Sunday, May 15, 2016

Crossing the Valley of Death with Advanced Therapy




Crossing the Valley of Death with Advanced Therapy.

Is there hope for patients with advanced cancer?

Yes there is.

Yet, experimental treatments raise controversy. Although it seems obvious that new technologies are needed to supplement existing ones to help patients with currently incurable cancer, the Valley of Death, the gap between the laboratory and clinic, claims most projects. Unfortunately, crossing the Valley is not getting easier. Instead, it is more and more difficult every year to convert promising medical technologies into clinical trials. The one constant in biomedicine seems to be that regulation can only increase, leading to continuous increase in costs.

Experimental cancer therapy can mean many things, but usually it refers to a technology whose safety and efficacy has (not yet) been proven in rigorous clinical trials. Sometimes the situation can be that the drug has been used for some other patient population. Some drugs or treatment approaches never found a sponsor and thus there was no money for clinical trials, which cost millions. In fact, the current average cost of developing a new cancer drug has been calculated to be about 5 billion USD. The continuous increase in development costs is reflected in the price of drugs which have skyrocketed.

There are two basic approaches that can be employed in experimental therapy. When experimental therapy is administered according to a rigid protocol defined in advance the approach is called a clinical trial. There is always a chance of therapeutic benefit in clinical trials, because otherwise the trial would not be acceptable ethically. However, in fact the primary goal of a trial is to increase scientific information while patient benefit is a secondary goal. Clinical trials are the main mechanism by which clinical medicine improves and thus they are of critical importance for humankind including future patients and their close ones.

Experimental therapy can also be given in an individually tailored manner without a strict protocol, and in this scenario the only purpose is to try to help the patient. In fact, the aim of the intervention separates clinical trials from experimental treatment most clearly; is the primary goal to increase scientific knowledge or to help an individual?

Experimental therapy is based on science and it should be distinguished from “alternative therapy” which means therapy not based on science.

It can be easily be overlooked that most “routine” treatment is also experimental on the patient level. For example, if there is a “treatment A“, which is based on rigorous scientific evidence, it usually means that hundreds or thousands of patients were treated in clinical trials in comparison to “treatment B”. Perhaps A was effective in 60% and B in 45%. Thus A became the “standard therapy” used for all patients, even though 40% did not benefit from it, and in fact some patients who received A without effect might have benefited from B.

In the case of metastatic cancer, the most depressing aspect of routine therapy is not the fact that it may have low efficacy, or that it can cause severe side effects. Instead, the worst part is that it is well known what it can do at its best. With several exceptions, including many blood cancers, a proportion of pediatric cancers and certain rare adult solid tumors, cancer which has spread beyond local areas cannot be cured with routine treatments. This news usually comes as a shock to patients and their relatives.

Is there any hope?

Yes!

Many new types of treatment are entering clinical practice. As described in my book “Crossing the Valley of Death with Advanced Therapy”, cancer immunotherapy is one of the most promising. After more than 100 years of development many immunotherapeutics have entered late stage clinical testing and a few have already entered routine use. In contrast to most other classes of cancer drugs, immunotherapy appears to have curative potential even in the setting of metastatic cancer. However, currently only a minority of patients benefit and thus much work remains.

Unfortunately, the obstacles in the path of implementing scientific discovery for the benefit of patients continue getting more and more difficult. Nowhere is this more evident than in the story of the Advanced Therapy Access program. Utilizing the EU Advanced Therapy directive, and its “Hospital Exemption”, 290 patients with incurable cancer were treated with oncolytic adenoviruses, a potent form of immunotherapy. Although the treatment program can be considered a clinical success, a new department head of Finnish regulatory agency FIMEA asked the police to investigate if the individualized treatment program was in fact not a clinical trial done without a trial permit.  The book tells the story and also reviews the history of oncology, immunotherapy, gene therapy and oncolytic viruses.

Akseli Hemminki, MD, PhD
professor of oncology, scientist, enterpreneurer

Crossing the Valley of Death with Advanced Therapy. Published by Nomerta, Turku, Finland, 2015. Available at http://www.nomerta.net and several e-book stores globally

12 comments:

  1. Unfortunately, even though Helsinki City Library includes Overdrive access (and Overdrive offers the book), it is "unavailable in your region"...

    ReplyDelete
    Replies
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    2. I contacted herpes' I was told there is no herpes cure except treatment to
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    ReplyDelete
  3. AFRICAN TRADITIONAL METHODS OF CURING HERPES THAT IS GOING VIRAL!
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    ReplyDelete
  4. I'm very happy being Herpes free now. It was a sad incident that was announced to me after the check up in the hospital and I was diagnosed of HSV 2. I thank God now for using Dr.odey Abang to cure my virus. I'm not ashamed to say this because no virus of such can be detected in me. I'm Charlotte from Columbia. I thought about it many Times when I heard about this Herbal cures for Herpes. I was really happy when I came across blogs of comments of Doctors who run cures sicknesses and was comfortable to try Dr. Abang from patients testimony I came across here on my online page. I knew now they are real Africa herbalists who run cures for Herpes. There's every opportunity to be cure with natural herbs, because all medical prescriptions are derived from herbs and roots. Its really hard time living with Herpes on drugs which can't get you cure. I tried this and I can boost of myself now as a woman. I need to be loved and not to lost, get your instant cure to all sicknesses from Dr, Odey Abang.
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    ReplyDelete
  5. AFRICAN TRADITIONAL METHODS OF CURING HERPES THAT IS GOING VIRAL!
    Most traditional methods of roots and herbs today have been scientifically proven to cure almost all drugs resistant diseases without after effect.
    It worked for me years ago when I was depressed with herpes. After trying numerous other methods, It was actually an old Ibo lady who brought to my notice the healing effect of natural medicines. She too was permanently cured from HERPES long time ago through Dr Utu @ "drutuherbalcure@gmail.com" who among few, specialises in African roots and herbs for medicinal cure. Apparently roots and herbs have well been known as effective key treatment for herpes. She introduced me to Dr Utu who till date remain my savior, and he truly cleared my doubt. After taking his medication on the fourth week, I contacted him again who asked me to go for test and I was negative. From then till now I do my normal business no outbreak. I may not be a herbal fan but it definitely worked for me!

    ReplyDelete
  6. I'M Kelly FROM KENTUCKY.
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    ReplyDelete
  7. I'm so exited to share my testimonies about the Good Work of Dr.Ehiaguna who get me cured from herpes simplex virus (HSV1&2) with his herbs, I never thought that I will live on earth before the year runs out. I have been suffering from herpes, I had spent a lot of money going from one Hospital to another looking for way to get rid of this disease, the hospital have been my home everyday residence. Constant checks up have been my hobby not until this faithful day, I was searchingthrough the internet, I saw a testimony on how Dr. Ehiaguna helped someone in curing his herpes disease using his healingHerbs, quickly I copied his email just to give him a try I spoke to him, he told me that he is going to provide the herbal cure to me, which hedid, after i receive his herbs and i take it as instructed i was cure permanently from herpes my herpes disease was gone. so I decided to share my testimony, that nothing is impossible with God, God use a man to healed me. No matter what you are passing through, no matter how deadly the sickness is and no matter what the situation is God that did mine is still going to do yours, people suffering from herpes, brain tumor, kidney disease, pcos, AIDS, ALS,copd, asthma, athritis,herpes, Cancer,Hpv, any kind of disease, you can reach him now via ? Gmail address: drehiaguna@gmail.com or whatsapp +2348073908953 and you will be the next to testify of his great work.

    ReplyDelete
  8. what a great Joy in my heart i never believe there is a cure for Herpes because my doctor tested me Herpes positive and she told me there is no cure, i’m very happy today that i’m having a free life without this disease, i can remember some years ago when i was crying all through the night and day that i can’t get cured from this sickness, i found this herbal man email on internet when i was doing research on cure for Herpes i contacted DR.Ehiaguna to found out if i can get help from this disease, i was so surprise when he told me that he have the cure to it and he sent me the herbal medicine i was so happy when i get someone giving me hope that he can cured me i took the herbal for just 14 days, when i went for test after taking the herbal i found out that i am cured, i was so happy and surprise, i want to use this opportunity to inform you that there is cured to Herpes you can also contact him for his help as soon as possible so that you can get rid of yours once and for all you can reach him through his email via drehiaguna@gmail.com or whatsApp him on +2348073908953 You can also contact him on any disease in this he have all the herbal cure to it.. 

    ReplyDelete
  9. Hello, everyone! I'm here to explore blogs and forums about the wonderful and most safe cure for (Herpes Virus). I was positive about the deadly virus called herpes and I lost hope because I was outcast and rejected even by my closest friends. I searched on-line to know an enquirer cure for Herpes and I read someone's testimony on how he was cured from Herpes so I decided to contact the same herbalist because I know that nature has the power to heal everything. I contacted him to know how he can help me and he told me never to worry that he will heal me with the natural herbs from God! After 2 days of contacting him, he told me that the cure has been ready and he sent it to me via DHL and it got to me after 3 days! I used the med as he instructed (MORNING and EVENING) and i was cured! it's really like a dream but I am so happy! That's the reason I decided to also add more comments on Him so that more can be saved just like me! and you can get in touch with him via email chiefdrlucky@gmail.com or WhatsApp  +2348132777335 Kindly visit website https://chiefdrluckyherbaltherapy.wordpress.com/

    ReplyDelete
  10. All thanks to Dr Alli for curing my herpes virus/hpv with his herbal medicine, i do not have much to say but with all my life i will forever be grateful to him and God Almighty for using Dr Alli to reach me when i thought it was all over, today i am happy with my life again after the medical doctor have confirmed my HERPES SIMPLEX VIRUS / HPV of 5 is gone,i have never in my life believed that HERPES SIMPLEX VIRUS could be cured by herbal medicine. so i want to use this means to reach other persons who have this disease by testifying the power of Dr Alli that all hope is not lost yet, try and contact him by any means for any kind of disease with his email: ( Allispellhelp1@gmail.com ) or his whatsapp number +2348100772528 and get your healing

    ReplyDelete