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Claire Rayner, President,
The Patients' Association,
P.O. BOX 935
Harrow, Middlesex HA1 3YJ 26 October 1999

Dear Claire Rayner,

I am enclosing a copy of my brief on DIRECT TO CONSUMER ADVERTISING, prepared for last week's Kings Fund debate. I also wanted to come back to you on one or two points you made, plus one made in your name. I don't know if Margot James was actually quoting you, but clearly you'd agree with the gist:

"Commenting on the Pharmacia and Upjohn incontinence campaign, Clare Rayner, who I'm delighted to say is with us this morning, said that the job is to help people who have a very real symptom, that they often feel that they cannot possibly talk to their doctor about. They think they are unique; they don't think other people have the problem, and it is very comforting to know that it is common and treatable."

Of course some advertisements do help some people, and perhaps this is one, but I still fully support the point Joe Collier emphasised about the limitations and risks of drug advertising in general. Like Joe - but as a lay medicines policy analyst - I have spent much time examining thousands of clinical trials and other reports about drug effectiveness and risks, and I see drug advertisements every day. My conclusion too would be that advertising provides very little useful information and much that isn't. It presents risks more than benefits for health.

Sure, it's only one example, but maybe I can give you some idea of my concern by pointing to the difference between what might be inferred from the P&U incontinence advertisement and the quality of the drug the manufacturers seek to promote. The drug is Detrusitol (tolterodine, P&U) and the most striking thing about it seems to be that it is relatively ineffective for most people and would be positively troublesome for quite a few. The table in the 1999 Data Sheet indicates that fewer than two patients in ten experienced "no or minimal bladder problems after treatment" - very few more than the numbers who recovered without the drug (i.e. on placebo). But what advertisement would ever acknowledge such a modest effect, and does it really help to advertise widely, hinting that people have only to ask to get good drugs for them?







Detrusitol 2mg b.i.d


Statistical significance vs, placebo

Detrusitol 2mg b.i.d


Statistical significance vs, placebo

No. of micturitions per 24 hours

-1.6 (-14%) n=392

-0.9 (-8%) n=198


-2.3 (-20%) n=354

-1.4 (-12%) n=176


No. of incontinence episodes per 24 hours

-1.3 (-38%) n=288

-1.0 (-26%) n=151


-1.6 (-47%) n=299

-1.1 (-32%) n=145


Mean volume voided per micturition (ml)

+25 (+17%) n=385

+12 (+8%)



+35 (+22%) n=354

+10 (+6%) n=176


Number of patients with no or minimal bladder problems after treatment (%)











(n.s. = not significant * = p# 0.05 ** = p# 0.01 *** = p# 0.001)


I do not want to discount the possible value of this drug to the few who might benefit, nor would any doctor - especially not after seeing the full page ads in the BMJ (attached) of a happy, sprightly going-on-elderly woman, sitting in her bathing suit by the pool. Yes, "help free your patients from the restrictions of unstable bladder" is a good message, and perhaps the woman in the ad was "Freed by Detrusitol", and that would be good too. Still, the main claim seems extremely far-fetched: "Detrusitol effectively and selectively relieves frequency, urgency and/or urge incontinence". The smiling patient in the ad would represent only a small percentage of the patients that doctors could expect to see.

I can't help wondering if this satisfies the requirements of the pharmaceutical industry's code of practice - that claims "must be accurate, balanced, fair, objective and unambiguous". If it does comply, what does it tell us about the standards to be expected if DTC advertising takes hold? I expect to pursue the point.

Then there are questions about the benefits of treatment in relation to alternatives, and possible risks. Advertising naturally distorts understanding on this; it is not meant to give a balanced view. Its purpose is to steer patients towards drug treatment and towards the belief that, if something is "treatable", it will be cured. The clear implication of any drug advertisement is that benefits greatly outweigh the risks, yet for many patients this cannot be true. See, for example, the list of adverse effects reported in clinical trials, in the current U.S. Pharmacopeia monograph on tolterodine:

Dry mouth 39.5%
Headache 11%
Dizziness 8.6%
Gastro-intestinal symptoms, specifically abdominal pain 7.6%


Constipation 6.5%
Dyspepsia (upset stomach) 5.9%
Urinary tract infection 5.5%
Abnormal vision, including problems with accommodation 4.7%
Influenza-like symptoms (joint pain) 4.4%
Nausea 4.2%
Diarrhea 4%
Xerophthalmia (dry eyes) 3.8%
Chest pain 3.4%
Somnolence (drowsiness) 3%
Dysuria (difficult urination) 2.5%
Hypertension (dizziness) 1.5%
Flatulence (stomach gas) 1.3%

It's hard to imagine any advertisement on TV even beginning to spell out the problems that might arise. Even in the British Medical Journal advertisement, aimed at professionals, the small print description of side effects occupies one-quarter the space of the headline, "Freed by Detrusitol". Consumer advertising would inevitably communicate much less:

"Side-effects: Those reported include common (>1/100) dry mouth, dyspepsia, constipation, abdominal pain,

flatulence, vomiting, headache, xerophthalmia, dry skin, nervousness and paraesthesia; less common (<1/100)

accommodation disturbance and chest pain; uncommon (1/1000) allergic reactions, urinary retention and confusion."

During the King's Fund debate, you said you got the impression that "basically you (Joe Collier & I) … just loathe the industry and loathe advertising." I didn't have an opportunity to respond then, but perhaps I can now - first by underlining the main points Joe made. Yes, I do think advertising tends to distort understanding and there are some serious problems with "bought consultants, bought patient groups" - and there's little doubt in my mind either that, with much less and better advertising, there'd be a great improvement in prescribing.

Like you, I passionately believe in having better-informed professionals and patients, and much better communication between them. The present situation is pretty appalling - but I have no doubt it would deteriorate if advertising were to fill this information vacuum. The underlying problem is endemic professional, commercial and government secrecy and I feel sure it sustains vast amounts of ill-health. So I would naturally be inclined to support any measure for real openness - but to offer pretty empty panaceas really isn't going to help.

It's not that I loathe advertising or the industry; it's more that the arguments advanced in the debate in favour of DTC advertising seemed to me opportunistic and insubstantial, not well thought through. Problems of inequality do urgently need to be addressed, but what will be achieved by promoting the illusion that everyone can have the best? The US healthcare system is notorious for inequality of access and high costs: why import more of the system that helps to fuel precisely the problem we need to address?

The argument that DTC advertising improves compliance (as opposed to increased levels of consumption) remains to be made. It should not be hard to prove this effect, if it exists, given the $1.5bn spent on DTC advertising in the US last year. I know of no evidence to suggest anything like commensurate gains.

Margot James' suggestion that DTC ads would reduce the amount of bad prescribing and iatrogenic illness seemed like extreme wishful thinking. However, her point that DTC advertising would accelerate the switch from older to new drugs did seem important for another reason - i.e. that far less is known about the risks of new drugs. As a general rule, it makes no therapeutic sense to promote the widespread use of new drugs, when their effects are least well understood.

Finally, can I please ask if the support you expressed for DTC advertising mainly reflects your own involvement in the P&U campaign, and some specific concern about the need to improve treatment of incontinence and promote understanding of the distress it can cause? Or does it derive more from your wider interest in patients' rights and welfare? I wondered about this after reading comments attributed to you, characterising protests about the non-availability of Viagra (sildenafil) on the NHS, as "childish howls of frustration from a menacing mob of elderly but immature blokes who want to recapture an illusory lost youth". Perhaps you were misquoted, or I've misunderstood the context, but I find it hard to reconcile this with the sympathetic concern expressed in your voice-over and in the remarks attributed to you at the top of this letter.

I hope this better explains my position and I'd welcome any comments you might have. I shall also shortly be posting this letter to our website (over 75,000 visitors per year) and would of course be happy to include any response from you.

Yours sincerely,
Charles Medawar


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