"there will be no generic versions of these drugs. At least not for 12 years, "...........

[joeycola]

She is talking of new House bill.




http://fdlaction.firedoglake.com/2009/10/29/house-health-care-bill-a-death-sentence-for-my-fellow-breast-cancer-survivors/

House Health Care Bill: A Death Sentence For My Fellow Breast Cancer Survivors (and others who need certain drugs)

By: Jane Hamsher Thursday October 29, 2009 10:30 am

I'm Jane, and I'm a breast cancer survivor

I'm Jane, and I'm a breast cancer survivor

There was much celebration on Capitol Hill today with the announcement of the new House health care bill. For myself, as a three time breast cancer survivor, there was tremendous sadness and disappointment in the Speaker.

Nancy Pelosi made a choice with regard to the lifesaving biologic drugs I took when I was in chemotherapy that will cost many of my fellow breast cancer survivors everything they own, and quite possibly their lives.

Jeanne Sather is another breast cancer survivor. In 2007, she wrote on her blog The Assertive Patient:

I love Herceptin, a drug I have been getting to treat my metastatic breast cancer for more than five years now….The main reason I love Herceptin is that it is a targeted antibody, without the side effects of traditional cancer drugs: hair loss, fatigue, nausea, vomiting—you know the list.

The cost..................

But thanks to Representatives Anna Eshoo and Joe Barton, there will be no generic versions of these drugs. At least not for 12 years, if the House health care bill announced today passes. And because of an “evergreening” clause that grants drug companies a continued monopoly if they make slight changes to the drug (like creating a once-a-day dose where the original product was three times per day), they will never become generics. Instead of the Waxman-Deal amendment that granted much more reasonable terms to biologic patent holders, Speaker Pelosi chose the Eshoo-Barton amendment. And we could all be paying for that choice for the rest of our lives.

Breast cancer boards are filled with women who have been turned down by their insurance companies for Herceptin because they only cover generic drugs, or because they only pay a portion of the $48,000 a year (or more) that the drug costs........................

[sentelle]

1. Of course

It would be even worse if a drug actually 'cured' things, rather than managing them.
But US Drug companies haven't 'cured' anything in 30 years. And its intentional, because managing the disease is more profitable to them than curing it.

Really they should all be charged with crimes.

(on edit) its not that I am not sympathetic, I am, but I am just pissed off at the *Legal* drug pushers out there, big Pharma.

[sharp_stick]

2. My what a well thought out

and full of shit post. Almost as idiotic as they guy that tried to tell me that Pharma companies had a cure for cancer but wouldn't let it out of the basement.

on edit: I left out any supporting documentation because the post before did the same.

[John Q. Citizen]

6. Why would big pharm make less money when they could make more money?

They aren't humanitarian organizations. Their legal responsibility is to make their share holders as much money as is possible.

Hence they work to find ways to manage disease instead of working to find ways to cure disease. There is more money in it.

Why is that a surprise to you?

[ej510]

8. Where is the profit in curing diseases?

[mayya]

45. the Big Pharma Cartel makes money by Maintaining disease, not curing it

The Big Pharma Cartel, with the help of the FDA, suppresses real cures. People with real cures are destroyed, bankrupted and imprisoned to protect the interests of the Cartel.

Ditto for the Fake Food Cartel (Monsanto, ADM, etc).

Big Government + Crony Capitalism = Fascism

[sentelle]

15. I never said they were hiding anything

Hiding implies spending money on R&D, testing etc. I never said they actually *had* anything.

Most of them would prefer to make boat loads of money creating 'treatments' to make long eyelashes, or 'boner' pills, literally anything that keeps people coming back, day after day, for more whatever it is people need to be 'whole' again.... I don't know about anyone else, but when I hear "I need my meds" I can't help think of a strung-out junkie, regardless to whether the drug is legal or not.

Its a question of profits over philanthropy. and a decision of success (money) over any sort of lasting legacy to humanity.

But then again, I was just accused of a conspiracy theory. Can you name a drug that has come out to cure (by definition 'cure' means that at some point, the patient can stop taking the drug without the fear of imminent death) *any* disease or illness in the last 30 years?

[Jennicut]

3. My disease is a manageable one. There is no cure (yet).

I have diabetes. There are some generic brands out there for diabetes but I have to take insulin and there is only a few companies that make it. I take Lantus, which is made by Sanofi-aventis. I have no love for big Pharma but I want to live. Wish we had more choice out there.

[Occam Bandage]

4. So, doctor, which diseases are they hiding the cures for?

If there's such a preponderance of evidence that criminal charges are in order, surely you could name the diseases for which cures exist but are suppressed.

[John Q. Citizen]

7. They aren't even sought, so there is no need to supress. You don't suppose the

reason pharma companies exist are humanitarian or socially driven do you?

They spend their money where they can make the most money.

That would be managing disease, since they get a buyer who has to return purchase. It's not their purpose to cure disease. Their purpose is to make as much money as possible.

[sentelle]

16. The only difference between a drug dealer and big pharma

with a drug dealer, the first dose is free.

[Posteritatis]

18. Yes, yes, all health researchers on Earth are united in one big perfect conspiracy

Well, aside from the idiots who claim vitamin C cures everything from influenza to severed heads, that is.

[Name removed]

19. Deleted message

Message removed by moderator. Click here to review the message board rules.

[treestar]

37. Why is that true of them as opposed to any other industry?

If they could come up with a cure, they could sell it, too. They'd get the money from the customers, not the company that was supposedly deliberately coming up with a drug that only managed the disease.

Competition to make a profit isn't all bad. Granted, freepers and the like make too much of it and don't account for the people who fall through the cracks and have blind faith in the market.

But there's no reason to take the equally dismal opposite view, that they can only make money by harming others and that's all they seek to do.

I could accuse the IT industry of forcing us to computerize everything because they make a profit on it, and that they waste half my time every day with computer issues. It could work for any industry.

[ElboRuum]

5. The whole cure conspiracy?

Yeah... that...

Let me help you out with this. There is no conspiracy. Up until the creation of antibiotics and vaccines, medicine cured nothing either. Medicine prior was generally involved with symptom and pain management (and a lot of quackery to boot). Since then, the focus has been on trying to keep up with bacterial resistance to antibiotics, surgical cures to problems, transplants, cancer treatments, and emergency/intensive care. Pharmacologically, the next possibility are antivirals and biologics, however, virii are even more mutagenic than bacteria, which is why they've haven't cured any viral infection once contracted. Biologics targeting cancers are just at the very beginning of development and look very promising, so OF COURSE, Pharma wants to put lockdown on manufacture. In the history of medicine the discovery of antibiotics as cure and vaccine as prophylaxis was the EXCEPTION, not the rule.

[John Q. Citizen]

10. Salk donated his polio vaccine to the world. That wouldn't happen today, because he would be sued

by the corporate share holders.

The point is, the money isn't directed at finding cures, the money is spent on finding management techniques.


It's like the tobacco companies did all that research on nicotine addiction and then used it help sell more product, of course. While they claimed to not know tobacco was addictive. That's par for the course, not the exception.

Big pharma still produces the necessary precursors for making meth because somebody makes a pile of money off it both legally and from illegal diversions


It's all about money. And that's not a conspiracy, it's a value system.

Look at the TV advertising of pharma products. That should be criminal enough for anybody.

[ElboRuum]

31. Point Taken...

And you are correct about that Salk would have probably worked for pharma, so he wouldn't have had a choice in the matter.

However, I think you, as many do, overestimate what the state of the art is in medical research. There is no "value system" holding back anything. Of course there are the realities of economics, but medical research is not being hamstrung by those values. It would be fairer to say that access to the benefit of that research may be hamstrung by those values by pricing them outside of the range of affordability of those that require it.

The fact is that there is very little that CAN be cured. Cancer research, stem cell research, and gene therapy research proceeds apace, but curing bacterial infections was, in the face of these challenges, the low-hanging fruit. It's efficacy seemed to make everyone believe that there was, after vaccines and antibiotics, just a small step to a magic pill for everything. If you want to understand WHY pharma products are advertised on TV, its because people WANT a magic pill for everything. It's something they've come to expect.

[Mimosa]

40. Drugs which manage but not cure...good point, Sentelle.

My buddy who's a teaching MD has speculated about how the pharmaceutical industry doesn't come up with any medicines that cure.

[flpoljunkie]

9. Only in America are drug companies allowed to charge insanely obscene prices for life saving drugs.

It is not right, but we let it happen. We stand by and let our Congress put the profits of the special interests, who fill their campaign coffers, rather than the public interest.

It will never change, if we do accept this is the way our Congress is allowed to operate.

[damntexdem]

11. We need pharmaceutical reform, too.

I favor the idea of doing away with drug patents. The feds would put up additional billions of dollars to support drug development, including through preparation for the market. Then, all drugs would be generic, available to all companies willing to produce them to specified standards. It would mean billions of dollars of spending up front, and then save the government and the rest of us much more thereafter.

[pinto]

12. I hope there's pressure in joint committee to reduce this protection window for biologics.

Elsewhere, I've heard Congressional support for 5 years or 7 years, more in line with standard patents on medications.

[johnaries]

39. The idea of the amendment is to promote "biosimilars",

so they don't have to wait the current 12 years.

[KansasVoter]

13. It costs close to a 500 million dollars to develop a drug........

And then if it fails in Phase III trials you start over with another drug.

So you have to recoup the 500 million on a drug that is successful.

So if you want drugs that saves life's you have to finance the development somehow.

Currently that is by making money off the drugs that make it.

[Better Believe It]

14. A false and misleading assertion. The hidden truth behind drug company profits

KansasVoter .... you've been mislead by big Pharma propaganda.



Johann Hari: The hidden truth behind drug company profits
Ring-fencing medical knowledge is one of the great grotesqueries of our age
August 5, 2009

This is the story of one of the great unspoken scandals of our times. Today, the people across the world who most need life-saving medicine are being prevented from producing it.

Our governments have chosen, over decades, to allow a strange system for developing medicines to build up. Most of the work carried out by scientists to bring a drug to your local pharmacist – and into your lungs, or stomach, or bowels – is done in government-funded university labs, paid for by your taxes.

Drug companies usually come in late in the process of development, and pay for part of the expensive, but largely uncreative final stages, like buying some of the chemicals and trials that are needed. In return, then they own the exclusive rights to manufacture and profit from the resulting medicine for years. Nobody else can make it.

Although it's not the goal of the individuals working within the system, the outcome is often deadly. The drug companies who owned the patent for Aids drugs went to court to stop the post-Apartheid government of South Africa producing generic copies of it – which are just as effective – for $100 a year to save their dying citizens. They wanted them to pay the full $10,000 a year to buy the branded version – or nothing. In the poor world, the patenting system every day puts medicines beyond the reach of sick people.

The argument in defence of this system offered by Big Pharma is simple, and sounds reasonable at first: we need to charge large sums for "our" drugs so we can develop more life-saving medicines. We want to develop as many treatments as we can, and we can only do that if we have revenue. A lot of the research we back doesn't result in a marketable drug, so it's an expensive process.

But a detailed study by Dr Marcia Angell, the former editor of the prestigious New England Journal of Medicine, says that only 14 per cent of their budgets go on developing drugs – usually at the uncreative final part of the drug-trail. The rest goes on marketing and profits. And even with that puny 14 per cent, drug companies squander a fortune developing "me-too" drugs – medicines that do exactly the same job as a drug that already exists, but has one molecule different, so they can take out a new patent, and receive another avalanche of profits.

As a result, the US Government Accountability Office says that far from being a font of innovation, the drug market has become "stagnant". They spend virtually nothing on the diseases that kill the most human beings, like malaria, because the victims are poor, so there's hardly any profit to be sucked out.

Please read the complete article at:

http://www.independent.co.uk/opinion/commentators/johann-hari/johann-hari-the-hidden-truth-behind-drug-company-profits-1767257.html

[KansasVoter]

22. And I know this first hand....

"Although it's not the goal of the individuals working within the system, the outcome is often deadly. The drug companies who owned the patent for Aids drugs went to court to stop the post-Apartheid government of South Africa producing generic copies of it – which are just as effective – for $100 a year to save their dying citizens. They wanted them to pay the full $10,000 a year to buy the branded version – or nothing. In the poor world, the patenting system every day puts medicines beyond the reach of sick people. "

I know 100% true stories about drug companies not pursuing any research on viable AIDS compounds because they know there is no pay back to cover their costs. If they find a solution to AIDS they will have to give it away. And stock holders don't like that. Amazing.

Remove the profit from drugs and I guarantee no one will make them.

Let the labs and colleges get FDA approval if you think it is so easy. I will be waiting.

[KansasVoter]

23. Are you dumb?

Based on this logic, then the labs/colleges with the Malaria cure should patent it, and just do the FDA Pase I,II,III studies part themselves and then they are free to give the drug away. If the false story you linked to is true why does that not happen? Please provide an answer.

[Better Believe It]

25. Because we have a for profit private drug and private insurance industry

that fund and control most members of Congress who write legislation.

You might find this hard to believe, but Wall Street and corporate America leaders are mainly concerned with enriching themselves and don't view themselves as heading up public service organizations looking after your interests.

You didn't know that?

[KansasVoter]

26. Now you are worse.......

So the colleges are being forced to sell their compounds to the drug companies and not allowed to develop it themselves? Wow, how does the New York Times miss a story like that?

Hell, if it is so easy, I suggest you buy a compound and submit it to the FDA.

[John Q. Citizen]

17. It's amazing how naive the average person is. They believe all the corporate bs without asking any

questions.

Guess what?

What you wrote isn't true.

[KansasVoter]

21. Guess what, you are wrong........

There are about 5000 chemicals for sale at any time for any drug company to purchase! From labs, colleges, etc.

Yes, some are cheap to buy. The ones with a lot of potential are not cheap.

If the chemical was a sure thing then the company would not sell it.

If it was so damn easy then there would be 1000s of companies developing drugs in the USA alone.

And hell, any of you are welcome to buy them also and go through the phase I, I and III testing. Be my guest. Then you can seel them for cost.

These "all corporations are evil" idiots on this board should start a car company or drug company. They make it sound so easy!

[Lithos]

20. Not true

The people who develop the drugs are not the same as those who manufacture and sell them. Typically drug manufacturers buy into a product well after there is some proof it will succeed and survive the process.

You can think of it in dot com terms. The R&D portion is the dot com who comes into existence to make the drug. The profit only happens when they are bought out. If they fail, then they go out of business with no loss/cost to the drug manufacturer and no passed on cost to you. Ie, the drug manufacturer assumes almost zero risk for the development of the drug.

On Edit:

As for that mythical $500 million dollar figure, there are a ton of assumptions that the Pharmas are making with it - obviously with the intent of scaring you.

Some include:

- This is a pure extrapolation of a number from a 1987 Tuft's study whose methodology and calculations were based on a very narrow set of guidelines.
- The Tuft's study never was compared to actual costs.
- It assumes only the most novel of drug development (completely new drugs coming in from scratch - not those with any history or reuse.) Most drugs being developed do not fall into that category as they are really me too drugs (other COX inhibitors, statins, etc.)
- It does not include the large tax write offs, tax deductions (R&D is almost a pure deduction) and or subsidies which R&D efforts enjoy (such as State/University funded labs).
-

Just by deducting the tax and opportunity costs alone, the cost for the most expensive drug (the truly novel one) R&D is really around $110 million. The me-too costs come in much, much cheaper than that and carry virtually no risk.

The whole scary point the Pharmas are trying to sell everyone is that they live in a risky world. The truth of the matter is otherwise, if it were truly a risky industry, why would almost all of the players report consistently high profits year after year?

See: https://www.citizen.org/documents/ACFDC.PDF

L-

[andym]

27. Much of what you say is true

But the cost of the phase III clinical trials are really the barrier for new drugs to enter the market. These really do cost at least the 110 million and usually at least 2X-5x this for cancer drugs. Of course some of the money can be recouped, but the cash is still needed to proceed. A critical reason that the small companies that develop innovative drugs get sold to big pharma is that it increases the chance for the product to reach market. It is very difficult to raise the 100-500 million dollars without very good looking Phase1/2 data.

Still, after a drug is developed, Pharma usually spends quite a bit more than the development costs on marketing.

One way to get around this would be for the govt to sponsor phase III trials for the smaller companies, in return for a capped price on the drug after development. But this would require at least 10-20 billion to start 100 trials/year I would think,

[Telly Savalas]

43. Presumably the marketing is paying for itself.

If I'm a Pharma bigwig, I'm not going to spend $50 million on marketing unless I have reasonable certainty that this marketing is going to generate an addition $50 million in profit from sales that wouldn't have occurred in the absence of the marketing. Otherwise I'm just throwing money away.

The main issue with pharma advertising is that it boosts medical costs by promoting unnecessary medical treatment. i.e. it's not driving up the price per pill, but rather it's increasing the number of pills taken.

[joeycola]

30. You pouched those talking points from the drug companies.

[jeanpalmer]

42. We spend about $500 million a day

on war in Iraq and Afghanistan. For every day or two we keep waging these wars, we coould buy the rights to one of these drugs, and distribute it gratis to whoever needs it. It would be a two-fer in that we would be helping the people over there and the people here.

[mayya]

44. the Big Pharma Cartel wants it that way to keep out the competition

They are an FDA-enforced Cartel. The drugs do not have to improve health; they just need FDA protection, marketing, and Medicare payments. They make the $500M back from Medicare tax money alone.

[vaberella]

24. But don't these have to do with patent laws?

This is not a national thing this is a worldwide problem.

[slipslidingaway]

28. No, this is in addition to patent laws...

posted about this earlier today

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=385&topic_id=395772&mesg_id=395805

"Sen. Tom Harkin: Keep in mind what we’re talking about here. We’re not talking about patents. Everybody gets a 20 year patent… What we’re talking about here is data, data exclusivity… How do you get that data? You get it through FDA supervised trials… Where do they do those clinical trials? Academic health centers. Who supports academic health centers? Our taxpayers… When should that data be released so that another company out there, some other entrepreneurs, can look at the data and say… I’ll bet if we changed this and did this, we might come up with a new formulation that might actually help something else. They’re still going to have to go through their clinical trials… At least they’ll be able to look at the data. If you don’t do that that means that the company can sit on that data for 12 years. Then they let the data out. Clinical trials will take another 7 years or more, so you’re going to have at least a whole 20 year run in there… before anyone can ever surface with anything even comparable to what that drug or that biologic is..."

[joeycola]

34. Thanks for this.

[slipslidingaway]

35. You're welcome, there seems to much confusion on this topic. n/t

[Vidar]

29. K&R

[slipslidingaway]

32. Several Democrats pushed and voted for this amendment, a few questioned...

the necessity of the 12 year period.

[slipslidingaway]

33. Correction - at least not for 20 years n/t

[depakid]

36. If this passes, Democrats will be no better than Republicans

And in fact- as has been seen before- many basically ARE Republicans and corrupt to the core.

[Mimosa]

41. The same corporations own most members of Congress and Senate. n/t

[johnaries]

38. 12 years is the current standard. Please read Eshoo's response.

http://www.huffingtonpost.com/rep-anna-eshoo/setting-the-record-straig_b_340106.html