Cancer drugs that the Food and Drug Administration (FDA) approved last year cost a yearly average of $171,000. For many cancer patients and their families, treatment may simply be unaffordable.
Alarmingly, some evidence even suggests that only a few of these treatment drugs have (legitimate) positive effects. This has Americans wondering why — with a seemingly endless stream of cancer research funding — patients still have few real and lasting answers.
The FDA’s Role in the Drug Approval Process
Drug companies (or their sponsors) must first test any new drug on animals to determine its safety and effectiveness before they can move on to human test subjects. Once positive effects are shown in animal studies, they perform human tests to determine further whether it can safely and properly treat a disease or provide a measurable health benefit, i.e., extend cancer patients’ life expectancy.
Any drug company that wishes to sell a new drug in the United States must send their test results to the FDA for review. This review happens through FDA’s Center for Drug Evaluation and Research (CDER). CDER exists to ensure that generic and brand-name drugs work appropriately and offer more health benefits than known risks. Moreover, the center only tests drug quality, safety, and effectiveness standards — it doesn’t perform any drug tests of its own.
The center has a designated team of pharmacologists, chemists, statisticians, and physicians who review the company’s data and proposed labeling. Such a diverse team ideally enables them to arrive at unbiased decisions. Should the CDER team confirm that the health benefits of the drug outweigh the known risks, the FDA approves it for sale.
But Just How Effective is Chemotherapy?
Chemotherapy is most often used together with other treatments for cancer. An Australian research team wanted to know just how useful chemo is on its own, particularly when it comes to the patient’s survival rate.
Unfortunately, when it comes to the chances of surviving 5 years after only undergoing chemo, they were rather small. They took this data from USA and Australia from the years 1990-2004.
When one compares it to Australia’s 60% survival chances, when it comes to just chemo, it is a staggeringly low 2%.
However, it should be noted that the results varied depending on the type of cancer in question, as well as which stage it was in. As an example, with stomach cancer, the survival rate was only 1%, while in the case of testicular cancer an astounding difference of 41.8%!
The reason for this lies in the fact that some types of cancer react more easily to chemo than others.
Additionally, Hodgkin’s disease, cervix, and ovary, testis and non-Hodgkin’s lymphoma, are the five cancers most sensitive to chemo. And with these five, the survival rate of 5 years solely due to cytotoxic chemotherapy was 14% back in 1998.
Conclusion? There are instances where chemotherapy can be effective by itself. This especially when it comes to the chemo-sensitive cancers. However, those only accounted for 8.4% of the incidence back in 1998 in Australia.
The Side Effects of Chemo
Useful or not, it’s no secret that chemotherapy comes along with a number of difficult and disruptive side effects, both physically and emotionally. Some of these side effects will go away immediately after treatment has stopped, while others can last months, years, or the rest of a patient’s life:
Damage to normal, healthy cells (especially blood-forming cells in the bone marrow, hair follicles, and cells of the mouth, digestive tract, and reproductive system)
– Hair loss
– Easy bruising and bleeding
– Nausea and vomiting
– Appetite changes
– Mouth, tongue, and throat problems, such as painful swallowing and sores
– Nerve and muscle problems such as numbness, tingling, and pain
– Skin and nail changes, such as dryness or pigment (skin color) change
– Urine and bladder changes, kidney problems
– Mood changes
– Libido and sexual function changes
– Fertility problems
“People who refused chemotherapy treatment live on average 12 and a half years longer than people who are undergoing chemotherapy… People who accepted chemotherapy die within three years of diagnosis, a large number dies immediately after a few weeks.” says Dr. Jones of the common cancer treatment of choice.
FDA: In Defense of Cancer Drug Approvals
Despite approving many promising cancer (or chemotherapy) drugs, FDA officials seem to be okay with the current lack of evidence of improved survival.
In USA Today, the director of FDA’s Oncology Center of Excellence, Dr. Richard Pazdur highlighted the fact that cancers grow at both quick and slow rates. Due to the different growth speeds, some studies take longer to see whether a new cancer drug improves survival or quality of life.
The FDA’s hope is to allow patients to benefit as soon as possible from these approved drugs. Yes, this means that there won’t always be an absolute certainty that cancer patients who take it will survive. Fortunately or unfortunately, this is a risk that some may take because cancer patients don’t have time on their side.
He also maintained that newer and more advanced targeted therapies extend patients’ lives by years instead of months in some cases. Immunotherapy, for example, stimulate patients’ immune systems to combat cancer cells. In the case of advanced melanoma patients, immunotherapy drugs have helped increase survival rates from five percent to thirty-forty percent today.
Although these results may seem small in the grand scheme of things, for people like Dr. Richard Schilsky, senior vice president and chief medical officer at the American Society of Clinical Oncology, “There is a lot of excitement about these [immunotherapy] drugs and for good reason. There’s no diminishing the progress that’s been made.”
Here’s Some Statistics for You
For metastasized cancers, chemotherapy is almost always the first option. But it is not rare either for other treatments to be used in combination with it. If one chooses to undergo chemotherapy by itself, there are certain factors that one needs to take into consideration.
The stage the cancer is in, the type of cancer, each individual’s health status. But also any past medical history, among other things.
Cancer Journal for Clinicians had published a detailed review on June 2016 concerning the recent studies on cancer therapies and survival statistics across the USA.
They took this data for analyzation from two sources: The SEER Program and the NCDB (the National Cancer Data Base).
Most worth noting is the data on comparing specific cancer types, and also the various methods and combinations used for treatment.
Particularly in the case of breast cancer, there is a reported improvement in survival rates.
It is thanks to a few factors: chemotherapy, targeted drugs, and hormone therapy, but also thanks to the increased awareness which leads to earlier detection and the widespread use of mammography.
Because of these, there has been an improvement in the last three decades when it comes to the general five-year survival rate for female breast cancer patients.
For the sake of being more specific, the five-year, ten-year and fifteen-year breast cancer survival rates are 89%, 83%, and 78%, respectively.
Here Are Some Helpful Graphs
This shows the female cancer treatments divided by which stage the cancer has reached
For muscle-invasive bladder cancers the following breakdown of treatment patterns was:
For Nonsmall cell lung cancer the following treatment patterns were found:
These stats and treatment patterns help highlight the range of treatment methods available, as well as the importance of understanding that different types of cancer respond to chemotherapy differently. Finally, it also helps show that often more than one treatment method is used, not just chemotherapy alone.
The Importance of Cancer Survivors’ Quality of Life
As of January 1, 2016, America had over fifteen-and-a-half million cancer survivors. By 2026, research suggests that America will have over twenty million cancer survivors. According to the American Cancer Society’s Facts and Figures (2016-2017), one of their goals is to provide the highest possible quality of life for patients during and after treatment.
When we think about a person’s quality of life, there are many things to consider:
emotional (or psychological) well-being
And as you read the stats below, it is clear that, while peoples’ quality of life is absolutely important, it can look different from person to person.
Quality of Life Statistics
– 25% percent of cancer survivors report a decreased quality of life due to physical problems
– 10% report the same, but due to emotional problems
– Long-term cancer survivors (five years or more) report a similar emotional well-being to those with no history of cancer
– Many long-term cancer survivors report a significantly lower physical well-being compared to their peers
– In the long-term, people who went through more aggressive and invasive treatments report an overall poorer functioning and quality of life
So, while the FDA may approve some cancer drugs (or chemotherapy drugs) that end up being ineffective, they also take ones off the market if the life-threatening side effects outweigh the health benefits. There are a lot of cases wherein people aren’t necessarily upset with the side effects but rather, how little extra time a drug seems to give them (i.e., only months).
However, highly targeted treatments such as immunotherapy are shining hope on a dreadful disease. As technology and medicine advances, These treatments may not cure cancer, but as technology and medicine advances hopefully approved cancer drugs will significantly improve the length and quality of life.