Truth in Trials Act

TRUTH IN TRIALS ACT -- (Senate - November 19, 2004)

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.