- This topic has 12 replies, 6 voices, and was last updated 11 years, 1 month ago by
.
-
Posts
-
A gentlemen on another forum sent me this info today and I wanted to share it…
I did a little reading on new gout drugs. Here is some info that might be interesting, or not.
1. Cheap Colchicine will leave the market this year. A company called URL Pharma has secured 3-year exclusivity for colchicine, now branded as Colcrys, and will jack the price to $5/pill.
2. Arcalyst (rilonacept) is a drug from Regeneron that will probably be approved by the FDA in early 2012. It is meant to be used with allopurinol to reduce the frequency of gout flares. Clinical trials showed 73% to 80% fewer flares in patients taking allopurinol + rilonacept, vs pts on allopurinol + placebo.
3. Krystexxa (pegloticase) from Savient has been recently been approved by FDA. It is a drug for patients with very severe gout – deforming/crippling gout. Clinical trials showed it was very effective for about 1/2 of those patients, the other 1/2 couldn't tolerate or didn't get beenfit from the drug. This is an expensive IV infusion drug.
4. RDEA594, a drug from Ardea, appears not particularly more effective than allopurinol in lowering serum uric acid, but the combination with allopurinol appears – though data is very preliminary – to be more effective that allopurinol alone. This drug is at least 2 years from the market.
5. Apparently 90% of gout cases are treated by primary care doctors, who under-treat the disease (e.g. don't prescribe high enough allopurinol dose) and aren't particularly up-to-date on the disease. This is claimed to be one obstacle to development of more effective gout drugs – drug companies aren't sure there's really a market here.
Interesting overview! Most here are only too aware of limitations in treatment/management but with the increasing incidence of gout and people being less willing to suffer, this should change.
A pity it's the old drug driven ethic 'ruling the roost' , rather than proper care and advice from medics who understand the body, medicines and human nature equally well!
Luckily in tthe UK Colchicine is still cheap, if underutilised.
Colcrys? Where are the regulators when you need them- holding out their greasy caps, often enough… Aspirin next?
azasadny said:
A gentlemen on another forum sent me this info today and I wanted to share it…
I did a little reading on new gout drugs. Here is some info that might be interesting, or not.
1. Cheap Colchicine will leave the market this year. A company called URL Pharma has secured 3-year exclusivity for colchicine, now branded as Colcrys, and will jack the price to $5/pill.
2. Arcalyst (rilonacept) is a drug from Regeneron that will probably be approved by the FDA in early 2012. It is meant to be used with allopurinol to reduce the frequency of gout flares. Clinical trials showed 73% to 80% fewer flares in patients taking allopurinol + rilonacept, vs pts on allopurinol + placebo.
3. Krystexxa (pegloticase) from Savient has been recently been approved by FDA. It is a drug for patients with very severe gout – deforming/crippling gout. Clinical trials showed it was very effective for about 1/2 of those patients, the other 1/2 couldn't tolerate or didn't get beenfit from the drug. This is an expensive IV infusion drug.
4. RDEA594, a drug from Ardea, appears not particularly more effective than allopurinol in lowering serum uric acid, but the combination with allopurinol appears – though data is very preliminary – to be more effective that allopurinol alone. This drug is at least 2 years from the market.
5. Apparently 90% of gout cases are treated by primary care doctors, who under-treat the disease (e.g. don't prescribe high enough allopurinol dose) and aren't particularly up-to-date on the disease. This is claimed to be one obstacle to development of more effective gout drugs – drug companies aren't sure there's really a market here.
Great. Thanks posting this. It is clearly based on the recent Lancet article I mentioned in another thread, which I don't know how to post. I was going to do a similar summary, but you've saved me the trouble
5. Apparently 90% of gout cases are treated by primary care doctors, who under-treat the disease (e.g. don't prescribe high enough allopurinol dose) and aren't particularly up-to-date on the disease. This is claimed to be one obstacle to development of more effective gout drugs – drug companies aren't sure there's really a market here.
Oh yes, oh yes, OH YES! As each and every new $$$$$$piricey$$$$$$ drug reachhes the market the only way for them to sell it is to denigrate cheap wonderful allopurinol. Lancet got the first sentence precisely correct and hedged on the second. THe second, for honesty's sake should read “Properly prescribed allopurinol works well and thus for any new drugs ”drug companies aren't sure there is a market there” for medication costing 20 to 100 times as much.
Until febuxostat was started in development one never read a WORD about the problems with daily allopurinol. All of a sudden the propaganda started coming out…I've read a LOT about allopurinol for many many years and it was always described as one of the safest drugs in the pharmacopeia. Had me scratching my head until a couple years later TADAAAA: febuxostat. Cause and effect in neon lights.
I would bet half my scrotum that several/many doctors were “paid” for their excellent opinions of the new drug and of course, those opinions make no sense unless allopurinol is dissed: “side effects, allergic reaction, doesn't work well, let's start you on 100 mg,” and on and on. Of course many doctors are merely paid a “premium” to prescribe certain pricey drugs…the same story hits the news every month, only the names of the doctors and drugs change names.
As for #1:1.
Cheap Colchicine will leave the market this year. A company called URL Pharma has secured 3-year exclusivity for colchicine, now branded as Colcrys, and will jack the price to $5/pill.
Somebody BIG at the FDA was bought and paid for plain and simple. He should be uncovered, charged with bribery and fraud, and sent to prison for 20 years. Those at the drug company who did the bribery should be charged with runniing a criminal enterprise under the RICO statutues.
Anyone who hasn't yet gotten his stash of generic cochicine should ask his doctor for 60 post haste.
trev said:
…
Colcrys? Where are the regulators when you need them- holding out their greasy caps, often enough… Aspirin next?
trev, you ask the wrong question! When are they (but who is they?) going to throw the regulators (the bought FDA employees=government) into jail and the key away???
It ain't NEVER going to happen because the GOVERNMENT won't go voluntarily into jail.zip2play said:
...Somedoy BIG at the FDA was bought and paid for plain and simple. He should be uncovered, charged with bribery and fraud, and sent to prison for 20 years. Those at the drug company who did the bribery should be charged with runniing a criminal enterprise under the RICO statutues.
Somebody, Zip??? I don't think it's just somebody. I Think half or more of who make up the FDA are bought (or are still paid by their former employers. Don't forget, quite a few of the so-called FDA employees were pharma boys, and mostly of the upper echelon.
zip2play said:
Lancet got the first sentence precisely correct and hedged on the second.
To be fair, it does say elsewhere:
Allopurinol doses used in these trials were fixed and
too low; this fact cannot be emphasised enough. One
could reasonably argue that if allopurinol doses were
titrated to serum urate concentrations, the febuxostat
advantage might vanish, although the side-eff ect profi le
of allopurinol might also change. Accordingly,
febuxostat should be considered mainly for patients
intolerant to allopurinol, for those whose gout is not
controlled with other urate-lowering treatments, and
for those with renal insuffi ciency (but whose creatinine
clearance is higher than 30 mL/min).and in their final observations:
Time will tell how febuxostat or the pipeline drugs fit
into gout treatment algorithms. At the risk of sounding
critical, we remind readers that confusion about how to
use long-available drugs is a persisting issue with our
management of gout. Addition of new drugs alone will
not correct these pre-existing misconceptions. The
diagnosis should be substantiated by identification of
intra-articular monosodium urate crystals, guidelines
about the start of urate-lowering treatment should be
followed, prophylaxis against flares early in such
treatment should be given, low enough concentrations
of serum urate should be targeted, and long-term
adherence by patients should be sought. Most
patients with gout are handled by primary care providers
and fewer than 3% by rheumatologists.
Rheumatologists seem to be somewhat, but not
impressively, better at achieving target concentrations
of serum urate than primary care physicians (mean
serum urate concentrations 353 versus 413 μmol/L,
respectively, p=0·0004).81
A major concern is the continued use of allopurinol at
300 mg daily, or less in renal insuffi ciency, since these
doses are clearly inadequate in most patients.
Clinicians often use suboptimum doses of allopurinol in
patients with renal insufficiency for fear of precipitating
worsening renal failure or the sometimes fatal
allopurinol hypersensitivity syndrome. Nevertheless,
the approach should be to start low and go slow, with
careful monitoring while titrating upward to achieve
target serum urate values. Evidence that treatment of
hyperuricaemia in these patients might improve renal
function is encouraging. Higher doses of allopurinol
in patients with gout and renal insufficiency are not
associated with increased risk of hypersensitivity, but are
associated with better achievement of target serum urate
values (86%). Undertreatment for fear of side-effects
does disservice to patients since they are on a dose of
medicine that will not achieve the therapeutic goal,
which is to stop attacks and resolve tophi, but merely
slow the rate of progression.
These same principles should apply to dosing of
febuxostat, or other urate-lowering treatments, apart
from drugs like pegloticase, for which the reason for
failure is generally the development of antibodies against
the drugs, not inadequate dosing. The excitement
generated by the appearance of new therapies offers an
ideal opportunity to re-educate our patients and ourselves
about gout so as to improve outcome in this highly
treatable disease.It's an interesting, although highly technical article, which survrys recent trials and the results of new approaches to gout treatment. I think it would be worth adding to the GoutPal data base.
IF ONLY SOMEBODY WOULD TELL ME HOW!
Odo,
Thanks for filling out the Lancet reference. Good stuff. I'll bet it pissed off Takeda Pharmaceutical to read that.
As for adding to the database, it require gout-pal's wearing a pointy blue cap cap studded with stars, a wand, an incantation, and few sprigs of henbane or eye of newt… I get confused which.
odo said:
It's an interesting, although highly technical article, which survrys recent trials and the results of new approaches to gout treatment. I think it would be worth adding to the GoutPal data base.
IF ONLY SOMEBODY WOULD TELL ME HOW!
From the other thread:
odo said:
Anyway, I have just downloaded a PDF of the latest Lancet article on new gout drugs (mainly febuxostat). I will post it if I can remember how (clues please)
Sorry, odo the method you used last time no longer works, but I'll introduce a new method soon.
In the meantime, the best way is to use a free online storage facility, upload to your public area, and link here.
@everyone: This is also great for automatic backups. I link my data storage folders to DropBox, so files are automatically backed up remotely whenever I save them. It also means I can access them from any where I can get an Internet connection.
Sorry, I sat on the pointy hat
zip2play said:
Odo,
Thanks for filling out the Lancet reference. Good stuff. I'll bet it pissed off Takeda Pharmaceutical to read that.
I don't think it's anything new to Takeda. They are absolutely aware of the negligent way that allopurinol is prescribed. That's why they are spending $millions on flashy websites, advertising campaigns, medical seminars, etc, etc. If febuxostat isn't pushed properly, it will suffer the same fate as allopurinol – untrusted through misunderstanding and mismanagement – and the $trillions potential is lost.
They'll be pretty relaxed in the knowledge that no other dealer will have the funds to push generics in the same way. It's a mindset that's almost impossible to beat, as where we see offensive marketing strategies, they simply see any publicity as an opportunity for more deals. They also monitor this forum, so they're probably meeting now to plan more spin on this issue.
@OP 5. Apparently 90% of gout cases are treated by primary care doctors, who under-treat the disease (e.g. don't prescribe high enough allopurinol dose) and aren't particularly up-to-date on the disease. This is claimed to be one obstacle to development of more effective gout drugs – drug companies aren't sure there's really a market here.
Sorry to keep seeing this perspective crop up again and again- the medics have been trained by the Drug Co's to create their market by focussing on the limited success meds can only so often bring. They also wear off in effect over time of use.
Added to this is the underprescribing of UL meds, that only trims back the endemic problem – another thread on GP, on unsymptomatic hyperuricemia, touches on exactly the same issue.
Only when blood UA is properly monitored and treatments titrated in accordance- as discussed, will this scourge of gout be managed well.
Until then a lot of the residue is going where the sun don't shine -but failing to make a successful exit thereto!
PS: On the monitoring of this site by Drug Co's- I say good, may they well blush on occasion, and with >1M hits, getting to be a force for good specifically on this issue.
I'm sure GP can resist a buy out! 🙂
GoutPal said:
In the meantime, the best way is to use a free online storage facility, upload to your public area, and link here.
@everyone: This is also great for automatic backups. I link my data storage folders to DropBox, so files are automatically backed up remotely whenever I save them. It also means I can access them from any where I can get an Internet connection.
Sorry, I sat on the pointy hat
Okey dokey – abracadabra!
- You must be logged in to reply to this topic.