March 23rd, 1998

HORROR APPROACHES AGAIN
By Jackie Alan Giuliano

History is an easy thing to ignore. Through ignorance and greed and, sometimes, just plain inexperience, much suffering has been caused by industrialization and technology. Making a mistake once - or even twice - can often be forgiven. But when greed is allowed to run rampant and rationalizations are made to the horrors of history, the gap between our minds and our souls widens.

The front page of the March 26, 1998 Los Angeles Times carries an article about the U.S. Food and Drug Administration's plan to approve the use of Thalidomide again. This move will spell the beginning of a genetic nightmare that even those sponsoring the action admit to.

Dr. Cynthia Moore, of the U.S. Centers for Disease Control, said at a conference last fall that, "If thalidomide is made available in the United States, it will be used by women of childbearing potential, and babies will be born with thalidomide birth defects." FDA official Dr. Debra Birnkrant said "It's probably true, unfortunately." Yet approval appears imminent. Sadly, even the head of the thalidomide survivors organization is helping them write the warning labels.

I feel so moved to action by this article that I am repeating a section of another Healing Our World commentary called "What Could Possibly Be Next" which addressed the thalidomide controversy last fall. Those of you who feel moved by this issue must contact the U.S. FDA now (see Resources below).

Since the end of World War II, bigness has been the goal of the industrialized nations. "Centralization, concentration, and accumulation became the watchwords of modernity," says Jeremy Rifkin. He says that "everywhere there was a mad scramble to develop and enlarge . . . building up, expanding out, filling - a world of gigantism had cast a menacing shadow over earthly affairs."

This history has created a drive in our Western culture, and all those who aspire to be like us, for high-speed efficiency. Time is perceived to be a premium, a scarce resource that is only of value when it is filled to overflowing. We have created artificial and arbitrary standards by which we measure the effectiveness of our day and our lives. These "artificial time worlds" as Jeremy Rifkin calls them, increase our separation from the rhythms of nature - which are the rhythms of our bodies and our lives. We are cut off from the inherent pace, tempo, and cycles of the natural world.

War are without a deep connection to the rhythms and cycles of the natural world which are our own personal rhythms and cycles as well. We have relied on television and the other media to tell us what is important and what is news. This has resulted in disproportionate responses to world events and tragic omissions in our awareness of that which the media decided was not news for the day.

As spring envelopes the Northern Hemisphere and the wildflowers bloom, the U.S. Food and Drug Administration is recommending that the obscene and deadly drug, Thalidomide, be approved for use again. They say it is to treat a complication of leprosy, a rare, but curable, disease that affects 2 million people throughout the world. They say that it can give relieve to sufferers of AIDS and cancer.

But at what cost to our future and to our children? On Saturday, September 6, 1997, the Los Angeles Times had a small article about this on page 6, at the top of a page dominated by a mattress sale. In the San Diego Union Tribune where I saw it at the time, it was on page 8. The story said the FDA is recommending "tightly controlled" use. Today, March 26, 1998, it is on page one of the L.A. Times. Approval seems imminent.

Thalidomide was developed in the 1950s in Germany, first as a sedative and then widely used as a pill to ease morning sickness. But soon, thousands of babies were born without arms or legs or with flipper-like feet. Some had only a head and torso. In many cases, the pregnant women took only 1- 100mg pill, often borrowed from a friend.

Between 1958 and 1962, over 12,000 babies in 48 countries were born terribly deformed. The L.A. Times article casually states that "the drug was never sold in the United States because an FDA scientist uncovered early signs of toxicity and blocked approval. Still, some Americans got it overseas or in clinical trials." What they didn't tell you was that 3,000 Americans were given the drug between 1958 and 1962 as part of a marketing study! At least 9 Thalidomide children are the result of that giveaway. The lies and deceptions run deep in our world.

In 1993, the Arts and Entertainment Television Network program called "Investigative Reports" exposed the Thalidomide crisis. Still, no one heard. No one listened. It was "news" for an hour. Then we went on with life. Fortunately, I recorded that program and put it in my library. I knew it would be important. I watched it again this morning and cried again. Let me share with you some of what I learned through my tears because you will not learn it from TV or newspapers or the FDA.

There are 8,000 survivors of Thalidomide in the world today. There are 3,000 in Germany, 1,000 in Europe, and others in Japan, Asia, and Latin America. There is a small group of 230 in Brazil who are still fighting today for compensation and recognition. Brazil is an example today of Thalidomide use out of control.

In 1993, over 8 million Thalidomide tablets are manufactured per year in Brazil and over 10,000 tablets per year in South Wales in the United Kingdom. Thalidomide is being used to treat not only the side affects of leprosy drugs, but in Britain it is widely used to treat a condition that results in terrible mouth ulcers in AIDS and non-AIDS patients. It has even been used to treat back pain in Britain. In the U.S., it is being studied as a treatment for tuberculosis. Since its worldwide withdrawal (it was never really "banned") in 1962, Thalidomide has been quietly coming back. The Brazilian and British governments claim that the use of the drug is tightly controlled and the World Health Organization has even recommended its use. Yet A&E's Investigative Reports program found many Thalidomide children in Brazil, some as old as 21 years!

Brazil has the 2nd largest leprosy population in the world - and many of them are just a few blocks away from the glitzy Rio de Janeiro. Over one-half of the 150 million people in Brazil live in abject poverty. Forty million are malnourished, 20 million are illiterate, and one baby in every 10 dies. There is a new case of leprosy every 18 minutes! Today leprosy, probably the most misunderstood disease in the world, is curable with powerful antibiotics. Leprosy is a disease that attacks the nerves. The victim looses feeling in their limbs and fingers and when they get wounds or have accidents, they don't notice the damage. This is where the belief arose, fostered by motion pictures, that the disease makes your limbs fall off. Thalidomide is being used to treat the side affects of the antibiotics being used to treat the disease.

Many doctors worldwide say that there are alternatives to Thalidomide and that there is no excuse for using this deadly drug. But the officials who approve such things never venture into the slums or the Amazon rain forest where the drug is terribly abused.

A&E found many tragic cases throughout Brazil of pregnant women who were given Thalidomide by their doctors and who felt they were not adequately warned. Well-meaning husbands who were being treated for their own symptoms and didn't understand gave their pregnant wives the drug. One of these cases was a 9-year old boy, born without legs, his mother given the drug by a doctor. She receives no money at all for her son's disability. Another victim, a 21-year-old woman, rarely ventures from the leper colony where she lives in Brazil.

In a small town in Brazil, 9 year old Michele waits at the bus stop to go to school. The driver passes her by because she has so much trouble getting onto the bus with her artificial legs - they do not bend.

In the Amazon rainforest, Thalidomide is given out freely. The undereducated people, many who travel three days in canoes to get their drugs, do not understand the connection between taking a pill and having a deformed baby.

Officials say that distribution of the drug is tightly controlled. A&E sent a 23 year old woman into one of the local wholesale pharmacies that carries Thalidomide. The woman, accompanied by a hidden camera, was sold three bottles of 10 tablets each of Thalidomide with no prescription! And to make matters worse, the bottles had badly worded warnings in English only - the woman spoke only Portuguese!

This is what we miss when we let the news media set our priorities for us. The past is forgotten. In the L.A. Times article, one of the world's top leprosy physicians said to the FDA panel that "one day a Thalidomide baby will be born." Such ignorance is inexcusable. They have been - and are being born - today.

The FDA panel's solution to the risks: accept a proposal by one of the companies that hopes to sell Thalidomide, the Celgene Corporation in New Jersey. The company says that all you need to do is require a patient and a doctor to both sign a form that says they both understand the risks before the drug can be dispensed. Our modern-day solution to many problems is to post a sign or get a signature on a form - this somehow relieves the perpetrator of responsibility. They are being blinded by the billions of dollars to be made by re-releasing this drug.

I am enraged that the U.S. FDA could come to such a reckless conclusion. We must work together to stop this horror. Many Thalidomide survivors had hoped that their generation would be the last - an example of medical science gone mad. They had hoped that lessons would be learned. Some even support the release of the drug in a vain attempt to find meaning in their senseless struggles. It is so ironic that the very drug that resulted in tighter control of drugs and serves as the shining example of medical folly is back - in a big way.

I was horrified as I searched the Internet for information on Thalidomide and discovered the large amount of misinformation, particularly among AIDS support groups. One web site minimized the issues with statements like "Thalidomide was once widely used during pregnancy to relieve morning sickness. While it is no longer used for this purpose, it is potentially useful in the treatment of several AIDS-related conditions." The description goes on to say that "the most serious side effect of thalidomide is the potential to cause birth defects. It was found to cause deformed limbs in the children of women who took the drug early in pregnancy. Appropriate birth control methods (e.g., birth control pill plus barrier method for women, condoms for men) must be used by people of child-bearing age who are taking thalidomide." The follies of history are minimized and lost with descriptions and rationalizations such as these.

And the Celgene Corporation stands to make a lot of money from the authorization of this drug. Sadly, one of the driving forces behind the idea of using Thalidomide rather than create a new drug is economics. What a surprise. A brand new drug would cost millions of dollars more in research and testing. Thalidomide is kind of a "freebee" to the pharmaceutical industry since so much is known about it. Call me crazy, but this is not the right reason to use a drug that has caused so much anguish.

This is just one of many ticking time bombs in our world - time bombs that we miss because the news media sets our priorities. We have lost our connection to the natural cycles of the world, natural rhythms that, when honored, tie our minds and our hearts together. When we listen to the natural rhythms of the world, it is not all that difficult to call an abomination an abomination. There is no need for a cost-benefit analysis, no need for an advisory panel. Some things are wrong. Period.

Those who suffer from the symptoms that Thalidomide is treating deserve relief. They deserve to have all the money necessary made available to find the right substances or approaches that will ease their suffering. Common people in the world came up with $160 million in three days for Princess Diana's charities, and the billionaire father of Diana's companion who also died in the crash offered $8 million to build a hospital for children. Money is not the issue. There is plenty of money in the world. It's about choices.

The issue is about our values. We can make the right choices. We must make the right choices. We must not be afraid to call things by their right name.

I want to know why
The rain is falling
I want to know why
There is a rainbow in the sky
I want to know why
The people are hungry
Why
Life in this country is at a
standstill
Why
The days seem to grow longer
And life shorter
Why
The people are forced to
tighten their belts
Watching their harvest
Being shipped off
Why
Children have no milk on their
table
Neither rice to eat
I want to know why
Those children are singing
Why
There is a red moon sleeping in the sea
Why
Soldiers are trained to kill
To hate
To rage
To savage
To steal
Why darkness is coming
As darkness has
Reigned
For so long . . .
But above all
I want to wake up in the
morning and hear
Everybody shouting
WHY? WHY? WHY?
--Helvecio Mendes

RESOURCES 1. Contact the FDA and tell them that you do not want history repeated. Alternatives must be explored. Tell them you want them to spend money to develop new ways to treat the diseases that thalidomide seems to affect. Tell them the price of thalidomide is too high. The FDA is a large organization. Send your electronic comments to the following locations: http://www.fda.gov/comments.html or to the FDA Center for Drug Evaluation and Research at cderexsec@cder.fda.gov

2. You can read the FDA's side of the story at http://www.fda.gov/fdac/features/1997/697_thal.html

3. Write to the Chairman and Chief Executive Officer of the Celgene Corporation to express your views. Tell them to put corporate greed second to human responsibility. He can be reached toll-free at Tel: 800-896-6766, 7 Power Horn Drive, Warren, NJ, 07059.

4. To view some of the results from the studies of the use of Thalidomide with AIDS patients, visit http://www.gmhc.org/aidslib/ti/ti911/ti911g.html Prepare to be angry at the ease that they deal with the birth defects issue.

5. Read a position paper calling for an end to the current use of Thalidomide by the Thalidomide Victims Association of Canada at http://www.thalidomide.ca/

6. An interesting perspective on what will happen if Thalidomide continues on its course for approval from the FDA can be found at http://w3.aces.uiuc.edu/DLM/Liberty/Tales/Thalidomide.html

7. Read any of the works of Neil Postman for an outstanding analysis of the media and technology and their affect on our lives. Powell's on-line used and new bookstore can help you find them. Visit them at http://www.powells.com/

8. Visit Changelinks for a comprehensive listing of activist happenings in Southern California as well as links and articles at http://www.labridge.com/change-links/

9. Get help with the complexities of life with thought provoking articles at the Context Institute. Visit them at http://www.context.org/

10. Visit a comprehensive list of peace listings at http://www.nonviolence.org/links.htm

11. Learn about spring and the wheel of the year at http://www.pagespub.org/paganpages/Lena/spring.htm

[Jackie Giuliano can be found tearing what's left of his hair out in Venice, California. He is a Professor of Environmental Studies for Antioch University, Los Angeles, and the University of Phoenix Southern California Campuses. He is also the Educational Outreach Manager for the Outer Planets/Solar Probe Project, a NASA program at the Jet Propulsion Laboratory to send space probes to Jupiter's moon Europa, the planet Pluto, and the Sun. Please send your thoughts, comments, and visions to him at jackie@deepteaching.com and visit his web site at http://www.jps.net/jackieg}