The Food and Drug Administration says that some 180 medically important drugs have been in short supply, many of which are older, cheaper generic drugs administered by injection that have to be kept sterile from contamination.
[...]
Although there is limited data on how many patients have been harmed, a survey of 1,800 health care practitioners last year by the Institute for Safe Medication Practices found that a third of the physicians and a fifth of the pharmacists knew of adverse patient outcomes because of shortages, including some deaths from microbes resistant to the backup drugs. Cancer patients receiving less effective drugs may well face increased risks in the future.
Nobody is sure just what is causing the shortages because drug manufacturers are not required to report any reasons to the F.D.A. But several factors are likely to be involved…[including] reluctance to invest in production-line improvement for low-profit generics when high-priced brand-name drugs bring in far higher profits. Sweeping consolidation in the generic drug industry means that fewer companies are left in that market to make up for a shortage.
Certainly my primary training facilities have experienced impressive shortages, everything from steroids to sedatives to paralytics to electrolyte replacement solutions and likely a host of others I’m not privy to. And at least partly the focus is on the profit margins afforded some of these drugs as compared to others. It certainly seems, by anecdote, that the vast majority of the shortages involve relatively cheap generic pharmaceuticals. Which makes the pharmaceutical companies current villains in some eyes as they focus on drug development, and more importantly production, for biotech and other “profit” drugs.
The industry is pouring money into clinical trials for cancer drugs (see chart).
This is part of a shift in how big drug firms do business. For years they have relied on blockbusters that treat many people. Now they are investing in more personalised medicine: biotech drugs that treat small groups of patients more effectively.
[...]
The snag, from society’s point of view, is that all these drugs are horribly expensive. Last year biotech drugs accounted for 70% of the increase in pharmaceutical costs in America, according to Medco, a drug-plan manager. This trend will continue as drug firms develop new ways to treat, for example, multiple sclerosis and rheumatoid arthritis.
Indeed, spending on pharmaceuticals in total, and as a percentage of all therapies actually, continues to rise well past inflation even as we struggle currently to supply effective, very necessary generic drugs in enough quantity. That wouldn’t be so remarkable if we were making remarkable advancements in treating patients but that doesn’t appear to be borne out on large scale. What it takes to get a drug to market and then push physicians to use it is remarkably skimpy on evidence. PLoS Medicine’s most downloaded paper ever is titled, “Why Most Published Research Findings Are False.” In profiling the author of that paper The Atlantic points out something I agree with,
Doctors may notice that their patients don’t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence-based medicine, and contributing to Ioannidis’s shockingly high estimate of the degree to which medical knowledge is flawed. That we’re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don’t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.
[O]f all the 197 new drugs approved in the past decade, only 70% had data to show they were better than other treatments (and that’s after you ignore drugs for conditions where there was no current treatment).
But the problems go beyond just using the wrong comparator: most of the trials we rely on to make real-world decisions also study drugs on highly unrepresentative, freakishly ideal patients. These patients are younger, with perfect single diagnoses, fewer other health problems, and so on.
This can stretch to absurd extremes. Earlier this year, some researchers from Finland took every patient who’d ever had a hip fracture and worked out if they would have been eligible for the trials that have been done on fracture-preventing bisphosphonate drugs, which are in wide use.
Starting with all 7,411 fractures, 2,134 patients get excluded straight off, because they’re men, and the trials have been done on women. Then, from the 5,277 remaining, 3,596 get excluded again, because they’re the wrong age: patients in trials had to be between 65 and 79. Then, finally, 609 more fracture patients get excluded, because they’ve not got osteoporosis.
This leaves 1,072 patients. So the data from the trials on these fracture-preventing drugs are only strictly applicable to about one of every seven patients with a fracture: they might still work in those who’ve been excluded, though that’s not a judgment call you should have to make; and one problem, in particular, is that the size of the benefit might be different in different people.
Dr Leemon McHenry, a medical ethicist at California State University, says nothing has changed. “They’ve just found more clever ways of concealing their activities. There’s a whole army of hidden scribes. It’s an epistemological morass where you can’t trust anything.”
Alastair Matheson is a British medical writer who has worked extensively for medical communication agencies.
[...]
“The whole thing is a big lie. They are promoting a product.”
Matheson expects an article he wrote about a new cancer treatment to appear in print later this year, with an oncologist considered a “key opinion leader” (KOL) by planners listed as the author in his stead. “You’d do the same thing if you were selling cornflakes,” Matheson told me. “It’s no different.”
In reviewing a book for the New York Review of Books the former editor-in-chief of the highly respected medical journal The Lancet had this to say about the current state of medical publishing,
[J]ournals have devolved into information laundering operations for the pharmaceutical industry.
When the pharmaceutical companies can’t supply the drugs in part because they’re peddling much higher margin drugs on flimsy evidence, packaged as solid, then perhaps such criticism is fair enough.
Now excuse my ignorance on the subject but it appears the major offenders in this piece had experiences that pre-dated their availability in the United States without incidence. What I mean is that it appears the high rate of complications and failures is limited to the United States as compared to, say, Europe. That may reflect some clinical difference such as surgeon training or patient selection or something along those lines.
But I wonder how much the litigious culture of the United States works to either:
One, bring these issues truly to light so that perhaps the complications with these hips happen just as frequently elsewhere but it goes under reported without the culture of broad civil court
or
Two, how much these problems are made hyperbolic by the same culture.
There are literally dozens of these videos on YouTube. Is there something comparable in say, Germany?
I remember back in 2004 when a Wisconsin girl became one of the singular, confirmed and well documented cases of an individual surviving rabies without the vaccine.
Tests in early May revealed she had the disease after Precious’s grandmother took her to the doctor because of flu-like symptoms that grew so serious her grandmother said they began to resemble polio.
The hospital said doctors followed the protocol first established [in Wisconsin]. Precious was placed in a drug-induced coma as she received anti-viral medications.
She spent two weeks in intensive care undergoing the treatments, and immediately showed that her immune system was strong. She was then moved to the hospital’s general pediatric unit, where she remained Sunday.
Although rabies claim only approximately a dozen people in the United States a year it is a terrifying disease. Failing the vaccine, even best care, the “Wisonsin protocol,” bodes for a poor prognosis. Anyone with open skin exposure to feral or suspicious mammals, including bites or scratches, should certainly seek immediate care.
The 2004 reported survival with coma is found in NEJM.
I recently talked about what changes came into effect on the New Year under the Affordable Care Act. One of the tangential things I didn’t comment on was an executive Medicare regulation running parallel to congressional efforts which came into effect January 1st and promised to pay providers for any time spent discussing end of life issues with patients.
The new rule says Medicare will cover “voluntary advance care planning,” to discuss end-of-life treatment, as part of the annual visit.
Under the rule, doctors can provide information to patients on how to prepare an “advance directive,” stating how aggressively they wish to be treated if they are so sick that they cannot make health care decisions for themselves.
Section 1233 of the bill passed by the House in November 2009 – but not included in the final legislation – allowed Medicare to pay for consultations about advance care planning every five years. In contrast, the new rule allows annual discussions as part of the wellness visit.
The proposal for Medicare coverage of advance care planning was omitted from the final health care bill because of the uproar over unsubstantiated claims that it would encourage euthanasia.
The new rule says Medicare will cover “voluntary advance care planning,” to discuss end-of-life treatment, as part of the annual visit.
Critics decried the new rule as taking control away from patients and devaluing life and setting up death panels.
There is…something at least vaguely disturbing about a government incentivizing doctors to [discuss end of life issues] as part of an expansive regulatory program that has, as one of its primary goals, cost reduction.
At least the linked to criticism at Hot Air,
There is nothing wrong with patients planning for contingencies through advance directives. There is also nothing wrong with doctors discussing those options with patients ahead of those decisions. As the spouse of a patient who has faced life-threatening circumstances on more than one occasion, I certainly understand why these conversations need to take place before the pressures of acute circumstances come into play. This new regulatory effort at least puts the conversation where it belongs, in routine wellness visits, rather than as a five-year set conversation. It also appears to make this a voluntary conversation (at least for now), one the patient can decline without any repercussions.
I couldn’t agree more but I would argue that there should be reimbursement for it at anytime, anywhere.
Lacking a pallative care team there may be no one outside my team, the neurosurgery service, who sees as much end of life issues. Neurotrauma, aneurysmal bleeds, primary central nervous system cancer, bad things. And the choices family have to make in the heat of the moment are gut wrenching and painful and full of angst.
Patients and their physicians need to have conversations with families present concerning end of life issues well before anything happens. The young and the old need to have the conversation. In some ER with a loved one with a massive subdural on Coumadin, with me, is not the place to have the conversation for the first time.
The best way to promote people discussing end of life issues with their physicians is to pay physicians for such discussions. Too bad the political establishment on the right has a problem with that.
I have a strong desire to give a significant amount of my time post training. And maybe the sad thing is the more specialized you are the less you have to offer out in the developing world. Maybe I picked the wrong specialty.
That said, there are wonderful examples of specialist surgeons doing international humanitarian work.
My mother is part of a group that does congenital heart defect work at a number of locations around the world. It’s incredible to have her as an example. For her life in general, but for her dedication in this regard in particular. Below is an incredible video of some of the work the group she is a part of does:
The intersection of social media and privacy has made an older generation, and even some of my own generation, incredibly uncomfortable. There is talk of present and future consequences. Lost jobs, lost income, civil judgments, loss of respect/embarrassment, even criminal penalties for all that you put online. There is an idea that the blurring of intimate boundaries will come back and bite a whole generation.
Being online has responsibilities and consequences, no doubt. But Facebook isn’t going to cost most people a future job or a future election. The social rules are, as we speak, changing in terms of how we judge people for their private lives that they make public. The whole world is using social media and putting themselves out there. Tough to judge someone for your same acts.
Because those involved in health care and social media have the often near unique oppurutinities to not only dismiss their own privacy online but to do so for others. Horrific stories are rife. Take this one for example,
William Wells arrived at the emergency room at St. Mary Medical Center in Long Beach on April 9 mortally wounded. The 60-year-old had been stabbed more than a dozen times by a fellow nursing home resident, his throat slashed so savagely he was almost decapitated.
Instead of focusing on treating him, an employee said, St. Mary nurses and other hospital staff did the unthinkable: They snapped photos of the dying man and posted them on Facebook.
It is unfortunate if such scares providers and health systems away from social media like blogs, Facebook and Twitter.
As Ed Bennett comments,
“We already have guidelines; social media is simply another form of communication. It’s no different from e-mail or talking to someone in an elevator,” Bennett said. “The safe advice is to assume anything you put out on a social media site has the potential to be public.”
It’s a form of communication with the potential, as all others, to be abused. But more importantly, it has great potential to further provider-patient discourse and aid in health.
No patient privacy protections will ever be perfect. No patient-provider communication rules will ever absolutely guarantee professionalism and accurate information at all times. But guidelines and rules can limit such problems while furthering patient’s access. That holds no matter the medium.
The proliferation of easy mass communication tools should be embraced by health care, not cowered from. As always there are appropriate and inappropriate uses which health care providers should be counseled on and which should carry rewards and penalties. But just because social media is new shouldn’t make it scary.
I participated in a dilation and curettage on a woman who was experiencing an incomplete abortion. I was in the room before the procedure and the OR nurse offered to let me do a pelvic exam on her, since the patient was already anesthetized. Although I was fascinated by the opportunity, and initially was tempted by the learning experience, I didn’t want to do it without her permission, and made myself consider her as a patient and a person, not as a pathology or anatomy in front of me.
This from a medical student’s experience, writing over at Mom’s Tinfoil Hat and linked from a longer piece at The Unnecesarean. An alarmist piece.
Medical facilities where training takes place already face somewhat of a stigma. No patient wants to be a “guinea pig.” Certainly not in the dramatic examples given of non-consensual invasive pelvic exams.
But for every anecdote given there is the opposite. I have never seen nor heard in the number of places I’ve done rotations, of medical students doing pelvic exams on patients under anesthesia without those patient’s permission. Anecdotes like the above scare off patients from teaching facilities. Such is a shame.
Teaching facilities provide an unparalleled level of integrated, multi-specialty care. It features physicians who are often leaders in their field. It often offers a team of physicians, students and others who can afford the time and focus that patients deserve.
The horrors that can befall patients are not limited to an academic setting and so I hate to see anecdotes like above go unchallenged.
I love electronic health records. To be honest I don’t know how physicians functioned before them. Imagine having results coming back on 10 patients at various points throughout the day and not getting to any of it until the next day. I’m sure it was functional, if less efficient.
But there’s a downside. Namely when the EMR system goes down, it’s not like the entire health care organization returns fluently to the good ol’ days of paper records and reporting. At least in my experience.
A couple of weeks ago the county hospital that is my primary training ground shut down the EMR system in it’s entirety for 24-hours of maintenance and upgrades. The time I spent tracking down labs, talking to the radiologists (when everyone else is trying to), having to haul myself to the actual nursing stations of the 6 different floors my patients were on to put in orders was painful. So is the fact that the half dozen consult notes I hand wrote are essentially lost forever. Nevermind the fact that when faced with the time constraints of a busy weekend on call my notes on paper became decidedly less detailed; which is probably never a good thing.
That said, except for scheduled outages, the EMR systems I have worked with have had decidedly few ‘hiccups’.
I love electronic records and order systems and PACS.
I don’t think there is anything nobler than being a physician. In it’s most prime form it is service to life’s most basic needs.
Certainly there are professions and lives with similar dedication. But lawyers and journalist I can’t reasonably place amongst them. This from someone who favors liberty and transparency in society above most else; certainly things that lawyers and journalists can help foster.
And yet, for all the respect thrown towards physicians by society, even amongst the access crisis and the accusations of greed, you can’t help but get the sense that some people are delusional. I take this from a speech by Gerry Spence,
“[Lawyers] are the most important people in America,” Spence said. “There is no other profession in America that fights for freedom, that fights for what America is about, that fights for justice for ordinary people.”
[...]
“I want to ask you which would be more important: If all of the doctors in the country somehow disappeared or all the trial lawyers in America somehow disappeared?” he asked. “We can live without medical care, but we cannot live without justice.”
Spence was a prominent trial lawyer, a near celebrity trial lawyer, who may be prone to such hyperbole. But the reality is no American will ever need a lawyer quite like they need an operation for a perforated bowel. Not even if facing criminal charges to potentially include execution as punishment, if for no other reason than the difference in acuity amongst the two examples.
To claim the legal profession as more important than the practice of medicine borders on delusional.
“Journalism is not brain surgery; it’s more difficult than that,” said Andrew Cline, an assistant professor of journalism at Missouri State University, who has written on the perception of bias in news coverage.
There are people who do great things with their lives, on par with any healing effort. But a trial lawyer and a mainstream journalist cannot claim their importance to society as such. And the fact people exist who think such shows that, for all the respect it is granted, there may still not be quite enough for exactly what physicians do.
er·ror
/ˈɛrər/ Show Spelled[er-er] Show IPA
–noun
1. a deviation from accuracy or correctness; a mistake, as in action or speech: His speech contained several factual errors.
2. belief in something untrue; the holding of mistaken opinions.
3. the condition of believing what is not true: in error about the date.
4. a moral offense; wrongdoing; sin.
A contextual error occurs when a physician overlooks elements of a patient’s environment or behavior that are essential to planning appropriate care. In contrast to biomedical errors, which are not patient-specific, contextual errors represent a failure to individualize care.
The above appears in a work by Weiner, et al in the Annals of Internal Medicine last month. I’m terribly poorly read on healthcare QA and medical errors but it appears to be a relatively novel concept. A search by title or keyword for “contextual error” in Medline reveals a total of three articles. The two other than Weiner’s have nothing to do with the idea as his group defines it.
I like the idea; I think it raises important considerations.
I don’t like the way Weiner’s group designed a study to document the prevalence of contextual errors.
He sent undercover patients into doctor’s offices with regular complaints: a diabetic with blood sugar out of control. Raging asthma. Need for a hip replacement. They functioned as the “secret shoppers” of health care.)
In each case the actors could present a standard version of the problem, or versions where they offered a clue to an extra fact, something all physicians would agree should change the plan of care, if it were known. For the patient with raging asthma, one clue was “it’s been worse since I lost my job.”
A smart doctor would ask if new financial problems meant the patient could not pay for medicines. With that information in hand, the doctor could readily change to cheaper medications or identify a source of support. If a doctor fails to pick up on that clue, however, then they are likely to add new prescriptions. That would be the wrong decision.
Physicians only asked follow-up questions about those clues to good care about half the time. When there was a problem in the patient’s life situation, like inability to afford medicines, doctors only came up with an appropriate plan of care one time in five. Four times out of five, the patient left the office without receiving good care.
I’m not sure the example given represents a mistake on the part of the physician. Not in full. Not enough to claim,
That error rate is unacceptable.
Patient non-compliance with therapy is a failure of the medical system, but it is largely a patient side error. I’m not denying the responsibility of providers to promote social health and situations that facilitate patient compliance. But a patient who presents to a physician with worsening of his symptoms and doesn’t offer the fact that he’s been non-compliant with the recommended therapy because he can’t afford it, well, that is fully on the patient.
Telling physicians they’ve made a mistake for not ferreting out the complex situations in which patients aren’t compliant during a fifteen minute office visit is bollocks.
