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Monday, 23 July 2012

Dutch cardiologists threaten: not supplying an approval for new anticoagulation medicine will cost more than 600 lives yearly! Will it really, or is this the pharmacy lobby at work?!

Today, a pressing statement was published by four leading cardiologists and a pharmacologist in the Dutch newspaper De Telegraaf (  These cardiologists lobbied for a quicker approval of new, oral anticoagulation drugs. If this approval doesn’t happen soon, this might cost hundreds of lives of heart patients per year, according to the cardiologists. Here are the pertinent snips of this article:

Four cardiologists and a farmacologist urged Dutch Minister of Public Health Edith Schippers and the Dutch Council of Health Insurers (CVZ) to hurry up with the approval and subsequent reimbursement of a new generation of oral anticoagulation medicine.    

According to the leading Dutch cardiologists, the political and administrative lingering will lead each year to the death of at least 600 thrombosis patients and thousands of unnecessary hospitalizations.

The newly developed drugs are already waiting for at least a year on their official approval for reimbursement from the Dutch Minister of Public Health and the CVZ. With this approval, between 800 and 1300 haemorrhages per year could be prevented, according to these experts in the area of anticoagulation and heart rhythm disturbances. The new drugs are much more effective and saver than the currently used anticoagulants. These are now administered to 225,000 patients with the rhythm disturbance atrial fibrillation.

Earlier, critical articles have been published in Medisch Contact (i.e. Medical Contact) on the new generation of anticoagulation drugs. A number of investigations shows indeed a lower risk of getting a haemorrhage. However, although a meta-analysis in BMJ shows that the new, oral anticoagulation drugs are at least as effective as enoxaparine, the better they prevent veneral thrombosis, the more (dangerous) bleedings occur.

When new and better drugs can help patients that have basically life-threatening diseases to have a better quality of life in spite of their illness, I am of course in favor of such medicine.

Still, I can understand the reluctance of the Minister and the Dutch Council of Health Insurers to speed up the approval process for these new drugs.

Here are my reasons:

  • Drugs in an aging society, like the Dutch society is, are a multi billion Euro business. Especially drugs for chronical diseases, like thrombosis and heart failure and ‘welfare’ diseases, like excess cholesterol and diabetes type II, are geese with golden eggs. No companies are better aware of this than the pharmacy giants like Merck & Co Inc (MRK), Bayer AG (BAYRY) and Novartis AG (NVS). This is the reason that litterally billions of dollars are invested in medicine for these welfare diseases and much less money in an anti-malaria medicine that can save the life of many millions of poor people on earth;
  • Many established surgeons, pharmacologists and cardiologists are virtually on the payroll of the big pharma companies. These people get compensated in kind by big pharma for endorsing their medicine and get a.o. courses, seminars and meetings at the most beautiful spots in the world for a token price. There are many connections between big pharma and surgeons that are not disclosed to their patients or the general public. Many of these physicians are not in a situation anymore that warrants objective advices to their patients or the general public;
  • Some big pharma companies have a dubious reputation for funding investigations into their medicine; more than once, these investigations have been executed according to the principle: ‘who pays, decides…’. Straight-forward fraud with testing results has not been proven often. However, there have been cases where unfavorable results and (sometimes fatal) complications among patients have been deliberately left out of the investigation in order to make the end results more favorable for the medicine in question. One of the most notorious cases was that of Vioxx, an arthritis drug that ‘may have led to more than 27,000 heart attacks and sudden cardiac deaths, before it was pulled from the market…’;
What I don’t like in the plea by these cardiologists is the smell of fearmongering that the article spreads. Calling numbers of deaths and hospitalizations as a consequence of not having a certain medicine is making use of statistics that are impossible to prove. Especially when you reckon that these new drugs can also have negative side-effects, like an elevated risk for bleedings. Mark Twain already said in one of his books: ‘there are lies, damned lies and statistics’.

When statements like these are uttered by people whose objectivity can be under jeopardy of their personal interests, you should always be very careful with it. Not that I doubt the objectivity and personal integrity of Dutch cardiologists, but just in case…

If these new anticoagulation drugs are indeed much better than the existing drugs, I don’t have any doubt that their official approval will be due. But there is no need to hurry things, as too much haste in case of medicine for life-threatening diseases can also have fatal results.

All opinions in this article are mine, unless a link to an external article is mentioned

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