Senate Probe into Pharma Sponsoring of US Bioethics Center

The last few days, a buzz in the world of bioethics has been about the inclusion into a US Senate probe into the ties between the pain-killer pharma industry and various "medical" and patient interest groups, of the Center for Practical Bioethics, to quote their webpage, "a nonprofit, free-standing and independent organization". The CPB is particularly known in the US for its direct outreach and activism visavis politicians, health care institutions and the medical establishment - not least in the area of end of life and palliative care.

The probe specifically targets the possible ways in which painkiller producing pharma companies, among which are giant Johnson & Johnson, via financial donations and in other ways, have had the mentioned groups - among them CPB - inspire and/or promote "misleading information about narcotic pain-killers". In short: the suspicion is that the companies have paid the organisations money to play up the reasons for using opiate based painkillers (e.g., morphine) or palliative meds that function like opiates, while playing down the salient negative side-effects and risks of such drugs. The background of the probe is said to be "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers.".

The tie to CPB is thereby established by its well-known and long-term advocacy of effective palliative care and pain-relief. The center's founder Myra Christopher holds the Kathleen M. Foley Chair in Pain and Palliative Care at CPB, sponsored by the company Purdue Pharma, manufacturer of OxyContin and other palliative drugs. According to the Kansas City Star, CPB is well known for its ties to Purdue Pharma as well as several other pharma companies:

...as recently as last month, Purdue was a leading sponsor of the center’s annual dinner and symposium, contributing $25,000 of the $280,000 that the event raised

Myra Christopher is one of the experts mentioned by name in the letter announcing the Senate probe.

Also The Washington Post has reported about the probe, and a longer version of that article can be read here. A particularly fishy part of the story expanded on there is that, as the probe was announced, The American Pain Foundation, self-described as "the nation’s largest organization for pain patients", and one of the organisations targeted by the probe, announced its own shut-down due to "irreparable economic circumstances". From the bioethics and CPB angle, this becomes extra uncomfortable, since Myra Christopher has held honorary positions in APF.

Further details about some publications/reports of Christopher that have had a role in advocating expanded use of strong painkillers, or to play down the ethical importance of, e.g. addiction risks or calling into question routines for monitoring patients who are on painkillers for such risks, can be found in the second half of the Kansas City Star article, which also contains comment by bioethics researchers Carl Elliott and Summer Johnson McGee.

Both of these hold out that the notion of pain and suffering as a health problem in its own right is fully defensible one. In consequence, pain can motivate medication that brings various health risks – just as risk of dysfunction or death can. However, the Senate probe does not seem to question this general point. Both Johnson McGee and Elliott also point to the practical problems created by  a supposed academic and independent institution advocating policies of great financial benefit to certain parties while, at the same time, being funded by these very parties. My own take is that, even if the money does not lead to outright and calculated intellectual dishonesty or fraudulent behaviour, human psychology has to be taken into account. The money arrives because the funding party likes what one is saying and as one becomes increasingly dependent on the financial support, one will (like it or not, conscious or not) become less and less likely to say something else.

Christopher is reported as insisting that the money from Purdue Pharma always has arrived with "no strings attached". It remains to be seen if the Senate probe will unveil information consistent with that claim or not. But even if it did, that does not take away the problem described above, and to me, the problem with CPB financial dependence on the pharma industry grows as the quote hints that Christopher does not realise this elementary point.

Read more here: http://www.kansascity.com/2012/05/11/3607147/senate-panel-studies-bioethics.html#storylink=cpy

Court Acquits Swedish Neonatal Doc Charged with Murdering Newborn Baby in Controversial Case

Today, the verdict was announced in a very controversial case in my country regarding a neonatal intensive care doctor, who has been charged with murdering a newborn baby by administrating high doses of sedatives (here, here, here, here, here, here, here, here). The doctor is acquitted of the charges of manslaughter. It remains to be seen if the prosecutor decides to take the case further to appellate court.

The case has sparked heated discussions and not so little confusion in the medical, political and ethics expert community. Leading voices of medicine have somewhat lost their marbles and made megalomaniac claims about doctors being immune from prosecution whatever they do to their patients in the name of best practice. There has also been rather peculiar criticism about the prosecutor taking a long time bringing the case to court, where the unspoken message seems to be that medical doctors should somehow be treated differently than other people in criminal proceedings - reminding a bit about how Julian Assange or Mr. Strauss-Kahn have been reasoning around their own persons in relation to the rape charges they are or have been facing.

All of this has, to my mind, been sheer nonsense. Of course, it is immensely burdensome for anyone to face serious criminal charges. Even more so if your own view is that you have made nothing wrong, but rather the best you can. It is also completely understandable and justifiable that the legal defense and friends of those charged do their best to have the person charged described as innocent in media. However, the principle of equality before the law stands far above any such individual consideration. Take a deep breath and think about for a moment how society would look like if we let that principle slide and this should be crystal clear to anyone.

Now, there have been several attempts to make a spin on the case settled today according to which it is not about a real legal issue, but rather about a more hazy underlying problem of an ethical nature. The idea has been that the critical issue is whether doctors are allowed to take risks in order to achieve effective pain reduction in dying patients. However, albeit indeed being an interesting issue in its own right, that has never been the centre of discussion in the present case. Doctors are allowed to take such risks according to Swedish law, end of story. But they are not allowed to murder people as this is defined in criminal law. It is the latter that has been the base for the prosecutor's claim in the case decided today. 


Instead of making my own explanations of how I read the court's decision, I have made a quick translation of the court's own press summary. The Swedish original is here. Read for yourself and make up your mind!

Solna District Court today acquitted the doctor who was prosecuted for manslaughter or attempted manslaughter of an infant at Astrid Lindgren's hospital in Solna fall of 2008. The district court has not found it proven that a crime has been committed. The district court has not found it proven that the doctor has done something that was not be medically justified.
The district court has not found the evidence sufficient for showing beyond reasonable doubt that a crime has been committed. The prosecutor's claim is based on an analysis of forensic evidence, which has demonstrated an exceptionally high concentration of thiopental in the blood from the deceased child. The district court has not considered this result to be sufficiently reliable to fully serve as the basis of a conviction. The district court does not believe that one can draw any more far-reaching conclusion of the analysis results than the one that thiopental, although observed in a high concentration, it is unclear how high the concentration was. Given this uncertainty about how high the concentration was, it is conceivable that the occurrence can be explained by the fact that the child had received thiopental on previous occasions during hospitalisation. This means that there is no evidence that a crime has been committed and the doctor is already on this ground freed of the charges made.
 The district court has not considered that the prosecutor with sufficient certainty has proven that the doctor has acted in any way that was not medically justified when the child died.
In the debate related to this case, it has been claimed that the case concerns the distinction between what a doctor can and cannot do when it comes to relieving pain and anxiety in end of life care. This is not correct. The prosecutor's contention is rather that the child has been poisoned, that the child has been receiving a very high lethal dose of thiopental administered in order to effect that the child would die, not in order to relieve pain or distress. There is no doubt that such conduct, if it had occurred, is punishable as manslaughter under Swedish law, whether or not it had been prompted by reasons of compassion and whether or not the child would have died anyway within a very short time. As has just been said, however, the district court did not consider it proven that such a criminal act had in fact taken place.

Legal Right to Die Comfortably for the Lethally Ill or Injured finally Confirmed in Sweden – but the Line Between Palliation and Murder is Still Undefined...

Today the Swedish National Board of Health and Welfare (NBHW), my country's highest authority on the application of health care law and associated ethical codes, delivered its ruling on a publicised case where a 31 year old woman, totally physically incapacitated since 6 years of age, appealed for the right to have the respirator keeping her alive since 25 years turned off and then to receive palliative care powerful enough to effectively ameliorate the resulting pain and anxiety.

To grant such wishes has indeed been established practice within Swedish health care since at least a decade back, not least in the case of old people who decline nutrition and liquid. The received opinion among doctors, officials and ethicist alike has been that the acceptability of this practice is a logical consequence of the principle of respect for personal autonomy in health care, combined with the approval of palliation as a legitimate medical aim by itself. However, a recent criminal prosecution against a neonatal doctor at the Karolinska Hospital, where surprisingly high amounts of the rests of powerful sedative drugs where found after an autopsy of a newborn child following a decision to terminate neonatal intensive care treatment that had been judged to be medically meaningless, has cast doubt on the legality of the established practice. Legal scholars, as well as the National Council of Medical Ethics, has pointed out that the aim of palliation after withdrawal of life-saving treatment may conflict with established criminal law regarding killing, since palliation necessarily brings a risk for hurrying death along, especially so with powerful palliation and in the case of fragile patients in a terminal stage. And Swedish criminal law statutes regarding, e.g., manslaughter do not mention imminent death by natural causes as a factor that excludes an act from falling under the legal ban. As an effect, doctors treating severely, chronically ill patients who wished to have life-support withdrawn and to receive effective palliation up to the time of death, became hesitant to grant these wishes. This is the background to why the woman appealed to NBHW; to ask it to let her doctor of the hook created by the uncertain legal situation.

The ruling is most welcome just due to the need for having the legalities straightened out, and even more so due to its content. NBHW had two alternative positions to choose from, besides the one actually taken: (1) to deny people suffering from deadly diseases or injuries the right to have their personal autonomy respected; and effectively to grant the right of the state to force adult and fully decision competent people to undergo very burdensome medical procedures for indefinite times, or (2) to grant the medical professions a right to effectively torture their patients, by affirming the rule of respecting autonomy while denying palliation as a legitimate medical aim. The NBHW instead states clearly that adult, decision competent patients have an unequivocal legal right to have ongoing medical treatment terminated (and unwanted treatment never to be initiated), even when the treatment has a life-supporting function. It moreover rules that dying patients have a right to effective palliation within the limits set by the established practice within this branch of medicine – thereby licensing the use of anesthetics besides, e.g., morphine.

Within the palliative medical practice and profession (and, evidently, within the NBHW), it is well-established that all palliative drugs, pain- and anxiety-killing as well as sedative, bring some risks of a slightly shortened life-span. Thus,  the ruling implies the legal acceptance of medical procedures that bring such risks without being balanced by the reduction of other risks for a shortened life-span. The palliative effect is recognised as a sufficiently important factor by itself. However, the question still remains how far this reasoning can be taken before the above-mentioned potential conflict with criminal manslaughter statutes is actualised. For the job of the NBHW is not to apply criminal law, only administrative law governing health care and medicine and, should there be a conflict, legal principles are clear: criminal law trumps any sort of administrative ruling.

Currently established palliative drugs and dosage can presumably cover most needs arising in this area of medicine. Especially so since the use of anesthetic for palliative purposes is a part of this practice since many years. One may hope, therefore, that an actualised legal conflict will never occur. However, the theoretical room is there, and it would take just one unforeseen case to reopen the can of worms.