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Thread: Can a private company make a profit out of a cure for chronic SCI?

  1. #31
    Senior Member mcferguson's Avatar
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    Oct 2009
    San Antonio, TX
    Thank you, Dr. Wise for your recent posts. They are very informative and encouraging.

  2. #32
    Senior Member rdf's Avatar
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    Someplace between Nowhere and Goodbye
    Thanks Wise. Viewing a spinal cord injury cure as a 'gateway therapy" for other conditions is intriguing.
    Quote Originally Posted by Wise Young View Post

    Most of the companies that are in the "care" business are not invested just in spinal cord injury but in all kinds of chronic disabilities from stroke and head injury to multiple sclerosis and spinal cord injury. None of them would have a compelling business interest to keep spinal cord injured people disabled.

    More important, companies would make a lot more money if they had a single treatment that can restore function in people with chronic spinal cord injury. For example, a treatment like Fampridine for multiple sclerosis has the potential to make a billion a year, even though it is used to treat only 100,000 people. Interferon treatments of multiple sclerosis, which affects only about 400,000 people in the United, was what made Biogen successful.

    Even with one-off curative treatments, such as stem cell therapies, a company would be able to make a billion per year just treating 10% of a million people each year for ten years. For example, if our clinical trials show that umbilical cord blood is beneficial in spinal cord injury, it would drive the umbilical cord use into the stratosphere. At present, about 10,000 cord blood units are used per year. It could potentially expand the use by tenfold or greater.

    Many companies regard spinal cord injury as a "gateway" therapy to other conditions, such as brain injury and even peripheral nerve injuries. If one were to include therapies for all types of neck and back injuries, the numbers are huge. For example, over a million people per year get whiplash with 2-4 weeks of sick leave on average. If there is a therapy that accelerates recovery from that, think of how much profit can be made.

    We should not forget that the government is one institution that has a very strong interest in curing spinal cord injury. After all, they are the insurance of last resort right now for all veterans who have spinal cord injury. They have to pay for the care of all the people with spinal cord injury who are not employed and are not independently wealthy, i.e. a majority of people with spinal cord injury. It would seem to me that this is an organization that has a strong interest in seeing that a cure for spinal cord injury happen.

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  3. #33
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    Baldwinsville, N.Y.
    Dr. Wise,
    It is interesting listening to you. Thank you, What kind of drug is 4-AP? Is the main goal for chronics nerve regeneration or am I missing something. I am a T-10 complete Asia "A". My surgeon said to fix people like me they have to develop some type of nerve bridge to connect the cord. Are they trying to come out with a drug to do this? Thanks again.

  4. #34
    Wise thank you for all the info. Just make your trials meaningful and start the ball rolling. The Purdue study mentions that the side affects of 4ap COULD be diminished with their product. I know it is just new and experimental.

  5. #35
    Quote Originally Posted by Wise Young View Post

    I use to feel the way you do in the 1980's, feeling frustrated because so few companies were willing to invest significant funds into developing spinal cord injury therapies. I went to every company and worked with them. Most of them believed that it would be too expensive and too difficult to develop therapies for spinal cord injury and the market was too small for them to profit from the investment. At the time, I felt that the only way to get around this problem was to form a company, to show them that spinal cord injury therapies would be profitable.

    In 1995, I took a year sabbatical from NYU Medical Center and helped Ron Cohen found Acorda Therapeutics. We started from our living room and gradually got funding from venture capitalists, licensed therapies from various institutions (Fampridine was one of them), and then took the treatments to clinical trials. In 2003, we tried to go public to raise $75 million for Fampridine (Source). It failed. Our clinical trials on Fampridine for spinal cord injury failed. Many wrote us off for dead. I served on the Board of Directors of Acorda from 1995 to now.

    In 2006, Acorda tried again and became one of the most successful biotech companies in the history of Wall Street. In February 2006, we went public at a modest price of $6/share. The stocks drifted down to $2/share by Sept 2006. Then we announced the first successful clinical trial result. The shares shot up to $24, as high as $36, and then stayed around $25 for the past three years, except for a brief period when the stock slipped to $18 last summer upon speculations that the FDA was not going to approve Fampridine. Investigators who put money into Acorda during the six months after the IPO made 300-1000% return on their investment. The formal approval of Fampridine is coming up next week and the drug is predicted to earn $900 million revenues per year in the United States.

    It is stories like this one that makes large pharmaceutical companies turn their heads and growing biotech companies work harder to invest in spinal cord injury therapies. Over the last decade, many companies have announced their interest and intentions to invest in spinal cord injury therapies. I don't have the time to discuss all of them but let me mention just two. Novartis has invested probably hundreds of millions into the development of Nogo antibodies for regeneration of the spinal cord. Biogen is another multibillion company that is investing in the nogo receptor. They recently hired Doug Kerr, probably to run that program.

    Take a look at the small biotech companies. Geron is one such company. Despite all the difficulties, they continue to hang on and insist on running a clinical trial of embryonic stem cells to spinal cord injury! Why are they doing it? It is because they are seeing how a company like Acorda is successful. If you do a search for biotech companies that say spinal cord injury in their mission statements, you will find many dozens such companies. They are all doing so because they think that they can make money. This is a huge change from the late 1980's and early 1990's when I was going on the rounds to pharmaceutical companies to ask them to invest in spinal cord injury research.

    Stemcyte is another such company. Why in the world should an umbilical cord blood stem cell company become interested in donating umbilical cord blood to ChinaSCINet? Well, if the trial is successful, this means that Stemcyte will sell a lot more umbilical cord blood units. But the other reason is that the CEO of Stemcyte (Ken Giacin) came from Johnson & Johnson where he developed a passion for curing spinal cord injury. He helped developed and commercialize the iBot with Dean Kamen. He has been an incredible supporter of ChinaSCINet trials. Without him, I don't think that we would be this far along.

    We face several major problems in terms of raising funds for clinical trials. The first is that many companies, particularly small biotech companies, are surviving by the skin of their teeth and therefore have little or no money to give to others. They are what I call taker-companies. They are not giver-companies. Second, the recession has affected the large companies as well. While the pharmaceutical companies have not been decimated like retail and construction companies, they have been battered by the recession. Combined with the cyclical nature of companies gaining and losing large-blockbuster drugs (such as Lipitor), companies such as Pfizer don't have as much money to give out for non-essential research and marketing efforts. Third, governments are in deep deficits and will be cutting their support of research. This is happening both at the federal and state levels in the United States. Of course, it is happening in Italy.

    We need to be opportunistic. Relatively few countries have money in the global recession. China is one of them. Norway is another. Brazil will be a major source because they have discovered a huge oil repository off their coast. India is a source a s well because they are growing faster than any other country in the world. I know the Corinne has been writing to me about trying to do something. Perhaps what we can do is travel together in the upcoming Norway, Australia, and Italy trip that I am making in March. That way, I can introduce you guys to all the people and scientists that I know at the meetings. We can talk at length about the companies that have succeeded and failed, and who and where the good people are.

    Thank you Wise for giving us this clear view on this issue.
    I belive the economic recession has touched the bottom already and in a few months the economy should slowly get better. At least this is the feeling around here.
    After the meeting in Florece I have been in regolar contact with Corinne and a few other people that were there. We have been "scanning the horizon" carefully, trying to figure out what is the most effective thing we can do with the time and energy we have. I am really hoping it will be possible to travel together as you are proposing, I am sure it will be very productive.
    Last edited by paolocipolla; 01-13-2010 at 02:36 PM.

  6. #36

    I can appreciate that you disagree with what I have written, and I say this with all due respect. I have thought long and hard.

    I never called for a "complete destruction of the medical research system". Only the pieces (with regards to spinal cord injury research) that have proven over time to be ineffective, or no longer viable in current economic conditions.

    Quote Originally Posted by Wise Young View Post

    Most of the medical treatments that are now being used successfully to treat people have been developed, vetted, and applied through the clinical trial system established in the past 60 years. This system is what has led to medical industry that we know. While it has its flaws and needs reform, the answer is not to scrap it altogether. Let me give you an example of what the system that you argue against has produced to date:

    1. Vaccines. These are by far the most effective therapies ever used by medicine. Smallpox, polio, measles, chickenpox, whooping cough, rabies and many other diseases were eradicated or largely controlled by vaccines. It is true that it doesn't work for all diseases, such as AIDS and influenza, which evolve faster than vaccines can be developed to prevent them, but diseases that have stable molecular mechanisms are controlled by vaccines.

    2. Antibiotics. These are by far the second most effective therapies ever developed by the clinical trial system. They have basically eliminate bacterial infections as a major cause of death in the world. Unfortunately, through misuse and overapplication, we have created resistant organism faster than the industry can produce new antibiotics. However, they have saved millions upon millions of lives.

    3. Organ transplants. Organ transplants were made possible not by surgery but by the
    development of two calcineurin inhibitors, cyclosporin and tacrolimus. These immune-suppressant drugs have saved many thousands of people through kidney and heart transplants. All these were developed through systematic clinical trials.

    4. Corticosteroids. This is the mainstay of anti-inflammatory treatments. Without
    corticosteroids (which by the way includes methylprednisolone), many people would have suffered needless inflammatory damage and perhaps have died from their inflammatory conditions, from skin to organ damage.

    5. Anti-epileptic drugs. If you have epilepsy or know somebody with epilepsy, you would not be saying what you are saying about drugs and the clinical trial system. These drugs are what provides quality of life to millions of people who suffer from childhood or post-traumatic epilepsy. It is true that it doesn't work all the time but they do work on enough people so that they are a real boon for humankind.

    6. Insulin and other anti-diabetic therapies. If you have diabetes, you would be dead if
    insulin had not been developed by companies who used clinical trials to establish the treatments of diabetes. It is not a cure but it has provided millions of years of life to people with diabetes.

    7. Cancer therapies. It is not true that we do not have cures for cancer. Current therapies for cancer are curing many many people. My wife would not be alive today if not for cancer therapies. She is cured. I can say the same for thousands of people.

    8. AIDS. Research and clinical trials transformed AIDS from a terrible and invariable fatal
    disease into one that is largely controlled and has given many people decades of nearly
    disease-free lives. This was done in the space of 20 years, from the early 1980's when we did not know what the disease is to the late 1990's, when the combination antiviral therapies were discovered.

    It's wonderful that so many human beings have been helped (over the past 60 years) by the system we are discussing . Unfortunately, no treatments have been applied to (restorative therapies) alleviating those who suffer daily with spinal cord injuries*. Thank you for your in depth analysis of the system. You have proven my point.

    Quote Originally Posted by chasb View Post

    Insanity is loosely defined as : Doing the same thing over and over again, but expecting a different outcome.
    My proposal is:
    Quote Originally Posted by chasb View Post

    2) Conduct fee based clinical trials were the patients that enroll pay a substantial fee. This fee is applied for the aggressive physical therapy after the fact. Thus eliminating any morality issues, charging patients for unproven cell therapies.

    Quote Originally Posted by chasb View Post

    I realize I am nowhere near your (pay grade) expertise level. These are just my ideas for the broad strokes. I look at this problem (SCI cell therapy) as a safe, with an extremely difficult combination. The doctors/ clinics, who up until now, have been dialing in their same combination, over and over again. It's no wonder they have been getting the same (non) result. My idea is to dial in as many combinations in as short of period of time as possible, without compromising quality or safety. Once a combination works, THEN it is tested against the placebo.

    For the sake of this hypothetical outline. You have three trial sites. U.S.A, China, and India
    (expand worldwide as necessary). A different (fee based) combination cell therapy is scheduled at each location. Each trial conducts a 50 patient enrollment. Once the enrollment is fully subscribed, the specific trial is set in motion. Patients travel to the trial location(s).

    An independent assessor (1 for each trial location) is scheduled to conduct the ASIA examination on each patient, prior to the cell therapy. This will ensure a highly credible uniform assessment throughout the continuing process. These assessor(s) maintain the examination files separate from the trial infrastructure. The doctors involved with the cell injections have no access to these assessments. Once a trial combination is fully subscribed, the next trial (combination) is subscribed & so on.

    I imagine there will be some fashion of 3D imagery associated with the injection sites. The
    cells/ combination drugs are injected. The patients are monitored for a period of time to ensure complications are not present. The patients return home with trial packets to document their physical therapy/ other requirements. Possibly a monetary rebate provided to motivate high quality, complete after-care documentation.

    A central data file location can be easily set up to post (using a patient number ) the ASIA
    examination results, the cell therapy type & patient provided, after documentation. The critical data is available for all doctors who are involved within the trial network to evaluate & ensure that duplications do not take place until substantial results are verified.

    I realize this is a simplistic view with broad strokes. The real work involved is a thousand
    times more difficult. What we do know is, what has been done in the past is not working. The cell therapies are to splintered, and the documentation is shoddy & sporadic.

    You had the keen foresight to begin the critical steps arranging the trial network years ago. Imagine what could be achieved if the extremely time consuming function of fund raising was, to a large extent alleviated. You could then focus your time (and energy) expanding the infrastructure for the trial testing network.

    Its common knowledge that patients are spending huge cumulative amounts on cell therapies over seas. If the patients were aware of the most promising cell therapies & injection techniques became available, full subscription would be ensured. An immediate side benefit would be, the unscrupulous operators would be exited from the process.

    Quote Originally Posted by Wise Young View Post

    I strongly disagree with the premise and your recommendations. The type of "research" that you propose is not research.
    Wise you consistently have stated:

    Quote Originally Posted by Wise Young View Post

    We face several major problems in terms of raising funds for clinical trials. The first is that many companies, particularly small biotech companies, are surviving by the skin of their teeth and therefore have little or no money to give to others.
    Quote Originally Posted by chasb View Post
    Assuming arguendo that $400 Million has been spent on spinal cord therapy procedures, with little or no improvement, as well as spotty clinical documentation:

    It is now time for the 4 Million plus (an growing) spinal cord injured patients to decide what
    is best for them. A fee based, ongoing combination therapy network. A network where the most up to date cell combination therapies/ injection techniques are applied. The results of which, are posted in a central data base for all doctors concerned to have access. Working toward the ultimate goal of one day making paralysis a word, not a sentence.

    The money is already being spent by the patients. It is time to harness this powerful asset. In the process, as a secondary consequence, put the scam artists out of business.

    Quote Originally Posted by Wise Young View Post

    You are amongst a growing group of people in the spinal cord injury community...
    Whenever a group of people begins to assemble there is a reason.

  7. #37
    Quote Originally Posted by chasb
    It's wonderful that so many human beings have been helped (over the past 60 years) by the system we are discussing . Unfortunately, no treatments have been applied to (restorative therapies) alleviating those who suffer daily with spinal cord injuries*. Thank you for your in depth analysis of the system. You have proven my point.

    Thank you for a wonderfully thoughtful and well-expressed response. I am afraid that I still disagree with you but let me take it one argument at a time. In my first post, I wanted to make the point that the medical system has produced many therapies that have helped millions of people. I argued that we need to give that system a chance to help people with chronic spinal cord injury. Your response is that it has not and therefore we need to change it.

    Your proposal is very interesting and incorporates a recent change in the FDA that permits patients to pay for parts of the therapy that are known to be effective, e.g. rehabilitation, and that there should be a universal database that puts together the data from all the patients who are trying different combination therapies. As you point out, patients are already paying and engaging in medical tourism. You are suggesting that we harness this.

    I realize that you have other points but let me respond to these aspects of your proposal first.

    1. What you are proposing is an uncontrolled clinical trial. There have been several attempts to organize people who are going overseas for their therapies. For example, Wayne State University and the Rehabilitation Institute of Michigan in Detroit tried to provide this service. People who can afford it were evaluated first in Detroit, went overseas to Lima or Huang, and then came back for their rehabilitation. Several dozen patients have gone this route. I don't think that it has yielded any significant publications or convincing data that the therapies work or do not work. The main reason is that these trials have no controls. Because there are no controls, they will never be convincing to the medical establishment.

    2. The approach is quite expensive. It may cost as much as $80,000 for a patient for the rehabilitation phase alone in the United States. The rehabilitation may be covered in part by insurance if it is part of an organized and FDA-approved clinical trial but I doubt that most insurance companies would be willing to subsidize the rehabilitation for an individual experimental therapeutic approach chosen by the patient. So, the majority of patients who can go this route must be people who are independently wealthy and can afford this approach.

    3. There are not enough patients with the same conditions and treatments to yield statistically valid conclusions. The patients will be of all types, with many different levels and different severities. The therapy will be all types, combination and otherwise. Given such diversity, it is doubtful that sufficient patients with similar conditions and treatments can be lumped together to yield statistically valid conclusions about the therapies.

    4. Trials have to be properly designed. The clinicians must be able to deliver the same therapy every time. The evaluators have to be trained to examine the patients in the same way. I have just spent 5 years of my life training doctors in China to do this. We will have to do this with American doctors to run the clinical trial network in the United States. Doctors think that they can do the examinations. They can't without training.

    If clinical trials were easy and cheap, we would be doing a lot more of them. However, every other field has clinical trials. Why not spinal cord injury? There are over 100 clinical trials on multiple sclerosis going on in the United States. There are less than a dozen for spinal cord injury. There is no difference in the number of patients affected by multiple sclerosis compared to spinal cord injury. Yet, they have a lot more clinical trials. Why? Because their community supports clinical trials. The spinal cord injury community does not or at least has not until recently.

    Last edited by Wise Young; 01-13-2010 at 08:41 PM.

  8. #38
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    Quote Originally Posted by paolocipolla View Post
    I am trying to find good reasons to convince a private company to put money into chronic SCI cure so I wonder:

    1) Can a private company make a profit out of a cure for chronic SCI?
    2) Who can make a profit out of a cure for chronic SCI? Just health care sistem?
    3) Why should a private company put money into a cure for chronic SCI? If not for profit social responsability? Image return?
    This is for cancer, cancer in research for cures in general. But the parallels are there for sci though, for example, -cluster collaboration and so on. They do good. Read, understand and learn. Well, if private corporate investment and funding is necessary for sci cures, that is.

  9. #39
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    Quote Originally Posted by Wise Young View Post
    Perhaps what we can do is travel together in the upcoming Norway, Australia, and Italy trip that I am making in March. That way, I can introduce you guys to all the people and scientists that I know at the meetings. We can talk at length about the companies that have succeeded and failed, and who and where the good people are.

    Norway March?

  10. #40
    Quote Originally Posted by Leif View Post
    Norway March?
    I hope so.

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