Category: Research

Cancer Awareness

10/28/2016

October is Breast Cancer Awareness month and I felt I should contribute this article to help teach at least in a little way. As a doctor, I really want to enlighten not frighten, but firstly I would like to give you a quick definition of what Cancer is.

What is Cancer?

It's a disease that is caused by unusual replication of abnormal cells in a part of the body. There are different causes that lead to this unusual replication of cells (carcinogenesis). For example, exposure to radiation (sunlight), genetics, air quality, smoking, etc.
Breast Cancer is the unusual division of Breast cells. Although this cannot be prevented, early detection provides the best possibility for a successful treatment.

In Sub Saharan Africa, breast cancer is makeup one in four diagnosed cancers and one in five cancer related deaths in women. Majority of cancers in Africa are diagnosed at an already advanced stage of the disease. This is common in those parts of the world due to lack of screening and early detection services. In addition, there is limited awareness of early signs and symptoms of cancer among the public and health care providers. Stigma associated with a diagnosis of cancer also plays a role in late stage presentation in most parts of Africa.

Like I earlier stated, early detection gives you your best chance at successfully managing and eventually fighting off this disease. Early detection means finding the Cancer before it spreads to other parts of the body. By following these 3 Steps, you will help increase your chance of detecting cancer early.

1) Breast Self Awareness: Breast Self Awareness helps you to become familiar with how your Breast normally feels and look. Knowing this will help you identify any changes in your breast, if you notice any changes make sure you report it to your physician promptly, but do not panic 8 out 10 lumps are not cancerous.
Changes to look out for include:
• A lump or thickening in or near the breast or in the underarm.
• A change in the size or shape of the breast
• Dimpling or puckering in the Skin of the breast
• A nipples turned inward towards the breast
• Discharge (fluid) from the nipple when you aren't breastfeeding
• Scaly, red, or swollen skin on the breast, nipple or areola (the dark area of skin at the center of the breast).
Often these symptoms are not due to cancer, but if you notice any changes in your body, it's advisable to see your physician immediately so that a proper diagnosis can be conducted.

2) Well-Woman Exam; It is recommended that women visit their family physician or gynecologist each year for an annual Well-Woman Exam. In addition to a routine pelvic exam and Pap smear the doctor may perform a brief breast exam to check for abnormalities.
The well-woman exam is a great opportunity for you to discuss with your physician any questions or concerns you have regarding your breast health, for example your doctor may help you determine the most appropriate frequency for your early detection steps.

3) Mammogram: In its early stages, breast cancer does not usually cause symptoms. The National Breast Cancer Foundation recommends that women ages 40 & older get a mammogram every year. A mammogram is an X-Ray of the breast; it is a safe way to detect cancerous tumors and other abnormal conditions. Women who have screening mammograms have lower chance of dying from breast cancer than women who do not have screening mammograms.
Mammograms can detect cancer or other problems before a lump becomes large enough to be detectable to touch. They provide an effective way to find breast cancer in its early stages when treatment is usually the most successful, considered safe, quick and relatively painless.
When breast cancer is detected early (localized stage) the 5 year relative survival rate is almost 100%, this is why it is so important for you to schedule regular exams.

Please discuss with your physician on how often you should have breast exams. Women with a first degree relative who has been diagnosed with breast cancer (parent, sibling, and child) may need to begin mammography earlier and should consult their physician about the timing and frequency of the exams.

Policy updates in developing countries. Its time!

7/31/2011

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By Chigozie Nwachukwu

The 1996 meningitis outbreak poses an excellent case study in judging the regulatory climate in Nigeria. The outbreak resulted in mass panic and typically panic breeds chaos. Amidst the panic several incidents that clearly jeopardized the lives and welfare of the people occurred. The most prominent of such circumstance was the trovafloxacin clinical trials. These trials resulted in the unfortunate death of 11 children in Kano at the hands of the researchers from Pfizer Incorporated. Pfizer carried research on a select group of 200 children and infants, randomly chosen from crowds at a meningitis epidemic camp. About half of the group was given trovafloxacin which was an untested antibiotic. In addition, the researchers gave a dangerously low dose of a comparison drug made by Hoffmann-La Roche to the children. This action resulted in the deaths of five children after being treated with the Torvafloxacin, while six others died after taking the comparison drug. Others were left deaf, paralyzed, blind or brain-damaged. What made it the more suspicious was that parents were banned from the trial sites and their consent was not sought; there were generally unaware of the fact that Trovan was an experimental drug, with life-threatening side effects that was "unfit for human use."

The less publicized matter stems from how these patients and their family were also completely blindsided and bombarded by products and therapies with no proof of efficacy and/or safety. Desperate for cures, parents took their children in the hundreds to opportunistic men and women in search of cures. People with absolutely zero understanding of or experience with human physiological function became the arbiter of health for the desperate. Of course these were in most cases pointless exercises as these charlatans were out for their own gains with no fear for consequence, which is unfortunately typical.

The entirety of this circumstance gives rise to many questions and shows the result of having an ineffective system in place; from clinical trial ethics to product marketing regulations. Although these incidents happened fourteen years ago, it will be very short sighted to believe regulations to forestall any repetition has caught up. Despite growth in regulatory activism and general regulatory development, there are still loop holes that “encourage” poor health product development process including clinical trials and marketing. This means the Government should put time and effort in updating regulatory mandates and recommendations while effectively executing what is currently on the books.

There should be stronger language in defining “drugs” in order to prevent fraudulent products from entering the market. There should be greater emphasis on regulations governing ethical practices, with a strict enforceable penalty for any ethics violators. A more stringent approval process for treatment therapies should be established including stronger GLP, GMP and GCP requirements. The regulatory agency should be given the responsibility of protecting the health of the people and given the authority and resource to ensure that marketed products are genuine and tested for safety and efficacy (unfortunately, the current system puts the onus for determining genuineness on consumers who are typically naïve on what constitute genuine). Resource should be available to educate the public on the differences between genuine and fraudulent products. This also means, more openness on the drug review process (including acceptance and rejection criteria). Most importantly, the regulatory agency should be giving the authority to persecute violations of established standards and mandates. I believe these as well as other regulatory developments will help to ensure greater product safety and will also promote better health quality. An alternate benefit includes an increase in competitiveness for the country in the global pharmaceutical market.

Particularly in this current global era, calling for better regulation on drug products and therapies cannot be overstated. Presently, an estimated 50,000 clinical trials are being run worldwide and in excess of 40 percent of these new studies are taking place in nontraditional research areas (countries with little share in the world’s pharmaceutical market yet as a result of declining health resources are experiencing epidemiological changes). Interestingly enough, the bulk of these trials ranging from gene therapy studies for rare diseases to studies for treatments for more common disorders; from studies of compounds imitating existing drugs to studies in search of secondary uses for them are commercially sponsored. This current trend in globalization makes it necessary for the Nigerian government to act to ensure that the incident of 1996 will remain history; otherwise, this time around the resulting disaster might be unimaginable in scale.

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Policy updates in developing countries. Its time!

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