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.

The hidden truth about statins

 The hidden truth about statins

 

June 12, 2010 in Heart Disease, Medical Industrial Complex | 63 comments

 

Statins are the most popular drugs in history. Drug companies made $26 billion selling statins alone in 2008. 25 million Americans take them, and the number is growing each year.

One reason why statins are the best-selling drug category by far is that 92% of people taking them are healthy. The FDA has approved the prescription of statins to people at low risk for heart disease and stroke, who don’t even have high cholesterol. Two years ago the American Academy of Pediatricians recommended that statins be prescribed for kids as young as eight years old.

With sales statistics like this, you’d think statins are wonder drugs. But when you look closely at the research, a different story emerges. Statins have never been shown to be effective for women of any age, men over 65, or men without pre-existing heart disease. Early studies did suggest that statins are effective for men under 65 with pre-existing heart disease, but later, more rigorous clinical trials has not confirmed this benefit.

In addition, statins have been shown to have serious side effects and complications in up to 30% of people who take them. Studies have also shown that the majority of these adverse events go unreported, because doctors are largely unaware of the risks of statins.

Watch the two videos below to learn the whole story. Or, you can read this article for a concise summary of the evidence.

Video Presentation

[Two video presentations in the original article here.]

Handouts

• Statin research summary: lists the eight statin studies performed in 2008 – 2009, including the drugs and populations studied and the results. If you’re currently taking a statin, you might consider printing this out and taking it to your doctor as a springboard for a conversation about whether statins are right for you.

References

ENHANCE
KasteleinJJ, AkdimF, StroesES, for ENHANCE investigators. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 2008;358:1431-43
CASHMERE
O’Riordan M. CASHMERE: no IMT effect with atorvastatin over 12 months. (link)
ACHIEVE
O’Riordan M. ACHIEVE stopped: IMT study with Niacin/Laropiprant halted by Merck & Co. (link)
SEAS
Rossebø AB, Pedersen TR, Boman K, et al. Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 2008;359:1343-56
GISSI-HF
GISSI-HF Investigators, Tavazzi L, Maggioni AP, Marchioli R, et al. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomized, double-blind, placebo-controlled trial. Lancet 2008;372:1231-9
CORONA
Kjekshus J, Apetrei E, Barrios V, et al. Rosuvastatin in older patients with systolic heart failure. N Engl J Med 2007;357:2248-61
AURORA
Fellström BC, Jardine AG, Schmieder ME, et al for the AURORA study group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009;360:1395-407
JUPITER
Ridker PM, Danielson E, Fonseca FA, et al, for the JUPITER Study Group. Rosuvastatin to prevent vascular events in men and women with elevated C-Reactive protein. N Engl J Med 2008;359:2195-207

Coconut Oil and Heart Disease

Brian Shilhavy
CoconutOil.com

I imagine everyone is different, but here’s my experience so far. In 2004 at age 61 I had a mild heart attack and blocked artery. My total cholesterol was 101 in the hospital. A couple of months later it was 134, after taking my cardiologist’s drug store. I stopped all drugs after that, realizing after researching them that they were worthless. I then came across virgin coconut oil. I have been taking between four and six tablespoons per day with meals since then. The results-
2004 HDL 45,LDL 73,TRIG 81,LDL/HDL Ratio 1.6, Total 134
2005 HDL 73,LDL 111,Trig 47 LDL/HDL Ratio 1.5, Total 193
2006 HDL 97,LDL 113,Trig 39,LDL/HDL Ratio 1.2, Total 218.
My next test will be in December. My 2005 results literally shocked my cardiologist. He said HDL doesn’t increase like that in people my age. I also passed a nuclear stress test last year. I saw my regular doctor last week, and he said I’m beating the odds on not having another attack. I think the [Virgin Coconut] oil along with a change of diet is the reason why. Roderick – The Coconut Diet Forums

When measurements of serum cholesterol (cholesterol levels in the blood) were first done, only the total of both HDL (“good cholesterol”) and LDL (“bad cholesterol”) were read (Note that even the concept of “bad” LDL cholesterol is being challenged today since also need this form of cholesterol to survive!). Now that testing has become more sophisticated, researchers look more at the balance of these two types of cholesterol. They note whether a substance raises cholesterol levels of HDL or LDL levels. In some cases, certain foods lower total cholesterol, but only by lowering HDL cholesterol while at the same time actually raising levels of the LDL cholesterol. Studies now show that coconut oil actually increases HDL cholesterol, while lowering LDL. So total cholesterol levels may actually increase, but in a very favorable ratio.

Population Studies

Coconut oil (and all saturated fats) has been blamed for many years as a cause of increased cholesterol levels, which supposedly leads to heart disease. But studies done on traditional tropical populations that consume large amounts of coconut oil show just the opposite. One of the best ways to study the affects of coconut oil on human nutrition is to look at tropical populations that get most of their caloric intake from the saturated fat of coconut oil. Logic would dictate that if the saturated fat/cholesterol theory of heart disease and obesity were correct, those populations with the highest consumption of saturated fats would be the most overweight and have the highest rates of heart disease. Such is not the case.

In a study published in 1981, the populations of two South Pacific islands were examined over a period of time starting in the 1960s, before western foods were prevalent in the diets of either culture. The study was designed to investigate the relative effects of saturated fat and dietary cholesterol in determining serum cholesterol levels. Coconuts were practically a staple in the diets, with up to 60% of their caloric intake coming from the saturated fat of coconut oil. The study found very healthy people who were relatively free from the modern diseases of western cultures, including obesity and heart disease. Their conclusion: “Vascular disease is uncommon in both populations and there is no evidence of the high saturated fat intake having a harmful effect in these populations.”¹

I had been taking Tropical Traditions Coconut Oil for obvious health benefits when I realized one day that my knees weren’t hurting, so I stopped for a day or two and they hurt again. I have one artificial knee, and one that isn’t in very good shape, and they used to hurt all the time. When I resume the oil, the pain goes away, so that makes me very happy. Also, my cholesterol went from 242 to 218. I take about 2 teaspoon/day and haven’t gained any weight, although I eat anything I want, so it works for me. Darleen – Othello, WA

Another study was done on the Indian subcontinent comparing traditional cooking oils with modern oils in relation to prevalence of atherosclerotic heart disease and Type-II diabetes. Their conclusion: “In contrast to earlier epidemiologic studies showing a low prevalence of atherosclerotic heart disease (AHD) and Type-II dependent diabetes mellitus (Type-II DM) in the Indian subcontinent, over the recent years, there has been an alarming increase in the prevalence of these diseases in Indians–both abroad and at home, attributable to increased dietary fat intake. Replacing the traditional cooking fats condemned to be atherogenic, with refined vegetable oils promoted as ‘heart-friendly’ because of their polyunsaturated fatty acid (PUFA) content, unfortunately, has not been able to curtail this trend. Current data on dietary fats indicate that it is not just the presence of PUFA, but the type of PUFA that is important–a high PUFA n-6 content and high n-6/n-3 ratio in dietary fats being atherogenic and diabetogenic. The newer ‘heart-friendly’ oils like sunflower or safflower oils possess this undesirable PUFA content and there are numerous research data now available to indicate that the sole use or excess intake of these newer vegetable oils are actually detrimental to health and switching to a combination of different types of fats, including the traditional cooking fats like ghee, coconut oil and mustard oil, would actually reduce the risk of dyslipidaemias, AHD and Type-II DM.”²

Dr. Janaki Gooneratne’s Sri Lanka Study

In 2011 Dr. Janaki Gooneratne, the head of Food Technology at the Industrial Technology Institute in Sri Lanka, carried out an extensive research project to establish whether there was a relationship in the consumption of coconut oil with cholesterol, in the Gampaha District of Sri Lanka – an area known as the “Coconut Triangle” due to large coconut consumption.

Associations between selected cardiovascular disease risk factors and Coconut Fat intake were investigated by Dr. Goonerante using the Chi-square test. The data was then further examined in a multivariate model adjusting for potential confounding variables and analyzed using SPSS statistical software. The results of this extensive research concluded that consumption of CF at 16.4% of total energy per day had no CVD risk on the study population. (Read about the study here.)

Dr. Goonerante believes that her extensive research is the first study of this magnitude on coconut oil ever conducted anywhere in the world. Since coconut oil is a product that cannot be patented, it is very unlikely that such studies like this will ever be funded in western nations, and it is now up to the coconut oil producing countries to carry out this research and vindicate coconut oil from the attacks against it over the past several decades in the western nations like the U.S.

I have been on Virgin Coconut Oil (VCO) since early June (1T per day in oatmeal and using it on my skin). I had a blood test performed at the end of August. My total cholesterol did go up since last year from 168 mg/dL to 187 mg/dL currently as did my Triglycerides from 60 mg/dL to 72 mg/dL (all within normal range). My HDL (“good” cholesterol) jumped from 60 mg/dL to 85 mg/dL! My LDL (“bad” cholesterol) dropped from 96 mg/dL to 87 mg/dL. My Cholesterol/HDL ratio dropped from 2.8 ratio units to 2.2 ratio units. I live in a dry climate, but my skin is soft and smooth from using VCO. I find that the oil rids my face of wrinkles as others on the list have experienced. When I have dinner with my son at the restaurant where he works, his co-workers assume that I am a friend his age. They don’t believe him when he tells them that I am his mother. I had gained 20 pounds from forced inactivity due to disc problems in my back, but I have lost those and am now a size 4-6 again. I will definitely keep using the VCO. Gayle The Coconut Diet Forums

Faulty Science

In a lecture given in Viet Nam in 1996, Dr. Mary Enig stated that “The problems for coconut oil started four decades ago when researchers fed animals hydrogenated coconut oil that was purposely altered to make it completely devoid of any essential fatty acids. The animals fed the hydrogenated coconut oil (as the only fat source) naturally became essential fatty acid deficient; their serum cholesterol increased. Diets that cause an essential fatty acid deficiency always produce an increase in serum cholesterol levels as well as in increase in the atherosclerotic indices. The same effect has also been seen when other highly hydrogenated oils such as cottonseed, soybean or corn oils have been fed; so it is clearly a function of the hydrogenated products, either because the oil is essential fatty acid (EFA) deficient or because of transfatty acids.”³

What about studies where animals were fed unprocessed coconut oil? Enig wrote: “Hostmark et al (1980) compared the effects of diets containing 10% coconut oil and 10% sunflower oil on lipoprotein distribution in male Wistar rats. Coconut oil feeding produced significantly lower levels (p=0.05) of pre-beta lipoproteins (VLDL) and significantly higher (p=<0.01) alpha-lipoproteins (HDL) relative to sunflower feeding.”⁴ She also cited a study by Awad (1981) on Wistar rats fed a diet of either 14% (natural) coconut oil or 14% safflower oil. She stated: “Total tissue cholesterol accumulation for animals on the safflower diet was six times greater than for animals fed the [unhydrogenated] coconut oil. A conclusion that can be drawn from some of the animal research is that feeding hydrogenated coconut oil devoid of essential fatty acids (EFA) potentate the formation of atherosclerosis markers. It is of note that animals fed regular coconut oil have less cholesterol deposited in their livers and other parts of their bodies.”⁵

Do Saturated Fats Clog Arteries?

Saturated fats are probably the most maligned fats in the popular media today. They are often blamed for “clogging arteries” and leading to heart disease. However, an examination of the research and science behind saturated fats leads one to a vastly different conclusion, suggesting that the attacks against saturated fats have been primarily political and economical, and not scientific. While we will provide a brief summary of the science behind saturated fats here, we encourage you to examine the research more closely yourself.

First of all, saturated fats are essential to our health. They comprise about 50% of our cell membranes, and some proportion of saturated fats are found in all fats and oils, whether plant based or animal based.

In recent years some have made claims that too much saturated fats in our diet can lead to higher cholesterol levels and clogged arteries, which leads to heart disease. So an anti-saturated fat campaign was launched in the U.S. in recent years. As a results, Americans have consumed less saturated fats than any other nation, yet the U.S. is still a world leader in deaths from heart disease. Obesity rates are also at an all-time high. Many are now questioning the “wisdom” behind the low-fat nutritional advice that has dominated the popular media (see Coconut Oil and Weight Loss.)

Does research support the claim that saturated fats like coconut oil raise cholesterol levels and clog arteries? This “lipid theory” of heart disease, which blames high cholesterol levels as causing heart disease, is seriously being questioned by researchers and doctors. Malcom Kendrick M.D., Dr. Mary Enig Ph.D., Uffe Ravnskov M.D., Ph.D (author of The Cholesterol Myths), George Mann M.D., Sc.D, and many other top researchers have written extensively on the flaws of the “cholesterol theory” of heart disease.

As to the research on “clogged arteries”, a study was done at the Wynn Institute for Metabolic Research, London, examining the composition of human aortic plaques. This study found that the “artery clogging fats” in those who died from heart disease were composed of 26% saturated fat: the rest (74%) were polyunsaturated fatty acids, such as those found in vegetable oils commonly consumed in today’s modern societies. Their conclusion: “No associations were found with saturated fatty acids. These findings imply a direct influence of dietary polyunsaturated fatty acids on aortic plaque formation and suggest that current trends favoring increased intake of polyunsaturated fatty acids should be reconsidered.”⁶

My doctor wanted me to start taking pravachol to lower my cholesterol, which was 219. He said because you are diabetic, I don’t want you to have a heart attack once your blood sugars are under control. I told him I wanted to see if I could bring my cholesterol down naturally with VCO and eating right. I began taking VCO last spring when I read about it in Woman’s World Magazine. At the time I had a lot of problems with hypothyroid, fibromyalgia, IBS, candida, super dry skin and skin rashes, etc. I have stopped taking all meds for my gastrointestinal symptoms and my skin is now silky soft and smooth. My blood work done on December 4, 2003 showed my cholesterol was down 31 points to 188 mg/dl. Ann The Coconut Diet Forums

Hi I don’t post often but felt I had to on this one. I just got back from the Dr.’s office and my total cholesterol went [down]. My doc was SO happy. I’ve been going to her for over 15 years and dreaded every time I got the blood test. It was always the same thing – a lecture. I had always used olive oil for years but started using coconut oil for most of our cooking (olive oil occasionally). My cholesterol results after at least 15 years of being high: triglycerides was 187…now 109. Cholesterol, total was 260…now 185. Chol/hdlc ratio…5.41…now 4.1. Glucose….105…now 94. My doctor was ecstatic. I believe I already mentioned this, but I can now use these statistics for anyone that gives me a hard time [about using Virgin Coconut Oil.] Sally Ann The Coconut Diet Forums

Virgin Better than Refined Coconut Oil

A recent study done in India comparing refined coconut oil (CO) with Virgin Coconut Oil (VCNO) found that VCNO obtained by wet process has a beneficial effect in lowering lipid components compared to CO. It reduced total cholesterol, triglycerides, phospholipids, LDL, and VLDL cholesterol levels and increased HDL cholesterol in serum and tissues. The results demonstrated the potential beneficiary effect of virgin coconut oil in lowering lipid levels in serum and tissues and LDL oxidation by physiological oxidants. This property of VCNO may be attributed to the biologically active polyphenol components present in the oil.

I use virgin coconut oil, olive oil, and butter in my cooking and add extra virgin coconut oil to my smoothies, and I also eat coconut oil just by the tablespoon. My total cholesterol went down over 100 points. HDL and LDL were great! My coworkers could not believe I was eating so much fat and watching my cholesterol levels go down. I had to take a fasting [blood] test to prove it to them. I have lost 18 pounds in three months. I have learned a new way of life and it’s easy. I’m healthier for it, too. I will never count calories again! Laurel – The Coconut Diet Forums

References
1. Prior IA, Davidson F, et. al. “Cholesterol, coconuts, and diet on Polynesian atolls: a natural experiment: the Pukapuka and Tokelau island studies.” American Journal of Clinical Nutrition. 1981 Aug;34(8):1552-61.
2. Sircar S, Kansra U. “Choice of cooking oils–myths and realities.” Journal Indian Medical Association. 1998 Oct;96(10):304-7.
3. Mary G. Enig, Ph.D. “Health and Nutritional Benefits from Coconut Oil: An Important Functional Food for the 21st Century” Presented at the AVOC Lauric Oils Symposium, Ho Chi Min City, Vietnam, 25 April 1996
4. Mary G. Enig, Ph.D
5. Mary G. Enig, Ph.D
6. Felton CV, Crook D, Davies MJ, Oliver MF. Wynn Institute for Metabolic Research, London, UK. “Dietary polyunsaturated fatty acids and composition of human aortic plaques.” .Lancet. Oct,1994; 29;344(8931):1195-6.
Article Source: http://www.coconutoil.com/coconut_oil_heart_disease.htm

Read the full article here.

FDA Expands Advice on Statin Risks

If you’re one of the millions of Americans who take statins to prevent heart disease, the Food and Drug Administration (FDA) has important new safety information on these cholesterol-lowering medications.

FDA is advising consumers and health care professionals that:

• Routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed. Such monitoring has not been found to be effective in predicting or preventing the rare occurrences of serious liver injury associated with statin use.
• Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users.
• People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.
• Some medications interact with lovastatin (brand names include Mevacor) and can increase the risk of muscle damage.

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Read the rest of the FDA article here.

Assessment of Coronary Artery Disease by Cardiac Computed Tomography

Assessment of Coronary Artery Disease by Cardiac Computed Tomography

Read the full article here.
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Conclusion

EBCT has undergone a 20-year period of testing for reliability and validity and is now established as a useful technique in identifying individuals with or at risk for CHD. MDCT is a promising tool for coronary calcium scoring while additional studies evaluating progression, reproducibility, and outcomes are currently under way. Radiation doses, reproducibility, and validation studies must be taken into account when choosing a cardiac CT study. Serial coronary calcium scans to noninvasively assess progression rates of coronary calcium and CT angiography to assess NCP are now starting to be reported, but the data are premature at this time. The most promising use of these technologies is calcium scoring for risk assessment of the asymptomatic individual, whereby elevated calcium scores may trigger more vigorous application of both lifestyle and/or pharmacological therapies targeted to lower cardiovascular risk and CT angiography to rule out the presence of coronary stenoses in certain subsets of symptomatic patients.