A “National Cancer Plan” for Germany: Cui bono?

The Federal Ministry of Health wants to achieve a fundamental reorientation of cancer therapy together with the German Cancer Society, the German Cancer Aid and the Working Group of German Tumor Centers. For this purpose, a “National Cancer Plan” was announced and four areas of action for improvements were described: “Further development of early cancer detection”, “Further development of oncological care structures and quality assurance”, “Strengthening patient orientation” and - discreetly left out in the Ärzteblatt article - “Ensuring efficient oncological Drug therapy”. (Federal Ministry of Health 2009). “The time is ripe” is the headline of the “Deutsche Ärzteblatt” on July 3, 2009 when reporting on the National Cancer Plan (Richter-Kuhlmann 2009). For what?

>> In view of the rapid development of the marketing of the healthcare system in this country and worldwide, time is of the essence: no other sector of the healthcare system will experience similarly good growth.
Prognosis confirmed as for cancer. The oncological pharmaceutical market, still the second largest today, will have grown into the leading drug market by 2010; annual growth rates of between 12 and 15 % by 2012 with sales of 75 to 80 billion US $ are forecast (Gavell 2008). This means that current sales will double within the next 5 years. In the United States and the EU alike, the majority of oncology products sold (70 %) have only been introduced to the market in the last 10 years. So far, 10 manufacturers share 75 % of the global market. Almost 2,000 new cancer therapy molecules are in development, 790 of which are in Phase II. 131 of these preparations are not new developments, but are being tested for approval for additional cancer indications. In phase III studies, the proportion of indication extensions already accounts for a third; for drugs that are about to be approved, it is the majority (43/50). 20 of these drugs, which are in the late phase of development, are intended to be effective against the common new cancers such as breast cancer and pancreatic cancer, while ten additional substances are to be used against non-Hodgkin's lymphomas, prostate carcinomas and malignant melanomas. According to the analysts, promising developments can be expected especially for advanced lung cancer, gastrointestinal carcinoma and esophageal cancer. The reason for the optimistic economic mood: cancer cases are increasing worldwide. And there is no serious threat to this optimistic expectation in sight. Why is that?
We are getting older and older. While 160 years ago women in Sweden had the highest life expectancy (45 years), today Japanese women have the highest life expectancy at 88 years. Life expectancy in industrialized countries has increased by 2.5 years per decade, and the linear slope has not shown any declines to date. (Oeppen & Vaupel, 2002). Cancer is a disease of older people; according to the Robert Koch Institute, the average age of onset in Germany is 69 years (Robert Koch Institute 2008). Since 1970, the incidence of cancer has been rising steadily in Germany and across Europe, including age-specific in age groups over 40 years. The rate of new cases under the age of 40 is very low at 76 new cases per 100,000 men, and almost twice as high for women at 127 per 100,000 women. This gender ratio shifts to the disadvantage of men as they get older. Among men over 60 years of age, 1,315 per 100,000 develop new cancer, and among women, 871 per 100,000. In people over 80, the rate of new cases increases to approximately 3,000/100,000 men and 1,700/100,000 women. (Saarland cancer register, time series on cancer incidence 2009). The absolute number of new cases of cancer in Germany is currently 440,000 people annually; in Europe's 25 member states there are a total of 2.3 million new cases, with more men (1.25 million) affected than women (1.04 million). ). With 320,000 newly diagnosed cases, breast cancer is the most common cancer in the EU25, followed by around 300,000 new cases of prostate cancer, around 300,000 colon cancers (163,000 cases in men and 134,000 cases in women) and 165,000 cases of lung cancer (194,000 men, 71,000 cases in women) (Coleman et al., 2008).
The expansion of ineffective “cancer prevention”
The German early cancer detection program, financed by the statutory health insurance companies, is a sham, just like the term “cancer prevention”. Although factually incorrect, it continues to be used persistently. With the early detection measures offered, which are sometimes only supposed, it is propagated that one can “prevent” cancer, i.e. prevent it. Neither is the catalog of services to which those with statutory health insurance are entitled to actual early cancer detection - e.g. palpation examinations for breast cancer, rectal cancer, prostate cancer - nor are the examinations suitable for early detection such as Pap smears for cervical cancer or early detection examinations for colon cancer systematically and with the the required high quality is offered. What is particularly bad is that the mammography screening program, which was launched in 2005 despite considerable resistance, has not yet provided any evidence of whether it meets the necessary European quality requirements; After four years of operation, there is neither transparency about the results nor about the devices used and their very different radiation exposure and image quality. The declared aim of the National Cancer Plan to increase the use of this poor offer underlines the aim of promoting growth in the oncology market. Poor early cancer detection does more harm than good because it leads to more late diagnoses without reducing cancer mortality.
The comprehensive expansion of the “clinical cancer registry”
Cancer registration without reference to the population can only provide very limited conclusions about the quality of early detection programs or the success of cancer treatments, because the “clinical cancer registries” that work with the data from individual clinics are always dealing with a selection of specific cancer patients, namely those who are in be treated in their respective clinic. Such registration then primarily serves the goal of documenting the increasing number of treatments for lucrative oncological cases in one's own clinic every year. However, there are no plans to expand and improve the epidemiological cancer registries that are still not functioning in many federal states, such as those in North Rhine-Westphalia, Hesse or Baden-Württemberg, which could provide urgently needed population data!
Secondly, the National Cancer Plan sees the task of the clinical cancer registries as reviewing the application of so-called S3 guidelines and awarding certificates to oncology centers for compliance with these guidelines by the German Cancer Society (German Cancer Society (DKG) 2008). A European certification of breast centers, which has already been awarded by the European Society for Breast Science (EUSOMA) to 30 specialized breast centers in Germany and other neighboring European countries (European Society of Mastology 2005), has been persistently ignored by the DKG for years. Significant deviations between the European and German requirements primarily concern the specialization of the experts working in the breast center, the pre- and postoperative case discussion in the interdisciplinary team required according to European criteria for each affected woman and the collaboration with other European breast centers as well as the transparency of the treatment results in one continuously updated European database. In contrast to the S3 guidelines of the National Cancer Plan, the benefits of adjuvant chemotherapy are assessed much more critically in the European Breast Centers and their use is recommended less frequently. In European breast centers, much more emphasis is placed on the agreement between imaging and histopathological diagnostics before the operation and a safe and cosmetically satisfactory removal of the tumor in a healthy patient, since these parameters largely determine the later prognosis. The benefit of adjuvant chemotherapy for all women with an initial diagnosis of breast cancer is relatively low.
A fundamental problem with current medical research is its increasing dependence on the medical device industry. The randomized, controlled long-term studies, which are essential for assessing the effectiveness and tolerability of new substances, have generally been financed for many years by the respective manufacturer of the drug under study and are often also planned, evaluated and published. The dangers of this dependency are manifold: they range from possible data manipulation to the suppression or non-publication of undesirable results as well as the premature termination of studies at the point of maximum therapeutic success, with the result that these studies often produce little meaningful results about the actual results Allow effect and potential side effects. The long-term effects of the substances on the survival of people affected by cancer treated with them are hardly any examined endpoint anymore, but only “disease-free survival”, i.e. the time until a recurrence of the disease is observed.
Such substitute study endpoints tend to make the effectiveness of a new therapy appear better than it actually is. Drug approval, especially when less and less time is required between research and market approval, is often done on the basis of insufficient scientific evidence, a potentially life-threatening experiment for all of us. The increasing powerlessness of regulatory and approval authorities in the face of the pressure to bring new medical products onto the market is accompanied by massive marketing, which is particularly aimed at opinion leaders from scientific societies as product advocates for the inclusion of the product in guidelines and clinical treatment recommendations. Almost all doctors working in clinical research and treatment now have extensive relationships, especially with drug manufacturers (Angell 2009), with the result that the appointment of independent experts to approval committees or guideline committees is becoming increasingly difficult. The consequences of these widespread conflicts of interest, which have now become the norm rather than the exception, are frightening: objective information based on evidence-based, high-quality guidelines can no longer be provided (Martiny et. al for the Health Transparency International Germany working group eV 2009).
Under the heading of improved patient information, the EU Commission recently decided to largely relax the advertising ban for prescription drugs, including media advertising. Experience from the USA shows that after the advertising ban was lifted, sales of prescription drugs within one year led to an increase in the cost of drug supply by around 12 %, with an increase in sales of 6 % and with no increase in the quality of health care.
Particularly in the cancer sector, appropriate information that reduces fears is essential, but at the moment it is simply utopia. Using the example of the HPV vaccination campaign, in which the DKFZ is involved in both development and patent use, the question arises as to how and where independent information can still be guaranteed. In view of the criticism that has now become loud about the vaccination (Dören et al. 2008) and its rapid and expensive introduction compared to other countries (in Germany, health insurance companies pay 477 euros for the vaccine instead of 210 euros like in the Netherlands or Great Britain), they went Institutions praised as high-quality sources of information in the National Cancer Plan, such as the Cancer Information Service (KID) or the German Cancer Aid, are not at a distance from the vaccination campaign - quite the opposite. The former head of the DKFZ and Nobel Prize winner Prof. Harald zur Hausen advertised the blessings of vaccination in a full-page advertisement in a major daily newspaper on July 6, 2009 - in the name of www.forum-chemie-macht-zukunft.de.
Ensuring an efficient oncological
Drug therapy
In this field of action, the growth goal of the National Cancer Plan is formulated most clearly: “In recent years there has been a development that so-called targeted, very expensive cancer drugs are increasingly being used, in which great hopes are placed in terms of effectiveness, tolerability and quality of life. In the coming years, a number of other drugs will come onto the market, which will be associated with a significant increase in the costs of oncological therapies.” (National Cancer Plan, Area of Action 3.) The hopes for a substance alone justify its market launch and every price, a careful one Scientific verification, including cost-efficiency, is no longer required, let alone a concept developed as to how protection can be achieved in view of the high pressure with which the new products are to be pressed into the “oncology market” as quickly and as expensively as possible of the patient/consumer can still be guaranteed. The “National Cancer Plan” from BMG, DKH and DKG reads like a 5-year plan to generate enormous needs, especially in the area of medication, to ensure that the increasing amounts of substances in the “oncological drug market” are supplied to a sufficiently increasing number of “consumers”. and that they are willing to pay the prices charged by the product manufacturers, no matter how high, without ever being able to receive proof of benefit.
A national cancer plan that serves the well-being of the individual affected and the population as a whole must pursue the opposite goal of the growth of disease and suffering: it must reduce the risk of disease, reduce the burden of disease and lead to a reduction in cancer incidence and cancer mortality through a variety of preventive measures.
Primary and secondary prevention strategies are of proven benefit to a National Cancer Plan. As a guideline for this, the European Code against Cancer (last revised in 2003) should be remembered, which is the basis for current considerations in the European Union to improve the fight against cancer (Albreht et al. 2008). It contains essential basic rules for the general improvement of health, which would lead to a reduction in cancer cases and cancer deaths, but would also reduce other chronic diseases such as cardiovascular diseases and diabetes mellitus:

1) Don't smoke; If you are a smoker, try to quit as quickly as possible. Never smoke in the presence of non-smokers as you will endanger them in the short and long term. Smoking not only causes cancer, but also chronic obstructive pulmonary disease, cardiovascular disease and sudden infant death syndrome. 25-30% of all cancers diagnosed in Europe are due to tobacco smoking.
2) Avoid being overweight: Obesity (body mass index [BMI]) of 30 kg/m2 and above is a major risk factor for morbidity (cancer, diabetes, cardiovascular disease) and mortality.
3) Daily physical activity: Many studies show the protective effect of physical activity against cancers such as colon cancer, breast cancer, uterine cancer and prostate cancer. 30 minutes a day are enough, at least three times a week. More exercise could contribute even more to cancer prevention.
4) Increase your daily intake of fruits and vegetables: Eat at least 5 portions of them a day. Reduce foods that contain animal fats.
5) If you drink alcohol, do so in very small quantities, maximum 2 drinks = 20 grams of alcohol per day for men and 1 drink = 10 grams of alcohol per day for women. There is no minimum safe dose with regard to the development of cancer.
6) Avoid too much sun. It is particularly important to protect children and young people.
7) Be extremely strict in applying laws that protect you from exposure to carcinogens. Follow all health and safety instructions when handling such substances. Follow radiation protection regulations.

Programs to combat cancer mortality through early detection
8) Women over 25 years old should participate in a cervical cancer screening program, the testing interval is between 3 and 5 years
9) Women over 50 should participate in organized mammography screening programs for early detection of breast cancer.
10) Men and women over 50 years of age should participate in colorectal cancer screening programs using fecal occult blood (FOBT) testing followed by colonoscopy at 3-5 year intervals if the test is positive.
11) Participate in vaccination programs (entire population) against hepatitis B to prevent hepatocellular cancer. (Martin-Moreno & Magnusson 2008)

With such a national cancer (prevention) plan, the profit expectations of the oncological pharmaceutical market would not be fulfilled in the next 5 to 10 years. In return, the quality of life and life expectancy of the population in Germany would increase significantly. On such a central question of democracy, citizens in Germany must be asked which national cancer plan they want. <<