Full Text of SR0035 94th General Assembly
SR0035 94TH GENERAL ASSEMBLY
|
|
|
SR0035 |
|
LRB094 06999 RXD 37120 r |
|
| 1 |
| SENATE RESOLUTION
| 2 |
| WHEREAS, The drug industry funds 80% of the clinical trials | 3 |
| conducted for new drugs; and
| 4 |
| WHEREAS, Drug companies have a history of designing | 5 |
| clinical trial research studies that by the nature of the | 6 |
| design favor a positive outcome for their product; and | 7 |
| WHEREAS, Two studies published in 2003 in the Journal of | 8 |
| the American Medical Association and the British Medical | 9 |
| Journal showed that the odds are 3.6 to 4 times greater that | 10 |
| commercially sponsored studies will favor the sponsor's | 11 |
| product than studies without commercial funding; and | 12 |
| WHEREAS, Drug companies have the untenable power to publish | 13 |
| only the data from clinical trials that they choose to publish; | 14 |
| and | 15 |
| WHEREAS, This power has led to the suppression of important | 16 |
| clinical trial data that warns of the health hazards and | 17 |
| limited efficacy of a number of drugs that have made it to the | 18 |
| market; and | 19 |
| WHEREAS, A number of drugs have been pulled from the market | 20 |
| or reevaluated for labeling after suppressed and new clinical | 21 |
| trial data has been made public, some examples include | 22 |
| Omniflox, an antibiotic pulled in 1992; Rezulin, a drug for | 23 |
| diabetes pulled in 2000; PPA, a decongestant pulled in 2000; | 24 |
| Fen Phen or Redux, a drug for weight loss pulled in 1997; | 25 |
| Vioxx, a drug for pain relief pulled in 2004; Paxil, Zoloft, | 26 |
| Effexor, and Lexipro, relabeled in 2004 for dangerous side | 27 |
| effects; and | 28 |
| WHEREAS, The suppression of clinical trial data continues | 29 |
| to create a national health crisis; and |
|
|
|
SR0035 |
- 2 - |
LRB094 06999 RXD 37120 r |
|
| 1 |
| WHEREAS, The drug companies are profiting more than 3 times | 2 |
| the average of other Fortune 500 industries and have a | 3 |
| financial interest in producing and publishing only clinical | 4 |
| trial data that favors their products; and | 5 |
| WHEREAS, The prioritization of profit over scientific | 6 |
| integrity and public health is an egregious and | 7 |
| life-threatening practice; and | 8 |
| WHEREAS, There is a need for a public database that | 9 |
| registers all clinical trial studies being performed and that | 10 |
| publishes the results from those trials in a publicly | 11 |
| accessible database; and | 12 |
| WHEREAS, The FDA accepts roughly 200 million dollars | 13 |
| annually from the drug industry; and | 14 |
| WHEREAS, According to an article published in the Journal | 15 |
| of the American Medical Association in 2004, more than half of | 16 |
| the members on FDA expert advisory panels in charge of | 17 |
| approving drugs have direct financial interest in the drug or | 18 |
| topic they are evaluating; and | 19 |
| WHEREAS, The FDA cannot always be an objective body when | 20 |
| reviewing and monitoring drugs if it is so financially beholden | 21 |
| to the drug companies; and | 22 |
| WHEREAS, An internal FDA survey found that about two-thirds | 23 |
| of agency scientists are less than fully confident in the FDA's | 24 |
| monitoring of the safety of prescription drugs now being sold; | 25 |
| and | 26 |
| WHEREAS, The same survey found that more than one-third of | 27 |
| those scientists had some doubts about the process for | 28 |
| approving new drugs; and |
|
|
|
SR0035 |
- 3 - |
LRB094 06999 RXD 37120 r |
|
| 1 |
| WHEREAS, Over the last 12 years, the FDA has slashed its | 2 |
| budget for monitoring adverse reactions to drugs already on the | 3 |
| market in favor of increasing its budget for approving drugs; | 4 |
| and | 5 |
| WHEREAS, The FDA approval time for drugs has decreased by | 6 |
| half in recent years, 27 months in 1993 and 14 months in 2001; | 7 |
| and | 8 |
| WHEREAS, The relaxed vigilance of drugs that are already on | 9 |
| the market and the increased rate of drug approval means that | 10 |
| more drugs are on the market and that less care is being taken | 11 |
| to ensure the efficacy and safety of these drugs; and | 12 |
| WHEREAS, The chairman of the Senate Finance Committee, GOP | 13 |
| Senator Charles Grassley of Iowa, has suggested that an | 14 |
| independent board of drug safety may be needed to ensure the | 15 |
| safety of medications after FDA approval; and | 16 |
| WHEREAS, An independent board of drug safety with no ties | 17 |
| to the drug industry is essential to ensure the proper | 18 |
| monitoring of newly released drugs; and | 19 |
| WHEREAS, Having the FDA and drug industry in charge of the | 20 |
| current monitoring system, as is presently the case, presents a | 21 |
| direct conflict of interest, entrusting the very people who | 22 |
| developed, approved, and profit from the product with the | 23 |
| responsibility of reevaluating and pulling that product from | 24 |
| the market if warranted; and | 25 |
| WHEREAS, This drug safety board would have no involvement | 26 |
| in the original approval of drugs but would closely monitor | 27 |
| adverse drug reactions reported to their agency and would | 28 |
| conduct follow-up clinical trials on drugs whose safety has | 29 |
| been called into question; and |
|
|
|
SR0035 |
- 4 - |
LRB094 06999 RXD 37120 r |
|
| 1 |
| WHEREAS, The present system is an established oligarchy | 2 |
| where the drug industry designs the studies, decides which | 3 |
| studies to publish, reaps the financial reward of the high | 4 |
| priced, heavily marketed drugs, and then takes responsibility | 5 |
| for judging the safety and efficacy of their product once it is | 6 |
| making millions in the marketplace; therefore, be it
| 7 |
| RESOLVED, BY THE SENATE OF THE NINETY-FOURTH GENERAL | 8 |
| ASSEMBLY OF THE STATE OF ILLINOIS, that we urge the President | 9 |
| of the United States, the Congress of the United States, and | 10 |
| the U.S. Food and Drug Administration to establish an | 11 |
| independent board of drug safety and a public database of all | 12 |
| clinical trial data to ensure that the safety and efficacy of | 13 |
| drugs that are sent to market and that stay on the market are | 14 |
| subject to the scrutiny of the public and doctors and | 15 |
| researchers who have no financial ties to the drug industry; | 16 |
| and be it further
| 17 |
| RESOLVED, That suitable copies of this resolution be | 18 |
| delivered to the President of the United States, the President | 19 |
| pro tempore of the U.S. Senate, the Speaker of the U.S. House | 20 |
| of Representatives, the Director of the U.S. Food and Drug | 21 |
| Administration, and each member of the Illinois congressional | 22 |
| delegation.
|
|