Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Wednesday, March 28, 2012

Drug Innovation 1: On Cancer, Bioequivalence and Clinical Trials

To distinguish discussions related to intellectual property rights (IPR) like compulsory licensing, I am starting a new thread in this blog just on "Drug Innovation". This is slightly different from the thread on "IPR and Medicines".

My elder brother who died of prostate cancer more than five years ago would have been 57 years old this week had he survived the disease. His diabetes plus emotional sadness when his wife died several months earlier due to colon cancer further aggravated his condition.

My other relatives, wedding godparents, friends, family members of friends, also died of cancer. There are different types of cancer, probably about 200, and all of them are dangerous. Perhaps all of us have cancer cells in our body, but our immune system are just strong enough to kill those cells, or at least keep them at bay and prevent them from expanding and invading other organs of our body. Our immune system is our best physicians, our best medicines, our best disease examiner, all rolled into one. It is very important therefore, that we keep our immune system strong and efficient, by not injecting too many substances that can weaken them -- like cigarettes, alcohol, fatty food and so on. A little of these substances, like when we attend parties, would be fine and our immune system should be able to repair minor damages. It is the excessive use of such substances that can create more damages in our body.

Medicines and vaccines help boost our immune system in killing undesirable cells like cancer. Usually, old medicines are less efficient in doing this job as human understanding of each disease improve through time. Thus drug innovation is a must. Diseases mutate and evolve, so treatment against such diseases must also evolve.

The business of medicine innovation should be depoliticized whenever possible. There are existing rules governing patent, trademark, copyright and other IPRs, all players, innovator and generic manufacturers especially, understand those rules and do their respective business plans and marketing that are compliant with those rules. That is why I question and oppose moves or proposals that governments should issue compulsory licensing (CL) and related political schemes that disrespect private property rights.

What governments should do, is encourage the entry if not proliferation, of more innovator companies. If there  will be 20 or 50 different innovator companies that develop and roll out new medicines (on top of existing, off-patent drugs) per disease, then the patients will greatly benefit. Competition among such innovator companies will bring down prices of such innovator drugs. Then another round of competition will follow once the patent expires as dozens if not hundreds of generic producers come in to produce their own branded drugs for each disease category.

I am posting below three articles by Reiner Gloor in BusinessWorld on dates indicated. Reiner is the Executive Director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP), the federation of mostly innovator pharma companies in the country. The three papers are:
1. Beating Cancer,
2. It all begins in innovation, and
3. The value of clinical trials.

The subject of bioequivalence and related tests for safety and efficacy of generic drugs before they will be introduced to the public are discussed. These are useful information that need to be shared to the public.

The most expensive drugs are those that do not work and hence, do not kill a particular disease, no matter how cheap they are. Because an ailing patient would have more complications as the disease inside his.her body is not treated and allowed to expand and inflict more damage in other internal organs of the patient.
------------


Posted on 06:05 PM, February 02, 2012

Medicine Cabinet -- By Reiner W. Gloor


Beating cancer



Major non-communicable diseases were among the important health issues that gained the attention of world leaders in 2010. In a United Nations summit, political leaders agreed to a plan of action that sought to address alarming trends involving four major non-communicable diseases (NCD) that have developed to become the world’s biggest killers.

The four major NCDs are cardiovascular diseases, diabetes, chronic respiratory diseases, and cancers that have altogether prematurely claimed the lives of 38 million people, representing about 63% of the total global deaths in 2008. Studies indicate that the major NCDs are affecting the developing world and lower-income populations hardest.

This is particularly true for cancer, which accounted for about 7.6 million global deaths in 2008. By 2030, cancer deaths are also expected to soar to 11 million worldwide. The World Health Organization (WHO) also disclosed that about 70% of all cancer deaths occur in low- and middle-income countries.

Cancer can affect any part of the body. A defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. This process is referred to as metastasis which is the major cause of death from cancer, the WHO said.

Locally, the Department of Health recently led the observance of the National Cancer Awareness Week in a campaign to boost public consciousness on the disease. Such an awareness drive is important specifically for the Philippine Society of Medical Oncology (PSMO), which considers information as a keystone to preventing and treating cancer.
The need to raise awareness on cancer has become more evident with the GLOBOCAN Project report, which estimated that there had been more than 51,000 cancer deaths in the Philippines in 2010.

The GLOBOCAN Project, which provides global incidence of, mortality and prevalence from major types of cancer, reported that leading new cancer deaths among Filipinos in 2010 include those involving the lung, liver, breast, colon/rectum, leukemia stomach, cervix uteri, brain, prostate and pharynx.

Among Filipino men, lung and liver cancer comprise 43% of all new cancer deaths. These top two killer cancers affected more than 12,000 Filipino men.

On the other hand, breast cancer was the number one cause of new cancer deaths among Filipino women also in 2010. It is estimated that more than 4,000 Filipino women died of breast cancer or 18% of all total deaths during the same year. Around 2,197 women and 1,984 others succumbed to lung and cervical cancers, respectively.

Breast cancer also topped the list of new cancer cases in 2010 followed by lung, liver, colon/rectum, cervix, leukemia, stomach, prostate, brain and ovarian cancer. The top 10 leading sites comprise 68% of all new cases.

Despite the threats posed by cancer, the disease can be reduced and controlled by implementing strategies for prevention, early detection and care for patients with cancer. These include modifying key behavioral and dietary risk factors as well as early detection and screening tests which are important in the diagnosis and treatment before cancer becomes advanced. Vaccination against human papilloma virus (HPV) and hepatitis B virus also help in cancer prevention.

PSMO President Dr. Felycette Gay Martinez-Lapus explained that the fight against cancer requires a collaborative effort among the physician or physicians, the patient, the patient’s family and friends.

She added that treating cancer is a delicate balancing process. The general aim is to reduce tumor growth while ensuring that any potential side effects do not compromise the patient’s quality of life to the extent that the treatment does more harm than good.

Dr. Martinez-Lapus acknowledged that in recent years, there has been a surge of innovative drugs which has forever changed the landscape of cancer treatment.

She said that as opposed to about 40 years ago, life expectancy have increased with new medicines that target the cancer cells directly. Today, targeted therapy is more precise in that it is formulated to act against a specific type of cancer unlike previous treatments.

At the moment, researchers are working on more than 800 innovative medicines that are either undergoing clinical trials or regulatory review. Due to these developments, cancer can now be better managed and even beaten.