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A Brilliant Plan For Preserving Pharmaceutical Progress

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Almost a decade ago, during the antediluvian period of the internet, on a now-defunct and little-read precursor to this blog (before actual “blogs” were even invented), DrRich wrote a piece entitled, “Phillip Morrissing The Drug Companies.”  In that piece he predicted that, since the American media and the American legal profession had just finished savaging the tobacco companies, they would turn their great engine of destruction (highly-tuned engines of destruction being a terrible thing to waste) on a new target, one that some might consider less worthy of destruction than the evil tobacco companies but a ripe target nonetheless, namely, the pharmaceutical industry.

Many of DrRich’s readers laughed at him, but a few wisely sold all their drug stocks. (These latter would be very happy campers today had they not re-invested their profits first in Pets.com, then in REITs. If one is going to follow DrRich’s investment advice, one ought not jump too far ahead.)

Today the editors of the Wall Street Journal, for all practical purposes, have placed the official seal of validation on DrRich’s long-ago prediction (though, unaccountably, they fail to mention DrRich by name).   The WSJ notes that the big drug companies, in the few weeks since the Obama budget was sent up, have engaged in an incredible acceleration of mergers – though not in the manner of “creative destruction” that usually typifies such deals, but rather, in the manner of trying to construct a hardened shelter in which to survive the coming nuclear winter. The government price controls and the rationing of drugs which the drug company executives seem to have found in that proposed budget (apparently lobbyists take their jobs seriously enough to actually read legislation before it is voted upon, even if our congresspersons do not) appear to have convinced said executives that the game is about up.

Now, nobody needs to remind DrRich that drug companies are evil. DrRich has watched along with all his readers as the drug companies have fired off a never-ending parade of “me too” drugs mainly aimed at keeping the joints, bowels, bladders and genitalia of aging baby boomers nicely lubed up, then running a steady stream (so to speak) of television commercials regarding same, that render it far too embarrassing to watch prime time television any more with preadolescents. DrRich has watched the drug companies systematically fail to publish research that makes their products look less than spectacular; routinely over-hype research that suggests a modicum of effectiveness; callously corrupt doctors with plastic, logo’d ink pens, and legislators with huge campaign contributions and rides on private jets equipped with plenty of booze and bimbos (causing the indignant legislators to propose rules against logo’d ink pens); and most annoying of all, gouge American citizens with astronomical prices for their new drugs while selling those same drugs to Canadians and other undeserving foreigners at greatly discounted prices.

Still, most objective observers will reluctantly admit that, unlike the tobacco companies, every now and then a drug company will do some good. Here and there they manage to come up with a real breakthrough product that cures a disease, prolongs survival, restores functionality, or relieves suffering. That is, the pharmaceutical industry (in spite of all their evil behavior, which DrRich hastens to remind his readers he has formally acknowledged, as recently as in the prior paragraph) has done a lot of good over the years. Ask a parent whose child has survived acute leukemia, or the person who has survived a life-threatening infection, or the woman whose heart attack or stroke was aborted with clot-busting drugs, or – yes, this too –  the aging Lothario who once again can enjoy fine and durable erections upon demand. For such individuals, even if today they would join us in cheering on the demise of the pharmaceutical industry, recent advances in drug treatment have undeniably improved their lives.

But the real question we must address before allowing the pharmaceutical industry to roll itself into a ball and hide in the shadows for the duration, is not, “What have you done for me lately?” (since their inventions will live on even if they do not), but rather, “What can you do for me tomorrow?”  Some of us in the boomer class, for instance, would like to think that current research in the areas of Alzheimer’s, Parkinson disease, kidney disease, heart attack, stroke, arthritis, osteoporosis and cancer will allow us to remain healthy and functional for a few extra years. And judging from the massive amounts of money American citizens of all ages donate to medical research of all types, it is apparently not held among the whole of the populace that medical progress has already gone far enough. Many of us would not be entirely pleased to stand pat right here. Many of us would like to see more improvements.

And here is where we run into a dilemma.

Everyone agrees that the cost of new prescription drugs has been kept obscenely high in the name of maximizing profits, and that the rising cost of drugs has been one of the prime drivers of healthcare inflation. Accordingly the plans that apparently have been included in the Obama budget proposal to check those prices – techniques such as federal price controls, drug re-importation and the like,  (but again, who’s actually read the thing?) – will greatly restrict if not eliminate the huge profits made by the evil men (and, one must say it, women) who run these drug companies.

The problem, of course, is that if the potential for reaping large (obscene, if you insist) profits from new drugs is significantly curtailed, the hugely expensive process necessary for drug companies to bring new drugs to market will be proportionally curtailed. So if we place price controls on drugs, then we’d better be happy with the drugs we have today, because those are likely the only drugs we’ll have tomorrow.

There are some who would be quite satisfied with this outcome, and who would readily sacrifice pharmaceutical progress to keep prices low. And judging from the recent election results, these may even constitute a majority of Americans. Still, others of us appreciate the fact that every few years some truly earth-shattering drug will hit the market, and would think it a shame if progress on such drugs – even if they are but a few scattered islands in a sea of boutique pharmaceuticals – were to come to a halt, and even if for a good reason.

So here’s the question: Can we have our cake and eat it too? Can we bring down the price of the drugs we buy, while at the same time allowing at least some pharmaceutical advances to continue?

DrRich is delighted to reply, “Yes, we can!”

And he hereby humbly offers a plan to achieve this very end. It is a system of voluntary price controls. Of course, DrRich is talking here about us doing the volunteering – we the consumers – and not the drug companies.

DrRich’s Voluntary Price Control System works like this:

1) Each American will make a formal declaration of whether or not he/she wants to participate in a system of voluntary price controls on drugs.

2) Those who opt to participate will receive immediate, substantial discount pricing on all available prescription drugs, such pricing to be fixed by a sympathetic government agency whose makeup includes a wide diversity of representation, except, of course, that drug company representatives and their physician shills will be specifically excluded.

3) “Available prescription drugs” under this price control system will be any drug whatsoever appearing in the U. S. Pharmacopoeia – that is, any legal prescription drug – as long as that drug has been on the market for at least five years.

4) Individuals who choose not to participate in the price control system will pay whatever price the drug companies feel like charging them for all their prescription drugs, but they will be allowed to receive any drug, as soon as it is approved for marketing, with no five-year waiting period for new drugs.

5) Individuals may switch their status (between participant and non-participant) only during one 30-day window every 2 years, determined by their month of birth.

Why DrRich’s Voluntary Price Control System is brilliant:

For drug companies it is the prospect of making large profits from new drugs, and only that prospect, that drives drug development. So as long as we want new drugs to be invented we’ve got to allow for the profit incentive to continue, as odious as we may believe that to be. The chief advantage of DrRich’s system is that it maintains at least some of the profit motive – to whatever extent citizens opt to be non-participants in the Voluntary Price Control System.

Given the growing hue and cry for price controls on drugs, one can confidently predict that only rich people will opt for this non-participant status. Therefore, a side benefit of this plan is that the rich – those who, after all, can afford it, and who, by virtue of the very fact that they are rich, owe much to the rest of us – will fund virtually all progress in drug therapy. Again, this is a burden they ought to feel obligated to bear, being rich and therefore, well, obligated.

In contrast, under the universal, mandatory price control system of the kind that many politicians seem to favor (and which may be voted into existence in a matter of days) drugs available to our citizens would be essentially “frozen in time,” and henceforth there would be little or nothing new under the sun.

Of course, under DrRich’s Voluntary Price Control System, access to new drugs would be similarly restricted for participants. Yet this voluntary system would be far better to even those who choose to participate than would be a universal price control system – because under DrRich’s plan at least some drug progress would continue. And as new prescription drugs matured in the marketplace, and once their hidden dangers and side effects – during the 5-year “shakedown period” –  manifested themselves on the physiology of the wealthy (nya-ha-ha), these drugs would (eventually) become available even to plan participants, and at a substantial discount to boot.

The bottom line: a five-year lag in gaining access to new drugs is vastly better than never having any new drugs at all, especially when the burden of paying for all that drug development, and the risk of becoming early adopters of new, relatively unproven, relatively risky pharmaceuticals, falls entirely on the rich.

So, while at first blush you may not like DrRich’s system – it being two-tiered and all – on further objective and logical reflection DrRich is confident you will see that it is far better for everyone than the universal system of price controls which now appears imminent.

DrRich suggests you contact your legislators immediately to recommend to them this brilliant new plan, before it is too late. In making your case, you might remind your dedicated congresspersons that a robust pharmaceutical industry is inherently good for America (what with all the campaign contributions, airplane rides, booze, bimbos, etc. it provides to grease the wheels of American democracy).

**This post was originally published at Dr. Rich Fogoros’ Covert Rationing Blog**

Blood Pressure Medicine Cures Facial Deformity

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There is an article (see reference below) in the June 12, 2008 issue of the New England Journal of Medicine (h/t Medpage Today) that shows some amazing regression of hemagiomas using propranolol.

Hemangiomas of infancy are the most common tumor of infancy. They typically appear within a few weeks after birth and peak within three months. Hemagiomas are more common in girls than boys, more common in white than other races, and more common in preemies. Most of these lesions are innocuous and regress without treatment. Up to 75% shrink to insignificance by the time the child reaches school age. However, 5-10% of the lesions that will ulcerate during the rapid growth phase in the first 6 months of life. Ulceration is the most common reason for referral to specialists, and may be associated with pain, bleeding, infection, disfigurement, and scarring.

This one series of photos shows the results:

Panel A shows the patient at 9 weeks of age, before treatment with propranolol, after 4 weeks of receiving systemic corticosteroids (at a dose of 3 mg per kilogram of body weight per day for 2 weeks and at a dose of 5 mg per kilogram per day for 2 weeks).

Panel B shows the patient at 10 weeks of age, 7 days after the initiation of propranolol treatment at a dose of 2 mg per kilogram per day while prednisolone treatment was tapered to 3 mg per kilogram per day. Spontaneous opening of the eye was possible because of a reduction in the size of the subcutaneous component of the hemangioma.

Panel C shows the patient at 6 months of age, while he was still receiving 2 mg of propranolol per kilogram per day. Systemic corticosteroids had been discontinued at 2 months of age. No subcutaneous component of the hemangioma was noted, and the cutaneous component had considerably faded. The child had no visual impairment.

Panel D shows the child at 9 months of age. The hemangioma had continued to improve, and the propranolol treatment was discontinued.

Christine Léauté-Labrèze, M.D., of Bordeaux Children’s Hospital, and colleagues used the drug to treat two infants with heart disease (one with cardiomyopathy, the another with increased cardiac output) who just happened to also have hemangiomas. Unexpectedly, the lesions began to fade. They then used propranolol on nine other children with hemangiomas with similar success.

Johns Hopkins researchers have developed a protocol for the beta-blocker as a first-line treatment for the skin disorder. Propranolol could replace or supplement steroids such as prednisone which are often used currently. The children receive 1 mg/kg of propranolol on the first day, divided over three doses, and 2 mg/kg — also divided in thirds — after that.

Prednisone use carries the side effects of growth retardation, elevated blood sugars, and reduced resistance to infection.

Propranolol has side effects that include hypotension and hypoglycemia, but these are short-lived.

So far, Dr. Cohen and Katherine Puttgen, M.D., also at Johns Hopkins, say they have treated 20 patients with propranolol. Working with cardiologists, they decided to hospitalize the infants for the first two days of treatment to monitor for possible side effects such as hypotension or hypoglycemia. (They have seen none so far.)

Dr. Léauté-Labrèze, and colleagues reported that they are applying for a patent for the use of beta-­blockers in infantile capillary hemangiomas.

REFERENCES

Propranolol for severe hemangiomas of infancy; New Engl J Med 2008; 358: 2649-2651; Léauté-Labrèze, C et al

Ulcerated Hemangiomas of Infancy: Risk Factors and Management Strategies; eLiterature Review (John Hopkins Medicine) , Oct 2007, Vol 1, No 4; Bernard A. Cohen, MD, Susan Matra Rabizadeh, MD, MBA, Mark Lebwohl, MD, and Elizabeth Sloand, PhD, CRNP

Related Blog Posts

Vascular Birthmarks (July 15, 2007)

Early Surgical Intervention for Proliferating Hemagiomas of the Scalp — An Article Review (Sept 1, 2008)

**This post was originally published at the Suture For A Living blog**

Why You’re More Likely To Die On Saturdays and Sundays

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Patients don’t choose the days they get sick.

There are several studies, specifically dealing with heart attacks, showing that the mortality rate increases when a patient visits the hospital during the weekend.

It appears that the same goes for upper GI bleeding. MedPage Today discusses a recent study showing that “patients with nonvariceal upper gastrointestinal hemorrhage had a 22% increased mortality risk on weekends, and those with peptic ulcer-related hemorrhage had an 8% higher risk.”

Staffing issues, leading to delayed endoscopies, appear to be chief culprit. Minutes count in cases of GI bleeding, so the delay is a likely explanation for the higher mortality rates.

Especially in community hospitals, doctors often cover for one another, and in general, there are less physicians available. Short of having more doctors on call, a prospect that faces long odds as hospitals are loathe to pay specialists for additional call, I’m not sure what can be done to rectify this statistic.

One suggestion is to have so-called “bleed teams,” where staff can be quickly mobilized to respond solely to acute GI bleeds. But again, this likely would require more staff, and it’s dubious that hospitals are willing to bear the additional cost.

**This post was originally published at KevinMD.com**

A Patient Outwits His Doctor

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One of our patients came off sedation and was extubated.

A few hours later, the doctor came by to assess the patient’s mental status.  He asked,

“How old are you, Mr. Smith?”

The patient replied, “I was born in 1924.”

It wasn’t really the answer the doc was looking for, so he asked again,

“But how old are you?”

And the patient looked up at the doctor and said,

You do the math.”

**This post originally appeared at Gina Rybolt’s CodeBlog.**

What If Other Parts Of Life Were Like Healthcare?

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robert-lambertsHealthcare is bizarre.  Anyone who spends significant time in its ranks will attest to the many quirky and downright ludicrous things that go on all the time.  But I am not sure people realize just how strange our system is.  Perhaps it would be interesting to see what it would be like if other parts of our lives were like healthcare.

1.  Get up in the Morning

The first thing that happens in your day is that your alarm fails to go off.  Although you have major things happening, nobody ever has explained to you exactly what you are supposed to do and when.  You watch the morning TV show and it seems that some experts say you should go to school while others say you should avoid school at all cost.  You call a friend who says that she knows someone who went to school and it destroyed their liver.  Another friend goes to school every day and is just fine.

Confused, you turn to the Internet and go to a website that explains that you should base your schedule on the pattern of tea leaves in a cup.  This site claims that your normal schedule is actually fraught with secret appointments that will, unbeknown to you, make you have cancer.  It states that those people in power are making you go through this dangerous schedule so they can make money off of you.  They don’t care for you like the people who made this webpage (and for $400 you can have 6-months of magic tea leaves).

Finally, you decide that you are going to go with the majority opinion and go to school.

2.  School

You go to your bus stop and wait.  You keep waiting.  You know that the bus was supposed to come at 8 AM, but after an hour you begin to wonder if you missed it.  Calling the bus service, you find out that the bus got caught up doing some extra routes.  There is a shortage of buses, and so the ones that remain have to do twice as many routes as is feasible.  After a two hour wait, the bus finally arrives to take you to school.

The first teacher comes into the classroom and looks very distracted.  She teaches general studies and is staring at a curriculum that contains a huge amount of subjects.  As she is doing her lessons, she furiously takes notes on her own teaching so that she can submit documentation to the school board and prove that she taught you.  This is the only way she gets paid.

In total, she teaches for about 15 minutes and documents her teaching for 45 minutes.  You want to ask questions, but the bell rings and you have to move on to your next class before any can be answered.

The next teacher only teaches a small specialized subject.  This teacher is paid four times more than the first teacher.  Instead of teaching and answering questions, however, he is constantly making you take tests.  Apparently, the school system pays a huge amount for making you take tests, but very little for teaching lessons that would make you do well on those tests in the first place.

School is finally over, but you don’t feel like you got much out of it (except for taking a lot of tests and getting more confused).  You decide that a trip to the store would perhaps make you feel better.

3.  The Grocery Store

Upon entering the grocery store, you notice something odd.  There are very few different brands of items stocked on the shelves.  Your choice is limited to only the brands that have struck the best deal with the grocery chain.  These brands have to send the grocery store a large “rebate” check because they are carried exclusively in this store.

When you go to the meat counter and ask for some steak, the butcher asks you if you have first tried the ground beef.  You may not purchase steak unless you have first tried and disliked the ground beef.  The ground beef, of course, is actually ground turkey, but the butcher says that these two are basically interchangeable and so the substitution is permitted.

The grocer can’t post prices because all customers have different negotiated prices.  Posting prices, in fact, would be considered collusion since other grocers could find out exactly what this grocer is charging.  Some congressman in California decided that grocers are all crooks and should not be allowed to share what they charge for things.

You go to the cash register to pay.  The total is $380, but the cashier informs you that your negotiated price is only $150.  A poor person behind you has not had the chance to negotiate a price and so must pay full price for everything.

There are a few people in the store who don’t have to pay anything.  They have had the price negotiated for them by the government, and so will come to the store very often.  They sometimes come for real food, but are often coming for candy and cigarettes – all paid for by the government.

This experience leaves you more tired and confused, and so you decide to go home.

4.  Home

Coming home, you notice that your house is under construction.  There is a new wing being built that contains all sorts of the newest and fanciest gadgets, such as flat-screen TV’s, the fastest computers, and wonderful new kitchen appliances.  Going into the house, you notice that there is no running water or heat.  Apparently, there are all sorts of grants and low-interest loans to pay for the fancy gadgets, and so contractors find it much more profitable to do that instead of fixing water or heating.

Your mother is in the kitchen trying to make dinner, but instead of cooking she is staring into a cookbook and at the ingredients you brought from the grocery store.  You assume she can make due with what you brought, but she just sighs helplessly.  Despite the fact that your mother is incredible at improvising meals, she is required to follow a cookbook that doesn’t fit the ingredients that are available.  This makes dinner taste pretty bad.  Your mother, obviously angry about this, gives you a weak smile and tells you to finish what is on your plate.

After dinner, you settle down to watch some television.  As you are finally starting to relax, a knock on the front door breaks your peace.  At the front door stands a police officer.  ”You are only authorized to be in the house for two hours today, so I am going to have to ask you to leave.”

You try to explain that two hours is not enough to get the rest you need, but the officer threatens a stiff fine and forces you to leave.  Before you can get your necessary things, you are forced to leave – without an explanation of how you are supposed to survive on the streets.

(to be continued)

**This blog post originally appeared at Dr. Rob Lamberts’ blog, Musings of a Distractible Mind.**

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