So sorry to hear of your loss of John and my heart goes out to you. Such a shock and understandably you should be angry and casting about for the reasons why this happened.

A few facts to help you move through this dreadful situation you are in. You may be able to do a couple of things, when you feel you are able, to help others and make sure John remains a hero.

The prescribing information or package insert that the doctor would have read contains a warning in a big black box about sudden death from the infusion. A "black box warning" as it is referred to is the highest level of warning in the US and your doctor would have known about it. However, your doctor was trying to save your husband so the benefit in his mind would have outweighed the risk.

Eli-Lilly owns Imclone but Erbitux is manufactured and distributed by BMS in the US. You need to ensure that the doctor reports the death to BMS so they can update the information (and maybe strengthen their warning). You can also do it yourself if you are up to it.

Your husband died suddenly and unexpectedly in hospital. In Australia, any sudden or unexpected death in hospital invokes an autopsy and I thought the same was true in the US (check this as I am unsure). The fact they didn't jump to it may be because they are assuming his death was a forseeable event and associated with the cancer. An autopsy will help clarify things.

All cancer treatments, including Erbitux, cisplatin and radiation can cause death. However, oral cancer is a guaranteed death sentence without treatment so the risk is thought to be worth it.

The oncologists are used to working with the risks and do everything they can to minimise them. Maybe they sometimes slip a bit and assume that everyone knows that death is a risk of treatment but do not expect anyone to reject treatment because of it. To mention it at a time when people are working their way through the shock of diagnosis may be an added unecessary stress (IMO a wrong decision but others may appreciate this). I imagine that having the Erbitux in hospital on the ward would have been assumed to be "monitored", although I am suprised they started an infusion at 10.30 at night when reactions would not have been as easily observed with the ward being dark, junior doctors on duty and everyone asleep.

The Martha Stewart insider trading scandal relates to your regulatory body (the FDA) refusing to approve Erbitux initially. This is not unusual and was no biggie from a healthcare perspective. The scandal was around the investors trying to dump their stock before news hit the papers and destroy the share values. At the time, ImClone only had one product and it was a disaster (short term) for them and probably a disappointment for the doctors who had been trialling it but there was never any suggestion that Erbitux was not a good drug -the FDA just needed more proof. The FDA went on to approve Erbitux a couple of years later when further clinical trials answered their questions.

I must also state that I have worked for a pharmaceutical company for nearly 21 years and am very proud to do so.

Again, so, so sorry you are going through this and we are all here for you. Writing of your experience is one step towards helping others and hopefully, one day you will be able to take comfort in knowing you have saved others from going through what you are experiencing today.


Karen
Love of Life to Alex T4N2M0 SCC Tonsil, BOT, R lymph nodes
Dx March 2010 51yrs. Unresectable. HPV+ve
Tx Chemo x 3+1 cycles(cisplatin,docetaxel,5FU)- complete May 31
Chemoradiation (IMRTx35 + weekly cisplatin)
Finish Aug 27
Return to work 2 years on
3 years out Aug 27 2013 NED smile
Still underweight