Who Regulates Press Releases? The Case of Bayer's "Melt-in-Your-Mouth" Erectile Dysfunction Tweet

Digital Pharma caught Bayer posting a Tweet - via its @BayerUKIreland Twitter account - that seems to violate new social media guidelines published by the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI).

Here's the Tweet stream that Digital Pharma preserved:

The tweet in question states "First and only melt-in-the-mouth erectile dysfunction (ED) treatment launches in the UK today." It includes a link to a LEVITRA BRANDED press release. I have preserved the press release as a PDF version (here) of the original Web version. I did this because Bayer might remove the original after it reads this post.

The PMCPA code states: "If a company wanted to promote a medicine via twitter it would have to ensure that if the medicine was prescription only, the audience was restricted to health professionals and that the message, in addition to any link to further information, complied with the Code. In addition companies would also have to ensure that recipients had agreed to receive the information. Given these restrictions and the character limit on twitter, it is highly unlikely that the use of this medium to promote prescription only medicines would meet the requirements of the Code. Using twitter to alert health professionals about the publication of a study on a medicine is likely to be considered promotion of that medicine."

As Digital Pharma points out, tweets are viewable by the general public and therefore cannot be "restricted to health professionals" as required by the PMCPA code: "The @BayerUKIreland account has about 500 followers, some are clearly members of the public, but many show no information as to followers’ location or occupation. As an open account all its tweets are on public display and indexed by search engines like Google."

BTW, I could NOT find the tweet by searching Google OR by examining the @BayerUKIreland Twitter stream. That's because Bayer DELETED the tweet according to Digital Pharma. This immediately raised red flags.

But does the Bayer tweet violate the PCMPA code?

In a previous post (see "Brits Beat FDA & PhRMA: Issue Social Media Guidance for Pharma. This BI Tweet May Not Pass Muster") I pointed out that Tweets such as the following from Boehringer Ingelheim (BI) may violate the PMCPA code:

The BI tweet mentions a BRAND name and its indication, but does not include fair balance information. The Bayer tweet, however, does NOT mention a brand name, just the indication and a benefit of a treatment (ie, "dissolves in the mouth in seconds, there’s no need to take it with water and it’s discreet").

Although the Bayer tweet does not mention a brand name, it may still be considered promotion of a drug in the UK. If so, does it violate the PMCPA code? According to Bayer, "Despite the recent publication of a discussion paper from the PMCPA, the position on use of social media and digital communication in relation to prescription medicines remains far from clear."

Bayer's Unregulated Press Release Posted via Twitter is NOT Balanced
Another issue that is FAR FROM CLEAR to me is how the Bayer PRESS RELEASE can pass regulatory muster in the UK. According to Digital Pharma, Andrea Postles (@AndreaPJPostles, LinkedIn public profile), PR & Media Relations Manager at Bayer UK, said: “We have sometimes ‘tweeted’ approved news releases where we know that the content, while of interest, is nevertheless non-promotional, and contains only factual and balanced information."

To which I say BULLSH*T! You can read the "approved" press release here. It is clearly NOT "non-promotional" as Ms. Postles claims.

For example, the first paragraph of the press release states: "Today marks the launch of the first ED treatment available as an orodispersible tablet. In contrast to other drugs of the same class, the new formulation has been designed specifically to be discreet and convenient, has a minty flavour and dissolves on the tongue within seconds."

Here's another example of promotional language found in the second paragraph of the press release: "Levitra orodispersible was developed to help remove the known barriers associated with erectile dysfunction medication by providing men with a more convenient and discreet treatment option which may also help to lessen the embarrassment surrounding the condition."

I'm sold! Where do I get it?

OK, so the press release IS promotional. It mentions the brand name and benefits. But shouldn't it also mention possible side effects and safety information -- ie, the fair balance? Contrary to what Ms. Postles says, the press release does NOT contain "balanced information." There is NO mention of any possible side effects, other treatment options, risks, etc. It's all about LEVITRA and its benefits.

Most pharma product-specific press releases I have seen have a section entitled something like "IMPORTANT SAFETY INFORMATION." The Bayer press release has NO such section. How can it be called balanced?

The importance of PR as a marketing tool has increased DRAMATICALLY, IMHO, with the ascendancy of Twitter and other social media applications.  Pharma corporate communications people seem to be taking a leading role in using social media to promote products while claiming what they do is NOT marketing or promotional. This is a hot topic that I will explore with colleagues in tonight's #socpharm chat at 8 PM Eastern. Join us!

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P.S. @Alex__Butler tweeted this: "@pharmaguy on the broad point of press materials they are public and covered by the code/clause 22; http://t.co/U9FM6UC" which links to the 2011 version of the ABPI Code of Practice for the Pharmaceutical Industry (here). Clause 22.2 states:

"Information about prescription only medicines which is made available to the public either directly or indirectly [my emphasis] must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.

"Statements must not be made for the purpose of encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine."

A press release is information that is intended for journalists with the intent that they will write a story about the information in the press release. Thus, the Bayer press release was made available "indirectly" to the public -- and even directly because of the Tweet linking to the press release.

The press release is "misleading about the safety of the product" because it contains NO SAFETY INFORMATION whatsoever!

Although the press release does NOT directly "encourage members of the public to ask their health professional to prescribe a specific prescription only medicine," the benefit statements made in the press release are simple for the average Joe (or Nigel) to understand and certainly aim to encourage the public to get a prescription of this product.