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What is required for safe usage of biopharmaceuticals?
A commentary on the Judiciary Committee Hearing on June 23, 2004
Tongwen Wang, Ph.D.
12/2/2004

[PureInsight.org] Today is Wednesday. I could be at home and working in my lab in downtown Seattle. But a friendship in Washington DC, established in the past three weeks, gently holds me behind for extra time to work on the non-profit organization, The Whole Elephant Institute. Last night, my friend Jeff turned around from his computer screen and passed me a note on an event. This morning, the other friend here in the house, Court, gave me a ride. I found myself inside the Senate House, room 226. The hearing I attended was “The Law of Biological Medicine”. It was an impressive group of people, from Senators, to leaders of the Food and Drug Administration (FDA), attorneys, a physician and a biological researcher. Everyone was working with a kind heart, which I could feel. The key issue, to my understanding, is on how to handle the off-patent biological molecules that have been used as medicine, such as insulin.
In his opening statement, Senator Hatch said by way of introduction:
“The area of biologics is of growing medical and economic importance. The biotechnology market posted a total of about $30 billion in sales last year, which is expected to double to over $60 billion by 2010.

“We will see a concurrent explosion in the numbers of biologics; there are now over 150 FDA-approved products on the market, with an additional 350 in various stages of human clinical testing and over 1,000 others in the development pipeline.

“But more important than commercial considerations, it is the hope of many that biological products, such as those that may one day be developed from embryonic stems cells, could lead to cures to many diseases that cannot be successfully treated today. Biopharmaceuticals appear to represent the future of medicine.”

I felt sadness in my heart: such a great expectation and enthusiasm from so many people towards scientists, who are supposed to find the way to health. But the reality is far different from this expectation.

I am a molecular biologist, currently residing at Seattle, Washington. I have spent most of my past 16 years in studying molecules, trying to understand their synthesis, modifications, activities and regulations. The observations made in my lab have been published in some of the best scientific journals, such as Science and Cell. As a consultant for Biotechnology and pharmaceutical companies, I also learned the drug discovery aspects and the profit generating aspects of the companies. Currently I am the Principal Investigator for a research laboratory at an Immunology Research Center in Seattle and hold an affiliate Assistant Professorship at the University of Washington, and have been an American Cancer Scholar. Several years ago, I received a grant from America Cancer Society, which generously provided me with almost one million dollars to study a set of molecules, which are implicated in cancer formation. I remember I stated in the proposal that my studies of these molecules could lead to some kind of cancer therapeutics. Many labs are doing a similar type of work. Quite a lot of resources have been put into these types of work. But in most of the scientists' minds, the research is for discovery, not for finding a cure. The statements for “curing cancer” or “finding molecular therapeutics” have been simply a method of grant writing craftsmanship. Usually four years of studies would lead to some publications, which are then buried in very specialized scientific journals, known only to a few people in areas that are directly relevant to the published work.

So here I am, listening to the hearing. I noticed that I am facing new topics that are equally bothering and require some reflection.

The topics touched upon, during the more than two hours of the hearing, concerned major issues that, if unresolved, can affect every one of us. Because of this, I feel that it is my responsibility to take this matter seriously and voice my comments.

First, regarding the molecules that are called biopharmaceuticals, we should know that they are molecules made by our cells and act upon our cells, in an extremely powerful way. Insulin, for example, is critical for regulating the glucose metabolism and lacking its function leads to diabetes. Interferon gamma is a protein that is critical for the activation of the immune system to launch battles against viral infection. These molecules act upon many cells at once and are not only potent but also very sophisticated in every aspect of their making, modification, activation and function. For the same cell, the molecule can do different things at different times, at different dosages and working with different combinations of other proteins. The responsiveness of cells to the same molecules can constantly change. Different people's cells also can respond differently to the same dosage of the molecule, since the responses depend upon the protein activities inside of the cells. I can go on to list all the complications, but a simple summary is that the molecules are not mechanical entities, but living entities. To manipulate these molecules for a single-minded purpose, we need to be fully aware of the sophistication of these molecules. Otherwise, it is like a child who does not understand what a bomb is, playing with a bomb. However, the current state of our science has not yet resolved the mysteries of these molecules. In fact, no scientist can be confident enough to say that he knows the molecule so well that its behavior is predictable. Even for insulin, a molecule that has been used as a biopharmaceutical for so many years, its mechanisms of action are still not fully understood, thus its actions under new circumstances are unpredictable. Now the production of these molecules so far has been achieved in artificial systems that in fact are very different from human cell environment. The alterations of these molecules in these artificial systems are major and the conditions for the making of these molecules determine the qualities of the molecules produced. The protocols for making these molecules involve multiple steps and the application of many different reagents, which also include biological products from animals, such as the serum from cattle. Thus, even if the protocol for making insulin is totally standardized, the quality of the produced insulin is determined by so many factors along the production line that nobody can guarantee the safety of the products until the final product is put into clinical tests. In other words, the production of a powerful biological molecule is an art that is still only mastered by a few. Even the few who have mastered the art cannot guarantee the safety of these molecules without testing in a real person, since the reagents involved are fresh and could be a sources of contamination by dangerous factors such as an undetected deadly virus.

Because of these factors, it could be a fatal mistake for policy makers to overlook the seriousness of the issues, just because of the consideration of achieving a goal of reducing the price of the drugs or for the sentimental pursuit of winning a competition. Lots and lots of precious lives are involved in these decisions. While sitting amidst a room full of people today during the hearing and listening to the comments on trying to speed FDA approval, I had an image in my mind, quite vivid, of the speeding Titanic, on the night of the deadly crash into the iceberg. No matter how advanced in our intellectual pursuit, human errors due to human weaknesses, even at one individual level, could bring the disaster to an entire nation, or even more. This is the sadness of a scientist, who sees that the pure-hearted pursuit for intellectual knowledge has been misused many times by irresponsible ignorance, for an ignorant pursuit of self-gratification that disregards the fundamental laws which the scientist honors.

Thus, I propose that the best safeguarding mechanisms we can do, in fact, is nation-wide education. The public, who supported all the research that has led to the current understandings of these powerful molecules, is entitled to know all aspects of these molecules, if they are counting on the application of these molecules for their health. The policy makers, to assure their ability to make the correct current decision, also require an in-depth knowledge of these molecules and the art of the management of these molecules so that wise leadership is possible. The other critical aspect of the required education is on the science of life in general. In a society where people's minds are dominated by competition for profit, irresponsible actions are bound to occur. The production of biopharmaceuticals can not be allowed to afford such irresponsibility. The real challenge we are facing is basic human quality. Again and again, in recent years, I see the true importance of human beings’ being able to reflect on the fundamental issues we are facing, instead of continuously pursuing profit and immediate material benefits. This is a very big topic which I will not extend further at present, but I recommend some of the essays listed on our website .

Based upon these analyses, I do worry about the current state of biopharmaceuticals in areas such as China where no safeguarding mechanisms have been imposed. I know there are many people who are considering going to China to start biotechnology companies for the cheap labor and loose policies. In the past several years, we have heard bad news from China. The news was covered up carefully and it took some very brave people to risk their safety and even their lives to bring these issues out to the international community. These included the HIV/AIDS crisis due to unsanitary blood collection methods, SARS of mysterious origin, and the persecution of 100 million innocent Chinese Falun Gong practitioners who simply believe in Truth, Compassion and Tolerance. Under such conditions, if it is allowed for generic biopharmaceuticals to be produced and exported from China, what will be the consequences? If American companies go into China to make products using cheap labor, can we trust such products? Isn't it also the responsibility of the scientific community and the government officials here to safeguard such practices? I see an urgent need for a hearing to be called for examining the practices in this area in China to avoid potential biotechnology disasters.

I have also heard that FDA will hold scientific forums on this topic. Here I urge the scientific community to take an active role in helping the government officials to have sufficient scientific information for correct decisions to be made. It is time for scientists to take on a new role in educating the public and all policy makers who need health-related knowledge in order to do their job well. I also hope that the government has new policies implemented to encourage scientists to do more dry science, that is, to analyze and integrate the currently existing knowledge and therefore help to reduce the amount of waste resulted from rushed or redundant experiments, due to competition. The new non-profit organization I am working on has the mission of delivering frontier molecular biological observations to the general public through artistic expression and also actively enhancing the cross talk between the ancient Eastern science and modern Western Science. My heart holds a beautiful wish for this work to blossom for the benefit of all of us at this critical time of history.

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