[Congressional Record (Bound Edition), Volume 150 (2004), Part 18]
[Senate]
[Page 24228]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          TRUTH IN TRIALS ACT

  Mr. GRASSLEY. Mr. President, the Federal Government has a long-
standing obligation to monitor the purity, safety, and effectiveness of 
the medicines that are available to the public. For this reason, I 
would like to express my opposition to S. 2989, the Truth in Trials 
Act. This legislation reverses almost 100 years of progress that we 
have made by undermining any scientific evidence about medicine and 
replacing it with popular referendums passed by slick ad campaigns.
  There was a time in this country when individuals and businesses 
could market anything as a medicine and make any claim for its 
effectiveness. Because of this, a flood of narcotics and stimulants 
were freely marketed as nostrums sold over the counter and through the 
mail. Often these ``miracle cures'' were miscellaneous concoctions made 
from unknown ingredients. In addition, these nostrums were often 
accompanied by endless testimonials from satisfied customers on how 
well these products performed.
  Thankfully, our grandparents and great-grandparents, who had to deal 
with these practices, woke up to the fraud that was being perpetrated 
on the public by these ``snake-oil salesmen.'' These dangerous drugs 
were creating a major addiction problem, and the unknown ingredients in 
these cures were actually doing a great deal of harm. In response to 
demands from the public, truth in labeling was born.
  Consumers in the early 1900s took steps to ban dangerous drugs to 
determine what drugs had medical uses that could be demonstrated to be 
safe and effective. Based on this experience, the Pure Food, Drug, and 
Cosmetic Act, FDCA, of 1906 was passed, which required food and 
medicines be pure, and the contents of medicines be labeled. In 1938, 
the FDCA was amended to add the requirement that all medicines be safe, 
and the Food and Drug Administration was created to regulate this. In 
1962, the FDCA was further amended by the Harris-Kefauver amendment, 
which added an additional requirement that any medicine must also be 
effective, and further required the FDA to establish efficacy 
standards.
  Furthermore, a variety of laws were passed to deal with the 
distribution of dangerous drugs. The first of these was the Harrison 
Narcotics Control Act of 1914. The next major piece of legislation on 
drug control was the Marijuana Tax Act of 1937. These and other laws 
covering various types of drugs were replaced in 1970 when the 
Controlled Substances Act was signed into law. This Act further defined 
the process that a substance had to go through to become an acceptable 
medicine. In addition, a five-tier scheduling system for all 
pharmacological substances was established, allowing for the 
categorizing of all medicines and other pharmacological substances 
based on their abuse potential and accepted use as a medicine.
  Unfortunately, this does not mean that we will no longer have 
unscrupulous business enterprises that promise salvation through snake-
oil products. Over the past 60 years, the FDA has developed a careful, 
proven method for testing and approving drugs. This process is the 
standard by which the rest of the world measures the safety and 
effectiveness of their drug approval system.
  Americans today have the world's safest, most effective system of 
medical practice, built on a process of scientific research, testing, 
and oversight that is unequaled. Every drug prescribed as medicine in 
this country must be tested according to scientifically rigorous 
protocols to ensure that it is safe and effective before it can be 
sold.
  To this date, over 15,000 scientific, peer-reviewed studies into the 
medicinal value of marijuana have been published, and not one 
demonstrates that smoking marijuana has any medicinal value for any 
condition. In fact, there is medical evidence to suggest that marijuana 
may actually aggravate some of the conditions it is supposed treat.
  On top of all that, there are legal, effective medicines that are 
already currently available and meet all of the guidelines that have 
been established by the FDA. This includes Marinol, which is a legally 
available, FDA-approved form of a marijuana extract that is currently 
being used as a treatment for nausea and AIDS wasting syndrome. In 
addition, there are many other medicines that have been developed and 
received FDA approval that do not have the hallucinogenic side effects 
that come with smoking marijuana. These are medicines that meet 
scientific standards and do not rely on anecdotes and testimony for 
validation.
  Certainly, we all want to provide relief for people who are sick and 
dying, but smoking marijuana has not been scientifically proven to have 
any medicinal value. By allowing patients and caregivers to use and 
provide marijuana through the political process, we clearly bypass the 
safeguards established by the FDA to protect the public from dangerous 
or ineffective drugs.
  I urge my colleagues to join me in opposing this bill and other 
efforts to legalize marijuana.

                          ____________________