PROFESSOR DRESSLER ON THE CURRENT STATUS OF BOTULINUM TOXIN THERAPY

Q: Professor Dressler, the botulinum toxin therapy has now been around for almost 30 years. Where do we stand today?

Dressler: The good news is: Botulinum toxin therapy is now a well-established therapy, especially for the many forms of dystonia. This means that we have standard procedures, guidelines, consensus statements, registrations, we have longterm experience and plenty of safety data.

Q: You paint a positive picture. Aren’t there any problems?

Dressler: Yes, there are problems, indeed. The biggest problem is the availability of the botulinum toxin therapy. Many patients would be perfect candidates, but they are not treated. In former days public awareness was the problem, now it is the restrictions of the health care systems. Depending on the particular system, obstacles are different and manifold: In some countries, like Germany, the drug is covered, but not its application, so less and less physicians and hospitals are offering this service. In other countries, such as the UK, there are regional NHS budgets restricting the purchase of the drug. In some places, for example in France, the number of licensed injectors is limited. Availability in non-industrialised countries is a completely different problem. Given the size of this problem, we are heavily engaged to bring this therapy to those countries where there is a dramatic need.

Q: Who can help? There are many patient organisations.

Dressler: For patient organisations it is very difficult to understand the problem: All of our hybrid health care systems are extremely complex and cause and effect are linked in a multifactorial pattern. And, even if the problem is identified: There is a fierce competition these days for resources and organisations with few patients are often pushed aside.

Q: What about the pharmaceutical industry?

Dressler: Botulinum toxin drugs are ‘old’ drugs. Traditional life cycle management suggests to slow down investments, especially in market development. So, sales figures are stagnant: A typical vicious cycle. Fierce competition erodes the price. One of the manufacturers has axed its research department altogether. For another one, take-over battles resulted in an exodus of experienced research and product staff. One new US manufacturer has an interesting new product idea. Registration studies are currently under way in the US and Europe. This is a good sign.

Q: What about Asian botulinum toxin manufacturers?

Dressler: So far, Asian manufacturers have been focused on aesthetic applications and on markets outside of Europe and of North America. However, I see that this focus is currently changing. There is growing interest in the therapeutic area and in Europe and North America. This will soon produce a new global competition and – hopefully – a revival of the industry’s enthusiasm. A huge potential is inside of China. Currently the Chinese botulinum toxin manufacturer is realising this potential and is investing in a therapeutic expansion within the country.

Q: What about basic research?

Dressler: Many grand old figures of basic botulinum toxin research have retired or are on the brink of retirement. Most of them will leave without replacement. Spending on botulinum toxin research in biodefense and in food safety has come down, as both threads are no longer top public priority.

Q: What about your specialty, clinical research?

Dressler: In the late 1980’s, 1990’s and even in the early 2000’s research got away with the search for the low-hanging fruits. Early on, we realised that these times would soon be over and we embarked on a planned and detailed research program focused on translational botulinum toxin research. This means that we identified basic aspects of botulinum toxin therapy and studied them with preclinical and clinical methods. This research included studies on product comparisons, stability, immunology and binding, on antibody-detection systems, dose-effect curves, injection site pain and studies on cost-effectiveness. Our studies with the strongest impact on patients were our recent studies on treatment algorithms. They clearly changed the way botulinum toxin therapy is now performed.

Q: What are those studies on treatment algorithms?

Dressler: Using new low antigenicity botulinum toxin drugs we introduced the high dose therapy, the short interval therapy and the re-start therapy.

Q: Why are these studies important for patients?

Dressler: With the option to use botulinum toxin in doses of up to Botox/Xeomin 1500MU, the high dose therapy, we can now treat more wide-spread dystonia and more severe dystonia. This has changed the dividing line between botulinum toxin therapy and deep brain stimulation. With the short interval therapy we can now help those patients in which botulinum toxin therapy lasts less than 12 weeks. This may increase the time of optimal treatment by up to one quarter or 3 months per year. The re-start therapy is for patients with antibody-induced therapy failure. When their botulinum toxin antibody titres drop during a treatment pause, botulinum toxin therapy can be re-started with a low-antigen botulinum toxin drug and sensitivity is re-gained and maintained without new antibody formation.

Q: Professor Dressler, what is your resume?

Dressler: There are clearly many challenges for botulinum toxin therapy. They include availability, the industrial environment, the situation in basic research and the stagnation in clinical research. But there is also hope: New competition and well-planned research can and will push botulinum toxin therapy to the next level.

Q: Many thanks, Professor Dressler

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