This suggestion by Sandeep Jauhar, in a recent essay in the NY Times, is what everyone expects from physicians – and as we are all human, mistakes are made, a name slips in the hallway or elevator, we share an interesting vignette with colleagues etc. But what “Jane/John Doe” (JD in HIPAA speak) may not realize is who else has access to their information. Not only do pharmacies sell the information from doctors’ prescription pads (patients’ names scrambled). The so called “patient identifiers” and medical histories are passed on to third parties, called “business associates” (e.g. lawyers, CPAs). There seem to be few checks and balances in place. If the business associates breach patients’ privacy, it seems that at best their contracts get cancelled. Meanwhile somewhere in the US, a medical records department is giving a doctor a hard time obtaining vital information on a sick patient in the ER and I cannot find my patient because all the patient names are removed from the doors. Some comments on recent news about un-informed consent in emegerncy medicine research (for examples, click here), so eloquently highlighted by Chris McCoy yesterday, point in the same direction. When people say, I quote, “I suppose in a godless nation, a scientist will see nothing wrong in doing whatever he wants just to get his share of the limelight”, I conclude that we as physicians have to work hard at regaining or patients trust. Reclaiming privacy is a vital step.

This morning the  Washington Post published an article about trials for new trauma resusitation guidelines. The journalist seems shocked - shocked! – that consent is not obtained in emergency situations, and “experimental” treatments are being tested on people.

I’m actually amazed at the lengths the investigators have gone to explain the new treatments. The protocols approved by Institutional Review Boards, but also ethics committees at the NIH. That I expected. But the fact that they are going out into the community to seek “community approval” is a step beyond. Short of going door to door, that allows the concerns of those who may be affected to be heard and involved in the process. And yet, some people are still raising ethical concerns.

Let’s flip this situation on its head. What if science has advanced our understanding of shock physiology since the current protocols were written decades ago? What if we had identifited treatments that had been tested on animals and shown to be more effective than what we are currently doing? What if the new techniques had been tried in controlled settings (like hospital ICUs) and found to be better? But then when researchers suggested using this new techniques in the field, government bureaucrats stepped in and stopped it because consent could not be obtained from every individual who might be involved? Can you imagine the uproar?! Non-medical pencil-pushers are preventing us from saving lives! Who are they to insist that we keep doing the same thing, when that wasn’t proven to begin with?

We’ve tried these therapies on animal models, and found them to be potentially better. But the only way to find out is to try them on real humans in real situations. Unfortunately, the real world is not neat and clean, with time to obtain traditional consent and discuss the risks and benefits with patients.

What is truly sad to me are the comments from other readers: comparing this to Nazi experiments, suggesting that the profit motives of companies and the FDA is inspiring greed, “human guinea pigs”, etc. It is a disappointing sign that patients have lost the trust and faith in our profession. The vast majority of physicians and scientists are driven by the desire to do what is best for our patients and to advance the understanding of our world and our bodies.

A 45% increase in heart attacks with Avanida- I am pretty sure GSK ran this analysis themselves – who would not in this day and age? I am not saying that I blindly believe everything Steve Nissen says – let’s be honest, even if “THE Journal” has published this study, Nissen admits it has its flaws. Furthermore, while the man prides himself (publicly at the ACC a while back) in giving all the money he gets from drug companies to charity, he still TAKES money and who says that the attention he gets that way is not a benefit and would influence him?

However there is certainly something fishy and now that the debate rages in most major papers (see Washington Post, New York Times), one has to ask the question “Didn’t they know?” and it underscores that people like PhRMA officials, who want to make us believe that we get a full disclosure from the sales reps, are just full of….. well, fimus equinus (feel free to correct my Latin). I hope other PPAR antagonists – like Gemfibrozil – do not get sucked up in the debate (see Wall Street Journal). Taking mostly care of cardiac patients, I can probably count the number of times I have written for Avandia on one hand – but I have more than once seen heart failure patients come in taking that medicine (heart failure, to my knowledge, has always been one of the warnings). I guess we cannot blame that on GSK – other than the reps have done a good job of NOT informing these prescribing docs of the dangers of Avandia.

One argument the pharma industry always uses to justify datamining prescription information is that they want to warn physicians effectively about potential dangers of their drugs. If you are a doc, think back how much Avandia you have written for in the past few months. If that number is more than zero, and GSK does not send you their letter (which, BTW, is refuting the NEJM study), they are not tracking you well enough, or again… it’s all fimus equinus.
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The Topahkal Family Medical Office is a small “community” clinic located in the heart of the South Valley, a very poor part of Albuquerque.  We recently moved into a new building, 3 times the size of our original clinic.  This means a yard 3 times the size as well and for some reason it seems the weeds here are 3 times bigger.  A veritable jungle of budding tumble weeds before they are ripe to be plucked by the wind and tossed across the desert of the southwest.

As a community clinic we rely on the resources and generosity of our patients and their families to “take ownership” over aspects of the clinic and put their pride and care into “their” clinic.  It’s a theory and one that we are actively engaged in exploring at the Topahkal.  One could look at the unfinished work as us being lazy (or underfunded, or overwhlemed), or one could look at all the unfinished work as opportunity for our patients to give back.  Most of our patients pay their fair-priced bills and feel it’s been a reasonable exchange of our time for their care.  But now and then a patient comes along who felt deeply inspired by the work we do in their life, and even if they do pay their bill, they feel compelled to give more.  This has happened a fair amount already – a beautiful huge mural painted on the outside walls by some patients, alot of cleaning, tons of renovation work, a cement wheelchair ramp…

One instance stands out.  A middle-aged man came in to my office this past friday.  He was the first one there, arriving an hour before clinic opened and was eager for his visit.  He had a history of substance abuse (pain pills, crack, cocain, alcohol) and anger.  He was recently involved in a major fight with his “friends” and had suffered many blows to the body.  He was in alot of pain.  He had already been seen in an ER and had the usual full body CT scan so after examining him I was able to comfortably reassure him that his wounds were only skin deep.

While speaking with him a wound much deeper than the skin surfaced.  He was tired of being an angry man, tired of being on drugs, tired of being in conflict with the world, he talked of having been raped a few years prior, he broke down in tears in front of me stating that he was close to active suicidality, contemplating buying a gun to end his life.

I listened, asked gentle questions, and then offered him some care.  He was highly suspicious of western medicine so we used Flower Essence therapy.  I had him and his girlfriend spend some time with a volunteer at the clinic to identify his core issues of anger and depression and then mixed up some medicine for him.  His tension was visibly relaxing from being heard, acknowledged and honored for his pain.

Fortunately, we have a volunteer massage therapist who also does Mexican traditional medicine and he had a cancellation at that moment so I was able to refer this man immediately into a “limpia” (emotion/soul cleansing).  He left seeming much relaxed after the visit but i’m skeptical enough to have kept my hopes neutral.  He had been in a terrible place when he arrived.

A few days later I was out “weeding” and fixing up our pond before clinic started.  He drove up in a beautiful beat up old dodge pick up truck with a simle on his face.  He had lost a phone number I had given to him and was returning to get the referral again.  He noticed at that point how weedy our yard was and offered to clean it up for free, in appreciation for what we had done for him.  I’m always cautious when offered help as many people offer and few follow thru.  but I took him at his word.  I went inside and spent 7 hours seeing patients.  At the end of the night he came in with a bigger smile on his face, a sense of pride clearly visible, and an eagerness to show me what he had accomplished.  I stepped out side and there was not a single weed standing.  It was amazing.  Not the weeds, but  the transformation in just a few days of a man who had been on his knees in humiliation, pain and anger, ready to kill himself, now having some dignity and pride and commitment.

We used a number of different “modalities,” who knows which or what combination made the difference.  I’m a believer that it was the power of care shared in any vehicle that can convey.  Regardless, it’s just the start of a very long journey he has to take to reclaim his humanity, to find in himself a kind soul, a generous and capable being.  But it’s a good start, and I’m glad that my weeds could play an important role in his healing process, and that they are now compost instead of allergen and eye-sore.
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Andru Ziwasimon MD

Finally the datamining of prescription information gets some national front page coverage. Check out the article (read more link below), featuring our own Rupin Thakkar and Jean Silver-Isenstadt. When reading some comments, it is clear that many people are upset about this.
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In a recent Boston Globe Op-ed (“Does a drug firm’s free lunch influence doctors?”, May 18), Scott Lassman, senior assistant general counsel of the Pharmaceutical Reserach and Manufacturers of America (PhRMA), asks a question that has been answered with a resounding Yes! on several occasions by sound scientific research. The “pharmaceutical industry’s commitment to patient education”, that Lassman mentions is really not the topic. Do not get me started on direct to consumer advertising – it is as much education as a cereal box teaches you about a heart healthy diet. Why would a pharmaceutical representative give me a pen inscribed with the label of the drug she is selling? If it were to help me write for a generic alternative, she would not have done her job (she is after a all a sales representative).

Ironically, Lassman chastises the authors of a recent study investigating physician-industry relations for giving their research subjects a $20 check (a common practice in research to compensate for time lost). He compares it with the amount reps spend on lunch for doctors. While a “modest lunch in a workplace setting” is common, so are lavish dinners worth well beyond that, including speakers honoraria of several thousand dollars. Mr. Lassman either has no idea what his clients are doing, or he knowingly misrepresents the facts.

Mr. Lassman also suggests states that “pharmaceutical experts are a key source of information” for physicians. He is right. The one I use is a phone call away and has a ‘PharmD’ behind her name. Lassman seems to endorse replacing a whole profession, as well as numerous scientific journals, with pharmaceutical representatives who may be well intentioned and know their ‘stuff’, but who have often a limited background in science and often do not know much about alternative treatments. And again, they are sales representatives, and even the most naïve person would not assume that they are unbiased. When I am “asked about a drug that may be life changing” – and word usually gets around pretty quickly about those few – if I do not know about it I say ‘I will read up on it, let me get back to you’. If I learn about a dangerous side effect of a drug that is unknown, who better to report it to than the FDA?
This debate is really about trust. Who does the patient trust more – the physicians, trained to choose the best drug for his ailment, or the drug company, who wants to sell its drug? No doubt, the origin of the pharmaceutical industry is the “shared goal” of improving “the lives and health of patients.” However they answer primarlily to their shareholders, while this physician answers to his conscience.

Every meal you take, every script you create;

Every study they fake, every drug you dictate…

Big Pharma is watching you.

Find out what the NPA is doing to protect prescription privacy.

So the New Hampshire law prohibiting the commercial use of prescription information was found to violate the First Amendment (read about it here). What? Yes, it prohibits commercial free speech. What is free commercial speech?  A topic unto iteself (interesting summary here), but it is bascially defined as “expression related solely to the economic interests of the speaker and its audience”. It is not untouchable and can be banned if the State has a “substantial interest” in regulating the speech, the regulation is in proportion to that interest, directly advances that interest and uses the most limited means to achieve that interest.

Now, the sale of prescriber data by the AMA and health information organizations such as IMS and Verispan to the pharmaceutical industry is clearly in the commercial  interest of those parties – they use it to generate profit, namely by targetet detailing of physicians by sales reps. The detailing of physicians is at best neutral and often biased toward the benefits of the drug that reps are selling (really, you say, what a surprise!).  And since academic detailing is in its infancy and poorly funded, the drugs that get pushed are often the newest ones.

Now we all know that “new” is not always “best”, and these days they are often only non-inferior. The VALIANT trial, just as an example, compared Valsartan ($56/mo) against good old Captopril ($15/mo) after heart attack and found it to be “equivalent”….. I have not seen a lot of patients on Captopril lately, I certainly have seen plenty on Valsartan. And the sale of prescription data can pinpoint  the providers that are prescribing captopril (or drug generic XYZ instead of ABC), and who would you think would get a visit from the sale rep for ABC first?

So can we then assume that targeted detailing is not necesarily (you may say never!) in the interest of patients? Then does it not become a substantial interest if the State to limit that practice? These are just some thoughts that come to mind, even if protecting the private sale of databases containing personal information is somehow what the authors of the First Amendment had in mind…..

We are adaptable creatures, and while that is generally good, sometimes it’s a problem. We have no difficulty taking prompt action when faced with a sudden calamity, like a bleeding head wound, say, or a terrorist attack. But we are not good at moving against the creeping, more insidious threats — whether a slow-growing tumor, waistline or debt.

It’s as true of societies as of individuals. We did not muster the will to reform our long-broken banking system, for example, until it actually collapsed in the Great Depression.

This is, in a nutshell, the trouble with our health care crisis. Our health care system has eroded badly, but it has not collapsed. So we do nothing.

For at least two decades, polls have shown that most consider our health system seriously flawed. With family insurance premiums now averaging $12,000 a year, the insured fear it will become unaffordable, and businesses regard health benefit costs as their single greatest obstacle to competing globally.

People without insurance are proven to be more likely to die, and 28 percent of working-age Americans are now uninsured for at least part of a year. Emergency rooms, required to care for the uninsured, have become so full they turned away 500,000 ambulances last year. As a result, large majorities support the idea of fundamental change…

from Atul Gawande’s commentary “Can this Patient be Saved?” NYTimes May 5,2007. (thanks to Donkey O.D. for sharing the full piece, which is otherwise on the pay-only section of the Times website).

The bolded section above (emphasis mine) is a pet peeve of mine — we’ve put billions and billions into disaster preparedness and bioterrorism work in the past few years, and we’ve taken billions OUT of more insiduous killers like chronic disease programs, integral public health mechanisms, and such basics as housing, food, transportation, etc.

I’m a doctor at a county hospital and clinic in Los Angeles, where we mostly treat the uninsured, underinsured, or undocumented. We’re the safety net hospital in the area. However, we’ve been packed to the brim and have had to say no to ambulances (channel them to other county or non-county emergency rooms) over and over and over again. Now that’s what I call scary. Spillover from a safety net hospital.

Also — the cost that Gawande mentions for health insurance for a family isn’t overstated. In my state of California, individual health plans are more than $4500 a year, and family plans are definitely more than $12,000 a year. And what’s minimum wage, in California or in the U.S.? You do the math. (Obviously this cost is too high even for middle-class folks!) That’s seriously problematic.