USA - towards a new look on thalidomide
Thalidomide was never approved in USA . Now strong forces acts to peruse new uses of the drug. One out of very few Thalidomide's in USA is Christine Block. In this text she tells about herself and about the upcoming demand for Thalidomide.
Christine Block is one of approximately 10 Thalidomide's living in USA . The drug was never approved in the 1960s. She is concerned about the new widened use of thalidomide in North America .
First of all, although I am an American citizen and have lived in the USA for 15 years, I was actually born and raised in Madrid , Spain . I consider myself as much an American as a Spaniard. My parents are from New York City and travelled to Spain as tourists many years ago. There they remained and had three children, my two sisters, Kendra and Sonja, and me. We were educated in the British school system in Madrid .
Of the various interests I have, my primary ones are classical music, the theatre, reading, and walking in the woods. While my sisters and friends were listening to rock and roll, I could not get enough of Beethoven and Tchaikovsky. I love sports, especially gymnastics and ice skating. My disability and heart condition limit my ability to participate in sports, but I do enjoy watching them. I swim whenever I can find a good pool or sea (if it is not too cold!).
When I was eighteen years old, I ventured forth alone to the Far Northwest of the USA , the State of Washington . It was like being a pioneer.
Thalidomide was never approved by the Federal Drug Administration (FDA) for use in the USA due to concerns of its safety. This was a landmark decision which changed the policies for approving drugs by the FDA. I have been told that at one time, about 288 new drugs were approved every year. After Thalidomide (in the 1960's) only about 18 new drugs are approved each year. After 20 and 30 years of very strict rules, pharmaceutical companies and the Women's Movement, that is working hard to loosen the strict rules on approving new birth control drugs, have been very forceful in trying to get the FDA to change its rules. Especially strong has been the AIDS Movement in demanding that everything possible should be done to get the necessary drugs to the market in order to save people from certain death. The FDA policy is starting to change. As the FDA Commissioner David Kessler say, "Back in the 1960's and 1970's, the post-thalidomide era, FDA's mission was to keep unsafe products off the market. But in dealing with AIDS, we have learned that our job is not only to keep unsafe drugs off the markets but to get safe and effective drugs to the market... The pendulum has swung."
I earned my Bachelor of Arts degree at Pacific Lutheran University , and my Master of Social Work degree at the University of Washington . For eleven years I have worked as a medical social worker in hospitals. Then, I was the Social Work Director of a nursing home. My job included working with older people and their families, management, and supervision. Now I'm back as a social worker employed by the city of Seattle . But professionally, I am interested in returning to medical social work in rehabilitation medicine.
Seattle , located on the west coast in the state of Washington , "the Emerald City ," is where I live - very far from my other home in Spain . The city is on the water, the Puget Sound . It is covered with trees and surrounded by spectacular mountains. My favourite is Mount Rainier, also known by the Native American Indians as Mount Tahoma .
Seattle could almost be paradise, but it has a few problems: It rains very often, it has very steep hills, and when it snows the city falls apart because of the traffic chaos. From one window of my apartment on Queen Anne Hill, I can see the Space Needle, the downtown skyline, and on a clear day- Mount Rainier . The port is busy with the sounds of ships coming and going from the Orient, South America , Alaska , and elsewhere. The area is well known for two very important industries, Boeing aircraft and Microsoft computer software.
Considering my disability, and a unique one at that in this country (I am the only Thalidomide in the state of Washington that I know of), I have been able to achieve many wonderful dreams. For the last fifteen years, I have lived in a foreign country on my own, completed my education, developed my career, enjoyed a good lifestyle, travelled a bit, and made some good friends. Hopefully, with my life yet to come, I will have the opportunity to achieve many more dreams.
Activist movements pick on the FDA
It is during this climate of strong activist movements affecting the strict rules of FDA policies that thalidomide is making its return. The drug is used in research for treatment of a variety of diseases, such as ENL (a painful and deforming symptom of leprosy); Tuberculosis; Graft versus host disease, CGVHD, (when the new bone marrow tissue tries to reject its new body and causes such symptoms as blindness, mouth ulcers, loss of teeth and death); Blindness (thalidomide may be useful against eye disorders); Oral and genital ulcers; And finally AIDS and HIV. This has been perhaps the most studied area. The researchers have found that Thalidomide inhibits the cause of HIV symptoms, and it fights cachexia (Severe weight loss in AIDS-patients. One extreme was a patient weighting 60 kilos = 132,277 lb = 9,448 stone , who had diarrhoea with 10 bowel movements daily for a whole year. Three days after thalidomide was given the diarrhoea stopped and the patient gained 10 kilos = 22,046 lb = 1,575 stone ).
The American Disabilities Act was passed to protect the right of people with disabilities to equal access of education, housing, employment, and to the community in general (e.g., transportation). This Act moved the Disability Movement forward towards a better future. I find that many American people with disabilities insist upon being as independent as possible with as little help from the government as possible.
In fact, very few people with disabilities qualify for any kind of government assistance. For many of us this is "OK" because all we want is the opportunity to compete with everyone else to achieve our goals.
How interacting with others?
Frequently, I question whether or not my disabilities have limited me in my life. Physically, my disability prevents me from doing what others do. What I feel about my disability influences how I interact with others. Since I am the only one with my disability it creates extra anxiety on the part of others towards me. With every person I meet, I feel that I must first make them calm and comfortable around me by using humour and a calm tone, just so that they may begin to get to know me as a person, let alone a potential mate or employee. It is a continuous tight rope on which to walk.
Yes, my disability has negatively affected me in many aspects of my life. However I do feel it has influenced the person I have become in a very positive way. The disability is only part of who I am.
Excellent market potential
One of the first companies given permission by the new, more lenient FDA to develop and use Thalidomide in clinical trials to treat AIDS-relate symptoms is Celgene Corporation. Celgene has looked at the risk versus benefit of developing thalidomide and feels it has such excellent potential despite its negative history. The company's ultimate goal is to develop more potent drugs (based on thalidomide) with fewer side-effects. Celgene has renamed the drug "Synovir," perhaps to improve the marketing potential.
The President of Celgene, Sol Barer (whom I interviewed by telephone), say that science has come a long way since the 1960's and that the company are being very careful with their clinical trials to prevent any chance of a female volunteer taking thalidomide if there is a possibility of pregnancy.
I hear desperation
But am this enough? Even with all the regulations, could there be problems? These are some of my questions that have not been fully answered. I hear the desperation of people suffering from terminal, painful diseases who seek an answer to their agonies. But could such desperation lead to unsafe measures? Could people who are dying be persuaded that Thalidomide is the answer and then try to get it on the black market since it is, still, only in the clinical trials with the researchers? At this time there are two groups that supply experimental drugs to AIDS patients through telephone orders: Life link and Healing Alternatives. Both import thalidomide from Brazil and say they have "been extraordinarily careful." The President of Life link says "Thalidomide's problems in the 1960's were based on ignorance. People seeking the drug now are more knowledgeable."
The ultimate dilemma
We face the ultimate dilemma: While the government tries to protect the population from possible harmful drugs with regulations, people who are dying and looking for a cure or an answer to suffering are taking desperate and, perhaps, unsafe measures. They do this by pressuring agencies to quickly approve drugs or by looking for them on the black market.
If thalidomide is going to be approved, there will be warning labels on bottles, intense education of doctors and of patients, and close monitoring of patients throughout the treatment. How, and when, thalidomide is given could also be a factor, e.g. while the patient is in the hospital, or during clinic visits through injections.
As a person with a disability associated with thalidomide, I find it extraordinary that it may be very helpful to people who are suffering with other problems. However, I do hope those who take it legally (through the researchers) or illegally (through the black market) do take every measure to prevent another person from being born with a thalidomide-type disability.
Need of an international clearing house
My vision for the international Thalidomide's body; UNITH, is a place to meet fellow Thalidomide's from around the world; a clearing house of information for members regarding issues of support, family life, medical technology concerns; a place where, new people affected by the drug, or anyone affected similarly, can come for support (such as the children from Brazil and their families). My friend David said, "Thalidomide is the last thing we have in common. We all have unique backgrounds and our disabilities have affected us in different ways. Nevertheless, we have been through it, now we can help others.
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