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Archive for the ‘Ethics’ Category

Friday, September 28th 2012

Is The Ideal of Evidence Based Medicine Foolhardy?

The Guardian has an excerpt from Dr. Ben Goldacre’s book Bad Pharma. The piece in The Guardian looks at how negative data for treatments, specifically commercialized ones, is suppressed and how that severely skews the ideal of evidence based medicine.

Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite.

[...]

In 2003, two [systemic reviewes] were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

[...]

How do industry-sponsored trials almost always manage to get a positive result?

[...]

You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them. Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine.

The book is yet out and won’t be, in the United States at least, until January. When it is I’m inclined to pick up a copy based on the above.

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Tuesday, September 11th 2012

Who Cares About The Physiology

Long before I read this excellent post from Dr. Karen Rommelfanger, I’ve also wondered about the lack of intentional use of placebos in patient treatment. Not that in clinical practice the prescription of placebos doesn’t happen, because it does. Maybe not with maliciousness or whole intention, but I can think of situations where say a patient with poorly controlled, poorly explained symptoms requests a therapy with low harm but low or no efficacy just as a matter of appeasement. Studies certainly back up the idea that physicians use placebos.

While the ethical arguments against the intentional use of placebos are well spoken, I think the issue is becoming less and less black and white within the bioethics community. Beyond Dr. Rommelfanger’s piece, here is a piece by Michael Brooks in The Guardian.

Giving a placebo is not the same as doing nothing, which means that sometimes prescribing a placebo is better than doing nothing. People are not biochemical versions of computer programs, where a particular input will give a particular output. Being a doctor isn’t about being handcuffed by evidence-based medicine, it’s about using skilled judgement in tandem with the best available evidence – including evidence about the efficacy of placebos.

Placebos are not without there downsides for sure. There is a level of deception in adding legitimacy to patient’s with psychosomatic symptoms. Considering the lack of success in strategies that attempt to convince Conversion disorder victims they are not sick however, placebo therapies deserve a consideration. I think there is a way to describe potential placebo treatments to patients so that they understand risk-benefits, the key element in making an informed decision, without describing the strategy as a placebo.

Intentional placebo therapies deserve consideration in some scenarios and shouldn’t be painted off as completely unethical.

Wednesday, September 5th 2012

Not Even All Physicians Understand Acuity Apparently

I’ve written about trying to communicate acuity to families. Maybe that needs to be expanded to encompass the same to other physicians.

To be fair I’m sure some of this, perhaps much of it, rests solely on my shoulders. Recognizing that I’m still going to make an accusation that talking life and death with families and patients is a skill not fostered in many providers. More accurately for this anecdote, and importantly for the care of patients, some physicians flat out fail to recognize the necessity of such discussions and decisions by families.

A while back I saw in consult a young man with a subdural hematoma who had been found down at home after days unseen. He was young but it was a serious injury that had, presumably, persisted unmitigated for some time, likely on the order of > 24 hours. It was not an unreasonable question about how the parents would want to proceed. And while I can’t offer quotation marks this is near verbatim from the consulting physician:

- I don’t think you can blame a parent for not wanting to make a life or death decision about their child on the spur of the moment
- I don’t think a family’s decision has any bearing on triage

These comments came as they got more and more frustrated with my lack of transfer orders while I had lengthy conversations with the family and awaited their decision on whether to proceed with surgery or not. The argument was that I should transfer the patient to the neurosurgical service and the family could then take their time deciding on whether to proceed with surgery or not. My argument was that if the family elected for end of life care there was no need for transfer.

To be fair I’ve changed the story considerably, for obvious reasons, but attest fully that those consulting physician comments are essentially synonymous with the actual quotes. I don’t feel comfortable adding the quotation marks lest I transcribed a word here or there. I’ve left out my own parts of the conversation that prompted those remarks, and thus considerable context. But I would argue there is no context you can give those comments where they are not incredibly naive. Everyday physicians throughout the hospital ask families to make spur of the moment life and death decisions. Everyday a family makes a decision for or against a laparotomy in an unstable trauma patient or a craniectomy in a patient with a head injury. And the decision is, often, to go now or not at all. This story doesn’t completely reflect that urgency but the principle remains. It was at that moment that the surgery offered maximal benefit. There’s no decision to wait until tomorrow or the next day, it is now or we discuss other options such as maximal medical care or end of life care.

The discussion with families obviously lacks that crassness but, as I’ve discussed previously, frankness is not always a bad thing. In a very empathetic way the family needs to be aware that they need to make a quick decision. And so for a consulting physician to hold it against me that I was awaiting a family’s life or death decision before proceeding seemed surreal and disconnected. It still does. It is hard to imagine a physician so removed from the reality of acute care in a large county hospital. It is hard to imagine a physician who would hold in so low regard a family’s wishes in determining the next step in care.

I think that this particular conversation was the most remarkable I’ve ever had with another physician concerning patient care. Maybe my incredulousness is misplaced. With admittedly only half of essentially a made up story, my side, at your disposal let me know in the comments if you think I’m way off base.

Saturday, July 28th 2012

Doctor As Drug Trafficker

Being a physician who focuses solely on pain is a dangerous occupation apparently just see here or here or any other examples.

‘Pill mills’ are a real problem (and not just in Florida) which routinely make the news. So the following story is remarkable only in the example of brazenness that actually got reported.

The deputy…showed ["Dr."] Atiga the dog X-ray [and] told the doctor she was in a car accident several weeks before her visit and needed “something way stronger” than the Tylenol she claimed to be taking, according to an audio recording of the visit reviewed by The Times.

The doctor asked few questions before listing the drugs he could prescribe.

“Do you want to try Vicodin ES?” he asked. “Or do you want to try others? … Roxicodone? Or oxycodone? … Or whatever you want….Maybe some Valium or Xanax.”

The deputy chose Roxicodone and pulled out two X-rays of the dog. Atiga examined them and referred to specific bones, explaining what they were to the agent, according to the recording.

“That’s the hip joint right there,” the doctor said, apparently indicating one of the dog’s bones.

Glendora police had received complaints “that for the right amount of cash” the doctor would “write prescriptions for you” and pocket the cash, Police Capt. Timothy Staab said.

“He was well-known among drug addicts and prescription medication addicts,” Staab said. “He was the doctor to go to.”

The doctor is believed to have asked patients, who paid hundreds of dollars for prescriptions, to give his receptionist a $50 tip “for her time and troubles,” Staab said.

Atiga has a prior felony conviction for taking illegal kickbacks in return for referring Medicare patients for home health services, according to state medical board records.

Indeed, the x-ray above is one of the images the undercover deputy showed the physician.

This kind’ve activity is apparently far too common and a real stain on the physician as a brand. I know there are times when there is reasonable disagreement about the appropriateness of certain actions by doctors, especially as it relates to prescribing opiates and other higher class pharmaceuticals; cases where aggressive government action is worthy of criticism. But cases such as the one above, so blatant are real problems and need to be routed out and dealt with.

Monday, July 23rd 2012

Research At Your Peril

A physician can’t employ novel, potentially dangerous, treatments on you, even with your permission, without crossing off Institutional Review Board approval. The IRB critique process is designed to weight the risk/benefit of the proposed study and assure appropriate informed consent of the subjects. And in the case of new drugs or devices, the physician can’t do it without running through the Food & Drug Administration.

And so the confusion out at UC-Davis right now, involving the chair of neurosurgery, is likely to grab some attention.

In 2008, [UC-Davis neurosurgery chair Dr. J. Paul Muizelaar and his colleague Dr. Rudolph J. Schrot] proposed treating a glioblastoma patient with bacteria applied to an open wound to “attack the tumor,” then later withholding antibiotics and letting the bacteria do its work.

Schrot contacted the FDA but ultimately was cautioned that animal studies were needed first.

Back at UC Davis, IRB chairman [Dr. John] Anderson…was also skeptical. Anderson told Schrot in an email that denying this patient the treatment would be “likely devastating to this family,” but that he believed the FDA and UC Davis “won’t allow this product to be used in humans without further testing,” internal documents reveal.

Despite the initial roadblock, Muizelaar and Schrot “strongly believed that the intervention with intentional wound infection was promising for patients who otherwise faced certain death,” according to [a letter from Harris A. Lewin UC-Davis' vice chancellor of research]

[...]

Between October 2010 and March 2011, the physicians went forward with three procedures on humans with malignant brain tumors, surgically introducing probiotics into their open head wounds.

[...]

Schrot got IRB permission to move forward on Patient No. 1 with a “one-time procedure” that was “not associated with any research aim,” the letter states.

University documents show that the physicians believed they had been given the go-ahead for all three surgeries, but officials later determined that they had been misinformed or were misunderstood by the doctors.

Muizelaar and Schrot stressed to The Bee that all three patients, in consultation with their families, gave their consent.

[...]

In the case of Patient No. 1, the investigation found, Schrot had made an “incorrect statement” about restrictions on the bacteria’s use, leading IRB staff to incorrectly conclude that such review was not necessary, Lewin told the FDA.

As for Patients 2 and 3, the university found that treating them with an “unapproved biologic” amounted to human-subjects research – and thus required prior review and approval.

The idea of infections stemming cancer progression is hardly unprecedented and is reported in the literature for everything from lung cancer to bone cancers. Indeed, even intentional infections in cancer patients have a history. And, although two recent relatively large retrospective studies from 2009 and 2011 failed to show post operative infections improved survival in GBM, the issue remains equivocal with more anecdotal reports supporting the idea that infections may promote an immunologic response against the tumor itself.

Much of the issue seems to center on the idea of these bacteria as a ‘biologic’. If what Drs. Muizelaar and Schort did constituted ‘research’ of a biologic then there is likely real trouble ahead and much, if not all, of UC-Davis’ federal research funds, from all sources, could be at risk. It probably bodes well that if the University thought there was something wrong going on here that they self reported it and potentially did so in a relatively timely fashion.

I’m not going to jump to conclusions here. Although two patients seems to have had poor outcomes, potentially related to the treatment, it seems very plausible that this is a matter of bureaucratic misunderstanding. I understand the idea behind IRBs and the reasoning of a level of paternalism that most bioethicists feel patients need,

Arthur Caplan, director of medical ethics at New York University’s Langone Medical Center, said that desperate people are especially vulnerable and need added protections.

“If you’re dying, you’re kind of like reaching out to anything that anybody throws in front of you,” said Caplan, who recently left the University of Pennsylvania’s Center for Bioethics to assume the New York post.

“That’s why so many people over the years are pursuing quack cures in Mexico and all kinds of questionable treatments,” he said, speaking in general terms. “They’re not able to think straight because they’re at death’s door.”

Caplan said that institutional review boards are often misunderstood, with many people believing that such strenuous oversight is “a lot of bureaucracy to get in the way of trying something to save lives.”

In reality, he said, the committees are an essential safeguard for research subjects, who may not get an unbiased view on a researcher’s consent form of the study’s risks vs. benefits.

Maybe the informed consent portion should be the sole purview of the IRB. It is true that the ‘informed’ in informed consent can be a matter of contention, there is very often a wide discrepancy in information between a provider and patient. However, if Drs. Murzelaar and Schort, provided a reasonable view of the risks versus very potential benefits to these patients, even if the use of the bacteria actually under law fell to the FDA for permission, I would be inclined to step back, take a very libertarian view and think much unnecessarily is being made of the situation.

I’m sure fuller details are to follow. It is unfortunate that this is playing out so publicly at present.

Saturday, June 2nd 2012

Do We Resuccitate Too Many People?

It is distressingly easy sometimes for DNR/DNI status to be miscommunicated or lost in the urgency of a code situation. Apparently in hospitals around the world.

The National Confidential Enquiry into Patient Outcome and Death reviewed the care given to 585 acutely-ill patients who ended up having a cardiac arrest.

The watchdog concluded that cardiopulmonary resuscitation (CPR) had wrongly become the default setting.

[...]

Details of whether or not to give CPR was recorded in the notes of only 122 patients in the study of hospitals in England, Wales and Northern Ireland.

Of these, there were 52 cases where doctors had performed resuscitation on patients who had explicitly said they did not want it.

I’ve heard of cases where there is confusion during codes as to a patient’s code status. This really needs to be a conversation that physicians have with every patient that enters the hospital from eighteen to ninety-eight, whether there for a cellulitis or end stage CHF. The places I’m at it’s true the nursing staff usually has that discussion but it’s something that the admitting physician, the first one to see the patient, should bring up as well and document well.

Do not resucitate and do not intubate orders do not mean that you or your family member are not going to be treated. It does not mean that you’re taken less seriously as a patient or priority within the hospital. It merely is planning for the unthinkable. You don’t put together emergency rations and a battery powered radio and flashlights expecting a natural disaster but instead in case.

A DNR order means that in the event of cardiac arrest or events leading to such no measures will be taken to resuscitate the heart including cardioversion by shocking or chest compressions or drugs to help make the heart beat. A DNI order means that no tube will be placed into the trachea to allow for mechanical ventilation in case the patient stops breathing on his own. The decisions are usually made together as DNR/DNI orders.

A DNR/DNI decision can be a sensitive topic of discussion and a difficult decision, not only for patients themselves but, sometimes even more so, for families when patients cannot make the choice for themselves. There are several things to consider when seriously pondering a DNR/DNI decision. First and foremost is the patient’s pre-hospitalization condition, independence and quality of life. This is probably more important than the patient’s actual prognosis from whatever condition the patient is being treated in the hospital for. The fact is that, independent of what disease your battling in the hospital, if you go into fullblown, true cardiopulmonary arrest you are very unlikely to do very well. Patients who get ACLS – chest compressions, shocks and drugs to restart their heart – and intubated for arrests do very, very poorly. In this study just 11% of patient’s who coded survived to hospital discharge. Some patients who survive are left with devastating new deficits, including potentially brain damage or long term care requirements such as tube feedings or ventilation.

Second, patients and family should consider the financial cost of cardiopulmonary arrest. As morbid as this sounds, ACLS leaves patients who are already unlikely to survive their hospitalizations, with significant ICU stays and undoubtedly significantly increase the cost of the patient’s last days of life. Patients who survive these codes to hospital discharge may require longterm care outside the hospital with significant financial burden to their families. I know this can see a tactless consideration but if we’re honest with ourselves it should be an important one when deciding DNR/DNI status.

Third, patients and families should consider the quality of death they desire. While providing for the best chance of survival following a cardiopulmonary arrest a code, and the care that follows, can be a brutal and undignified process. It is true there is likely no pain associated with a code but chest compressions will leave patients with broken ribs and long term time on the ventilator and other procedures in the intensive care setting can be upsetting to family and friends.

A DNR/DNI decision is a very personal decision. Ideally it is something that should be discussed with family and their physician before a patient requires hospitalization. At the least however both the admitting nurse and physician should have early conversations with all patients to clarify their wishes if the patient was to suffer an arrest.

Sunday, May 20th 2012

Counterfeit Medications

Counterfeit pharmaceuticals are on the rise. Consider the several discoveries of fake Avastin in the United States, the latest announcement of such coming just last month.

The FDA said on Tuesday it had identified a new batch of bogus vials of the injectable cancer treatment containing none of Avastin’s active ingredient, bevacizumab.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said it was looking into how the latest counterfeit batch entered Britain before being sold in the U.S. market.

With costs of a complete treatment running $40,000 to $100,000 specialized drugs like Avastin are probably the most promising target for counterfeiters. The problem is hard to get ahold of. Many pharmacutical companies in India for example blatantly ignore international patents and produce technically counterfeit drugs, but, admitting the potential questionable production quality, at least intended as efficacious. If you include these violations of intellectual property rights India produces more than 75% of all counterfeit drugs.

What is obviously more alarming however is the problem in the western world, the example like that of Avastin. Less than 1% of all drugs in the United States are counterfeit it is true. But the problem appears to be on the rise.

[T]here is no question that counterfeit medicines are a huge and growing problem, the human costs of which are immense. Patients the world over have suffered injury, nontreatment, and death. High-profile cases include individual tragedies — such as the death of the 18-year-old American Ryan Haight, who in 2001 overdosed on prescription drugs he had purchased online — to public health disasters. During a 1995 meningitis outbreak in Niger, for example, 50,000 people were accidentally inoculated with fake vaccinations. 2,500 of them died. And over the last decade, hundreds of children have died from tainted counterfeit cough syrup.

International organizations like Interpol and WHO certainly take the problems seriously but obviously the tracking of international drugs, as they start to cross borders, is difficult. Without domestic enforcement in countries where production happens the problem is difficult to address. And in many of these country’s their is little available police resources for such a problem low on the triage, and indeed, sometimes there is even a lack of will for such.

Tuesday, May 15th 2012

Lovesickness Is An ICD-10 Diagnosis

This is an incredible story out of the United Kingdom. A family is claiming malpractice over a little girl’s death from tuberculous. The most sensational stuff is some of the etiologies some of the physicians tried to ascribe to the girl’s symptoms.

An inquest heard that her GP, Dr Sharad Shripadrao Pandit, accused her parents of “mollycoddling” her.

Shockingly, he even claimed her symptoms were brought on because she was ‘lovesick’.

Inappropriate to judge stories of malpractice out of a newspaper. But if even a modicum of truth is in the transcripts out of the Coroner’s Court are true then this is a horror. My thoughts are with her family.

 

Wednesday, February 1st 2012

Expanding The Definition of Brain Death

I still love The Onion

Tuesday, November 8th 2011

A Critical Review of Recombinant Human Bone Morphogenetic Protein-2 Trials in Spinal Surgery

Background

  • Although the specifics of assessment and technique in fusion remain for debate spinal fusion for pain with spinal instability has become a generally accepted treatment
  • Surgery for fusion attempts to promote new boney growth between the unstable vertebral segments
  • Early last decade saw the rise in the clinical use of a naturally occurring cytokine, bone morphogenic protein-2, which serves to promote osteoblast differentiation and new bone formation in the body
  • Initial studies demonstrated great success, as compared to bone grafts alone, in promoting boney fusion between unstable segments when BMP was used during surgery
  • The Spine Journal June 2011 issue is dedicated to editorials and studies reviewing the growing evidence that BMP use has a number of risks that were underreported as adverse events in the initial studies which trumpted its use. Amongst these studies is a literature review by Carragee et al which criticizes the lack of reported adverse events in the initial industry sponsored BMP studies

Carragee, Eugene, Eric Hurwitz, and Bradley Weiner. “A Critical Review of Recombinant Human Bone Morphogenetic Protein-2 Trials in Spinal Surgery: Emerging Safety Concerns and Lessons Learned.” The Spine Journal 11 (2011): 471-91.

Design

  • Systemic review looking at adverse events reported in original 13 industry sponsored publications looking at rhBMP-2 use in spinal use representing 780 patients versus adverse events reported in subsequent publications and FDA data sets

Results

  • 13 original studies of BMP
  • All first authors had significant financial ties to Medtronic, the industry manufacturer of BMP
  • Meta-analysis of the 13 studies shows 0 complications associated with BMP
  • Review of subsequent studies, unpublished data from the original studies submitted to the FDA leads the authors to conclude that BMP has a true adverse event rate of 10-50%. Newer studies may also associate the product with a cancer risk
  • Dr. Carragee’s group proposes that the financial ties of the authors of the original 13 studies may help explain the lack of reported complications with BMP

Conclusion
Spine surgery is facing a real scandal with BMP. The association with cancer and the implication that financial considerations influenced the studies which led to its approval as a device by the FDA and to its widespread use is a big enough story that it has crept out of the pages of Spine and into the mainstream media. Reuters, the AP have both reported on it, as have major papers like the San Francisco Chronicle and the New York Times and the Wall Street Journal.

Infuse and other BMP based products are likely rightly dead and recalls are in the future. As for what this plays into the long going debate about the association between researchers and industry remains to be seen. But this is a big deal.

I’m going to be less than reactionary here. I think severing the ties between academic medicine and industry is impossible without hurting the common good. This country is the leader in advancing medical science partly because of funding from industry. I think the oversight is going to have to come from the academic institutions themselves. That’s a tough thing and there are major obstacles to people policing their colleagues. I’m not sure exactly what form that might take. But certainly I don’t think the government is not in a position to police it all. And the alternative is severing all ties to industry funded research.