- This topic has 24 replies, 10 voices, and was last updated 9 years, 9 months ago by
.
-
Posts
-
This is about comparing biologics, but see page three for what they recommend trying first:
“If you have been newly diagnosed with rheumatoid arthritis, studies show that other less costly and safer medi –
cations work just as well as biologics, so you should try those first. These include nonbiologic DMARDs, such as
hydroxy chloroquine (Plaquenil and generic), sulfasalazine (Azulfidine and generic), minocycline (Dynacin, Minocin,
and generic), and methotrexate (Rheumatrex and generic).”http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/BBD_Rheumatoid_Arthritis.pdf
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
Here’s something that caught my attention:
“SAFETY
In studies, about 13 percent of people who took a biologic experienced serious or life-
threatening side effects (but many people, about 12 percent, who received a placebo also
had serious side effects).”@aoshi_xken wrote:
Here’s something that caught my attention:
“SAFETY
In studies, about 13 percent of people who took a biologic experienced serious or life-
threatening side effects (but many people, about 12 percent, who received a placebo also
had serious side effects).”Hi Aoshi and all,
I hope you don’t mind me butting in here, but I always wonder about these types of results. For instance, of the 12% of folks who were on placebo, what else were they taking during the studies for their RA? Or, were they taking nothing? It’s quite rare for any study group dealing with RA to actually have a placebo group that is taking nothing (one of the big ethical questions Brown struggled with). This sort of interpretation really doesn’t inform the reader of much and seems to downplay the “life-threatening” side-effects of the biologics, because the placebo group also experienced “serious side-effects” (note: doesn’t say “life-threatening” – “serious” is not necessarily “life-threatening”). In other words, the inference the authors seem to be making is that the placebo-group’s “serious side-effects” (which were?) could happen to anyone, whether on the drug or not. I have trouble buying that sort of statement. What about you? What if some in the 12% placebo group got sick with a pneumonia, but were also taking methotrexate – yes, very serious, but was it life-threatening? Does this make the 13% of those who experienced “life-threatening” side-effects while on biologic drugs more acceptable? Not really…comparable in terms of safety (making mtx the safer drug), maybe, but is a 13% risk of losing one’s life while on a biologic an acceptable risk? Perhaps, for some with very severe disease, yes…but, for others, with less severe disease, perhaps not. This is where subjectivity comes in…the risks we’re each willing to accept.
By way of example…
One of the issues with the MIRA trials is that those interpreting the results downplayed minocycline’s effects when comparing it to the placebo group, because what they failed to mention was that the placebo group were allowed to take their usual NSAIDs. See page 18 of The New Arthritis Breakthrough:
“Another phenomenon, the so-called placebo effect where patients not receiving the treatment show improvement anyway, has always been a factor in the testing of arthritis drugs, and with MIRA it was even higher than expected. In this case, it was attributed to the fact that patients were encouraged to continue taking stable doses of NSAIDs throughout the trial. But although clinical improvement in joint swelling and tenderness began at week twelve for both groups, it leveled off the the placebo group in week twenty-four, while patients on the minocycline continued getting better through to the end of the study. “
So, I think what really concerns me in the interpretation of drug trials are things like this, as well as “duration of study.” Did side-effects become more obvious the longer one was on the drug or was the study time period too short to tell? Many drug trials only take place in spans of 6 months or a year and there isn’t always any follow-up after the study. Most follow-ups come in the shape of adverse effects reported to the FDA down the road and it’s always possible for % risk to increase over time. In the case of Celebrex, the serious side-effects (e.g. stroke) were not known for a number of years. There was a lot of hoo-haw about withdrawing this drug from the market, but ultimately it’s still on the market, but now has a black box warning on it…considered an “informed consent” kind of thing that removes liability from the drug company, though many folks never even read those warnings. Further, what if a person has a predisposition to lung fibrosis (one of the contraindications for biologic use) and doesn’t yet know it? This may take 10 or 20 years to become fully realized (maybe while a person is still on the drug or long after it’s been stopped?). Another concern is “who is interpreting these results?” Are they an independent study group (market study group? physician group? patient advocacy group?) and are they drawing upon their own statistical analysis or drawing up statistics that were interpreted by others (drug companies? physicians? independents?). Are there any conflicts of interest (e.g. ties to the drug developer?).
One of the reasons why minocycline is often refused to those with scleroderma is because they are told it was proven “not to work.” There has only been one study by Mayes since Dr. T’s “Minocycline in early diffuse SD trials.” The Mayes study was analysed by a statistician and also frequents here on occasion. What she discovered through her analysis was that the results of those who withdrew from the study early (for whatever reason) had their results included in the final statistical analysis, thereby causing the study results to be very skewed! The study was also undertaken within a span of time in which would not be considered adequate to see definitive results, as minocycline generally can take a year or more to really kick in for some SD patients. Yet, this “one” study is still being quoted to SD patients asking their rheumies to try this benign treatment as being the definitive proof that the treatment doesn’t work.
These are just a few examples of why certain statements in articles like this can become taken as “fact” by the medical community when, in reality, they are broad statements that really don’t give the consumer a complete picture. These diseases are hard and, until a cure is found, the choices we must all make are such challenging ones (very quickly on the heels of receiving a devastating diagnosis when we are at our most vulnerable), so I don’t mean to bring anyone down with these comments. Really, I just think that as the kind of folks who frequent this forum are all generally the types of people who want to self-advocate and make the best treatment decisions possible that it is crucial to read any study and its analysis with a critical and discerning eye. Although science aims to be neutral and just to report objective results, quite often the study authors lend their commentary to these results and they become universally taken as fact by both doctors and patients alike. Each of us has to discern what the risk/benefit is for anything we put into our bodies and to do this in the most informed way possible.
Thanks for posting this Consumer Report article, Suzanne…it was really interesting. 🙂
@Maz wrote:
This sort of interpretation really doesn’t inform the reader of much and seems to downplay the “life-threatening” side-effects of the biologics, because the placebo group also experienced “serious side-effects” (note: doesn’t say “life-threatening” – “serious” is not necessarily “life-threatening”).
Thanks for posting this Consumer Report article, Suzanne…it was really interesting. 🙂
I had the exact same thought about ‘life-threatening’!
The reason I posted the article was because I thought it was good to see Consumer Reports recommend mino be tried first, before a biologic. How many RA patients are even told it is an option? Maybe someone will see it and ask their doctor.
As far as side effects, one way to keep the reported side effects in a trial low is to exclude patients who have them! See the bottom of page 10 and page 16 here re: pediatric Enbrel studies – http://www.effectivehealthcare.ahrq.gov/ehc/products/108/916/JIA_Disposition-of-Comments_20120104.pdf
Mom of teen daughter with Poly JIA since age 2. Current med: azithromycin 250 mg MWF.
@Suzanne wrote:
The reason I posted the article was because I thought it was good to see Consumer Reports recommend mino be tried first, before a biologic. How many RA patients are even told it is an option? Maybe someone will see it and ask their doctor.
As far as side effects, one way to keep the reported side effects in a trial low is to exclude patients who have them! See the bottom of page 10 and page 16 here re: pediatric Enbrel studies – http://www.effectivehealthcare.ahrq.gov/ehc/products/108/916/JIA_Disposition-of-Comments_20120104.pdf
Hi Suzanne,
Absolutely with you there – let’s hope the info will help someone who may need some literature in their bid to obtain a mino script. 🙂 It’s interesting to note that patients are given various reasons not to try minocycline – either the doctor says it’s only used in mild-early cases or as a last resort when all else has failed. I think the main problem with this is that in clinical practice doctors just don’t recognize the early worsening phase and don’t inform their patients of this. When a doctor reluctantly rx’s minocycline for a trial 2 or 3 month period, they are simply not giving the treatment enough time to work and it’s during this time that the patient inevitably feels worse, especially in the high 100mg BID dose that is usually prescribed….ach dear. 🙄
Thanks also for sharing the pediatric Enbrel study peer-reviewer comments…fascinating stuff and right on point with regard to why it’s so important to read any study with a critical eye. Even peer-reviewers may miss study flaws that lead to misinformation that the public is fed. It’s kind of gob-stopping to think that it would be very easy for any regular doctor to miss the small print with regard to study retractions and corrections. All too often black box warnings arise as a result of serious drug side-effects, well after patients have been harmed, and that these warnings are not so much to protect the patient (who may be told these events are “rare”), but to protect the company that manufactures the drug. 🙁
Maz how come your so smart, you really should go into medical field we need people like you.
have a nice day
geryMaz –Evidently the FDA shares your thoughts as Black Box warnings have been issued for Humira and other biologics –Guess they dont buy into that placebo “finding “
richieA Canadian friend said his union said their health insurance was going to go up because of biologics. I told him about this article.
The first rheumy I went to refused to give me minocycline and pushed the biologic w/mtx combo that he wanted to start me on immediately: it had only a 40% success rate. It seems deceptive for marketed products not to clearly identify the success rate. (I found it in the small print of the biologic brochure.) When I asked him about this and the black box/toxic info, his reply was, “Well, we all die of something….”
I changed to a new dr & asked the new rheumy for Rx mino/AP; which he okays, even though he is not familiar w/this protocol.
I believe I read that AP w/mino has a 80% success rate!Hi while minocycline is successful the success rates for RA is about 60 % —for scleroderma 80 % –still far qabove biologics-
richieTo Ritchie’s point about the overall success rates, I also wonder how many people stop treatment because they are mistaking a “herx” for a “flare”, or don’t give the treatment enough time to really begin working. Or, perhaps they are working with a doctor that simply doesn’t know enough about AP to treat it properly with Mino and other related antibiotics and just give up.
In short — I suspect that many people give up too fast with AP in certain circumstances.
You must be logged in to reply to this topic.