16 replies to this topic

[chriskuo]

On today's LLS CMLwebcast, Dr Shah stated he had heard that the generic would be 30-40% of the cost of Gleevec.

[Gail's]

Good news!

[Antilogical]

30% of $100K = $30,000 per year, or $2,500 per month.  Still outrageous.

[Buzzm1]

ELSEWHERE:

Imatinib 400 mg Prices — Generic Version

http://www.pharmacyc...matinib/400 mg/

[Gail's]

How can you find out whether a drug sold online has quality and safety standards? Seriously, I'd consider lower cost of these meds if I could verify safety & potency.

[scuba]

30% of $100K = $30,000 per year, or $2,500 per month.  Still outrageous.

 

Competition will drive the price down. India alone will be selling  Imatinib for about $200 a month. They already do. When patent expires, one can buy from India at that price or pay $2,500. Which one do you think the insurance companies will support?

 

Without a money making incentive - these drugs would never have been invented. It's a good thing.

[Dom]

"Without a money making incentive - these drugs would never have been invented. It's a good thing."

Generally, that's true. But my understanding is that Novartis did not pay much of the research that went into gleevec, they simply picked up the patent at the end. The research was done mostly on the public dime. I never understood why the government didn't take the patent and then just got the pharmaceuticals to distribute it at a small markup.

[chriskuo]

Many drugs made in India do not meet FDA standards so the prices will be nothing like the prices in India for non-qualified drugs. There is a substantial cost to FDA compliance. I would not trust a drug bought off the street in India.

[chriskuo]

Anti logical,


Remember that insurance companies already negotiate a substantial discount off the list price. From what I can see they are paying about $5-6K per month.

[nanakrauss2]

Mine is covered by my Medicare Advantage Plan and a charity funded by Novartis and others. I pay zero. The generic will probably cause my insurance to insist on the lower cost drug but I will lose my charity funded portion. So for me, I will go from paying zero to ???  The whole system stinks!!!

[scuba]

"Without a money making incentive - these drugs would never have been invented. It's a good thing."

Generally, that's true. But my understanding is that Novartis did not pay much of the research that went into gleevec, they simply picked up the patent at the end. The research was done mostly on the public dime. I never understood why the government didn't take the patent and then just got the pharmaceuticals to distribute it at a small markup.

 

Dom,

 

I don't believe that is correct (i.e. "Novartis did not pay much of the research that went into gleevec").

 

 

Publication number US5521184 A Publication type Grant Application number US 08/234,889 Publication date May 28, 1996 Filing date Apr 28, 1994 Priority date Apr 3, 1992 Fee status Paid Inventors Jurg Zimmermann Original Assignee Ciba-Geigy Corporation

 

According to Wikipedia on Imatinib (http://en.wikipedia.org/wiki/Imatinib - section on History), "Gleevec  was invented in the late 1990s by scientists at Ciba-Geigy (which merged with Sandoz in 1996 to become Novartis), in a team led by biochemist Nicholas Lydon and that included Elisabeth Buchdunger and Jürg Zimmerman^[43] and its use to treat CML was driven by oncologist Brian Druker of Oregon Health & Science University (OHSU).^[44] Other major contributions to imatinib development were made byCarlo Gambacorti-Passerini, a physician scientist and hematologist at University of Milano Bicocca, Italy, John Goldman at Hammersmith Hospital in London, UK, and later on by Charles Sawyers of Memorial Sloan-Kettering Cancer Center.^[45] Druker led the clinical trials confirming its efficacy in CML.^[46]"

 

^{And here is Dr. Druker's words on Imatinib's invention:}

 

"So in 1988, Nick Lydon, who led a drug discovery group at a pharmaceutical company that eventually became Novartis, came to talk to me. He was interested in developing drugs to block a family of cellular enzymes implicated in several cancers. I said to him: "If you want to develop targeted chemotherapies, C.M.L. is the disease to study. We know the most about it — and, if we can figure out a way to block this enzyme, we can turn off the cancer switch."

So in Nick's lab at the pharmaceutical company, he began screening for agents that worked on C.M.L. He'd send me his best compounds. I found one, STI571, that was better than the others; it would kill every C.M.L. cell in a petri dish. By 1995, STI571 was a lead compound set for clinical development."

 

The point of this is that to be successful in drug development, the Pharma company's have to work with medical researchers in a Clinical setting to validate the chemistry, it's effect and side effects. It is a long painstaking process. But the risk is largely borne by the Pharma company's. They can't afford to take the risk if there is no payout with lots of money coming in for patient treatment. It's like drilling for oil. Some wells (i.e. drug tests) are going to be dry - and the money spent on those dry wells is money gone. The same is true for drug company's; the successful drugs have to pay for all of the failures. I don't know if Novartis was subsidized by  the Swiss government. I can't find any references - but I haven't really looked.

 

This is why the Patent system basically works - it gives the company's time to recover their costs and make a profit before generic's hit the market. We can debate whether the amount of money they make is "fair", ethical or even moral, but it is clear that money incentive is needed in some form to drive this kind of innovation - and to drive lots of it. Many company's are now engaged in this line of research. 

[Dom]

Very interesting, Scuba. I very much agree that the capitalist system is necessary for medical research, and I have no complaints with a company gaining a profit from its research. I was looking at this post:

http://www.keionline.org/node/1697

There, I found ...

"Novartis was not "the innovative force." Not only was all the basic research done in academic institutions, but so were the initial clinical investigations that showed STI 571 to be specifically effective against CML cells in vitro and in vivo. In fact, it took a few years for Brian Druker, the investigator most responsible for these latter studies, to convince Novartis that it should invest in a crash program to develop Gleevec and to undertake large-scale clinical trials.
Relman, A. (2003). Book Review: Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting. Medical History. JAMA, 290: 2194-2195"

http://lists.essenti...ber/005475.html

That, of course is basic, or phase 1 trials. Phase 2 was a different matter, but not very different.

[scuba]

Very interesting, Scuba. I very much agree that the capitalist system is necessary for medical research, and I have no complaints with a company gaining a profit from its research. I was looking at this post:

http://www.keionline.org/node/1697

There, I found ...

"Novartis was not "the innovative force." Not only was all the basic research done in academic institutions, but so were the initial clinical investigations that showed STI 571 to be specifically effective against CML cells in vitro and in vivo. In fact, it took a few years for Brian Druker, the investigator most responsible for these latter studies, to convince Novartis that it should invest in a crash program to develop Gleevec and to undertake large-scale clinical trials.
Relman, A. (2003). Book Review: Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting. Medical History. JAMA, 290: 2194-2195"

http://lists.essenti...ber/005475.html

That, of course is basic, or phase 1 trials. Phase 2 was a different matter, but not very different.

 

Your reply is very interesting as well !

 

I wonder why the patent only lists one author? and from the Pharma company that claims to invent it. Novartis bought the small Pharma company that's why Novartis owns the patent. It seems there is quite a story here.

 

It's probably safe to say that all were needed to bring this important breakthrough to market. The patent author invented the "molecule". Druker showed how it can work in treating patients. That's why Druker is the hero in all of this and a great one at that.

[Gail's]

I find all of this interesting. Obviously Druker pretty much knows the most about this drug development. I met another gleevec user thru LLS and she told me she is a Druker patient. She told me that Druker said he and some colleagues flew to Europe to try and arm twist Novartis to get going on the manufacture of gleevec. If I had the $550 not including labs tha his office charges for your initial visit, I would be in his office ASAP. Mostly because I think my onc is too new to hematology oncology.

[scuba]

I find all of this interesting. Obviously Druker pretty much knows the most about this drug development. I met another gleevec user thru LLS and she told me she is a Druker patient. She told me that Druker said he and some colleagues flew to Europe to try and arm twist Novartis to get going on the manufacture of gleevec. If I had the $550 not including labs tha his office charges for your initial visit, I would be in his office ASAP. Mostly because I think my onc is too new to hematology oncology.

 

This is a case where the scientists at the Pharma company's do research and find out something compelling and then go look for Clinical application. Dr. Druker was contacted and became excited about the potential and then followed up with Novartis (which formed in 1996 with the merger of Sandoz and Ciba-Geigy). That's where the arm twisting by Druker occurred. Novartis didn't believe there was a commercial application of the compound given the costs of FDA approval (years of trials with potential of failure). Imatinib would have sat on the shelf if it hadn't been for Dr. Druker.

 

Dr. Druker pushed Imatinib through. It is Ciba-Geigy (Jurg Zimmermann), however, who is credited with the chemical innovation:

 

http://www.ncbi.nlm....pubmed/21426055

https://www.youtube.com/watch?v=N7QHZKXxy_g

 

Watch the above Youtube video of Jurg Zimmermann, inventor of Gleevec, thank Dr. Druker for being first to apply this life-saving compound. It will bring a tear to your eye as he recalls his invention.

 

Together, these professionals unleashed a whole new class of research where the commercial success became pre-ordained. Bristol-Myers-Squibb and the others all learned that they can make money with these class of drugs and off to the races - nilotinib, Dasatinib, Ponatinib (although pulled for toxic reasons) and others. CML is the one disease that Pharma is nailing now (cheerleading hat on).

 

I do wonder how many other compounds, that could treat other life threatening diseases, get discovered in Pharmaceutical labs and then go untested and fade away for lack of a "Dr. Druker" to push it and test it at the Clinic level? It is chemistry after all - and these compounds can be quite toxic and risky to test (i.e. expensive). 

 

Thank you to the pioneers.

[Dom]

Great video, Scuba. Thanks for that.

[Gail's]

Yes, thanks scuba. It still amazes me that anyone had interest in or cared enough about CML patients to spend the time to study our disease. I heard about a man in archaeology whose life work was the study of a particular species of prehistoric fish. His specific focus was on the scales of the fish. That type of interest and dedication must be admired. Especially from someone like me whose brain flits from interest to interest.