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In the case of cervical cancer, of which there are about 1 5 new cases each year, the situation is different; now that the role of specific papillomaviruses in the development of this cancer has been confirmed, experiments on animal papillomavirus infections have shown that these can be effectively prevented by vaccination.

At present, efforts are underway in a number of countries to produce vaccines against human papil- lomavirus infections; the first clinical tests are already in progress.

If these are successful, we can look forward, not only to an effective prevention of cervical cancer, but also to a means of preventing the earlier pre-cancerous stages of the disease, which them- selves also require treatment.

Chemopreventive measures are today still very much in their infancy. For ex- ample, we still know far too little about the exact components of our diets which contribute to the development of cancer and those which can offer direct protection against the disease.

Howev- er, a series of clinical studies have pro- duced promising first results and should encourage intensified research efforts in this area. What, then, is the present situation with regard to clinical research, particularly clinical cancer research, in Germany?

And what are the projects and pro- grams that can really contribute to changing the prospects, especially of cancer sufferers?

Clinical research is research on and for the patient as well as patient-related re- search In the laboratory aimed at im- proving prevention, diagnostics, thera- py, and rehabilitation.

Its role is to con- tribute to the avoidance of disease, to enable early and accurate diagnoses to be made, to optimize therapy, and to shorten the course of the disease and the period of convalescence.

Seen from this viewpoint, one might ask whether clinical research in Ger- many can match the level set by the English speaking countries. The Ger- man Research Association Deutsche Forschungsgemeinschaft, DFG , the Max Planck Society, the German Can- cer Aid Deutsche Krebshilfe and cer- tainly a good number of other organiza- tions have, particularly over the last two decades, made significant efforts to im- prove the situation by offering grants for study periods abroad, by initiating clini- 14 The Fight Against Cancer in Germany cal research groups, and by sponsoring selected clinical research projects.

These efforts have undoubtedly had a measurable success, but by interna- tional standards one that lags behind other countries.

Can we attribute this overall unsatisfac- tory situation to particular structures of the German research environment?

It is my belief that we can, and in the follow- ing I will try to give what I see as the most important arguments. For a young medical student, Germany offers no wide-ranging course of study with the possibility of finally gaining a Dr.

Doctor of natural sciences , equiv- alent to the English or American M. It has only been very recently that some efforts to intro- duce such a program have been made.

Once the status of post-doctorate has been achieved, it is very difficult to make up for the lack of a basic ground- ing in natural science and molecular bi- ology.

If the German universities were called upon to develop carefully devised inter- disciplinary courses of study leading to a doctorate in natural sciences for interested students of medicine, this would create a new basis for clinical research in this country and would probably also have the beneficial side effect of counteracting the currently falling numbers of students of physics and chemistry.

The graduate-support programs of the German Research Association are cer- tainly a step in the right direction, but in my view do not go far enough.

Here a joint initiative needs to come from the Conference of Arts and Education Min- isters of the German States. Much has been said and written about the routine burden on German univer- sity hospitals, and also about the signif- icant teaching duties, which together leave very little time for concrete re- search projects.

Even though the struc- ture of the university hospitals is cur- rently being fundamentally changed, such that expenditure for research and teaching is being separated from the funds needed for treating patients, are these measures that are likely to give Increased impetus to clinical research?

In one sense they are. The reduction in the number of beds and the shortening of hospital stays can both make more time available for scientific endeavors.

But the parallel efforts to reduce staff and save money, the lower number of patients available, and the decreased opportunity to carry out careful long- term controls are all likely to have the opposite effect.

Training, on the one hand, and time and opportunity for research, on the other, can be identified as important factors underlying the problems in clini- cal research.

But beyond these, what are the prospects for the scientifically oriented physician? The competition for suitable thesis topics and for the sup- port of hospital directors is enormous and this occasionally leads to the publi- cation of poorly founded predictions and.

In the worst case, even to the fid- dling of results. These, of course, are extreme exam- ples. Many of the senior physicians and externally funded professors who leave their jobs are people who would like to have continued their scientific activities, but are not given any long-term oppor- tunity at the teaching hospitals, remain unsuccessful on the appointments car- ousel, and are forced by their contracts with the insurance Institutions and the state, regional, or municipal hospitals to give up their scientific work.

It is clear that the best people should be selected to head our university hos- pitals. But In the process, many talents are possibly left by the wayside, talents that are not directly suited for leading our perhaps rather too conventional university hospital structures.

These people may see the move into practical medicine as one alternative and the somewhat rougher road of a career abroad as another.

When one nowa- days visits hospitals, especially re- search-oriented hospitals, in the USA, 15 Fig. I am convinced that this is a reflection of another, particularly important, struc- tural problem: the comparatively poor opportunities for clinicians to do re- search at non-university hospitals.

This is not the case for the clinically oriented medical doctors, much as they may be envied by some natural scien- tists.

They can of course seek employ- ment In a research position at a number of the above-mentioned institutes, but for the clinical research which Is their main concern there are very few oppor- tunities outside the universities: the Max Planck Society only pursues clini- cal research as a somewhat peripheral activity; the Max Delbruck Center in Berlin and the Deutsches Krebsfor- schungszentrum engage in a certain amount of clinical research; a few insti- tutes of the WBL, e.

The shortcoming here is easy to define: in Germany there is no form of organ- ization in the non-university clinical sec- tor which represents the cause of clini- cal research.

But this must not be a measure that works to the disad- vantage of university research - It must supplement, support, and stimulate the latter.

It must provide the additional scope, lacking due to the restricted number of positions at our universities, to give talented young people the op- portunity to develop their potential in clinical research as well.

For this purpose, roughly 30, per- sons in Heidelberg are being interviewed. A preserved blood sample should help to clarify any relationships between genetic factors or nutritional ingredients and cancer that do not become evident until sometime in the future.

What initially appears to be a kaleidoscope-like image is actually a cylinder which contains the blood samples from participants in the stud.

The responses are immediately entered into the comput- er. Afterwards, as a token of appreciation, the study participants receive an analysis of the composition of their daily nutritional intake with recommendations for any necessary changes in their eating habits surely serve as the seed for the devel- opment projected here.

A minimal solution, so to speak, would be the creation of interactive structures between clinical university and non-uni- versity research.

But anyone who has been practically involved in such schemes knows the amount of difficul- ties they entail. These are temporary re- search units, which operate like a de- partment of a National Research Cen- ter under the leadership of an appoint- ed clinician within the university hospi- tals.

Three of these units are equipped with their own beds. They are simulta- neously provided with well-equipped la- boratories in research centers. A coop- eration agreement regulates the fund- ing of the units.

These units are struc- tures that are Integrated into the normal running of the hospital; without ques- tion, they suffered from a number of teething problems and necessitated a considerable learning process for both parties in the agreement.

The difficulties encountered in the initial phase included the status of the head of the unit in relation to the clinic direc- 17 tor, the integration of the specially fund- ed research staff into the clinical activ- ities - for example, night shifts and weekend shifts -, also the recognition of the work done in such units for the spe- cialist medical qualifications, as well as many other details.

The difficulties were compounded by the different mode of funding and by legal problems concern- ing sideline activities.

Nonetheless, with good will on both sides, most of these questions could be solved and negotia- tions over several years led to the first units being established, the oldest of which has now been operating for three years.

The existing cooperation units are led, if in some cases only temporarily, by young and talented physicians who have also demonstrated their scientific enterprise.

As a result, following a good two years in this position, the head of the first unit has now been appointed to a university professorship.

This is of course a gratifying and desirable devel- opment, even though It clearly hampers the coherent building up of the units.

The lability of such structures, which can be additionally burdened by a change in the leadership of the corre- sponding university hospitals, becomes particularly evident here.

Clinical cooperation units are nonethe- less an element that can to some ex- tent compensate for the structural weaknesses of clinical research in Ger- many - in the same way as the clinical research groups of the Max Planck So- ciety and the German Research Asso- ciation.

The opposite approach, namely the creation of research opportunities for university clinical groups in the non-uni- versity research sector, is also being pursued to an increasing extent and has shown itself to be thoroughly suc- cessful in certain cases.

It is my experi- ence that the day-to-day availability of the clinical partner is often a problem here. Experiments that are set up in a spare moment In the evening are not always the best conceived results are not always followed up to the neces- sary depth and in a few cases are too rapidly and uncritically accepted.

The discussion so far has been restrict- ed to aspects of the interaction between university and non-university structures and has not touched upon the clearly very important interaction between clinical and fundamental re- search within the universities them- selves.

This is indeed a matter that Is relevant to the founding of new and highly regarded Interdisciplinary univer- sity centers for clinical research.

Today one hears much about the im- provement of technology transfer from research into practice, and also from research into the hospital.

Special spear- head projects are intended to give addi- tional impetus to these developments, and further support Is provided by an aggressive patenting policy and public- ity designed to attract venture capital.

What is the present situation regarding the transfer of results from biomedical research Into clinical practice? Is this occurring with the necessary efficiency to satisfy the justified concern of the tax-payer and the patient that what they see as high research expenditure is also accompanied by progress in prevention, diagnostics, and treatment of disease?

Here I believe that further efforts are necessary to modify and im- prove existing structures. In one channel the transfer is almost too fast: the practical implementation of new diagnostic tools.

Monoclonal anti- bodies, the polymerase chain reaction PCR , hybridization kits, and enzymat- ic reactions often find their way into routine diagnostics faster than would be justified by a thorough prior evaluation.

The reasons for this are as obvious as they are simple: the introduction of new testing procedures quickly leads to re- sults, is frequently lucrative, and raises the reputation of the clinical laboratory involved.

When this leads to an im- poved early diagnosis and a shorter and simpler treatment then such a de- velopment can only be applauded. The other side of the coin, however, is a potentially over-hasty judgment about predisposition to disease, e.

This can lead to unnecessary preventive measures being taken and to patients being scared by test results whose prognostic significance Is insufficiently determined.

In contrast, the transfer of methods for disease prevention and therapy fre- quently occurs in a rather sluggish and lethargic manner.

Here, too, the rea- sons are easy to identify: the introduc- 18 The Fight Against Cancer in Germany tion of a suitable vaccine for disease prevention requires a prior period of clinical testing in order to prove that it is both effective and harmless, and also conditions for its production that are far above normal laboratory standards.

The costs for manufacture and clinical testing are enormous, frequently reach- ing eight- or nine-figure sums, and have to be carefully calculated and balanced against the expected profit.

Here the transfer into practice can only take place via the pharmaceutical industry. The time required is often alarmingly long; a vaccine against certain papil- lomavirus types, which has good pros- pects of preventing the occurrence of a high proportion of modifications of the cervix and cervical cancer itself, will probably only be introduced at the be- ginning of the next century, even though the underlying discoveries were made about 20 years earlier.

A similar situation pertains In the trans- fer of new therapeutic approaches into clinical use, although here the time schedules are not always as long as for the above-mentioned vaccines.

Non- etheless, the manufacturing require- ments, quality control, and precllnical and clinical testing still swallow time and money in amounts that state-fund- ed scientific institutes can scarcely af- ford, such that here too a collaboration with the pharmaceutical Industry is es- sential.

This collaboration has undergone a vis- ible change in the recent past; along- side the previously described govern- ment initiatives, the reorganization of many industrial companies with its con- comitant reduction in staff and cutting back of research activities has more or less forced industry to intensify its in- volvement in state-funded research in universities and non-university facilities.

At present this is undoubtedly a particu- larly invigorating element In the transfer of results from clinically oriented funda- mental research into clinical practice.

Since the pharmaceutical industry is re- liant on patents to protect its products, this collaboration requires a change in the protection of inventions policy of the scientific institutes involved.

In particu- lar the universities have often offered their professors the opportunity to pat- ent their ideas and subsequently utilize the patents themselves.

But due to the rapidly growing patent fees and legal costs, particularly for International pat- ent applications, and often in the ab- sence of suitable contacts to potential industrial partners, the personal re- sources of the inventor are very quickly exhausted.

In view of the Inevitable ad- ditional delay In the publication of sci- entific results that is entailed, these cir- cumstances have led to a widespread lack of interest in patenting.

This also has a lasting influence on the development of clinical research and can only be corrected by a change in the patenting policy of the institutes concerned.

It Is in my view absolutely essential not only that technology- transfer positions be created in the uni- versities, but also that the universities take advantage of patents themselves, thereby also accepting the risk of the patent registration and later giving the inventor an appropriate share in any profits.

A possible model would be that employed by the Max Planck Society and other non-university institutes, whereby the institute, the department, and the inventor each receive one-third of the earnings from a patent.

In the past, the main need for action was perceived as being a need to change our clinical structures. Although this Is still the case, there are other matters now of even greater urgency: to change our system of higher educa- tion, to expand the spectrum of clinical- ly oriented research opportunities, and to achieve significant changes in pat- enting policy and in the transfer of re- sults, in particular from the universities, into clinical and industrial practice.

I be- lieve that this medium- to long-term aim urgently requires the support of individ- uals who are aware of the present defi- cits - people from the teaching, re- search, and hospital professions, and from legislative and executive sectors.

However, this must not distract us from that fact that, particularly in relation to fighting cancer, other political measures could today already prevent many thou- sands of cases of premature Illness and death.

Our greatest and at the same time most tragic failure must be acknowledged here: it is the failure of our efforts to check the consumption of tobacco in our country.

About 70 people die each year In Germany from cancers caused by tobacco smoke. The World Health Organization estimates the total number of deaths in Germany due to tobacco smoking, including those from diseases of the heart and respiratory tract, at per year.

This is 0. One really has to stop and think about these numbers in order to comprehend the extent of the tragedy.

The British epi- demiologist Richard Peto has calculat- ed that, on average, each of these peo- ple loses more than eight years of life. Among other objectives, specific goals will include the identification of substances in food that both promote and provide protection against cancer, as well as the treatment of cancer precursors so that these will not develop into a tumor.

Following chemopre- ventive treatment, this particular arrangement of equipment can, for example, detect the activity of genes that indicate the effectiveness of the administered therapy hybrid- ization experiments light of the bizarre fact that the annual tax revenue from the tobacco industry reaches the fantastic sum of DM 20 blUlon in this country.

Thus each to- bacco-related death corresponds to earnings of DM 1 80 per year - a calculation which we should empha- size to those holding the political re- sponsibility.

This sum should also be held up against the burdens due to to- bacco-related diseases, which must be carried by the health insurances, other welfare facilities, the families, and the victims themselves.

Fundamental cancer research in Ger- many is undoubtedly flourishing, even though weaknesses can still be identi- fied.

In order to strengthen clinical can- cer research, changes in the research environment are necessary and must be initiated in the next few years.

Harald zur Hausen Chairman and Scientific Member of the Management Board of the Deutsches Krebsforschungszentrum 20 Conditions and Structures in Research Conditions and Structures in Research by Josef Puchta Over the past few years, the Deutsches Krebsforschungszentrum has continu- ously strengthened its international rep- utation as a center of competence in the field of cancer research.

This is evi- denced by the increase in the number of publications, the vast majority of which appear in high-ranking journals, and by the high citation index of these publications.

Furthermore, a number of prizes have been awarded to scientists from the Deutsches Krebsforschungs- zentrum, including the Leibniz Prize of the German Research Association DFG , the Karl Heinz Beckurts Prize for Technology Transfer, and the Beh- ring-Kitasato Prize.

Moreover, in the years since 1 , more than 25 young Fig. Since the early 1 s, for the first time in this century, a decline in cancer mor- tality has been registered in Germany.

The new edition of the Atlas of Cancer Mortality in the Federal Republic of Germany published in fall gives more detailed information about this re- markable trend.

Although one can hard- ly credit individual research facilities with such achievements, this decline clearly serves to demonstrate how long-term research can lead to the de- sired end.

According to opinion leaders from sci- ence, economy, and politics alike, bio- sciences and biotechnology rank among the key technologies of the 21st century.

Here, experts predict the crea- tion of high-profile jobs in science and economy and see an investment in the future.

The reality, however, is much more down-to-earth. Staff Situation At the beginning of , the number of staff employed at the Deutsches Krebs- forschungszentrum was equivalent to 1 full-time positions.

There are The Federal Ministry for Edu- cation, Science, Research, and Tech- nology has dictated a 1. For the Deutsches Krebsforschungszen- trum this means a loss of about 60 such positions between the years of and , equivalent to more than 8 percent of the existing number.

In addition, due to the significant cuts in staff funding from the University Special Program for the Deutsches Krebsfor- schungszentrum, about 50 positions for young scientists can no longer be filled in future.

The career prospects for the up-and-coming generation of scientists have been reduced by this develop- ment, which also contradicts the con- cept of bloscience being a leading sci- ence of the next century.

Today, a large number of the best young scientists are already leaving Germany to seek jobs in non-European countries, particularly in the United States.

The existing legal regulations for tem- porary employment contracts and the current employment protection legisla- tion certainly do not facilitate a flexible management of staffing plans.

More- over, conflicts with the staff representa- tives are predestined. As a result, the flexibility of the staff plan is being re- duced.

The great significance of human re- sources for a research center Is evident and does not need to be discussed here.

Despite the expected restrictions, the Deutsches Krebsforschungszen- trum will continue its efforts to attract top scientists and to retain the best per- formers at the Center.

In view of the conditions mentioned above, i. Inflationary adjustment and In- 22 Conditions and Structures in Research Fig.

In , more than research projects with a financial volume of more than DM 34 million were carried out at the Deutsches Krebsforschungszen- trum, the main sponsors being the Ger- man Research Association DFG , the European Union, the German Research Ministry, and Industry.

The amount of external funding received is a result of hard scientific work and high-quality proposals - a remarkable achievement considering the Increasing competition for external funding.

Equally gratifying is the significant Increase in scientific cooperations with industry - a fact which also manifests Itself In the finan- cial volume stemming from such coop- erations: In it reached about DM 5 million.

Apart from these intensive efforts to win independent funding, an increasingly Important role In compensating some- what for the stagnant situation in basic funding is also played by private dona- tions and estates dedicated to cancer research.

Patent Situation Alongside fundamental research, the Deutsches Krebsforschungszentrum also attaches growing importance to the exploitation of research results.

In this context, the patent initiative of the Research Ministry has clearly set the right course. Technology transfer bridges the gap between research and commercial application.

Hopefully, the increasing collaboration between sci- ence and industry will encourage syner- gy effects that will help preserve the in- novative resources and competitive- ness of the German economy and create new jobs.

In the light of this ar- gumentation, technology transfer can be seen as a management task and thus represents an important part of the policy of a research center.

In spring , the Center began to re- establish its unit for technology transfer, which reports directly to the Manage- ment Board.

Indeed, the ultimate aim behind patenting special know-how and Inventions Is their ex- ploitation, normally in the form of a li- cense agreement.

The fact that today it Is possible to both publish and patent an idea within a short space of time leaves little room 23 for argument against such an applica- tion.

This means, patenting does not exclude publishing. A registration can be carried out within just a few days, and thus the proprietary rights are se- cured - whether or not a patent Is later awarded.

The Center bears all patent application and maintenance costs. In , these amounted to more than 1 million DM.

In , the revenues will exceed the costs. For companies working In bio- technology, a field marked by global connections, it is particulary important to have licensed not only a national, but also an international patent.

For the Deutsches Krebsforschungszentrum this means that patent application and maintenance costs will probably in- crease over the next few years.

The Deutsches Krebsforschungszen- trum grants inventors a share of 30 per- cent of the license revenues from an In- vention. The decision taken by the Federal Min- istry for Education, Science, Research, and Technology in spring to place percent of the revenues from the economic exploitation of patents at the disposal of the research center Instead of 60 percent as in the past is a posi- tive and welcome incentive to utilize patents.

I am pleased to be able to report that at the beginning of , the total number of patents awarded or pending at the Deutsches Krebsforschungszentrum amounted to about and that a con- tinuing increase can be observed In the number of applications.

In the field of biosciences, it often takes a long time before the material benefits from the li- censing of patents can start to flow back, because in many cases lengthy and expensive clinical trials have to be conducted first - something which is not necessary, for example, in an area such as mechanical engineering.

As a rule, several years elapse between the granting of a patent license to a compa- ny and the introduction of a corre- sponding product onto the market.

One obstacle to the licensing of patents continues to be the stipulation in appen- dix IV of the financial statute of the HGF facilities, according to which it is not per- mitted to grant an exclusive license the latter requiring an individual application for permission from the sponsor , i.

In view of the long amortization period of the develop- ment and patenting costs, this Is a mat- ter that calls for action. To avoid misinterpretation I should like to stress once again that the Deutsches Krebsforschungszentrum continues to be a facility engaged in application oriented fundamental research.

It is not intended to restrict these activities in any way. BioRegio In fall , the Rhein-Neckar triangle was chosen as one of the three winning regions out of 17 entries of a competi- tion organized by the German Re- search Ministry.

The Deutsches Krebs- forschungszentrum made a crucial con- tribution to the entry of the region and has strongly supported the realization of the concept.

The BioRegio competi- tion has turned out to be a strong cata- lyst for the advancement of biotechnol- ogy. Feder- al funding now goes into these projects with the Industrial partner bearing up to 60 percent of the overall project costs.

Several new companies offering dozens of highly-qualified jobs have al- ready been established and we expect further foundations of new companies from existing organizations, including the Deutsches Krebsforschungszen- trum.

Alongside providing advice to po- tential founders of new companies, the Center supports them in every possible way, e. These three components are meanwhile well established, and the first projects have been granted sup- port.

The next few years will tell wheth- er this Interaction of science and econ- omy fulfills its promises and whether the perceptible new trend towards the creation of a sound basis for biotech- nology in Germany will persist and con- tinue to create new jobs.

Guidelines of the Federal Research Ministry The guidelines for a strategic reorienta- tion of the existing research structures 24 Conditions and Structures in Research in Germany issued in summer by the Research Minister have initiated a discussion which has also influenced the HGF research facilities.

The institutes are then given the opportunity to apply for these funds on a competi- tive basis by submitting project applica- tions.

For the Deutsches Krebsfor- schungszentrum this means that funds of several million are not initially as- signed to the budget, but have to be applied for on a competitive basis.

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