FDA Approves Another Crohn's Treatment

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A new drug treatment... already used to treat MS. Odd, that's the second drug that is useful in treating both IBD and MS. Speaking of odd, not sure I like the odds of getting a potentially fatal disease as a side effect 1:4000 And $30,000.00 US per year. WOW! Why do these drugs cost so much? So the drug co's can get richer off of our misery... IF they don't kill us in doing so
 
You got it right Kev its all about money. Dont treat the Illness treat the symptoms, that will keep them on our pills forever.
 
The story didn't give you the full bit of information you needed. All three cases occured in people given Tysabri AND Interferon at the same time due to the whole standard of care requirement in clinical trials. Not a single patient developed PML who has taken Tysabri in the absence of other immunosuppresants. If you read closely even Humira and Remicade are believed to potentially cause PML as its caused by a virus that remains dormant in everybody until the immune system is suppressed. In the case of Interferon + Tysabri, the combination was enough to allow the virus to become active and deadly.

It does carry quite the price tag, but that is still cheaper than remicade assuming it isnt 30k after insurance. Humira runs about $600 a year for the patient and 20k a year for the medication cost to the insurance. The biologics are expensive, but so far they work very well.

Hopefully this will make people a bit more willing to accept Tysabri as an option if they run out of other options ahead of time. The data on PML after re-evaluation is very convincing that the treatment is in fact safe when not taken with other immunosuppressants.

Edit: The reason they cost so much is the manufacturing process and the cost to recoup the research that goes into these drugs. They are fermented millions of dollars at a time in large fermenters (think beer only larger). If a batch is suspected to have a flaw or be contaminated, millions of dollars go down the drain. The purification processes are also expensive and require a very large influx of money to maintain them to ensure protein purity. It seems expensive, but the cost to make these drugs is massive...when genentech built their newest protein plant, they had to hire every stainless steel welder west of the mississippi due to the massive size of the fermenters. Then each plant has to be completely sterilized frequently to meet the FDA standards required of them. The entire business of biologics is insanely complex and while the cost seems high, for the relief it is a minor blip really.
 
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I wish they would spend some research time on diets or natural remedies for Crohn's (Green tea, Turmeric, herbs, fish oil etc.........); but I guess there is no money in God made substances for big pharmaceutical companies........
 
Hey Saidinstouch... Thanks for the added info. I wonder what the risk is for any sufferer who has been on immuno suppressors prior to taking the Tysabri?

As for the costs of this or other similar priced drugs, well, I have my doubts the major portion of the upfront costs of these drugs are based on the expense of the manufacturing process. What is the basis of my conjecture? Well, once the patent expires, seems that competitors are very able to produce similar 'generic' versions at a fraction of the brand name price. And, although the cost of the equipment/facilities for these drugs are a major expense... I've been part of an unrelated industry where the cost of equipment/facilities are comparable... hi end IT manufacturing.
1.5 micron clean room facility cost about $1.2 million per 10 foot/square to build... (course that was years ago, old technology.. now they're down to less than .25 microns.. and those costs are considerably higher today). A robotic assembler... those ran about $2.5 mil a piece, most assembly lines had 2 - 3, and typically there would be 6 - 10 lines running simultaneously.
Yet, in the field of hi end electronics manufacturing, competition drives the cost to the consumer way, way down. R&D is a business expense, and the electronics industry HAS to write it off, and recoup those losses from gross profits. In the 80's, a basic home computer cost $2500... today a basic PC can be had for less than $500. The only other argument is the difference in volume... but even that gives me pause for thought. I may purchase 1 big ticket hi end electronic device once or twice every other year at most, but folks taking these drugs pretty much tied in to every week, every month at best..., and for an indefinite period to come. There may be only 500,000 people with IBD in the US (I haven't a clue what the worldwide pop is), but even if only one in five of them uses a remicade, or a humira, even a tysabri... then that's 100,000 X 52 weeks, or X 12 months, or whatever.
No, the drug co's hide behind their R&D costs, the tests for FDA approval, the costs of facilities, equipment, etc.. (wonder what their lawsuit costs are??).. but I think the biggest 'culprit' is their profit margins. And I think if one could examine their profit margin compared to other industries, that it would be crystal clear WHY we pay so much. Course, I'm definitely biased!
 
Supposedly the risk is low or nil if you have been off of them for a period of time so your immune system can get back to normal. Also, Tysabri is a TNF-inhibitor from what a remember (thouch I could be wrong) and is humanized like Humira so being on a Humira or Remicade before Tysabri should be less of a risk than a different class of suppressor like Interferon.

For normal pharmaceuticals, that is the case, but with these biologics, the process IS the patent. The final patent is only a side-board really, at least as far as the FDA is concerned. There are no bio-generic drugs because it is difficult to prove the protein produced from a modified process is the same protein. When these companies create a drug every supplier they choose has to remain in business for the duration of the drugs production life or the process to get the FDA to approve a new supplier is very tedious. When it comes to biologics, its a whole other world compared to standard small molecule-pharma. I'm not saying the costs aren't slightly out of proportion, its just that the usual expectations are sort of thrown out the window because of the inherent risk of the drugs themselves and how the FDA regulates them.

Its a very interesting topic and most of my information comes from a class I took led by a longstanding member of Genentech who subsequently put the first HIV vaccine into humans safely. We went over a lot of the technology used and the costs and scales that go into biologics and it was simply amazing to learn what goes into a simple little shot or vial that provides me with so much relief.
 
Pharmaceutical companies spend around 31% of revenues on administration and marketing. 14% is spent and R&D. Profits margin is around 16%.

Most businesses are doing well to have a 3-5% profit margin.

Here is an excerpt of an article I found. Link is below.

http://www.nybooks.com/articles/17244

In the past two years, we have started to see, for the first time, the beginnings of public resistance to rapacious pricing and other dubious practices of the pharmaceutical industry. It is mainly because of this resistance that drug companies are now blanketing us with public relations messages. And the magic words, repeated over and over like an incantation, are research, innovation, and American. Research. Innovation. American. It makes a great story.

But while the rhetoric is stirring, it has very little to do with reality. First, research and development (R&D) is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits. In fact, year after year, for over two decades, this industry has been far and away the most profitable in the United States. (In 2003, for the first time, the industry lost its first-place position, coming in third, behind "mining, crude oil production," and "commercial banks.") The prices drug companies charge have little relationship to the costs of making the drugs and could be cut dramatically without coming anywhere close to threatening R&D.

Second, the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). The great majority of "new" drugs are not new at all but merely variations of older drugs already on the market. These are called "me-too" drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,

If I'm a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?[4]

Third, the industry is hardly a model of American free enterprise. To be sure, it is free to decide which drugs to develop (me-too drugs instead of innovative ones, for instance), and it is free to price them as high as the traffic will bear, but it is utterly dependent on government-granted monopolies—in the form of patents and Food and Drug Administration (FDA)–approved exclusive marketing rights. If it is not particularly innovative in discovering new drugs, it is highly innovative—and aggressive—in dreaming up ways to extend its monopoly rights.

And there is nothing peculiarly American about this industry. It is the very essence of a global enterprise. Roughly half of the largest drug companies are based in Europe. (The exact count shifts because of mergers.) In 2002, the top ten were the American companies Pfizer, Merck, Johnson & Johnson, Bristol-Myers Squibb, and Wyeth (formerly American Home Products); the British companies GlaxoSmithKline and AstraZeneca; the Swiss companies Novartis and Roche; and the French company Aventis (which in 2004 merged with another French company, Sanafi Synthelabo, putting it in third place).[5] All are much alike in their operations. All price their drugs much higher here than in other markets.

Since the United States is the major profit center, it is simply good public relations for drug companies to pass themselves off as American, whether they are or not. It is true, however, that some of the European companies are now locating their R&D operations in the United States. They claim the reason for this is that we don't regulate prices, as does much of the rest of the world. But more likely it is that they want to feed on the unparalleled research output of American universities and the NIH. In other words, it's not private enterprise that draws them here but the very opposite—our publicly sponsored research enterprise.

Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)

If prescription drugs were like ordinary consumer goods, all this might not matter very much. But drugs are different. People depend on them for their health and even their lives. In the words of Senator Debbie Stabenow (D-Mich.), "It's not like buying a car or tennis shoes or peanut butter." People need to know that there are some checks and balances on this industry, so that its quest for profits doesn't push every other consideration aside. But there aren't such checks and balances.
 
Really enlightening reading. Thanks and a tip of the hat to Dan. Interesting in particular are a couple of points. One that they combine Admin & Marketing in the costing breakdown. Now, it may be just my suspicious nature at work here, but factoring both together WOULD make it easier to hide or fudge the figures as to what the Marketing costs truly entail; perhaps payoffs, kickbacks, you name it. Spin doctors to cover up 'goofs'.
Second, given my very basic math skills... seems that Admin/Mkrtg & RnD only add up to 45%... even allowing for profits, seems there is a "sizable" figure missing from the equation. Think if the bulk of that were "costs", the companies would broadcast that, just to show how much they invest in the production of their products. To me, it looks like they've built in a "fudge" factor of approx. 30%... Think what we'd save if our drugs were 30% cheaper... Think about it, the trickle down effect. We pay that much less, insurance companies pay that much less, hospitals, clinics, etc., etc.. The cost to the taxpayer would go down, our insurance premiums would go down, our drug costs... well, you get the picture. Ahhh, wouldn't it be nice
 

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