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Arthritis Relief and Joint Replacement

Dr. Ira Kirschenbaum shares information and advice about osteoarthritis, rheumatoid arthritis, joint replacement and more -- from symptoms and prevention of arthritis and other promising treatments.

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WebMD Health News

Monday, January 02, 2006

Money for Nothing and Cures Ain't Free
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Reading the newspaper is always a good thing. It is not to learn about news. It is to learn about what trends are happening next which generally are not good for the average person. I make sure I read a variety of sources since the news is really the opinions of those writing it. Sort of like this blog except here on WebMD Blogs we at least admit they are opinions while the NY Times, Washington Post, etc. actually believe they are reporting something objectively.

Just before Christmas, I read an interesting article in the New York Times business section. Let's call it an early Christmas present for people with rheumatoid arthritis...from the Devil himself.


"Rivals Laying Siege to Amgen's Near Monopoly in Anemia Drugs," by Andrew Pollack

"...Amgen's critics say that while its anemia drugs have truly helped people, its near monopoly is lasting much longer than patent law was meant to allow." Further in the story, Pollack quotes Gary Peterson, of Renalweb, a website about dialysis..."Simply put, this is a monopoly within Medicare that is now working against the patients it was intended to help and is costing U.S. tax payers billions of dollars."


Together, both of these statements represent classic examples of the depths of brain depth in logic. While one can always argue that pharmaceutical companies make a lot of money frequently, both authors need to be reminded of a few facts.

First, considering Amgen has won every patent challenge it has faced in every US court, how is it possible that its patent has lasted longer than it was meant to? Patents and other inventions are not "meant" to last any length of time. They last, by definition for as long as the law allows. Currently, biologic patents last twenty years from the time of application. When Amgen obtained its patents, the law stated that patents last 20 years from the time of their granting. Amgen, by moving their patent applications in at carefully timed moments did what any good business would do: they protected their intellectual property for as long as it could.

As it turns out, Amgen's flagship product Epogen, was so successful that the company was able to and had the incentive to develop Enbrel (etanercept). Embrel is a most recent biologic agent for the treatment of rheumatoid arthritis.

To quote from the respected Harrison's Textbook of Medicine (online version): "Clinical trials [of etanercept] have been shown to be remarkably effective at controlling signs and symptoms of rheumatoid arthritis...Repetitive therapy with these agents is effective with or without...methotrexate...[T]hey have also been shown to slow the rate of joint damage assessed radiographically and to improve disability...[S]ide effects are uncommon."

It is interesting that in the music and entertainment industry, protection of intellectual property is for 28 years, and then renewable for another 28 years but these drugs, which cost investors millions to produce get twenty years.

This is often the double standard in business and medical business. While the US taxpayers spend billions on missiles and other tools of mass destruction, it seems that when a drug helps millions of US taxpayers without question, someone thinks that is "working against the patients." I don't know, but where I come from, things that save lives are a bargain. Things that kill people are a waste of money.

According to the New York Times article, for renal dialysis patients, Epogen costs $7,000-$10,000/year and for chemotherapy patients, about $1,200/month. All told, the entire nation - Medicare and private insurance spends about 2 billion dollars on Epogen and 1.2 billion dollars on Embrel. Put in perspective, President Bush's defense budget is at over $400 billion.

Medicine is an amazing bargain. In addition, if the success of Epogen stimulated capitalism to work its magic and get Amgen to invest in Embrel which seriously helps the over 2.1 million American with definite Rheumatoid arthritis and potentially the 59.4 million Americans projected to get some form of arthritis by 2020 (Source: NIH, also see Future Approaches to Arthritis Treatment), I would strongly disagree with Mr. Peterson's assessment that extended patents are working against the taxpayers and Mr. Pollack's assessment that the patent was intended to last that long.

In fact, if I was one of those millions of Americans I would simply say thank you to Amgen and its researchers. I would sell off 300-400 Tomahawk missiles to the highest bidder and buy more of this stuff. I would close some more unnecessary bases and invest in more biologics. I would pull out say...130,000 or so troops in Iraq and freakin' buy Amgen and give out the drugs it sells for free.

When will we stop treating healthcare like it is a resource that is rationed out and defense spending as an unlimited money pit? If all the roads the federal government built, all the prisons it maintains, and all the social programs it supports worked half as well as Epogen, we would all live in a better world.

Cures cost money but they are sure worth every penny if you are the one who needs one.

Dr. K.

(Disclaimer: Dr. Kirschenbaum is NOT a consultant to Amgen, has never been a consultant to Amgen and in fact has never even met a sales representative or any employee of the Amgen company. Further, he does not even own Amgen stock. So there.)

Related Topics: Use of Enbrel in Psoriasis, New Rheumatoid Drugs Work Well, Fast Diagnosis and Treatment Key to Managing Rheumatoid Arthritis



Posted by: Ira Kirschenbaum, MD at 11:52 PM

11 Comments:

Anonymous Anonymous said...

You make some interesting points in this article in constrasting drug spending vs defense spending.
One point is quite a bit off base though. The development of Enbrel had nothing to do with revenue obtained from Epogen, since Enbrel was developed by an entirely different company (Immunex) which was later purchased by Amgen.

6:28 PM  
Blogger Harmon Chamberlin said...

When Ira Kirschenbaum attacks the New York Times and the Washington Post, two of the most respected newspapers in the world, it is obvious that he is a regressive bigot that is only interested in greed for money. It is not reasonable to accept any opinion from someone who takes the side of the rich against people who cannot afford the medicine he is pedeling.
Harmon Chamberlin, Dallas Texas

9:24 PM  
Anonymous Anonymous said...

I have osteo-arthritis and have already had a hip replaced at age 49.

Here Here to anything that will relieve the suffering of people with frozen joints!

My personal opinion is that it is like combat, if you have not "been there, done that", you can never truly understand what it is like. Pain may be subjective, but looking at a wheelchair before age 50 is NOT FUN!

8:45 PM  
Anonymous Anonymous said...

I agree it would be nice if the government would take defense money and buy this drug and give it out to those of us that need it. I would have to say since that is not likly to happen in my lifetime I am happy the patent is limited to 20 years. As I do not have insurance and keeping this drug in the hands of one company keeps the price out of my range so the fact that you state 2.1 million americans have RA, your statistcal information should be based only on those 2.1 million Americans that actually have insurance in order to be based correctly and on fact.
But, I do agree I would rather some of this money spent on military weapons be diverted to healthcare and border defense.

3:37 PM  
Blogger Christina said...

I will leave my comments here for whatever they may be worth...

I am a 29 year old female who has RA. I was diagnosed with JRA at 18 months, and did remarkably well as a child with disease. According to rheumatologists and doctors, even "out-grew" the disease. So, Febuary 15, 2005 I was again diagnosed with RA, this time as an adult patient with a much different prognosis.

My rheumatologist and I had been hopeful initially that methotrexate would give me the relief I needed, and we could put off the need to begin treatment with biologics for awhile. No such luck. My experience with biologics has been one with a double-edged sword.

While the benefits they offer me r/t my disease are remarkable, so are the complications as a result from the stress of juggling finances to afford the medication that insurance does not want to pay for.

I am a nursing student, who has to work full-time while in school and still ask my father for help because my insurance company doesn't want to eat the $1200 per month cost of a single drug. I cannot blame the insurance company--I don't want to pay $1200 a month for one drug either!!!

I agree, pharma companies deserve to make a profit, it's capitalism and the "American Way." However, perhaps they should consider cutting back on the marketing campaigns & the funds spent paying doctors stipends to give presentations about their (pharma's) drugs to other physicians who are attending conferences/meetings at lavish hotels over the weekend...these conferences would astound the average patient...I know they did me the first time I encountered one.

Perhaps drug reps should take a cut in pay so that patents wouldn't have to last 20 years for the pharma companies to recoup the R&D dollars. Perhaps the CEOs would take a pay cut? See where I am going with this--why should our nation have to sacrifice national defense in a world where that seems to be a necessity just as medication is for all of us with RA, cancer, diabetes, or any other disease? Perhaps if there were more of us RA patients on the steps of the Capitol lobbying we would see more federal dollars spent on research--that's what the breast cancer patients have done to get their funding (I've particpated in that lobby as well). Perhaps if more of us (patients of all diseases) showed up, bank statements and testimony in hand, at the headquarters of these companies--if we put a face on this disease maybe it would change...let's face it, this issue is faced by everyone who faces illness, especially a chronic one.

12:54 AM  
Anonymous Mary Boden said...

I am a 50 yr. old single mother of a 17 yr. old autistic child. On my 49th birthday, I was diagnosed with osteoarthritis, RA, & also carpal tunnel. I was referred to a reumatologist ( which I obtained medicaid for a short time). The only thing that was done, was exrays at that time. I lost the medicaid(every time that I would come up for review for it, I would have a different case worker, & if they felt I did not qualify, I did not get it). My work status never changed( I am a housekeeper), nor did my finances. Therefore, I am trying to survive this on my own & with Gods help. It is really tragic that there is no help for people in need out there & the cost of meds & doctors are so expensivive. What is one to do? I still go to work, although I am slowing down more than ever before due to the arthritis in my hips, knees, hands,neck & back. I am the only caretaker of my son which is very demanding under the circumstances. This is a tragic world that we live in when you cannot afford the medical attention that you need & deserve. God bless all.

11:23 AM  
Anonymous Anonymous said...

The best thing for patients is to have drugs that are in the same class, and manufactured by different corporations. This is what will keep a drug's price down, when there is competition between corporations. Otherwise, the companies have no incentive to fairly price their drugs. It is also beneficial medically for both patients and their doctors, when they are more than one choice within the same class of drugs. Lastly, Amgen was playing games with the patent laws just before the laws changed. Now, any patent has 20 years of protection after the application for it is filed, similar to the situation in Europe.
One more thing - I think it's great that the NYTimes article discussed how many other biotech companies are developing drugs similar to those produced by Amgen.

4:40 PM  
Blogger Ira Kirschenbaum, MD said...

I really enjoyed everyone's comments. Even Mr. Chamberlin who actually I think believes that the press is beyond criticism. They are not. They are in the SELLING newspapers. While he may respect these newspapers I reserve my respect for the people writing the articles. If an article in either paper is incorrect or biaesed as it was in the reporting of the Amgen patents then they have earned criticism. End discussion.

The point of the discourse in healthcare is to show many sides of a topic. As I noted, the pharmas are quite greedy but in this particular case, they are not. It is actually Medicare that is at fault. Medicare is corrupt, run by corrupt politicians, and supported by more corrupt consultants. The patients are seriously being injured by the inadequacies of Medicare. Somehow the press has convinced the world that the govermnment actually cares about the health of the population- nonsense.

Pharmas and insurance companies need regulatory and price controls but not at the expense of innovation and not to pay for governmental inefficiencies and disorganization.

Any more comments???

Dr. K.

10:25 PM  
Anonymous Anonymous said...

Here is a belated comment. The reason why many say that Amgen's patent has continued longer than it should have is because Amgen was able to take advantage of a loophole in the patent law that has now been closed. Basically, drug companies were changing molecules that had no impact on the drug's function but that made the chemical formula "new" for patent purposes. That's a simplified version of what happened. So Amgen received additional patent protection even though nothing new or better was associated with the drug. Certainly, drug cos. are profit making organizations, but many drug cos., including Amgen, have profited greatly by being able to use government funded basic research. It's a two way street -- eventually, doctors, including you, will have to realize that cost matters, and for many it is THE determining factor in whether they are treated or not. Please don't try to tell me that the uninsured get what they need -- my father's cancer diagnosis was delayed for months by providers who wouldn't treat him because he lacked insurance.

Barbara

5:56 PM  
Anonymous Anonymous said...

P.S. Neither EPO nor Enbrel is a "cure" for anything. In fact, very few recently marketed drugs are cures in the normal sense of the word. Drug cos. don't have an incentive to look for cures -- not that they wouldn't bring a drug to market for that reason, but it's not their overarching incentive when developing new drugs.

Barbara

9:53 PM  
Blogger Ira Kirschenbaum, MD said...

Always enjoy the comments.

The issue with Amgen is only WHO will make the money. Amgen OR the generic producers who are no real bargain.

Believeme- doctors know that cost matters.

If you want to make real change- why don't you vote in a Congress that will do real insurance reform and pharmaceutical reform.

That is the answer. Tell congress what you want. They will laugh at you because they are so cirrupt they make Amgen look good.

I suggest you tune in to 2 upcoming posts on Mad About Medicine on Roche Pharmaceuticals and the issue of expectation vs. entitlement.

If you expect providers to treat for free then why don;t the insurance compaies give insurance plans for free. That is actually a better plan. The profit of the insurance companies would pay for the cancer treatments of everyone's father for 9000 years.

Dr. K.

12:41 AM  

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