Jumpin' Jupiter: How About a Little Statin Common Sense

Well, by now I am certain most of you have heard that the FDA, based on the results of the JUPITER Study, has approved rosuvastatin (Crestor) for men over 50 and women over 60 with normal LDL-cholesterol levels (LDL <130>2.0 mg/dL), elevated high-sensitivity C-reactive protein (hs-CRP >2.0mg/dL) and triglycerides under 500 mg/dL.

I have had a chance to review both the glowing recommendations and scathing condemnations of this FDA action and find them to be as frustrating as they are amusing. I THINK A LOT OF FOLKS NEED TO GET A GRIP! I advise EVERYONE to read Dr. Davis' well-reasoned, common-sense analysis of the JUPITER results on his latest HealthCentral blog post. He brilliantly dissects the issue for us and calmly separates the useful health info from the useless hysteria on both sides of the aisle.

Here is my take/synopsis and some important things to remember.

1. Always bear in mind the difference between cause and association. Nobody said CRP "causes" heart disease. In fact, it is more likely than CRP is simply an indicator that you have something else that does cause heart disease (i.e. CRP is just "associated" with heart disease). Find that root cause and treat it. A statin may not be the best treatment for the specific root cause of your elevated CRP (but maybe it is).

2. Virtually all drugs have good effects and unwanted side-effects. But, the effects are different for everyone. Statins reduce LDL cholesterol and CRP - no question. They are neither magic nor poison. My advice is to study, analyze, ask questions then make an informed decision. I take Crestor (5mg) - but as little as I think is prudent based on my unique circumstances!

3. It is worth mentioning that researchers found a signficant increase in diabetes among participants. Factor this into your personal equation.

In short, it is nuts to both crucify statins or propose they be put in the water supply. I mean, really, does it a take a rocket scientist to figure this much out?

Looking out for your heart health,


HeartHawk

New Genetic Link for Vitamin D and Heart Health

And now comes more genetic proof that Vitamin D is an important heart health player. Once it became established that a "Vitamin D receptor" existed in the heart it was only a matter of time before researchers began teasing out why nature put it there.

New research shows that a gene variant of CYP27B1, which blocked production of an enzyme responsible for Vitamin D activation, accounted for a greater than two-fold risk for congestive heart failure (odds ratio 2.14, 95% CI 1.05-4.39). For a quick stats lesson on all that numeric gobbledygook it means that the researchers were "confident" that if they repeated their research 20 times they would get a result showing a increased risk of anywhere from 1.05 to 4.39 in 19 of the trials (95% of 20). The 95% figure is considered the minimum confidence threshhold for accepting a statistical result as valid. You can also look at the "confidence interval" (CI). If the interval does not include "1" (no risk difference) you are fairly certain your experiment determined a greater risk (a range above 1) or a lower risk (a range below 1). We can decipher "odds ratio" another day!

Of note was that a single SNP (the C allele of SNP rs4646536 for all you gene freaks out there like me) was the culprit. The large NIH VITAL Trial will provide more definitive data on both Vitamin D and Omega-3 links to heart disease when it is completed sometime in 2014. Until at least then, I will be taking my 8000IU of Vitamin D (what I need to hit a blood level of 60ng/dL - everyone is different).

Looking out for your heart health,


HeartHawk

To Nap, Siesta, Perchance to Sleep?

Time for a "Seinfeld" blog about next to nothing. Which is about how much sleep I got last night. Along with a bottle of 2007 Malbec I just bought, it got me daydreaming about the 2007 EPIC study that drew an association between napping and heart disease. I say association because nothing in the study proved napping causes a reduction in heart disease. The EPIC people (mostly cancer researchers) simply noted that people who napped had fewer coronary deaths. It could be they are just a more laid-back bunch!

Fortunately, the CARDIA study provides some hard data on sleep and calcium scores that supports a good night's sleep. For those who are Track Your Plaque Members the TYP Library provides the best heart disease reversal "Cliff Notes" on the issue (as it almost always does). Here is the link.

Sleep and the Track Your Plaque program:Does sleep quantity or quality cause plaque to grow?

That's all for today. Time for that nap!

Looking out for your heart health,


HeartHawk

CETP Redux: Lower is Better . . . No, Wait, Higher is Better?

Higher HDL inhibits heart disease, right? CETP inhibits HDL production, right? Ergo, find an agent that inhibits CETP, raises HDL, and you will reduce heart disease right? Well, maybe! Then again, maybe not.

The torcetrapib debacle showed that CETP can be inhibited thereby generating spectacular increases in HDL but you actually increase risk due to side effects like raising blood pressure (side effects that are not produced by newer agents like anacetrapib and dalcetrapib). There is also some question that the HDL produced by CETP inhibition may be defective. Now comes a new study that shows CETP inhibition in and of itself my be atherogenic.

Given that one of my problems is low HDL, I was so damn hopeful that CETP agents would be part of my personal cure. I think it is time to bet my family farm on something else while we wait another decade for the evidence. Yes, I think it will take that long to figure it all out. I suggest we start dreaming about some other miracle advance (sigh)!

Looking out for your heart health,


HeartHawk

Cool New Heart Scan Technology

In another sign that Dr. Davis and Track Your Plaque had it right all along, a small study at Beth Israel Deaconess Medical Center of the RCadia Automated CT Analyzer provided a high negative predictive value and may help move patients quickly through the emergency room.

"the algorithm of ECG, serial enzymes, and perfusion imaging is both expensive as well as time-intensive, so clearly there is a need for a quick noninvasive test, and recent studies have shown that [coronary computed-tomography angiography] CCTA fits the bill very nicely. But there are problems with CCTA—one of them is the off-hours availability of expert coronary CTA readers,"

The automated analyzer could have a role as a second reader in the emergency-department setting as an aid to normal expert CCTA readers. It's available at all hours, it interprets raw data—there's no waiting for 3D reformats—and there are cost savings to be had from rapid triage of this group of patients,"

Dr Girish Tyagi
Radiological Society of North America 2009 Scientific Assembly.

The study pitted the analyzer the consensus interpretation of two expert readers. For 100 analyzable studies, the automated analysis yielded a negative predictive value of 98%. The COR Analyzer's overall sensitivity was 83% and its specificity was 82%. RCadia Analyzer identified five of the six patients with significant stenosis found by the expert readers (five true positives, one false negative) and yielded 16 false positives and 78 true negatives.

Not perfect but the fact that "big money" is starting to invest in the technology and hospitals are beginning to use CCTA as a replacement for the expensive, time-consuming (and wasting) series of ECGs, enzyme tests, and perfusion studies speaks volumes!

Looking out for your heart health,


HeartHawk

About Ads on This Blog

Yeah, I guess I am a phillistine now that Google Ads run on my blog. As you probably know Track Your Plaque is a non-paying gig and we refuse to run ads on the member site (members voted this down even if it meant reducing the $6.65 per month membership fee that keeps the site out of hock). So, we are experiementing with "monetization" (fancy word for running ads) on the free, non-member stuff like our blogs.

NOTE: These ads are not endorsements by me or Track Your Plaque! They are what they are, links to sites with products and services that the advertisers believe will interest readers of this blog. Caveat emptor!

Regards,


HeartHawk

Whistleblowers Unite! And Get That Second Opinion!

We can only hope that this whistleblower wins his case! Basically, this doc claims he was fired for objecting to an arrangement where by a manufacturer of medical products was offering advance access to new products (in this case a heart valve) only if a hospital raised their purchases of the company's other products (such as stents).

So, let's be clear about the allegation here. The suggestion is that if a hospital wants the latest and greatest medical technology it would have to commit to purchasing products that it decided it did not need before. LIKE MAYBE A STENT THAT MIGHT OTHERWISE HAVE NOT BEEN RECOMMENDED TO SOME UNSUSPECTING PATIENT?

The moral of the story is that the pressure to do unnecessary procedures is real. Always get a second opinion!

Looking out for your heart health,


HeartHawk

P.S. This is also why I value the posts from Track Your Plaque's "Spy on the Inside" our very own member who works in a cath lab!

Defining a Cure for Heart Disease

When can I be considered "cured" of heart disease or, more accurately, Coronary Artery Disease (CAD)? This is a subject that has plagued me for years and especially since I became involved with Track Your Plaque (TYP).

It seemed so simple at first. If I reversed or halted the progression of coronary calcium then I was "cured" (note that TYP does not make this hard claim of a cure - but you DO dramatically reduce your risk of a heart attack and I need a frame of reference to start the conversation).

The subject becomes even murkier when you consider the independent clinical experience of heart attack prevention pioneers Dr. Davis and Dr. Blanchet. Davis seem to feel that there is considerable risk reduction even if coronary calcium progresses but is held under 10% per year. Blanchet pushes the limit to about 15%. Both doctors rarely see heart attacks in their practices and other leading heart docs like Dr. Arthur Agatston (the doc of South Beach Diet fame and inventor of the gold-standard Agatston coronary calcium scoring system) made this statement.

"I'll let you in on a big secret. Physicians who practice aggressive prevention have seen heart attacks and strokes practically disappear from their practice. It's that simple — this approach [plaque reduction] can literally prevent heart attacks and strokes and save lives."

So when can I consider myself "cured" of heart disease and why is it so important to define a standard for a cure? Let's tackle the second, and easier, question first.

It is no secret I am a numbers guy. I need a target a goal. More selfishly (my competitive neurosis is showing) I need to know when I am winning and when I am losing. Put more simply, I need to know how to "keep score!" What number and unit of measure signals that I am “cured.” Even more importantly, I need a method of comparing and ultimately selecting the different heart disease treatments and programs available in my search for a cure.

To answer the first question, I believe there is a spectrum of possible standards in defining a cure for heart disease. At one end we have a practical definition, "No heart attacks." At the other end of the spectrum we have a far more complex definition, “No detectable coronary plaque.”

Without tipping my hand I’d like to ask those who read my blog to answer a simple poll question, “Under which condition would I consider myself "cured" of Coronary Artery Disease (CAD)?”

I’ll follow-up later with more thoughts on the subject of what constitutes a cure and we can begin to debate the issue!

Looking out for your heart heath (and a cure),


HeartHawk

More Healthcare Hijinks!

As a healthcare consumer advocate I always marvel at how little knowledge - even common sense - exists among so-called "health professionals." I think I'll devote series of blogs to some of my most recent "healthcare hijinks" experiences.

I get a great deal of my healthcare at a local clinic which in the past six-months has really taken great strides to improve customer service. They are very friendly, aggressive about getting back to patients about their healthcare (they even have a new online system where you can check test results as they become available), and the improvement is noticeable. But this is more a tale of inability to think on your feet - a skill that I feel is basic to the notion of healthcare.

I had some crazy TSH readings (typical of anyone with early Hashimoto's Thyroiditis) so my endocrinologist was tweaking my meds over a series of weeks. It is common for a doctor to relay information to one of their nurses who, in turn, (keep in mind these are college graduates experienced with medications and patient care) interfaces with the patient on issues such as dosage adjustments.

Let me first preface my diatribe with the fact that the nurse I am about to take to task was friendly, courteous, and worked hard to follow up with me (I am often difficult to reach because of my crazy schedule). Maybe it was just a "bad day." Nonetheless, I was left wondering just how competent the person on the other end of the phone was.

The nurse called to say the doc wanted to up my dose of Armour thyroid from 1/2 grain to 3/4 grains twice per day and the nurse asked if I wanted a new prescription. I said we could proabably still use my current prescription but would have to renew it much earlier as I will be using a 50% bigger dose. This is where the keystone cops episode begins.

The nurse remarked, "But your prescription is for 1 grain." I explained that since my dosage changes so frequently (and because it is far cheaper to do it this way) I use 1 grain pills that I simply split into 1/2 grain doses. At that she remarked, "But the doctor wants you to take 3/4 of grain." My retort was, "Yes, but I can also split the 1/2 grain pieces into 1/4 grain pieces. I could even take three 1/2 doses three times per day (which I believe would be the superior way to take any thyroid preparation containing T3)." At that point she was completely befuddled. After a short course in remedial math (which I am still not certain she comprehended) I convinced her that 1/2 grain plus 1/4 grain equaled 3/4 grains and that three 1/2 grain doses was the same amount of medicine as two 3/4 grain doses.

Afterwards, we laughed it off and she ended with,"Well, I am really not familar Armour Thyroid". What a shame for the doctor's thyroid patients! Now, even in the "far out" world of Armour Thyroid (sarcasm intended) basic math (like 1/4 plus 1/2 equals 3/4) still holds true!

As I mentioned, perhaps it was just a bad day with a little brain fog (I guess that is scary in itself). But it made me both laugh . . . and think! Of course this is not as bad as when I went to the pharmacy with a prescription for therapeutic vitamins and walked away with a prescription for coumadin - but that's another story (i.e. always read your labels)!

Looking out for your health,


HeartHawk

Finally, No More Begging and Conniving for Blood Tests

If you have heart disease or just about any serious health issue you have probably been in this boat. You don't feel right, there has been a change in you treatment, or, dammit, your just plain curious - you want a blood test. The old way was to call your doctor, wait for an appointment, then beg or connive your way into getting your doc to order the test (I have gotten REALLY good at conniving over the years). And, of course, this is no guarantee you will actually GET the test. You are at the complete mercy of the medical establishment.

BUT NOT ANYMORE!

A new technology called liquid chromatography/tandem mass spectrometry allows accurate blood assays with a single drop of blood and a paper-like carrier medium keeps the sample stable for extended periods of time and can be easily transported via mail.

BREAK YOUR BLOOD TESTING CHAINS AND BEG NO MORE!

Now you can get common blood tests ANYTIME YOU WANT! I was skeptical at first but Doc Davis finally, after his own test (that's TYP Nurse Dawn's hand in the photo - talk about giving blood for the cause), convinced me - so here is my SHAMELESS PLUG for TYP - you can review and order kits by clicking here. Oh, and one more thing, TYP members get a discount!

Regards,

HeartHawk

Common Sense: $1 Million Per Ounce

Now just how much do you think this little observation cost?

The obesity epidemic in the US is due solely to increased food intake

That's right, this "revelation" is based on reporting at the 2009 European Congress on Obesity and the combined genius and interpretation of no less than:

Deakin University, Melbourne, Australia
World Health Organization Collaborating Centre for Obesity Prevention
US Department of Agriculture
National Health and Nutrition Examination Survey
American Heart Association
American College of Cardiology

But, look at it this way. There was probably no chance McDonald's, KFC, Burger King, and Taco Bell were gonna break the news!

Would you like fries with that? Somtimes, ya just gotta laugh!

HH

Anti-Platelet Ad Nauseam

Why do I torture myself? Number 1 answer: I am a masochist, of course! I read a fair number of medical journals and reports and lately all I hear about are anti-platelet medications like clopidogrel, prasugrel (see my last post) and now ticagrelor (where the hell do they get these names - sounds like anime' characters - Ticagrelor, ruler of all Mythica!) . As I punned earlier - it's starting to get thin.

Like prasugrel, ticagrelor is not even out of trials, yet they are hyping the hell out of a product you cannot even buy. It's claim to fame (should it be determinined in Phase 3 that it does not kill more people like torcetrapib did) is that its effect is reversible - SO YOU CAN HAVE HEART BYPASS SURGERY FASTER AFTER STOPPING IT! I kid you not. Oh, and while it does not contribute to "major bleeds" to any greater extent than other agents it does show an increase in "minor bleeds." I don't know about you, but whenever I bleed I consider it a major event.

Given that the market for clopidogrel alone is $8 billion we can expect more of the same with everyone scratching for a piece of the action. Here is a clue for the rest of us.

YOU DON'T NEED ANY OF THIS STUFF IF YOU DO NOT HAVE HEART DISEASE!

Let me put it this way. An ounce of heart disease prevention (or a half ounce of heart disease reversal) is worth $8 billion of clopidogrel! Practice informed, self-directed healthcare instead of uninformed drug and surgery healthcare (Time to plug Track Your Plaque).

HH

Clopidogrel vs Prasugrel: The Arguments are Getting Thin

Watching drug manufacturers duke it out over competing products is like watching a tragic comedy - you don't know whether to laugh or to cry. Witness the latest antics in the fight over the wildly profitable market for anti-platelet drugs currently dominated by clopidogrel.

Clopidogrel (Plavix most notably) has been around for years as a first line anti-thrombotic with indications for use in numerous cardiovascular conditions including post-surgically after stent implantation. Given its age it has also been studied extensively and all its warts are well-known.

Most comic is the fight for dominance between clopidogrel and prasugrel. I say comic for one major reason - prasugrel is still under investigation - you can't even get it in the US at this point. But this hasn't stopped the marketers from attempting to pit it against clopidogrel which goes off-patent in 2011.

The latest "hit job" on clopidogrel comes from analysis based on the TRITON-TIMI 38 trial. Researchers dicovered that there are several common gene variants among patients receiving clopidogrel that may reduce its effectiveness thereby increasing the risk of subsequent heart attack, stroke, and mortality. What was conveniently NOT CONCLUDED was whether simply taking more clopidogrel could overcome this reduced response.

Now guess who is a major sponsor of the TRITON-TIMI 38 trial? If you guessed Daiichi Sankyo and Lilly, the two co-developers of prasugrel, you win today's Sherlock Holmes award! Now, do you suppose anybody has studied whether certain gene variants affect the efficaciousness of prasugrel - not yet - but you have to wonder what the folks at Bristol-Meyers (the holder of the Plavix patent) are working on.

Now, don't get me wrong, I love a good fight. Let the druggies battle it out. But as consumers we need to cast a watchful eye over the message. Prasugrel is not even FDA approved yet and there are no long-term studies on it. Who know what warts may pop up. Your genetics may indeed sway you away from clopidogrel one day but don't think it is without its own, at present, hidden warts.

The devil you know may be better than the devil you do not. Of course, here is where I plug informed, self-directed health care programs like Track Your Plaque which offer tangible results in preventing and reversing heart disease. The ONLY real solution is to never need clopidogrel OR prasugrel in the first place!

Looking out for your heart health,


HeartHawk

I'm Baaaa ... aaack!

Yes, the reports of my demise are greatly exaggerated. I'd like to say something artsy like, "I was taking a sabbatical to 'rediscover my voice'." - but that would be a load of crap. The truth is more akin to being really busy and not sure what to write. But, "being busy" is nothing but an excuse. People MAKE TIME to do what they like! And how can an arrogant and opinionated guy like me not know what to write? Here's my answer.

I write a lot. But every forum has it's boundaries and rules of decorum. Also, it is a little dishonest to post the same material on multiple blogs (not to mention that sites that have you under contract get a wee bit upset if you repost paid for material on free sites). So, where am I going with this - back to my roots!

On other blogs I have to be the "good cop." This blog is my outlet to be the "bad cop!" Expect my prose to be biting, opinionated, edgy, and designed to draw both complements and criticism. It is done from my heart (pun intended) and without apology. I may go after third parties but am ALWAYS respectful of commenters - so let's debate. If you are one of those third parties then comment back and watch my tone change. My opening shots are intended to get your attention - not wound! We may not always like it but we are in this together.

When I started this blog it was to be a no holds barred comment on the state of heart health care. I promised, "a hell of a ride" so hold on tight - be mad, be glad, be anything but but bored!

Regards,


HeartHawk

More Customer No-Service

There was recent post on the Track Your Plaque Member Forum about hand-held body-fat analyzers that piqued my interest. I wondered if they really work. So, I attempted to contact the company in question. Their on-site customer service e-mail form did not work so I went "under the hood" of their website (it's great to know these tricks) to get the internal e-mail address (which they do not publish) used by the form so I could send it myself. Here is what I sent.

Your website contact form did not work – it kept asking to supply a “referrer” for which I saw no field to enter. Here is my question

What is the difference in technology and accuracy of your products that offer "two point" versus 'full body" sensing. I’d like to understand the technical difference before I select which of your fat analyzer products to buy.

Thanks

I got this curious reponse.

Dear Mr. Hearthawk:

Thank you for the email this morning and the opportunity to address this issue with you. I am happy to assist you in getting this situation resolved.

I certainly apologize for the issue you describe in your email. Unfortunately, there are some issues that need more intervention than email provides and I believe this is one of them, simply in the interest of time for you. In order to best serve you, please call our Consumer Support team, toll-free at 800-634-4350. Our trained representatives are available Monday through Friday, 830a to 430p CST to assist you over the phone and try to resolve your issue without sending your unit in for repair. If repair is necessary, we can set up your file to start the process or provide valuable options to your particular situation.

Please have the following information available in order to expedite your call:

1. Model number (from the sticker on the back/bottom of the unit)
2. Serial number (from the sticker on the back/bottom of the unit)
3. Proof of purchase
4. Your case number of 1205305

We appreciate your interest in our products, thank you for contacting Omron Healthcare and look forward to hearing from you soon.

Jennifer Kelly Customer
Service Representative
Consumer Support
Omron Healthcare, Inc.

Ahhhh, this e-mail is so obtuse in so many ways.

1. I did not send the e-mail "this morning." I sent it weeks earlier.
2. I did not have any complaint. I asked a simple question. What are they apologizing for?
3. I do not own any Omron products. I trying to determine whether the hand-held model would serve my purposes.
4. Aren't they even a tiny bit interested in why their customer support form doesn't work?

I did call the representative who agreed that neither the hand-held or foot-scale models would be accurate given they only measure half your body. They suggested that for accuracy you buy their more expensive model with both foot and hand sensors.

Brilliant! They were late, clearly never read my e-mail, droned on in a non-repsonsive way, never bothered to inquire about their non-functional web-form. All the hallmarks of a company who pretty much doesn't give a damn about their customers.

HH

A CETP Phoenix Rising from the Ashes of Torcetrapib?

Gene investigation and pharmaceutical research may be working together to revive cholesterol ester transfer protein (CETP) inhibition as a means of combating heart disease. The failure (both therapeutic and financial) of Pfizer's novel CETP inhibition agent "torcetrapib" literally pushed Pfizer off the heart drug development cliff and with it perhaps the finest heart drug research team in existence.

But recently, the Women's Genome Health Study led by Dr. Paul M Ridker has discovered variants in the gene for CETP that impact heart attack risk. They note that the risk is partially but not completely reduced by a rise in HDL. Torcetrapib was found to raise blood pressure (BP) along with other adverse effects such as effects on aldosterone. It was thought that these effects overwhelmed the postive effect of raising HDL. This new study raises the hope that the negative effects were only peculiar to torcetrapib but not other similar agents.

Merck's anacetrapib and Roche's dalcetrapib are two potentional CETP inhibitors in Phase 2 and Phase 3 trials repectiviely that do not exhibit the toxic effects found with torcetrapib. Dr. John Kastelein, who is involved with both trials added, "When you have a number of patients in different clinical studies and there is still doubt about whether the mechanism works at all, research such as this by Ridker et al is good . . . torcetrapib was about the worst choice Pfizer could have made. They thought a few millimeters of mercury were nothing compared with the immense power of a 70% increase in HDL-C. But everyone was lulled to sleep—no one understood at the time that the elevation of blood pressure was only the tip of the iceberg and below that was a whole metabolic derangement that was extremely harmful."

The Women's Genome Health study was divided into two parts. First, they looked for common genetic variants associatied with HDL. Baseline HDL was measured among the 18,245 particpants (caucasion females at or above 45 years of age) who were followed for ten years. They discovered nine locations in the genome with at least one genetic variant or SNP (single nucleotide polymorphism) that were associated with HDL. Eight of these locations were already known to influence HDL, but one was new.

The second and most important part of the work found that among all the SNPs associated with raising HDL, all those linked to lowering heart attack risk were found on the CETP gene sequence. Whenever a CETP SNP raised HDL it also reduced heart attack risk. One such CETP SNP (rs708272) was associated with a 3.2 mg/dL increase in HDL and a 24% lower risk of heart attack. Such as small HDL increase should not produce such a profiund reduction in risk. Something else is clearly going on!

Perhaps this is not the end of the line for CETP agents that some had predicted. The Phoenix may be rising!

Looking out for your heart health,


HeartHawk