Bayer hits back at Iberogast critics

Bayer Consumer Health has instigated a pharmacy marketing campaign defending its Iberogast gastrointestinal brand following a series of attacks from a German Member of Parliament (MP).

In June, Kordula Schultz-Asche MP submitted an amendment to the German Medicines Act, the BMG, to try to force the federal government to take action against Bayer, which has so far refused to put warnings regarding possible liver damage on packs of its Iberogast gastrointestinal products sold in the country.

“Pharmaceutical manufacturers are currently able to delay the inclusion of drug warnings and precautionary statements,” commented Schulz-Asche on her website. “We want to reverse this, because it must not be the case that patients are not informed, or only after a delay, about possible side-effects.”

The amendment targeted a “loophole” in the regulation, Schultz-Asche explained, which meant that firms could appeal against recommendations by the German federal institute for drugs and medical devices, BfArM, resulting in a suspension of their legal force while cases were under judicial review. As a result, companies were currently under “no obligation” to implement BfArM’s recommended text changes, she added.

If taken on board by the German federal parliament, the Bundesrat, BfArM would have the power to force firms like Bayer to immediately implement the recommended changes to patient information, resulting in significant numbers of packs being recalled.

To defend its brand, Bayer has now launched a brochure aimed at pharmacists and consumers that gives advice on the correct dosage and use of Iberogast and answers frequently asked questions about the product.

Across eight pages, Bayer gives an overview of the effects of each of the nine medicinal plants contained in Iberogast, the correct dosage and an overview of how what symptoms the product can relieve.

Launching the brochure – which is available to download from the Iberogast.de website – Bayer said that Iberogast could be used to alleviate “numerous functional and mobility-related gastrointestinal complaints such as stomach pain, abdominal cramps, flatulence, bloating, heartburn or nausea”, all of which were also symptoms of irritable bowel syndrome.

“Iberogast’s nine medicinal plants all work together,” the company continued, “on different parts of the gastrointestinal tract”.

“The product is well-tolerated and provides quick and effective relief,” Bayer insisted, “and controlled clinical trials and surveys of more than 50,000 patients and the treatment of over 80 million people since its launch, confirm the efficacy and safety of Iberogast’s unique formula.”

Schulz-Asche has been hounding Bayer for months, following the recommendation in January by Swiss medicines agency, SwissMedic, that packs of Iberogast in Switzerland would have to include additional information about side effects, following “recent reports of very rare but sometimes serious liver damage” (OTC bulletin, 23 March 2018, page 8).

SwissMedic, while admitting that this side effect was “very rare”, argued that as the effect was “not predictable” and could be “serious, even life-threatening in the long run”, had decided to recommend an adjustment to the patient information for the product.

Responding to the news, Schulz-Asche called out Bayer for not also including additional information on packs of Iberogast sold in Germany, writing on her website that the firm had a “moral obligation” to be “fully transparent about the benefits and dangers” of its products. “Bayer’s behaviour fosters mistrust of the entire pharmaceutical industry,” she claimed, “especially when risk information is knowingly concealed.”

Schulz-Asche also blasted her colleagues in a letter to the Bundestag for not responding to the concerns raised by SwissMedic.

Prior to launching the consumer brochure, Bayer defended its decision not to include warnings, responding that the firm continued to “review and assess the medical risks and benefits of Iberogast on an ongoing basis”.

Iberogast included a “low dose of greater celandine extract”, Bayer explained, adding that “while there have been isolated reports of liver damage associated with celandine in high doses of 8mg and above per day, the recommended daily dose of Iberogast contains only 0.3mg of the substance”.

The health and safety of its consumers were Bayer’s “top priorities”, the firm insisted. “Bayer is taking all necessary measures to ensure that the medical benefit-risk ratio of its products is continually assessed,” the company pointed out.

Bayer said it remained “committed to a dialogue with health authorities around the world”, but as the “facts” remained “unchanged”, it was not “currently planning” to change Iberogast’s patient information.