I read this on IHUB I read it, but don’t participate I’m bored, so will address this very obnoxious twit

You’re aware that this little letter writing campaign was tried previously, and failed. (Thanks for the reminder, I didn’t participate in that one)

The product is cleared in 50 countries (or whatever) because efficacy is not a criteria (sp) for clearance.

(In my world, efficacious means the p value is less than 0.05. This is also the world the FDA should be in. Which planet do you hail from?)

In the US, it is. And that’s why it’s not cleared.  (The Actipatch is efficacious based on the data given. Try debating the study set-up, and I would take this more seriously, but BIEL has the numbers.)

Writing letters attempting to sway politicians to clear a product because folks are abusing another is simply not going to work.  (Google that-try REGEN among many others)

It has never worked in the history of the FDA. (Google that-try REGEN among many others)

BIEL attempted this once, and it failed. (we are lucky you were not a Wright Brother)

And I know, I know…there is a new sheriff in town at the FDA..but the regulations don’t change. (They do, though, don’t they, except for Flat Earth morons with a Soviet mindset.)

Show efficacy and the product will be approved. Don’t, and it won’t.  (you seriously never heard of Google)

No amount of letter writing can make the clinical trial data magically significant. (AIDS protesters managed it by marching in front of the FDA—political pressure. Are you saying letters don’t work from commoners and we have to take it to the streets? Or are you just ignorant in general?

But if it makes you feel better, continue on. (Thanks you for validating my existence, TENS Troll.)

What’s up with lee Harvey Oswald and Rafael Cruz? Cruz dropped out after photos of Oswald and Cruz’s dad popped up on the Internet. Bizarre, I have yet to see lying Ted deny the veracity of the photo. All he said was his dad didn’t kill Kennedy. Was his father in the photo or not? There’s footage of the father walking though an airport being interviewed and saying he was not in New Orleans at that time yet other sources are saying he was. These other sources are not even saying the father was in the photo with Oswald, they are just saying the father had been in New Orleans at that time. Somebody is lying. The dad went up to Canada and worked for Zapata oil, the Bush owned CIA front.

Margaret Hamburg, former FDA cheiftaness is looking at jail time for corruption. She was installed at the FDA for being good at laundering campaign money for Hillary. It was during her tenure BIEL got denied for their FDA application.

Reason I mention it is this–Does anyone else recall someone from TENS being on the review board that rejected the Actipatch?

*TENS is a rival to BIEL in the industry If I recall, there was someone associated with TENS that helped scuttle BIEL’s application.

Telling, isn’t it? The crook Hamburg, installed by crooks–possibly installing crooks on review boards to bleed a few more shekels out of her already lucrative government sinecure?

My memory is not absolute, but I am always generally right about this kind of thing. I will look it up The FDA is going to have a class action suit on their hands if they don’t step up, and while BIEL doesn’t have the clout to fight it, BRAUN most definitely does.

The Bush Clinton Crime Cartel is running us into the ground We need to stop letting them inflict cucking funts like Hamburg on us.

 

10th, northern tier: Carol D. Sides, Tina Pickett, Mario Scavello, Ryan Belz, John Wells, Mark Stoicheff (Sides, Pickett and Scavello are endorsed by the Trump campaign, but all three have publicly committed to voting for the top vote-getter in the 10th District. Belz, Wells and Stoicheff are not endorsed by the Trump campaign.)

 

Donald Trump

3rd, NW PA: Lynne Ryan, Dan Vete, Jim Keffalas

4th, Harrisburg / York: Matthew Jansen, Marc Scaringi, Joe Sacco

5th, NW PA: James Klein, Ash Khare, C. Arnold McClure (Khare and McClure are endorsed by the Trump campaign, but have publicly committed to supporting the top vote-getter in the 5th District.)

6th, Philly suburbs: Wayne Buckwalter, Vicki Lightcap (Lightcap is endorsed by the Trump campaign, but has publicly committed to supporting the top vote-getter in the 6th District.)

7th, suburban Philly: Ralph E. Wike III, Jan C. Ting

8th, suburban Philly: Barry Casper, Jim Worthington, Sean Shute

9th central PA: Debbie Taylor, Cody Raymond Knotts, Joseph Lamantia

10th, northern tier: Carol D. Sides, Tina Pickett, Mario Scavello, Ryan Belz, John Wells, Mark Stoicheff (Sides, Pickett and Scavello are endorsed by the Trump campaign, but all three have publicly committed to voting for the top vote-getter in the 10th District. Belz, Wells and Stoicheff are not endorsed by the Trump campaign.)

11th, central / NE PA: David McElwee, Rick Morelli, Andrew Shecktor, Marlene Loose. (Shecktor is endorsed by Trump, but has said he would support another candidate who wins the district and statewide vote; Loose is not endorsed by the Trump campaign.)

12th, western PA: James Vasilko

13th, suburban Philly: Gilbert Cox, Lauren E. Casper, Tom Ellis

15th, Lehigh Valley: Scott Uehlinger, John K. Reber Sr., Patrick Kerwin (Uehlinger is endorsed by Trump but has said he would support the top vote-getter in the 15th District.)

16th, Lancaster County: Marc Lemon

17th, NE PA: T. Lynette Villano, Gloria Lee Snover, Carolyn L. Bonkoski, George Paul Blauer, Theresa Santai-Gaffney. (Blauer and Santai-Gaffney are not endorsed by the Trump campaign.)

18th, SW PA: Justin DePlato, John Petrarca, Thomas J. Uram

 

The Musical Icon Prince just passed away, possibly by an overdose. I was a fan. I had Diamonds and Pearls playing in my car’s cassette deck for about a year a while back. It is tough to classify his genre. He was pretty original.

In a not unrelated news update, the FDA appears to be showing signs of gearing up to (finally) approve/allow the Actipatch by Bioelectronics to be sold OTC (over the counter) in the USA. More on this later

This approval will ultimately be due to the never say die attitude of Andrew Whelan, the mastermind at the Bioelectronics corporation. He saved this technology by shifting the focus from the USA and its Big Pharmaceutical Company owned FDA to Europe. One advantage of Europe’s Socialized medicine (there are several disadvantages) is the drug companies have less influence on the regulatory process, since the governments there are footing the bill more so want to try to keep it cheap. Bioelectronic’s Actipatch, a chronic pain treatment which utilizes the induced magnetic field generated by pulsed electromagnetic waves to alleviate pain is certainly an effective, affordable, and easy to use system for pain management. Actipatch’s popularity in Europe has generated independent testing by prestigious institutions and increased sales of the product.

Meanwhile, the FDA in the USA has never allowed the Actipatch to be sold here. Americans, you see, take drugs for pain. This is the American Way, and it kills a lot of people each year. People notice when a famous person buys it. Prince is the FDA’s latest victim.

Prince supposedly was taking Percocets, a legal prescription painkiller. People develop a tolerance and have to start ramping up. The Actipatch could have prevented this. This is drug free treatment. There are no dangerous byproducts breaking down in your liver and kidneys.

I mentioned earlier I think the FDA is finally going to cave in to political, economic, and scientific pressure and approve the Actipatch for sale in the USA and now I will list why I think this. My evidence is somewhat circumstantial and this might be tedious if you aren’t interested in this sort of thing so bear with me Also, a true expert will doubtless be offended by my attempt at explanation. I am trying for “less is more” here. Also, if you are too exacting in your FDA terminology, relax Approval and Clearance for Marketing are distinct. I get it.

  • The Actipatch has three paths to approval
    1.  de nova-primarily for brand new technologies
    2. predicate device-basically the Patch can get grandfathered in by referencing something similar which was already approved This is tricky for the Patch because the the most similarly approved application was listed as diathermy for directed heat treatment. Basically, the predicate device got approved in 2002, but the FDA got the mechanism wrong The true mechanism is actually now called  DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT, basically So, the FDA was not letting the Patch get approved because it would not accept the original as a predicate different mechanism). The FDA recently updated the Biolectronic listing to show that they will be  accepting the original predicate for the new mechanism–DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT. This could be the FDA tipping its hand that it is lining up its ducks for imminent approval
      1. To sum, click here and look at ” Device Classification Name Look at Decision-substantially equivalent (SESE)
      2. Now, click on Statement. It references the 2002 as the predicate device!!!!!!!
      3. !!!!!!!!!!!
      4. Takeaway-this got updated DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT was not getting to use the 2002 approved device as the predicate It seems to obvious as a giveaway, but apparently the FDA is getting ready to move.
    3. There is a third route to approval, arduous and you wind up needing a prescription for the thing called the PMA route, the October OTC reclass by the FDA hopefully rules this out

So above is the first bit of circumstantial evidence I have to present Below is the second

Import Alert 89-08

This one is a bit more of a stretch, but it is a revision regulating import that popped up when I searched the FDA site with these key words- DIATHERMY, SHORTWAVE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT

What I got out of reading this was devices are getting blocked if they lacked proper labeling. One of the previsions in the October reclass stated the devices might need additional labeling to be allowed to be sold in the USA Not banned,just need the correct labels sounds like pending clearance for marketing

Here is the buy-in: The FDA is in slightly uncharted waters here and wants to do this correctly So, they are getting what they can ready prior to the official announcement

None of these delays helped Prince of course

 

Notes:

BRAUN and the Oxford University study should materialize pretty soon as well, so Bioelectronics may have a huge month in May-2016

 

 

MINNIE M0USE D0LLAR

fields composite 3

Recently, the most heroic woman in the history of the world, Michelle Fields, was brutalized by the evil Nazi Corey Lewandowski. After much thought, I composed a meme to immortalize the depths of her suffering. Though my small tribute pales in comparison to the magnitude of her victimization, I still must try to do justice, somehow, in my own meager way, and only wish my meming skills were more refined.

My meme may be too subtle for some, so let me explain. When Corey Lewandowski grabbed Michelle Fields’s upper arm, he may just as well have stuffed her into a gas chamber, hence the Anne Frank and Auschwitz references. True, Corey is Jewish, but since this doesn’t really work for my meme, I will ignore this fact.

Now, I know it appears from the video that Corey never made contact with her lower arm, and that Michelle and her little crew are lying their asses off. Have you ever considered we have the power to make our own reality? If we believe it in our mind, is it not true? As I said to my wife, who used to throw apples over the concentration camp wall to me (my memoir coming out next month), if you think about it, what is truth in a universe where electrons scream about in high speed quantum orbitals and the barrier between matter and energy is not easily definable?

Michelle Fields seems like a fairly good representation of her caste–a trust funded entitlement case who got bored and decided to try her hand at political assassination. Let’s hope the next delusional yenta who goes after Trump doesn’t have a knife or gun in her hand. The man has been physically attacked at least once in the last few weeks, and has been getting death threats for months. Frankly, I wish the Secret Service really had given Fields a beatdown for grabbing Trump. In new age media terms, Michelle Fields raped Donald Trump with her hands.

Of all staged events in this campaign, this one is really pissing me off the most. When the second video came to light which showed the whole thing from a fresh angle that absolutely nothing happened, Michelle Fields panicked and doubled down on her lie. Meghan Kelly stopped bringing her on her show (Kelly is a shameless cow). Nobody is apologizing to Trump and Lewandowski though.

So the story fades out as the Corporate Media looks away in embarrassment now that the scam is revealed. However, it is out there that the fake story happened because it was covered so much and so appallingly unfairly.

What I will remember is Trump stood by a loyal soldier, not out of blind loyalty but because Corey Lewandowski was doing his job, was doing it well, and deserved support. Also, Fields is disgusting.

 

 

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