Monday, April 9, 2012

I Want My XZK!

Recently I have been developing written handouts for my patients regarding cardiovascular disease (CVD) prevention.  As I was researching over-the-counter (OTC) supplements for heart health, and assessing the scientific validity behind them, I came across a stunning study from China which indicates that Xuezhikang (XZK), a preparation of a common dietary supplement, red yeast rice (RYR) may be more effective at preventing CVD than any of the prescription drugs marketed by Big Pharma.

Extracts of RYR have been used as a food flavoring and for therapy of circulatory disorders in China for centuries.  These extracts can lower cholesterol primarily because of the presence of substances known as monacolins.  One of these, monacolin K, is identical to lovastatin, which was originally isolated from a mold.  Lovastatin was subsequently found to lower cholesterol by interfering with an enzyme critical for its production, and was marketed as Mevacor, after approval by the FDA.

Mevacor was the first of a class of drugs known as "statins" which are the most common drugs used to treat high cholesterol in this country.  Marketed under brand names such as Zocor, Lipitor and Crestor, these drugs became a multi-billion dollar industry in the 1990's and 2000's.  Lipitor alone was responsible for $12.4 billion in sales in 2008.  In the mean time, dozens of clinical studies were performed to show the benefits of statins in reducing CVD risk in a broader range of patients, including those with normal or modestly elevated cholesterol levels who were not considered candidates for statin therapy just a few years previously.  Researchers, pharmaceutical companies and the FDA were all acting to ensure that more and more people would be candidates for their "wonder drugs".

In 1998, the FDA ruled that since monacolin K is identical to lovastatin, that RYR products containing it were subject to regulation as drugs, and banned them.  In 2003 RYR products began to trickle back into the market.  If they made no claims about cholesterol and did not contain monacolin K, then RYR products were not subject to FDA regulation.  In 2007 the FDA issued a statement warning that consumers should "…not buy or eat red yeast rice products…may contain an unauthorized drug that could be harmful to health".  From the FDA's perspective, consumers might not realize that they were exposing themselves to the potential side effects of lovastatin, including liver damage, muscle aches, and kidney failure.

XZK (Xuezhikang) is a partially purified RYR with multiple components.  Each 300 mg. capsule contains about 3 mg. of lovastatin, so the recommended dose of 4 capsules daily means a 10-15 mg. dose of lovastatin daily.  The usual recommended daily dose of Mevacor is 40-80 mg. 

Between 1996 and 2003, nearly 5,000 Chinese patients with a documented history of a heart attack were entered into a study to determine whether XZK could prevent subsequent heart attack, need for angioplasty and bypass surgery, and the risk of death from all causes, as well as from heart disease specifically.  The average level of LDL-Cholesterol (LDL-C, "bad cholesterol") in the study group was 129.  U.S. guidelines recommend an LDL-C level of under 100 in patients like these, under 70 if they are diabetic.  Each patient was followed for an average of 4.5 years.

The results were astonishing.  Fatal and non-fatal heart attacks were reduced by 33% and 62% respectively.  Total cardiovascular deaths were reduced by 30%, and all-cause deaths were reduced by 33%.  Although not a primary or secondary endpoint of the study, cancer deaths in the XZK group were reduced 56%.  These impressive results were obtained despite the treatment group experiencing a relatively modest 18% drop in LDL-C.  Statins at typically used doses lower LDL-C from 35-50%.   No serious side effects were reported in those taking XZK, and the number of patients in the two groups who experienced any side effects or discontinued treatment was the same.

How impressive are these results?  The CARE (Cholesterol And Recurrent Events) trial, which utilized pravastatin in a very similar patient population, demonstrated only a 24% reduction in fatal and non-fatal heart attack, and no significant reduction in all causes of death.

There are a few caveats here, most obviously, the question of whether the results of a study done on a (presumably) Chinese-only population are applicable to a US population consisting of many ethnic groups, and whether other formulations of RYR are as effective as XZK in reducing CVD risk.  There is speculation that XZK's non-monacolin  components, such as isoflavones (antioxidant compounds found mostly in legumes, which are thought to reduce the incidence of some cancers) may have contributed to the results.

So where can you get this amazing, natural supplement that may significantly reduce the risk of dying of a heart attack or cancer?  The short answer is, you can't.  XZK's lovastatin content prevents it from being sold in the United States, and other forms of RYR don't have the weight of a large clinical trial behind them.  Intrepid online shoppers, however, may be able to find a source.

Thursday, April 5, 2012

Trayvon Martin: I don't know but I've been told...

In following the Trayvon Martin tragedy, the only thing that seems certain is that nobody reporting on this has any idea what really happened the night of Feb. 27 in a gated community  near Orlando.  From the beginning, the media coverage of the case, spearheaded by that icon of dispassionate journalistic integrity, the Rev. Al Sharpton, has been at best sloppy and inaccurate, and at worst deliberately distorted in order to pander to the race baiting lynch mob.

Today CNN backed off from reports that an "enhanced" recording of Zimmerman's 911 call revealed him using a racial slur.  New analysis of the tape reveals that Zimmerman said "f***ing cold", not f***ing coon", as has been widely reported.

Earlier this week NBC apologized for an "error" after a 911 call from the shooter, George Zimmerman, leader of the neighborhood block watch, was edited in order to make it appear that Zimmerman racially profiled Martin.  Here is NBC's edited version...

Zimmerman: “This guy looks like he’s up to no good.... He looks black,”

And the unedited version...

Zimmerman: "This guy looks like he’s up to no good. Or he’s on drugs or something. It’s raining and he’s just walking around, looking about,”

Dispatcher: “OK, and this guy – is he black, white, or Hispanic?”

Zimmerman: “He looks black.”

Photos of Martin and Zimmerman were both badly out of date, depicting Martin as a baby-faced tweener, and a Zimmerman as a frowning pudgy man.


It would be weeks before more recent photos like the ones below surfaced.  Like the 911 tape edit, the national media's choice of photographs seems calculated to support its preconceived analysis of the case. 


It was reported that Zimmerman had called the police 46 times since January 1 of 2011.  Somebody did not fact check, a recurring theme in the reporting on this case.  Although Zimmerman did call the police 46 times, logs released by the police show that the calls were made over a period of more than 7 years, not 14 months.  Only 5 of those calls reference black males.

The Fox News affiliate in Orlando, on the day following the shooting,  interviewed an eyewitness to the struggle between Zimmerman and Martin prior to the shot being fired.  The witness claims to have seen Martin on top of Zimmerman, with Zimmerman crying for help, directly corroborating Zimmerman's story.  For 25 days, while the lynch mob was whipping up a public frenzy, WOFL (rhymes with "waffle") did not report on the interview.  When they finally did air a story, they disingenuously attributed it to "someone we have not heard from before".

The media have repeatedly reported that Zimmerman outweighed Martin by 100 lbs. or more.  Police estimated Martin's weight at 160 lbs.  He stood between 6'1" and 6'3" tall.  Zimmerman is 5"7"-5"9' tall and currently weighs 170-190 lbs.

It is being reported as fact that Zimmerman continued to follow Martin after being told not to by the police dispatcher.  This is the crux of this story.  If Zimmerman continues to follow Martin after being told not to by the police dispatcher, then many, including myself, believe that Zimmerman forfeits any protection under the "stand your ground" law.  If, as Zimmerman claims, he returned to his vehicle and was sucker-punched by Martin then he had every right to defend himself.

It is clear from the 911 tapes that an out of breath Zimmerman was chasing Martin when told by the dispatcher that he should stop.  Zimmerman says "OK", and makes arrangements to meet the police.  The call goes on for almost 2 minutes after Zimmerman says he stopped following Martin.  No footsteps or wind noise can be heard as Zimmerman tells the police how to find him.  There is no indication that Zimmerman continued his pursuit of Martin after being told not to.

Zimmerman's story must be viewed with skepticism.  There is nobody left alive to refute it.  And it doesn't pass the smell test.  Where are Zimmerman's bloody clothes?  Where is the documentation of Zimmerman's injuries?  Why wasn't Zimmerman tested for alcohol and drugs?  What happened between the time Zimmerman says "OK" to the dispatcher's instructions to stop following Martin and the moment of the fatal gunshot?

But the story the lynch mob is telling is so full of outrageous lies and distortions, it makes Zimmerman's account look better by comparison every day. Zimmerman's past brushes with the law and his numerous 911 calls to police are considered fair game, as is speculation that his father, among others, conspired to keep him from being charged with a crime.  Any digging into Martin's past is met with claims of smearing Martin's reputation, blaming the victim, lack of relevance, and, of course, racism.  I guess it's not relevant that Martin was in Zimmerman's neighborhood that day because he was serving a 10 day suspension from school for an undisclosed third violation of school policy, and to ask why he was suspended for that length of time proves that you are a racist.

The race card has been played in this early and often. A selection of quotes...

"Your entire police department is nothing more than a collection of incompetent, bigoted, unprofessional a**holes." --Tracey Martin, Trayvon's father


"He was executed for 'WWB' in a 'GC.' Walking While Black in a Gated Community."--Georgia Rep. Hank Johnson

"This investigation is laced with racial profiling, lies and murder. Trayvon was hunted, chased, tackled and shot. -- Florida Rep. Fredrica Wilson

"This case demonstrates profound racial inequality, not only juvenile -- it also demonstrates the racial profiling in this country,"--Jesse Jackson

What is so mind-boggling about the incident is that so many people have reached unshakable conclusions about exactly what happened that night when almost none of the facts are known.  There is almost no credible evidence in the public record that sheds light on what really happened.  We have several 911 calls, one of which was deliberately edited to support the notion that Zimmerman racially profiled Martin.  Another has been trotted out, like a Rorschach test for racism, in which seemingly everyone hears what they expect to hear.  A third recording, which chillingly captures someone's screams, which are stifled after a single gunshot, has been offered as evidence that Martin, not Zimmerman was screaming prior to the fatal shot.  This despite the fact that Zimmerman's voice scored a 48% match, and Martin's voice was not checked against the 911 tape. We have seen the initial police report, which indicates that Zimmerman had grass stains on his back and was bleeding from his nose and head.  And, of course, the surveillance footage from the police station taken approximately 25 minutes after the shooting occurred, which, on the surface at least, do not seem to show the injuries Zimmerman claims to have sustained.

That's it.  Some 911 calls, a redacted police report and a few minutes of surveillance video.  That's all we know about the Trayvon Martin shooting, everything else is just what we've heard, and everyone doing the talking seems to have an axe to grind.