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Introduction to Problem
As the second-leading cause of deaths related to cancer in men throughout the United States, approximately 192,000 men are given the news that they have prostate cancer every year. Of those, approximately 27,000 die from the disease, (What is, 2009). “Prostate cancer is the most common cancer, other than non-melanoma skin cancer,” (Thomas, 2012). The prostate is a gland in the reproductive system of men. The prostate is considered to be an exocrine gland and it is located immediately underneath the bladder, and just in front of the rectum. Exocrine glands are ones that have a secretion that goes outside of the body. Examples of these also include the sweat gland. The prostate gland is estimated to be the size of a walnut and this has the potential to develop serious cancers, particularly among men with a high level of testosterone. Various types of cells make up a prostate gland. However, almost all of the cancers relating to prostate are located in the gland cell. The technical term for prostate cancer is adenocarcinoma. Many of these cancers have the ability to grow rapidly, but it is most often associated with slow growth. Scientists have shown that older men, and occasionally those who are younger, who died of another disease, also had prostate cancer, but it didn’t lead to their death and wasn’t a problem during their lives, (What is, 2009).
Approximately 81 per cent of men will catch prostate cancer in its early stages of development. While the cancer grows at a relatively slow speed, most of the men who catch it early will choose a very aggressive treatment option. They will ask that the prostate be removed, or they will undergo radiation treatments that could make them incontinent, impotent or both. In approximately 10 per cent of cases, the man will refuse treatment, and this is often against the opinion of the doctor and family members. The man could continue to suffer severe pain due to the presence of the cancer, though this isn’t enough of a hindrance for many people. A “watchful waiting” strategy would mean that doctors simply treat for the pain that is caused by not eliminating the cancer, (Parker-Pope, 2012).
Many doctors hypothesize that the cancer starts from extremely small changes in the shape and size of the cells of the prostate gland. A protein that is produced in the cells, which is called a prostate-specific antigen, escapes into the bloodstream, sometimes resulting in the spread of the cancer. The PSA level can be monitored by checking the man’s blood. A high level of PSA can indicate that there is prostate cancer, or another kind of condition with the prostate present. The levels can also help doctors to determine the stage that the cancer is in, which will help them determine the best treatment. The treatment that is chosen, depends on the request by the patient and with the stage in which the cancer has developed, (What is, 2009).
The disease is most prevalent among men who are over age 65, and it is very rare in men who are younger than 45. As a person gets older, their risk for contracting the disease increases. Among those who contract the disease, there is a 15 per cent chance that either a brother or a father was also diagnosed. African-American men are at double the mortality rate compared to men of any other race, and they contract the disease more often than other races. Other risk factors include obesity, sexually transmitted diseases and a poor diet. One of the most challenging aspects is that there are usually no symptoms during the early stages of the disease. Typically, doctors discover men with prostate cancer during routine checkups or during a blood test.
However, there are signs that indicate prostate cancer is present. For example, the victim might urinate more often, get up at night to go pee, trouble starting urination, difficulty continuing to urinate once he starts, blood in the urine and urinating could cause pain. If the prostate cancer is in an advanced stage, there could also be bone pain that is often situated in the spine, pelvis or ribs. The cancer can also be the catalyst to tumors showing up in other area of the body.
The treatment for the disease is usually radiation or surgery to take the prostate gland out. Drugs can also be used to attempt to reduce the levels of testosterone, which causes the prostate tumors to develop, are used after radiation or surgery. However, these methods aren’t always effective, and when they aren’t there is a more recent development that could change the survival rate of men suffering from prostate cancer.
Like many practices, this treatment does have its controversies. These include issues around the cost. While the numbers haven’t been officially tallied this drug is expected to be extremely expensive. Early estimates peg the drug at costing about $93,000. However, the makers said the drug’s price is comparable to that of other drugs that help fight cancer, when considering the cost for each extra month of life. The debate about whether the price is justified by the approximately four months of extended life is up for debate. There is the Provenge vaccine, but there are problems around the drug because there isn’t enough of it to go around. Dendreon, the manufacturer, can’t produce enough of the product to fill all the orders. The price is also extremely high, which will cause many people to be left out of the purchase. Medicare and other insurers have contemplated whether or not to cover the drug. But there are solutions to these concerns.
Proposed Solution
Before introducing the solutions, it is important to establish the foundation in which the Provenge vaccine was developed. In 2010, the Food and Drug Administration approved the vaccine Dendreon Corporation’s Provenge. This vaccine isn’t considered a definitive cure, but men who have limited treatment options have hope that it will work. A study showed that men who receive the Provenge live about four months longer than those who don’t receive it – 26 months compared to 22 months, (What is, 2009).
Doctors hypothesize that the vaccine can destroy the advanced prostate cancers and the healthy tissue is left unharmed. When the vaccine is injected into the blood, rather than into the tumor itself, the body’s immune system didn’t go into overdrive, which is what it was doing when the vaccine was injected directly into the tumor. The vaccine can work by triggering the body’s immune system to become familiar with antigens and to recognize them. These are distinctive proteins located on the surface of cells. It should be noted that only some men with prostate cancer will benefit from this treatment.
A New York Times article describes the test that developed the vaccine, where thousands of snippets of genetic codes were taken out of healthy prostates and then they were inserted into a virus. The virus was then injected into a mouse that had prostate cancer. Before each dose a prostate cancer patients white blood cells were taken and they were combined with a protein to create a dose of sipeuleucel-T. The mouse produced an array of antibodies that were keyed up to recognise a different antigen that is at the surface of the prostate cancer cell. “Each dose of sipuleucel-T contains autologous mononuclear cells, including antigen presenting cells, that were activated ex vivo via culture with a recombinant fusion protein consisting of prostatic acid phosphatase (PAP) linked to granulocyte-macrophage colony stimulating factor (GM-CSF), an immune cell activator,” (Pollack, 2010). Having many proteins in the immunogenic viruses led scientists to be able to better understand the immune system. When injected into the mice, its body suspected that it was being invaded by the virus, in which case it attacked and destroyed the cells, or prevented the onset of cancer cells. In other words, the immune system was able to identify the menacing cells before they had a chance to become cancer cells. This was all due to the fact that the antigen was generated. When applied to humans, it is suspected that this will result in decreased size and number of cancer sites and an increase in the time it takes for cancer cells to develop. This could also help increase the survival time or rate of the patient.
This practice, while seemingly complicated, is really only about removing a patient’s white blood cells before sending them away to a lab and having them activated by being exposed to a protein that is evident in prostate cancer cells. These cells are returned to the patient approximately three days later by a process that is very similar to a blood transfusion. Each patient is required to have this done three times, with about two weeks of time left between each of the doses. Those who receive this treatment have reported only a few side effects, which included chills, fever, fatigue, headache, joint aches,
nausea and back pain. These side effects generally disappeared in a few days, (Derbyshire, 2011).
The treatment is a solution to those who are in the advanced stages of prostate cancer. The approach essentially trains the body to target the cancer cells before they have a chance to form into a tumor. The treatment is only available to those whose prostate is at the metastatic level. This means that the cancer has taken over the lymph nodes, which is in addition to their presence in the prostate gland. The bone can also become infected with the disease. Also, only those who have had their prostate cancer grow, even after other forms of treatment, will be allowed to use the drug, (Glode, 2012).
More specifically, patients whose cancer is not responding to hormone therapy are allowed to use the drug. Also, when a bone scan or CT scan proves that there is a spread of the disease to the lymph nodes or bones, excluding the lungs, liver and brain, can receive the drug. The patients who have brain, liver or lung cancer have a much lower survival rate, and this is why preference is given to those who don’t have the cancer cells spreading to those areas. There also needs to be little or no pain that is related to the cancer. The liver, kidneys and bone marrow also need to be fully functioning. Finally, those who have a history of autoimmune disease or serious lung or heart disease are not allowed to receive the treatment, (Glode, 2012).
Medicare agreed to cover the drug last year, and private insurers also came on board. However, doctors were initially upset over what they called a lengthy wait for reimbursement. But there may be a wait before the controversy becomes too heated. Dendeon, which is the company that manufactures Provenge, doesn’t yet have the capacity to produce enough to fill every order. While the company is pursuing additional capacity resources, there is no timeline given to the full application of the drug.
Works Cited
A. Parker-Pope F.D.A approves ‘vaccine’ to fight prostate cancer. The New York Times. (2010, April 29).
D. Derbyshire. The prostate cancer vaccine that targets tumours with and ’80 per cent success rate.’ Daily Main Online. (2011, June 20).
D. Thomas. Prostate cancer vaccine provenge: is it really worth it? University of Texas. (2012, Jan. 27).
M. Glode Provenge: A Customized Treatment for Advanced-Stage Prostate Cancer Patients.University of Colorado Hospital. (2012)
T. Parker-Pope. Choosing ‘watchful waiting’ for prostate cancer. New York Times. (2012, July 23).
What is Prostate Cancer? What Causes Prostate Cancer? Medical News Today. (2009, May 14).