How DTB makes a difference
Over the years, DTB has led successful campaigns in the UK to remove or restrict certain medicines, curb excessive promotional claims and expose weaknesses in prescribing decisions. DTB articles have also influenced the establishment of best practice, national guidelines and healthcare policy. Here are some examples:
Examples of action on advertising and other promotion
Following publication of the article 'Nutritional supplements for macular degeneration' (DTB 2006; 44: 9-11) DTB complained to the MHRA in January 2006 that the promotion of the nutritional supplement Viteyes was making medicinal claims and therefore breaching the law. As a result, the MHRA brought about withdrawal of the relevant advertising.
DTB complained to the MHRA in November 2006 about misleading promotional claims for the bisphosphonate drug Bonviva (ibandronic acid). The complaint was upheld and the company had to undertake not to repeat the claim.
In 2005 DTB identified a key error in UK and other national guidelines on the risks of chickenpox in pregnancy (DTB 2005; 43: 69-72 and DTB 2005; 43: 94-5), which prompted a commitment from the Department of Health in England to amend its guidance.
A DTB article 'New drugs from old' (DTB 2006; 44; 73-7) raised awareness about the various questionable means drug companies use to extend the patent lives of their brand name products.
Simvastatin over the counter
A DTB article 'Simvastatin over the counter' (2005; 43: 25-8) discussed the findings of the consultation exercise that preceded the reclassification of simvastatin 10mg from a Prescription-only medicine to a Pharmacy medicine (now marketed as Zocor Heart-Pro).
The Medicines and Healthcare products Regulatory Agency (MHRA) had reported this consultation as showing that "about two thirds of respondents were in favour" of the proposed reclassification. However, DTB's analysis of the consultation responses indicated that, in reality, only a minority of respondents supported the proposal.
Having initially disputed this conclusion, the MHRA subsequently accepted that DTB's analysis was correct. The MHRA cited an "administrative error" as the reason for its incorrect reporting of the consultation. As a result of this episode, the MHRA amended the report of the consultation on its website.
It also published a list of respondents on its website, along with the full text of all the responses where the respondent had given consent for public disclosure. It now uses this model for all reclassification consultations.
Health Select Committee inquiry into the Influence of the Pharmaceutical Industry
In October 2004, DTB gave evidence to the Health Select Committee Inquiry into the Influence of the Pharmaceutical Industry, highlighting key weaknesses in various aspects of how the industry is regulated. The committee published its report in April 2005. Several of our concerns were reflected in the committee's final report and recommendations. Of note, in its response to the report, the Government cited DTB as an important source of independent advice for doctors.
Withdrawal of pimecrolimus advert
A DTB article in May 2003 'Pimecrolimus cream for atopic dermatitis' reviewed Novartis' new topical immunosuppressant licensed for the treatment of patients aged 2 or over with mild or moderate atopic dermatitis.
DTB found no convincing evidence to justify the use of pimecrolimus in the first-line management of this disease. DTB also pointed out that an advertisement for this cream was misleading, in that it showed a child apparently aged under 2 years and so implied its use in this age group. We called for the advertisement to be withdrawn and a corrective statement to be published.
Shortly afterwards, as reported in the BMJ ('Drug company accused of breaking advertising regulations'. BMJ 2003; 326: 1106), Novartis said "The boy used for the advertisement was actually 2 years and 5 months old." But they admitted that the Medicine and Healthcare products Regulatory Agency too had drawn their attention to the fact that "the boy looks younger to many people." Novartis said it was "sorry for this misunderstanding" as it was "not our intention to give the impression that pimecrolimus should be prescribed to children younger than 2 years." The company also withdrew the advertisement, published a correction in all the journals where the advertisement appeared and subsequently issued a new advertisement.
DTB on MMR
In April 2003, at the height of controversy and public anxiety in the UK about claimed risks from the MMR vaccine, DTB published an article on 'MMR vaccine - how effective and how safe?'. This was very well received by both healthcare professionals and patients.
Withdrawal of Yasmin advert
In April 2002, Schering Health Care launched its combined oral contraceptive (COC) pill Yasmin in the UK with an advertising campaign that centred on claimed 'lifestyle' advantages of the product.
In our August 2002 article 'Is Yasmin a "truly different" pill?', we concluded that the company's claim that Yasmin is "the pill for well-being" was unjustified and misleading and should be withdrawn. We also argued that there was no compelling published evidence that Yasmin offered any advantages over other, longer-established, COCs with regards to weight gain, skin condition or premenstrual symptoms.
In September 2002, we received a letter from Schering's solicitors threatening to sue us for defamation on the grounds that "the article has damaged the reputation of Yasmin and the Company". However, the Company subsequently had to withdraw their threat. In December 2002, we learned that as a result of our complaints the company had withdrawn the advertising. And subsequently was required to produce a corrective statement.
We published a more in-depth report of this story in March 2003.
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