New breakthroughs in Cancer treatment have been giving hope to millions of people across the world
Cancer, the very name sends shivers down the spine. Till date, scientists are unaware of the cause of this dreaded disease which has started affecting the children as well as the newborn. According to an Indian Council of Medical Research (ICMR), estimate 17.3 lakh new cases of cancer are likely to be reported in India by 2020 and the survival rate would be less than 45 per cent, it said. The biggest problem is late reporting of the cases. Only 12.5 per cent patients reach hospitals at recoverable age, the study said.
Cancer is basically a group of diseases characterised by uncontrolled growth and spread of cells. Most common causes of the disease are excessive use of tobacco, alcohol, inactivity, excess body weight besides genetic conditions, mutations and hormones. Many of these causes can be checked and thus Cancer can be prevented. But, with excess use of chemicals as preservatives, fertilizers and insecticides, Cancer has gradually become a lifestyle disease.
The treatment known so far, have been through drugs (chemotherapy), radiation and surgery. Most existing cancer drugs and treatments are poisons, designed to attack and kill cancer cells. Most of these treatments attack not just cancer cells, but healthy cells, too. Thus, people taking the drugs too often suffer horrible side effects. They become thin and weak. They lose their hair and their colour.
But now, the next revolution in cancer therapy may have arrived. It’s called “molecularly targeted therapy.” The treatment consists of drugs designed at the molecular level of the cell to specifically attack and kill only the cancer cells of a specific type of cancer. And they are tailor-made to recognize specific molecules unique to specific cancers.
The model drug leading the way is Glivec, also known as STI571.
It is active against a relatively rare form of leukaemia which is characterized by the excessive overproduction of white blood cells. Approximately 7,000 Americans are diagnosed with CML each year. Doctors are extremely hopeful that the drug could provide a model for similar drugs to treat cancers affecting many thousands more people.
This year, alone, Glivec is getting a priority review by the US Food and Drug Administration for treatment of CML as a result of its positive clinical findings and will be available to patients within the next few months.
The first gene therapy for cancer, approved by the US Food Drug Administration in August, will transform the treatment of a particular kind of cancer in children and young adults. It’s transformative because it uses a patient’s own immune cells to attack the cancer cells. The hope is that this is just the first of many other drugs capable of harnessing a patient’s immune system.
However, this therapy, called Kymriah and similar ones in the pipeline raise difficult challenges for policy-makers.
The new therapy was developed to treat children and young adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). Called Chimeric Antigen Receptor (CAR) T-cell treatment, it works by genetically re-engineering a patient’s T cells, white blood cells in the immune system. The altered T cells are then infused into the patient to attack the cancer cells.
Clinical trials by researchers found that 52 out of 63 patients were in remission three months after receiving a one-time infusion. However, the therapy also has life-threatening neurological and other side effects experienced by 76 percent of patients, and it increases the risk of patients developing secondary cancers.
The authors point out that as CAR T cell cancer treatments continue to be tested in clinical trials before obtaining FDA approval, “the FDA and Institutional Review Boards (IRBs) with oversight over human subjects research must carefully scrutinize [the risk benefit profile] to determine whether the potential benefits of the investigational treatment justifies permitting cancer patients to enroll in a study.”
The authors raise concerns that many patients who could benefit from the therapy will not have access to it-at least not for a while. That is because the highly specialized skill needed to genetically
re-engineer the patients’ T cells, administer the infusion, and treat the serious side effects are in short supply. Kymriah will be available at certified treatment centers in only 16 states, all but four with just one treatment site.
“Even if the problem of limited availability can be solved, the cost of treatment still raises important questions of justice,” the article explains. Kymriah will cost $475,000 for a one-time infusion, and FDA approval of a therapy does not guarantee that insurers will cover it.
“If CAR T cell therapies prove as safe and effective as other recent breakthrough treatments, the benefits will be tremendous, and demand will be high,” the authors write. “However as has been the case with other recent beneficial but high-priced drugs, CAR T cell therapies may lead to higher health care costs, highly limited access, and even greater inequalities in access and health outcomes. For the public to benefit from breakthrough treatments without breaking Americans’ health care system or pocketbooks, ethics and wise policymaking need to catch up to the science.”
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