The Power of Pharmaceutical Companies - : Latest Jobs In Pakistan 2022

Sunday 1 August 2021

The Power of Pharmaceutical Companies

 My name is Michael Monstein, I have two children. I got the diagnosis out of the blue. Two weeks later my life was different and it has never been the same since then. He has an aggressive cancer. Two chemotherapies failed. If left untreated, it would take two or three months to die. It's serious, it's really serious. His last hope: gene therapy with cancer killer cells. For example Kymriah from Novartis. Cost: 370,000 francs. And Kymriah is just the beginning. The new drug Luxturna was injected into his eye. Cost: $ 850,000. Zolgensma is the most expensive drug in the world: $ 2.1 million. How great is the willingness of society to bear the costs and when do you let someone die cheaper? How do these prices come about? The pharmaceutical industry naturally tests the market in this regard. 

What does he give and where is the limit? Will the health insurance companies pay the record prices? 370,000 francs is a lot of money, too much for us. What can you do there? It's tough. You don't really see how things could go on in the future. Cancer is getting over-fried. We hope so. Michael Monstein has a rare and aggressive form of lymph gland cancer. His crooked mouth is also caused by the disease. His last hope is called Kymriah; a completely new therapy, approved last autumn. The patient's own immune cells are taken. These are sent to a Novartis laboratory in the USA. There the cells are genetically modified ... ... And reprogrammed into cancer killer cells. 

The killer cells are multiplied, frozen and sent back to Switzerland. The patient receives the killer cells with a single infusion. Novartis sets the price for the infusion at 370,000 francs. It is initially unclear whether the health insurances will reimburse Kymriah. They have teamed up to negotiate a discount together. My name is Martina Weiss. At Helsana health insurance I am responsible for contract negotiations with the pharmaceutical industry. We are currently negotiating with Novartis about compensation for Kymriah. 370,000 francs are too much. It is not known how Kymriah will work in the long term, whether the cancer will not return. For us it is not entirely clear how the price comes about. We didn't get a listing and don't know why the price has to be so high. 

Does the pharmaceutical industry normally do that? I've never seen one before. I think you try to go in with the highest possible asking price because the whole thing is ultimately always a matter of negotiation. The first quotation also sets a precedent. This is a problem and if you ask me the solution, I cannot tell you. It is discussed whether the health insurances should only pay in case of success. But what does success mean in cancer? A solution is a long way off. For the time being, each fund decides for itself. Michael Monstein's cheap budget Atupri refuses to pay Kymriah. The benefits are not clear enough, they say. To be honest: I was pissed off. For me it is a testament to incompetence. It comes down to a kind of Wild West. Those who can afford it have the chance to get therapy. 

And with the others you don't know whether it is possible. Two-class medicine? Yes. The relatives want to finance the therapy themselves: the hospital demands half a million as security. Kymriah is dangerous therapy. After the infusion, some patients come to the intensive care unit. Dear Gabi is ready to grant 50,000 as an advance withdrawal. For me it is also an advance withdrawal.  When my brothers bought their houses, they withdrew the amount. So far I haven't used it, now I would like to use it for it. It touched me very much that many people around me think that if you get 10,000 francs, you will get it, even if I know that is not a lot. There are very many such people. 

That touched me very much because it is clear to everyone here that in the worst case scenario, the money is simply gone. And in the worst case scenario, it was of no use - and is gone. A year and a half after treatment, 40% of patients like Michael Monstein have cancer gone away, Novartis says. Still, but it could be more. Sure, but with the drug I'm currently on, I had a 20% chance of success. There were days when I thought that was it. It does not work. I just hoped that it would be as quick as possible in the end. The family doesn't watch forever and I don't have to be in pain forever. And just lying around as drug-addicted vegetables. 

Because of the price dispute, around a dozen cancer patients cannot be treated. Critics could say that the health insurance company is responsible for the fact that the negotiating poker with Novartis is deadly No patients die because they are running out of time. It's not like this. If so, the responsibility rests with all of us because we haven't found a solution yet. It's not a great situation for anyone. Michael Monstein's family raised half a million. He is the first Swiss lymph cancer patient for Kymriah. Meanwhile, immune cells were taken from him. Today they will be sent. There they should be converted into cancer killer cells. So-called CAR-T cells. Will that succeed? Michael Monstein's cancer is growing, every day counts for him. The cells take a certain amount of time to be produced. In the best case, this is 4 weeks. 

But it may take a little longer because so many products are coming in. Regarding the money, the Zuger Kantonalbank would issue a bank guarantee for the amount. We would deposit everything into a blocked account. For this purpose. We make sure that it is not touched, but then you can continue. May I feel the lymph node? Kymriah was approved based on patient studies. Funded by Novartis. You can feel at least two here. Experts criticize: The effect of Kymriah has been tested on fewer than 100 patients worldwide. Follow-up was less than two years and Kymriah was not compared with any existing therapy. That is why one does not know the long-term effect. This criticism applies generally to studies on rare diseases. 

It's the same everywhere, it's intuitively like that, although it has to be said that there have been studies with CAR-T cells that had to be stopped because there were deaths with them because there were too many side effects. Is that crazy already? Yes, although we have to say we are also talking about a patient clientele who otherwise have to die, who have many comorbidities. The world has just gotten impatient and so have our patients, they don't say let's wait five years now. That's the problem. The study of the deaths did not involve Novartis. Novartis is conducting follow-up studies on safety and effectiveness. What do you think of the price Novartis wants - the 370,000? I have to say about the prices in general not only related to Novartis, I think the prices are horrendous in many areas, but I think that these are things that we cannot understand, for the patients and for us doctors, but apparently someone allows that, there are interests behind it. 

Why you want to be good with the companies. Why then? Locations. Because they could also produce in India or China. The jobs in Basel? Jobs, well and of course, for example Switzerland, Switzerland doesn't have that much industry but a few really important, globally important pharmaceutical companies. At the Novartis plant in Stein in Aargau, we meet the person responsible for Europe for gene therapies: Emanuele Ostuni. This will be an important location for us here. People don't like to talk about numbers here. Can Swiss patients expect a price discount if the transport costs to the USA are eliminated? No, says Ostuni. The place of production does not matter for the price. What is relevant is the value that gene therapy has. The value of gained lifetime. A paradigm shift: in the past, the pharmaceutical industry justified its prices with high research costs. 

The principle of value-based prices is wrong, say health insurance companies, because a human life is ultimately priceless. The health insurers estimate that the premiums will rise by over 10% within 10 years due to the drug costs. Aren't you concerned that the health system could collapse if you keep doing this? No, I am not afraid, I think we will find solutions. We are open to ... Discounts? We are ready to take risks together with the health insurances and cantons in order to make the therapies accessible. Risk sharing, says the pharmaceutical industry. The premium payers bear the risk. The risk for Kymriah, which incidentally was not invented at Novartis. The trail of the cancer killer cells leads to Pennsylvania University. 

Not an isolated case: over 60% of newly approved drugs in the US do not come from pharmaceutical laboratories. My name is Carl June and I am an immunologist. My team invented Kymriah in 2004. I'm 65 now, but i've been working on this project since 1992. Carl June - named one of Time Magazine's 100 Most Influential People in the World last year. First, we tested cell therapy on HIV patients because they lost a lot of immune cells. Two years later my wife died of ovarian cancer. Then I switched my research to cancer. At that time, however, he did not receive a dollar from Pharma. This is because the research initially only worked on mice but not on humans. Without donations, we would never have been able to develop this therapy. Philanthropists and the government supported us. Was it millions? Yes, it was definitely 20 million that I got between 1999 and 2012.

The collaboration with Novartis began in 2012. So the riskiest phase was paid for with tax money? Yes, all of the basic research that showed that the concept of cancer killer cells works was done at universities. The breakthrough in 2010 - with cancer patient Douglas Olson. But the story of 7-year-old Emily Whitehead went around the world. The girl suffering from leukemia was saved thanks to Kymriah. Seven years after the infusion, Emily is still cancer free. Kymriah works better in children than in adults. Hundreds of investors called us back then. And luckily also Novartis, which wanted to market the research. The invention is one thing, says Novartis, but bringing the research to market is time-consuming and expensive. Insiders say: Novartis paid the university around 225 million euros for the exclusive right to sell Kymriah. And Novartis pays the university around 5% of the sales price for each infusion. 

The group does not comment on that. The healthcare industry is not transparent, it was not created for the benefit of the patient. At our university, cancer killer cells cost around $ 55,000 per patient. That’s no profit. Almost seven times cheaper. But the university only does small studies with Kymriah. For marketing approval, Novartis had to fund worldwide studies and has built centers for the manufacture of the therapy. Michael Monstein is still waiting for his cancer killer cells from the USA. Suddenly a message from Novartis: The company is giving him the Kymriah. We felt great joy. Big relief. There is a lot of money involved. How is it for the rest of Kymriah's patients? I don't know the plans. From an ethical point of view, it is perhaps a sensitive question to whom Novartis gives this as a gift. Yes of course. Kymriah was given to the first two Swiss patients because negotiations with health insurers are dragging on, according to Novartis. 

Michael Monstein, family man: He will lose the race against time. Novartis USA announces: It was unable to reproduce its cancer killer cells well enough to produce Kymriah. 19 days later he dies. My name is Paul Kleutghen, I worked in the pharmaceutical industry for 30 years, most recently as CEO. I am now retired and have had cancer for five years. These are the medications I have to take on a daily basis. These pills are the most important, they are against cancer. I have to take one capsule a day. One piece costs $ 750 - and interestingly, they are made for a dollar! What do you think of the price of 370,000 francs for Kymriah? It's crazy. This product was made at the expense of the US taxpayer! Have you seen the pharmaceutical industry differently in the past? The answer is yes for two reasons: First, I wasn't a patient. 

Second, I was part of the system, my family benefited from it. I didn't know any better then. I had internalized the company perspective. As you get older, your perspective widens. Paul Kleutghen was CEO of a company that was acquired by Novartis in 2002. He says: At Kymriah, Novartis also benefited from a 50% tax discount on the cost of their studies. The US is rewarding research on rare diseases. We taxpayers paid part of the development of Kymriah. In return, we get a slap in the face from Novartis! He created a pricing model for Kymriah. It is based on the information from Novartis that it invested over 1 billion dollars until it was approved for the market. I calculated a fair price for Kymriah: this year it's $ 200,000. This is on the condition that 1700 patients are treated in the USA and Europe. 1700 of potentially around 14,000 patients. As more patients are treated, the price can be reduced. And to around half of 370,000 francs. The fair price is calculated so that Novartis achieves the average operating profit of 20.7%. 

Research costs averaging 17.3% are also included. The Santésuisse health insurance association is also demanding 200,000 francs for Kymriah. I've looked at the model, it's full of incorrect information. Then give me the correct numbers! I can't do that, it's not our data. The criticism of the lack of transparency in the pharmaceutical industry is growing worldwide, from the World Health Organization, the health insurance companies and the population who pays the premiums. Aren't you concerned that Novartis will suffer damage to its image? No, I don't see any damage to our image. The whole system must be transparent, not just one party. Our government demands transparency, it publishes drug prices. It's the other way around. That could be discussed more broadly, that is something else. 

When he's got enough strength, train he with his dogs, says Kurt Benninger from Bern. The 71-year-old also has lymph gland cancer. Because of the price dispute, he had to wait three months for the decision of his health insurance company to pay for Kymriah. Could you afford it if the cash register didn't pay? If I was 100% sure that it would work well, I would sell the house. But I can't do that. If it doesn't work well, my wife won't have anything either. Then I wouldn't do it. If society didn't pay for you, wouldn't you? No. It's too risky. Because the chances of recovery are not that high? Yes. There are around 110 Kymriah patients in Switzerland every year. Cancer patients for whom all therapies have failed. This also includes Anton Schlösser, 64, a teacher in Graubünden. 

The question is what is a human life worth. To put it in a nutshell: If a young person asks - they are over 60 - how long is their lifespan? Is it worth it, even with a cure at best? Is it worth it? Does it hurt to hear something like that? No, but I also got to know young people in the hospital who, from that point of view, needed it more. I've lived my life to some extent. It was nice so far. I'm almost ashamed even though I didn't set the price. It's very uncomfortable. You feel so guilty. Although it's the only thing left for him. You certainly don't say no. Do you feel guilty now? Not really. Because I was healthy for a long time. I've deposited for decades and never needed anything. It came as a surprise. His health insurance company also pays for Kymriah. 

The price negotiations between the health insurers and Novartis lasted four months. It went to and fro like in a bazaar. Some tills left the table, the others reached an agreement with Novartis. Insiders say: The health insurance companies wanted a 45% discount for Kymriah against lymph cancer. Too much for Novartis. The contract partners have agreed on around 20-30% discount, depending on the success of Kymriah. So around 250,000-300,000 francs. But nobody wants to talk about it. Because: The agreement is confidential. It is so secret that health insurers like Concordia, which are not part of the deal, only find out about the discount once they have signed the contract. I think it's scandalous. It's the first time, as far as I know, that we're entering into a contract where we don't even know the price. It is absolutely new in the Swiss healthcare system. 

Prices and contract content are transparent. You can see what you have to pay for hospital treatment. Cost transparency is very important in healthcare. Otherwise we will completely surrender ourselves to large companies. Kurt Benninger has to go to the cell collection again. In the United States, Novartis did not succeed in producing the killer cells. Same as with Michael Monstein. It's not a good feeling, of course. It looked good at first, but then there were too few. In the Kymriah approval study, a third of the patients could not be treated at all. Either the killer cells could not be produced or the patients became too sick during the waiting period or died like Michael Monstein. 

Meanwhile, good news from the USA for Anton Schlösser: It worked for him, the cancer killer cells are on their way to Switzerland. Then you get those immune cells back, these CAR T cells, which are even stronger than normal immune cells; and what happens when immune cells are in action: There are side effects. That can cause a fever, that can cause circulatory problems. Organs such as the kidney can also fail, as has been observed in around 20% of patients who actually had to go on dialysis. Cancer killer cells can heal - and kill. They are the last hope therapy for patients who otherwise die. My name is Alfred Scheidegger, I am a risk capital investor. Here in San Francisco, I'm attending the largest health care conference. 

Alfred Scheidegger: He invests in small biotech companies that develop new cancer drugs. His goal: to sell the small companies to pharmaceutical companies. With profit. Mr. Scheidegger, what's going on here? It's like a wedding market. Unbelievable. You meet all biotech companies, especially those with an oncology focus. Or pharmaceutical companies that take over the small companies at a later point in time when they have produced evidence of the cancer drug in humans. In our case. 60% of the new drugs are not developed by pharmaceuticals - but by small biotech companies. They need a lot of money for the studies with patients. And this money comes from investors like Alfred Scheidegger and Markus Hosang. 

His company often invests in the early stages of research. The pharmaceutical industry pays the most when a biotech company is about to bring a new drug onto the market. Novartis buys US company Avexis for almost $ 9 billion! Gilead buys the biotech company Kite for fast 12 billion! Novartis is now asking the record price of $ 2.1 million for the Avexis therapy. That has a certain influence on the price, because the calculations are related. You have to get the investments back: Of course, in the end it is part of the market price. 

At Kymriah, Novartis has left out biotech companies and investors through the contract with the university, saving billions. For Inselspital patient Kurt Benninger, the production of Kymriah worked on the second attempt. 43 ml for 370,000 francs? This is a discussion, to be honest, I don't want to get into it now. I don't run them at the bedside. I'm still too attached to life. I have the feeling that it can't be that yet. The hope that it will work is very great. Anton Schlösser received his infusion two days ago. How is it, how are you? Good so far. Weary. Or? I fall asleep anyway when I want to watch something. 

Can you already tell whether Kymriah is working? It's too early. We hope of course, but it's too early. Of course we have high expectations. Now do I have to go there for a moment? Miller? A canton representative on the line: New problems with Kymriah. Because the therapy counts as hospital treatment, the cantons have to pay 55% of the costs. No, we're starting this in parallel, it bites its tail because the health insurance company only gives the cost credit under the reservation that the canton does its part. And if you say that upside down, that's why i'll run it in parallel. Because each of them both says that of course they only do it if the other has agreed. We go to Jenny Lee, an investment banker from Hong Kong. 

It covers China. China does most of the studies on cancer killer cells worldwide. Market watchers say: If the therapy is approved there, it will cost around $ 70,000. Jenny Lee says: The Chinese government is putting the pharmaceutical companies under pressure. They had to make their medication cheaper in order to be approved. And the pharmaceutical industry played along. In return, the firms can sell much larger quantities. If the pharmaceutical industry keeps the prices high, they will be too expensive for the Chinese healthcare market. Then we all lose. Is it a matter of profit or life? The existential justification of a private company is to make a profit. And that comes before life. 

You can't ask the question like that. Anton Schlösser's wife documents his therapy with the cell phone. Are they sad? No. Depressive? Neither. Nervous? No. In the first few days: fever and chills. Only slight side effects of the killer cells. The same picture at the Inselspital. Kurt Benninger also has a fever. But otherwise he's fine. Do you subjectively have the feeling that it is useful? I can not say that. You don't know yet. This biotech company conducts research in an area that is booming: drugs for rare diseases, so-called orphan drugs. Kymriah is also an orphan drug. We focus on rare diseases, the law provides incentives for this. In the USA and the EU, orphan drugs are granted exclusive marketing rights: competitors will not approve similar products for up to 10 years. 

The law is built to be worthwhile. If you get market approval, you get a certain degree of exclusivity over several years. A competitor cannot just enter the market. That's Exclusivity The rare disease law in the United States was created over 30 years ago. Today the politician who initiated it criticizes: Some pharmaceutical companies would take advantage of the monopoly to increase their profits. Orphan drugs and market exclusivity: The topic also reached Switzerland a few years ago. Dear colleagues, in accordance with the Council Regulations, at the beginning of the debate on this business I will disclose my interests: I am President of Intergenerika, the Swiss Association of Generic and Biosimilar Manufacturers.

In order to promote the development of drugs for rare diseases, the pharmaceutical companies are to maintain market exclusivity for so-called orphan drugs for ten years. During this period, no other medicinal product should be authorized for the same therapeutic indication, unless it is proven to be safer or more effective. The point is: pharmaceutical companies are not social institutions. They only do research when they expect a profit. A monopoly is needed for there to be any new drugs for rare diseases. This is created through market exclusivity. When Sebastian Frehner came to Parliament, he gave an access badge to the Novartis representative at the time. Novartis and Roche donated almost 900,000 francs to the bourgeois parties last year. 

At the end of the debate, we must state that it was not the patients who won through this revision of the Therapeutic Products Act, see Sector that it was essentially about which pockets can be filled better. During the whole of the committee's deliberations and here in the room today, I was accompanied by the feeling that I, and perhaps others with myself, can only see through a fraction of what is going on in the background in terms of lobbying and lobbying. And that had consequences. I received a reprimand from Pascal Brenneise, the then Domestic Manager at Novartis. Switzerland boss, yes. What did he say? He wrote an email to Beat Jans and me because he wanted to meet us and talk about our attitude. We would not behave in a pharmacy-friendly manner when it comes to legislation. I felt it was an undue interference in my parliamentary work. 

Has that ever existed before? I haven't seen it before or after. The debate lasted two years. The National Council voted twice for market exclusivity, but the Council of States was against. The monopoly did not come through, but a weakened measure that protects orphan drugs. One month after the Kymriah infusion. Anton Schlösser is extensively investigated. Did Kymriah work, did the cancer go away? First i'll show you the old pictures again. There was the bull around the port. And then the main mass was in the muscle box. And of course on the lower leg. Afterwards, where you only have idle activity. Something is already going on in the muscle box. But it's a lot less. I couldn't have imagined better. With the tumor mass that was there before that it would be gone completely without any traces of inflammation? Can you say he's over the mountain or could cancer come back? 

We don't have a crystal ball, we don't know that. That can never be ruled out, as data for Kymriah or treatment rates with CAR-T cells are still too short. Meanwhile at the Inselspital: Kurt Benninger's cancer also disappeared immediately after the treatment. Of course I am happy to be able to go home. And no longer have to wear this mask. Still best wishes. Enjoy it! His doctor doesn't want to take stock yet. According to the Novartis study, it takes about a year to find out which patients have no lymph cancer. Over half die. And: Nobody knows how the cancer killer cells develop in the body in the long term. Brave new medical world. Record expensive hope of survival. Anyway, Kymriah is just the beginning.

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