Los nuevos medicamentos contra el cáncer: ¿motivo de esperanza o perjuicio? | DW Documental

As suddenly as ca

ncer

, the questions arise, what possibilities do I have, how much time do I have left? The good news is that one in two people with ca

ncer

can be cured, but the people we will meet in this documentary have a terminal illness. Their hopes are based on modern anti-cancer drugs. cancer, many of them offer the promise of being able to live longer and better with cancer. On the one hand, this explosion of new developments is beneficial for many patients. On the other hand, there are many preparations that escape critical evaluation, so there is only one option left: try it and to have hope being completely honest you don't really know in advance and if a medication will work you can't say a word it's like being trapped in your own body and I would never have associated those signs those side effects with this medication how safe and effective these new ones are cancer drugs that are also investigated before going on the market, we are in a situation in which we have more and more drugs approved in an accelerated manner with less and less certainty about their real benefit and we are in a situation in which we spend a lot of money on They spend a total of 8.6 billion euros annually on anti-cancer drugs and the trend is increasing.

What can these modern drugs do and what can they do? And since 2007, Marion Ring has suffered from chronic blood cancer. It is incurable. The disease is always there. in his daily life on his vacation photos from his last cruise trip look at this about taking off that terrible cortisone face those fat cheeks I am horrified to see this now this makes me a little embarrassed you don't have to it is your life and also my life I am too too fat but look, although I look so horrible, notice how splendid you look at me. In 2013, she had the first serious symptoms and had to be hospitalized for six months with chemotherapy and large amounts of cortisone.

She managed to keep the cancer under control for a while but it kept coming back and it left her without strength my god it is difficult to walk short distances from the bed maybe wash a little and then return or something like that it is only possible to understand it if you feel it yourself this exhaustion this endless exhaustion that is why I am so attached to this that I would have happened if I had not treated it then inevitably I would have died if not treated chronic lymphocytic leukemia leads to death with therapy as my teacher always says if the therapy works well you can also grow old with it the chemotherapy stopped working a few years ago it could not be do nothing more for patients like marianne ring however now there are new cancer drugs on the market that is what their hope is based on when you have a serious illness like mine where there are very few special medications then you are left between a rock and a hard place and in At some point you have to say that you want to live, you want to survive, and you actually feel grateful that these special medications are now available.

For years, you participate as a patient representative on specialist committees. You are familiar with the medical system. You know that new and new ones are always coming onto the market. promising things modern oncological drugs as anti-cancer drugs are called are usually the last hope to prolong life in cases of incurable cancer in this clinic we can film despite the pandemic the berlin field community hospital an anthroposophic clinic that offers treatments modern cancer treatments in their certified cancer centers every morning pharmacies deliver anti-cancer medications specially designed for the patient in addition to chemotherapy hopes are based on new immunological and antibody therapies that block more precisely than chemotherapy Certain mechanisms of the tumor cell Oncologist Arne Música has worked at this outpatient tumor therapy center since 2017.

Here we have an antibody that we usually administer along with chemotherapy. Here we have two antibodies for a patient with breast cancer that, like the key to a lock, are suitable for a special property of tumor cells, new therapies sometimes cost much more than classic chemotherapy, many of these expensive medications are not designed so that a patient is cured from the therapy, that is, the therapy would make the disease progress less quickly and ideally the quality of life is preserved so that the patient can continue to be independent and as a second effect it can also lengthen their life.

For oncologists like Arne Music, the range of therapeutic options increases from year to year, there are currently on the market 237 anti-cancer drugs, more than a third of which are novel preparations that can be combined again and again with each other and prescribed for more and more types of cancer. In this market of hope, he tries to stay the course almost daily. new advertisements here for example we have a preparation that has been approved for prostate cancer a preparation for patients with a certain form of breast cancer here are two preparations suitable for patients with malignant melanoma and finally an antibody preparation for a certain form of cancer of blood may not be more than two or three days of informative material as probably all my colleagues receive it the highlighted ones of course are related to marketing they are all like quantum leaps hwan complicated it is for you to always keep up to date it is a considerable effort Of course it works independently of reading the specialized magazines.

In reality, for me this is an important source of information because it is not prepared in an advertising way during the consultation. I do not have time to obtain the background information. This means that I have to do it later during my time. free so that I can obtain in-depth information two floors above in the oncology ward the emergency alarm sounds the health of a seriously ill patient has deteriorated dramatically many of the patients in this ward already have advanced cancer in the fight to prolong more their lives freedman sad and his team always look for the optimal dose and combination of active ingredients bad news for a patient what is known is a massive liver progression to put it simply the liver deteriorates rapidly she also sees it that way and that is why she wants to go to hospice when the cancer has won the battle and when the medication could offer a few more weeks or even months of life will the patient respond to the therapy will be one of the lucky ones these are difficult questions to be completely honest in reality it is not known in advance if a medication will always work, there are patients who respond and others who don't.

This is the usual way of informing the patient by telling them that we have a suggestion and that we would recommend it. It is possible that it will help. There are also many people who are very afraid of therapy. who feel very insecure should do it or not and that is where we try to offer the patient as much information as possible so that they can evaluate it and not unnecessarily reject a therapy that could possibly help them that is always the field in which we all work together marion ring also has to inform himself, weigh and be able to decide his leukemia had worsened and he needed a new medication.

At that time there was a very promising preparation that had been on the market for just over four years and was supposed to fight blood cancer better than chemotherapy. classically, reality had no alternative, right, at that time, not because we had already tried the alternatives that existed with conventional medications, so as we always say, my professor says it, in principle nothing really innovative emerged and that is why for a year and a half or two years he read all the studies he had in his hands on this medication very carefully, time and time again he told me there is one and with it an older man is also treated and it also works very well and then you completely trust him he decides to take the new drug and routing is an enzyme inhibitor that can precisely slow the growth of diseased blood cells the approval study showed that 42.6 percent of the subjects responded to the drug however after two weeks during their short vacation in the cruise something unexpected happens I noticed it the last night I told my husband let's go to bed I'm a little cold chills and stuff and when we got up in the morning and we wanted to leave the ship then it started I didn't find my wedding ring I always took it Quito at night it was a great panic where is the wedding ring where is the ring I had to look for it and ask him because it was on the other finger and then we disembarked and the bus situation happened my husband told me here comes the bus take the ticket I took out my wallet but then I wanted to enter a pin that instead of opening it and taking out his ticket and then it goes through your head what is happening I also had trouble finding the words and in the parking lot I wanted to briefly tell our friend something about the trip and I started but I couldn't say a word so I thought what's happening here you can't utter a single word it's like being trapped in your own body that is to say you have what you want to say in your head I had the images of what I wanted to say and I couldn't make it out. nothing came out the next day she even drove to work with the car because she believed that the symptoms would surely disappear but the opposite happens she is hospitalized the diagnosis atrial fibrillation which causes a circulatory disorder in the brain what is called transient ischemic attack or abbreviated haiti the doctor who he treats her in the clinic at helios debug berlin writes in the medical record we consider atrial fibrillation and air as unwanted pharmacological effects of brooklyn and the light came so suddenly and without warning no one could have suspected that this would happen it took him six months to recover of the side effects, that risk was not known, his doctor, professor bold and ter blood, who is not only an oncologist but also president of the drug commission of the german medical association, who knew at that time about the drug, we had about four years of experience and We knew that it was very effective in some patients who had already been pretreated with other drugs or who had had a relapse of their disease.

We also knew that there were some side effects but they only occurred sporadically, such as cardiac arrhythmias, which is why at that time prescribed this medication and was relatively convinced of it after other patients responded very well to it, so as a doctor you logically also reproach yourself because you think that you are a patient who is actually doing well and who has a disease that you can survive. about 10, 20 or 30 years old and suffers from serious toxicity that could possibly also have had serious consequences due to that toxicity. The side effect of light did not appear in the 2014 study because it was not discovered by the manufacturer.

There were less than 200 patients. approved based on a study with 195 test subjects for ivu trini in 2010 and 95 years after approval an international team of researchers evaluates the world's largest who database for side effects until then about 90 thousand patients worldwide had been treated with and brut inhibits the analysis resulted in 13 thousand 500 of them suffered serious side effects 303 died of cardiovascular diseases 254 developed a circulatory disorder like air in the brain in this evaluation of a very large registry it can be clearly observed that some of these side effects especially circulatory disorders in the brain are not so strange as originally suspected a side effect that we must without fail inform our patients about even if it occurs very rarely so that they can also react quickly if necessary and stop taking the medication only in September 2019 around 5 years after its approval appeared the side effect of aite in the summary of product characteristics and the recommendation to monitor patients regularly we request an interview with the hans company in the company that sells and burutin and ve in europe trade name of the female fica just want to answer In writing we asked them what they think of the accusation by doctors that very little information was available on possible side effects before approval.

Janssen responded, among other things, with reference to numerous studies without indicating whether these were carried out before. o after approval there are more than 150 clinical programs in progress for the implica and eight phase 3 studies have been conducted in chronic lymphocytic leukemia and we continually monitor the safety of our medicines and the appearance of possible side effects and also the benefit-benefit ratio. The risk of the implication remains positive when doctors were able to prescribe the first of these modern drugs about 20 years ago there was great hope many even thought that the cancer would soon be defeated still for now however after the initial euphoria followed disappointment a Analysis conducted in 2014 by the American National Cancer Institute in71oncology drugs showed that new active ingredients could slow tumor growth in an average of just over two months statistically some drugs only provide a survival benefit of a few weeks for medical staff it is not easy to deal with this there used to be a drug that Pancreatic carcinoma was advertised very strongly for pancreatic disease and it finally turned out that the life extension was minimal, about 14 days, but statistically significant.

Well, let's use the 14 days, it's not much in terms of a longer period, but everyone involved is under a certain pressure to act, what doctor would say I won't do it or I won't offer it or what patient would say beforehand I don't want it and their populations have been re-registered in which it has been noticed that it doesn't work at all so we can leave it right away and then We could see that if it worked for some patients who could be characterized then it could be used there. This is a subsequent registration investigation. How do these drugs actually work?

How exactly do the drugs come to market? What obstacles must they overcome to be prescribed in Germany? of approval is the European medicines agency ema in Amsterdam this is where pharmaceutical manufacturers submit their applications for approval they must prove that the medicine or a new combination of active ingredients works and is harmless a regular approval is developed like this in phase 1 the drug is tested on a few patients here it is about how the body processes into medicine in phase 2 the drug is tested depending on the disease on several hundred test subjects compared to a control group that receives a old drug here the effect of the new drug must be tested in phase 3 the preparation is administered to several thousand patients the objective is to determine its safety efficacy and especially also the possible strange side effects of the new agent but increasingly it is being left aside this standard to accelerate approval with the aim that innovative active ingredients reach the patient as soon as possible some products are approved under certain conditions after phase 2 peter ludwig returns and represents the german medical college at the ema he has been criticizing for years This process in the field of oncology I see this very critically because we have not a significant increase in accelerated approval procedures often the knowledge is insufficient regarding the situation in which this drug is particularly effective in the patients and we know very little about the safety of side effects I would like regulators to only approve these accelerated processes in absolute emergencies as with lakovic 19 we find extreme examples like this a drug developed for a special tumor mutation and approved at an accelerated rate for 17 types of cancer however it was tested on very few subjects this drug was tested on less than 10 patients for more than half of the cancer types for appendix cancer liver cancer and prostate cancer there was respectively only one subject since 2015 on 28 percent of all oncology drugs came to market through an accelerated process we go to colony to the institute for quality and efficiency in health care abbreviated publicly funded tomas caixa directs the drug evaluation department reviews all the studies that are publish about a new drug the objective of this accelerated approval of this type of oncology drugs is to make certain new drugs available at an early stage for patients since we do not have any data on whether these new drugs are really better than the previous ones.

It is possible to deduce from this data whether these patients really benefit from them. This is one of the reasons why we check each new drug after its approval to see if it is better than the current standard therapy. If we look at these approval procedures and evaluate each new drug and also each new area each new type of cancer for which a drug is approved so we see that approximately only half of these new approvals are an advantage compared to a previously approved standard therapy what do you think this is not enough I think and it's not to say that you always have to make sure that any new therapy is much better than what's been on the market until now but you still wouldn't like to say at least I would like to see progress through a recently approved drug in 46% of oncology drugs approved since 2011 the icc bid could not determine any additional benefit i.e. no advantage we met with the responsible medical director of the european approval agency emma hans jörg isolate virtually in her private office in austria is familiar with accusations that drugs are coming to market too quickly and that there should be more data, much of what critics say is not wrong, it's just that on the other hand we have patients who say they really want to wait another two years, they want to continue studying. until you no longer have the opportunity to get this product what is the right balance point we are talking about drugs with poor data that do not cure anyone in that context it is justified to continue saying we must get everything to the market as quickly as possible that is said when one is healthy we hear patients and patient representatives say that they are also sick we do not expect a cure we are satisfied with receiving a certain improvement in our situation that means we take small steps the question is is it a small step reason enough to first take a drug to the market and secondly to put it on the market quickly, is the uncertainty we have about the therapy acceptable or is it not acceptable, who should be the final authority in that case.

I believe that it should be the patients who will later receive these products, leaving the decision to the patient. marion ring is one of those who would have liked to know more about the side effects simply to be able to better prepare for possible risks such as english when driving to work in my car I really had an incredibly active guardian angel it would have been better to know more at the Regarding if then I had not put myself at risk with the car and things like that but I would have called my doctor at night this happened since I have to do something and he would have told me to go directly to the hospital and to stop take the medication I am firmly convinced of this but what happens if you do not have the data and if you do not know you cannot act accordingly the experts debate speed and quick access to the medication or more data on effectiveness and side effects is not just for patients who must wait for a potentially healthy therapy for their serious illness, the problem from my point of view is that this is only one side of the coin.

It may be the case on an individual basis that such a risk is accepted due to the lack of information that is not taken into account is that those patients who prefer to act in a different way than say, I want to know better how this medication can help me, as well as the side effects that this medication causes, as well as whether or not this medication will improve my quality of life in compared to previous chemotherapy these patients are actually left alone some of the new anti-cancer drugs are considered innovative advances with completely new mechanisms of action are bestsellers in ecology are prescribed ten thousand times more in the oncology ward of the clinic happel hou we will meet petra mer who has been a kinesio therapist for six years suffering from skin cancer and now the metastasis has spread throughout her body she struggles to keep moving for example for the last three days I have managed to do this again before it was impossible to lift the leg and in this way the upper muscles are strengthened this is the most important thing to be able to walk her oncologist at that time resident prescribed the innovative drug ni bolumar brightman sad o but petra's lung metastasis emerges to make it easier for her to breathe good morning good as you are today today I am fine now I can move independently again according to the guidelines of the society of oncology nor bolumar was in your case one of the medication options my oncologist told me that this is relatively new that it is successful especially against skin cancer and then I accepted it immediately and as I said I was satisfied it had no side effects at least not that I felt and I have high hopes for this medicine several studies show that it can significantly regress the disease and that also happens often in this specific case the therapy unfortunately did not respond but on the

contra

ry the tumor spread even more we have the statistics from which we all start that are the basis of our recommendations based on the guidelines but the effect they have on each individual can only be discovered in the course of the therapy as it was when they gave him the diagnosis that did not work well I have to say that it was devastating and above all being told well it could happen that he would soon suffocate what is his situation now and his prognosis well now the prognosis is with brain metastasis we will not get very far nor volume a can significantly regress cancer in 2019 it was one of the 10 best-selling active ingredients in Germany with such success in the market it is quickly copied currently around 20 drugs are being investigated with the same mechanism as neither volume bean that only in detail have different effects this poses important challenges for treating physicians which is the appropriate drug there is hardly any research on whether the second third or fourth fifth or even sixth representative of this group is better than the first because sometimes it is argued that we need something more because it has good properties and the sixth is better than the first unfortunately very often we do not have any study on it but then it goes on the market for approval second third or fourth fifth or sixth but there are hardly any studies direct comparisons between these substances and that is a great dilemma for the decision on therapy already in the field petra mero who has returned home in the hospital they could no longer do anything for her fortunately she has had no side effects but not even bolumar could stop the growth of metastasis petra mer which is one of the 60% for whom the drug has no effect according to the approval study for 40% of patients this can be a blessing because it prolongs their life for several months or sometimes even years for her, however, it is just a great disappointment.

I think the most important thing is to be able to talk about it, to be honest, for a doctor to say that was all. millimeters my prognosis would say if I read this it is miserable how much time do I have left a week a month that is what matters to me now I am also glad to be home of course there is no other way petra mer who died a few weeks after our visit those affected are fighting and they hope it is not known if the drugs will work, they will also work and for how long what can be said with certainty is that health insurers spend more and more on cancer drugs year after year the reasons longer life expectancy more sick people many new active ingredients and especially because the new drugs are much more expensive than the old ones, the cost of cancer drugs increased from 230 million euros in the 1990s to 8.6 billion euros in 2019 that the new ones have produced oncological drugs with respect to overall cancer survival rates at the robert koch institute in berlin data from all german cancer registries are pooled for some time now cancer is not necessarily a death sentence currently more than half survive cancer close screening he compares survival rates over the years here we can see the progress in survival rates in the 90s we had greater progress in the numbers than in the last decade according to the robert koch institute since the late 90s Thanks to early detection, surgical techniques, radiation and chemotherapy, the survival rate increased significantly by 12 percentage points until 2007.

The hope was that with new targeted oncology drugs, the survival rate could increase even more, but since the use of these drugs in the next 10 years until 2017 it only increased by three percentage points constantly increasing costs and few satisfactory successes then how can the cost of medicines be at least controlled the government established a control system in 2011 the objective effective medicines at fair prices here in the federal joint committee it is discussed whether a new drug is better than the previous standard one year after approval the final price is negotiated between health insurers and manufacturers based on this evaluation we met with georges chava a representative of the patients in the federal joint committee or abbreviated gba let's take a look on the one hand are the representatives of the medical insurers and the lic bit that carries outthe scientific evaluations for the gba and on the other hand the representatives of the patients and behind them the representatives of the doctors and the hospitals the manufacturers the pharmaceutical companies are not here the pharmaceutical companies do not participate in the consultations they must be independent here we must evaluate how well, it really is a new drug, it is better for the patient or not and the manufacturer has the opportunity to demonstrate this by presenting a long file in which he can explain the advantages of his new preparation.

Usually the discussion continues until they can agree whether to decides that the medicine is better than the previous standard the price can be higher if the evaluation is negative it should not cost more anyway the medicines will remain on the market we also have to talk about the fact that this is an unsatisfactory condition because in In reality these drugs have not been researched enough to be allowed on the market I think that is a big problem Often the remedies are approved when the study has not yet been completed and there are only provisional results The studies are often minimal to achieve the result faster at the lowest possible cost because each day of anticipation to bring a drug to the market represents a lot of money for the pharmaceutical industry once the drugs are on the market regardless of how well they work the gba with its evaluations can only influence the price not has the power to remove a drug from the market we investigate in comparison with other sectors the profit margins of the pharmaceutical industry are well above the average in studies and specialized magazines we also find figures on the and brut inhibits its research and development cost about $388 million as of the end of 2019 this drug had raised around $25 billion worldwide the ema has given libro team and what is known as orphan drug status an incentive to develop therapies for very rare actually a good idea orphan drug status aims to compensate for unprofitable research into diseases that affect no more than five in ten thousand people on the web advantages for the manufacturer include no registration fees and a monopoly on the market for ten years, however, increasingly these subsidized drugs are developed very profitably in 2019. 20 orphan drugs obtained revenues of more than 1 billion euros each.

This development seems very worrying to me because we are investing the money in the wrong channels and there are a large number of metabolic diseases in children or other diseases genetic diseases that are very rare where manufacturers are not motivated enough to invest and develop new medicines Janssen's tiny book ranked second in 2019 among drugs orphan drugs with higher sales volumes worldwide the 'hand can withdraw orphan drug status just because an orphan drug becomes a bestseller we ask if jansen sees the possibility of abandoning orphan drug status and sales of partner market or lower the price in view of revenue janssen responds the european commission decides on the granting of orphan drug status and on prices we are guided by the benefit for patients as well as the added value in relation to alternative therapeutic options In addition, the price of medicines is regulated in detail by law, we regulate by the evaluation of benefits by the federal joint committee GBA, and in addition, the price of a therapy must also generate a profit that serves as an incentive for pharmaceutical companies to carry out more research. and development, oncological preparations are the most expensive element of drug spending.

For example, new gene therapies that are currently being researched with great intensity cost up to 275 thousand euros per patient. Forecasts assume that the costs of oncological drugs will increase throughout the world. 10% each year how long can our health insurers continue to endure this the pharmacist is asked by frank asthma the expert who knows first hand the price negotiations between health insurers and pharmaceutical manufacturers now works as a mediator trying to intercede when medical insurers and manufacturers cannot agree if the remedy has an additional benefit then that benefit must be evaluated in some way in monetary terms it is how much you are worth who knows and that is precisely the negotiation the additional benefit is worth a thousand euros or thirty thousand euros and there is an old merchant saying dear friends let me tell you that a discount is added in advance the price will certainly be excessive because the manufacturer knows that in the end he will not get it approved the pharmaceutical companies are not a non-profit association they must also make profits but Please you must also take into account the financial viability of the national health systems, that is, that is what they live off of who pays them at this moment they are digging into their pockets taking whatever they can take and that is really something shameless. in the prices of some pharmaceutical manufacturers what the Association of Research Pharmaceutical Manufacturers says about this responds to us in writing modern oncology drugs allow many patients to live with cancer longer and more often even without cancer In this way new medicines create added social and economic value Adolf Hitler Ludwig would like more data more funding for independent research to better understand the opportunities and risks of new medicines due to the large number of medicines that are entering the oncology drug market because it is very lucrative because there you can get very high prices we also have many drugs that we do not need and currently it is very difficult for oncologists to separate the wheat from the tares in the case of new drugs marion ring started recently Taking another new medication against his chronic leukemia helps him and so far he tolerates it relatively well.

I promised my little daughter that she would reach 80 years of age. In the meantime, it has been really difficult. I am trying very hard but in a tolerable condition. I can continue living without major restrictions that the disease does not affect me too much that I can enjoy life and that I can stay with me for a long time.