Save Our Bones Bulletin: Study Reveals Most Drugs Are Ineffective, NSAIDs Increase Risk Of Heart Attack After Just One Week, European Regulatory Body Rejects Evenity

Vivian Goldschmidt, MA Drugs News

Evidence-Based
6 min Read
save our bones bulletin

Today's Bulletin provides valuable information and breaking news about Big Pharma and the harmful side effects of the drugs they produce.

We'll look at a German study that examined the efficacy of new drugs prescribed by doctors. Unsurprisingly, the results were grim. Then we'll turn to a Canadian study that supports what we already know about the class of common painkillers called NSAIDS: they're bad for your heart. This new information confirms the immediacy of that danger.

Then some positive news- at least for Europe. The European equivalent of the FDA has rejected Amgen's osteoporosis drug Evenity. The FDA has recently approved the drug in the United States- a big red flag that further undermines faith in this regulatory body.

New Drugs Fail To Add Health Benefits

As more and more drugs enter marketplaces around the world, developed and pushed by international pharmaceutical companies, one important question is too rarely examined: are these drugs making anyone healthier?

The German Institute for Quality and Efficiency in Health Care set out to find the answer to that question through a scientific study on the efficacy of new drugs. The result was none too surprising: most drugs don’t provide any health benefits.

Relevant Excerpt:

“According to the study… more than half of the new drugs entering the German healthcare system show absolutely no added benefit.

Between 2011 and 2017, researchers examined 216 drugs that passed regulatory approval and entered the German market. Most of these assessed drugs were also approved by the European Medicines Agency for widespread use throughout greater Europe.

Alarmingly, only a quarter of those drugs showed any significant medical added benefit based on the available evidence. What’s more, 16% showed even a minor added benefit, and a whopping 58% of studied drugs did not show any added benefit over standard patient care.”1

The authors of the study recommended a far more strict drug approval process, and changes to the health care system that will only reward safe and effective drugs- instead of allowing Big Pharma companies to attain dizzying profits off of drugs that are at best having no benefit, and at worst causing serious harm.

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Synopsis

A German study found that new drugs entering the market are by and large failing to provide health benefits above those provided by standard patient care. Only a small percentage of drugs showed health benefits.

Over The Counter Painkillers Significantly Increase Heart Attack Risk

A study at McGill University in Canada examined the safety of common painkillers like ibuprofen (Advil), naproxen (Aleve), and other non-steroidal anti-inflammatory drugs (NSAIDs).

The researchers examined the risk of a heart attack while using NSAIDs, and found that taking any dose of NSAIDs for one week, one month or more than a month increased heart attack risk by an incredible 20 to 50 percent.

Relevant Excerpt

“Researchers at McGill University in Canada say that the risk of heart attack while using these painkillers increased with dosage size and was at its highest in the first month of ongoing use.

The research team analyzed several healthcare databases in Canada, Finland, and the United Kingdom, recording results on more than 446,000 people. Of that sample, 61,460 suffered a heart attack.

Previous research found that certain NSAIDs contributed to higher incidents of myocardial infarction (heart attack), but the timing of the risk, the effects of dose level, and treatment duration were not well understood.

Overall, the risk of heart attack increased in patients by between 20 and 50 percent if using NSAIDs versus not using any kind of pain medication.”2

In addition to this and other known risks, it’s relevant to mention here that NSAIDs, like all drugs, are acidifying and therefore damage your bones.

Synopsis

Researchers at McGill University have discovered that taking NSAIDs increases the risk of a heart attack after just one week of use.

European Regulatory Body Rejects Osteoporosis Drug Approved By FDA

Evenity (romosozumab) is an osteoporosis drug developed by pharmaceutical giant Amgen, the manufacturers of another osteoporosis drug, Prolia (denosumab). After the FDA initially rejected the drug in 2017, Eventiy was later approved for use to treat a more narrowly defined high fracture risk population in 2018.

The most glaring danger of romosozumab, and the one that gave the FDA pause, albeit momentary, is the risk of cardiovascular events. These risks, which include stroke, heart attack, and death, lead the European equivalent of the FDA, the Committee for Medicinal Products for Human Use (CHMP), to reject the drug.

Relevant Excerpt

“The marketing authorisation application (MAA) of the drug was based on the findings of a large development programme, which included three phase 3 studies among others, which featured close to 12,000 patients.

CHMP said that its negative opinion was due to results suggesting that patients subjected to the drug had an increased risk of serious effects on the heart or circulatory system, including heart attacks or strokes.

Apart from that, CHMP said that when all the findings of the drug’s clinical development were looked at together, there were more deaths in patients aged more than 75 years who were subjected to the medicine.”3

Romosozumab blocks sclerostin, a protein that inhibits and mediates new bone formation. Over the course of 12 monthly injections, this action results in increased bone mass, but after 12 months it ceases to be effective.

The drug requires a follow-up prescription for a bisphosphonate that will stifle the body's bone remodeling process and preserve the new bone mass. As Savers know, bisphosphonates cause harm to the quality and health of bones by interrupting the body's natural process of building new bone and removing old and weak bone.

These drugs are not safe, and they're not effective.

Synopsis

The CHMP (the European equivalent of the FDA) has rejected Amgen's injectable osteoporosis drug Evenity (romosozumab) because it causes stroke, heart attack, and death in a significant percentage of patients.

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As explained in the Osteoporosis Reversal Program, the right diet and regular targeted exercise, combined with simple lifestyle changes, form a multi-pronged approach to building stronger bones and reducing the risk of fracture.

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References

1 https://www.studyfinds.org/big-pharma-fail-no-evidence-of-added-benefit-in-most-new-drugs-study-finds/

2 https://www.studyfinds.org/common-painkillers-heart-attack-ibuprofen/

3 https://www.pharmaceutical-business-review.com/news/chmp-evenity-negative-opinion/