Thalidomide

# Since the mid to late 1950's, Thalidomide has been a controversial drug. Since its introduction it has seen its highs and its lows. From devastating birth defects, to a treatment for some life threatening cancers, Thalidomide could be considered the Jeckel and Hyde of the pharmaceutical world. The question that the pharmaceutical world is asking itself now is weather the risk of the possible devastating birth defects that can happen is worth the possible life saving benefits that could be gained. Thalidomide has been the topic of debate since its uses as a treatment of certain cancers has been discovered.

# The drug was first introduced in the Europe. Thalidomide was prescribed to pregnant women to try and combat morning sickness. Thalidomide was also used as a sleep enhancer in other patients. It was not until 1961 that the drug was linked to the horrific malformations such as babies being born with flipper like limbs. It was also blamed for other birth defects effecting the eyes, ears, heart, genitals, kidneys, nervous system and digestive tract. The possibilities of subjecting more babies and their families to the effects of Thalidomide has many people upset about the idea that it may be coming back on the market. Just one dose of the drug to an unborn baby can cause dire effects. It takes a very small amount to cause any one of the serious problems listed above.

# Thalidomide was never produced or distributed in the United States, but a handful of "Thalidomide babies" were born to American families. Seven thousand to twelve thousand babies were born with defects due to Thalidomide in other parts of the world, including Europe and Canada. (Snider, 1995) As a result of the numerous problems with the drug, the FDA has created new guidelines for preclinical animal test to learn if a new compound causes birth defects before it ever enters humans. (Brown, 1997) Teratogenic, or birth defect causing, drugs are normally yanked off the market way before studies have been done to see if they have any other applications. The views of the pharmaceutical world are that nothing can be gained from a drug that causes life altering birth defects.

# Now, years later, Thalidomide has been given a chance to redeem itself. Early research has shown that the drug has been effective in treating a variety of ailments such as leprosy, tuberculoses, HIV, arthritis, and even cancer. Can there be a silver lining to the dark cloud of Thalidomide? Can such a devastating drug be used to perform miracles? That is what scientists are trying to find out.

# After seeing the risks involved with Thalidomide, from birth defects to possible nerve damage, you might be asking yourself why anyone would ever consider taking such a drug. The answer to that question is that they would consider the drug as a last hope, or to prolong or add comfort in their final days. When a person is given no hope for a cure, any possibility becomes what could be the light at the end of a very dark tunnel. In some situations, conception is the last ting on their mind, so the possibility of birth defects is out of the question.

# Researches have found that Thalidomide can inhibit the growth of HIV in test tubes. (aegis, 2002) This is a glimmer of hope to a hopeless disease. Other benefits an HIV patient could get from Thalidomide are treatment of mouth ulcers and chronic wasting, two of the most debilitating symptoms of the disease. Trails for the drug have been limited and research is still in its early stages. Thalidomide is, by no means a cure for HIV or Aids, but it is, at this point, a very hopeful treatment.

# Imagine being a parent of a child with a life threatening form of cancer. The doctors have just told you your little girl has only six weeks to live. You start doing the things you think a parent on your situation should do, spending a much time as possible with your child. In your frantic search for a glimmer of hope in this, your darkest time, you come across Thalidomide. It is a drug that may save your child's life, or at least prolong it. There is one draw back. You may not be able to get the drug to treat your child because of it careless use and lack of testing during its first release. What would you do? You would the same thing any other loving parent would do, which is anything in your power to make that drug available. That is what is happening all over the world today.

# By far the most promising use for the ill-fated drug is to combat some types of cancer. USA Today published an article on the drug stating a case involving a 12-year-old boy with a brain tumor. The boy had received every treatment available. The boy's parents were finally told that nothing further could be done to save their child. They were told to spend what was left of his time wisely and cherish him while they could. Not willing to accept that, the boy's parents went searching for alternatives. They came across Thalidomide. They were aware of the drugs horrific past, but they where excited by the clinical trails where the drug delayed growth of certain types of cancer. After beginning treatment with Thalidomide, the boy experienced a dramatic change for the better. Most of his symptoms had disappeared and he was feeling more normal than ever before. (Fackelmann, 1999) He finally had a chance to grow up and live a normal life.

# The way Thalidomide works is that it, in effect, starves the cancer. It cuts off the blood supply to the tumors. Since tumors need blood to survive and grow, the drug cannot survive. In a groundbreaking trail, 39 patients were recruited with a type of brain tumor called giloblastoma. In the half of the group, the drug either stopped or slowed the growth of the tumors. The tumor shrank by more than half in two cases. In one case, the effects lasted more than 18 months. The drug did not alleviate the cancer, but it did slow the effects of the disease. (Fackelmann) Patients were given a new lease on a life that they thought would be over in a matter of weeks. Their remaining time on earth was prolonged by as much a year. This is remarkable.

# The next step was to try Thalidomide in combination with other cancer fighting treatments. A study was done when combining Thalidomide with chemotherapy. Of the 53 patients with giloblastoma, 37 people saw improvements. The tumors shrank in 12 of the cases and in one it completely vanished. (Fackelmann) Then main goal of the study was accomplished when they proved that the drug prolonged the lives of people with the cancer.

# In 1998 the Federal Drug Administration (FDA) allowed the sell of the drug to treat lepracy patients under tight restriction. When the drug is prescribed, the patient is required to be enrolled in a government-monitored registry. (Neergaard, 1998) Celgene Corporation, the