Let me start out by asking a naïve question as two things come to mind: a car nicknamed "cab-baggage car" that became cabbages and a poem fragment saying that the time has come to talk of many things; of shoes and ships and sealing-wax of cabbages and kings. Professor Dr. Klaus-Dirk, Doctor, let me ask.
Why should buying drugs be different from the purchase of a car or cabbage?
Leaving Kings out, there is certainly a long list of health benefits from vegetables, such as cabbage. Cabbage has therapeutic properties for stomach ulcers, arthritis, visual problems, heart ailments, also for Alzheimer’s disease. Cabbage is rich in vitamins, minerals, and other nutrients; vitamin C, sulphur and beta-carotene. Drugs based on sulphur fight infection. Sulphur deficiency can result in microbial infection and a reduced healing capacity of a wound. So YES to cabbage, on a weekly basis, throughout life! Go to the neighbourhood market where there is no need for a prescription. But although cabbage packs a punch, it is extremely limited to deal with a life threatening microbial infection. By contrast an antibiotic with its highly concentrated active agent, does it better.
At some point in our lives we buy a car and take a pill. For both, there are tips for use and taking. From a public health point of view, we must understand the power we hold in our hands when driving a car. Damage is done when the energy of impact is deposited in the body. The more energy absorbed the greater the bruising. Wearing a seat belt in a car with air bags can reduce the impact and damage; eye injuries for example are reduced. Road accidents are serious events! In being prescribed a medication by a doctor we must be compliant; that is take it as recommended, in amount - dose, in frequency and report any side effects. Today, side effects are given in a leaflet when buying the drugs at a pharmacy.
Medicines are not commodities like cars, so rules of the market should not apply blindly to them. Medicines are entirely related to either preventing the illness or responding to the sick individual or population; in my opinion, the discussion about medicines/drugs should go in the direction of public good, non-restricted and available to all. Vaccines prevent and curb sickness in a population but people still come down with the flu. The percentage of the population vaccinated is crucial and should be as close to universal as possible to confers herd immunity. It’s a matter of all for one and one for all.
Can we review the process that brings a new drug to patients, to the market ? Talk us through the path Professor.
The path and process take place within and outside of the pharmaceutical industry as science looks for more effective products to treat new and older returning diseases. The path or route to a pill is common but extremely complex. It moves from conception and discovery to synthesis, testing and approval for the market. It takes years and comes with a high cost from compound discovery to popping of a life saving pill by the patient. Computers are used in all stages from pipeline entry through discovery and final pill. Chemical structures are examined and formulas manipulated. Structure can be spatially viewed, rotated, modified, simulated, and tested. Insight is gained using computational methods; how the compound might be absorbed-uptake, distributed and metabolised within the body or how it is broken down and its waste products excreted.
What about patient toxicity?
Toxicity to the patient must always be addressed. Think of a compound that cures a deadly disease but poisons the patient. The cure is 100% effective but the side effects are lethal. Alcohol is a good aesthetic but blood levels at which it becomes adequately effective are too close to the level that might kill the patient. Drinking contests in Scotland have seen one of the contestants’ still standing die with the last dram downed.
Can we speed up the process of finding new drugs?
Rational drug and medical product discovery and design, protocol approval and systems becomes more important. The aim is a faster success rate of selection for the market of say one or two compounds from many in the pipeline. The drop out drugs may have cost a fortune; the main candidates will cost another fortune through design and testing. Testing might include in the laboratory, in vitro and in people, in vivo. Testing in humans (from medical students to patients) is a hierarchical process referred to as a clinical trial. Protocols are clinical guidelines for therapy of disease conditions. Patient selection is crucial. For example kidney transplantation becomes less effective with the age of the patient. So it maybe a must for a candidate aged 40 and questionable at eighty. At 40 it is a medical decision, at eighty the criteria are different.
Dr Branka Legetic: there seems to be a serious lack of new antibiotics in the pipeline. How do antibiotics fit into what we have just said, Doctor?
Numerous infections: pneumonia, salmonellosis, tuberculosis, gonorrhoea, become harder to treat. Two recent events draw attention to the severity of what is called antibiotic resistance and the need for new drugs. In 2016, the United Nations General Assembly elicited a commitment from Member States to address the root cause of antimicrobial resistance and to take rational action, nationally and internationally. This year the WHO conducted the World Antibiotic Awareness Week. Somewhere in its web site, there is a cartoon showing a woman saying “no” to an anticipatory man. Its caption reads, never share antibiotics with another person (not even family). Resistance to antibiotic therapy can affect anyone, any age, any country and is made worse where antibiotics can be bought without a prescription, are over-prescribed or where standard treatments and guidelines are not applied or where infection prevention and control are poorly developed as public health issues. The biggest threats are to global health, food security and development.
Doctor: Are we are heading to a time when common infections and minor injuries might again kill indiscriminately?
This is implicit in much of the thinking within the international community for which there is a need for urgent action; more solidarity and humanitarianism. A reduction in inequality will go a long way.
We need action on two levels; use of best practices to cut down on antibiotic resistance and get new antibiotics out of the pipeline. At the same time we must become more humanitarian; products from industrial countries must be available to vulnerable groups in the poorer parts of the world. Global health is promoted by Professor Jeffrey Levett and Ilona Kickbush, my German Swiss colleague relates and to the treatment with pharmaceutical products. I note also ECPD’s interest in health diplomacy. In most western countries we have well developed institutions such as NICE for benefit and cost analysis and to check up on product outcome. It is part of what is called evidence based medicine. If the outcome cannot be proved the pill will not be made available in well financed systems such as either Bismarckian or Beveridge.
Professor, you are concerned about hospital over-capacity as well as unnecessary medical treatments. I would think that over-capacity may be important at a time of mishap-disaster as a surge capacity. Once when drinking good red wine with two excellent surgeons, brain and heart, I asked them to tell me their best cuts.......the answer was those they didn't do. We should be thinking of the many many medical treatments that are not really necessary. By cutting back on them we could save lives by using the savings somewhere else.
How do you decide Professor?
One answer: the quality of the medical indication needs to be checked against a second opinion; secondly we could give the insurance funds more power to reject financing of unimportant services. In our new environment paying for performance is the new key phrase. As a first step one has to find out why overcapacity exists; hospitals, beds and services Some direction can be found in OECD studies. The public sector is perhaps doing too much while within it closing of a hospital is almost impossible. I think we need more research and development of new procedures and services and we must continue to improve human capital though education and by keeping society healthy.
Doctor, give us a few words on your prepared paper for the conference?
Yes! I focussed on universal health coverage as the only way forward to protect patients and their families. Access to medicines with fair pricing means balance between a reasonable return on investment for pharmaceutical companies and an affordable drug price to protect public health systems and other payers from bankruptcy. Fair pricing is not a simple concept and procedures are not always transparent. It seems that a multi-stakeholder approach is the only viable one. Governments must be enabled to play a stronger role in negotiating prices and in influencing R & D for medicines that are of relevance to public health such as the still ongoing battle to roll back malaria, bring tuberculosis once again under control and deal with the consequences of Ebola, HIV and SARS like conditions. These are agenda items for the WHO.
Dr Branka Legetic, we hear that health care in South East Europe is moving up the political agenda. Doctor can we reference it to drugs?
I do not readily perceive health as being high on the agenda in Serbia. Serbia does not have yet a list of essential medicines. I would argue that the South East (Balkans) should work closer with the North West (Northern Europe). Activities like this conference help to bring the region and Europe closer together. And what you Jeff have been campaigning for; public health, human security and health diplomacy.
Professor Dr. Klaus-Dirk, you have the last word, a summary please as the leader of the conference in Opatija?
The ECPD is a mandated University for Peace established by the United Nations. It consistently provides insights: into human security, religious intolerance, reconciliation in a multi-cultural setting, analysis of space between globalization and regionalization and of course pharmacoeconomics. During our 4th ECPD pharmacoeconomics conference, together with my colleague Benno Legler our call was for a new approach to the pharmaceutical industry asking for more of its great benefits. Instead of health care as a cost factor it should be viewed as a growth sector with an increasing work force and new career opportunities. Our understanding of health was discussed within the concept of the economic footprint of the industrialized health economy and with its ensuing contribution to health and the overall national economy.
Read also Part I
The 4th annual Conference (2016) of the European Center for Peace and Development (ECPD) and University for Peace established by the United Nations, Belgrade, was directed by Professor Dr. Klaus-Dirk Henke, Technische Universität Berlin. During the event he was recognized with great appreciation for significant contributions and activities in pharmaco-management and health economics. in Part II my conversationalists are Henke and Dr. Branka, Legetic, International Consultant, Former Regional Advisor PAHO.
Henke, K.-D. (2006): The Funding and Purchasing of Health Care - A Book with Seven Seals, in: Journal of Public Health, Bd. 14, Nr. 6, 385-390.
Henke, K.-D., und Ostwald, D. A. (2012): Health satellite account: the first step, in: Behavioural and Healthcare Research, Bd.3, H.1., S. 91 - 105.
WHO (2017) Fair pricing Forum–meeting Report
OECD, 2013, Managing hospital volumes – Germany and experiences from OECD countries, Paris, Executive Summary.
Levett Jeffrey, Political Wall Flowers, Butterflies for Global Health? 2017
Werling E, Hamelmann C, Henke KD. Health economy reporting: a useful tool for evidence based investments for health and development. A case review from Germany. Copenhagen: WHO Regional Office for Europe; 2017(Investment for Health and Development Review).