ASA Adjudication on Regent Medical Ltd

Ad

A magazine ad, for Hibiscrub antiseptic wash depicted a woman washing in the shower and stated "Going into hospital? Concerned about MRSA? Preparation starts at home." Text continued; "Many healthcare professionals use Hibiscrub in hospital and now it's available to you to use at home. One third of people have MRSA bacteria living on their skin. If you are one of them, there could be steps you could take to protect yourself at home. Hibiscrub is the hospital strength antiseptic that kills 99.99% of MRSA bacteria that may be living on your skin and goes on working for up to six hours. So by whole body washing with Hibiscrub before you go into hospital you could help reduce the risk of infection from MRSA."

Issue

The complainant challenged whether:

1. the ad was irresponsible because it might encourage consumers to wash regularly with Hibiscrub, which they believed might have a damaging effect on skin by eliminating healthy skin flora, because of the strength of the product;

2. the claim "kills 99.99% of MRSA bacteria that may be living on your skin" could be substantiated; and

3. the advertisers could substantiate the claim that Hibiscrub could reduce the risk of infection from MRSA.

The ASA challenged whether:

4. the claim "So by whole body washing with Hibiscrub before you go into hospital you could help reduce the risk of infection from MRSA" was misleading, because it implied that the product could protect against infection from MRSA for the duration of the hospital visit.

CAP Code (Edition 11)

Response

Regent Medical Ltd trading as Molnlycke Health Care Group (Molnlycke) explained that Hibiscrub was a pharmaceutical product licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) and sent evidence to show that.

1. Molnlycke believed the ad would not encourage consumers to wash regularly with Hibiscrub, because they said the use of the product in the ad was clearly linked to a visit to hospital. They also sent a skin irritation study for Hibiscrub that they believed showed no ill effects. They concurred, that whole body washing with the product would reduce natural skin flora, but drew attention to the label on the product, which they said gave precise instructions for Hibiscrub use.

2. They said the claim that Hibiscrub killed 99.99% MRSA bacteria was supported by published studies and studies commissioned by Molnlycke Health Care. They sent several published studies, and the results of the study they had commissioned, in support of this.

3. Molnlycke said the significant reduction in bacteria in the supporting studies they had provided was evidence that Hibiscrub could reduce the risk of infection from MRSA.

4. They said because the ad stated clearly that the product worked for up to six hours they considered that it did not imply the product would work for the duration of a hospital visit.

Assessment

1. Not upheld

We noted Hibiscrub was a pharmaceutical product licensed for "pre-operative surgical hand disinfection, antiseptic handwashing on the ward and pre-operative and post-operative skin antisepsis for patients undergoing elective surgery", where "antisepsis" meant the inhibition of the multiplication of germs, and "elective surgery" meant surgery not urgently required due to an emergency. We also noted the label on the product gave precise instructions for Hibiscrub use, and those instructions stated that consumers should wash the whole body twice with 25ml of Hibiscrub both the day before and the day of an operation and that this could be repeated after the operation (avoiding the operation wound) from the third post-operative day. We considered the headline claim "Going into hospital? Concerned about MRSA?" made it clear that the ad presented Hibiscrub use in the context of a visit to hospital and concluded that the ad was unlikely to encourage consumers to use the product on a regular basis.

On this point we investigated the ad under CAP Code clauses 2.2 (Social responsibility) 7.1 (Truthfulness) 50.4 and 50.14 (Medicines) but did not find it in breach.

2. Upheld

We noted that Molnlycke had commissioned an independent laboratory to test Hibiscrub against MRSA in 2006 and that results showed a 99.99% reduction of viable MRSA strains 42 and 43 bacteria in a two-minute time frame in vitro. We noted that an independent  peer-reviewed study from 1978, conducted on people in the laboratory under conditions which sought to mimic handwashing in hospital theatres, showed a 99.99% reduction in resident bacterial skin flora after the fifth day of scrubbing once a day with 4% chlorhexidine gluconate, the active ingredient in Hibiscrub. However, we also noted that this study was not MRSA specific, that the incidence of MRSA had increased in the UK since the 1970s, and further noted that new strains of MRSA had also emerged since the 1970s. We accepted that there was an extensive literature published in peer reviewed scientific journals describing the efficacy of chlorhexidine for general rapid skin disinfection. However, we also noted that several studies pointed out that in vitro laboratory tests for the efficacy of the active ingredients in anti-bacterial handwashes were not equivalent to clinical trials on people and a study sent by the advertiser indicated that chlorhexidine had been found to be more effective against MRSA in laboratory tests than in hospital situations. Because Molnlycke did not provide evidence to show the product would kill 99.99% of MRSA bacteria on the skin when used by consumers in their homes we concluded that the claim "kills 99.99% of the MRSA bacteria that may be living on your skin" could mislead without qualification.

On this point the ad breached CAP Code clauses 7.1 (Truthfulness) and 50.1 (Medical and scientific claims).

3. Not upheld

We noted that two of the peer reviewed medical studies sent by the advertiser, which were conducted in hospitals during outbreaks of MRSA in 1995 and 1994, indicated that another active ingredient, not present in Hibiscrub, may have been more effective at reducing rates of infection than chlorhexidine, the active ingredient in Hibiscrub. Nevertheless, we accepted that a third study sent by the advertiser showed that patients who showered twice with 4% chlorhexidine gluconate had considerably lower general bacterial count at their surgical incision site in the operating room compared to those who showered with medicated soap and water or povidone-iodine. Again, this study was not MRSA specific. We noted that surgical hand scrubs were valued intuitively in hospitals but that scientific studies had not proven that surgical hand scrubs reduced surgical wound infections because of anxieties about the ethics of conducting surgeries without handwashing in control groups. We considered that the phrase "by whole body washing with Hibiscrub before you go into hospital you could help reduce the risk of infection from MSRA" was not statement of fact but a statement of possibility based on the supporting evidence that Hibiscrub reduced the amount of bacteria on the skin, including MRSA, combined with accepted medical wisdom that bacteria at wound sites could cause infection. We accepted that this statement of possibility was reasonable in the light both of the evidence provided and of generally accepted medical understanding.

On this point we investigated under CAP Code clauses 3.1 (Substantiation) Truthfulness (7.1) 50.1 and 50.11 (Medical and scientific claims) but did not find the ad in breach.

4. Not upheld

We noted that the ad stated Hibiscrub "goes on working for up to six hours". We considered that, because the time duration for which the product was likely to have an effect for was stated, consumers were unlikely to infer from the ad that one application would be sufficient for the duration of a hospital visit.

On this point we investigated the ad under CAP Code 3.1 (Substantiation) 7.1 (Truthfulness) 50.1, 50.4, 50.11, 50.14 (Medical and scientific claims) but did not find it in breach.

Action

The ad should not be shown again in its current form.

Adjudication of the ASA Council (Non-broadcast)