Friday, May 19, 2017

The campaign to sell PCSK9

Expensive PCSK9 inhibitors should be used to treat LDLc greater than 189 mg/dl before trying inexpensive low dose triple therapy treatment.

In my book, The Tubby Theory from Topeka, I documented my success with triple therapy for high LDLc for about 200 patients.

I advised starting with lowest dose of a generic statin.  I have updated my advice from using generic simvastatin (Zocor) to lipitor (Atorvastatin) and now generic rosuvastatin (Crestor).
Zetia is now generic but there is a 6 month window where the company is allowed to sell the generic for $1.00 less than brand Zetia.
Endur-acin is an over the counter niacin which has a proprietary matrix that causes very little flushing and side effects.  1,000 tablets can be purchased on line for $90.  I advise 2 tablets (1,000 mg) a day.

I am Diabetic type 2 and have gotten my LDLp down to 333 with this triple therapy.  That is the lowest number/value Liposcience lab will give for LDL particles measured with NMR.  I have lost 80 pounds since 2006 but I gained back 50 lbs despite intensive exercise after 5 years.  I then went on Atkins since 2011 with 60% fat and less exercise.  No false hope for diet and exercise.

I am very skeptical of the usual recommendation of diet and exercise as the  10 year long LOOK AHEAD trial resulted in a negative study to prevent cardiovascular events more that the control.

I take:
 Lipitor 10 mg/d
Endur-acin (Niacin) 1,000 mg a day.
Cost about $100 a year.
This gets me to the lowest LDLp possible while eating 60% fat and walking 1-2 miles a day at a 20 minute per mile pace.

I gave my patients a third drug if they could not get to goal.
 Zetia 10 mg (ezetimide).
Presently, ezetimide is sold as generic and hopefully with go down in price.
At high price start with one half tablet.
(Note: there are hyperabsorbers of cholesterol that have great benefit with this drug)

I am at the NLA meeting in Philadelphia.  Last night I went to a dinner sponsored by Amgen.  I have great regard for the panel that participated in the discussion of Optimizing Patient Outcomes in the Era of PCSK9 Inhibitor Therapeutics. 

Doctor Harold E. Bays presented 3 case studies to treat a high LDLc.  
The problem for me with his questions is low dose triple treatment was never offered as a choice in the answers. 
Niacin was rarely mentioned and when it was it was diminished. 
To Dr. Bays credit he did say he didn't think there was a wrong answer in the quiz but the audience had been guided by the speakers to vote 90% as PCSK9 inhibitor use as the correct answer.
This is a manipulation of the Fourier trail 2 year data as being more important than 50 years of positive outcomes with Niacin. 
Niacin has a better long term decreased mortality 6.2%(CDP increased from end of trial) result than any statin (3.2% from 4S decreased from end of trial. )
"We therefore conclude that treatment with simvastatin for up to 8 years in patients with CHD is safe and yields continued survival benefit."
"Statin treatment for 5 years was associated with a legacy benefit, with improved survival and a substantial reduction in cardiovascular disease outcomes over a 20-year period, supporting the wider adoption of primary prevention strategies"

4-No long term outcomes for PCSK9. Fourier trial was stopped early after 2 years because it reached a 15% reduction in events. 

Niacin low dose is extremely safe after decades of use. 
We have no idea what the effect of decades of PCSK9  will be. 

Please place triple therapy with Niacin on the list of choices for treatment. 


Monday, May 1, 2017

HOW MUCH PROTEIN TO PREVENT LOSS MUSCLE MASS DURING DIET

Also read 

Review of NYT article on maintaining muscle with loss link



How much protein for each individual?
2.4 grams of protein for each kg of lean body weight.  
Difficult for people to figure lean body weight without bioelectrical impedance scale.
5-1-17:    Wt.              Fat%
              204 lbs          24.9%
               92.5 kgs       22.8 kg

Subtract 22.8 (total fat) from 92.5 (total body weight) = 69.7 (lean body weight)

Thus for me:
2.4 X 69.7= 167.28 grams of protein per day.

 Diet yesterday:     Protein       Calories     Carbohydrates      Fiber:

Breakfast
3 eggs fried in butter     18g             300                 0                           0
3 slices bacon                9g              165                 0                           0
Butter 1 TBSP                                  100
Lunch:
Atkins Beef                   16g             310                9g                            3g
Almonds  28 nuts           6g              170                6g                           3g
Atkins shake- vanilla      15g            160               2g                             1g
Tenderloin fillet 7oz        56 g            490               0                             0
Cauliflower 1 oz                0.5             14               1.1 g
Butter 1 TBSP                                   100
Pistachios  I bag              5g              120                8g                         2 g
Light/Lively yogurt           12g             80                  9g                         0
Martini Pear/Apple                            355                18g
Red wine 12 oz               0g            240                 6g

TOTALS                  Protein        Calories       Carbs                   Fiber
                                       137g          2504 cal            59g                       9g

FASTING GLUCOSE 126
SERUM KETONE LEVEL 1.7

Friday, March 24, 2017

Who has healthiest hearts in the World?

 Who has healthiest hearts in the world?
Very interesting but there is still some heart disease in the tribe. 25% in elderly.  Thus is this age, inflammation (age) or genetics with high cholesterol?
There are silver bullets for early atherosclerosis and the sooner it is treated with multiple drugs the less chance of a cardiac event.

One thing is clear, the lower the LDLc or LDLp or apoB the less cardiac events occur.
I think the drug company paid a billion dollars on PCSK9 trial.



1-NEJM 2017 PCSK9 drug Rx

"At 48 weeks in the evolocumab group, the LDL cholesterol level was
reduced to 
1-70 mg per deciliter (1.8 mmol per liter) or lower in 87% of the patients,
2-to 40 mg per deciliter (1.0 mmol per liter) or lower in 67% of the patients,
3-and to 25 mg per deciliter (0.65 mmol per liter) or lower in 42% of the patients,

as compared with 18%, 0.5%, and less than 0.1%, respectively, of the patients in the placebo group (P<0 .001="" all="" br="" comparisons="" evolocumab="" for="" of="" placebo="" vs.="">
 
<0 .001="" all="" br="" comparisons="" evolocumab="" for="" of="" placebo="" vs.="">2-Tracy has a LDLc of 17

"At a time when the target for low-density lipoprotein (LDL) cholesterol, more commonly called 'bad cholesterol', in Americans' blood is less than 100 milligrams per decilitre (a level many people fail to achieve), Tracy's level is just 14."

3-IMPROVE IT trial for Zetia

Conclusions

"1-When added to statin therapy, ezetimibe ( resulted in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes.
2-Moreover, lowering LDL cholesterol to levels below previous targets provided additional benefit."



This chart above shows it took 7 years to get a good result with Zetia combo.
The Niacin  combo trial was stopped after 3 years AIM HIGH TRIAL.






This chart shows results of many trials lowering LDLc. The lower the result the better the outcome.

AIM HIGH trial stopped after only 3 years.  If AIM HIGH  was allowed to go on for 7 years as above IMPROVE trial did, I suspect AIM HIGH would have had similar good results .
LDLc went below 65 on combo Rx.



​This is Terry Jacobson's slide at the Master NLA program last year.
It is a shame this trial was stopped early due to side-effects that later turned out to be insignificant.


While reports of Egyptian mummies and Amazon tribe and elderly Japanese women are interesting they are not hard science.

Thursday, March 2, 2017

Rand Paul tries to get into secret meeting on Repealing ACA

This history shows why GOP not likely to Repeal and Replace Obamacare.   It was extremely difficult for Obama to pass it.


The incident today with Rand Paul in the basement of Congress not allowed in a secret meeting on ACA reminds me the secrets meetings reported in the link.  Watching how sausage is made is not for the squeamish.


20 page report on How Obama passed ACA. 
link above


‘After looking at this old transcript,  I don’t think GOP has much of a chance to Repeal or Reform Obamacare.
Repeal and Replace Obamacare is the most important issue facing the USA.   Unfortunately the Media discusses what they think will raise ratings as being the most sensational news.
As I read this transcript I was amazed how similar Obama"s and Trump’s effort
to make the

‘Sausage” of Obamacare.

I think Obama got his bill passed as the media did not focus on the secret 
 meetings, as they will with Trump.


I high lighed much of the transcript so readers can skim through the 20 pages quickly.

Saturday, February 18, 2017

Validation of Sponge Theory with MiRNA's sent out by fat cells


Fat Cells talk to other cells- new data link




This is a clip from Science Magazine with link above.

This may be the final piece of my Sponge Theory in the Reduced Obese that I first formulated in my book, The Tubby Traveler from Topeka.

In 2012 I published the reason why people who lose a lot of weight can't maintain their weight loss.  It is because the billions of excess become shrunken but the never go away.   The fat cells with low fat are know to put out very little Leptin.  This tells the brain the body is starving.  Thus people gain weight on low calorie diets by increasing appetite, lower body temperature and lower metabolism rates.   Apparently it is not only leptin doing this which has receptors all over the body it is also done by MiRNA's  as exomes in the blood according to the new data provided in the article above.

 Not only does the low level of leptin cause weight gain but the MiRNA's cause weight gain because there are so many excess fat cells that individually send out so many MiRNAs the body will regain weight.

Thursday, February 16, 2017

Health Care

A bleak week for Obamacare

Aetna's CEO sees a 'death spiral' and the Trump administration's stabilization plan may be too little, too late.

Obamacare’s health insurance markets are flirting with financial disaster — and that’s before Republicans have had a chance to lay their hands on the law they’ve vowed for seven years to repeal.

The insurance markets, which have been bleeding money, have taken one hit after another this week, beginning with news that Humana would become the first major insurer to pull out of the market completely next year.
 Molina — which had expected a $60 million profit on the exchanges for 2016 — reported a $110 million loss on Wednesday, and will assess ongoing participation at a later date. “There are simply too many unknowns with the marketplace program to commit to our participation beyond 2017,” said CEO Mario Molina.
Other insurers are sounding alarms about the imperiled market.
“Death spiral” is how influential Aetna CEO Mark Bertolini summed it up Wednesday morning, predicting that plans will flee, creating insurance deserts in swathes of the country. President Donald Trump blasted out Bertolini’s remark in a tweet.
The Trump administration, which hasn’t yet delivered its promised repeal and replace plan to Congress, is sending mixed signals.
One minute it’s weakening Obamacare by taking steps that dampened enrollment. Another minute it’s trying to entice insurers to stick around long enough to transition to an eventual GOP replacement — but with steps that industry analysts say may fall short.
“I don’t know that it’s going to keep insurers in if they were otherwise inclined to exit,” said Caroline Pearson, an expert on the Obamacare marketplaces at consulting firm Avalere Health.
The administration’s zigzags haven’t placated worried insurers, who see another year of red ink from enrollees that are older and sicker than they had expected. Congress’ paralysis on repeal and replacement translates into precisely the kind of uncertainly that makes risk-averse insurers want to run for cover.
And Trump’s executive order, signed just hours after his inauguration, unnerved the health plans with its call for government agencies to abolish as much of the law as possible through administrative action. That fueled fears that his administration won’t enforce the individual mandate requiring most Americans to get coverage.
“There’s no way of knowing from outside if the left hand doesn’t know what the right hand is doing or if the Trump administration is somewhat conflicted,” said Larry Levitt, senior vice president at the Kaiser Family Foundation.

Trump has said he’d send a repeal plan to Congress soon.
But his new HHS Secretary Tom Price offered no specifics in his first meeting with Republican senators since his confirmation last week, according to several lawmakers who attended Wednesday.
“It was a good meeting but I don’t know that too much new was revealed,” said Cory Gardner (R-Colo.).
"For each of my questions he came up with the same answer,” said Bill Cassidy (R-La.). “We have the House, the Senate and the administration negotiating on this.

HHS on Wednesday proposed a set of new rules to stabilize the market,
partly by
1- cracking down on loose enrollment rules that insurers have complained allowed some Obamacare customers to wait until they get sick to seek coverage.
2-They would also shorten the enrollment period to six weeks for 2018, and set out other fixes that insurers see as a down payment — but consumer groups say will raise costs even more, further discouraging younger and healthier people from signing up.

Despite the headlines generated by Humana — which had already exited much of the market before this year — most health care experts don’t see a death spiral. Blue Cross Blue Shield plans dominate the markets in many states, and so far those plans aren’t pulling out.
But Anthem, which sells Blue-branded plans in 14 states, has warned that it may reconsider participation if steps aren’t taken to improve the market’s financial viability..
“We still need certainty about short-term fixes in order to determine the extent of our participation in the individual market in 2018,” said Anthem CEO Joseph Swedish, on a call with investors earlier this month.
Jeff Goldsmith, a veteran health care consultant, said Bertolini’s apocalyptic rhetoric is a bargaining tool to impel Congress and the Trump administration to make insurer-friendly changes to the markets.
”They don’t have a choice,” Goldsmith said, of the Trump administration’s efforts to prop up the markets. “They’ve got kind of a dead patient there.”
Indeed, there are some states that already look fraught for 2018. In Tennessee, Humana is currently the only carrier in 16 counties. If no insurer fills the void, that would leave roughly 50,000 Obamacare customers with no place to turn for coverage.
“In most of the country the marketplaces have been stabilizing,” said Levitt. “This program was always going to take some care and feeding to work going into the future. … If you’re losing money right now, and you don’t think the law is going to be around in a couple of years, why stick around?”

ACA changes to be expected by Secretary Price?

Secretary Price to dismantle ACA?


"On his first day in office, Trump signed an executive order directing federal agencies to pare back elements of ObamaCare that do not require a congressional vote, The Wall Street Journal reported. Price is expected to follow through on the "order."
Until recently chairman of the House Budget Committee, Price has proposed repealing Obama's health law and replacing it with:
1-  tax credits, 
2- health savings accounts and
 3-high-risk pools for sick, costly consumers.

Democrats say those ideas are inadequate and would leave people unprotected against significant health expenses.Republicans have yet to produce a replacement plan and have differed over when they will do so.

Citing Price's long-time support for revamping the Medicare program for the elderly, Senate Minority Leader Chuck Schumer, D-N.Y., said that with Price's confirmation, "The Republicans launch their first assault in their war on seniors." Trump has said he won't cut Medicare.
Republicans see Price as a knowledgeable leader who will help scuttle Obama's health care overhaul, partly by issuing regulations weakening the law. Democrats describe an ideologue with a shady history of trading health care stocks and whose policies will snatch insurance coverage from Americans."

ACA and Medicare Death Spiral?

Aetna Inc. Chief Executive Officer Mark Bertolini escalated his criticism of the Affordable Care Act, saying Obamacare’s markets are nearing failure as premiums climb and healthier individuals drop out.
 
We have heard about death spiral for a long time not only for ACA but also for Medicare.
ACA and Medicare have to be tweeted to save them.  GOP would not do it under Obama now they have to.  Tweet the plan not total repeal is the answer.
I'm glad Aetna is leaving the ACA market.  One step closer to single payer system without the middle man.
This article is so stunningly superficial.

“It is in a death spiral,” Bertolini said in a video interview with the Wall Street Journal that aired Wednesday on the newspaper’s website. He predicted
that more insurers will drop out of the market for 2018, following Humana Inc.’s decision to quit Obamacare entirely for next year.
If this happens or better yet before it happens ACA should allow anyone to buy Medicare as their primary medical insurance.  This allows people to buy insurance across state borders. 
Aetna, too, is mulling whether to further reduce its presence in the markets set up by the ACA. The company cut its footprint to four states for this year, from 15, after losing about $450 million on sales of ACA plans last year.
Bertolini has been saying for months that the ACA’s markets are deteriorating. In October, he said that rising rates would push healthy people away from Obamacare, leaving insurers with sicker customers, and forcing premiums even higher.
This is the real question: Did ACA keep premiums from raising even more?
The increasing burden of medical costs as fewer and fewer healthy customers enroll are among the conditions that create an insurance death spiral.
To my knowledge there is no data this is true.  The penalty for not buying insurance is much higher now. 
Some health-care experts have disputed the idea that Obamacare is experiencing a death spiral. Matthew Fiedler, a fellow with the Center for Health Policy at the Brookings Institution, says the small decline in Obamacare enrollment in 2017 compared to 2016 was probably not driven by climbing premiums. Most individuals get subsidies, helping cushion the effect of rising costs.
I listened to Rand Paul's talk about the bill he put follow to replace Obamacare.
He wants to put high risk people in a risk pool. 
Apparently he will not give these people any subsidies.  He said his plan does not cost the gov't?
Where is the data showing how well risk pools worked before and if it was working why did we need the ACA to make a law covering them?
“Marketplace premium increases had little if any impact on marketplace sign-ups, providing strong evidence against claims that these increases would send the individual market into a death spiral,” he wrote in an analysis published Feb. 8 on the Brookings website.

Wednesday, February 8, 2017

Which is best lipid test and is the size of LDLp most important?

 Lab Corp done on 2-1-17 measures small LDLp.
The new item is the statement :
"LDL levels not sufficient for LDL size determination." 
I have an excellent LDLp at less than 300.<300 .="" p=""> 
<300 .="" p="">At this level of low LDLp, size of particles not important as the concentration gradient is so low,  few particles go into the wall of the artery.
 

 My Quest results 1-26-17
My concern is that LDLp small of 163 puts me at moderate risk.
The HDLp LARGE was too low according to Quest and put me at high risk.
Here is a table comparison of the two results. The numbers are different in LDLp because two different methods are used.

I have followed my advanced lipid testing since 7-26-06
when my first
LDLp was 534,
HDLc 54,
non-HDLc 70.
All my results at:

Brian's Lab results link

My first advanced lipid testing was done in 1993 by Sequoia Lipid Clinic by
 H. Robert Superko MD.
Total Cholesterol  149
LDLc 94
HDLc 33
TG 157
Small dense LDL particle size.
 LDLsubclass pattern was B
Non-HDLc 116

In 1993 Doctor Superko suggested I treat the pattern B with:
Appropriate diet
Exercise
Reduction of excess body fat
(I have finally achieved this, see:
Free manuscript of The Tubby Traveler from Topeka

Secondary therapies suggested by Dr. Supergo included nicotinic acid and gemfibrozil.
I knew the side effects of these drugs and didn't take either of them.



Final Conclusion by me:

1- Size of LDLp not important if LDLp is less than 1,000.<1 b="" by="" method.="" nbsp="" nmr=""> 

2- NMR done by Lab Corp is the best advanced testing.  


More context:

I have been on an Atkins type diet since 1-2011, which means I have been on 60% fat (so called bad and good fat).
Most low carb high fat gurus claim the large LDLp is safe (safer?)
At this point I disagree with the Atkin type people.
If your LDLp is less than 1,000 NMR , there are not enough small particles to cause disease.
If you already have plaque then get LDLp less than 750 NMR.
I have been taking atoravastin 10 mg/d and Endur-acin (niacin) 1,000 mg a day for a decade.

See my book Tubby Theory from Topeka










update trials of Alzheimers

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