Editor’s Corner: A Shock in Paradise

Aristoteles Giagounidis, MD
Head of the Department of Oncology, Haematology, and Palliative Care, Marien Hospital, Düsseldorf, Germany

The town of Düsseldorf is located near Germany’s western border with the Netherlands, situated on the beautiful Rhine, with its bright reflections, sailing boats, and leisure activities by the harbor. It is home to first-class schools (including international schools for expats, the Heinrich Heine University, and the Robert Schumann Conservatory), world-renowned art galleries, concert halls, opera houses, theaters, and Michelin-starred restaurants. Pollution is low and commutes are short. The city is exceptionally safe. The hospitals are excellent. Education is basically free to citizens, and universal health care is available without significant co-pay. It is no wonder that, in 2019, Düsseldorf ranked sixth on a list of cities with the highest quality of life in the world.1 It is a real paradise.

Working in a regional medical center in Düsseldorf, I regularly see patients from abroad, particularly Russia, the Middle East, and North Africa. I’ve often wondered why many of them buy all the medication for their entire treatment course in Germany before flying back home to continue treatment. It turns out that many patients fear that they might not be given the necessary medication in their home countries. Clinics might use cheaper, less efficacious drug copies or may simply commit fraud – the infusion might not contain any drug at all.

These con games are unimaginable in paradise, aren’t they? Here in Germany, drug prices are among the highest in the world (second only to the U.S.²) and doctors and pharmacists have high incomes. There is no incentive to cheat patients.

Well, not so fast.

Düsseldorf was recently rocked by an unprecedented scandal that affected patients with life-threatening malignancies who rely on treatments with expensive drugs, including antibodies such as rituximab, trastuzumab, and pertuzumab.

Last year, the German Federal Court of Justice issued its final ruling against Peter Stadtmann, a pharmacy owner with a chemotherapy manufacturing license, who was arrested in 2016 for having prepared a shocking number of diluted or substance-free infusions. The prosecuting attorney cited more than 14,500 cases in which Mr. Stadtmann produced versions of high-cost medications that had little or no active ingredients.3

In the German system, regional hematology/oncology practices purchase their chemotherapies and immunotherapies from among 250 pharmacies that are accredited for the manufacture of these drugs. Most of these are relatively small, independent businesses. Hospital pharmacies are prohibited from interfering with the public sector. For these specialized pharmacies, the handling and sale of oncology drugs may be an enormous business. As was revealed during the trial, the pharmacy involved with the recent scandal had annual revenue of more than €50 million (approximately $60 million USD), most of which came from hematology/oncology medications.

The indicted pharmacist was exposed by two employee whistleblowers: an accountant who wondered why the purchase and sales numbers didn’t match and a pharmacist who provided authorities with a bag supposedly containing immunotherapy that was revealed by mass spectrometry to contain only saline.

The repercussions of this case were widespread, affecting many patients. I was asked regularly where our hospital obtained our chemotherapies, who monitored the manufacturing process, and what measures could be taken to ensure nothing like this ever happened again.

In fact, we realized that “Vieraugenprinzip” (four-eyes principle or dual review) was not compulsory in our pharmacy. After heated discussions, we opted to implement random sampling of chemotherapy bags to send for pharmacologic examination. The German government vowed to increase surveillance, including by conducting unannounced visits to pharmacies.

The question of quality management extends beyond these measures. As clinicians, how do we ensure that every patient in our care receives the best possible treatment? Do we ask regularly for second opinions? Do we discuss each of our patients in tumor boards? How do we keep up with medical knowledge while managing our daily workload? How do we implement a process of quality assurance while also teaching our students?

These questions might not rank among our top priorities, but they should. I have personally treated several patients with breast cancer who experienced metastatic relapse of their disease after being treated at a nearby oncology center that procured its drugs from Mr. Stadtmann’s pharmacy. It was heart-wrenching to witness these patients fight their deadly disease while plagued with doubts about whether they received the full dose of chemo-immunotherapy at their initial treatment.

Mr. Stadtmann declined to comment on any issues related to the case. We may never know if he acted entirely on his own or what motivated him to commit these crimes. He was recently sentenced to 12 years in prison. His pharmacy license is permanently revoked and he will have to pay €13.7 million in fines to health insurance companies.3

However, he will not be tried for injury or murder because the court was unable to determine which patients were specifically harmed by his misdeeds. I complained about this to one of my patients with breast cancer who works as a tax investigator for the local government. She chuckled and reassured me: “Don’t you worry! Once the main case has been settled, they are going to ask us to investigate his tax declarations.” Tax evasion – as in many countries – is no joke in Germany. Now I was smiling, too.

Aristoteles Giagounidis, MD
Associate Editor

References

  1. Business Insider. The 10 Cities with the best quality of life in the world. Accessed May 30, 2021 from https://www.businessinsider.de/international/the-10-cities-with-the-best-quality-of-life-in-the-world-2019-3/?r=US&IR=T.
  2. Kanavos P, Ferrario A, Vandoros S, et al. Higher US branded drug prices and spending compared to other countries may stem partly from quick uptake of new drugs. Health Aff (Millwood). 2013;32(4):753-761.
  3. Federal Court of Justice. Judgment in the so-called “pharmacist” procedure for violating the Medicines Act, among other things, is final. July 7, 2020. Accessed June 21, 2021. https://www.bundesgerichtshof.de/SharedDocs/Pressemitteilungen/DE/2020/2020088.html.