Hal's decision making model. Hal's decision making model. Educating people about risks & benefits of drugs

Transcription

1 Hal's decision making model Educating people about risks & benefits of drugs Facts Values Steven Woloshin, MD, MS & Lisa M. Schwartz, MD, MS and H. Gilbert Welch, MD, MPH VA Outcomes Group, White River Junction, VT Center for the Evaluative Clinical Sciences, Dartmouth Medical School, Hanover, NH Good decisions Outcomes Group Hal's decision making model Getting people the facts has not always been a FDA priority Facts Values [information in drug labels should] appear only in such medical terms as are not likely to be understood by the ordinary individual " Good decisions Federal Food, Drug, and Cosmetic Act, 3 Fed. Reg (December 28, 1938) 1

2 Assertion of efficacy - no data Data about popularity -- none about efficacy in an ongoing landmark study, over 90% of the 31 patients receiving CRIXIVAN, AZT, and 3TC reduced their HIV serum viral load below the limit of detection may help you live a longer, healthier life stopped 2

3 Chance of stroke... without lipitor: 2.8% with lipitor : 1.5% The wrong data Incomplete data LIPITOR improves your chance of being stroke free from 97.2% to 98.5% 3

4 People need data "Brief summary" How well does it work? What is the chance of the outcome if I take or do not take the drug? What side effects does it cause? What is the chance of different problems if I take or do not take the drug? Data about side effects No data about efficacy How to get people the data Require data about drug benefit and side effects in ads so consumers can make informed decisions Put this data in the brief summary in a simple tabular format so people can see it and bring it to the doctor Precedent: the FDA's nutrition facts box 4

5 Prescription Drug Facts: PRIDCLO (pricogrel) To reduce clotting in order to reduce the chance of having or dying from a heart attack Men and women with heart or vascular disease (a stroke or narrowed blood vessel in the leg) People with bleeding problems, liver or kidney problems None Descriptive information Eat a low saturated fat/low cholesterol diet, don't smoke, exercise more, look into other medications PRIDCLO STUDY FINDINGS 20,000 adults with heart or vascular disease were given PRIDCLO or aspirin for 2 years. Here's what happened: What difference did PRIDCLO make? Did PRIDCLO help? Aspirin (325mg a day) Fewer people had a heart attack (0.6% fewer) 3.3% 33 in 1000 No difference in dying from a heart attack PRIDCLO (75 mg a day) 2.7% About 1.4% in both groups 14 in 1000 Simple tabular display of quantitative info Benefit data No difference in dying from anything About 5.5% in both groups 55 in 1000 Did PRIDCLO have side effects? Life threatening side-effects No difference in strokes from bleeding into brain About 0.5% 5in 1000 Fewer people had major stomach bleeding (0.7% fewer) 2.7% 2.0% 20 in 1000 Fewer people had abdominal pain (1.5% fewer) 7.1% 5.6% 71 in in 1000 More people had bruising (1.6% more) 3.7% 5.3% 37 in in 1000 More people had diarrhea (1.1% more) 3.4% 4.5% 34 in in 1000 More people had a rash (0.7% more) 3.5% 4.2% 35 in in 1000 Side effect data Pridclo was approved by FDA in Studies show that most serious side effects or recalls of new drugs happen during their first 5 years of approval. Prescription Drug Facts: PRIDCLO (pricogrel) To reduce clotting in order to reduce the chance of having or dying from a heart attack Men and women with heart or vascular disease (a stroke or narrowed blood vessel in the leg) People with bleeding problems, liver or kidney problems None Isaac's Questions Eat a low saturated fat/low cholesterol diet, don't smoke, exercise more, look into other medications PRIDCLO STUDY FINDINGS 20,000 adults with heart or vascular disease were given PRIDCLO or aspirin for 2 years. Here's what happened: What difference did PRIDCLO make? Did PRIDCLO help? Aspirin (325mg a day) Fewer people had a heart attack (0.6% fewer) 3.3% 33 in 1000 No difference in dying from a heart attack No difference in dying from anything PRIDCLO (75 mg a day) 2.7% About 1.4% in both groups 14 in 1000 About 5.5% in both groups 55 in 1000 Can people understand the information in the box? Would it help them judge the benefits/harms of drugs Would they think the drug facts box is helpful Did PRIDCLO have side effects? Life threatening side-effects No difference in strokes from bleeding into brain About 0.5% 5in 1000 Fewer people had major stomach bleeding (0.7% fewer) 2.7% 2.0% 20 in 1000 Fewer people had abdominal pain (1.5% fewer) 7.1% 5.6% 71 in in 1000 More people had bruising (1.6% more) 3.7% 5.3% 37 in in 1000 More people had diarrhea (1.1% more) 3.4% 4.5% 34 in in 1000 More people had a rash (0.7% more) 3.5% 4.2% 35 in in 1000 Pridclo was approved by FDA in Studies show that most serious side effects or recalls of new drugs happen during their first 5 years of approval. 5

6 Can people understand the box? Two studies 1. Boston Study Trained field interviewers from the Center for Survey Research (University of Massachusetts) went door to door in the greater Boston area and conducted 203 in-person interviews 2. Vermont Study Convenience samples of 2 populations: Prior enrollees in lecture series (Dartmouth Community Medical School) VA patients and families 274 returned completed surveys Boston Study: Benefit box Prescription Drug Facts: PRIDCLO (pricogrel) To reduce clotting in order to reduce the chance of having or dying from a heart attack Men and women with heart or vascular disease (a stroke or narrowed blood vessel in the leg) People with bleeding problems, liver or kidney problems None Eat a low saturated fat/low cholesterol diet, don't smoke, exercise more, look into other medications PRIDCLO STUDY FINDINGS 20,000 adults with heart or vascular disease were given PRIDCLO or aspirin for 2 years. Here's what happened: What difference did PRIDCLO make? Did PRIDCLO help? Aspirin (325mg a day) Fewer people had a heart attack (0.6% fewer) 3.3% 33 in 1000 No difference in dying from a heart attack No difference in dying from anything Did PRIDCLO have side effects? Life threatening side-effects PRIDCLO (75 mg a day) 2.7% About 1.4% in both groups 14 in 1000 About 5.5% in both groups 55 in 1000 No difference in strokes from bleeding into brain About 0.5% 5in 1000 Fewer people had major stomach bleeding (0.7% fewer) 2.7% Fewer people had abdominal pain (1.5% fewer) 7.1% 71 in 1000 More people had bruising (1.6% more) 3.7% 37 in 1000 More people had diarrhea (1.1% more) 3.4% 34 in 1000 More people had a rash (0.7% more) 3.5% 35 in % 20 in % 56 in % 53 in % 45 in % 42 in 1000 Pridclo was approved by FDA in Studies show that most serious side effects or recalls of new drugs happen during their first 5 years of approval. Boston Study: Benefit box Prescription Drug Facts: PRIDCLO (pricogrel) To reduce clotting in order to reduce the chance of having or dying from a heart attack Men and women with heart or vascular disease (a stroke or narrowed blood vessel in the leg) People with bleeding problems, liver or kidney problems None Eat a low saturated fat/low cholesterol diet, don't smoke, exercise more, look into other medications PRIDCLO STUDY FINDINGS 20,000 adults with heart or vascular disease were given PRIDCLO or aspirin for 2 years. Here's what happened: What difference did PRIDCLO make? Aspirin (325mg a day) Did PRIDCLO help? Fewer people had a heart attack (0.6% fewer) 3.3% 33 in 1000 PRIDCLO (75 mg a day) 2.7% No difference in dying from a heart attack No difference in dying from anything About 1.4% in both groups 14 in 1000 About 5.5% in both groups 55 in 1000 Did PRIDCLO have side effects? Life threatening side-effects No difference in strokes from bleeding into brain About 0.5% 5in 1000 Fewer people had major stomach bleeding (0.7% fewer) 2.7% 2.0% 20 in 1000 Fewer people had abdominal pain (1.5% fewer) 7.1% 5.6% 71 in in 1000 More people had bruising (1.6% more) 3.7% 5.3% 37 in in 1000 More people had diarrhea (1.1% more) 3.4% 4.5% 34 in in 1000 More people had a rash (0.7% more) 3.5% 4.2% 35 in in 1000 Pridclo was approved by FDA in Studies show that most serious side effects or recalls of new drugs happen during their first 5 years of approval. Health Affairs

7 Study participants (n=203( n=203) Mean age (range) 52 years (30 to 91) Female 65% Education <high school 15% some college 39% college grad 25% >post grad 22% Extremely Hard Reactions to the facts box How easy or hard is it to understand the box? Average rating Extremely Easy 7

8 Would you prefer to see this ad with or without the facts box? Prefer ad without box Strongly Slightly No Preference Prefer ad with box Slightly Strongly Applying the data "How effective is OFECOX compared to ibuprofen in treating arthritis symptoms?" BEFORE benefit box 70% More effective Same Less effective 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Applying the data "How effective is OFECOX compared to ibuprofen in treating arthritis symptoms?" Applying the data "How effective is OFECOX compared to ibuprofen in treating arthritis symptoms?" BEFORE benefit box 70% More effective Same Less effective 0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% 8

9 Applying the data How effective is OFECOX compared to ibuprofen in treating arthritis symptoms? "How effective is OFECOX compared to ibuprofen in treating arthritis symptoms?" BEFORE benefit box AFTER benefit box More effective Same Less effective 70% 38% p=< % 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100% Extracting the data "What percent given OFECOX said it had an excellent effect on their arthritis" Vermont Study Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) 95% of participants answered correctly 9

10 Study participants (n=274( n=274) Mean age (range) 60 years (40 to 79) Female 57% Education <high school 12% some college 19% college grad 38% >post grad 31% Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) Correctly extracting narrative facts When was first approved by the FDA? 92% answered correctly Should a pregnant woman consider taking? 92% answered correctly How long were the women in the study followed? 91% answered correctly Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) Extracting the data What proportion of women on got a blood clot? 89% answered correctly Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) Manipulating the data 2.7% - 1.4% = 1.3% How much did change the chance of getting breast cancer? 71% answered correctly 10

11 Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) Applying the data -basic Mrs. Jones hears about an even newer drug to prevent breast cancer -NEWDRUG. NEWDRUG is identical to TAMOXIFEN (e.g. the same side effects, etc.) except NEWDRUG does not lower the chance of dying from breast cancer? Which drug should Mrs. Jones take? a. TAMOXIFEN 86% said TAMOXIFEN b. NEWDRUG c. Either drug is ok Prescription Drug Facts: (tamoxifen) Applying the data -basic Mrs. Jones hears about an even newer drug to prevent breast cancer -NEWDRUG. NEWDRUG is identical to TAMOXIFEN (e.g. the same Makes sense: you are told TAMOXIFEN side effects, etc.) except has more Women benefit given and same harm a sugar pill (20 mg a day) NEWDRUG does not lower the chance of dying from breast cancer? Which drug should Mrs. Jones take? 86% said TAMOXIFEN Prescription Drug Facts: (tamoxifen) a sugar pill (20 mg a day) Applying the data - advanced Suppose the tamoxifen study included a third drug - OTHERDRUG. OTHERDRUG is also identical to TAMOXIFEN (e.g. the same side effects, etc.). In the study, 1% of the women taking OTHERDRUG got breast cancer over the 6 years. Which drug should Mrs. Jones take? 69% a. TAMOXIFEN said OTHERDRUG b. OTHERDRUG c. Either drug is ok Who should (1) not search take it? table Women to who see are pregnant that or breastfeeding 1.4% taking Applying the data - advanced This Prescription is a harder Drug Facts: task since (tamoxifen) you need to do 2 things: TAMOXIFEN got breast cancer (2) compare this to the 1% with OTHERDRUG Makes sense: OTHERDRUG has a sugar pill same harm but more (20 mg benefit a day) than TAMOXIFEN. 1.4% Suppose the tamoxifen study included a third drug - OTHERDRUG. OTHERDRUG is also identical to TAMOXIFEN (e.g. the same side effects, etc.). In the study, 1% of the women taking OTHERDRUG got breast cancer over the 6 years. Which drug should Mrs. Jones take? 69% said OTHERDRUG 11

12 How much does education matter? Summary People's response to the Drug Facts Box How many of the seven quantitative questions were answered correctly? People said it was easy to read the tabular display Most participants - even those with lowest formal education could extract, manipulate and apply the quantitative information in the drug facts box 0 < High school n=33 Some college n=52 College graduate n=104 Educational attainment > College degree n=85 Next steps The focus of this talk has been consumers - testing simple tabular displays to replace the brief summary in direct to consumer drug ads We think there the box may also serve a larger purpose - it may be equally useful in helping physicians make good prescribing decisions. LISA tomorrow 12