# Presentation: 124534

## Some Suggestions for FDA’s Risk Communication Strategies

- John Paling PhD The Risk Communication Institutewww.riskcomm.com

**A Different Perspective**

## FDA’s Drug Safety InformationMarch 2007

**	*****The increased openness will enable ******patients and their healthcare professionals ******to make better-informed decisions about ******individual treatment options***

**FDA’s Drug Safety Information****March 2007**

## Paling’s Perspectives 

**IMHO Nothing is more important than that FDA leads an effort to develop good risk communication practices**** for the agency and industry and ****starts to model that in its own communications.**

**	****“****Better-informed decisions . . . ” will only come if FDA provides more data and context than at present**

**Paling’s Perspectives **

## Inside A Bee Hive

***Bees represent perfection - especially when it comes to effective communication***
***And TEAMWORK***

## Paling’s Perspectives 

**	****Perceptions not based on realities are only revealed when the routine explanation is challenged**** **

**Paling’s Perspectives **

**	****Avoid sources of *****mis*****understanding and skepticism- e.g. not qualifying “Safe and effective” ; not countering the impression that listing risks is primarily a legal CYA**

## Paling’s Perspectives 

**	****FDA must accept the challenge  ****to communicate the numbers **

**Paling’s Perspectives **

**	****Lesson from EPA =  Dose makes the poison **

**	****Communicating probability is the essential first step to making an informed decision about ****risks and benefits **

## Provisions in FDAAA readverse effects in clinical trials 

**	****Secretary shall publish “a table of adverse effects  . . With  number and frequency of such events . . . **
**	****Shall post with the tables . . . information to enhance patient understanding and to ensure that such risk tables do not mislead patients or the public.”**
***     ******Section 801 (a), Section 402(j)(3)(I)***

**Provisions in FDAAA re****adverse effects in clinical trials**** **

## Patient Information Sheets A to Z

**Patient Information Sheets A to Z**

***See Joel Davis in Health Affairs 26 2007, 863-870***

## Patient Information Sheets A to Z

**Patient Information Sheets A to Z**

## Communicating ProbabilitiesUsing estimates of numbers

**Communicating Probabilities****Using ****estimates of numbers**

**1. Relative risks - do not give “information”**

** ****E.g. *****Increased risks from Hormone Therapy***
**	****26% of breast cancer****41% of stroke and**** 29% of heart attack and cardiac death**

## Communicating ProbabilitiesUsing estimates of numbers

**2. Confusion comparing probabilities in 1 in  x format**

## Instead of this

** **

** **

- 20 year 		...	1 in 1667
- 25 year 		...	1 in 1250
- 30 year 		...	1 in  953
- 35 year 		...	1 in  378
- 40 year 		...	1 in  106
- 45 year 		...	1 in    30
- 49 year 		...	1 in    11

- Risk of Mother having a Child with Down Syndrome

## Rephrase using common denominator

** **

** **

- 20 year 	...	fewer than 1 in 1000
- 25 year 	...	fewer than 1 in 1000
- 30 year 	...	approx       1 in 1000
- 35 year 	...	approx       3 in 1000
- 40 year 	...	approx       9 in 1000
- 45 year 	...	approx     33 in 1000
- 49 year 	...	approx     91 in 1000

## Communicating ProbabilitiesUsing estimates of numbers

**3. Positive & Negative framing**

## Negative Vs Positive Framing

** **

** **

-   	Breast cancer risks from HT
- 	Over a 5-year period, *4 women out of 1000* will get breast cancer as result of taking HT

*IN OTHER WORDS:*
*	**996 women out of 1000* will stand to get the benefits of HT and will _not_ get breast cancer as a result of treatment

## Suggestions

**Try to Use**
**Absolute numbers with a common denominator,**
**Show positive framing and negative framing.**

**Suggestions**

## Patient Information Sheets A to Z

**Patient Information Sheets A to Z**

**	****The evidence showed that on average,  2 extra people out of 1000 showed suicidal behavior  ****(while 998 out of 1000 took the drugs and did not report suicidal behavior)**

## Risk Communication Provisions in FDAAA 

**	****Within one year, Commissioner of FDA ****shall submit to congress a report on how best to communicate to the public the risks and benefits of new drugs ...**
***     ******Section 904, 121 stat944 ***

**Risk Communication Provisions in FDAAA **

## Patient Information Sheets A to Z

**Patient Information Sheets A to Z**

**Communication by descriptive words**

**	****While most patients prescribed Cipro tolerate the medicine, *****rarely***** patients develop  serious adverse reactions  which may include: **
**	**
**	****(6 items-no indication of levels of probabilities)**
**	**

## Miscommunication of descriptive words

**Miscommunication of descriptive words**

*          *
**“****Rare” Side effect **
**“****Less Likely”**

**Meaning  1 in 25    to     1 in 100**

**Meaning  1 in  5     to     1 in 20**

*          ***“****Low Risk”**

**1 in 5    to**

** ****1 in 10,000**

## Communicating ProbabilitiesUsing descriptive words

**Communicating Probabilities****Using ****descriptive words**

## Analogous process worked for nutrition 

**	****A consistently applied communication standard might even educate consumers, expanding their range of effective decision making (as the FDA’s Nutrition Facts Panel may have done (Moorman 1996)**

**Analogous process worked for nutrition **

## Visual Aids To Improve Understanding

## Suggestions

**Consider Using Simple Visual Aids**
**To avoid the deceptive impressions of relative risks **
**AND**
**To enable the Benefits Framing to be shown**** side by side with the Risks Framing**

**Suggestions**

## All Risks Must be Seen in Perspective

** **

**Daughter’s letter home from college**

**Paling’s Wife’s Perspectives**

**All Risks Must be Seen in Perspective**

## A BIG RISK involves

**(ODDS  X CONSEQUENCES)**

**RESILIENCY – (ODDS  X CONSEQUENCES)**

**	****	****                   ****ODDS**

**Paling’s Perspectives **

**A BIG RISK ****involves**

## UK’s Public Risk Register

**UK’s Public Risk Register**

## While communicating risks, can FDA alsoPromote Healthy Behaviors?

**Four simple behaviors can have a major **
**positive effect on your health**
**	*****Combined Impact of Health Behaviors and Mortality in Men and Women: The EPIC-Norfolk Prospective Population Study. Khaw et al Jan 8, 2008 ***
***	******PLoS Med 5 (1):e12.doi:10.1371/journal. Pmed.0050012***

- While communicating risks, can FDA alsoPromote Healthy Behaviors?

## Four health behaviors combined predict . . . An estimated equivalent to 14 yr in chronological age

## Suggestion 

**	****Now FDA is being asked to improve its communications, needs to provide a riskcomm primer**

**Suggestion **

**	****Produce an overarching  one page summary**** of basic risk communication perspectives **

## Overarching Perspectives

**1.****	****FDA is committed to give best efforts to protect the health and safety of American families.**

**Overarching Perspectives**

**3.****	****Yet all drugs have risks and patients should always consult their healthcare professionals when making decisions about their medical choices**

**2. ****When used as directed, most FDA- approved treatments offer far more benefits than risks for most people.**

## Overarching Perspectives 

**Overarching Perspectives **

**4. ****Different people have different responses to different treatments and so patients need to be alert and report if their treatment seems to be having no effect or an adverse effect on them**

**5.****	****Estimates of risks from a population of people may not apply to any particular individual - but it is the best doctors have to go on in predicting your best options**

**6.****	****Some decisions that FDA has to make when it approves treatments are very complex and so it is always willing to make changes in the light of new knowledge**

## Overarching Perspectives for Dealing with Uncertainties 

**Overarching Perspectives for ****Dealing with Uncertainties**** **

**7.****	****Talk to your doctor about your the risks and benefits of your treatment options and make sure you know if there any warning signs you should look out for**

**9.****	****Remember, you can greatly increase your chances of a good outcome by keeping yourself as healthy as possible by your personal choices about what you eat and drink, and whether you exercise and don’t smoke.  **

**8.****	****Learn more about your treatment /condition by reading the relevant information provided by (new and improved) FDA website **