Drug Cost A Likely Death Sentence - Page 12

On June 23 2011 10:00 Probulous wrote:
Calm down people, there is no need to get hysterical. You can't discuss with someone if they are shouting at you.

There seems to be a lot of meaningless platitudes in this thread, which is a disservice the OP. So here are some points to consider. If you don't like them or have a counter argument please use some facts and figures so the discussion moves on.

Is developing a drug expensive?
This is a complicated question because the price is determined by many factors. Mostly it is due to the following:

• Research Costs including Clinical Testing
  
• Regulation costs including compliance testing, application costs
  
• Cost of drugs that don’t make it.
  
• Production costs of the drug including shipping, storage and administration
  
• Incidence of disease
  
• Regularity of use
  

In 2006 the Clinical Trial Benchmarking put average per patient costs for clinical trials at $26,000.00 USD ( http://www.lifesciencesworld.com/news/view/11080 )

The number of patients required per trial depends on the expected benefit as well as expected toxicity profile, however most registration trials have a minimum of 500 patients.

Thus we can expect using rough estimates that each registration trial would cost approximately
$26,000 x 1000 = $26,000,000

That is a big number. Even if my number estimates are high (I can tell you they are an underestimate), you are still looking at millions of dollars per trial. Now this is only the successful final phase III trial. There are also the previous Phase I and Phase II trials, which have costs of $1.5 Million (100 pts at $15,700 per patient) and $400,000 (20 patients at $19,300 per patient).

This doesn’t include the other costs of development including side trials for clarifying indication scope, toxicity effects, additional indications, local populations, costing trials and the list goes on.
So for a drug that miraculously reached Phase I with no costs, had a perfect phase I,II and III trial, the total clinical costs would be approximately $28 Million

Now consider that most drugs have multiple clinical trials running. An example being one of our new compounds have 9 different registration trials running at the moment and you immediately up the costs to the almost $300 Million.

It is not hard to see how the $1 Billion price for reaching the market is easily achievable.
http://onlinelibrary.wiley.com/doi/10.1002/hec.1454/abstract

Less than 5% of cancer drugs that reach animal testing phase ever get to market. Whether the company makes a profit on those 5% is not certain. Most drugs don’t even get to animal testing phase. I work for a large pharmaceutical company, where we run over 1 million unique screenings a day looking for potential target matches.

This is pretty decent description of what happens during development.

Or alternatively


Now if you have a problem with accepting that bringing a drug to market is expensive please provide some counter argument as to why this is not the case.

Why is he being charged $500k for a life saving drug
As has been mentioned previously this is a rare disease with an incidence of “1-2 cases per million” ( http://en.wikipedia.org/wiki/Paroxysmal_nocturnal_hemoglobinuria#Epidemiology ). Thus the drug company can only expect to treat about 70 patients in Canada with which to recoup their costs. This assumes all patients would benefit and the company can get to them. Alexion is a small pharma company they have very little to diversify their costs and so have to charge the high price.

But life is sacred and pharma is making money from sick people!
Nobody is arguing that the sick should be taken advantage of. Quite the opposite, the Canadian system is celebrated as on of the best in the world because it provides the greatest benefit at the lowest cost.

It is built for this purpose. It was designed, legislated and constructed specifically to minimise costs whilst maximising benefit for the whole country. This is where ethics come in and to argue the ethics of a nationalised health service is really pointless now. Suffice it to say that the Canadian health system is constructed to treat as many people as possible at the lowest cost possible.

As for Pharma making money off of sick people, I counter with Pharma companies do not make people sick. In fact, often it is people who make people sick. I don’t see you guys up in arms about Intel, or Razor or Blizzard or any other company that vicariously supports a sedentary lifestyle. Lack of exercise and the increase in sedentary lifestyle is a known risk factor for diabetes and heart disease. So why should we support companies that support such a lifestyle?

But Probulous, Pharma companies need sick people so they can make money. I will concede that if there was no sickness there would be no need for pharma companies. There would also be no need for hospitals or doctors. Are they evil as well?

So what do we do?
This is the question that should be asked. I assume that this person has already approached the company directly for support. Most large companies have a compassionate use program but as mentioned Alexion is small. Moving countries isn’t going to help because, as mentioned, Canada has one of the best systems in the world. There may be countries where this is listed but good luck getting in with the condition. I guess you could try and look for a trial that is enrolling?

Probulous, you are a heartless bastard!
Maybe I am, I don’t believe this is the truth but it is not beyond the realm of possibility. I feel for this young man, no-one enjoys making these decisions. It is an ugly reality that rationing of medication is real and cannot be avoided. Unfortunately, this is reality.

Please if you disagree with what I have said, outline where and how you disagree. Otherwise this discussion just descends into rhetorical shouting matches.

On June 23 2011 10:35 Ryuu314 wrote:

Very good post and well researched.

I just want to point out, however, that the vast majority of pharma, especially the bigger ones, make way more money on their drugs than they spend on research. My friend is the head of a drug testing company based in China that does drug tests for both American and Chinese pharma (it's in China 'cause tax is easier or something iunno).

Even though research for one round of new drugs will cost up to or around a billion USD, the thing is, the drugs that do make it through are very often charged astronomical cost, such that they can make a LOT of $$$ for it. The reason is NOT purely due to "covering research costs." It's because patent laws are strange and incomplete. Once a drug comes out onto the market, it's only a matter of time before another pharma is able to make their own copy of the drug. Usually by altering the makeup of the drug with some inactive ingredient/chemical. Of course, it's much more complex than I can describe, but the basic premise is quite simple. What does this mean? It basically means that the pharma that develops the drug originally will only have a small window of time where they can make maximum profits. As such, they will crank up the price of the drug to extremely high, sometimes extortionate prices before the inevitable copies come out.

Pharma companies exist to make money. They do that very, very well.

In the OP's friend's case, however, is a little more unique. The above process I described is usually for medication for diseases that aren't all that rare. In this case, the OP's friend's illness is so rare , that's is completely impossible for the company to make any kind of profit, or even to attempt to break even on costs, without charging an astronomical amount for it.

This case is tragic and I truly wish there was something that could be done. But the fact of the matter is, pharma is a business, and a very well-run, fined tuned business. I wish the OP and his friend good luck. Definitely try to get some donations; it may help... :\

I wonder if there's any government in the world that subsidises all life-threatening medications?

On June 23 2011 11:52 cLutZ wrote:
Pretty sure the rare blood disease, not the cost is the death sentence.

On June 22 2011 11:31 Voltaire wrote:
I thought Canada had universal healthcare? Or is this friend in the US?

On June 23 2011 04:45 Baarn wrote:
It's too bad drug companies don't have to conform to Duty to Rescue.