I have learned that most people want a simple sound bite answer or conclusion. The edges of medicine always operate in the grey and nuanced.
It has long been dogma in Lyme circles that immune suppressing drugs, e.g. Enbrel are very dangerous and should not be used. The same is true with prednisone.
I have patients who get the occasional injection by their rheumatologist; joint pain gets better and they are no worse for the wear.
The drug is used for psoriasis amongst other many other conditions. The drug has serious side effects: its use should not be taken lightly.
A study suppressed by Pfizer, brought to light be the Washington Post, was based on insurance company data considering outcomes of hundreds of thousands of patients and found those taking Enbrel had a 64% decrease in the incidence of Alzheimer's disease.
Enbrel impairs the function of TNF alpha, a master cytokine responsible for trafficking immune cells.
Pfizer did not make the disclosure because: a generic version will be available. A shiny new, me-too drug promoted heavily by pharm reps costing obscene amounts of money will take its place. Doctors will be given shiny data, along with lunch, proving equivalency? with the old drug.
The myth that generics are poor (dangerous) and lack quality control may be resurrected.
Watch out for first year generic prices: cute trick. For the first year a single company is given a monopoly and only required to reduce the price by 20%. "See, the generic is almost as cheap as the brand," the rep will inform a doctor. This is a bad pro big-pharma rule passed by Congress decades ago I'm sure) by the way. Cheap is a relative term.
The pharmaceutical giant, Pizer has excuses, reasons why it withheld the data, for example, they claimed the data is wrong because of biological plausibility: the molecule is too large to cross the blood brain barrier.
Really? I care if the molecule gets into the brain; maybe it's an advantage. The brain has its own immune system which needs to be tweaked lightly. Ask anyone who has had a brain Herxheimer reaction knows. The Cytokine storm which may make you crazy results from peripheral cytokine reactions/overproduction primarily. And there is no data the molecule cannot get into the brain. Cytokines get in the brain.
Alzheimer's is in part motivated by inflammation. Other major factors are: production of amyloid beta protein (AB) (plaques and tangles), genetic factors and multiple external factors.
It is thought that AB protein is a naturally occurring antibiotic which responds to inflammation. Discussed elsewhere. Lyme resides in the brain along with many bacteria, viruses, protozoans. It is true that spirochetes have been reported to aid in the transportation of AB into the brain. Infection (or colonization) may be omnipresent and therefore not the whole story -- or the most critical piece.
The vast majority of my patients present with cognitive complaints. Many or most Lyme patients, at one time or another fit the criteria for a disorder call MCI, minimal cognitive impairment. The mainstream medical community considers this a pre-Alzheimer's condition, often.
What's a Lyme patient to do?
First off, if symptoms completely resolve with usual therapy do nothing.
If you are a patient who has had very aggressive therapy, e.g. months of IV antibiotics and cognitive symptoms persist, look up MCI and consider the following:
Get an AB PET. The tests measures metabolic activity in the brain and the presence of early AB protein deposition. IF the test is positive you are at very high risk for developing Alzheimer's.
Prednisone and Enbrel have largely been dangerous seen as because patients are misdiagnosed and not also treated for Lyme. Enbrel is likely tolerably safe, in many cases, considering benefit to risk ratio.
A lot of money has been spent searching for an Alzheimer's cure. To no avail. Nothing very promising in the literature.
I for one am very angry with Pfizer. I suppose it is typical behavior in the industry. We still need big pharma. Don't throw out the baby with bathwater. Hold them accountable. But, do not conclude big pharma is corrupt therefore all drugs developed through the system are fruit of a poisoned tree and are therefore inherently untrustworthy and dangerous -- in addition to being immorally overpriced.
It's a bad syllogism. Drug companies are a very necessary evil.
Getting back to Enbrel Is this a silver bullet?. More comment, biostatistics and analysis are required as well as prospective RCT medical studies. Since the drug will be generic soon big pharma will not finance the research. Fortunately, Alzheimer's, a burgeoning epidemic as our population ages, is well funded through private sources.
Ideal prospective studies, which will likely be done make observations moving forward starting with a baseline current population. The process is slow.
Retrospective, population studies, primarily manipulation of data already there will not take long. These studies are never as good as prospective studies but perhaps good enough.
If you want my bottom line: don't run out and get Enbrel-- YET.
I am not endorsing the use of the drug for any medical condition, including Alzheimer's,
This site is for informational purposes only. Medical care can only be delivered by a certified medical practioner who properly evaluates your particular issues. Please don't diagnose or treat yourself.
6 comments:
Unfortunately, generics lacking quality control is not a myth. :-(
I have often wondered about the role of steroids or other immune suppressing drugs in the situation of a disease like lyme. If you use them, opposed by antibiotics, would that reduce the inflammation that causes many symptoms while killing pathogens......would that work? Especially with patients who can't do herxes for various reasons.
But there are so many questions about lyme treatment that we don't have answers for because our government has ignored them and pretended they don't exist.
Thanks for sharing your work. I now need to add some interactivity to the offline map, so that a user can get info after clicking on a point.
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