia;” Nimeiri HS, et. al., Gynecol Oncol. 2008 Apr 17 (Epublication ahead of print).]

Epirubicin Improves Overall Survival Better Than Ifosfamide When Combined with Paclitaxel and Cisplatin

Epirubicin (Ellence®) produced longer median overall survival (OS) than ifosfamide (Ifex®) in a recent phase II randomized clinical trial comparing (i) cisplatin, paclitaxel and ifosfamide, with (ii) cisplatin, paclitaxel and epirubicin, in newly diagnosed advanced epithelial ovarian cancer patients. In this trial, patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with cisplatin/paclitaxel/epirubicin (CEP arm) or cisplatin/paclitaxel/ifosfamide (CIP arm) for six cycles every 21 days. Two hundred and eight patients were randomised between the two treatment arms. The Phase II clinical trial finds were as follows:

  • After a median follow-up of 82 months, median overall survival (OS) was 51 months in the CIP arm, and 65 months in the CEP arm; and
  • 5-year survival rates were 43% in the CIP arm, and 50% in the CEP arm.

The trial investigators note that the OS findings seem longer in duration than is commonly reported, especially considering that more than 50% of the newly diagnosed advanced ovarian cancer patients were suboptimally debulked or cytoreduced after their first surgery. The trial investigators concluded that this unexpected finding might be a consequence of the close surgical surveillance and aggressive chemotherapeutic approach.

[Source: “A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis;” Fruscio R. et. al.; Br J Cancer. 2008 Feb 26;98(4):720-7.]

Comment: Although small in size, this Phase II randomized clinical trial suggests that aggressive surgical intervention followed by aggressive polychemotherapy (involving epirubicin or ifosfamide in tandem with paclitaxel and cisplatin) may increase overall survival in newly diagnosed, advanced-stage ovarian cancer survivors. The findings of at least one major clinical study cite that optimal cytoreduction, as a stand-alone independent factor, provides up to a 50% increase in actuarial survival. In the U.S., an “optimal” cytoreduction is generally defined as a surgical procedure that results in 1 centimeter or less of macroscopic cancer present within the body after surgery. The surprising results of the study discussed above seem to indicate that a suboptimal cytoreduction or debulking surgery followed by aggressive polychemotherapy may be beneficial in extending overall survival in newly diagnosed, advanced-stage ovarian cancer survivors. The issue of what measure should be used to define an “optimal” cytoreduction or debulking is not without controversy with the ovarian cancer arena.

Avastin Used in Combination with Taxol and Paraplatin Will Become the Clinical Gold Standard Treatment by 2011

“Avastin Used in Combination with Taxol and Paraplatin Will Become the Clinical Gold Standard Treatment by 2011, According to a New Report from Decision Resources

WALTHAM, Mass., April 23 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that surveyed oncologists say that a therapy’s effect on overall survival is the attribute that most influences their prescribing decisions in advanced ovarian cancer. Clinical data and expert opinion show that Roche/Genentech/Chugai‘s Avastin (bevacizumab) plus the regimen of paclitaxel (Bristol-Myers Squibb’s Taxol, generics) and carboplatin (Bristol- Myers Squibb’s Paraplatin, generics) has advantages in this attribute over the combination of paclitaxel/carboplatin, the current sales leader in ovarian cancer treatment.

The new report entitled Ovarian Cancer (Advanced): Therapies Must Increase Survival over Paclitaxel/Carboplatin to Successfully Enter this Generic Market finds that, according to surveyed oncologists, a drug that offers improved median overall survival compared with paclitaxel/carboplatin would earn a 50 percent patient share in the ovarian cancer market. Surveyed oncologists indicated that they would prescribe Avastin plus paclitaxel/carboplatin to 29 percent of their patients with advanced ovarian cancer. As a result, Avastin plus paclitaxel/carboplatin will earn a 22 percent patient share in the U.S. advanced ovarian cancer market in 2016.

The report also finds that Avastin plus paclitaxel/carboplatin will earn the clinical gold-standard status for treatment of advanced ovarian cancer in 2011, following its approval for the indication in 2010. Surveyed oncologists indicated that Avastin plus paclitaxel/carboplatin has competitive advantages in efficacy over paclitaxel/carboplatin, the current gold standard.

‘Avastin plus paclitaxel/carboplatin has the same delivery attributes and only marginally different safety attributes when compared with paclitaxel/carboplatin,’ said Jenna Avent, analyst at Decision Resources. ‘However, the regimen of Avastin plus paclitaxel/carboplatin has better efficacy when compared to the current gold standard, paclitaxel/carboplatin, and oncologists rate efficacy as the most important parameter in the treatment of advanced ovarian cancer.’”

[Quoted Source:  “Avastin Used in Combination with Drugs from Bristol-Myers Squibb Has Advantages in Survival Rates Over the Current Sales-Leading Therapy for Advanced Ovarian Cancer,” News, EarthTimes.org, April 23, 2008][Emphasis added].

Ovarian Cancer Developments Presented at the 2008 Annual AACR Meeting

I have set forth below a list of several significant ovarian cancer developments that were presented at the 2008 Annual Meeting of the American Association For Cancer Research (AACR) held on April 12 – 16, 2008 in San Diego, California.

“I’m Strongs to the Finish, ‘Cause I Eats Me Spinach”* — Popeye May Have It Right When It Comes to Ovarian Cancer Prevention

Brigham and Women’s Study Finds Eating a Flavonoid-Rich Diet Helps Women Decrease Risk of Ovarian Cancer –Findings from the Nurses’ Health Study

Boston, MA – New research out of the Channing Laboratory at Brigham and Women’s Hospital (BWH) reports that frequent consumption of foods containing the flavonoid kaempferol, including non-herbal tea and broccoli, was associated with a reduced risk of ovarian cancer. The researchers also found a decreased risk in women who consumed large amounts of the flavonoid luteolin, which is found in foods such as carrots, peppers and cabbage. These findings appear in the November 15, 2007 issue of the International Journal of Cancer.

‘This is good news because there are few lifestyle factors known to reduce a woman’s risk of ovarian cancer,’ said first author Margaret Gates, ScD, who is a research fellow at BWH. “Although additional research is needed, these findings suggest that consuming a diet rich in flavonoids may be protective.”

The causes of ovarian cancer are not well understood. What is known is the earlier the disease is found and treated, the better the chance for recovery; however, the majority of cases are diagnosed at an advanced (metastasized) stage after the cancer has spread beyond the ovaries. According to the National Cancer Institute, the 5-year relative survival rate for women diagnosed with localized ovarian cancer is 92.4 percent. Unfortunately, this number drops to 29.8 percent if the cancer has already metastasized.

In this first prospective study to look at the association between these flavonoids and ovarian cancer risk, Gates and colleagues calculated intake of the flavonoids myricetin, kaempferol, quercetin, luteolin and apigenin among 66,940 women enrolled in the Nurses’ Health Study. In this population, 347 cases of epithelial ovarian cancer were diagnosed between 1984 and 2002.

Although total intake of these five common dietary flavonoids was not clearly beneficial, the researchers found a 40 percent reduction in ovarian cancer risk among the women with the highest kaempferol intake, compared to women with the lowest intake. They also found a 34 percent reduction in the risk of ovarian cancer among women with the highest intake of luteolin, compared to women with the lowest intake.

‘In this population of women, consumption of non-herbal tea and broccoli provided the best defense against ovarian cancer,’ concluded Gates, who is also a research fellow at the Harvard School of Public Health. ‘Other flavonoid-rich foods, such as onions, beans and kale, may also decrease ovarian cancer risk, but the number of women who frequently consumed these foods was not large enough to clearly evaluate these associations. More research is needed.’

The National Cancer Institute funded this research.”

[Quoted Source: “Brigham and Women’s Study Finds Eating a Flavonoid-Rich Diet Helps Women Decrease Risk of Ovarian Cancer — Findings from the Nurses’ Health Study,” Brigham and Women’s Hospital Press Release, dated November 13, 2007 (citing findings from “A prospective study of dietary flavonoid intake and incidence of epithelial ovarian cancer;” Gates, M.A. et. al.; International Journal of Cancer, Volume 121, Issue 10, Pages 2225 – 2232 (November 15, 2007))].

Comment: In addition to spinach, foods richest in kaempferol include tea (nonherbal), onions, curly kale, leeks, broccoli, and blueberries.

* In 1933, Max and Dave Fleischer’s Fleischer Studios adapted Thimble Theatre characters into a series of Popeye the Sailor theatrical cartoon shorts for Paramount Pictures. These cartoons proved to be among the most popular of the 1930s, and the Fleischers-and later Paramount’s own Famous Studios-continued production through 1957. Since then, Popeye has appeared in comic books, television cartoons, a 1980 live-action film (Popeye, directed by Robert Altman), arcade and video games, and hundreds of advertisements and peripheral products.

Early references to spinach in the Fleischer cartoons and subsequently in further stories of Popeye are attributed to the publication of a study which, because of a misprint, attributed to spinach ten times its actual iron content. The error was discovered in the 1930s but not widely publicized until T.J. Hamblin wrote about it in the British Medical Journal in 1981. Until that time, the popularity of Popeye helped boost sales of the leafy vegetable 33% in the U.S.

Avax Technologies Announces Initiation of Clinical Study With Autologous Ovarian Cancer Vaccine

AVAX Technologies, Inc. (OTC Market:AVXT.OB) today announces it has received FDA approval to begin enrollment into a Phase I-II clinical trial of OVax® for patients with advanced, chemotherapy-refractive ovarian cancer. [For a copy of the clinical trial inclusion/exclusion criteria refer to “OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse.”]. The study will be performed in collaboration with Cancer Treatment Centers of America, Inc (CTCA). It will be centered in the CTCA hospital in Zion, Illinois, although patients also will be referred from other CTCA hospitals in Tulsa and Philadelphia, and its out-patient clinic in Seattle.

Up to 42 eligible patients with stage III or IV ovarian carcinoma will be enrolled. These patients’ cancers will have progressed despite initial surgery and chemotherapy and failed to respond to one or two salvage chemotherapy regimens. They will undergo debulking surgery, and tumor tissue will be sent to AVAX for production of vaccine. Post-operatively, they will receive intraperitoneal chemotherapy with a taxane and then will be enrolled into the protocol.

Three doses of OVax will be tested, and each of the three doses will be analyzed for immunological efficacy with the goal of optimizing the dose for treatment of patients in future trials.

‘We are enthusiastic about receiving FDA clearance to start this important clinical trial and with the opportunity it affords us to collaborate with CTCA,’ stated Dr. David Berd, Chief Medical Officer of AVAX. ‘Clearly, better treatments for ovarian cancer are needed and we hope that OVax will eventually find its place as a relatively non-toxic therapeutic alternative for these patients. This alliance with CTCA will allow us to expand the therapeutic utility of the AC Vaccine platform along with our ongoing Phase I/II program in non-small cell lung cancer and our recently launched Phase III pivotal registration study in melanoma (MVALDI).’

As part of the business collaboration CTCA has made an up-front payment of $250,000 and will begin to make monthly payments of $25,000 upon the initiation of production of vaccines at AVAX’s Philadelphia manufacturing facility.

‘We are very excited to be part of a new chapter in the fight against ovarian cancer,’ said Dr. Edgar Staren, Chief Medical Officer at Cancer Treatment Centers of America. ‘Ovarian cancer is a very complex cancer that is often resistant to chemotherapy, radiation and surgery. At Cancer Treatment Centers of America, our commitment to cancer patients is to help fight their cancer with the most advanced medical technology available. This partnership with AVAX gives hope to ovarian cancer patients who are told far too often that there is nothing more that can be done for them. This treatment option will work well with our unique integrative care model that combines state-of-the-art traditional medicine with scientifically-based complementary therapies such as aggressive nutritional management and support, naturopathic medicine, physical therapy, mind-body medicine and spiritual support to go beyond treating the tumor and supporting the needs of the whole person – all under one roof.’

About the AC Vaccine Therapeutic

The AC Vaccine is an immunotherapy prepared by attaching a small chemical to the patient’s tumor cells in a process known as haptenization. This hapten modification allows the tumor cells to stimulate a T cell-based immune response to a patients own tumor cells. An early indicator of T cell immune activity is Delayed Type Hypersensitivity (DTH).

An understanding of what AVAX calls the immunopharmacology of the AC Vaccines is critical to their effective use. AVAX believes that the optimal dose, schedule of administration, and route of administration of human cancer vaccines must be established before they enter advanced phase studies, and that some competing vaccine technologies have failed because their developers ignored one or more of these parameters in early phase development. The optimum schedule and best route of administration (intradermal) to be used for OVax were determined by extensive phase I-II studies of MVax. The latest phase I-II trial was completed last year and the results will be presented at the 2008 [Annual] meeting of the American Society of Clinical Oncology (ASCO).”

[Quoted Source: “AVAX Technologies Announces Initiation of Clinical Study with Autologous Ovarian Cancer Vaccine (OVax®),” BusinessWire news release dated April 9, 2008.]

Comment: The OVax®vaccine clinical trial carries great promise. The trial will combine three potent approaches to battling ovarian cancer: (i) debulking surgery, (ii) intraperitoneal chemotherapy with a taxane drug, and (iii) a custom made vaccine created from the ovarian cancer survivor’s own tumor. Please watch the video below regarding the OVax® vaccine for ovarian cancer.

We Have Met the Enemy and He is Us* — But Not If Aethlon Medical Has Its Way!

Why can’t the human body immune system prevent all cancers? Because the immune system generally does not identify ordinary human cells — an essential building block of the human body — as a threat to the body, notwithstanding that such cells may possess an uncontrolled level of proliferation. To the extent that the immune system recognizes that certain cancer cells are “suspicious,” solid cancer tumors (including ovarian) further inhibit the attack capability of the immune system by secreting so-called “exosomes.”

Normally, immune system cells known as “T-cells” are entrusted with killing foreign invaders that may be harmful to the body. Exosomes secreted by ovarian cancer cells prevent the “expression” or activation of two biological markers (i.e., Jak-3 kinase & CD3-zeta) which must be present as a prerequisite for T-cell activation. Generally, the biological markers Jak-3 kinase and CD3-zeta are highly expressed in activated T-cell lines. When T-cells are subjected to ovarian cancer ascites fluid, the critical Jak-3 kinase and CD3-zeta biological markers are consistently absent. In sum, the exosomes secreted by ovarian cancer cells produce immunosuppressive activity within the human body and allow the cancer cells to avoid destruction by causing T-cell inactivation. The immunosuppressive activity associated with ovarian cancer is known to correlate with disease progression and reduced long-term survival.

Aethlon Medical, Inc., a pioneer in developing medical devices to treat infectious disease, developed a device known as the “Hemopurifier®” which is capable of removing immunosuppressive exosomes from ovarian cancer cell fluid, thereby allowing proper activation of immune system T-cells that are capable of killing cancer cells. In follow-on studies, Dr. Douglas Taylor at the University of Louisville demonstrated that the capture of exosomes by the Hemopurifier(R) resulted in reversing immunosuppressive activity (i.e., eliminate exosomes). Throughout the course of the studies, the Aethlon Hemopurifier® completely removed the immunosuppressive activity normally found in the ascites fluid of ovarian cancer patients.

Prior to conducting the follow-on studies mentioned above, Dr. Taylor documented that 60% of circulating exosomes were removed from the blood of ovarian cancer patients during the first pass (approximately 10-minutes) through a small scale Hemopurifier®. The capture data was consistent over the course of five different studies. Exosomes are released by solid tumors, lymphomas, and leukemia. Because exosomes induce T-cell apoptosis (programmed cell death), and block T-cell signaling, proliferation, and cytokine production, high concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in cancer patients. The ability to reduce the presence of circulating exosomes could reverse immune suppression and increase patient responsiveness to both immunotherapy and chemotherapy. As such, Aethlon believes that the Hemopurifier(R) addresses a significant unmet medical need in cancer care.

Dr. Taylor is a recognized authority on the causative effects of immune suppression in cancer patients. He is credited with the initial characterization of exosomes and is a leading peer reviewed author on the subject. Aethlon disclosed that Dr. Taylor did not receive nor request any compensation for conducting the research studies mentioned above.

“Based on emerging data, we envision the Hemopurifier(R) will become a treatment standard that enhances the benefit of therapies administered to those who suffer from cancer,” stated James A. Joyce, Chairman and CEO of Aethlon Medical.

Aethlon Medical Company Background

“Aethlon Medical is the developer of the Hemopurifier®, a first-in-class medical device to treat infectious disease. The Hemopurifier® addresses the largest opportunity in infectious disease, the treatment of drug and vaccine resistant viruses. The Hemopurifier(R) is a single use extracorporeal device that converges hollow-fiber filtration technology with immobilized affinity agents to capture viruses and soluble glycoproteins from the blood. The device has been designed to mimic the natural immune response of clearing infectious viruses and immunosuppressive proteins from circulation. Regulatory and commercialization initiatives in the United States are focused on bioterror threats, while international initiatives are directed towards naturally evolving pandemic threats, and chronic infectious disease conditions including Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Collaborative studies to demonstrate utility of the Hemopurifier(R) are being conducted with researchers at the Government of India’s National Institute of Virology (NIV), The U.S. Centers for Disease Control and Prevention (CDC), The United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and The Southwest Foundation for Biomedical Research (SFBR). Aethlon recently demonstrated safety of the Hemopurifier(R) in a 24-treatment human study and is now conducting follow-on safety studies at the Fortis Hospital in Delhi, India. The Company has also submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) related to advancing the Hemopurifier(R) as a broad-spectrum treatment countermeasure against category “A” bioterror threats. Additional information regarding Aethlon Medical and its Hemopurifier(R) technology can be accessed online at www.aethlonmedical.com.”

[Post Source and Quoted Post Source: “The Aethlon Hemopurifier(R) Reverses Immune Suppression in Cancer,” Aethlon Medical, Inc. News Release dated November 19, 2007].

*[Post Title Source: The “foreword” chapter of The Pogo Papers, written by Walt Kelly and published by Simon & Schuster (Paper) (June 1953). The complete Kelly foreword chapter quote (which is a paraphrase of a message sent in 1813 from U.S. Navy Commodore Oliver Hazard Perry to Army General William Henry Harrison after The Battle of Lake Erie stating “We have met the enemy, and they are ours”) is “There is no need to sally forth, for it remains true that those things which make us human are, curiously enough, always close at hand. Resolve then, that on this very ground, with small flags waving and tinny blast on tiny trumpets, we shall meet the enemy, and not only may he be ours, he may be us.” Walt Kelly first used the abbreviated quote “We Have Met The Enemy and He Is Us” on a poster for Earth Day in 1970.]

CNN Reports On the Hemopurifier®

Five Years Later, Patient Participating in Vaccine Trial Remains Free of Ovarian Cancer

“Like most women with ovarian cancer, 44-year-old Christine Sable of Lancaster, Pennsylvania, did not discover she had the disease until it was in the advanced stages and had spread to other areas of the abdomen. ‘I knew my chances of recurrence were very high-75 to 80 percent at that particular stage-and that the disease would likely recur within a year or two,’she says. ‘Once it recurs, it is difficult to cure.’

After aggressive surgery and chemotherapy, the only other option her doctor could offer was more chemotherapy. But the first round had been ‘very hard,’ Sable recalls. ‘I wanted to find something that would work with my own immune system and not be so harsh on my body.’

Then she learned about a Phase I clinical research study of an ovarian cancer vaccine developed by Kunle Odunsi, MD, PhD, Surgeon in Gynecologic Oncology and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park [Cancer Institute]. The vaccine is designed to trigger an immune response in the significant number of women who have tumors that test positive for the antigen NY-ESO-1.

The study was open to patients who had completed their initial treatments and who had no further evidence of disease; Sable fit the profile. She says the day she was accepted into the study was ‘one of the most exciting days of my life.’ She began treatment at Roswell Park in February 2004, and her immune system responded so strongly to the first five doses of vaccine that she received another five, then another five, each time experiencing a better response-with no side effects. Now 49 and still cancer-free, she returns to Roswell Park just once a year for continued monitoring.

Odunsi is currently leading a team of Roswell Park researchers who are working to improve the vaccine’s effectiveness. The vaccine is an important new focus in the search for better treatments for ovarian cancer, which is often difficult to treat. Sable says participating in the trial ‘was a very good experience; I was very well cared for. Dr. Odunsi is a gentle, kind man, brilliant and dedicated and very compassionate.’ In May of 2008, Sable will mark the fifth anniversary of her diagnosis and survival. ‘To have had this many years cancer-free is really amazing.’

The study in which she participated was supported by the Cancer Vaccine Collaborative Program of the Cancer Research Institute and Ludwig Institute for Cancer Research, and results were reported in the … [NY-ESO-1 Peptide Vaccine Phase I Clinical Trial Results, Odunsi, K et. al., Proceedings of the National Academy of Sciences, Vol. 141, no 31, July 31, 2007].” [Quoted Source: Science Daily News Release dated April 7, 2008.]

In March 2008, The Ovarian Cancer Research Fund (OCRF) awarded a $900,000 research grant to Dr. Odunsi and his colleagues at the Roswell Park Cancer Institute (RPCI) to fund a collaborative study with the stated goal of developing a promising vaccine to unleash the power of the immune system against cancer. The prestigious award will allow Dr. Odunsi and the RPCI research team to combine four different immunotherapy approaches, all designed to enhance the immune system’s response to ovarian cancer. [Source: “Roswell Park Cancer Institute awarded three-years funding for ovarian cancer vaccine,” a News-Medical.Net News Release dated April 7, 2008.]

Comment: Vaccine or immunotherapy can play an important role in an ovarian cancer survivor’s overarching treatment strategy. This aspect of treatment is often overlooked. It is important to be aware of the availability of vaccine therapy as early as possible in treatment because most clinical trials utilizing vaccine therapy require an extremely low disease “tumor burden” or no (macroscopic) evidence of disease as a prerequisite for patient eligibility. Low tumor burden or no evidence of disease is generally present immediately after chemotherapy treatment(s) resulting in “complete remission,” and/or surgery resulting in “optimal debulking/cytoreduction.” Christine Sable is an excellent example of an ovarian cancer survivor who is proactively managing her care through enrollment in a beneficial clinical trial.

The Roswell Park Cancer Institute, as of this writing, is currently recruiting Stage II through IV ovarian cancer participants for a Phase II vaccine clinical trial involving the use of “Recombinant Vaccinia-NY-ESO-1 (rF-NY-ESO-1) and Recombinant Fowlpox-NY-ESO-1 (rF-NY-ESO-1) in Patients With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen.” For more information with respect to this clinical trial, contact the Roswell Park Cancer Institute Clinical Trials Office at 877-275-7724.

I encourage you to watch the video segment below which addresses Christine Sable’s case, including an interview with Kunle Odunsi, M.D., Ph.D.., the Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park.

MediaSourceTV Video Segment Re

Christine Sable and Roswell Park Cancer Institute Clinical Trial Vaccine Program

Is It Possible to Have Ovarian Cancer at a Young Age?

The ovarian cancer survivor highlighted this week is Maddie Kullen. Mattie is different from virtually all other ovarian cancer survivors because she was diagnosed with the disease when she was 6 years old. Upon diagnosis, Maddie had a 6-inch tumor removed at Children’s Hospital Boston, followed by 16 weeks of chemotherapy. Maddie’s treatments are now over and she is cancer-free.

If you think a 6 year old cannot make a difference in the fight against ovarian cancer, you are absolutely wrong. Maddie is a spokesperson for Ovations for the Cure and participated in that group’s ovarian cancer awareness public service announcement. Maddie was also part of the Boston Marathon Jimmy Fund Walk. Her best idea was the creation of a program at Children’s Hospital Boston that provides young cancer patients with an ice cream break each week. This program is called “Sundaes on Saturday,” and it is supported by monies raised through Kullen family fundraisers. Please take time to watch Maddie’s ovarian cancer awareness public announcement below and visit Ovations for the Cure if you are interested in finding out more about the mission of that group.

When asked by a WBZTV Boston journalist to comment on her appearance in the Ovations for the Cure ovarian cancer awareness spot, Maddie simply responded, “Cool! And then once I saw the commercial I went back to watching kid shows.”

Comment: Although Maddie’s ovarian cancer diagnosis represents an extremely rare case, it is important to note that ovarian cancer does not discriminate when it comes to age, race or financial status. For more information regarding the early warning signs and symptoms of ovarian cancer, visit the H*O*P*E* blog page entitled, “Warning Signs and Symptoms.”

Maddie Kullen in Ovations For the Cure Ovarian Cancer Public Service Announcement

NOV-002 and Carboplatin Slow Disease Progression of Platinum Drug Resistant Ovarian Cancer

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced continued encouraging results in an ongoing Massachusetts General Hospital Cancer Center and Dana-Farber/Harvard Cancer Center (DF/HCC) Phase 2 trial of NOV-002 in combination with carboplatin in platinum-resistant ovarian cancer patients. Fifteen patients have now been enrolled and, to date, 60% (9) have had slower than expected disease progression. NOV-002 was well-tolerated, further extending the excellent safety profile NOV-002 has demonstrated in previous studies. Detailed results of this trial will be presented as a poster at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) taking place May 30 – June 3 in Chicago, Illinois.

‘I am encouraged by these results in platinum-resistant ovarian cancer, with NOV-002 (in combination with carboplatin) apparently slowing disease progression in over half of the treated patients. Most women who have failed three lines of chemotherapy would be expected to progress in about eight weeks. I am excited to present the trial results at ASCO,’ said Dr. Carolyn Krasner, medical oncologist at the Massachusetts General Hospital Cancer Center and the Principal Investigator. ‘We look forward to working closely with Dr. Krasner, the Massachusetts General Hospital Cancer Center, Dana-Farber/Harvard and other institutions on designing and implementing a larger NOV-002 trial for this indication,’ said Harry Palmin, President and CEO of Novelos. ‘Our objective is to commence the next Phase 2 trial in platinum-resistant ovarian cancer in early 2009.’

According to the American Cancer Society, in 2007 approximately 22,000 U.S. women were diagnosed with ovarian cancer and 15,000 women were expected to die from it. There is a lack of effective treatment, particularly in the case of platinum-resistant patients. Once a woman’s ovarian cancer is defined as platinum-resistant the chance of having a partial or complete response to further platinum therapy is typically less than 10% and only 10-20% with other available agents. Thus, there is a major unmet medical need for this indication. …”

[Source: “Novelos Therapeutics Announces Continued Encouraging Results in Ongoing Phase 2 Ovarian Cancer Trial at Dan-Farber/Harvard Cancer Center;” Novelos Therapeutics, Inc. Press Release dated March 31, 2008.]