SR0035 94TH GENERAL ASSEMBLY

SR0035 LRB094 06999 RXD 37120 r

SENATE RESOLUTION

WHEREAS, The drug industry funds 80% of the clinical trials conducted for new drugs; and

WHEREAS, Drug companies have a history of designing clinical trial research studies that by the nature of the design favor a positive outcome for their product; and

WHEREAS, Two studies published in 2003 in the Journal of the American Medical Association and the British Medical Journal showed that the odds are 3.6 to 4 times greater that commercially sponsored studies will favor the sponsor's product than studies without commercial funding; and

WHEREAS, Drug companies have the untenable power to publish only the data from clinical trials that they choose to publish; and

WHEREAS, This power has led to the suppression of important clinical trial data that warns of the health hazards and limited efficacy of a number of drugs that have made it to the market; and

WHEREAS, A number of drugs have been pulled from the market or reevaluated for labeling after suppressed and new clinical trial data has been made public, some examples include Omniflox, an antibiotic pulled in 1992; Rezulin, a drug for diabetes pulled in 2000; PPA, a decongestant pulled in 2000; Fen Phen or Redux, a drug for weight loss pulled in 1997; Vioxx, a drug for pain relief pulled in 2004; Paxil, Zoloft, Effexor, and Lexipro, relabeled in 2004 for dangerous side effects; and

WHEREAS, The suppression of clinical trial data continues to create a national health crisis; and

WHEREAS, The drug companies are profiting more than 3 times the average of other Fortune 500 industries and have a financial interest in producing and publishing only clinical trial data that favors their products; and

WHEREAS, The prioritization of profit over scientific integrity and public health is an egregious and life-threatening practice; and

WHEREAS, There is a need for a public database that registers all clinical trial studies being performed and that publishes the results from those trials in a publicly accessible database; and

WHEREAS, The FDA accepts roughly 200 million dollars annually from the drug industry; and

WHEREAS, According to an article published in the Journal of the American Medical Association in 2004, more than half of the members on FDA expert advisory panels in charge of approving drugs have direct financial interest in the drug or topic they are evaluating; and

WHEREAS, The FDA cannot always be an objective body when reviewing and monitoring drugs if it is so financially beholden to the drug companies; and

WHEREAS, An internal FDA survey found that about two-thirds of agency scientists are less than fully confident in the FDA's monitoring of the safety of prescription drugs now being sold; and

WHEREAS, The same survey found that more than one-third of those scientists had some doubts about the process for approving new drugs; and

WHEREAS, Over the last 12 years, the FDA has slashed its budget for monitoring adverse reactions to drugs already on the market in favor of increasing its budget for approving drugs; and

WHEREAS, The FDA approval time for drugs has decreased by half in recent years, 27 months in 1993 and 14 months in 2001; and

WHEREAS, The relaxed vigilance of drugs that are already on the market and the increased rate of drug approval means that more drugs are on the market and that less care is being taken to ensure the efficacy and safety of these drugs; and

WHEREAS, The chairman of the Senate Finance Committee, GOP Senator Charles Grassley of Iowa, has suggested that an independent board of drug safety may be needed to ensure the safety of medications after FDA approval; and

WHEREAS, An independent board of drug safety with no ties to the drug industry is essential to ensure the proper monitoring of newly released drugs; and

WHEREAS, Having the FDA and drug industry in charge of the current monitoring system, as is presently the case, presents a direct conflict of interest, entrusting the very people who developed, approved, and profit from the product with the responsibility of reevaluating and pulling that product from the market if warranted; and

WHEREAS, This drug safety board would have no involvement in the original approval of drugs but would closely monitor adverse drug reactions reported to their agency and would conduct follow-up clinical trials on drugs whose safety has been called into question; and

WHEREAS, The present system is an established oligarchy where the drug industry designs the studies, decides which studies to publish, reaps the financial reward of the high priced, heavily marketed drugs, and then takes responsibility for judging the safety and efficacy of their product once it is making millions in the marketplace; therefore, be it

RESOLVED, BY THE SENATE OF THE NINETY-FOURTH GENERAL ASSEMBLY OF THE STATE OF ILLINOIS, that we urge the President of the United States, the Congress of the United States, and the U.S. Food and Drug Administration to establish an independent board of drug safety and a public database of all clinical trial data to ensure that the safety and efficacy of drugs that are sent to market and that stay on the market are subject to the scrutiny of the public and doctors and researchers who have no financial ties to the drug industry; and be it further

RESOLVED, That suitable copies of this resolution be delivered to the President of the United States, the President pro tempore of the U.S. Senate, the Speaker of the U.S. House of Representatives, the Director of the U.S. Food and Drug Administration, and each member of the Illinois congressional delegation.