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.