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In 2002 and 2003 two significant US studies suggested that oestrogen, which is standard hormone replacement therapy (HRT), triggered breast cancer and doubled a woman's risk of the disease. As a result, HRT usage fell by a half and thousands of women suffered the debilitating effects of menopause.

According to Cancer Research UK, this drop coincided with a fall in the incidence of breast cancer.

Women dying needlessly

Tamoxifen is a widely used drug for the treatment of breast cancer. It works by blocking oestrogen and is usually given to women after surgery in an attempt to prevent the recurrence of the disease.

According to a 2013 article in The Lancet, tamoxifen and three similar drugs, reduce the incidence of breast cancer by 38% in women at an increased risk of the disease. Although tamoxifen is a lifesaving drug, it has significant side effects, including depression, blood clots, nausea, headaches and exhaustion.

A prescribed course of tamoxifen treatment is usually for five years. Women are failing to complete their courses and are dying needlessly.

A new HRT drug might prevent breast cancer

At the 2013 conference of the American Society for Reproductive Medicine in Boston, Professor Richard Santen from the University of Virginia and an expert on the role of oestrogen in breast cancer, presented findings, which suggested that the earlier US studies were flawed and a new FDA approved Pfizer HRT drug, Duavee, may actually help to prevent breast cancer.

Duavee contains bazedoxifene, which blocks the cancer causing effects of oestrogen, which means that it has the benefits of reducing the symptoms of menopause as standard HRT, but doesn't trigger cancer.

Some facts

Breast cancer is the most common cancer among women in England, accounting for 31% of all newly diagnosed cases of cancer in females.

Over the past 40 years there's been a 38% decrease in breast cancer mortality rates, but the incidence rates of the disease have steadily increased. Each year in the UK, around 50,000 women are diagnosed with breast cancer and each year, 12,000 women in the UK die of it.


Risk factors

Although breast cancer can develop for no apparent reason, there are certain risk factors which increase the chance that the disease will develop. These include: age, where you live, family history, being childless or having your first child over 30, not having breast fed, early onset of periods, continuously taking HRT and excessive consumption of alcohol.

Age is the strongest risk factor and breast cancer rates are climbing among older women. However, cases among younger women are increasing too. Each day in the UK, there are 27 new cases of the disease diagnosed among women under 50.

Wealthier nations have a higher incidence of the disease. The UK has the 11th highest incidence rate and Belgium has the highest incidence of breast cancer in the world.

About 5% of all cases of the disease are caused by a faulty gene, which can be inherited. The genes BRCA1 and BRCA2 are the most common. Scientists continue to explore mutations of these genes, but are also researching how more common gene variations may influence breast cancer risk.

Over 40% of breast cancer in the UK is preventable

In recent years, studies have examined the potential impact of environmental factors on the disease: the effects of exercise, weight gain and loss and diet.

According to the World Cancer Research Fund, 42% of all cases of breast cancer in the UK are preventable. Women who are overweight or obese are at a higher risk. Studies show drinking just one large glass of wine a day increases the chances of developing the disease by 20%.

The National Institute of Environmental Health Sciences in the US is funding a 10 year sister study designed to examine the possible causes of the early onset of breast cancer. Comprised of 50,000 women who have sisters with breast cancer, the study will collect information about genes, lifestyle, and environmental factors that may cause breast cancer.

New diagnostic tests

In time, 3D breast tomosynthesis is expected to replace conventional mammography. This is an extension of the digital mammogram and combines low-dose X-rays of the breast with 3D imaging technology in the expectation of obtaining a more in-depth view of breast tissue.

The Cleveland Clinic in the US hailed the FDA-approved 3D techniques as one of the top 10 medical innovations for 2013. A new study published in Lancet Oncology found that by adding 3D digital breast tomosynthesis to the standard 2D breast X-rays could reduce results that look like cancer, but are not, by 17%, without missing any cancers.

Aixplorer is a new FDA approved ultrasound 3D imaging system that could reduce unnecessary biopsies by helping to detect which lumps are malignant. Twenty per cent of women who have breast biopsies prove negative for cancer. The Aixplorer measures tissue stiffness, which is more prone to be cancerous. The technology's 3D images could also be helpful for screening younger women with denser breast tissue for cancer, since traditional mammography doesn't work so well in such patients.

A molecular breast imaging test in development, scintimammography, entails injecting a mildly radioactive tracer into a vein that attaches to breast cancer cells and can then be detected by a camera. The procedure detects early signs of breast cancer and explores suspicious areas detected by regular mammograms. Early studies suggest that scintimammography may be as accurate as the more expensive MRI scans.

Targeted therapies

As researchers have learned more about the gene changes in cells that cause cancer, they have been able to develop newer drugs that specifically target these changes. Such drugs are transforming the way cancer is treated.

The most well known targeted therapy is trastuzumab, which is marketed as Herceptin. Herceptin targets breast cancers that express high levels of HER2. Known as HER2 positive cancers they account for some 20% of all breast cancers.

Targeted therapies work differently from standard chemotherapy and often have different and less severe side effects such as sickness and hair loss. Targeted therapies have begun to make personalised medicine a reality and will continue to help clinicians tailor cancer treatment based on the characteristics of each individual's cancer.

Takeaway

Researchers from the Cleveland Clinic have discovered a single vaccination that can prevent cancer in mice that are genetically predisposed to the disease. Clinical studies in humans are expected to begin in 2015. The first study will include women with aggressive breast cancer who have recovered from standard treatment. A second study will include healthy women, such as Angelina Jolie, who have undergone mastectomies to lower their breast cancer risk.

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Is the communications guru, Maurice Saatchi right in thinking that the law is an obstacle to finding a cure for ovarian cancer?
 
There’s a bigger and more substantial obstacle: poor communications.
 
Saatchi might consider using his abilities, honed in building global advertising agencies, to improve ways scientists and doctors communicate and share clinical data and tumour samples in their endeavours to find a cure for ovarian cancer.  
 
Saatchi’s Medical Innovation Bill
In 2012 Saatchi introduced a private member’s bill to the UK’s Parliament, “to show that scientific progress has been stopped by law” and to encourage new therapies by legalizing the ability of doctors to use experimental treatments even if there is no proof they work. 
 
In 2011, Saatchi’s wife, the novelist Josephine Hart, died of ovarian cancer. He described her treatment as, "medieval, degrading and ineffective.” Doctors, he said, aren’t receptive to new and innovative therapies and don’t move away from the tried and tested, but unsuccessful treatments they know.
 
Speaking of his wife, he said, “She would have had the same procedure anywhere in the world: same drugs, same operation, same everything.” Saatchi’s Medical Innovation Bill is designed to change this by liberating doctors from generally accepted medical protocols and encouraging them to innovate.
 
Rarely in the UK does a private member’s bill become law, but Saatchi has triggered an important debate.  
Some Facts
Ovarian cancer is an age related silent killer of women. There is no effective early detection method for the disease and therefore it’s mostly diagnosed in advance stages. It accounts for five per cent of all cancer deaths among women. The average age for the onset of the disease is 63.
 
Each year, more than 204,000 women are diagnosed with ovarian cancer worldwide. About half die within three years of being diagnosed, partly because so few drugs exist to stop the cancer metastasising and no new treatment has been introduced for more than a decade.
 
Ovarian cancer and commercial interests
Despite being the most frequent cause of cancer related death from gynaecologic malignancies, ovarian cancer does not attract the same level of R&D interest from pharmaceutical companies as some other cancers. This is because pharmaceutical companies create value for their shareholders by concentrating their research resources on the discovery and development of patented blockbuster drugs that are expected to dominate the largest disease states for the duration of their patents.
 
As a result, smaller disease states, such as ovarian cancer, suffer from a relative lack of pharma-backed research resources. As a consequence, ovarian cancers’ mortality rates remain high, detection rates remain low and treatment options do not improve.
 
Obstacle to change
Saatchi has a point about English law. In 1957 an English High Court judge ruled that doctors must act in accordance with, “what the majority of doctors do, even if there are opposing medical views.” This ruling set a precedent for medical negligence cases and is reinforced by the world’s largest professional body for oncologists: the American Society of Clinical Oncology, which promotes evidence based treatment protocols for all cancers to its 30,000 plus members.   

Supporters & detractors
Saatchi’s Bill has its supporters. Lord Howe, the Minister of Health, believes that UK approvals for new treatments are “unacceptable” slow. "It takes an average of 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice," he said.
 
The Bill also has its detractors. Professor Karol Sikora, a leading authority on cancer and a director of CancerPartners UK, believes Saatchi’s proposal is unnecessary. "If a doctor wants to do something different and the patient consents, doctors can do wacky things," says Sikora, citing the alternative medicine industry, where there is little evidence to suggest that treatments work.
Targeted therapies
The science that underlies cancer therapies has changed from chemistry to genetics. Chemistry fuelled the growth of the pharmaceutical industry in the early to mid 20th century, which has now matured. In the late 20th century genetics gave birth to a new biopharmaceutical industry, which is growing rapidly.
 
Biopharmaceuticals, based on genetics and molecular science have given rise to targeted therapies and personalised medicine. This tailors medical decisions, practices and therapies to individual patients and corrects abnormalities at a molecular level. Such therapies offer the potential to reduce cancer’s unacceptably high mortality rates and raise its unacceptably low detection rates.
 
Several targeted therapies have been approved. The most well known is trastuzumab, which is marketed as Herceptin and used in early stage breast cancer patients with high levels of the HER2 protein.
 
Improved global communications and a cure for ovarian cancer
Targeted therapies require significant data flows between scientists and doctors: the bench-to-bedside approach.  Currently, at best, this is inefficient and at worse, it’s simply not done.
 
Breakthroughs in ovarian cancer research will not occur without significantly improving:
 
1. The collection and standardization of vast clinical data sets from different geographies
2. The creation and development of large-scale interconnected tumor banks with standardized tissue samples also from different geographies
3. The management and distribution of these vast clinical data sets and tumor samples to scientists able to combine genomic and clinical data, which is a necessary prerequisite for genetic, epigenetic and proteomic analysis.
 
Ovarian cancer breakthroughs will not come from professional cancer associations, nor from the endeavors of small charities and nor from doctors alone. All are inexperienced in global communications and big data management. Breakthroughs are more likely when well-resourced global organizations with highly developed big-data management skills get involved in medical research.
 
In September 2013 we came a step closer to this, when Google co-founder and CEO Larry Page announced that he is planning to launch Calico, a new company to use Google’s data-processing strength to shed new light on age-related maladies.
 
In a similar vein, Jonathan Milner the biotech millionaire and a founder of Abcam, one of the world’s largest retailers of research antibodies, is backing a venture to create a Wikipedia of genetic disease data to help diagnose an array of uncured conditions.   
 
Key takeaway
Maurice Saatchi should consider trading his ermine robes for shorts and T-shirt and head to Mountain View, California and combine his considerable communications skills and energies with those of Larry Page in an endeavour to, change the ways medical scientist create, share, communicate, collaborate and do research.”   

 

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