I have been advised to add this here by my consultant. It was my original intention to take out an ad in a national newspaper, but I can’t afford that! He has already seen this text.
When a treatment is designed as a result of a clinical trial which indicated that some significant property was common to all participants there are two possibilities,
1) that property is also common to the population as a whole and
2) a small minority of the population for whom that property does not hold has been missed.
Only one of those possibilities can be true but there is absolutely no way of predicting which! (And yes I have studied statistics, that senetence is by the book). Therefore stating that one treatment fits all may well be true, but it cannot be regarded as an incontrovertible fact Regarding it as a fact is wrong. It can only be a working assumption.
As a working assumption it is therefore wrong to design a treatment plan which specifically prevents the discovery of such a small minority.
The standard treatment plan for the associated condition of Myeloma Bone Disease (MBD) presumes that all patients will have a slow response to Zoledronic Acid and hence the procedure is
1. A full body MRI scan is taken before treatment starts
2. Zoledronic Acid is given once every 4 weeks for 2 years, which is 26 doses
3. A further MRI scan is taken at the end of treatment
Now suppose that there really is a small minority who have a fast reaction. Using the standard treatment, how would anyone ever know? The total lack of any intermediate scan of any type means such people would be undetectable.
Is that important?
Yes because
1. It was discovered by accident that my first treatment only needed 8 doses! My second needed only 12 (we
did 14 just to keep the consultant happy!). I cannot be the only fast reactor, therefore the previously
unsuspected minority exists
2. Either of those numbers mean 26 doses would be a significant over use of the drug
3. The cause of the serious side effects of Osteonecrosis of the Jaw (ONJ) and Stress Fractures has been
identified as being the over use of the drug.
The failure of the standard treatment to provide any intermediate scan means that it condemns patients with a fast reaction to the drug to a much increased risk of totally avoidable, painful and expensive to fix side effects.
To object to introducing intermediate scans on the basis of cost is false economy. Even though these side effects are not common, ONJ affects around 2%, the cost of sorting out the consequences is vastly more than cost of such scans when you factor in all the costs starting from the initial ambulance all the way to after care.
But there is a cheap way of providing scans! According to the price list of the private wing of my local hospital (in 2022, but not listed on the current web site), the smallest X ray they would take was priced at only £150. The underlying cost will obviously be less. One X ray per patient per treatment is therefore not a huge cost. One could therefore identify an area of bone most affected my MBD and take just one such small X ray to see if that area appears to be clear of MBD. I would suggest it be done after 8 doses as I was clear by then first time round (but slightly later second and subsequent times around). Here, all the medics will be saying “but an X ray doesn’t…” followed by a list. That is not relevant! The purpose of this X ray is not to look for any of those things, rather it is taken only to answer the question “do we need to take a better look with the MRI”. and that better look will only apply to around 2% of patients. For a few patients one might decide that an X ray which indicates “almost clear” would suggest a second X ray should be taken later on.
I was discovered to be a fast reactor 14 years ago. I naively assumed things would change. Out of curiosity I recently asked my consultant what had changed. The answer is nothing. In all that time nothing has been done, including the dissemination of the news of the existence of this minority. So, if after today’s date you are treated with Zoledronic Acid, are given no intermediate scan of your bones and then go on to suffer a stress fracture or ONJ, you should contact a medical lawyer with a view to suing for damages due to negligence as the information above is now public knowledge and should therefore have been acted on. Given that the current standard treatment is wrong for the reason given above, there may also be a case to be answered for those who have already suffered those side effects.
Hopefully the prospect of legal action will overcome the current inertia in the system before such action becomes necessary!
I am a 78 yr old patient diagnosed, approx 18 months ago, with IgG light chain myeloma with rib cage osteolytic lesions and a suspected small pulmonary embolism.I am currently ‘in remission’ after 8 cycles treatment with Velcade, dexamethazone and cyclophosphamide. Last August, after stopping all treatment, except zoledronic acid, I developed a continuous dry cough, acute breathing difficulties and a mild temperature. This was months before anyone thought of Coronavirus. I was admitted as an inpatient during which I was administered passive oxygen and i.v. antibiotics. The condition resolved and I was discharged after 7 days. I recently received the official NHS letter (via my GP) stating that I am considered at very high risk of severe illness should I contract the Coronavirus and that I should impose strict sheilding. I take ‘severe illness’ to mean severe pulmonary distress requiring respiratory ventilation and with a high probability of a terminal outcome. Recent statements in the media by senior medical authorities have suggested that active ventilation (machines) will be reserved for patients who are likely to benefit the most ( younger, fit and with no significant disease) and are most likely to survive the viral infection. I cannot see that a patient with my history would qualify. I am beginning to think that should I contract COVID-19, I will probably wish to decline hospitalisation and be treated at home with simple palliative/terminal care and hopefully have some final contact with my family. I would welcome comments from any other myeloma patient facing a similar dilema.
