FDA approves Actemra for GCA in the US

It hasn't been trialed in PMR (which is a prerequirement for approval) and PMR doesn't inevitably progress to GCA - only 1 in 6 who do have PMR as a symptom of their GCA do so. You cannot use a biologic as a preemptive strike - the numbers to treat to gain an advantage would be enormous and neither the health authorities could afford it nor the producers produce it. Biologics are still complex to make and that is the reasonf for their cost

As for cholesterol - I have always belonged to the "it isn't cholesterol that does the damage" cohort anyway but I do see that it is possible that statins do have a purpose - in preventing repeat attacks. It isn't lowering the cholesterol that achieves the result however - the lower cholesterol is a surrogate marker for whatever is going on. Having too low a cholesterol is actually even more likely to result in premature death or illness. The only people who truly need cholesterol lowered before having a cardiovascular event are those with familial hypercholesterolaemia. Otherwise other lifestyle changes should be used first. Slowly the truth about the real rate of side-effects of statins is creeping out - no study done since 2007 has replicated the claims from the manufacturers. Funny that...

my opinion on cholesterol is completely the opposite, but I'll focus on PMR:  There are at least 4 studies that show successful remission rates of PMR using that biologic.   As for health authorities being able to afford it, that's an issue for socialized medicine.  When the FDA allows I'll write the check and take my shot at it..  As for GCA only effecting 1 in 6, that is cold comfort to the 18%.  I don't have GCA, but the notion that I should wait until I get it to treat it and put my PMR in remission makes no sense.  

Would be interested in those llinks to the four studies.  A PM will allow you to send those links to me.

I gather you are in the USA  - how good that you can 'sign a cheque'.

You don't have to wait for FDA approval - just find a medic and 'sign a cheque'   Why you think you will be a 'one in six' is beyond me.  Glass half full person?

I would probably have lost my sight as 'signing a cheque' would be beyond my means and also the insurance csost.  I would be dependent on 'social' medicine.

They are VERY small studies - I've read about some of them. It needs a big Phase 3 trial to be done - and it hasn't happened yet. That will last at least 3 years and take time to set up and recruit subjects - so I wouldn't hold my breath.

However, as lodger says, if you have $17K per year to spend, there is absolutely no problem with you getting it I would have thought - I'm sure that Roche (or their US representatives) will happily sell you supplies. Then there will be the cost of someone to administer it but that won't be enormous.  I'd also dispute your sneer about "social medicine" - you will find that when large numbers of people with PMR are expecting to be handed tocilizumab instead of pred that everybody's insurance premiums will rise. Yours included. Even more people will be left with no affordable cover.

What I'm saying is that you don't know that the PMR will progress to GCA. Tocilizumab isn't sweeties either and has some potentially pretty bad side effects. There is as yet no information about the long term remission rate. It may be that it puts it into remission for 2 years but then it is back again. Another session of TCZ and another cheque.

And it may not work for all forms of PMR - thoughts are that there are different versions - which could account for why there is a sort of basic division where about a quarter of patients are able to get off pred in 2 years, about half need about 5 or so and the rest are more resistant and take even longer. Some forms of PMR may be different in mechanism from GCA. 

"lodger says, if you have $17K per year to spend"

In the case of RA, lodger would be absolutely correct.  however, in those studies, most were in remission in 6 mos.  in fact, what I recall is that the only ones that took longer or didn't go into remission reacted negatively to the treatment itself. A 100 per cent remission rate in those who complete.  You wouldn't take a shot a that???  As for the studies being small...my glass is half full.  I'll spend the money to get a chance at remission, and you can wait for the government to decide for you.  You needn't worry about Obamacare, it simply would choose not to cover it.  That's what's good about a private system subsidized by the gov't;  nothing.  As for sneering at socialized medicine...yes indeed I do sneer at it.  I've lived under it in several countries and its an excellent way to get second rate care.  The exception to that rule would be Australia, which seems to be both socialized somehow outstanding..or at least it was the last time I was part of that system.  Of course ALL of these countries with socialized medicine are subsidized to a great extent by the American system.  That won't last much longer though since our system is in shreds. 

I have lived in 2 countries besides the UK with socialised care. Both are superb. One thing is certain: when push comes to shove (even in the UK) with your complex broken leg or cancer you won't be left bankrupt for the rest of your life.

There was a pilot study done using leflunomide in PMR a few years ago - 22 out of 23 patients went into remission, the other was lost to follow-up. It is very very occasionally used - but I have met a few patients who have been on it. For some reason it didn't work for them and in one case it had to be stopped pdq because of life-threatening side effects. Just because pilot studies look amazing doesn't mean the Phase 3 stuff will be as good. I've worked on the following of clinical trials from beginning to end for over 30 years. Few of the "miracles" I met in that time have turned out to be as good as they thought or said. Some have truly had feet of clay.

So I hope you will forgive my scepticism. I think we should leave it there.

Mark, I live in Canada where we have publicly funded medicare.  There are problems here, mostly due to breaucratic mismanagement.  Why on earth did they cut back on the number of doctors they would train just in time to create a physician shortage as the boomers began to retire in droves!?  However a couple of years ago I had a broken leg.  I received first rate care from all the medical people involved.  I had to buy my crutches and adjustable splint, but they were covered by additional insurance we have through my husband's retiree medical plan.  We later donated them to the hospital for use by someone without that insurance.  My care consisted of initial treatment at emergency.  To confirm diagnosis I had an MRI as the break was virtually invisible in an ordinary x-ray.  I had regular visits to an orthopedic specialist for six, or was it eight weeks, with additional x-rays to make sure bone was healing straight.  None of the medical care cost me a cent.  At my last visit I was told that I could return to the doctor if I had any future problems with the leg, but I didn't have to do that.  For my part, I got physiotherapy for the leg covered partially by private insurance, but if I hadn't been able to afford it I could have received physiotherapy through medicare - although I would probably have had to wait for it.

Mark, I just found research online indicating that Vitamin K2 can help lower serum cholesterol. I'm very cynical about the industry with initials b for big and p.