The story of Rituxan and the weakest point in the system

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frodo
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The story of Rituxan and the weakest point in the system

Post by frodo »

Maybe some of you have heard about the history of Rituxan and Ocrelizumab. Ocrelizumab is a slightly modified version of Rituxan/Rituximab. As Rituxan was approaching FDA approval for treatment of multiple sclerosis (with very good results), it was also approaching the end of its patent. Therefore the company decided that it was not profitable to pursue the approval process for a treatment that would be available soon from other productors.

The history is explained by one of the participants in the last conference in his blog: https://neuroimmunology.wordpress.com/2 ... sclerosis/

I understand that a certification process is expensive in time and resources, and that no company in his mind would pursue such a bureaucratic pain for free, but, shouldn't this be performed by any other entity? Is there no public organization that pursues approval for generic medicaments?

And after these thoughts, Could be that things like Inosine or Lipoic acid are not certified simply because nobody assumes the cost of the process?
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Re: The story of Rituxan and the weakest point in the system

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It turns out that Rituximab patent expires in the US in 2015. This means that, by the time the phase III is over, the patent will be over too. So, no profit then in doing such an investment. To surpass this inconvenience Genentech invented a new drug, antiCD20 as well, but humanized (Rituximab is chimeric), called Ocrelizumab, and started the whole process again. Then, obviously, we got a phase II trial with ocrelizumab in MS. Results have not been published yet but have been presented at 2010 ECTRIMS meeting and show,as expected, an almost equal efficacy profile to that of rituximab. But a patient died on the ocrelizumab arm from an unexpected “systemic inflammatory syndrome”. That could be chance and still hope larger studies to be assured… but it was not chance. Several rheumatoid arthritis trials with ocrelizumab have been terminated because “the overall benefit to risk profile of ocrelizumab was not favorable in RA” what it really means that 7 patients died unexpectedly in the high ocrelizumab dose arms of the trials.

So, what have we now? Rituximab, an extraordinarily effective therapy, used for quite a long time now, pretty safe but that will never be approved for MS if phase III trials are not performed (and phase III trials are not planned to be performed) because that drug has become unprofitable. On the other hand we have an equally effective therapy, tested in phase II trials, to date showing a pretty less safe profile (to the point of having been stopped in other diseases) but potentially profitable if the company overcomes the safety issues. Guess wich one will be approved in a few years.

This is terrible. We don’t have so many choices to give our patients to throw away the best ones or have to wait several more years. But it’s terrible not only for MS patients… Rituximab has been tested in small case series of myasthenia gravis, neuromyelitis optica, NMDAR encephalitis, Lambert Eaton myasthenic syndrome, CIDP, anti-MAG neuropathy… diseases that, if MS may not have rituximab phase III trials, they won’t for sure. And, in those case series, it has shown pretty good results that need to be confirmed in order to be approved and used routinely. If a bad commercial decision halts rituximab development or commercialization for all those diseases, MS included, it will be the most shameful story in neuroimmunology. So, if not big pharma, a consortium of neuroimmunology departments should perform that expected phase III trial and bring rituximab back to neuroimmunology therapy.

If, in the meantime, ocrelizumab, ofatumumab or any other treatment can be developed and results positive it will be welcomed, but not a single effective drug should be left behind.
To me, this is just another case of neurologists and other bank-vault guards standing in the way of disease treatment, because of a shameful capitalized monetary approach to medicine that protects bad medicine at the expense of good. Why can a physician not prescribe this drug which has had the misfortune of patent expiry? Why can a patient not get it, with informed consent? Because it might stand in the way of some profit on drugs which don't work as well? What kind of nightmare is this?
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Re: The story of Rituxan and the weakest point in the system

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It's a sad reality of our current system. There is little financial incentive to pursue approval for older medications, lifestyle based interventions, an other treatments which cannot be easily packaged, exclusively owned, and marketed.

The only solution would be to have a government funded program or a government funded incentive program for pharmaceutical companies.

Cheer: It really has nothing to do with clinical neurologists. Many neurologists prescribe rituxan off label, and many neurologists such as Stephan Hauser have spoken out about the rituxan story. I can't really blame the drug companies either. You can't expect them to pursue an endeavor which is certain to lose money. The can't stay in business in a competitive market if they do that.
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Re: The story of Rituxan and the weakest point in the system

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centenarian100 wrote:It's a sad reality of our current system. There is little financial incentive to pursue approval for older medications, lifestyle based interventions, an other treatments which cannot be easily packaged, exclusively owned, and marketed.

The only solution would be to have a government funded program or a government funded incentive program for pharmaceutical companies.

Cheer: It really has nothing to do with clinical neurologists. Many neurologists prescribe rituxan off label, and many neurologists such as Stephan Hauser have spoken out about the rituxan story. I can't really blame the drug companies either. You can't expect them to pursue an endeavor which is certain to lose money. The can't stay in business in a competitive market if they do that.
If they can't stay in business because everyone else can sell Rituxan too, maybe they should not be in business.
Cheer: It really has nothing to do
Are you addressing cheerleader? As far as I can see she has not joined in this discussion. Who mentioned clinical neurologists? Are you one? What makes you think clinical neurologists come into the picture at all?

If "private industry", in this case meaning drug companies, will not do a phase III trial because of an impending free-market (meaning patent-free) situation, it is incumbent upon government to do it.

It has been said right here recently that drug companies love it when something actually works, because they make more money. It is plain that, without patents, and the usury that they have come to mean (allowing millions to be charged for one life-saving drug), they do not care two hoots if something works or not.

In the case of MS, where only massive clinical trials can convince anyone of efficacy, because they don't know the cause of the disease, the dice are loaded against the patient. Am I wrong, "Cheer"?

Usury used to be illegal, and it is still damnably immoral.
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Re: The story of Rituxan and the weakest point in the system

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1eye wrote: Usury used to be illegal, and it is still damnably immoral.
This could be true, but in this case usury is not the problem. It is not usury just doing nothing about a subject. And that is what pharma companies do about generics.

They do not care about them for good or for bad. It can be said that is not solidarity, but for sure it cannot be classify as usury.
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Re: The story of Rituxan and the weakest point in the system

Post by 1eye »

frodo wrote:
1eye wrote: Usury used to be illegal, and it is still damnably immoral.
This could be true, but in this case usury is not the problem. It is not usury just doing nothing about a subject. And that is what pharma companies do about generics.

They do not care about them for good or for bad. It can be said that is not solidarity, but for sure it cannot be classify as usury.
The modern strict definition of usury might be "loan sharking". It is excessively high interest. But I use it to describe the practise of charging excessively high prices, where the patient must pay or die. It is in a class of its own, and there should be a special place in hell for this kind of "life-lending". Interest itself, not just excessive interest, used to be completely illegal. (Compound interest, often charged on loans to countries, is excessive and should be illegal.)

Not caring whether a generic comes to market, after a patent runs out, is evidence of a particular company's greed and its disinterest in curing anything -- the price of entry is running a successful Phase III trial. Some would say it is the FDA that is setting the bar too high, because after all nobody, not even the FDA, can say what the cause of the disease is. So this business of "modifying" an unknown thing, is just statistical smoke and mirrors, meant to make some doctors, who are willing to sell it on that flimsy basis, rich.
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Re: The story of Rituxan and the weakest point in the system

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1eye wrote:If "private industry", in this case meaning drug companies, will not do a phase III trial because of an impending free-market (meaning patent-free) situation, it is incumbent upon government to do it.
There is really no need for further studies. The evidence for b cell depletion in relapsing multiple sclerosis is overwhelming. It is really an issue of adoption and coverage by insurance companies. Doctors can't readily prescribe a medication if it is going to cost a patient $30,000/year.
In the case of MS, where only massive clinical trials can convince anyone of efficacy, because they don't know the cause of the disease, the dice are loaded against the patient. Am I wrong, "Cheer"?
Knowing the cause of the disease is irrelevant. We don't know what causes appendicitis, hashimoto's thyroiditis, and promyelocytic leukemia, but the treatments are excellent. We need clinical trials because otherwise we will have 1000 ineffective treatments for every one effective treatments. We would still be using blood-letting, snake oil, and radon water.
Usury used to be illegal, and it is still damnably immoral.
If the government wanted to limit drug prices, they would have to regulate drug prices. Otherwise, drug companies will charge as much as they can get away with. This is not unique to pharmaceuticals.
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Re: The story of Rituxan and the weakest point in the system

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Knowing the cause of the disease is irrelevant
That is beginning to sound like Donald Trump.
If the government wanted to limit drug prices, they would have to regulate drug prices. Otherwise, drug companies will charge as much as they can get away with. This is not unique to pharmaceuticals.
Do tell. The things that are unique are the alternatives, suffering and death. We let loan sharks operate. That doesn't mean it's a good idea. Neither is organized crime.
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Re: The story of Rituxan and the weakest point in the system

Post by centenarian100 »

1eye wrote:That is beginning to sound like Donald Trump.
??
Do tell. The things that are unique are the alternatives, suffering and death. We let loan sharks operate. That doesn't mean it's a good idea. Neither is organized crime.
So maybe a single payer system with price regulation is a good idea. It's interesting to read Dr. G's comments about the NHS of England. I suppose it has pluses and minuses

for instance here: http://multiple-sclerosis-research.blog ... ab-vs.html
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Re: The story of Rituxan and the weakest point in the system

Post by NHE »

centenarian100 wrote:So maybe a single payer system with price regulation is a good idea. It's interesting to read Dr. G's comments about the NHS of England. I suppose it has pluses and minuses

for instance here: http://multiple-sclerosis-research.blog ... ab-vs.html
You might want to watch this Frontline documentary "Sick Around the World."

http://www.pbs.org/wgbh/frontline/film/ ... dtheworld/

It discusses the pros and cons of health care systems from a variety of countries.
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Re: The story of Rituxan and the weakest point in the system

Post by centenarian100 »

NHE wrote:You might want to watch this Frontline documentary "Sick Around the World."

http://www.pbs.org/wgbh/frontline/film/ ... dtheworld/

It discusses the pros and cons of health care systems from a variety of countries.
Thanks for posting. I'll take a look at it.
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Re: The story of Rituxan and the weakest point in the system

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1eye wrote:
The modern strict definition of usury might be "loan sharking". It is excessively high interest. But I use it to describe the practise of charging excessively high prices, where the patient must pay or die. It is in a class of its own, and there should be a special place in hell for this kind of "life-lending". Interest itself, not just excessive interest, used to be completely illegal. (Compound interest, often charged on loans to countries, is excessive and should be illegal.)
It seems that a lot of people here think there is something inmoral in Genetech for leaving the research.

On the other hand, my original post didn't try to say that. Patent's expiration deadlines are some kind of expropiation for the public interest, and therefore now the public administration should be accountable for the future development of the product.

And as somebody said before the evidence of B-cells involvement in MS is overwhelming. But no doctor can prescribe a non-approved medication. Some organization should take the approval process further, and we as patients should complain until this is done.
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Re: The story of Rituxan and the weakest point in the system

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Maybe a letter-writing campaign to the president-elect?
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Re: The story of Rituxan and the weakest point in the system

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Why is it I think a letter-writing campaign to Trump is doomed to failure? Is it because he cares so much about sick people?
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Re: The story of Rituxan and the weakest point in the system

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1eye wrote:Why is it I think a letter-writing campaign to Trump is doomed to failure? Is it because he cares so much about sick people?
I am afraid so. But there are other countries in which such a proposal could work. What do you think about Canada or UK?
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