Amgen

Amgen Drug Prevents Heart Attacks, Not Deaths, Disappointing Experts

Posted by

0


Repatha, a new drug from Amgen, prevents heart attacks and strokes better than any medicine since the cholesterol-lowering statin drugs that are a daily preventative for millions of middle-aged people, according to a new study.

But the results fall below what doctors and patients had hoped for the drug, and set the stage for an intensified battle over Repatha’s $14,523-a-year list price, several times what the most expensive branded statins cost before they went generic.

“I think it’s a solid ‘B,’” says Harlan Krumholz, a cardiologist and epidemiologist at Yale Medical School, of the result. “If they’d met the expectations on what the drug was going to achieve, it would have made a big difference. On the other hand, they could have shown nothing.” Adds Steven Nissen, of the Cleveland Clinic and an Amgen investigator: “Now the debate is who should get the drugs.”

Analysts at investment banks and top cardiologists had been hoping that Repatha would reduce by as much as 30% the risk of a combined measure of heart attacks, strokes, deaths from heart disease, hospitalizations due to chest pain, and stent and heart bypass procedures. Instead, that result was just 15%, although the drug did better on reducing heart attacks and strokes, two of the measures that matter most. But Repatha also had no effect at all on whether patients died.

Repatha was not supposed to be just any drug. It is one of the first medicines developed based on the discovery of real-life mutants: people with variations in a gene called PCSK9 who have extremely low cholesterol levels and heart attack risk. Before Repatha was introduced, CVS Caremark, one of the largest managers of drug benefits for U.S. employers, warned that drugs like it could cost the U.S. healthcare system $200 billion. Yet Repatha sales last year were only $140 million globally. Praluent, a similar drug made by drug firms Sanofi and Regeneron, had sales of just $116 million. The drugs are injections, not pills.

The hope among investors and cardiologists was be that this 27,564-patient study, presented this morning at the annual meeting of the American College of Cardiology in Washington, D.C., and published in the New England Journal of Medicine, would blow the barriers that keep patients from getting PCSK9 drugs. Now doctors, patients and insurance companies still struggle with the question: is Repatha worth the money?

A Lower-Than-Expected Result

It wasn’t just genetics that got expectations for PCSK9 drugs hot. Reducing LDL as much as Repatha did should have resulted in a 31% reduction in heart attacks and strokes, says Sekar Kathiresan, a cardiologist and geneticist at Massachusetts General Hospital.

So why was the result only 15%? One reason is the measure of success Amgen chose. In order to get more statistical power in clinical trials, drug companies and cardiologists often lump “hard” measures like heart attacks, strokes and deaths together with less important but more common problems like being hospitalized for chest pain or needing a stent to open a clogged artery.

Repatha reduced the rate of heart attacks 27%, from 4.6 in 100 patients to 3.4 in 100 patients. It reduced stroke 21%, from 1.9 in 100 patients to 1.5 in 100. It reduced stents and heart bypass procedures 22%, from 7 in 100 to 5.5. But on hospitalizations for chest pain, it did nothing–1.7 of 100 people in both groups were hospitalized for chest pain.

It may be that chest pain is no longer a good measure for clinical trials, says Marc Sabatine, the Brigham & Women’s Hospital cardiologist who led the study for Amgen. Blood tests can now detect whether people with chest pain are having heart attacks or need stents. Those hospitalized for chest pain may actually have other problems, like acid reflux. “You’re not going to intervene on heartburn,” says Sean Harper, Amgen’s head of research and development.

Haste Makes Waste?

But Repatha also didn’t impact a more important measure: whether patients lived longer. On Repatha, 1.8 of 100 patients died of cardiovascular causes; for placebo, that figure was 1.7.  For the most part, these “cardiovascular causes” were not heart attacks and strokes, but sudden cardiac deaths, when a patient dies suddenly for unknown reasons. It could be that a cholesterol drug had no effect on sudden cardiac death. But only 0.4% of patients died from either a heart attack or stroke; the rates of fatal heart attacks and fatal strokes were actually better in the Repatha group, but were too small to draw conclusions. Doctors may just be better at preventing death compared to 20 years ago, when the first statin studies were run.

It could be that Amgen rushed too fast, choosing to run a gigantic-but-short study to get quicker results. Trials in which statin drugs prevented deaths lasted five years. Patients were followed, on average, for a little more than two years in this study. For both statins and the PCSK9 drugs, it appears that effectiveness takes time to appear, and is half what it would be expected to be in later years, says Rory Collins, an Oxford epidemiologist who is one of the world’s top experts on cholesterol medicines. A shorter trial means a much lower effect as a result. What’s more, it may take time to prevent deaths by preventing buildup in the arteries. “The underestimation could be a duration effect,” Collins says. “And it could be really quite substantial.”

That leads to the possibility that a longer trial might show better results. Sanofi and Regeneron are running a study of their PCSK9 drug, Praluent, in which all patients will take drug for at least two years. “My belief is whatever Amgen shows I hope we’ll have a better or higher result,” said Elias Zerhouni, the head of R&D at Sanofi, before seeing the Amgen results.

Patients Denied

A logjam in drug benefit plans has kept PCSK9 medicines from being used, even for patients who obviously need them. Take Cameron Credle, 30, a woodworker in Chapel Hill, N.C. At age three, he had a total cholesterol of 430 milligrams per deciliter, almost quadruple normal levels. (He has a genetic disease called familial hypercholesterolemia.) He’s spent his whole life trying to get his LDL down. Statins brought it down to about 250 mg/dL. It took him four months to get approval to try Praluent, the Sanofi/Regeneron drug. It gave him diarrhea. He spent another eight months getting approval for Repatha, instead taking samples of the drug his doctor obtained. He says his doctor’s office logged 15 hours of work to get him the medicine.

Craig Davis, 57, the former chief information officer of the Veterans Affairs Medical Center in Orlando, Florida, also has familial hypercholesterolemia. He went on federal disability after his second coronary bypass surgery. Three decades ago, he learned his total cholesterol was 840 mg/dL and his LDL 420 mg/dL. He’s been on statins since they were introduced, and got five stents between when he was 35 and 40. His next option would be a heart transplant, his doctors tell him. He wanted to switch to Repatha from Juxtapid, a $300,000-a-year drug that was damaging his liver. Getting approval took weeks. Then, he changed insurers–and was denied again. “It was a bureaucratic nightmare, and that’s coming from a career bureaucrat,” Davis says.

Both Credle and Davis were identified by the Global Healthy Living Foundation, a nonprofit that gets some funding from drug companies including Amgen. Both say they receive no compensation. Their stories show that there are people who would benefit from PCSK9 drugs who are clearly having trouble getting them. But the vast majority of patients are not at nearly as much risk.

The Pharmacy Middlemen

Answering the question of who should get Repatha is largely being left to the giant companies that manage drug benefit programs for insurers and employers, including CVS Caremark, Express Scripts and some units of UnitedHealthcare. Representatives of CVS and Express Scripts say they expect the results are good enough to drive increased use of the medicines. “If we sense the consensus is that this demonstrates there’s a substantial decrease in cardiac outcomes, it will increase the number of people increasing PCSK9 inhibitors,” says Troyen Brennan, the chief medical officer at CVS Caremark.

Steven Miller, the chief medical officer at Express Scripts, says that part of the reason the drugs weren’t being prescribed is that doctors weren’t pushing very hard for them, even for the sickest patients. He thinks that will change. “Getting the patients approved had been difficult, and because there was no endpoint data many practitioners didn’t push very hard,” Miller says. “Now that there is endpoint data they are going to be pushing a lot harder to write these scripts.”

Miller says Express Scripts has been working to make sure that patients who really need the PCSK9 drugs can get them. Half the denials of Repatha or Praluent at Express Scripts were because the company was asking doctors to send not just a lab value, but also an actual copy of a lab report. For a $14,000 drug, it seemed fair. But for doctors’ offices, this turned out to be difficult, because the lab report itself was not always in the medical record. Express Scripts has changed its requirements as a result, he says. Still, Miller says, companies like his are also “stewards” of their clients’ cash.

Is Avoiding A Heart Stent Worth $1 Million?

The question for many drugs is not whether Repatha prevents heart attacks–it clearly does–but whether that is worth the money. Sanjay Kaul, a cardiologist at Cedars Sinai Medical Center in Los Angeles, calculates that it costs $2 million to prevent a heart problem (cardiologist jargon: an event) at Repatha’s list price. “Even with 50% price discount, $1 million per event prevented is too steep a price to justify!” he says. David Rind, chief medical officer of the Institute for Clinical and Economic Review, says it would be “surprising” if the new results make economic analyses of Repatha look better.

“People care about more than just surviving,” counters James Stein, of the University of Wisconsin School of Medicine and Public Health. He plans to use PCSK9 drugs more.

Adds Nissen, the Cleveland Clinic cardiologist: “We give very expensive cancer drugs that extend life for six weeks. I just want to be able to offer patients the best therapies that are available. I look after many patients after [heart attack], they go out and they try to do things and their exercise tolerance is never the same. I follow patients who have had a stroke and now walk with a cane. They’re alive, but their quality of life is never the same. Do I wish these drugs cost $4,000 a year instead for $14,000? I do.”

Says Yale’s Krumholz: “The drug has been priced on speculation, in my mind. What do you get from a 60 mg/dL reduction in cholesterol? People thought you’d eliminate heart disease. But that’s not what happened here. But you’re in the range of what happens with statins. If you’re giving me a new statin, we should be paying pretty much what we paid when the statins were introduced. Why should we be paying a premium for that?”

Amgen, for its part, says that even at $14,000, Repatha is cost-effective. And it actually gets much less than that. Drugmakers pay rebates to pharmacy benefit managers; for a drug like Repatha, those rebates could be 30% or more.

Many doctors say one of their main takeaways from the trial will just be that lower levels are better, no matter how low a heart patient’s LDL is. Ethan Weiss at UCSF says he will start reaching for generic Zetia, a generic Merck drug, before he ever goes for the PCSK9 shots. What that means for sales, which Wall Street analysts hope will pass $2 billion for both Repatha and Praluent, is not clear. Another factor for investors to consider: there is ongoing patent litigation between the two companies that almost led Praluent to be removed from the market.

The debate over these amazing, potent and (still) potentially life-saving drugs is a snapshot of medicine in 2017. Science is great. But what does it cost in dollars and cents? We’re getting to the point where  we need to know.

Source : https://www.forbes.com

Denosumab increased adherence, BMD in postmenopausal patients.

Posted by

0


Patients previously treated with a bisphosphonate who still have a high risk for fracture may benefit from the addition of denosumab, according to data presented at ASBMR 2013.

 “We have in fact shown a more robust increase in [bone mineral density] at the end of the 1 year, based on total hip, femoral neck and lumbar spine. We also showed a larger reduction in bone turnover markers,” Jacques P. Brown, MD, of the CHU de Quebec Research Center and Laval University in Canada, told Endocrine Today.

The multicenter, randomized, open-label, parallel-group studies included postmenopausal women aged at least 55 years who were randomly assigned to denosumab 60 mg (Prolia, Xgeva; Amgen) subcutaneously every 6 months (n=852) or a bisphosphonate (ibandronate [Boniva, Roche] orrisedronate [Actonel, Warner Chilcott]) 150 mg by mouth each month for 12 months (n=851; mean age, 67 years). The mean T-scores of the patients were: –1.7 at the total hip, –2 at the femoral neck, and –2.4 at the lumbar spine.

 

The researchers conducted a combined post-hoc analysis on patients with a greater risk for fracture administered denosumab or bisphosphonate.

Patients at higher risk for fracture who were administereddenosumab appeared to have a significantly increased BMD compared with those assigned to a bisphosphonate at the total hip (2.2% vs. 0.8%), femoral neck (1.8% vs. 0.3%), and lumbar spine (3.8% vs. 1.4%), according to 12-month data.

“The important finding was that patients who appeared to be noncompliant with bisphosphonates improved their level of adherence when switched to denosumab,” Brown told Endocrine Today.

These findings were consistent with the overall study population (treatment-by-risk subgroup interaction P>.05), according to data. Further, adverse events and serious adverse events were similar between those assigned denosumab compared with those assigned bisphosphonates.

“There is a clear advantage to switching postmenopausal patients to a more convenient approach like a subcutaneous injection every 6 months,” Brown said.

Source: Endocrine Today.

 

New Cholesterol Drug PCSK9 is Likely to Prematurely Kill You.

Posted by

0


Story at-a-glance

  • A new class of drugs known as PCSK9 inhibitors promises to reduce LDL cholesterol levels to previously unheard of lows, dropping your level below 50. These drugs will undoubtedly kill many before the risks are fully realized
  • Your body needs cholesterol for the production of cell membranes, hormones, vitamin D, and bile acids that help you to digest fat
  • If your levels get too low, you increase your risk of dementia, violent and aggressive behavior, depression, suicide, cancer, Parkinson’s disease—and likely heart disease, as a result of cholesterol sulfate deficiency
  • Statin drugs, which one in four adults over 45 are using to protect their heart health, can paradoxically have significantly detrimental effects on your heart health
  • The most effective way to optimize your cholesterol profile and prevent heart disease is via diet and exercise.
  • cholesterol (1)

In 2004, the US government’s National Cholesterol Education Program panel advised those at risk for heart disease to attempt to reduce their LDL cholesterolto less than 100, or even less than 70, if you’re very high risk. Prior to this, a 130-milligram LDL cholesterol level was considered healthy.

In order to obtain the incredibly low LDL levels now recommended, you typicallyhave to take a cholesterol-lowering statin drug, and sometimes two or three of them in combination.

Now, a new class of cholesterol drugs known as PCSK9 inhibitors promises to reduce LDL cholesterol levels to previously unheard of lows. Indeed, this type of drug can drop your level below 50!

My prediction? These drugs will absolutely kill people—not just some, but MANY. I cannot warn you against this terrible idea enough. While many worry that their cholesterol is too high, few give any thought at all to the damage that can result if your cholesterol is too low.

This is a topic near and dear to my heart, as I drove (without drugs) my own total cholesterol levels down to a risky 75 when I was a naive young doctor. Alas, when it comes to cholesterol, lower is not always better. In fact, when your cholesterol levels go too low, a host of negative things happen in your body.

Unfortunately, lowering cholesterol levels has become so common in the US that nearly every American reading this either knows someone struggling to do so, or has struggled to do so themselves.

This despite the fact that there is no evidence to support the notion that having an extremely low cholesterol level is beneficial, and increasing numbers of studies point to significant risks associated with cholesterol-lowering drugs.

For example, a 2008 paper published in the American Journal of Cardiovascular Drugs1 cites nearly 900 studies on the adverse effects of HMG-CoA reductase inhibitors (statins), which run the gamut from muscle problems to increased cancer risk.

How Do PCSK9 Inhibitors Work?

Whereas statins (HMG-CoA reductase inhibitors) reduce your cholesterol by blocking an enzyme in your liver that is responsible for making cholesterol, these newer drugs, PCSK9 inhibitors, target and suppress a particular gene involved in the regulation of how much cholesterol your liver can actually filter out.

Researchers discovered that people with underactive PCSK9 genes had low levels of LDL. They also had low levels of cardiovascular disease. Since high cholesterol has long been mistaken as a primary cause of cardiovascular disease, these findings were akin to striking scientific gold… As reported in the featured article2:

“It’s this discovery that has Sanofi and two other major drug companies, Amgen and Pfizer, racing to develop a drug that mimics the gene’s effects. The best approach, experts say, will be through monoclonal antibodies: antibodies that are created in a lab and help your immune system fight a disease or, in this case, fight cholesterol…

‘This is not to replace statin therapy,’ said Joe Miletich, senior vice president of research and development at Amgen. ‘This is actually to get patients to (their) goal who can’t get there.’… ‘With a statin medication, you can often get somebody’s cholesterol between 70 and 100 mg/dL,’ said Dr. Elliott Antman, president-elect of the American Heart Association and a dean at Harvard Medical School. ‘If you use these monoclonal antibodies, you could see a number way less than 50.'”

I’ve told you before that the odds are very high— greater than 100 to 1—that if you’re taking a statin, you don’t really need it. From my review, the only subgroup that might benefit are those born with a genetic defect called familial hypercholesterolemia, as this makes them resistant to traditional measures of normalizing cholesterol.

In my view, this warning is just as applicable when it comes to PCSK9 inhibitors. Your body needs cholesterol and it doesn’t matter how you lower it: statins, PCSK inhibitors, or diet and exercise like I did. If your cholesterol drops too low, you will suffer health problems that I review in the next section.

The Health Hazards of Having Too Little Cholesterol

Your body needs cholesterol for the production of cell membranes, hormones, vitamin D, and bile acids that help you to digest fat. It’s not hard to see then why too little cholesterol can have such detrimental effects on your body—especially your brain, where it helps your brain form memories and is vital to your neurological function.

For example, research published in 20083 showed that low HDL is associated with poor memory and decline in memory in middle-aged adults. If you value your brain and want to keep it functioning into your senior years, you’d be well advised to pay attention to what it needs, and that includes cholesterol, along with healthful fats like omega-3. But impaired memory and dementia are just the tip of the iceberg when it comes to low cholesterol’s impact on your brain. If your levels get too low, you also increase your risk of:

Even more importantly, heart disease may in fact be a sign of cholesterol deficiency, according to MIT researcher, Dr. Stephanie Seneff. Considering the fact that conventional medicine has been telling us that heart disease is due to elevated cholesterol and recommends lowering cholesterol levels as much as possible, Dr. Seneff’s claims may come as a complete shock to some.

“Heart disease, I think, is a cholesterol deficiency problem, and in particular a cholesterol sulfate deficiency problem…”

She points out that all of this information is available in the research literature, but it requires putting all the pieces together to see the full picture. Through her research, she believes that the mechanism we call “cardiovascular disease,” of which arterial plaque is a hallmark, is actually your body’s way to compensate for not having enough cholesterol sulfate. In a nutshell, high LDL appears to be a sign of cholesterol sulfate deficiency—it’s your body’s way of trying to maintain the correct balance by taking damaged LDL and turning it into plaque, within which the blood platelets produce the cholesterol sulfate your heart and brain needs for optimal function…

What this also means is that when you artificially lower your cholesterol with a statin drug, which effectively reduces that plaque but doesn’t address the root problem, your body is not able to compensate any longer, and as a result of lack of cholesterol sulfate you may end up with heart failure.

Have High Cholesterol? Address the Cause!

Contrary to popular belief, high cholesterol is not a disease in and of itself. It is actually a response to something gone awry in your body. Cholesterol is produced whenever your cells become damaged, as it’s a necessary component in making new, healthy cells, so if you have a lot of damaged cells, you’re also going to have a lot of cholesterol in your bloodstream. This is a sign that your cells need, and are, being repaired. While most conventional doctors do not recognize this sign for what it is and put you on toxic cholesterol-lowering drugs, a more knowledgeable doctor will address the root problem, which is typically related to chronic inflammation brought on by:

  • A diet too high in sugar/fructose and grains
  • Too many processed, overcooked foods
  • Lack of exercise
  • Emotional stress
  • Smoking

The remedy involves, of course, addressing these factors by making simple lifestyle changes that are outlined in my optimizednutrition and lifestyle plan. Whatever you do, don’t fall for the mistaken belief that the lower your cholesterol goes, the better. If you lower your cholesterol through artificial means without addressing the underlying causes for your elevated cholesterol levels, your body will continue to degenerate. Leave the decision of how much cholesterol your body needs up to your body, and make the right lifestyle choices to keep your cells in their top condition. This way you get the best of both worlds: the right amount of cholesterol and a body in tip-top shape.

The Many Well-Known Health Hazards of Statin Drugs

First, if you are a woman, it’s critical for you to know that statins are classified as a “pregnancy Category X medication” meaning,it causes serious birth defects, and should NEVER be used if you’re pregnant or planning a pregnancy. Last year, the US Food and Drug Administration5 (FDA) also announced it’s considering additional warning labels for statin drugs. Among them are warnings that statins may increase your risk of:

  • Liver damage
  • Memory loss and confusion
  • Type 2 diabetes
  • Muscle weakness (for certain statins)

In all, statin drugs have been directly linked to over 300 side effects6, including:

Cognitive loss Neuropathy Anemia
Acidosis Frequent fevers Cataracts
Sexual dysfunction An increase in cancer risk Pancreatic dysfunction
Immune system suppression Muscle problems, polyneuropathy (nerve damage in the hands and feet), and rhabdomyolysis, a serious degenerative muscle tissue condition Hepatic dysfunction (Due to the potential increase in liver enzymes, patients must be monitored for normal liver function)

Statins Cause Hallmark Symptoms of Heart Disease and Diabetes

Sadly, while millions of people are told to use statin drugs as a form of “preventive medicine” to protect their heart health, research shows that these drugs actually can have significantly detrimental effects on your heart! How is that preventive medicine? For example, a study published just last year in the journal Atherosclerosis7 showed that statin use is associated with a 52 percent increased prevalence and extent of calcified coronary plaque compared to non-users. And coronary artery calcification is the hallmark of potentially lethal heart disease!

Statins can also:

  • Deplete your body of CoQ10, which accounts for many of its devastating health effects. CoQ10 is used by every cell in your body, but especially your heart cells. Cardiac muscle cells have up to 200 times more mitochondria, and hence 200 times higher CoQ10 requirements than skeletal muscle. Therefore, if you take a statin, you must take supplemental CoQ10, or better, the reduced form called ubiquinol.

A recent study in the European Journal of Pharmacology8 showed that ubiquinol effectively rescued cells from the damage caused by the statin drug simvastatin, thereby protecting muscle cells from myopathies. Again demonstrating the necessity of CoQ10 supplementation during statin therapy, a recent study9 evaluating the benefits of CoQ10 and selenium supplementation for patients with statin-associated myopathy found that, compared to those given a placebo, the treatment group experienced significantly less pain, decreased muscle weakness and cramps, and less fatigue.

  • Interfere with the mevalonate pathway, which is the central pathway for the steroid management in your body. Products of this pathway that are negatively affected by statins include sex hormones, cortisone, the dolichols (which are involved in keeping the membranes inside your cells healthy), and all sterols, including cholesterol and vitamin D (which is similar to cholesterol and is produced from cholesterol in your skin).
  • Increase your insulin resistance, which contributes to chronic inflammation in your body. Increased insulin resistance can lead to heart disease, which, ironically, is the primary reason for taking a cholesterol-reducing drug in the first place. It can also promote belly fat, high blood pressure, heart attacks, chronic fatigue, thyroid disruption, and diseases like Parkinson’s, Alzheimer’s, and cancer.
  • Increase your risk of diabetes by raising your blood sugar. When you eat a meal that contains starches and sugar, some of the excess sugar goes to your liver, which then stores it away as cholesterol and triglycerides. Statins work by preventing your liver from making cholesterol. As a result, your liver returns the sugar to your bloodstream, which raises your blood sugar levels.

Drug-induced diabetes and genuine type 2 diabetes are not necessarily identical. If you’re on a statin drug and find that your blood glucose is elevated, it’s possible that what you have is just hyperglycemia—a side effect, and the result of your medication. Unfortunately, many doctors will at that point mistakenly diagnose you with “type 2 diabetes,” and possibly prescribe another drug, when all you may need to do is simply discontinue the statin in order for your blood glucose levels to revert back to normal.

Beware: Statins Can Also Completely Negate Your Fitness Efforts

One of the major benefits of exercise is the beneficial impact it has on your heart health, and exercise is a primary strategy to naturally maintain healthy cholesterol levels. Alas, researchers recently discovered that if you take a statin drug, you’re likely to forfeit most if not all health benefits of your exercise. In fact, the study, published in the Journal of the American College of Cardiology10, discovered that statin use led to dramatically reduced fitness benefits from exercise, in some cases actually making the volunteer LESS fit than before!

The key to understanding why statins prevent your body from reaping the normal benefits from exercise lies in understanding what these drugs do to your mitochondria—the energy chamber of your cells, responsible for the utilization of energy for all metabolic functions. As mentioned above, the primary fuel for your mitochondria is Coenzyme Q10 (CoQ10), and one of the primary mechanisms of harm from statins in general appears to be related to CoQ10 depletion.

A 2011 review published in Applied Physiology, Nutrition and Metabolism11 pointed out that exercise actually induces changes in mitochondrial enzyme content and activity, which can increase your cellular energy production and in so doing decrease your risk of chronic disease. The fact that statin drugs deplete your body of the primary fuel for your mitochondria helps explain why certain statin users in the trial ended up with worse aerobic fitness after a steady fitness regimen. There simply wasn’t enough mitochondrial fuel in their system.

To Evaluate Your Heart Disease Risk, Get the Right Tests Done

If your physician is urging you to check your total cholesterol, then you need to be aware that this test will tell you virtually nothingabout your risk of heart disease, unless it is 330 or higher.

One of the most important tests you can get to determine your real heart disease risk is the NMR LipoProfile, which measures your LDL particle number. This test also has other markers that can help determine if you have insulin resistance, which is a primary cause of elevated LDL particle number and increased heart disease risk. The NMR LipoProfile test easy to get and all major labs offer it. Most insurance policies cover the test as well. Best of all, even if your doctor were to refuse to order it, you can order it yourself via third-party intermediaries like Direct Labs, or you can order the test online, and get blood drawn locally. Two other ratios you should pay attention to are your:

  • HDL/Total Cholesterol Ratio: (i.e. take your HDL number and divide it by your total cholesterol number.) This should ideally be above 24 percent. If below 10 percent, you have a significantly elevated risk for heart disease.
  • Triglyceride/HDL Ratio: Should be below 2.

I have seen a number of people with total cholesterol levels over 250 who were actually at low risk for heart disease due to their elevated HDL levels. Conversely, I have seen many people with cholesterol levels under 200 who had a very high risk of heart disease, based on their low HDL. For four additional risk factors for heart disease that do not involve your cholesterol levels, please see my recent article: Side Effects of Statins.

How to Optimize Your Cholesterol Levels Naturally

The most effective way to optimize your cholesterol profile and prevent heart disease is via diet and exercise. Seventy-five percent of your cholesterol is produced by your liver, which is influenced by your insulin levels. Therefore, if you optimize your insulin level, you will automatically optimize your cholesterol and reduce your risk of both diabetes and heart disease.

There is NO drug that can cure heart disease, as the underlying cause is insulin and leptin resistance and arterial wall damage—both of which are caused by eating excessive amounts of sugars, grains, and especially fructose. So, in addition to regular exercise, my primary recommendations for safely regulating your cholesterol and reducing your risk of heart disease include:

  • Reduce, with the plan of eliminating grains and fructose from your diet. This is one of the best ways to optimize your insulin levels, which will have a positive effect on not just your cholesterol, but also reduces your risk of diabetes and heart disease, and most other chronic diseases. Use my Nutrition Plan to help you determine the ideal diet for you, and consume a good portion of your food raw.
  • Start intermittent fasting, which will radically improve your ability to burn fat as your primary fuel and thus help improve your insulin and leptin signaling.
  • Get plenty of high-quality, animal-based omega 3 fats, such as krill oil, and reduce your consumption of damaged omega-6 fats (trans fats, vegetable oils) to balance out your omega-3 to omega-6 ratio.
  • Include heart-healthy foods in your diet, such as olive oil, coconut and coconut oil, organic raw dairy products and eggs, avocados, raw nuts and seeds, and organic grass-fed meats.
  • Optimize your vitamin D levels by getting proper sun exposure or using a safe tanning bed.
  • Optimize your gut flora, as recent research suggests the bacterial balance in your intestines may play a role in your susceptibility to heart disease as well.
  • Walk barefoot to ground yourself to the earth. Lack of grounding has a lot to do with the rise of modern diseases as it affects inflammatory processes in your body. Grounding thins your blood, making it less viscous. Virtually, every aspect of cardiovascular disease has been correlated with elevated blood viscosity.

When you ground to the earth, your zeta potential quickly rises, which means your red blood cells have more charge on their surface, which forces them apart from each other. This action causes your blood to thin and flow easier. By repelling each other, your red blood cells are also less inclined to stick together and form a clot.

Take Control of Your Health

The odds are very high that if you’re taking cholesterol-lowering medication, you’re wasting your money and taking unnecessary risks with your health. From my review, the ONLY subgroup that might benefit from statins are those born with a genetic defect called familial hypercholesterolemia, as this makes them resistant to traditional measures of normalizing cholesterol, which I reviewed above.

Remember, your body needs cholesterol for the production of cell membranes, hormones, and vitamin D, just to mention a few. Cholesterol is also vital to your neurological function. And there’s strong evidence that having too little cholesterol increases your risk for cancer, memory loss, Parkinson’s disease, hormonal imbalances, stroke, depression, suicide, and violent behavior.

Taking a drug that can reduce your cholesterol levels down to 50 or below is absolutely a recipe for disaster, when you consider all your biological functions that need cholesterol!

Also keep in mind that contrary to what you’ve been told by pharmaceutical PR firms, statins have nothing to do with reducing your heart disease risk. In fact, this class of drugs can increase your heart disease risk—especially if you do not take Ubiquinol(CoQ10) along with it to mitigate the depletion of CoQ10 caused by the drug. So please, carefully weigh the risks and benefits!

Poor lifestyle choices are primarily to blame for elevated cholesterol levels, such as too much sugar, too little exercise, lack of sun exposure and never grounding to the earth. These are all things that are within your control, and don’t cost much (if any) money to address. If you have a genetic defect, medication may be needed. If you don’t, you may be surprised at how quickly and easily your cholesterol levels will normalize when you start implementing the required lifestyle changes.

If you’re currently taking a statin drug and are worried about the excessive side effects they cause, please consult with a knowledgeable health care practitioner who can help you to optimize your heart health naturally, without the use of these dangerous drugs.

Source: mercola.com

EU Okays Afatinib for NSCLC, Filgrastim and Defibrotide.

Posted by

0


The European Committee for Medicinal Products for Human Use (CHMP) has recommended that the targeted agent afatinib (Giotrif, Boehringer Ingelheim) be approved for use in nonsmall-cell lung cancer (NSCLC) that tests positive for EGFRmutations.

Afatinib was recently approved for this indication in the United States under the trade name Gilotrif.

This is the third drug to target EGFR mutations in NSCLC; it joins erlotinib (Tarceva) and gefitinib (Iressa). Both are available in most countries in the world, with one notable exception — gefitinib is not available in the United States.

About 10% to 15% of NSCLC is positive for EGFR mutations in Western populations; in Asian populations, the incidence is higher.

Filgrastim Biosimilar

The CHMP also recommended approval for the growth factor filgrastim (Grastofil, Apotex) for the treatment of neutropenia, which is a biosimilar to Neupogen (Amgen). “Studies have shown Grastofil to have a comparable quality, safety, and efficacy profile to Neupogen,” the committee noted.

Filgrastim is a granulocyte colony-stimulating factor that regulates the production and release of functional neutrophils from the bone marrow. It is used in cancer patients to counteract the myelosuppressive effects of chemotherapy by reducing the duration of neutropenia and the incidence of febrile neutropenia.

Change of Mind on Defibrotide

In addition, in its July meeting, the CHMP recommended the approval of defibrotide (Defitelio, Gentium) for use in the treatment of severe hepatic veno-occlusive disease, also known as sinusoidal obstructive syndrome, related to hematopoietic stem cell transplantation. The product has orphan drug status for this indication.

The CHMP issued a negative opinion on this product in March 2012. But at the request of the company, the committee re-examined its stance. After that re-examination, it issued a positive opinion for the very narrow indication of severe veno-occlusive disease.

The mechanism of action of defibrotide has not been fully elucidated, the committee notes in its summary. The drug increases the breakdown of blood clots, and it might also protect cells lining the blood vessels, it notes. The most common adverse events are hemorrhage, hypotension, and coagulopathy.

Source: Medscape.com

FDA halts pediatric clinical trials of Sensipar following death.

Posted by

0


 

The FDA has stopped all pediatric clinical trials of cinacalcet hydrochloride following the death of a pediatric patient (aged 14 years) in a trial, according to a press release on the agency’s website today.

In a separate press release, the FDA wrote that they continue to collect information on the circumstances surrounding the death.

Cinacalcet hydrochloride (Sensipar, Amgen) is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis; hypercalcemia in patients with parathyroid cancer; and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. It is not currently approved for children aged younger than 18 years. According to the press release, clinical trials had been underway to determine the safety and efficacy of therapy in pediatric patients.

The drug works by decreasing the release of parathyroid hormone (PTH) from the parathyroid gland. It lowers high PTH levels leading to lower calcium levels in the blood; when calcium levels are too low it can result in health problems, according to the press release.

The FDA cautions that this announcement does not conclude that cinacalcet hydrochloride caused the death in a pediatric patient. However, they communicate that evaluations are ongoing and final recommendations will be released when review of this circumstance is complete.

In the press release, the FDA reminds health care professionals of the following:

  • Cinacalcet hydrochloride lowers calcium levels in the blood. Patients should be monitored for the development of low serum calcium levels (hypocalcemia).
  • The potential signs of low serum calcium levels include muscular problems such as muscle cramping, tetany, convulsions, paresthesias, and myalgias.
  • If serum calcium levels decrease below the normal range, appropriate steps should be taken to increase calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of a calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with cinacalcet hydrochloride.
  • Serum calcium levels should be measured within 1 week after initiation or dose adjustment of cinacalcet hydrochloride. Once a maintenance dose has been established, serum calcium should be measured monthly.
  • The most frequently reported side effects in adult clinical trials of cinacalcet hydrochloride were nausea, vomiting, and diarrhea.

·         Source: Endocrine Today.

Amgen Agrees to Pay $762 Million in Drug Marketing Case.

Posted by

0


drug-pays

In recent years, drug companies have paid out billions in fines to settle various federal, state and civil lawsuits.

Among the charges is promoting drugs illegally for off label use, which is common, even when it puts patients lives at risk.

It’s been said that imposing fines – even those that approach $1 billion or more – is simply not enough to deter this type of criminal behavior, as the drug company executives sitting at the helm are not held personally accountable (or subject to personal prosecution) and jail time.

This appears to be precisely the case, as time and time again drug companies are allowed to promote drugs for uses that could actually harm patients, or engage in other illegal, criminal activities, and they receive what amounts to a slap on the wrist as punishment.

Two drug giants, Amgen and Sanofi, are the latest to add hundreds of millions in settlement monies to the growing stash …

Amgen to Pay $762 Million in Criminal Penalties for Illegal Drug Marketing

According to one U.S. attorney, Amgen was “pursuing profits at the risk of patient safety”1 by selling and promoting the drug for unapproved uses. Prosecutors alleged that Amgen had promoted the anemia drug Aranesp to treat cancer patients not undergoing chemotherapy (the drug is only approved for those receiving chemotherapy). A later Amgen study actually showed that giving cancer patients who were not receiving chemo Aranesp increased their risk of death.

The company also was federally charged with promoting larger, but less frequent, injections of Aranesp as a way to edge out competing drugs – even though the U.S. Food and Drug Administration (FDA) had turned down Amgen’s requests for this approval, citing inadequate safety studies. In fact, one study actually found giving the drug at higher doses may increase cardiovascular risks …

Drug Promoted Off-Label Despite Research Showing Increased Heart Risks

In 1998, the Normal Hematocrit Trial was published, which explored giving higher doses of drugs to dialysis patients in order to boost their red blood cell count above those generally achieved with transfusion.2 The study found that patients receiving the higher drug dose were dying or having heart attacks at a higher rate than those receiving the lower dose; the trial was actually halted because of this.

However, rather than sounding an alarm bell, when the study was published the authors downplayed the danger, calling the increased death and heart attack rate “not significant.” And while no difference was found in quality of life between patients receiving the higher or lower dose, this was not noted in the published study. (Four of the study’s eight authors were employed by Amgen, and two have served as consultants.)

As the years went by, health care providers and the drug companies continued to profit from the ever-rising doses of these drugs being prescribed – despite continued studies coming out questioning their safety. It wasn’t until years later, in 2011, that the FDA put out a safety announcement calling for more conservative dosing of the drugs “because of data showing increased risks of cardiovascular events.”3

The New York Times further reported on Amgen’s charges:4

“A document summarizing the charges says that while sales representatives were not supposed to initiate discussions of off-label uses, they were trained to elicit questions from doctors. Such questions would provide the “necessary cover” for the sales representatives to provide the doctor with studies supporting the off-label use. Amgen referred to this as “reactive” marketing, the document said.

Amgen also managed to list the unapproved uses in a reference called a compendium. Medicare is required to pay for off-label uses of cancer drugs listed in an approved compendium. The compendium system is intended to make drugs more easily available to cancer patients, but critics say the compendiums do not adequately review the evidence.”

To settle the charges, Amgen has agreed to pay $612 million for civil litigation, along with $136 million in criminal fines and forfeit $14 million. The company has also agreed to sign a Corporate Integrity Agreement that requires executives to certify compliance with regulations, which would theoretically make it easier to prosecute them personally for any future offense. This is, unfortunately, just the latest drug scandal to be brought to the public’s attention… and it surely won’t be the last.

Sanofi to Pay $109 Million to Settle U.S. Kickback Charges

You might remember drug maker Sanofi, as I recently ran articles on them describing the revolving door between federal agencies and the drug companies. The chief and major science officer from the U.S. National Institutes of Health (NIH) took jobs at Sanofi as their president and chief scientific officer. Now the company has agreed to pay $109 million to resolve allegations that it gave free drugs to physicians as a form of kickbacks, which violates the False Claims Act.

The company allegedly gave out thousands of free “samples” of the arthritis drug Hyalgan that were contingent on future purchases and essentially used to lower the drug’s effective price. Sanofi then submitted false average sales price reports, which are used to determine reimbursements rates from Medicare and other government health programs, thereby causing the government to pay inflated rates for the drug.5

In this case no criminal charges were filed and, other than the paltry $109 million settlement, Sanofi only has to enter into a Corporate Integrity Agreement with the government that is supposed to leave them under enhanced scrutiny.

The Top 10 Drug Company Settlements

Big Pharma lawsuits, especially those that settle in the hundreds of millions or billions, are intended to compel these criminal corporations to straighten out, abandon their fraud and deception, their kickbacks, price-setting, bribery and all other illegal sales activities in favor of looking out for public health, which to date has been clearly ineffective.

Most of these settlements amount to a mere slap on the wrist for the drug company, which typically will continue right along with their deceitful behaviors. This is evidenced by the stunning frequency with which these major settlements occur:6

  1. 2007: Bristol-Myers Squibb paid $515 million for illegally promoting its atypical antipsychotic drug Abilify to kids and seniors (despite a black box warning that warned of potentially fatal side effects in the elderly). Other accusations included giving payments, kickbacks and expensive vacations to medical professionals and pharmacist to dispense its drugs.
  1. 2010: AstraZeneca settled for $520 million for trying to persuade doctors to prescribe its psychotropic drug Seroquel for unapproved uses ranging from Alzheimer’s disease and ADHD to sleeplessness and post-traumatic stress disorder (PTSD). Using Seroquel for improper use has been linked to an increased risk of death.

Company executives also promoted the drug for weight loss, highlighting one favorable study while burying others that linked it to substantial weight gain.

  1. 2007: Purdue Pharma paid $634.5 million for fraudulently misbranding Oxycontin, and suggesting it was less addictive and less abused than other painkillers. The company was charged with using misleading sales tactics, minimizing risks and promoting it for uses for which it was not appropriately studied.
  1. 2012: Amgen, the makers of anemia drugs Aranesp and Epogen, has been accused of handing extra profits to doctors who prescribe the drugs (by overfilling vials, then allowing doctors to charge insurance companies for drugs they got for free). Other accusations include misconduct involving claims of safety and efficacy, marketing, pricing and dosing of the drugs. Amgen has agreed to pay $762 million to settle the suits.
  1. 2011: Merck settles for $950 million to resolve fraudulent marketing allegations and safety claims related to Vioxx. Vioxx was pulled from the market in 2004, after it was shown to double the risk of heart attack and stroke. In addition to the $950 million, Merck paid hundreds of millions more to harmed patients and their families (Vioxx contributed to causing heart attacks in up to 140,000 people, half of which were fatal).
  1. 2009: Eli Lilly pays $1.4 billion for promoting Zyprexa for off-label uses, often to children and the elderly, and not properly divulging side effect information. For instance, Zyprexa was marketed as a sleeping aid for the elderly because one of its side effects is sedation, even though the drug also increases the risk of death.
  1. 2012: Abbott Laboratories settles for $1.5 billion for aggressively promoting their seizure drug Depakote for off-label use in elderly dementia patients, despite lacking evidence of safety or effectiveness (and a known increase of serious side effects, like anorexia, in the elderly).
  1. Currently pending: Johnson & Johnson will pay anywhere from $1.5 to $2 billion for illegal marketing of Risperdal and other drugs. The company not only heavily marketed drugs to children and the elderly despite inadequate evidence of safety or efficacy, they also hid data about drugs’ side effects.
  1. 2009: Pfizer pays $2.3 billion for marketing fraud related to Bextra, Lyrica and other drugs. Charges included marketing drugs to doctors for uses for which they had not been approved and giving kickbacks to doctors and other health care professionals for prescribing their drugs. This was Pfizer’s fourth settlement numbering in the multimillions in less than a decade.
  1. 2012: GlaxoSmithKline (GSK) to pay $3 billion for illegal marketing of Paxil and Welbutrin and downplaying safety risks of Avandia, among other charges. The company hid data about drug risks, marketed drugs for unapproved uses, and paid doctors (or gave them lavish gifts like expensive vacations) for prescribing their drugs. One of the most high-profile accounts involved television celebrity Dr. Drew, who reportedly received $275,000 from GSK to promote Welbutrin to treat sexual dysfunction associated with depression even though it hasn’t been proven effective for this purpose.

Are You Putting Your Health in the Hands of Criminals?

If you rely on drugs to stay well, or believe that if you get sick one day you’ll simply take a medication to “get better,” it’s worth recognizing that the same companies that are manufacturing and promoting those drugs have probably been convicted of criminal and fraudulent charges. You might want to reconsider your decision in light of these circumstances.

Putting your health, your very life, in the hands of these drug companies is a frightening prospect because the leading pharmaceutical companies are also among the largest corporate criminals in the world, often behaving as if they are little more than white-collar drug dealers. As these companies have shown time and again, they consistently put profits above human health … and this includes your health.

Adding salt to the wound, most of the top-selling drugs treat conditions that are better treated with lifestyle changes, healthy food and other forms of natural healing!

Source: Dr. Mercola

A Hat Trick for a New Type of LDL-Lowering Agent.

Posted by

0


In three separate phase II trials, a proprotein convertase subtilisin/kexin type 9 protease inhibitor achieves significant reductions in LDL levels compared with placebo or ezetimibe.

Statin therapy, which reduces both low-density lipoprotein cholesterol (LDL-C) levels and cardiovascular risk, is unsuccessful in many patients because of poor response, intolerance, allergy, or a combination of the three. Nonstatin agents also lower LDL-C levels; to date, however, few data support their effectiveness at improving clinical outcomes. Attention is now focused on investigational, fully human, monoclonal antibodies directed against proprotein convertase subtilisin/kexin type 9 (PCSK9), which impairs the liver’s ability to remove LDL-C from the blood. In three manufacturer-sponsored phase II studies of a subcutaneously administered PCSK9 inhibitor, AMG 145, investigators assessed the potential of this approach in different patient cohorts with or at risk for cardiovascular disease.

In the RUTHERFORD study, treatment with one of two doses of AMG 145 every 4 weeks resulted in significant reductions in LDL-C of up to 56% compared with placebo in 167 patients with heterozygous familial hypercholesterolemia on lipid-lowering therapy (statins with or without ezetimibe). At week 12, the proportions of patients reaching LDL levels less than 100 mg/dL were:

  • AMG 145, 350 mg: 70%
  • AMG 145, 420 mg: 89%
  • Placebo: 2%

The proportions of patients reaching LDL levels less than 70 mg/dL were:

  • AMG 145, 350 mg: 44%
  • AMG 145, 420 mg: 65%
  • Placebo: 0%

In the LAPLACE-TIMI 57 study, six tested dose regimens of AMG 145 all significantly decreased LDL-C compared with placebo in 629 patients with or at risk for cardiovascular disease who were taking statins (with or without ezetimibe). At week 12, AMG 145 reduced LDL-C by up to 66% compared with placebo in patients treated every 2 weeks and up to 50% compared with placebo in those treated every 4 weeks.

In MENDEL, the first study of a PCSK9 inhibitor as monotherapy, the same six regimens of AMG 145 were compared with placebo and with open-label ezetimibe (10 mg/day) only in 406 hyperlipidemic patients at low cardiovascular risk who were not taking a statin. At week 12, AMG 145, whether given every 2 or every 4 weeks, significantly reduced LDL-C compared with placebo by as much as 47% in the groups dosed biweekly and by up to 53% in the groups dosed every 4 weeks. The mean decreases in LDL-C level from baseline for the biweekly groups were:

  • AMG 145, 70 mg: 41%
  • AMG 145, 105 mg: 44%
  • AMG 145, 140 mg: 51%
  • Placebo: 4%

The mean decreases in LDL-C level from baseline for the 4-week groups were:

  • AMG 145, 280 mg: 39%
  • AMG 145, 350 mg: 43%
  • AMG 145, 420 mg: 48%
  • Placebo: 4%

The mean decrease in LDL-C level from baseline was also significantly greater in all AMG 145 groups than in the ezetimibe-only group.

AMG 145 was also associated with important reductions in lipoprotein(a) [Lp(a)] in the two studies that reported this endpoint. No serious adverse effects of AMG 145 were reported; the most common minor events were upper respiratory tract infection, nasopharyngitis, gastrointestinal symptoms, and injection site reactions.

Comment: According to these three promising studies, proprotein convertase subtilisin/kexin type 9 inhibitors have the potential to dramatically reduce low-density lipoprotein cholesterol and lipoprotein(a) with a relatively clean safety profile. If large, long-term outcome studies with hard cardiovascular endpoints establish the clinical safety and efficacy of these agents, PCSK9 inhibition could be a useful clinical tool in high-risk patients, including those with homozygous familial hypercholesterolemia, those who have not attained LDL targets or are intolerant to statins, and those with dramatic elevations in Lp(a).

Source: Journal Watch Cardiology

 

 

 

Anemia Drug Made Billions but at What Cost?

Posted by

0


Three anemia drugs — Epogen, Procrit and Aranesp — have been among the best-selling prescription drugs in the United States for years, generating more than $8 billion a year for their makers, Amgen and Johnson & Johnson.

They were blockbuster drugs that stimulate your body to produce new red blood cells, which supposedly helped boost kidney and cancer patients’ energy and, ultimately, enhanced their lives.

But now, after millions of people have taken these drugs, it’s come out that the benefits were “wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked.”1

Worse still, the Washington Post has uncovered a series of unsettling events that show just how far drug makers were willing to go to get rich …

Doctors Earned Profits of Up to 30 Percent Just for Prescribing the Drugs

And this was one of the first problems. Drug makers lobbied Congress in order to put a system into place so that doctors and hospitals would be reimbursed more for the drugs they prescribed to Medicare patients than what they actually paid for them. The markup could be as high as 30 percent, and the higher the dose prescribed, the more money they made.

According to Charles Bennett, endowed chair at the Medication Safety and Efficacy Center of Economic Excellence at the University of South Carolina, in the Washington Post:

“It was just so easy to do — you put this stuff in the patient’s arm, and you made thousands of dollars … An oncologist could make anywhere from $100,000 to $300,000 a year from this alone. And all the while they were told that it was good for the patient.”

Higher Doses Pushed to a Growing Number of Patients

Initially, patients with kidney disease, who often suffer from anemia, were the key target market for the drugs. If anemia is severe enough, blood transfusions are required to boost red blood cell counts. Epogen, Procrit, and, later, Aranesp, were able to accomplish the same boost in blood cells without the need for transfusions.

The Washington Post reported:

“The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.

The key to their marketing was the claim that the drugs at higher doses could make patients feel better. By 1994, the drug’s label, approved by the FDA, advertised a range of benefits: “statistically significant improvements for . . . health, sex life, well-being, psychological effect, life satisfaction, and happiness.””

These claims, however, were based on a series of incomplete and never-published research, some of which were drawn out over a decade or more only to show inconclusive results. One safety study on cancer patients that was supposed to be finished in 2008 is still not complete, and won’t be until 2017, according to Amgen, which will be nearly 25 years after the drugs were approved for cancer patients.

And as it turns out, the claims that the drugs lead to improved quality of life have since been withdrawn because they don’t meet the U.S. Food and Drug Administration’s (FDA) standards of proof.

Higher Doses Increased Patients’ Risk of Dying – Study Results Missing Key Data

In 1998, the Normal Hematocrit Trial was published, which explored giving higher doses of drugs to dialysis patients in order to boost their red blood cell count above those generally achieved with transfusion.2 The study did, in fact, find that patients receiving the higher drug dose were dying or having heart attacks at a higher rate than those receiving the lower dose; the trial was actually halted because of this.

However, rather than sounding an alarm bell, when the study was published the authors downplayed the danger, calling the increased death and heart attack rate “not significant.” And while no difference was found in quality of life between patients receiving the higher or lower dose, this was not noted in the published study. (Four of the study’s eight authors were employed by Amgen, and two have served as consultants.)

As the years went by, health care providers and the drug companies continued to profit from the ever-rising doses of these drugs being prescribed – despite continued studies coming out questioning their safety. It wasn’t until years later, in 2011, that the FDA put out a safety announcement calling for more conservative dosing of the drugs “because of data showing increased risks of cardiovascular events.”3

The Washington Posted reported:

“For years, a small Bethesda-based nonprofit think tank, the Medical Technology and Practice Patterns Institute, had been publishing studies that challenged the conventional enthusiasm for the drug and the government policies that it said promoted their overuse.

Then in November 2006, a study published in the New England Journal of Medicine reported that kidney patients targeted for higher doses were linked to higher risks of hospitalization, strokes and death. In December, a group of Danish researchers said that it had stopped a trial of Aranesp in cancer patients because of an increase in deaths and tumor growths. And that was just the beginning of the bad news …”

The FDA Finally Cracks Down

The Danish research seemed to be the breaking point for the anemia drug trio.

“Then the FDA cracked down,” The Washington Post reported. “The drugs’ use was ruled out in cancer patients considered curable, it was ruled out in patients considered just slightly anemic, maximum recommended doses were lowered, and the agency told doctors in many cases to use the smallest amount possible to avoid a blood transfusion.

The agency also began to look askance at the alleged benefits, for which the evidence, in retrospect, seemed flimsy. There was no solid proof, under revised FDA guidelines for such measures, that use of the drugs leads to “statistically significant” improvements in happiness and other benefits, the agency said. Those quality-of-life claims, once so critical to the drug’s adoption, were removed from the label.

… Last year, nearly two decades after the Office of the Inspector General first suggested it, the economic incentives to use more of the drugs on patients in dialysis disappeared.”

No major class-action suits have so far been filed against the drugs’ makers; it is often difficult to prove the drugs were the cause of death, particularly because patients who received them were typically already facing chronic health problems. Still, Amgen has put aside a reported $780 million to settle various claims, including some for alleged illegal sales tactics – a paltry compensation to those who have lost loved ones. This is, unfortunately, just the latest drug scandal to be brought to the public’s attention … and it surely won’t be the last.

Pharma Giant Pfizer Fined for Bribing Officials in Eastern Europe and China

Earlier this month, it was revealed that U.S. pharmaceutical giant Pfizer and its subsidiary Wyeth have been charged with paying off officials, doctors and healthcare professionals in Eastern Europe and China to secure approval and registration of the companies’ products.

The company allegedly paid millions of dollars in bribes from 2001 to 2007. The bribery was so blatant and entwined in the sales practices that they even offered points and bonus programs to improperly reward foreign officials who proved to be the best customers, according to the head of the SEC’s Foreign Corrupt Practices Act Unit. Obviously, such corrupt pay-offs puts honest companies at a disadvantage, James McJunkin, assistant director of the Washington field office of the Federal Bureau of Investigation pointed out.4

And that is the over-riding theme we see again and again – these companies are typically NOT honest, yet we trust them with the most sacred possession we have, our health. For punishment, Pfizer will be paying various fines ranging from $15 million to $26 million – barely a slap on the wrist for a company that makes billions of dollars a year.

Big Pharma’s Lack of Ethics, Regard for Patient Safety Seemingly Knows No Bounds

If it seems like the number of lawsuits that Big Pharma is settling―many of them out of court without going to trial―are rising, they are. From Merck’s $950-million Vioxx deal to the latest announcement that Pfizer has made an $896-million settlement with Prempro victims, the deals show no signs of stopping.  Most of the lawsuits are being filed in conjunction with, or aided by, the U.S. Department of Justice, many of them originating from former employees-turned-whistleblowers who divulged marketing misdoings by their employers.

The litigation and settlements are starting to rattle the drug industry, which is becoming no stranger to billion-dollar settlements. Most likely near the end of 2012, Johnson & Johnson reportedly will settle for as much $2.2 billion for its fraudulent marketing of the antipsychotic drug Risperdal.

That amount rivals what was the largest health care fraud settlement to date — $2.3 billion paid by Pfizer in 2009, also for illegally promoting uses of four of its drugs. However, now it’s come out that GlaxoSmithKline has agreed to a whopping $3-billion settlement – the largest in U.S. history for health care fraud — with the U.S. government, again for advertising drugs for unapproved uses, along with using gifts to persuade doctors to prescribe the drugs.5

Unfortunately, Americans are disproportionally supporting this behemoth of an industry. Americans, including children, are the most drugged people in the entire world, with the average adult taking 11 prescription drugs—each of which comes with an average of 70 different potential side effects that are then typically addressed with even more drugs…

The situation has gotten out of hand, especially since there’s a mountain of evidence supporting the use of alternatives, and there’s very strong evidence that some “alternative” treatments, such as diet and exercise, are FAR more effective, not to mention safer, than any of the drugs currently in use. My site is chock full of free comprehensive recommendations that can serve as an excellent starting point to break free from this fatally flawed paradigm. The tools I provide on this site will help you to reduce your reliance on the broken health care system, including its overuse of drugs, and provide you with the tools and resources to Take Control of Your Health.

Source:  Dr. Mercola