Today I paid a visit to the Managing Director of Mylan Pharmaceuticals, Lloyd Price. Mylan is the company that manufactured the antidepressant Fluox1 which, according to the NZ government, is the most likely cause of my son's suicide.
My dealings with Mylan in the time since Toran died have not been entirely fruitful.
In 2010 I wrote to them asking that they refund the $3 prescription fee I paid for the Fluox they manufacture on the grounds that the product didn't work as advertised. Just as I would if I bought a toaster that didn't cook bread or a pizza that made me ill. They declined my request for a refund.
In 2011, I called them to file an adverse drug reaction report on behalf of Toran. They told me I could file the report verbally and so I detailed the aggression, hostility, abnormal dreams, fatigue, suicidal thinking and eventual hanging of my child to them over the phone. Having expected to be told they would send me a form to fill in, I wasn't properly prepared to provide dates and details of Toran's reactions so did the best I could from memory. At the time, I asked that a copy of their record of my report be sent to me so I could make any corrections if necessary. When this didn't happen, I emailed the Regulatory Affairs Team Leader to ask her to send it to me. My email was met with a letter from Virginia Hazard, Mylan's lawyer, referring to my child as 'Mr Henry' and advising that Mylan would not provide me with their adverse reaction report because it was confidential.
I wrote back to them advising that
My right to obtain the health information you hold in relation to my child is clearly set out in s22(f) of the Health Act 1956 and rule 6 of the New Zealand Health Privacy Code 1994 which you will be aware covers health information held by pharmaceutical companies.
I do not consider your statement that “Mylan’s CIOMS is confidential” is sufficient grounds on which to deny me access to this or any other information you hold in relation to my son.
I ask again that Mylan provide me with all information it holds in relation to my son or provide proper grounds on which to refuse this request.
The response I received came as a shock. Mylan resiled from the position that I was not entitled to the information, but advised they needed me to provide copies of Letters of Administration from the High Court to prove I was Toran's legal representative.
Let me explain why this affected me so deeply.
My memories of Toran's death are of noise and chaos - running and screaming, terror and panic, desparate attempts at CPR - and then deathly silence. Him lying dead on the floor of the garage. Me sitting beside him feeling my world dissolve into total emptiness and asking over and over again in a tiny voice “am I still his mother, am I still his mother, am I still his mother?” And of being reassured by the medical people present that I was, that I will always be.
Motherhood is, of course, far more than a biological construct. Mothers protect their children's interests. They make decisions for their children. They are provided, as a right, with information about their child's educational progress, health status and other sensitive issues.
For Mylan to suggest that I needed a High Court judge to decide whether I still had that relationship with my son – the role of his mother – is one of the most hurtful things that has been done to me since Toran died. I recall my grandmother hating the fact that after my grandfather died she was referred to as his widow, not his wife. I understand how she felt. I am still Toran's mother, not his administrator or executor.
I wrote back to Mylan saying
I have not applied to the Court for a letter of administration for two reasons. First, I am the mother of my son who was a minor child at the time of his death and no health provider in New Zealand has ever questioned that I am his legal representative. A range of health and other providers in this country have provided me with the information they hold on my child including CARM, the Ministry of Health, my son’s doctors and the Coroner. All have accepted my status as my son’s legal representative without requiring proof beyond the fact that I am his mother. I assume Mylan is not disputing that I am in fact my son’s mother.
Second, the cost of such an application is prohibitive for someone who has lost their income and home following the sudden death of her child.
My legal adviser considers it unnecessary that I either provide proof that I am my son’s representative or that I incur the cost of obtaining letters of administration.
While this requirement may be standard outside of New Zealand, it is clearly not necessary in this country as evidenced by the fact that other organisations have produced information without it’s provision.
I therefore request that you send me the information you hold on my son without imposing a requirement which is unnecessary and which I find deeply distressing.
Their response was as follows
Mylan New Zealand Ltd (Mylan) regrets any inconvenience which may be caused by the request to provide evidence of your legal status as your son's representative. However the Health Information Privacy Code 1994 stipulates that a personal representative must be the executor or administrator of a deceased person and rule 11(1) HIPC prohibits an agency from disclosing health information to an individual unless it has reasonable grounds to believe that that individual is a representative of the diseased (sic) (emphasis added).
My family according to Mylan: the diseased and the representative of the diseased. While this is obviously a typo, its an incredibly freudian one given the way Mylan undoubtedly see Toran and I.
The letter goes on to say
Mylan requires you to provide evidence that you are Mr Henry's legal representative [and] reiterates its request that you provide letters of administration of Mr Henry's estate as evidence of your status as Mr Henry's legal representative.
This letter was dated 5th December 2011. Christmas for me is followed by the anniversary of Toran's death, Mother's Day (the day he was born), Easter (when he died) and his birthday in quick succession. I put my communication with Mylan on hold while I dealt with those dates and considered how to progress the matter.
A couple of months after Toran's birthday, on a Saturday morning while Bobby and I were having breakfast, I got a phone call from a Dr. Luigi Palombi, who advised me he was Mylan's new legal counsel. He explained that he had read Virginia Hazard's correspondence with me and was shocked at how I had been treated and wanted to apologise. He promised to send me the information I had requested and asked to meet with me in September.
I told him I would welcome the opportunity to talk to him about Mylan's ethics in not providing patient information leaflets inside their drug packaging and he said he hadn't known that was the case and sounded genuinely shocked. I was excited that an opportunity was being made for me to work towards making sure that Toran's death resulted in some changes in the way Mylan did business and relieved that I was to be provided with the information the company held on my son without further demands.
September came and went however with no word from Dr. Palombi. Watching me suffer the effects of having had my expectations raised and then dashed, my partner - author and blogger, Bobby Fiddaman (http://fiddaman.blogspot.co.nz) - emailed Dr. Palombi who advised that he had left Mylan on 3 August.
Back at square one, I decided I needed to find out whether Mylan was going to honour Dr. Palombi's promises to me or revert to Virginia Hazard's position. So I called the Managing Director Lloyd Price to find out.
Lloyd told me he was happy to provide me with the information Mylan holds on Toran but that he needed to make sure it was being released to the right person and asked that I take my passport and Toran's birth certificate to a Justice of the Peace who would certify that I was Toran's mother.
He sent me the following email after our conversation
Further to our telephone conversation today and consistent with our previous correspondence to you, to release the Health Information you have requested Mylan requires formal evidence of your relationship with Toran.
As discussed can you please obtain such from either a Justice of the Peace or other relevant authority and forward by electronic email to my team member Maria Venetoulis at the email address above.
Can you please detail your postal address on this correspondence so that we can forward this confidential email to your correct postal address following receipt of the appropriate information from you.
Now, I had a couple of issues with this. The first is that I was again being asked to jump through hoops that were completely unnecessary and the second that Mr. Price would suggest that his request was consistent with the request of Virginia Hazard.
Virginia was asking that I provide evidence that the High Court have authorised Toran's mother to administer his estate. Lloyd was asking that I provide evidence that I am Toran's mother. Kind of like being asked to buy a plane ticket so you can produce a boarding pass and then being told that's the same as being asked to provide your passport.
So, today I went to see Lloyd Price, taking Toran's birth certificate and my passport so that he knew I was Maria Bradshaw, mother of Toran Henry, and not some random woman who impersonates the mothers of dead children as part of the build up to Christmas.
I knew nothing about Lloyd except that he doesn't have much use for full stops and was probably not that great at the Sesame Street game where Elmo sings “one of these things is not like the other, one of these things just doesn't belong.” I expected he would be perfectly nice and throw around a few platitudes while trying to get rid of me as soon as possible.
Turned out I was right about the last bit. The bit after platitudes.
What actually happened was this. Lloyd photocopied my passport and Toran's birth certificate and promised I would have his file within 36 hours. A promising start which went rapidly downhill. Glancing at the photo of Toran I had in my hand, Lloyd said he had children the same age and commented that teenagers are irrepressible and that at that age you can't keep them down.
Umm... actually you can, Lloyd. You'll find that when they are given a drug that induces them to put a noose around their neck and hang themselves until they are dead, that they go very quiet.
Am I being unfair? Probably. Running an organisation supporting families bereaved by suicide, I know how uncomfortable it can be for others to confront the reality of our loss and how easily the wrong thing can slip out. Honestly though, reminding me that your children are full of life while mine is dead because of the drug you manufacture, was pretty insensitive Lloyd.
I then I said that while I had five minutes of his time I wanted to discuss with him the fact that I intended to send him a document outlining my recommendations for changes Mylan could implement as a response to the lessons learned from Toran's death. At this point, Lloyd decided to reframe our relationship so that he was the victim. A victim of my making, or facilitating others to make, allegations of wrongdoing by him and his company.
He told me sternly that Mylan had complied with all legal requirements and had a large team of scientists and compliance staff who made sure everything was done by the book. He then told me that he had not appreciated being called a liar by a blogger from the UK who had published the correspondence between Mylan and myself. He said both he and Luigi Palombi felt upset by what had been written about them.
When Bobby told Lloyd he was the blogger, Lloyd accused Bobby of being dishonest about being my partner and being present at the meeting only to gather information for a further blog. (Note to self to locate veterinary records in case Mylan's next move is to question my relationship with Little Bear and Pikelet, my cats as they have with my son and partner).
Bizarrely, he then shook my hand and wished me Merry Christmas, and when I cried and said that there will never be anything merry about Christmas for me again he told me to stop it, repeated that Mylan had complied with the law and then hugged me and wished me Merry Christmas again!
Lloyd had said he had a meeting in five minutes and I had turned up unannounced, so that was where the conversation ended.
So who is Lloyd Price? Google him and you will find little about him except that in the face of product recalls, he is on the record as saying that
product quality and patient safety always come first at Mylan” 2
He works for a company who claim that they are
committed to setting new standards in health care...we do what's right, not what's easy and impact the future through passionate global leadership. 3
So why the resistance to engaging with me in ensuring that what we know about Toran's death is used to prevent the future deaths of children on the Mylan drug Fluox?
The answer is of course simple. Doing what's right, not what's easy, might impact Mylan New Zealand's profits.
Lloyd Price is the managing director of the New Zealand branch of the 3rd largest generic drug producer in the world. A company with a market value of $9.72 billion that reported a 15% or $1.8 billion increase in revenues in 2009 including increased revenues of 214% from the Asia Pacific region which posted revenues of of $537.4 million for calendar year 2008 compared to $170.9 million for calendar year 2007,4. A company that also reported a 1717% increase in settlements totalling $225.7million from litigation related to fraud. Mylan explains
During calendar year 2009, we recorded net unfavorable litigation charges of $225.7 million. This amount consists primarily of a charge of $160 million related to a settlement in principle to resolve certain claims relating to the Company’s outstanding pricing litigation, and to reserve for the remaining pricing lawsuits to which the Company is a party, and a charge of $121 million related to the settlement of an investigation by the U.S. Department of Justice, concerning calculations of Medicaid drug rebates offset by certain litigation-related recoveries.5The company also reports
Our sales also can be impacted by additional labeling requirements relating to safety or convenience that may be imposed on our products by the FDA or by similar regulatory agencies.
Market perceptions of our business are very important to us, especially market perceptions of our brands and the safety and quality of our products. If we, or our brands, suffer from negative publicity, or if any of our products or similar products which other companies distribute are proven to be, or are claimed to be, harmful to consumers then this could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline. Also, because we are dependant on market perceptions, negative publicity associated with illness or other adverse effects resulting from our products could have a material adverse impact on our business, financial position and results of operations and could cause the market value of our common stock to decline.6
So lets get this straight Mylan - market perceptions are very important to you but patient safety is paramount. Toran's mother is pushing for Mylan NZ to include the FDA's Black Box warning on its drug packaging and apatient information leaflet warning of risks and adverse reactions in each pack of Fluox. This would increase patient safety but compromise market perceptions of safety. According to your public statements, when weighing these competing priorities, you would come down on the side of my requests for warnings.
Something's not right here Lloyd. There appears to be a disconnect between what you say and what you do. Which is why I'm about to question the honesty of Mylan's stated commitment to ethics.
To quote Mylan's Code of Conduct and Ethics
Ethics in business is much more than following the rules. It is leading by example, setting the tone at the top, having the courage to make difficult decisions, demonstrating the right values and creating the right culture in an organization.
In our brief meeting, you repeatedly stated that Mylan had complied with the law in its drug dealing. I have never disputed that this is the case. When I studied business however, the prevailing thinking was that leadership requires leaders to have regard to both the law and ethics. It requires that we meet our obligations to not only do things right, but to do the right thing.
To be fully human and be a part of civilized society means to go beyond what the law demands of us. It means to live according to ethical rules and principles, many of which ask more of us than the law does. The answer to "What should I do?" should therefore not be, "What can I get away with legally?" but "What does ethics ask or even require of me?"7
In the United States, the law requires that Mylan put a Black Box warning on packets of Fluox. In New Zealand, it does not. What does ethics demand of you Lloyd? Does it require that as a New Zealand citizen, leader of a New Zealand company and compassionate, honest human being, you provide New Zealand parents and patients with the same level of informed consent that is provided to American parents and patients? Or is it ok to just do the minimum required by law, to risk the lives of children rather than risk your profits?
It is hard to imagine how any law could demand that we care for strangers or require punishment if we don't. This is the proper role, however, of ethics. The penalty for violating an ethical requirement may not involve a prison term, but it can involve scorn or ridicule from others, or feelings of guilt or shame for having let ourselves down or disappointed our family and friends.8
My partner, who has witnessed the harm you have caused to me and my son made publicly available the evidence that under your watch, Mylan's claim on its website that
"We understand that "it's not about us" – it's about helping others – and we believe there's no situation we can't handle. We would do whatever it takes, work 'round the clock, cross any river and spare no effort – all to meet someone’s need.
does not stand up to scrutiny.
Lets be clear Lloyd. Your breach of ethics, not Bobby's blogging about it, invoked this penalty. Your failure to comply with the values you claim to espouse, gave rise to public scrutiny of your integrity. You are not the victim, but the catalyst for whatever scorn and ridicule arises from your behaviour. If you choose to behave unethically, to be dishonest in your dealings with others and are caught out doing so, any consequences are your doing. There were other choices you could have made. You could have chosen, like the Coroner and Toran's GP to hand over the information you held on my son without questioning my status as his mother.
The regulation of dangerous prescription drugs in New Zealand is inadequate. Your donning a halo for achieving legal compliance means little in an environment where unapproved drugs, proven to at least double the risk of suicide can be prescribed to children who have no diagnosis of any condition for which they are indicated, where consumers are denied the warnings mandated by other regulators and where those responsible for the production and distribution of those drugs are protected by a legal bar on prosecution.
In the past, slave owners, men who raped their wives, those who sent children down mines and those who denied women the vote were all compliant with legislation. Sometimes, Lloyd, the law gets it wrong and it is for this reason that the ultimate standards for what we should do are ethical, not legal ones.
Albert Schweitzer said that ethics is nothing else than reverence for life and that the first step in the evolution of ethics is a sense of solidarity with other human beings.
Do the right thing Lloyd. Put the Black Box warning on Fluox. Put a patient information leaflet in every box and amend the leaflet to acknowledge that the drug can cause suicidality. Respect my son's life and connect with my desire to prevent others losing their lives. Do what's right and not what's easy.
If you were sincere in wishing me a Merry Christmas Lloyd, this would really help.
7If It's Legal, It's Ethical??Right? Bruce Weinstein, PhD on October 15, 2007 Bloomberg Businessweek http://www.businessweek.com/stories/2007-10-15/if-its-legal-its-ethical-right-businessweek-business-news-stock-market-and-financial-advice
8If It's Legal, It's Ethical??Right? Bruce Weinstein, PhD on October 15, 2007 Bloomberg Businessweek http://www.businessweek.com/stories/2007-10-15/if-its-legal-its-ethical-right-businessweek-business-news-stock-market-and-financial-advice
DelusionNZ: Maria Bradshaw, who currently lives in County Wicklow, Ireland, writes of social models of suicide prevention, pharmacovigilance, and alternatives to psychiatric interventions for emotional distress.