Why fish stomps flax as a source of omega-3

May 5, 2010 in Food & Nutrition, Myths & Truths

 

I want to thank everyone for sending in their questions and voting on the next topic. The good news is that there’s a lot of interest in all of the topics I’m researching right now. The bad news is that there was no clear winner.

 

I’ve decided to go ahead with the series on fish and fish oil, but I may write about thyroid and diabetes simultaneously. I’m also going to experiment with shorter (although I’m clearly breaking that rule here), but more frequent, articles. Hopefully these will be easier for me to write and for you to read.

Finally, stay tuned for the first episode of The Healthy Skeptic audio podcast, coming up next week. I’ll be interviewing Stephan Guyenet, Ph.D, on the subject of obesity and weight regulation. Stephan is a senior fellow at the University of Washington studying the neurobiology of body fat regulation. He’s also the author of Whole Health Source, which is one of my favorite health related blogs.
Before we get into talking about the benefits of fish consumption, or how how much fish or fish oil you should eat, it’s probably a good idea to start with a basic review of the omega-3 fatty acids.

Essential Fatty Acids 101

A fatty acid is a chain of carbon, oxygen and hydrogen atoms with a carboxyl group on one end. Fatty acids are classified on the basis of how many carbon atoms are in the chain, as well as how many double bonds exist within the molecule.

Fish contain a variety of fatty acids, but the ones that are believed to confer the majority of the benefits are the long-chain omega-3 fats eicosapentanaenoic acid (EPA) and docosahexaenoic acid (DHA). These omega-3 fats are found exclusively in seafood and marine algae.
As you can see from the chart below, it is also possible for the body to synthesize EPA and DHA from the short-chain omega-3 alpha-linolenic acid (ALA). ALA is found in plant foods such as flax, hemp and pumpkin seeds and walnuts.

Click thumbnail for a larger version

However, research clearly indicates that the conversion of ALA to EPA and DHA is extremely limited. Less than 5% of ALA gets converted to EPA, and less than 0.5% (one-half of one percent) of ALA is converted to DHA.

A common misconception, especially amongst vegetarians and vegans, is that our need for EPA and DHA can be met by consuming flax oil and other plant sources of ALA. But the conversion numbers above clearly indicate that this isn’t the case.

Studies have shown that ALA supplements (like flax oil) are unable to raise plasma DHA levels in vegans, despite low DHA levels at baseline. (ref) So unless they are supplementing with an algae-derived source of DHA, it is likely that most vegetarians and vegans are deficient.

This is significant because researchers now believe that the majority of the health benefits we get from dietary omega-3 fats come from the longer chain derivatives (especially DHA, as I will explain below).

Is DHA essential?

In fact, some researchers have proposed that DHA is essential. When scientists label a nutrient as “essential”, they they’re not just saying that it’s “very important”. In the context of nutrition essential means that the nutrient cannot be synthesized in the human body, and must be derived from dietary sources.

According to today’s nutrition textbooks, there are only two essential fatty acids, omega-6 linoleic acid (LA) and omega-3 alpha-linolenic acid (ALA). It is believed that as long as these fats are present in the diet, all of the longer-chain omega-3 and omega-6 derivatives can be synthesized in the body.

As I pointed out above, while this is theoretically possible, in reality the conversion doesn’t work well. This is true even for healthy people, but it’s especially true for those with nutrient deficiencies, because the conversion of ALA to DHA depends on zinc, iron and pyridoxine.

The bioavailability of iron in plant sources is poor compared to animal sources, so iron deficiency is common in vegans and vegetarians. This is another reason why they tend to be poor converters of ALA to DHA.

Several other observations support the hypothesis that DHA is essential:

• DHA content in the tissues of all mammals is very similar despite widely varying intakes of omega-3 fatty acids. ¹
• DHA and AA, but not other omega-3 or omega-6 fatty acids, are selectively transferred across the placenta (PDF).
• 60% of the dry matter of the brain is lipid, and DHA and AA are the most abundant fatty acids of brain phospholipids (PDF)
• DHA status in newborns is much lower in those receiving formula with LA and ALA, than in those receiving milk or formula with pre-formed DHA (PDF)

It is possible that the primarily carnivorous diet of our ancestors, which ensured a consistently high dietary intake of DHA and AA, precluded the need to evolve efficient conversion mechanisms.

In other words, since we were eating a lot of meat and fish with pre-formed DHA and AA, our bodies didn’t need to be experts at converting ALA and LA in plants to DHA and AA. It is far easier for the body to assimilate pre-formed DHA and AA than it is to synthesize them from precursors.

What about EPA? Isn’t it essential too?

EPA is another long-chain omega-3 fatty acid that is conventionally believed to be responsible for the benefits of fish consumption.

EPA is often referred to as “anti-inflammatory”. However, according to this report on essential fatty acids by Masterjohn, EPA’s effect seems to be more of an interference with the metabolism of omega-6 arachidonic acid (AA) than the performance of any essential role itself.

Take a look at the chart again that I linked to in the beginning of the post. The fatty acids in blue boxes are less inflammatory, and those in pink boxes are more inflammatory. The chart shows that AA is used to synthesize prostaglandins that cause inflammation (indicated by the pink box on the chart). Because it has the same number of carbon atoms, EPA competes with AA for the enzymes that metabolize it. Since the prostaglandins made by EPA are less inflammatory than those made by AA (indicated by the blue box), EPA is often referred to as “anti-inflammatory”.

But while EPA is certainly less inflammatory than AA, it doesn’t make sense that the body would require an essential fatty acid just to block the inflammatory effects of of another fatty acid.
By contrast, DHA is used to synthesize compounds that play an active role in resolving inflammation. EPA only makes these compounds in the presence of aspirin (PDF). EPA is thus likely to simply be a byproduct of compromised DHA synthesis.

What does this mean to you?

Putting all of this information together yields the following conclusions:

1. DHA is the most important of the omega-3 fatty acids, and is primarily responsible for the benefits we get from consuming them.
2. DHA is likely to be essential, which means that you must consume it in the diet to prevent disease and ensure optimal function.
3. The conversion of plant sources of ALA, such as flax seed oil, to DHA is poor in healthy people and even worse in people deficient in certain nutrients. Vegans and vegetarians are especially prone to be poor converters of ALA to DHA.
4. If you’ve been buying flax oil in the hopes that it will help, you’d be far better off putting that money towards some fish or fish oil capsules.

Dietary changes over the past century have lowered the DHA status to a state of subclinical deficiency in many people. Countless studies show that this deficiency is at least in part to blame for the rising incidence of cardiovascular disease, inflammatory disease, mental and psychiatric disorders and suboptimal neurodevelopment.

DHA is not the only reason to eat fish, which is also rich in selenium and vitamin D. However, DHA is likely to be the primary reason why populations that eat fish on a regular basis have consistently been shown to healthier than those that don’t. We’ll discuss this further in the next article.

1. Jones PJH, Kubow S. Lipids, Sterols, and their Metabolites. In: Shils ME, et al., eds. Modern Nutrition in Health and Disease: Tenth Edition. Baltimore, MD; Philadelphia, PA: Lippincott Williams & Wilkins (2006) pp. 92-122.

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http://chriskresser.com/why-fish-stomps-flax-as-a-source-of-omega-3

Massaging the truth

Posted on March 7, 2012 by Dr. Davis

Massage therapist, Jonathan Sugai, posted this interesting comment on Amazon:

I first learned about Wheat Belly back in September 2011 in Northern California. My friend Seamus was eating some chili out of a can while we were waiting for our class at a seminar to start. I asked him why he was doing that and he said, “You gotta read this book called Wheat Belly!”

After he explained what the book was about, how quickly and dramatically his situation improved (his digestion turned around very quickly!), it made total sense why he was eating chili out of a can even though we had plenty of food served (most of it had some form of wheat in it!).

I immediately downloaded the book off Amazon and finished reading it on my way back home to Hawaii and my view on food had totally shifted. Life would never be the same again!

I knew eating bread would contribute to weight gain, however learning about all the OTHER information about the hybridization, the Gliadin, and all the blood sugar, inflammation, digestive, and neurological effects, OMG!!!

I am a massage therapist and part of a family business and now it is clear why we have so many people coming in with so many aches, pains, & injuries from seemingly routine activities. It is clear to me that consuming a diet with wheat triggers inflammation and creates all sorts of systemic problems and their bodies are no longer able to tolerate typical activities.

I realize why I’m seeing more clients not responding to our techniques that used to work well. The techniques are great, however the clients that are coming in are unhealthier than ever with rampant inflammation, pre-diabetic / diabetic, high cholesterol, nervous systems interfered with by gliadin, overweight, etc. etc. etc.

All of our clients who have made the transition to wheat free have lost weight, have more energy, and most of the joint pains and stiffness have gone away and their massage treatments are enjoyable again and we aren’t putting out fires anymore!

It is our responsibility to share and let everyone know in order to create change. Our friends & family will continue to see their health degrade if they continue on this path.

Until reading his comment, it hadn’t occurred to me that massage therapists could provide some very interesting observations on wheat elimination. I find it fascinating that, once his clients said goodbye to wheat, they responded better to his efforts.

Any other massage therapists out there that would like to weigh in?

http://www.wheatbellyblog.com/2012/03/massaging-the-truth/

How to Be the World's Worst Patient

Admitedly this part of the complete article is somewhat out of context since the leadin has been omitted here. I therefor encourage you to to trat the complete article here.
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How to Be the World's Worst Patient

....if you want to be considered the world's worst patient:

1. Do research: The worst thing you can do is to come into a doctor's appointment with a strong body of knowledge. Your doctor spent eight years in medical school. How dare you do your own research! This makes the doctor think you think you know more than he does. Harming his or her ego is an unforgivable error. Your best bet is to remain completely, totally ignorant and to rely on your distracted physician to take a complete health history, order tests based on their wisdom - never yours, and correctly diagnose you and write a prescription in under five minutes. They have practice quotas to fill, after all.
   
2. Ask your doctor to run tests they haven't ordered: Silly, silly patient ... do you seriously think you know more about your own body than your doctor does? How dare you question their wisdom! Just do what they tell you and trust that they know better than you do. On a serious note ... I'm not talking about asking your doctor to run unnecessary or extreme tests, I'm talking about asking your doc to add simple blood tests to the blood work s/he ordered, or to request a different type of test if your research has shown the type of test that was ordered is often incorrect or insufficient. You hired the doctor; they work for you. You have a right to request specific tests. Be prepared to prove and justify your request, but know that you definitely have the right to request additional testing if you believe it's warranted.
   
3. Refuse a prescription: The best option for every condition under the sun is obviously a prescription, so don't you dare ask to try to address something without a prescription. How dare you! Again on a serious note, I'm not talking about refusing a life-saving prescription or refusing to take a prescription to control a condition that could cause permanent damage, such as Type 1 diabetes or high blood pressure. I'm talking about asking your doctor to consider other options for mild conditions that are often corrected using lifestyle changes, or issues where your blood work is normal but on the verge of being abnormal.
   
4. Request a different prescription: Again, how dare you presume that you know more than your physician! I was once fired as a patient because I requested an alternative prescription for my thyroid condition. I happily shook the dust off my feet and moved on without looking back. The end result was that the alternative prescription, from a natural source that provided additional hormones, was an absolute life-changer that brought my blood levels to normal for the first time in years. The bottom line is that many new pharmaceuticals are put on the market each year. It is virtually impossible for your physician to know everything there is to know about every new prescription medication. Additionally, some health conditions have multiple prescription options. Many MDs fall into the habit of only prescribing one or two, usually because the sales rep for those meds did a really good job. No MD can say he or she knows every single side effect for every pharmaceutical. I once had a client who told his physician the medication the doctor prescribed was known to cause kidney damage. The physician very condescendingly told him he was wrong. This poor man came to see me because his kidney function fell to 40% after taking that prescription. If you are aware of side effects your physician is not, feel free to share your concerns and request an alternative. Take documentation proving your concerns if needed. If your MD refuses to consider your request, it may be time to interview new physicians. (On a side note to thyroid patients, hair loss is a known side effect of Synthroid that is listed in the patient information sheet, yet many physicians are unaware of and deny that side effect. If hair loss is an issue and you're on Synthroid or one of its generic alternatives, it may be time to consider alternatives and to make sure your dosage is correct.)
   
5. Mention another doctor: Silly, silly patient ... are you foolish enough to think that two heads are better than one and that another doctor's opinion might help provide more insight into your care? Blasphemy! It often makes sense to get a second opinion. I've spoken with patients who maintain relationships with three different holistic MDs simply because they want a variety of opinions and options. Having multiple doctors doesn't express a lack of faith in one, it simply communicates that you want the broadest depth of expertise applied to your case. It's fine. There is a limit, however. Running from doctor to doctor in search of one who will tell you what you want to hear is not always wise. Use common sense. If you come across a doc who is offended you have more than one doctor, it may be time to move on.

There you have it. So, tell me: Are you a "good" patient or "bad"?
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Good Works Wellness - Pamela Reilly

http://goodworkswellness.blogspot.com/

Fish oil: The natural triglyceride form is better

Posted on February 2, 2011 by Dr. William Davis

If you have a choice, the triglyceride form of fish oil is preferable. The triglyceride form, i.e., 3 omega-3 fatty acids on a glycerol “backbone,” is the form found in the body of fish that protects them from cold temperatures (i.e., they remain liquid at low ambient temperatures).
Most fish oils on the market are the ethyl ester form. This means that the omega-3 fatty acids have been removed from the glycerol backbone; the fatty acids are then reacted with ethanol to form the ethyl ester.

If the form is not specified on your fish oil bottle, it is likely ethyl ester, since the triglyceride form is more costly to process and most manufacturers therefore boast about it. Also, prescription Lovaza–nearly 20 times more costly than the most expensive fish oil triglyceride liquid on a milligram for milligram basis–is the ethyl ester form. That’s not even factoring in reduced absorption of ethyl esters compared to triglyceride forms. Remember: FDA approval is not necessarily a stamp of superiority. It just means somebody had the money and ambition to pursue FDA approval. Period.
Taking any kind of fish oil, provided it is not overly oxidized (and thereby yields a smelly fish odor), is better than taking none at all. All fish oil will reduce triglycerides, accelerate clearance of postprandial (after-eating) lipoprotein byproducts of a meal (via activation of lipoprotein lipase), enhance endothelial responsiveness, reduce small LDL particles, and provide a physical stabilizing effect on atherosclerotic plaque.

But if you desire enhanced absorption and potentially lower dose to achieve equivalent RBC omega-3 levels, then triglyceride forms are better.

Here are cut-and-pasted abstracts of two of the studies comparing forms of fish oil.

Bioavailability of marine n-3 fatty acid formulations.

Dyerberg J, Madsen P, Moller JM et al.

Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, Copenhagen, Denmark.

Abstract

The use of marine n-3 polyunsaturated fatty acids (n-3 PUFA) as supplements has prompted the development of concentrated formulations to overcome compliance problems. The present study compares three concentrated preparations – ethyl esters, free fatty acids and re-esterified triglycerides – with placebo oil in a double-blinded design, and with fish body oil and cod liver oil in single-blinded arms. Seventy-two volunteers were given approximately 3.3g of eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA) daily for 2 weeks. Increases in absolute amounts of EPA and DHA in fasting serum triglycerides, cholesterol esters and phospholipids were examined. Bioavailability of EPA+DHA from re-esterified triglycerides was superior (124%) compared with natural fish oil, whereas the bioavailability from ethyl esters was inferior (73%). Free fatty acid bioavailability (91%) did not differ significantly from natural triglycerides. The stereochemistry of fatty acid in acylglycerols did not influence the bioavailability of EPA and DHA.

(Full text of the Dyerberg et al study made available at the Nordic Naturals website here.)

Eur J Clin Nutr 2010 Nov 10.

Enhanced increase of omega-3 index in response to long-term n-3 fatty acid supplementation from triacylglycerides versus ethyl esters.

Neubronner J, Schuchardt JP, Kressel G et al.

Institute of Food Science and Human Nutrition, Leibniz Universität Hannover, Am Kleinen Felde 30, Hannover, Germany.

Abstract

There is a debate currently about whether different chemical forms of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are absorbed in an identical way. The objective of this study was to investigate the response of the omega-3 index, the percentage of EPA+DHA in red blood cell membranes, to supplementation with two different omega-3 fatty acid (n-3 FA) formulations in humans. The study was conducted as a double-blinded placebo-controlled trial. A total of 150 volunteers was randomly assigned to one of the three groups: (1) fish oil concentrate with EPA+DHA (1.01?g+0.67?g) given as reesterified triacylglycerides (rTAG group); (2) corn oil (placebo group) or (3) fish oil concentrate with EPA+DHA (1.01?g+0.67?g) given as ethyl ester (EE group). Volunteers consumed four gelatine-coated soft capsules daily over a period of six months. The omega-3 index was determined at baseline (t(0)) after three months (t(3)) and at the end of the intervention period (t(6)). The omega-3 index increased significantly in both groups treated with n-3 FAs from baseline to t(3) and t(6) (P < 0.001). The omega-3 index increased to a greater extent in the rTAG group than in the EE group (t(3): 186 versus 161% (P < 0.001); t(6): 197 versus 171% (P < 0.01)). Conclusion: A six-month supplementation of identical doses of EPA+DHA led to a faster and higher increase in the omega-3 index when consumed as triacylglycerides than when consumed as ethyl esters.

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Read the full article here.

30 Things You Need to Know about Medical Devices: Approvals, the Industry, and Safety

Feb. 27, 2012
* All of the facts below and additional information are compiled in the Public Citizen report, Substantially Unsafe, available at http://pubc.it/rMDUFA.

MONEY, POLITICS, AND PROFIT, BY THE NUMBERS

1.	In the third and fourth quarters of 2011, Congress, the White House, the Food and Drug Administration (FDA), and other executive branch agencies received visits from at least 225 registered lobbyists for the medical device industry.
2.	Of the 225 registered industry lobbyists, 106 (47.1 percent) previously held positions as congressional staff or in federal agencies.
3.	At least 36 device industry lobbyists hosted campaign fundraisers for members of Congress in 2011. These 36 lobbyists held 40 separate fundraisers for 31 members of Congress.
4.	The record shows that large companies with big profits are invoking the alleged plight of small companies to win a more permissive process for themselves.
5.	Collectively, the U.S. device industry earned $12.4 billion in profits in 2010, a 57 percent increase over its $7.9 billion profits in 2009.
6.	Five of the seven medical device companies spending the most on lobbying since 2007 are members of the Fortune 500.
7.	From 2011 through January 2012, medical device industry representatives had 30 meetings with the FDA, while consumer groups had only 12 meetings.
8.	The device industry made more than $19.9 million in campaign contributions between the 2006 and 2012 election cycles.

FLAWED APPROVAL PROCESSES

9.	Every year, the FDA receives reports of more than 200,000 device-related injuries and malfunctions, and more than 2,000 device-related deaths, according to an FDA consultant.
10.	The FDA’s Premarket Approval (PMA) process is intended to assess the safety and effectiveness of high-risk medical devices, including life-sustaining devices such as pacemakers, heart valves and implantable cardioverter-defibrillators (ICDs). The standard for approving a device under the PMA process is much lower than the one required to approve drugs. The approval of a new drug requires at least three phases of clinical testing, including at least two randomized, controlled, phase 3 clinical trials in most cases. In contrast, a PMA application for a device typically does not require more than one clinical trial, and that trial need not be as scientifically rigorous as would be required for a new drug.
11.	Only 1 in 100 new moderate- or high-risk devices are approved under the PMA process, which is ostensibly for high-risk devices. Most are approved through much less rigorous processes.
12.	Device makers are immune from most product liability claims arising from allegedly defective devices if the device in question was approved under the PMA process. That is, if the FDA approves a dangerous or defective device through the PMA process, federal law generally bars consumers harmed by the device from seeking redress in court.
13.	510(k) Clearance – A 1976 federal law also allows future proposed medical devices to be cleared under the 510(k) process if applicants demonstrate that the new device is “substantially equivalent” to a device already on the market (a predicate device). As a result, very few products cleared through the 510(k) process are subject to clinical testing. The Supreme Court spelled out the logical flaw in relying on substantial equivalence in a 1996 ruling: “Substantial equivalence determinations provide little protection to the public … If the earlier device poses a severe risk or is ineffective, then the latter device may also be risky or ineffective.”
14.	Industry’s core claim is that the FDA is taking too long to clear devices. But at least 95 percent of moderate- and high-risk devices are reviewed through the more lenient 510(k) process. The FDA says that it completes 90 percent of 510(k) analyses within 90 days and 98 percent of 510(k) analyses within 150 days.
15.	Predicate Creep: Over time, manufacturers may submit a series of products for approval under the 510(k) process, with each product differing slightly from an earlier product, either in the purported intended use or in technological features. Eventually, this allows the clearance of a device that is substantially dissimilar from the initially marketed product in a chain of sequentially cleared devices. This is called “predicate creep.” An example of this problem was the 2008 clearance of the Pathwork Tissue of Origin Test, which is a device that diagnoses tumors. Ultimately, the FDA’s sequential substantial equivalence rulings of medical devices created “predicate creep” and permitted it to clear a device for diagnosing tumors based on its similarity to a device that screens for illicit drug use.
16.	Under both the PMA and 510(k) processes, the FDA is obliged to fashion its requests for information in the “least burdensome” manner possible to the manufacturers from which the information is sought. Currently, the FDA asks only 8 percent of device manufacturers seeking clearance under 510(k) (excluding makers of in vitro devices) to provide clinical data from studies in patients.

SYSTEM TO RECALL DEFECTIVE DEVICES, DEFECTIVE

17.	The agency primarily depends on manufacturers and users, such as hospitals, to report events of injury or death related to the use of their devices. Manufacturers, in turn, are often unable to locate patients implanted with dangerous devices because there is not an adequate system to track which patients have received their products.
18.	Recalls are rising. The number of recalls for moderate- and high-risk devices in fiscal year 2011 (1,201) more than doubled from 2007 (566). (A recall may involve actions such as inspecting the device for problems, repairing or re-labeling the device, issuing notifications of a problem, or monitoring patients for health issues. Most recalls are initiated voluntarily by device manufacturers).
19.	The FDA lacks an internal system to analyze recall trends, which it might otherwise use in future decisions when reviewing a device for PMA approval or 510(k) clearance.
20.	Under the Safe Medical Devices Act of 1990, hospitals and healthcare facilities are required by statute to file a medical device report to the FDA and the manufacturer if there is a suspected device-related death. However, when there is a serious injury related to device use, facilities must only notify the manufacturer or, if the manufacturer is unknown, the FDA.
21.	There have been times when manufacturers chose not to send reports to the FDA when the facts of an adverse reporting to them clearly warranted disclosure. This occurred in the cases of Teleflex Medical’s Hem-o-lok ligating clips and Guidant’s Ventak Prizm ICDs. When the FDA reviewed the two companies’ adverse event reports, it found many instances in which a device reasonably could have caused harm to a patient but in which the companies determined the device was not to blame. Although user-facilities may have reported the adverse incidents to the FDA, both manufacturers withheld information that impeded the agency from taking appropriate action.
22.	The recall process does not remove defective devices from market in a timely manner. In 2009, a sixth patient died as a result of malfunctions of the Hem-o-lok surgical clip, which had been the target of a series of recalls since 2004.
23.	There is no reliable system in place for manufacturers to locate actual patients who have received their devices. Most manufacturers trace products only to distributors or healthcare facilities. Facilities, in turn, are charged with contacting the patients. Because of complications in this process, warnings sometimes fail to reach the right doctors or patients in time. For example, the manufacturer of a recalled hip implant said it could not trace the implants to the specific patients who received them.
24.	According to an October 2009 finding by the Department of Health and Human Services inspector general, the FDA does not adequately use adverse event reporting to identify trends in problematic devices.
25.	The FDA does not have clear policies in place to determine whether a recall really worked.

INDUSTRY-FRIENDLY LEGISLATION INTRODUCED

26.

As the reauthorization of the Medical Device User Fee Act approaches, members of Congress have introduced industry-friendly legislation aimed at further easing the approval and clearance processes for medical devices which would:

further reduce the already weak standards for clearing and approving medical devices; raise the priority of promoting of medical innovation in relation to the FDA’s core mission of protecting public safety; substantially weaken the “conflict of interest” prohibition for serving on the FDA advisory committee that oversees device approvals, allowing more people who have a financial interest in the medical devices under review by the committee to review applications; expand the pool of third-party companies that can review a device application to include those that have financial relationships with the device industry; require the FDA to rule on third-party reviews of a device within 30 days or granting automatic approval of the device on the 31st day, which would result in the elimination of independent oversight by FDA officials for many devices; prohibit the FDA from disapproving the methods used in any type of clinical trial conducted by a medical device company, including clinical trials conducted on human subjects.

PRESCRIPTIONS

27.	No future medical device premarket review system should rely on “substantial equivalence” to a device already on the market as evidence of safety and effectiveness.
28.	The standard for approving any high-risk (class III) device under the PMA process should be changed to “substantial evidence” of safety and effectiveness from the current “reasonable assurance” that the device is safe and effective. The current low standard threatens patient safety because it accepts data from poorly designed and uncontrolled clinical trials as acceptable evidence for establishing the safety and effectiveness of a device during the review process.
29.	Drop the least-burdensome requirement. For all submissions, the requirement that the FDA evaluate devices in a manner that is “least burdensome” upon manufacturers should be eliminated. It is in the best interests of patients and device manufacturers alike for the FDA to make its judgments based on all necessary information.
30.	Implement a requirement for all moderate- and high-risk devices to have unique device identifiers to allow for efficient and effective tracking of medical devices, particularly in the event of a recall. ================================================================= Read the full article here.

FDA: Atorvastatin/ezetimibe combo needs more data

This from The Heart.org

Vytorin has been plagued by controversy in recent years, particularly given the lack of benefit with the drug in the Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. In addition, many in the clinical community have criticized the company, as well as the FDA, for the delays in reporting hard clinical outcomes data with the ezetimibe/simvastatin combination. The Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) study is currently expected to be completed in June 2013.


Read the full article here.

I recently began reading CHRIS KRESSER's blog and find much of what he says very helpful.
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Preventing heart disease without drugs

June 15, 2008 CHRIS KRESSER L.AC

 

 

In today’s article we’ll discuss how to prevent heart disease without drugs. If you haven’t already read Part 1 of this series, which examined the problems with statin drugs, and Part 2, which debunks the myth that cholesterol causes heart disease, you might want to do that before reading this article.

Last week I mentioned the INTERHEART study, which looked at the relationship between heart disease and lifestyle in 52 countries around the world. What this study revealed is that approximately 90% of heart disease could be prevented by simple changes to diet and lifestyle.

Let’s just make this crystal clear: 9 out of 10 cases of heart disease are completely preventable without drugs. With sales of statin drugs reaching close to $30 billion this year with Lipitor alone bringing in close to $14 billion, this might come as some surprise. But the pharmaceutical companies are, quite literally, invested in people taking their cholesterol-lowering drugs in spite of the complete lack of evidence that lowering cholesterol prevents heart disease.

In order to understand the changes we need to make to prevent heart disease, we have to briefly examine what causes it. By now you know that the answer is not “cholesterol”. In fact, as I mentioned briefly in last week’s article, the two primary contributing mechanisms to heart disease are inflammation and oxidative damage.

Inflammation is the body’s response to noxious substances. Those substances can be foreign, like bacteria, or found within our body, as in autoimmune diseases like rheumatoid arthritis. In the case of heart disease, inflammatory reactions within atherosclerotic plaques can induce clot formation.

When the lining of the artery is damaged, white blood cells flock to the site, resulting in inflammation. Inflammation not only further damages the artery walls, leaving them stiffer and more prone to plaque buildup, but it also makes any plaque that’s already there more fragile and more likely to burst.

Oxidative damage is a natural process of energy production and storage in the body. Oxidation produces free radicals, which are molecules missing an electron in their outer shell. Highly unstable and reactive, these molecules “attack” other molecules attempting to “steal” electrons from their outer shells in order to gain stability. Free radicals damage other cells and DNA, creating more free radicals in the process and a chain reaction of oxidative damage.

Normally oxidation is kept in check, but when oxidative stress is high or the body’s level of antioxidants is low, oxidative damage occurs. Oxidative damage is strongly correlated to heart disease. Studies have shown that oxidated LDL cholesterol is 8x greater stronger a risk factor for heart disease than normal LDL.

Since there may be some confusion on this point, I want to make it clear: normal LDL cholesterol is not a risk factor for heart disease in most populations, but oxidated LDL cholesterol is. This points to oxidation as the primary risk factor, not cholesterol. Why? Because when an LDL particle oxidizes, it is the polyunsaturated fat that oxidizes first. The saturated fat and the cholesterol, hidden deep within the core of the lipoprotein, are the least likely to oxidize.

It follows, then, that if we want to prevent heart disease we need to do everything we can to minimize inflammation and oxidative damage.

Top four causes of oxidative damage & inflammation

1. Stress
2. Smoking
3. Poor nutrition
4. Physical inactivity

By focusing on reducing or completely eliminating, when possible, the factors in our life that contribute to oxidative stress and inflammation, we can drastically lower our risk for heart disease. Let’s take a brief look at each risk factor.

Stress

In the INTERHEART study, stress tripled the risk of heart disease. This was true across all countries and cultured that were studies. The primary mechanism by which stress causes heart disease is by dysregulating the hypothalamic-pituitary-adrenal (HPA) axis. The HPA axis is directly intertwined with the autonomic nervous system, and it governs the “fight-or-flight” response we experience in reaction to a stressor.

Continued activation of this “fight-or-flight” response leads to hyper-arousal of the sympathetic nervous system, which in turn leads to chronically elevated levels of cortisol. And elevated levels of cortisol can cause both inflammation and oxidative damage.

Stress management, then, should be a vital part of any heart disease prevention program. In fact, some researchers today believe that stress may be the single most significant factor in the cause and prevention of heart disease. There are several proven methods of stress reduction, including mindfulness-based stress reduction (MBSR), acupuncture and biofeedback. It doesn’t matter which method you choose. It just matters that you do it, and do it regularly.

Smoking

I assume that you are already well aware of the dangers of smoking, so I won’t spend much time on this one. For the purposes of this discussion, I will point out that smoking as few as 1-4 cigarettes a day has been shown to increase the risk of heart disease by 40%. But smoking 40 cigarettes a day increases that risk by 900%.

So if you smoke and you’re concerned about heart disease – quit.

Nutrition

Over the past century we’ve seen a consistent decline in the consumption of traditional, nutrient-dense foods in favor of highly processed, nutrient-depleted products. The flawed hypothesis that cholesterol causes heart disease has wrongly identified health-promoting foods like meat, organ meats, eggs and dairy products as harmful, and replaced them with toxic, processed alternatives such as chips, white breads, pastries, crackers, cookies, frozen foods, candy and soda.

There are two ways that nutrition contributes to heart disease: too much of the wrong foods, and not enough of the right ones.

The average American gets 57% of his/her calories from highly refined cereal grains and polyunsaturated (PUFA) oils. The #3 source of calories, behind grains and PUFA, is sugar and high-fructose corn syrup. Refined grains, polyunsaturated oils and sugar are all major contributors to both inflammation and oxidative damage.

Not only do refined carbohydrates, vegetable oils and sugar contribute to inflammation and oxidative damage, they are also completely devoid of micronutrients that would protect us from these processes. Meats, fruits and vegetables are all high in antioxidants that prevent oxidative damage, and rich in other micronutrients that play important roles in preventing heart disease.

More than 85% of Americans are not getting the federally recommended five servings of fresh fruit and vegetables each day. The intake of dark leafy green or yellow/orange veggies for the average American is equivalent to 18g – one-half of one small carrot. Iceberg lettuce, tomatoes, french fries, orange juice and bananas constitute 30% of fruit and vegetable intake for most Americans.

Many people know that the “Standard American Diet” is extremely unhealthy. But what most do not know is that the so-called “heart-healthy” diet that has been vigorously promoted for decades actually contributes to heart disease! The “heart-healthy” diet is high in refined carbohydrates and polyunsaturated oils, which, as we have seen, cause inflammation and oxidative damage.

On the other hand, saturated fats (which have been demonized by the medical mainstream) such as butter, coconut oil, lard, tallow and ghee are protected against oxidation and possess many other important health benefits. These fats are the ones we need to be eating to protect ourselves from heart disease.

It is extremely important to buy organic meat, eggs and dairy products that come from animals that have been raised on fresh pasture rather than in commercial, factory feedlots. See this article and this one for more information on why this is so essential.

Finally, it must be pointed out that not all “organic” products are healthy. Most packaged food (including organic cereals, crackers, chips and so-called “nutrition bars”) are full of highly refined carbohydrates, sugar, and vegetable oils. And by now, I don’t need to tell you what that means!

So what would a truly heart healthy diet look like, then? Download my Guidelines for Natural Prevention of Heart Disease to find out.

Physical Inactivity

Physical inactivity is likely a major causative factor in the explosive rise of coronary heart disease in the 20th century. During the vast majority of evolutionary history, humans have had to exert themselves to obtain food and water. Even at the turn of the 20th century in the U.S., a majority of people had jobs that required physical activity (farmers, laborers, etc.) Now the majority of the workforce has sedentary occupations with little to no physical activity at all.

Currently more than 60% of American adults are not regularly active, and 25% of the adult population is completely sedentary. People that are physically inactive have between 1.5x and 2.4x the risk of developing heart disease.

On the other hand, regular exercise reduces both inflammation and oxidative damage. Even relatively low levels of activity are protective – as long as they are consistent. A public review at Harvard University showed that 30-minutes of moderate physical activity on most days of the week decreases deaths from heart disease by 20-30%.

The best strategy for people struggling to find time to exercise is to make it part of their daily life (i.e. riding a bike or walking to work, choosing the stairs over the escalator or elevator, etc.)

When combined, the four strategies listed above will significantly reduce your chances of getting heart disease – without taking a single pill of any kind.

If you already have heart disease, or you are at high risk for heart disease (overweight, high blood pressure, diabetic, etc.), then you may need additional support. See my

Recommended articles

• Natural Prevention of Heart Disease Guidelines
• The Truth About Cholesterol Brochure
• Resources for further learning
• Recommended tests for heart disease
• Recent New York Times article questioning efficacy of cholesterol-lowering drugs

Read full article here.

Research alert: statins dangerous for pregnant women!

Research alert: statins dangerous for pregnant women!

December 9, 2008   by CHRIS KRESSER L.AC

Back in July I posted an article called Statins For Pregnant Women and Kids? criticizing a research study that actually recommended statins for pregnant women.

Well, it appears that even mainstream scientists are beginning to acknowledge the very real risks that statins present for pregnant mothers and fetuses.

Current clinical guidelines already recommend that women who are pregnant should stop taking statins but the advice is based on the knowledge that cholesterol is essential for normal fetal development.

But new research from The University of Manchester has shown that even water-soluble or ‘hydrophilic’ statins, such as pravastatin, can affect placental development leading to worse pregnancy outcomes.

According to Dr. Melissa Westwood, a Senior Lecturer in Endocrinology based at the Maternal and Fetal Health Research Centre at St. Mary’s Hospital, Manchester:

“Our study examined the effects that both lipophilic and hydrophilic statins had on a key biological system that is crucial for maintaining the normal function of the placenta, which acts as the nutrient-waste exchange barrier between mother and fetus.”

Fat-soluble statins like cerivastatin were already known to adversely affect the placenta, resulting in reducing growth. But the researchers also found that pravastatin – the water-soluble statin thought to be potentially compatible for use in pregnancy – had the same detrimental effect.

“These results clearly show that the effect of statins on the placenta is not dependent on their lipophilicity as had previously been suggested,” said Dr Westwood, whose findings are published in the Journal of Cellular and Molecular Medicine.

“While hydrophilic statins have not been reported to increase the incidence of fetal malformations, our research suggests that they will have a detrimental effect on placental growth, which is likely to result in poor pregnancy outcome.

“Healthcare professionals should continue to advise women to avoid the use of any type of statin once they plan to start a family or when a pregnancy is suspected or confirmed.”
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Read the full post here.

The followers of the Track Your Plaque program enjoy virtual elimination of risk.

Why are heart attacks still happening?

Posted on March 4, 2012 by Dr. William Davis

I’m a cardiologist. I see patients with heart disease in the form of coronary artery disease every day.
These are people who have undergone bypass surgery, received one or more stents or undergone other forms of angioplasty, have survived heart attacks or sudden cardiac death, or have high heart scan scores. In short, I see patients every day who are at high-risk for heart attack and death from heart disease.

But I see virtually no heart attacks. And nobody is dying from heart disease. (I’m referring to the people who follow the strategies I advocate, not the guy who thinks that smoking a pack of cigarettes a day is still okay, or the woman who thinks the diet is unnecessary because she’s slender.)
Two high-profile deaths from heart attacks occurred this week:

Davy Jones–The iconic singer from the 1960s pop group, the Monkees, suffered sudden cardiac death after a large heart attack, just hours after experiencing chest pain.

Andrew Breitbart–The conservative blogger and controversy-generating media personality suffered what was believed to be sudden cardiac death while walking.

It’s a darn shame and it shouldn’t happen. The tools to identify the potential for heart attack are available, inexpensive, and simple. The strategies to reduce, even eliminate, risk are likewise available, inexpensive, and cultivate overall health.

The followers of the Track Your Plaque program who
1) get a heart scan that yields a coronary calcium score (for long-term tracking purposes)
2) identify the causes such as small LDL particles, lipoprotein(a), vitamin D deficiency, and thyroid dysfunction
3) correct the causes
enjoy virtual elimination of risk.
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http://www.trackyourplaque.com/blog/2012/03/why-are-heart-attacks-still-happening.html

Alcoholic Surgeons Abound

Trust me, I know what I'm doing - I've been to med school!
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Alcoholic Surgeons Abound

If you feel wary about crossing the threshold of a hospital given the reality that medical error ranks third as a cause of death in the US, here's something that should scare the living bejeebers out of you should you ever need treatment. A new report just published in the Archives of Surgery says that one out of every six US surgeons has a drinking problem.¹ The finding comes from a survey sent out to more than 25,000 surgeons, 7,000 of whom responded. We can only imagine what the drinking problem rate might be among those who never returned the survey -- perhaps because they spilled rum on the answer sheet. Logic dictates that the numbers are probably worse among those who chose not to respond -- but one in six is terrifying enough.

Naturally, patients who submit to the surgeon's knife hope that their physicians hold to a high standard -- even a higher standard than the general populace, one would hope. Certainly, we pay our doctors well enough to expect no less. But in fact, the alcohol dependence rate among the general population hovers far below that of surgeons. Compared to the 15 percent of well-soused surgeons, only nine percent of the general population abuses or depends on alcohol. Also, it seems that of the physician groups, surgeons have a particular affinity for drinking, as studies indicate that doctors in general have about the same rate of substance abuse as the rest of us.²

It's also interesting to note that the worst of the worst were female surgeons, with an off-the-charts drinking problem rate of 25 percent.³ That means that one out of every four female surgeons has a drinking problem. Beware women in scrubs bearing scalpels! Male surgeons, on the other hand, came in at a still-disturbing 14 percent.

Why the elevated drinking rate among surgeons, in particular? The director of the study, Michael Oreskovich of the University of Washington, said, "The nature of the beast is that the percent of emergencies, the percent of after-hours work, and actual scheduled work itself all require an energy and concentration that is really different than a lot of other specialties." Although drinking may help with the stress of it all, certainly a martini or three won't help when it comes to the need for concentration and precise hand/eye coordination. And in fact, 77 percent of the 722 surgeons who admitted making a major medical mistake in the past three months did have a drinking issue. That's a 45 percent higher error rate than among non-drinking physicians.

There's so much to be horrified about in that reality -- not just the rampant drinking while working on patients, but also, the fact that more than 10 percent of the respondents made not just an insignificant boo-boo, but a major medical mistake, and in the previous three months to boot. To make matters worse, Dr. Oreskovich says that the alcohol abuse rate probably is much higher than what got reported in this study. The survey return rate was extremely low, and Dr. Oreskovich believes that may be because many of the surgeons who didn't return the survey didn't want to admit to heavy drinking, which is pretty much what I said earlier.

So the moral of this story is that if you need surgery, you'd better hope that the force is with you. That's especially true if you happen to need surgery in July, the worst month for fatal hospital errors. In July, errors spike by 10 percent. Perhaps the highly stressed interns and residents who predominantly begin their term of service that month are relying on pina coladas to make it through the day. Or maybe your doctor is just suffering from good old fashioned burn out. The bottom line is hope you're not forced to get surgery in July from a highly stressed alcoholic resident at the end of a 100 hour shift…who's wondering why he ever decided to go to medical school as he slices open your chest cavity.

On the good news side, those surgeons who engaged in rehab services had very low recidivism rates. But clearly, more surgeons need those services. Better yet, they need to stay off the sauce in the first place, particularly before cutting into human flesh.

You can just hope that if your surgeon has a substance abuse problem, the substance in question is a"smart" drug that improves concentration. Yet another recent study found that sleep-deprived physicians actually performed better surgery when they took a drug called Modafinil, which ostensibly boosts memory and brain power.⁴ Ritalin probably does something similar, and since we know at least seven percent of physicians have a drug addiction (as opposed to alcohol problem) and that Ritalin is a big favorite, keep your fingers crossed that your doc chose to get stimulated by a brain enhancer rather than sedated by alcohol, that is if he or she must indulge. Better yet, follow the Baseline of Health suggestions, take good care of yourself, and minimize your chances of ever needing surgical services in the first place.

¹ ByDuncio, Monica."One in six surgeons has an alcohol problem, study finds." 23 February 2012. CBS News Health Pop. 24 February 2012.
² "Physicians Are Not Invincible: Rates of Psychosocial Problems Among Physicians." Medscape Today. 23 February 2012. < http://www.medscape.com/viewarticle/410643_2>
³ "Alcohol problems not uncommon among surgeons: study." 23 February 2012. Reuters. 24 February 2012.
⁴ "Study: Doctors Taking Smart Drugs Perform Better Surgery." 17 October 2011. FoxNews.com. 24 February 2012. < http://www.foxnews.com/health/2011/10/17/study-doctors-taking-smart-drugs-perform-better-surgery/>

Read the full article here.