Statins May Not Be Effective As We Thought

Statins, the popular cholesterol-fighting medication, might not be as effective as previously believed in protecting seniors with no history of heart disease, according to a study published Monday.

NYU Langone Medical Center researchers looked at 2,867 healthy older adults who were taking statins and found no evidence to suggest they were living any longer as a result.

This was published in JAMA Internal Medicine.

Statins are sold under the generic name Pravastatin and under brand names such as Lipitor, Crestor and Zocor.

“Our study argues that the benefits of initiating statins in older patients, particularly those over 75, may not outweigh the risks,” said lead author Dr. Benjamin Han.

Potential side effects of statins include muscle pain, liver damage and increased risk of Type 2 diabetes, according to the Mayo Clinic.

“As the number of older adults in the United States is rapidly increasing, it is more important than ever that we improve our understanding of preventative interventions in aging patients, and the possible side effects and risks that accompany them,” Han said.

Reps for the makers of Lipitor and Zocor could not be immediately reached for comment on Monday.

A spokeswoman for Crestor’s maker AstraZeneca said: “The safety and efficiency of Crestor has been well established in more than 120 ongoing or completed clinical trials involving more than 67,000 patients worldwide over the past 13 years.”

Statins Don't Cut Heart Deaths Risk

When are doctors going to get the message? STATINS have done nothing to cut deaths from heart disease since being brought into widespread use more than a decade ago, a leading expert claims.

Professor Sherif Sultan, president of the International Society for Vascular Surgery, said millions of people should stop taking the heart drugs because side effects outweigh possible benefits. He told a conference in Brazil this month that the drugs should only be considered for patients who have had a heart attack and never for a child, woman or patient over 62 years old, as there was no evidence it could benefit them. He also said the medication did not reduce overall death rates in anyone.

His speech ‘Reality And Myth: A Tablet A Day Will Not Keep The Doctor Away’ analyzed studies on the cholesterol lowering drug and concluded the benefits were based on “statistical deception” and could not be relied upon because they were carried out by scientists employed by the drug companies.

Prof Sultan also highlighted studies showing a link with statins and increased risk of side effects including diabetes, cataracts, renal failure, liver failure, impotence, breast cancer, nerve damage, depression and muscle pains. He said: “People are taking this drug to prevent a problem and creating a disaster.”

Prof Sultan called on drug regulators to “rewrite” guidelines on the heart drugs prescribed to up to 12 million patients in the UK, or around one-in-four adults. He reignited the debate surrounding the drugs, the most widely prescribed treatment in the UK. The Queen’s former doctor of 21 years Sir Richard Thompson wants an inquiry.

Sir Richard, former president of the Royal College of Physicians, said: “Data needs to be urgently scrutinized. We are very worried about it and particularly side effect data which seems to have been swept under the carpet.”

However, proponents say hundreds of thousands are putting their lives at risk because they have stopped taking the treatment due to fears over their safety.

Mr. Sultan, professor of vascular surgery at the University of Ireland, questioned the link between high cholesterol and heart attacks, highlighting new data, which contradicted this. He also showed evidence from recent studies, which revealed statins accelerate hardening of the arteries, a key risk factor in heart attacks.

But Dr June Raine of the Medicines Healthcare Regulatory Agency said: “The benefits of statins are well established and are considered to outweigh the risk of side effects in the majority of patients.

“The efficacy and safety of statins has been studied in a number of large trials which show they can lower the level of cholesterol in the blood, reduce cardiovascular disease, and save lives. Trials have also shown that medically significant side effects are rare.”

This means that some experts are being paid, while others are doing research that is not funded by the statin manufacturers. Of all the articles I have read and blogs I have written, I can say that the statin side effects are real and not rare.

Older Women Using Statins at Higher Risk of Diabetes

Even though this study is from Australia, it still applies to older women in the United States. According to a University of Queensland (UQ) study, older Australian women taking cholesterol-lowering statins face a significantly increased risk of developing diabetes.

UQ School of Public Health researcher Dr Mark Jones said women over 75 faced a 33 per cent higher chance of developing diabetes if they were taking statins. The risk increased to over 50 per cent for women taking higher doses of statins.

"We found that almost 50 per cent of women in their late seventies and eighties in the study took statins, and five per cent were diagnosed with new-onset diabetes," Dr Jones said.

"Statins are highly prescribed in this age group but there are very few clinical trials looking at their effects on older women.

"The vast majority of research is on 40- to 70-year-old men."

Statins, a class of drugs that lower cholesterol in the blood, are prescribed to reduce the incidence of cardiovascular events such as heart attacks and strokes.

"What's most concerning was that we found a 'dose effect' where the risk of diabetes increased as the dosage of statins increased.

"Over the 10 years of the study most of the women progressed to higher doses of statins," Dr Jones said.

"GPs and their elderly female patients should be aware of the risks.

"Those elderly women taking statins should be carefully and regularly monitored for increased blood glucose to ensure early detection and management of diabetes."

The research was based on prescription and survey data from 8372 women born between 1921 and 1926 who are regularly surveyed as part of the Women's Health Australia study (also known as the Australian Longitudinal Study on Women's Health).

The research is published in Drugs and Ageing.

'Experts' Speaking Out Again about Statins

I expected this promotion from “experts” after my last blog because they must be short of funds and needed to blast the public about the need for statins. The questions they raised as being an unproven link between statins and diabetes is a reach. This is because the link between statins and diabetes is on solid ground and proven.

I need to question the titles given these “experts” by the author and if they are truly world-renowned researchers. It seems a little over the top and obvious that they are doing this to refill their coffers. By claiming that there is an unproven link between statins and type 2 diabetes, they have left themselves open to others that have shown in studies a 2 to 25 percent link. The “experts” only will consider a very high dose of statins as having a potential link if even then.

Charles H. Hennekens, M.D, Dr.P.H., the first Sir Richard Doll professor and senior academic advisor to the dean, the Charles E. Schmidt College of Medicine at FAU; Bettina Teng, BA, a recent pre-med honors graduate of the Harriet L. Wilkes Honors College at FAU; and Marc A. Pfeffer, M.D., Ph.D., the Dzau professor of medicine at HMS, emphasize to clinicians that the risk of diabetes, even if real, pales in comparison to the benefits of statins in both the treatment and primary prevention of heart attacks and strokes.

By over emphasizing the benefits of statins, they describe something that is very difficult to prove and happens to a less than 25 percent of people taking statins.

"The totality of evidence clearly indicates that the more widespread and appropriate utilization of statins, as adjuncts, not alternatives to therapeutic lifestyle changes, will yield net benefits in the treatment and primary prevention of heart attacks and strokes, including among high, medium and low risk patients unwilling or unable to adopt therapeutic lifestyle changes," said Hennekens.

In the accompanying editorial, Joseph S. Alpert, M.D., editor-in-chief and a renowned cardiologist and professor of medicine at the University of Arizona School of Medicine, reinforces these important and timely clinical and public health challenges in treatment and primary prevention.

"There is no threshold for low density lipoprotein cholesterol below which there are no net benefits of statins either in the treatment or primary prevention of heart attacks and strokes," said Alpert.

The authors and editorialist express grave concerns that there will be many needless premature deaths as well as preventable heart attacks and strokes if patients who would clearly benefit from statins are not prescribed the drug, refuse to take the drug, or stop using the drug because of ill-advised adverse publicity about benefits and risks, which may include misplaced concerns about the possible but unproven small risk of diabetes.

"These public health issues are especially alarming in primary prevention, particularly among women, for whom cardiovascular disease also is the leading cause of death, and for whom there is even more under-utilization of statins than for men," said Hennekens.

If you believe these “experts,” I would urge you to read my two blogs from January 24 and January 25 and go to Dr. Malcolm Kendrick's blog. Using his search for his blogs, below the two books listed in the right column and below the follow his blog, type in the word statins and bring up a list of his blogs about statins. Be sure to read this blog about the death of Dr. Duane Graveline for some still denied serious side effects.

Reasons to Avoid Taking Statins – Part 2

Ten things you really need to know before considering taking statins (Bold is my emphasis).

1. There are over 500 published scientific studies showing harmful or toxic effects of statins (This is an excellent resource.)

2. Common side effects include muscle damage, impaired heart muscle function, liver damage, muscle and joint pain, fatigue, impaired brain function, memory and cognition, loss of libido, depression, and reduced circulating levels of key nutrients such as coenzyme Q10, selenium, glutathione, these and other factors contributing to increased risk of atherosclerosis and heart disease

3. British private health insurer BUPA cites common side-effects of statins as stomach problems – pain, diarrhea, feeling sick and vomiting, jaundice, headache, sleep disturbances, dizziness, depression and extreme tiredness

4. Cardiovascular risk is over-predicted by risk calculators used by doctor’s to prescribe statins

5. There is no compelling evidence to show any benefits of statins for the very elderly, even though these are among the group with highest rate of statin medication

6. The 2011 Cochrane Review of the evidence from 14 randomized clinical trials (RCTs) showed that only high risk groups might gain some benefit in quality of life, while “Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk”.

7. Cochrane changed its conclusion with its review in 2014, recommending statins to all those with raised cholesterol, irrespective of risk. This revised conclusion was largely as the result of the influence of one trial headed by leading British statin advocate, Dr Rory Collins that was likely tainted by his Pharma interests. Additionally, Dr Collins has also tried his best, fortunately unsuccessfully, to bury the views of his scientific critics. The Cochrane review also discounts the importance of side effects—contrary to a gamut of evidence and clinical reporting over years, as well as the requirement to warn patients of such risks on product information leaflets.

8. The evidence that long-term use of statins significantly increases and approximately doubles the risk of type 2 diabetes is unequivocal. Brand new evidence from long-term studies also shows clear evidence that statin use increases the risk of acute and chronic kidney disease.

9. For those who have a low risk of suffering a heart attack, leading British cardiologist Dr. Aseem Malhotra argues that a daily apple will do more to protect the heart than using statins.

10. Find out how you can reduce your heart attack risk without using statins by leading metabolic cardiologist, Dr Mark Houston, Associate Clinical Professor of Medicine at Vanderbilt University School of Medicine; Director of the Hypertension Institute and Vascular Biology; and Medical Director of the Division of Human Nutrition at Saint Thomas Medical Group, Saint Thomas Hospital in Nashville, Tennessee.

In number 7 above, Dr. Malcolm Kendrick has several blogs about Dr. Rory Collins and is rather upset about his actions and his not reporting conflicts of interest. I am giving you two references from Dr. Kendrick referring to Dr. Collins. Reference one, Reference two.

Reasons to Avoid Taking Statins – Part 1

I like the opening statement from AnhInternational, which states - “If you hadn’t noticed that the statin bubble had burst, you were probably suffering a statin-induced fuzzy head and hadn’t managed to stay up with breaking news.”

Over the past months a flurry of long-term studies have been emerging, driving the last nails into the coffin of one of the most profitable drug classes the pharmaceutical industry has yet seen. Or so it might seem.

Statins are prescribed for the purpose of reducing cholesterol levels, which have long been viewed as a major risk factor for heart disease. How many people know the long-term risks (or benefits, or otherwise) of statins before they take them?

While the scientific edifice for this assertion may largely have collapsed, major health authorities like the US National Institutes of Health (NIH) are much slower to retract their argument that high cholesterol in the bloodstream leads to clogging up of arteries and increased heart attack risk. This misinformed and greatly over-simplified view results in over-prescription of statins, with the US being the number one prescribing nation in the world and the UK the second biggest. Over a million statin prescriptions are filled each week in the UK.

If they were talking about more sensitive measurements of C-Reactive Protein (CRP), sub-clinical low-grade inflammation, apolipoproteins profiles or oxidized fractions of very low-density lipoprotein (ox-VLDL), that would be an entirely different issue. But only doctors and practitioners really prepared to look at the totality of evidence, including emerging evidence, are presently using comprehensive cardiovascular risk profiles including some of these emerging markers. To top if off though, statin drugs themselves actually cause atherosclerosis and heart disease…

Big Pharma, and its servants in health and regulatory authorities, don’t give up so easily. Even the US FDA, while being forced to admit and communicate more evidence of harm, still argues that purported benefits in reducing heart disease outweigh risks, be these kidney, brain, muscle or eye damage, or increased type 2 diabetes incidence. More than that, seemingly outlandish new claims for other ‘spin-off’ benefits keep emerging, helping offset the bad publicity about side effects.

Among the headlines generated recently are:

• “Statins can halve patients’ risk of dying from cancer”. These data were based on observational studies, they were publicized at a conference, generated headlines globally—and have since been contested.
• “Statins may reduce dementia by a third”

• “Double duty drug: statins may fight MS”

• “Statins could reverse most common form of blindness”

An American Cardiologist Against Statins

I hope more doctors will learn from this doctor and follow her. Dr. Barbara Roberts, director of the Women’s Cardiac Center at The Miriam Hospital, is angry – and she’s speaking out.

Roberts, a cardiologist who is associate clinical professor of Medicine at the Alpert Medical School of Brown University, is the author of “The Truth about Statins: Risks and Alternatives to Cholesterol-Lowering Drugs.”

She does not mince her words when it comes to the new cholesterol guidelines recently published by the American Heart Association and the American College of Cardiology – which have suggested that millions of healthy Americans should start taking statins.

“The new guidelines are based on shoddy science and misinterpretation of the data,” she told ConvergenceRI in a recent interview. “This is a gift to Big Pharma. The American Heart Association has become little more than a propaganda arm of Big Pharma and Big Food. It’s a disgrace.”

Expanding the number of healthy people who take statins by the tens of millions, Roberts continued, “is going to reap a holocaust of adverse effects.”

Holocaust? Isn’t that too strong a word to use?

“No,” countered Roberts. “I will stand by that. For example, we may see upward of more than a quarter-million new cases of diabetes as a result. At a minimum, about 10 percent of new users of statins will suffer serious muscle side effects.” In addition, Roberts continued, “We will see increased instances of cognitive dysfunction, nerve damage, liver damage and an increased risk of kidney injury.”

Worse, Roberts said, “Nobody’s life is going to be extended; nobody’s life is going to be saved [by having healthy people taking statins].”

Roberts is not alone in debunking the new guidelines. She pointed to a Nov. 13 op-ed in The New York Times, written by John D. Abramson, a lecturer at Harvard Medical School, and Dr. Rita F. Redberg, a cardiologist at the University of California, San Francisco Medical Center and the editor of JAMA Internal Medicine.

“Statins are effective for people with known heart disease. But for people who have less than a 20 percent risk of getting heart disease in the next 10 years, statins not only fail to reduce the risk of death, but also fail even to reduce the risk of serious illness,” Abramson and Redberg wrote. Based upon the same data the guideline writers relied on, they continued, “140 people in this risk group would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness.”

Roberts said: “We have a saying in medicine. If you torture the data long enough, it will confess to anything.”

An alternative to statins

Roberts promotes an alternative to statins for most of her patients – a Mediterranean diet that is high in monounsaturated fats from olive oil and is low in red meat. “Adhering to the plant-based Mediterranean diet will lower your risk of heart disease just as much as any use of statins – without any side effects,” she said.

Very few physicians, Roberts continued, will read all 85 pages of the new guidelines. “What people have to do is to become informed patients. They have to read both points of view and come to a decision on their own,” she said. But it’s very important, Roberts said, for people to know that statins are not as innocuous as people have been led to believe.

The numbers in the studies, she reiterated, show that you would need “to treat more than 100 people for a number of years to prevent one event [of a heart attack].”

Further, she argued, “cholesterol is misunderstood. It’s not the villain it’s been said to be. Every cell has cholesterol; 25 percent of cholesterol is in your brain. It’s absolutely crucial to the function of the brain.”

Heart disease is still the number-one cause of death in adults, according to the Centers for Disease Control and Prevention, with more than 597,000 deaths in 2011, according to statistics released in January 2013.

Changes in diet and lifestyle -- as well as what Roberts’ terms “primordial” interventions are the best ways to address chronic heart disease – rather than prescribing statins.

“We need to stop subsidizing the production of corn and soy, which are the ingredients in many of the unhealthy foods that are foisted on people,” she said. “We need to try to limit the advertising to children of unhealthy food products such as Cocoa Puffs. We need to raise cigarette taxes even more. And we need to stop eliminating physical education classes.”

Most doctors have swallowed the Kool-Aid

Roberts is been an outspoken advocate against the misuse of statins. “I’ve never turned down a speaking engagement – from Pawtucket to Reykjavík, Iceland.”

Many doctors, she continued, don’t want to hear what she has to say. “They don’t want to hear it so much,” she said.

Why?

“Because they’ve swallowed the Kool-Aid, most of them,” she said. “I would be happy to talk with them and give them my perspective, that the use of statins is not supported by the medical literature.”

Further, Roberts continued, the fact remains that “we really don’t know the truth about statins. The reason I say that is because we know that a lot of studies that are undertaken never get published.”

Roberts cited a recent British Medical Journal article that showed that for all registered clinical studies, 29 percent of those trials never are published.

“It’s much more common for an industry-sponsored study not to be published,” she said. “Industry-sponsored clinical trials are four times more likely to report positive results than non-industry sponsored clinical trials. There could be a lot of studies that showed statins were not efficacious that we don’t know about because they have never been published.”

According to an email received AM of 01/06/17 a representative of Miriam Hospital says that Dr. Barbara Roberts is no longer associated with the hospital.  No reason was given and no other details were offered. 

Type 2 Diabetes from Statins

I am somewhat surprised, but appreciative that Om Ganda, M.D., Director of the Lipid Clinic at Joslin Diabetes Center is not trying to hide the fact that statins have the side effect of causing type 2 diabetes.

He does seem to be blunting the side effect, and is saying that it may be the higher doses causing problems. If you’re like nearly one-third of Americans over age 40, you probably take a statin. These cholesterol-lowering drugs are used for reducing risk of stroke and heart attack. They work by lowering the amount of LDL cholesterol, the so-called “bad cholesterol” in the blood. Statins also reduce inflammation around plaque in the blood vessels.

Despite their benefits, some people stop taking them because of side effects. The latest example, which is shown in numerous studies suggest that taking statins could increase the risk of developing type 2 diabetes. “Nobody expected it,” says Dr. Ganda.

In response to this mounting evidence, Dr. Ganda carried out a comprehensive review of all available evidence examining the association between statins and type 2 diabetes. The new review showed largely consistent results across 33 randomized controlled trials and observational studies.

“There does seem to be a slight, but significant increase in the risk of new-onset diabetes in patients on statin therapy,” says Dr. Ganda.

Of the 33 studies included in the review, one study found that taking statins was linked to a 25 percent higher risk of diabetes. However, the other studies revealed either no increase or a much smaller increase (2 to 10 percent) with various statins.

Dr. Ganda says that it’s important to note that the increased risk is over and above the risk people already have, because diabetes and prediabetes are so common today.

The review also showed that the highest risks are associated with the most intensive statin therapy. It appears that those on high-dose statins, which have a greater effect at lowering cholesterol, are more likely to develop diabetes than those on moderate-dose statins.

“The risk of diabetes is dependent on the dose of the statin – that is, how strong it is — and the correlation seems to be significant,” says Dr. Ganda. “But still, more intensive therapy is indicated because of all the evidence that we have, particularly in patients who already have cardiovascular disease.”

The reason behind the statin-induced diabetes remains unclear. “The cumulative evidence does show that most people who get diabetes on statins already have prediabetes or features of metabolic syndrome, he explains. “This means that starting statin therapy just ushers it in.

What to Think About - If you’re concerned about preventing diabetes from happening, adopting a healthier lifestyle is the first step. If you’ve been diagnosed with prediabetes and have to go on statin therapy, talk to your doctor about doing whatever is necessary to control or reverse your prediabetes. In general, that means staying active, eating a heart-healthy diet and controlling your weight.

“People should be educated about their choices,” says Dr. Ganda. “The results from this review provides yet another reason for people to monitor their diet and get regular exercise.”

Should You Avoid Statins? Despite the slight increase in diabetes risk from using statin drugs, this alone is not enough to avoid taking them, Dr. Ganda points out. “It’s important for people with diabetes not to stop initial statin therapy, because it lowers the risk of cardiovascular disease.”

Instead, he explains, statin therapy should be intensified in order to get LDL as low as possible. As we get older, our LDL cholesterol usually rises, probably due to an increase in body fat. This harmful cholesterol is what produces atherosclerosis, the buildup of plaque in the inner linings of arteries that restricts blood flow. The goal should be an LDL level below 100, closer to 70 if you have heart disease “This benchmark is stricter than it used to be because many trials have shown that the lower you get LDL cholesterol the better,” he says.

When these studies first came out some experts said that statins should not be used in the diabetes population, but that is the wrong approach, he adds. “There is no reason to avoid statins out of fear of developing diabetes. And those who do develop diabetes on statin therapy are still protected against cardiovascular disease, even after developing diabetes.”

In addition, please read this article which says in one sentence the following - “The association of statins with the risk for incident diabetes is less well understood, but in an earlier study, previous meta-analysis of 13 clinical trials of statins featuring a total of 91,140 patients suggests that the risk for diabetes associated with these medications is real.”

Parkinson's Risk Increases with Statin Use

New findings from a large national claims database show the use of cholesterol-lowering statin drugs to be associated with an increased risk for Parkinson's disease (PD), contrary to previous research suggesting the drugs have a protective effect for PD.

"We identified 20,000 Parkinson's disease patients and looked at whether using statins was associated with a higher or lower risk, and we found people using statins have a higher risk of the disease, so this is the opposite of what has been hypothesized," senior author Xuemei Huang, MD, PhD, vice chair for research at Penn State College of Medicine, Hershey, Pennsylvania, told Medscape Medical News.

While high cholesterol has been shown to have a protective effect on the risk for PD, the role of statin use has been the subject of debate.

In looking at the issue in a previous study of their own, Dr Huang and colleagues in fact found an increased risk associated with statin use, and they sought in the new study to further explore the association in a much larger cohort.

For the new study, presented here at the American Neurological Association (ANA) 2016 Annual Meeting, the researchers turned to data from the MarketScan Commercial Claims and Encounters database, including information on 30,343,035 persons aged 40 to 65 years between January 1, 2008, and December 31, 2012.

In the cross-sectional analysis, the use of cholesterol-lowering drugs, including statins or nonstatins, was associated with a significantly higher prevalence of Parkinson's disease (odds ratio [OR], 1.61 - 1.67; P less than .0001) after adjustment for age, sex, and other comorbidities, such as hyperlipidemia, diabetes, hypertension, and coronary artery disease.

For a comparative neurodegenerative group, the researchers also looked at the association of statin with diagnosis of Alzheimer's disease but found only a minimal association (OR, 1.01 - 1.12; P = .055).

The associations of cholesterol-lowering medications with PD were strongest among patients with hyperlipidemia, and there were no significant differences between lipophilic or hydrophilic statins, as well as the other nonstatin cholesterol-lowering drugs, in their effect on PD risk.

"We know that overall weight of the literature favors that higher cholesterol is associated with beneficial outcomes in Parkinson's disease, so it's possible that statins take away that protection by treating the high cholesterol," Dr Huang explained.

"Another possibility is that statins can block not only the cholesterol synthesis but also synthesis of coenzyme Q10 that is essential for cell function."

The researchers also stratified persons according to how long they had been receiving treatment by using a lagged matched case-control analysis of 2458 pairs of PD cases and controls.

In the cross-sectional analysis, both statins and nonstatin cholesterol-lowering drugs were associated with PD, but in the lagged case-control analysis of treatment duration, only statins remained significantly associated with PD risk.

"The increased risk of Parkinson's is more likely when statins are first used, so we think it could be that the statins 'unmasked' Parkinson's," Dr. Huang said. "Namely, people may be already on the way to Parkinson's and when they use statins to control the high cholesterol, it gives Parkinson's a push to reveal its clinical symptoms.

"Based on this data, we think caution should be taken before advancing statins to be protective of Parkinson's disease," she added. "The data are not clear yet."

A meta-analysis published earlier this year in the journal Pharmacoepidemiology and Drug Safety suggests that one reason for the inconsistencies in evidence of the role of statins is that many studies fail to adjust for cholesterol levels.

Many Doctors Hesitant about Statins – Part 2

What Are the Side Effects? All medicines can have side effects. With statins, the most common one is muscle pain. Anywhere from 5% to 20% of people who take statins report having it. And it's more common among people taking high doses. But it's not clear if those muscle symptoms are actually related to statins, or if something else is to blame.

"Most people can tolerate these drugs, but a handful of my patients do have muscle aches," Steinbaum says. If that happens, switching to a different statin, lowering your dose, or taking your pill every other day instead of daily might help. Talk to your doctor before you change how you take any medicine.

In very rare cases, statins can cause severe muscle damage that can be life-threatening. This may happen with certain statins, especially if it interacts with another drug that you take. Be sure to review all your prescription and over-the-counter medications and supplements with your doctor.

Other rare side effects include liver injury, so ask your doctor how often your liver enzymes should be tested. Ongoing liver monitoring is no longer recommended, but Steinbaum still advises it: "I still do liver checks often, because if you're taking a statin along with even something like Tylenol, you could have damage."

Memory loss or confusion and neuropathy (a pins and needles sensation) have also been reported, though they seem to be rare and more likely at very high doses. The FDA hasn’t concluded that statins cause those problems.

You might have also heard that taking a statin could raise your risk of developing type 2 diabetes. Research has found that some people do get a small rise in their blood sugar levels while they take a statin, but it's hard to say that these meds actually cause diabetes.

"I really looked at the data long and hard, and what I gathered is that most of the people who developed diabetes [after starting a statin] were going to get it anyway," Steinbaum says. "They were already at very high risk thanks to metabolic syndrome, being overweight, or other factors."

Cost may also be another issue for some people, though Nissen points out that you can now get some generic statins for as little as $10 per month.

What Else to Keep in Mind Whether or not you choose to take a statin, lifestyle changes still matter. "About 80% to 90% of the time, heart disease is preventable through modifiable risk factors," Steinbaum says. She notes that eating a healthy diet (including limiting sugar), being active, not smoking, and keeping your weight down are all key.

Still, there are other things you can’t change, like your age and your genes. Although diet and exercise are a must, they aren’t enough for everyone. Still, overhauling your habits might mean that you can take less medication, which can mean a lower risk of side effects.

Still on the fence? Talk to your doctor, and ask for more information that may help you decide.

Make sure you talk about “risk factors” that are not part of the latest risk calculator from the AHA and ACC. Those might include your family history, C-reactive protein levels (a marker of inflammation), or a personal history of gestational diabetes (a type of diabetes that only happens during pregnancy).

Your doctor may consider other things, too. Steinbaum sometimes orders imaging tests to look for calcification in the arteries or measure the thickness of the carotid artery, which carries blood from the heart to your brain, before she decides whether to recommend a statin for a particular patient. But those aren’t routine tests.

Although statins are still a go-to medicine, there is no one-size-fits all prescription. And if they don’t help you enough (along with diet and exercise), or you can’t take them because of side effects, there are also other types of cholesterol-lowering medicines.

It’s best to have an open, ongoing conversation with your doctor about the risks and benefits. Let them know how you’re doing. "If your doctor isn't having a dialogue with you about it," Nissen says, "you might want to find another doctor."

Many Doctors Hesitant about Statins – Part 1

This is not an easy discussion, and I have some serious doubts about the accuracy and validity of this study.

You're going over the results of some blood tests with your doctor. She/he tells you that your “bad” cholesterol (LDL) level is high. Will you need to take a statin drug to bring it down? The official answer used to be an easy one, but lately it's gotten more complicated. This I can agree is true.

For years, there were clear cut-offs -- numbers your doctor looked for. If your levels were above them, then your doctor was supposed to prescribe a statin plus lifestyle changes (healthy eating, limiting unhealthy fats, and being more active).

A healthier lifestyle is still definitely part of the plan. But the statin question changed a bit when the American Heart Association (AHA) and American College of Cardiology (ACC) updated their guidelines.

Now the only people who automatically get a statin based only on their LDL are those whose number is very high (190 mg/dl or higher). Otherwise, your doctor is also supposed to look at other things, such as whether you have diabetes and whether the AHA/ACC's risk calculator predicts that you have at least a 7.5% chance of having a heart attack or stroke within the next decade.

It's worth noting that many doctors are not following these guidelines to the letter, and that they've generated some controversy.

"I'm not [using them], and nobody else is, either," says Steven Nissen, MD, chairman of the department of cardiovascular medicine at the Cleveland Clinic. He prefers to use a combination of older guidelines and another risk calculator, called the Reynolds Risk Score.

Regardless of whether your doctor is on board with the newer guidelines, he or she should also consider other heart disease risk factors before making a recommendation.

Ultimately, the decision about statins is yours. You’ll want answers to these questions to help you decide.

What Can Statins Do for Me? If you take one, you can expect your LDL cholesterol to drop by anywhere from 35% to 50% or more, depending on the type of statin you take and your dose, Nissen says. And that could cut your chance of a heart attack or stroke.

Statins work in your liver. They block an enzyme that helps your body make cholesterol. They also lower inflammation in the arteries and stabilize plaque (cholesterol, other fatty substances, and clotting agents) that may have built up inside your arteries, says cardiologist Suzanne Steinbaum, DO, director of women and heart disease at Lenox Hill Hospital in New York. "That's more important than anything, because if plaque bursts it can cause a heart attack or stroke," she says.

Cardiologists generally agree that statins are a no-brainer for people who've already had a heart attack or stroke, because there’s strong evidence that they can help prevent a second one.

There's been some debate as to whether statins are as helpful in preventing a first heart attack or stroke. But most experts say there's plenty of proof that they're safe and effective for this purpose.

If you're at high enough risk for your doctor to recommend a statin, "I think you can safely say that a moderate dose will reduce the risk of either a heart attack or stroke by 30%," says Jennifer G. Robinson, MD, MPH, director of the Prevention Intervention Center at the University of Iowa.

She notes that several major studies -- including a review of 18 trials based on data on nearly 57,000 people -- have shown that statins lower the chances of developing both fatal and non-fatal heart disease, as well as cut the risk of dying from any cause during those trials. Robinson was vice chair of the team that developed the AHA/ACC guidelines in 2013.

When Will Doctors Believe in Statin Damage?

Most doctors will continue to insist on prescribing statins, but more and more evidence is coming to light about the damage to our bodies being caused by statins. Increasing numbers of Americans are being prescribed statin drugs to lower their risk of heart attack or stroke. The risks of these drugs to muscles and kidneys may be greater than previously thought.

Statins are also associated with a higher risk of type 2 diabetes and with more rapid deterioration in patients with chronic kidney disease.

Duane Graveline, M.D., M.P.H., and Philip W. Blair, M.D. writing in the spring issue of the Journal of American Physicians and Surgeons say, “The risks of these drugs to muscles and kidneys may be greater than previously thought.” Graveline and Blair calculate that between 2005 and 2011 there may have been nearly 2,000 deaths from rhabdomyolysis due to statins, based on the FDA's MedWatch records.

Authors conclude that statin-associated muscle and kidney damage are both more common and more insidious than generally believed. The "collateral damage is probably higher than most clinicians would consider acceptable." They advocate restricting statin usage until more is known about these effects.

Damage may be occurring even if the patient's CPK levels are normal, authors state. CPK (creatine phosphokinase) is the blood test doctors monitor to check for muscle damage. Although rhabdomyolysis is generally considered to be an acute crisis, there is a chronic progressive form as in the case report in the article.

Some 24 percent of Americans have a gene called SNIPS, which causes blood levels of statins to be much higher than expected, authors warn.

Also read my blog about statins causing hardening of the arteries, which was not reported in this study.

With all the bad news being found in studies lately, it is hoped that doctors will slow their efforts to over prescribe statins, but the American Heart Association is not backing down in their efforts to prescribe statins to more people. They are even pushing for prescribing to people that have normal lipid panels and young people.

Those of us following the research know that people are abandoning statins in greater numbers and won't allow future prescriptions, even if they are labeled non-compliant.

Statins Receive Scrutiny They Deserve

I like what is happening in Great Britain. I can only hope that the United States can learn from them. The Queen's former doctor, Sir Richard Thompson has called for an inquiry into the safety and efficacy of statins. This was after a review into key trials concluded the pills were not effective in protecting against heart disease.

The former president of the Royal College of Physicians and personal doctor to the Queen for 21 years said: “The statin data needs to be urgently scrutinized. We are very worried about it and particularly side-effect data, which seems to have been swept under the carpet. We have to be very wary of the doubts about statins produced by this new research and if we are wrong about widespread prescribing of this drug we have to stand up and say sorry.”

This is very powerful and would be a first for doctors or their organizations to admit something and to say “sorry.” The cholesterol-busting drugs are given to up to 12 million patients in the UK, or around one in four adults.

Supporters, including the British Heart Foundation charity, say they save lives and UK health regulators insist they are safe. Yes, they still do not recognize the more severe side effects and like the American Heart Association will continue to promote statins even when they may be proven wrong. Please read my blog here about statins causing hardening of the arteries, a leading cause of heart problems.

Critics say the risks, such as severe muscle pain, depression, fatigue, impaired memory, and stroke, outweigh the benefits others claim exist. They also claim that much of the data could not be trusted as it relied on trials carried out before 2005/6 when new rules were brought in to make scientific studies more credible. It was later found by independent experts that the studies have no effect on death rates.

Another is the 4S study published 1994, which the new study claims should not be relied on as it was run and analyzed statistically by staff paid by a manufacturer of statins. This “would today be totally unacceptable” said the new report’s lead author Dr Michel De Logeril. His report concluded, “Statins are not effective for cardiovascular prevention”. Dr De Logeril, a cardiologist at the University of Grenoble in France, added: “We cannot trust these trials. I would warn people not to take statins.”

He was backed by eminent London-based cardiologist Dr Aseem Malhotra, who said: “These are truly disturbing findings and fit in with the concept that all industry-sponsored studies should be seen as marketing until proven otherwise.”

Dr Malcolm Kendrick, who has studied heart health extensively agreed. He said: “This review confirms my fears that research on statins is fatally biased.”

Experts have urged anyone with concerns about the use of statins to contact their GP

Moreover, Fiona Godlee, editor of the British Medical Journal, added: “This carefully done piece of work reinforces the need for a thorough review of the evidence base on statins.”

CDC Reports Half of Eligible U.S. Adults Don’t Take Statins

This may be the best thing for them – see my blog here. I will be ditching statins over the next 45 days and I will not let a doctor convince me otherwise. In researching for the blog above, there were many articles on statins causing hardening of the arteries. Yet, the endocrinologists and cardiologists will not give them space on their websites. In a recent conversation with a cardiologist, when I mentioned this, he wanted to know where I read this and asked for URLs that I could email to him.

I did hear back from him and he said that he would need to rethink his policy of prescribing statins. He was gracious enough to say that he had not heard of these studies and even though most were behind paywalls, he did access them and was very surprised at what was in several of the studies. In the email, I did ask if he were able to read a couple of them, would he email me a copy. He did and for that I thanked him.

We have continued our discussion over the last several days and he thanked me for my blog referenced above and for including the statements by several doctors. While he was aware of Dr. Malcolm Kendrick's book “The Great Cholesterol Con”, he had not read it and with the URLs I had sent him, he had ordered the book.

I also asked him about the newest statin, the PCSK9 class. With our discussion, he said he would be in correspondence with Dr. Kendrick after reading his blog on this and reading my three blogs on the new drugs. He is not sure about prescribing presently, but stated he does have one patient that has asked about them and the patient fits the criteria, but he told the patient to wait.

Then he asked me for the results of my last lipid panel, which I sent to him. I received an immediate reply asking me how I had achieved the low levels for LDL, triglycerides, and a good reading for HDL. I said my way of eating and not following the food plan many registered dietitians push of carbohydrates and whole grains. I said I follow a low carb, high fat food plan with moderate protein. I eat lots of eggs and cheese that is not highly processed. I like sausage and bacon and I choose other high cholesterol foods that are not highly processed. I read food labels, ingredients, and avoid many canned foods except green beans and use a lot of dried beans that we use the pressure cooker to put moisture back into the beans. He asked how many carbohydrates I consumed per day. My answer was 30 to 50 grams per day and it varies by what I decide to eat for the day.

He commented that he had two patients eating very similar food plans and he said this must be why their lipid panels are always so good. He said he needed to stop for now, but that he would be back with more questions.

I have strayed from the topic so I will have to think about whether I really want to blog about the CDC saying half of eligible U.S. Adults don't take statins.

Hardening of Arteries Can Be Caused by Statins

This is a warning that statins may not be the miracle drug many cardiologists claim. People taking the drugs are more likely to suffer from hardening of the arteries, a leading cause of heart problems. And no, this is not the first time this has been said. See paragraph three below.

In addition, researchers found the drugs block a process that protects the heart.  This can “cause, or worsen, heart failure”, according to a study. The lead author says: “I cannot find any evidence to support people taking statins.”

In the research published in Diabetes Care (in 2012), scientists examining patients with type 2 diabetes and severe atherosclerosis discovered that coronary artery calcification was decidedly greater in more frequent statin users compared to those who were less frequent users. Even more disturbing, in a subgroup of participants who initially did not take statins, advancement of coronary artery calcification (CAC) and aortic artery calcification (AAC) was decidedly greater in those who used statins frequently.

Some side effects are skeletal weakness and muscle pain. Now Professor Harumi Okuyama, whose team studied a series of more than 20 major research papers on the drugs, says they could cause heart disease.

Dr Okuyama, of Nagoya City University, Japan, said: “We have collected a wealth of information on cholesterol and statins from many published papers and find overwhelming evidence that these drugs accelerate hardening of the arteries and can cause, or worsen, heart failure. I cannot find any evidence to support people taking statins and patients who are on them should stop.”

The researchers say the hypothesis that statins protect the heart by lowering cholesterol is flawed and that high cholesterol is not necessarily linked to heart disease. They also found statins have a negative effect on vital body processes linked to heart health.

They discovered patients taking the drugs were more likely to have calcium deposits in their arteries, a phenomenon directly linked to heart attacks. This is because statins block a molecule needed for the body to produce a vital K vitamin, which prevents calcification of the arteries. Dr Okuyama and his team say many earlier industry-sponsored studies, which show the benefits of statins, are unreliable.

Researchers says that high cholesterol is not necessarily linked to heart disease.  They claim this is because they were carried out before new European regulations were introduced in 2004, which insisted on all trial findings, both negative and positive, being declared.

The study states that before these new rules came into effect “unfair and unethical problems were associated with clinical trials reported by industry-supported scientists”.

Dr Okuyama’s team looked at studies before and after 2004. They found: “The epidemic of heart failure and atherosclerosis (hardening of the arteries) that plagues the modern world may paradoxically be aggravated by the pervasive use of statin drugs. We propose that current statin treatment guidelines be critically re-evaluated.”

Dr Malcolm Kendrick, who has studied heart health and statins, said: “This study demolishes the argument that these drugs should be prescribed to anyone, as the harms clearly outweigh any previously suggested benefits.”

Dr Peter Langsjoen, a heart specialist based in Texas who is co-author of the study, said: “Statins are being used so aggressively and in such large numbers of people that the adverse effects are now becoming obvious. These drugs should never have been approved for use. The long-term effects are devastating.”