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Ticks

It's the nymphal tick season now. These are the juvenile stage of the deer tick that are responsible for the most cases of tick-borne disease. After they get a bloodmeal on a rodent or bird or deer, they will fall off an molt and become an adult male or female tick. The little buggars are most active during summer months, when people are outside. They are amazingly small, so check yourself and your spouse thoroughly.

SWK

haven't noticed any so far. I always check myself, especially after a walk in the woods or after a round of golf. Wait, is that the same thing:)

Yup. There is lots of research out there showing that the year after a hard mast year you see an huge increase in said rodents and also tick abundances. As we know, last year was a huge mast year. Keep doing those tick checks. Additionally, people have different body chemistries, some of which are preferable to ticks other are not. Ticks happen to love me.

Back around 20 years ago there was a Lyme vaccine. It was a series of 3 shots. My kids got 2 shots then the doctor said they stopped making the vaccine. The doc said it was to expensive to make. Not sure if I buy that. I asked other doc's and was told there is no vaccine. I think with all the Lyme out there, there should be something to help stop this disease.

Yup. This has been a real frustration. The vaccine was effective but there was hysteria surrounding it largely from the anti antibiotic crowd, the same people who hold these bogus holistic Lyme disease healing clinics that don't work and allows the disease to progress to the terrible stages when the easy fix is a bout of Doxy. So basically, they pulled the plug on it. The vaccine is effective and there are many many scientists advocating for its re-release, but it's going to take lots of money to test it again properly and show that it works effectively. But as of late, no action on that front. Hell, there's a vaccine now for pets but not humans. Then again, pets can hire lawyers to file a lawsuit. . .

I had the series of three vaccines, when I went in to get the third, I was informed that it was the last of it. Apparently you are supposed to get a booster periodically which I haven't been able to do. I don't seem any worse the wear for getting it so I assume the info the doc gave me was correct which happens to be the same info that rbcss received. Basically not enough call vs expense.

In order for the drug companies to want to go through the FDA approval process again, which is a huge expense, I would imagine they are going to want to feel comfortable that the sales will be there. Although I wonder if they would have to go through the approval process if the formula remains the same as the original?

Wouldn't it have already gone through the approval process if it was already on the market ?.

My wife Is just finishing up her meds for Lyme disease.

I asked my wife about whether it would have to go through the regulatory process again, she works for a Pharmaceutical Company in regulatory compliance, which is what that would fall under. They audit the clinical trials to ensure that the company is in compliance with FDA protocol for getting a drug approved by the FDA. It's her opinion that it would not have to go through the regulatory process again being that it was already approved.

There was so much nonsensical backlash from the original formulation, they would certainly have to tweak it to re-release it, which would require regulatory approval.

Doc,

You mean the anti vaccine folks correct? I mean, the "anti"antibiotic "group" would be mainstream providers and their professional groups like the AMA. Over prescription, and other excessive uses of antibiotics is a legit concern... Let your kids eat some dirt people - and you should too :)

Vaccines though. The anti crowd is legitimately allergic to science and common sense. "herd immunity" is real, and widespread health issues as a result of immunizations are just not reality.

That was part of what I'd heard... the Lyme vac was not super effective (now would could surmise that's because what was once just Lyme now could be several similar tick bourne illnesses) - which may have been due to poor diagnostics of lyme disease historically. Add modest effect, high cost, and at the time, emerging but relatively low case numbers and drug companies likely did decide it was not worth it. Which, pardon the french, sucks butt.

I'd love to see more research here and ultimately some improved form of treatment.

Will,

The citation below is from the linked article (a good read if you have the time and interest) and highlights a lot of what Scott has alluded to as the root cause(s) of this vaccine being pulled from the market.

"The complicated history of LYMErix™ provides important lessons. Although the FDA did not revoke the licence, the manufacturer withdrew the product amidst falling sales, extensive media coverage, and ongoing litigation, even though studies indicated the vaccine represented a cost-effective public health intervention for people at high risk of acquiring Lyme disease [23]."

Underlined and bolded text to illustrate how hysteria (not to mention litigation) can shut down promising treatments or preventative options.

I'm sure you've seen all the 1-800-SUETHEM ads on TV; the public has been conditioned to think that all vaccines, drugs, etc. should be 100% safe; no risks, no possible adverse reactions and such. The truth is that's never going to happen and there will always be a very small segment at risk for these unfortunate situations.

These issues are clearly outlined and the significantly greater public health benefit shouldn't be drowned out by what amounts to fractions of a percentage point of adverse events. Unfortunately that isn't the case and more Pharma companies simply use a risk/reward formula that prevents a lot of viable treatment options or preventatives from ever seeing the light of day.

We all lose under this reality.

Mike,

Frustrating. It's amazing how quick people are to hit the "sue" button. Ugh. What's amazing, is that they have not tried to bring it back given the seeming increase (I'm not currently looking at total lyme cases at the moment) in illness.

Anti-Vaxers... They really dont "get" it...

Will

Will, at the end of the day, it is a business and it has to be profitable.

If Dr. Williams is right (and he very well may be). about it having to go through the FDA approval process again, It could be a huge expense coupled with the (no doubt) huge loss the first go around. I would assume the company would have to be convinced that the sales/profits are there. When a drug company develops a drug, they are looking at a global market. With a Lyme vaccine, in the whole scheme of things, they would be looking at a, for lack of better description, more of a regional market, I guess it boils down to, would they ever be convinced they could recoupe their expenses and make a profit?

bb,

Any time a modification is made to a product that had gone through FDA approval that manufacturer will need to submit a new 510(k) as they need to establish the new performance characteristics and any limitations for the product and any new risk factors identified.

At a bare minimum you're looking at a $1M price tag for that new clearance. The ROI for a vaccine is better than antibiotics which may provide a ray of hope the company would pursue a new vaccine.

By design antibiotics are primarily short-term regimens and the profits are much greater on drugs used long-term such as those used to manage diabetes, high-blood pressure, high cholesterol, etc.

And you hit the nail squarely on the head when you said that at the end of the day it's a business and it has to be profitable.

I hear you Mike, best case scenario from a cost standpoint is to not modify the original formula and characteristics. As Doc pointed out, it's probably un-realistic to think that could happen given the history. A 1 Mil filing fee would seem like a great deal if they could get away with just that. I highly doubt it though, if they modify, I'm sure they are going to have to list any adverse reactions and everything else you stated above. which I'm guessing means the whole process over again.

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