2.2 ~ The Public Needs to Know
Development of New Drugs
Professor Michael White
February 17, 2012
Because cancer is becoming a common killer amongst people of all ages, new drugs are being developed in the treatment of cancer to help prolong life and ease symptoms of the disease. Heart disease presently is our nation’s largest killer, but within a decade cancer may take its place. There are about 200 different types of cancer that effect 1 in 3 Americans and kills 1 in 4 every day. (Arnst, 2008) Cancer treatments are the most costly medical treatment in America. Each year $125 billion dollars is spent on treatments paid by Medicare and individuals. The American’s National Institute of Health states that, “by the year 2020 cancer treatment amounts could raise to $207 billion if prices continue to increase” (Arnst, 2008) Some treatments have an unaffordable price tag on them, like for example Prostate Cancer treatments could cost $44,000 a year, or Hodgkin’s Lymphoma costing $216,000 per treatment, and one of the most common cancers being Skin Cancer costing up to $120,000 just for four months of treatment. This cost is unreal in this day and age when the economy is in a recession. Everyone involved struggles with this problem and wonder how we will be able to afford the cost of cancer over the next decade. Most doctors will only recommend certain treatments depending on the patient’s out-of-pocket spending. The old generic chemotherapy is relatively cheap and is most commonly used in cancer treatments. (The Economist Newspaper Limited, 2011) Cancer patients whose disease has been caught in the early stages have a better chance of living a longer life and will benefit more from treatments. If it’s caught in the early stages, patients may be able to enroll in a clinical trial, but not everyone gets this chance. Clinical trials test patients with cancer, using experimental drugs that have not yet been approved by the FDA and compare them to drugs that are already used to treat the same kind of cancer. There are many parts to this process and can take many years to complete. The developers must get the funding first to begin the trial. The trial process includes determining the side effects, effectiveness, benefits, and risks of the new drug. Then it is presented to the FDA for approval. Then the FDA must make sure the new drugs are safe and effective. (National Institute of Health, 1999) This means the benefits must outweigh the risks for its intended use. Cancer drugs have potent ingredients that kill cancer cells. Unfortunately they also kill healthy cells which intern weaken the body’s immune system and makes patients more susceptible to infections and other serious health problems. Cancer can be more damaging to our bodies than the treatments themselves. One of the challenges for the FDA is getting the most promising treatments to the people who need them most as quickly as they can. Treatments may be approved even though there may be serious side effects and as long as the treatment is beneficial and the disease is life threatening. Only 8% of cancer drugs get approved compared to 20% of other illness drugs. Since 2005 the FDA has approved 18 new cancer drugs and the pharmaceutical companies are in the midst of developing 887 new cancer drugs. That’s a 26% increase since 2006. (Goozner, 2012) There is a lot of money (billions) put into developing new cancer drugs but very few are approved. If there are not any currently approved therapies, the FDA may allow an investigational treatment that is not part of a clinical trial. There is a gentleman named David Kessler, who used to be a director for the FDA from 1990-1997. He is pushing for an expedited review process of cancer drugs like the FDA did for AIDS in the 1980’s and 1990’s, which changed the face of AIDS dramatically. (Arnst, 2008)
Effective drugs used for cancer can help extend a patient’s life as well...
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