Tuesday, 6 June 2017

Protelos. Another Big Pharma drug bites the dust! Osteopathy sufferers beware!

The doctor's E-Magazine, Pulse, announced yesterday (5th June 2017) that GP's will have to review any osteoporisis patients treated with the drug Protelos, or Strontium Ranelate, as it "ceases to be available in the UK from August".

     Why is this?

The pharmaceutical company, Servier, said it was due to "decreasing numbers of prescriptions".

     Why the decrease in prescriptions?

Pulse says that this is due to evidence of a "heightened risk of cardiovascular events in 2014" so that it is now "only prescribed to patients who cannot use other approved treatments for the condition, and under careful monitoring."

In other words, Protelos is yet another drug that medical science, and drug regulators has passed as effective and safe has proven to be neither - certainly not safe!

The Pulse article says that Strontium ranelate has been used to treat severe osteoporosis in postmenopausal women, and adult men, who were unable to tolerate other osteoporosis drugs. Yet the history of the drug is more interesting than this!

First, reviewing the clinical trials that led to the drug's use, the evidence appears to show the most marginal improvement in bone fracture. Read about the two main trials on this Drug.com website.

               "When looking at results of the two studies taken together, fewer women in the Protelos group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Protelos compared with 389 out of 3,256 for placebo). This showed that the risk of breaking a bone is reduced."

For this marginal benefit, the Drug.com article goes on to outline the side effects - ischaemic heart disease (such as angina or a heart attack), peripheral arterial disease (obstruction of the blood flow in the arteries, usually in the legs), cerebrovascular disease (diseases affecting the blood vessels in the brain, such as stroke). Actually, there are many more serious side effects, see this NetDoctor website. But despite the (at best) marginal benefits, and the serious potential side effects, this conclusion was reached.

               "The CHMP (Committee for Medicinal Products for Human Use) decided that Protelos’s benefits are greater than its risks and recommended that it be given marketing authorisation."

Clearly they were wrong! Yet this is not unusual in the history of pharmaceutical drugs. Risks are measured in grams, benefits in kilograms! It is more profitable for the drug companies that way!

Second, whilst the drug has been approved in Europe, it was not approved by the FDA in the USA! Clearly, conventional medicine concluded, as it often does, that the was 'safe' for Europeans, but not safe for Americans! I have no explanation for why this should be - but it happens quite frequently, one way or another!

So now patients on this unsafe drug have to be called in, and the Pulse article makes it clear that doctors do not have too many alternative treatments for them. So perhaps osteoporosis patients need to look seriously to alternative therapies for a solution to their condition!

Yet the most serious feature of this news is the conventional medicine has used an unsafe drug for osteoporosis patients for over a decade, on the basis that it was safe. Again, this is not unusual for the pharmaceutical industry, and the supine drug regulatory agencies.

  • Protelos was approved in Europe in 2004 for the treatment of osteoporosis.
  • In 2012, this approval was extended to men with an increased fracture risk.
  • In April 2013 there was a recommendation to restrict the use of Protelos because of the risk of serious heart problems (including heart attacks), blood clots, and a range of other conditions such as serious skin reactions, disturbances in consciousness, seizures, liver inflammation and reduced number of blood cells.
  • In January 2014 the EDA, the European drug regulator, 'following an in-depth review' decided that that Protelos should no longer be used to treat osteoporosis. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee should not be available anymore as "the drug's risks outweigh its benefits".
So over three years have elapsed before Pulse has given this information to the doctor's who have been prescribing it.
  • How many osteoporosis patients have been taking this dangerous pharmaceutical drug since 2004 on the basis of wrong information?
  • How many osteoporosis patients have been taking this dangerous pharmaceutical drug since the EMA decided that the drug should be withdrawn?
  • How many patients of conventional medicine are taking other dangerous pharmaceutical drugs that have not been banned AT THIS VERY MOMENT?
These appear to be unanswered questions. Indeed, they are questions that are never asked! The pharmaceutical industry cannot be trusted. The conventional medical establishment cannot be trusted to regulate the powerful drugs industry. 

What needs to be learnt from this situation is that patients who accept conventional medical treatment are just not safe. And remember, patients on Protelos still do not know about the risks they face, and have been facing, courtesy of this drug, for many years.