Friday, November 21, 2008

Scare Balance or Scare Tactics? A Weak Case Against More DTC Risk Information

Based on some minimalist data reported in the Wall Street Journal, Bob Ehrlich of DTC Perspectives Blog concludes that "we need to be judicious how we approach patients with side effect information" in direct-to-consumer (DTC) advertising of Rx drugs (see "Fair Balance or Scare Balance"). The WSJ article cited some not-very-scientific research, which "shows" that "expecting to feel ill can bring illness on in some instances" (see "Power of Suggestion: When Drug Labels Make You Sick").

Clearly this WSJ article is another example of Ehrlich's expressed perception that the media "[hypes] negative outcomes with their 'death in your medicine cabinet' type stories." NOT!

In this case, the media is a great source of questionable research that Ehrlich can use to make a case against current FDA thinking that risk information is not adequately communicated to consumers in DTC ads. Here's what Ehrlich says:
"She [ie, Melinda Beck, the WSJ reporter] cites several studies which show how powerful the power of suggestion is in making us think we have side effects. In a study last year men taking a drug for prostate enlargement who were informed it could affect sexual function were three times more likely to actually have erectile dysfunction than those not told. In another study, subjects were given sugar water and told it could make them vomit. Of those told of the potential side effect, 80% actually did vomit.

"The point of Ms. Beck's column is that we need to be judicious how we approach patients with side effect information. I believe we need to do a better job giving patients the real odds of something happening to them."
The WSJ does not tell us much about the details of the studies cited except that one study was a "double-blind" -- impressive so far -- study involving 60 people -- NOT so impressive! The sugar water study was done in some unidentified hospital in the 60s (institutions did lots of weird studies on unsuspecting patients in the 60s!). Again, not impressive and hearsay as far as I am concerned.

The erectile dysfunction study involved 120 patients and was done at the University of Turin (see here) -- probably next door to the scientists trying to prove that the Shroud of Turin is authentic!

In the Turin study, 60 men were not counselled on the drug's sexual side effect and 60 men were told "...it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon." Only 107 men completed the study: 52 men in the first group reported problems compared to 55 in the second group.

This is the sort of small difference in a tiny sample that many experts would dismiss as not scientifically valid. In fact, that's exactly what GSK claimed when results from their own study suggested that Avandia may increase cardio-vascular incidents (see "Avandia: Enough Blame to Go Around").

What Ehrlich doesn't mention at all in his "Fair Balance" piece is the other side of the balance sheet: benefit statements made in DTC ads.

I am sure there are studies that show patients' symptoms IMPROVE when they are lead to believe that there will be improvement. In fact, many people given sugar pills in clinical trials DO improve precisely because of this "placebo effect." The WSJ article, like Ehrlich, focused only on the "nocebo effect."

But DTC ads include a lot of benefit statements that may induce more benefits just as effectively (or ineffectively) as risk statements induce more side effects, or claims of side effects. In fact, I would contend that the benefit statements -- especially when made by trusted celebrities like Sally Field -- are much more effective in inducing positive results than the side effect statements are at inducing negative effects.

The FDA may agree with me and they want to determine if there is actually a fair balance between risk statements and benefit statements.
"I propose FDA study the effect of risk communication in the context of the scare effects," said Ehrlich. "They focus on adequate communication of risk and side effects but not on whether it is interpreted wrongly. It would be interesting to see consumers place the odds of occurrence after seeing ads. I bet they vastly overstate the odds of serious side effects happening to them."
And I bet that they also vastly overstate the odds of benefits happening to them!

Ehrlich closes with:
"I am afraid that telling consumers everything that could happen to them is not protecting them or informing them. It is a shotgun approach that makes regulators feel better but does not promote real consumer protection."
In the Pharma Marketing News article "DTC Risk Communication: Is More or Less Needed?" I quote several experts on risk communication in DTC advertising, including my friend Harry Sweeney, Chair of the Executive Committee for the Coalition for Healthcare Communication. Harry was recently inducted into the Medical Advertising Hall of Fame.
"We ought to clarify that risk is a lot more than odds and probability," said Sweeney. "You have to have a hazard. You have to be exposed to the hazard. Then there's proportion -- the magnitude of the risk, which is not discussed in the pharmaceutical world. We are given tiny numbers upon which to make important major communications policy decisions."
Sweeney pointed out the need for a baseline of what consumers understand about drug risk before we can move the needle where it ought to be. He engaged the audience in a "parlor game" as a demonstration (see chart below).

7 comments:

  1. Clearly Mr Ehrlich has a conflict of interest here. He needs the pharma companies to attend his seminars subscribe to his magazine (if that's what you want to call it). Transparency is the key to gaining consumer trust and right now there is zero trust between the industry and consumers.

    Look at the case of Crestor data? I am sure that since the data is so great that reps are out promoting it to physicians..however if the data were bad they would be saying "we need to analyze the data more". People are not stupid and need to have ALL the facts before they make decisions about what to put into their bodies

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  2. The "parlor game", while clearly not a scientific survey, points out the difficulty in understanding risk -- for patients and for physicians.

    The one survey question asks "How safe are prescription drugs"? You may as well ask "How safe is driving?" Or "How safe is flying on the Space Shuttle". For the latter two cases, you'll get a different result if you measure risk by number of incidents per total number of trips and then by number of incidents per mile travelled.

    Risk (as well as safety) is relative, and needs to be weighed against benefit, QOL, etc.

    Poorly formed questions get meaningless answers.

    For more discussion on risk and safety, check out http://blogs.sas.com/hls/index.php?/archives/15-Safety-in-Numbers.html#extended

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  3. What I think Harry was trying to get at with his parlor game is the perceptions of the audience regarding drug safety in general. Once you know that, it is easier to develop a communications program that takes this into account. For example, if your audience were doctors who tend to believe drugs are pretty safe, your communication program to them would be different than to patients who generally think drugs are risky. You need a customized communication program; one size does not fit all in this case.

    But just from the look at the results of Harry's Parlor game (the chart), there appears to be 2 types of respondents -- a minority that thinks drug are pretty safe, and a majority that thinks they are risky (it's not a bell curve centered around neutral).

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  4. Anonymous12:17 AM

    "In the Turin study, 60 men were not counselled on the drug's sexual side effect and 60 men were told "...it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon." Only 107 men completed the study: 52 men in the first group reported problems compared to 55 in the second group.

    This is the sort of small difference in a tiny sample that many experts would dismiss as not scientifically valid."

    This is completely wrong, and it's alarming that someone with such a strong opinion on these matters would fail to interpret basic data. The link given in this post says the following:

    "Data are referred to 107 patients who completed the study. Group 2 patients (N=55) reported a significant higher proportion of sexual side effects as compared to group 1 (N=52) (43.6 vs 15.3%)."

    It appears "N" was misinterpreted as being the number of men reporting a problem. N is actually the number of subjects in each group who have completed the study, problem or not. The abstract states that 43.6% (or 24/55) of group 2 subjects reported a problem versus 15.3% (8/52) in group 1. That certainly is a significant difference, and it leads to the opposite conclusion from the one you've put forth.

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  5. Thanks for the correction. However, N is STILL a very small number upon which to base scientific conclusions. If I ran a survey and there were only 107 responses -- completions -- I would not say that any differences between one group of 55 (say pharma respondents) and another group of 52 (non pharma respondents) was scientifically significant.

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  6. bob ehrlich1:57 AM

    John I never said we do not need risk information in ads. I wrote the column to point out that we need to understand what risk communication really does for consumers. I have asked the FDA to put odds of occurrence tables in ads. They will only accept clinical trial data and I have asked they get a panel of neutral experts to use all avaialble data including post markteting data. Consumers need to know the real odds of bad things happening to them, not a litany of possible and highly improbable side effects listed together.

    I have lobbied FDA to require patient friendly brief summaries for years and have been openly critical of my supposed seminar attending audience for years over their lack of adequate consumer risk disclosure. Anyone who has heard me speak knows that. So please be fair and stop assuming I am a paid lobbyist for the drug companies. My seminars are well attended because we provide alternate views including past guests Ralph Nader, Henry Waxman, Joe Kennedy, Jerry Avorn, John Abramson and many other industry critics. Of course those who are ignorant choose to believe otherwise but I know you are well aware of the truth but sometimes choose to forget the facts in your critiques.

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  7. Bob,

    I must correct you by pointing out that I never accused you of saying there is no need for risk information in ads. I read what I wrote over and over and cannot find this. I also believe I was careful in quoting you extensively so that people can see that you were NOT advocating eliminating risk.

    What I said -- and I believe I have my facts right -- is that you never mentioned benefit statements in DTC ads. This struck me as odd because you started out talking about "fair balance" but never really talked about balance in your piece. And balance is really what we should be talking about. Hence, I tried to offer the other side of the balance equation and suggest that maybe benefit claims in DTC ads are too extreme leading people to believe they may reap more benefit than scientifically justified.

    IMHO

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