Kevin, M.D. - Medical Weblog

Physician-patient interaction

Interesting article from the NY Times investigating communication between physicians and patients. Here are some excerpts:

. . . Two decades ago, in 1984, researchers showed that on average, patients were interrupted 18 seconds into explaining their problems. Fewer than 2 percent got to finish their explanations.

. . . Research shows that only 15 percent of patients fully understand what their doctors tell them, and that 50 percent leave their doctors' offices uncertain of what they are supposed to do to take care of themselves. Studies suggest that women are better at building relationships with their doctors than men. The typical number of questions a male patient asks during a 15-minute doctor's visit is zero, while women average six . . .

I have to say, I sometimes fall into the "interruption trap" myself. I think this is a natural progression to our managed care environment. Physicians are compensated by quantity of patients seen, and are kept to a strict schedule - in most cases every 15-mintues. Physicians who are late, get sued.

. . . Today, however, the rise of managed care has helped make doctor-patient communication a major issue that is drawing increasing interest from researchers. Researchers have linked poor communication to misdiagnoses, the ordering of unnecessary tests, and the failure of patients to follow treatment plans.

The reason for the excessive ordering of tests is because everything a physician does has to hold up in court. Objective findings - like an imaging study or blood test - are much more concrete than subjective findings - like patient history. Much easier to order a test, than to listen for 10 minutes and then ordering the same test anyways.

For a number of reasons, adapting school lessons to real-life medical encounters often fails.

I can think of several reasons - physician trainees are shielded from the lawsuits; shielded from time pressures; shielded from managed care; and, most importantly, shielded from reality.

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US medicine in the Middle-East

Harvard Medical School is planning a medical campus in the United Arab Emirates. Some interesting points:

. . . there are enormous hurdles to fostering US-style health care in a region where medicine is so spotty that the 100 million Persian Gulf residents spend $25 billion a year getting treatment elsewhere, according to Dubai Healthcare City officials. Many medical school students enroll straight out of high school and receive little training to keep up with advances after they finish.

. . . By the late 1990s, the World Health Organization had identified diabetes as an epidemic that threatened to bankrupt governments in the Middle East if they did not take action. Doctors believe that genetic factors, such as traditional intermarriage of cousins, and lifestyle issues, such as their increasingly Westernized diet and limited exercise because of the heat, put Arabs at heightened risk for the disease.

. . . Arab interest in importing American medicine comes at an opportune time for medical schools and hospitals that have been battered by the limits on income as a result of managed care and a leveling off of private donations. . . the center eventually will bring in $4 million to $5 million a year in revenue.

Could exporting health care be a trend? Certainly everyone seems to benefit - foreign countries getting a taste of US-style healthcare, and US institutions finding an additional source of revenue.

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Behind the scenes at a Canadian mail-order pharmacy

Here is a nice article from the Boston Globe that investigates some of the issues of importing medications from Canada.

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Slow start for medicare cards

As a follow-up to what I wrote last week, it seems like the new Medicare cards are slow to take off. And why not? On one hand, you have a dizzying, confusing array of Medicare cards - on the other, you have Canada, which gives you better savings. The choice seems pretty clear. It confounds me how the government can so poorly implement a simple concept.

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Speaking english a disease?

Here's a nice joke from the BMJ:

For those of you who watch what you eat and drink, and worry about heart disease, here is the truth—according to a joke currently doing the rounds. The Japanese eat very little fat, while people in Mexico eat lots. Both groups suffer fewer heart attacks than the British or Americans. Africans drink very little red wine, while the Italians drink large volumes of the stuff—but both these groups too have fewer heart attacks. An epidemiological conclusion might be that you should eat and drink what you like: speaking English seems to be what kills you.

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Ignoring the evidence

In the article, Why do doctors use treatments that do not work?, several interesting points were made. It is making a case that we need to continually rely on the evidence, and less on empiricism. This is why it is so frustrating when I hear stories where EBM is tossed around like a "dirty word" and when physicians are making treatment decisions that are evidence-bereft.

. . . most drugs work in only 30% or 50% of people. Because patients so often get better or worse on their own, no matter what we do, clinical experience is a poor judge of what does and does not work. Hence the need for adequately powered randomised controlled trials.

. . . Even when empiricism is satisfied we can be misled by looking at the wrong outcome. Fluoride increases bone density. But it also increases the fracture rate. Flecainide for the treatment of supraventricular tachycardia makes the electrocardiogram look normal, but only after clinical trials (that some thought unethical) did it emerge that it increases mortality.

. . . Much of the clinical examination and diagnostic testing is more of a ritual than diagnostically useful. We continue to order routine blood tests before surgery without controlled trials to show benefit, and several case series that show that these tests rarely change outcomes or even management.

So, despite the examples above, why do physicians continue ignore the evidence? The following sums it up:

. . . Perhaps it is societal opinion (for which one ear of the medical profession is always pricked) that errors of omission are more reprehensible than errors of commission that is at fault. Is missing a rare diagnosis so much worse than harm from over-testing?

Let me address that last question - in our society, the answer is yes. Physicians are punished for missing the rare diagnosis, and never for over-testing. And until this changes, empiricism will trump the evidence more often than not.

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Paxil and irritable bowel syndrome

IBS is one of the more frustrating diseases to treat. Increased fiber intake, antispasmodic agents, and Zelnorm (for constipation predominant disease) are among the treament choices. However, in many cases, these treatments aren't enough and many patients unfortunately remain symptommatic. In the GI forum that I moderate, there are many who report refractory IBS symptoms.

Today comes a study from the American Journal of Gastroenterology that examines the effect of Paxil on IBS:

OBJECTIVES: The purpose of the trial was to determine whether a high-fiber diet (HFD) alone or in combination with paroxetine or placebo was effective treatment for patients with irritable bowel syndrome (IBS).

METHODS: Design: Trial of HFD alone (Group 1) followed by a randomized, double-blind trial of HFD with paroxetine or placebo (Group 2). Setting: Gastroenterology office in a 524-bed university-affiliated community hospital in Pittsburgh. Patients: Men and women, aged 18–65 yr, previously diagnosed with IBS but otherwise healthy. Intervention: Institution of HFD in 98 participants consuming low- or average-fiber diets. Allocation of paroxetine to 38 and placebo to 43 symptomatic participants consuming HFDs. Measurements: Overall well-being, abdominal pain, and abdominal bloating (Groups 1 and 2); food avoidance, work functioning, and social functioning (Group 2).

RESULTS: In Group 1, overall well-being improved in 26% patients, and abdominal pain and bloating decreased in 22% and 26% patients, respectively, with an HFD. In Group 2, overall well-being improved more with paroxetine than with placebo (63.3%vs 26.3%; p= 0.01), but abdominal pain, bloating, and social functioning did not. With paroxetine, food avoidance decreased (p= 0.03) and work functioning was marginally better (p= 0.08). Before unblinding, more paroxetine recipients than placebo recipients wanted to continue their study medication (84%vs 37%; p < 0.001).

CONCLUSIONS: The difference in overall well-being found in our paroxetine/placebo trial is greater than that found in previously published drug/placebo trials for IBS. Moreover, the difference in well-being applied to nondepressed recipients of paroxetine.

If we can add to our treatment options for IBS, this can only be encouraging. I'll probably try this with some of my more refractory patients.

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A slice on rising health costs

We all know that one reason for rising health costs is that newer technologies are more expensive. For one small example, consider the evolution from sigmoidoscopies to colonoscopies. The medical director Patient Care writes that sigmoidoscopies have virtually ceased once colonoscopies became a covered benefit under both Medicare and private insurance. Consider the charge for a sigmoidoscopy is several hundred dollars compared to over $3000 for a colonoscopy. Thus, the cost of screening for 100 patients increased from $20,000 to $300,000. Even taking into account that sigmoidoscopies should be performed more frequently (3-5 years compared to 10 years), this is a signficant increase.

While these advances benefit patients, there is a cost: rising health insurance premiums, more expensive medications, decreased physician access, a growing number of uninsured. Can we afford to be advancing so fast?

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Inevitable

It was only a matter of time that this would happen.

AP:
A businessman has sued the promoters of the Atkins Diet, saying the low-carb, high-fat meal plan clogged his arteries and nearly killed him.

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Scutmonkey comics

I got a good laugh from Michelle Au's scutmonkey comics. Very funny, very true. I particularly like the 12 types of med students.

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More on prostate cancer screening

Medpundit and DB has chimed in on the mainstream coverage of the deficiencies of PSA screening for prostate cancer that was discussed here on Tuesday and Wednesday.

Medpundit writes:
Beware of organizations made up of hospitals and urologists who call for lower thresholds for treatment. They have much to gain from the increased number of biopsies such lower thresholds would produce. Unfortunately, it's far from clear that patients would benefit as well.

Completely agree. As I have stated before, there is no mortality data that PSA screening saves lives. Lowering the thresholds would simply increase the amount of unnecessary testing.

DB writes:
We can try to interpret the evidence, although that will not necessarily protect us from malpractice . . . We can just believe in the religion of PSA testing. We could biopsy all men (not me thank you very much).

It seems that this is what we're heading towards. What point is there doing a PSA if a "normal" result misses cancer anyways? In today's environment, physicians are going to be defensive and will lean towards empiric biopsies.

Bottom line - a better test is needed than a PSA. Before we know it, the prostate biopsy will become the defacto screening standard.

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Rifaximin for traveller's diarrhea

The FDA approved rifaximin, a non-absorbed antibiotic that remains within the body's gastrointestinal system, for traveller's diarrhea. This is in contrast to most other antibiotics which are spread throughout the body. Cipro or Bactrim are medications that are currently used.

A review article has suggested that this therapy may become the treatment of choice once routinely available.

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Apology after a medical error

We're always told that a sincere apology after a medical error reduces the risk of an impending lawsuit. Here is a story of that theory in practice.

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More on biospies and normal PSAs

The mainstream press has caught wind of the NEJM study that was discussed here yesterday. Here are some quotes from the article:

. . . "This study adds to information that perhaps the PSA threshold may be dropped to 2.5 or so," said Gomella, the Philadelphia urologist. "The number 4 may not be the, quote, normal that we look at anymore."

. . . Some doctors fear the study findings will lead to even more unnecessary operations in older patients who are more likely to die of other causes before the cancer kills them.

. . . "I have a sneaking suspicion that what's going to happen is that people are going to start ... being more aggressive with low PSAs," said Dr. Siu-Long Yao, a prostate cancer specialist at the Cancer Institute of New Jersey. "I don't think it's warranted at the present time, but I think people will act on it."

There is no sneaking suspicion on my part - I am sure that this will increase the amount of prostate biopsies which will no doubt lead to unncecessary procedures. As you can see, some have even advocated lowering the threshold for biopsy.

Again, the public does not want to hear about the data (or the lack thereof concerning the measurement of PSAs with a mortality benefit). After listening to this study, men will start pushing for biopsies despite normal PSAs. Remember, physicians get sued for not doing a test - I am not aware of someone being sued for doing too much testing (enlighten me if I am mistaken).

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Cash for prescribing drugs

In today's environment where drug companies are being monitored closely (take TAP's recent lawsuit in the Boston area for instance) for physician kickbacks for prescribing drugs, comes this story from Italy:

A two-year investigation by the financial brigade found that the Italian subsidiary of Glaxo had mounted an illegal incentives scheme involving 4,713 people, including 4,440 doctors.

Glaxo clearly wasn't subtle in their efforts to influence physicians:

. . . Freebies doled out to doctors across Italy included all-expenses-paid travel, cash or free pharmaceutical drugs, the police found.

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Prostate biopsies with a normal PSA

In the May 27th issue of the NEJM, a study was released that concluded that biopsy-detected prostate cancer was not rare among men with PSA levels of 4 or less. Prostate cancer was diagnosed in 15 percent of cases in the group with PSAs of less than 4, and of those cases, 15 percent were high grade.

This begs the question - should the threshold for biopsy be lowered? The accompanying editorial opines not and gives several reasons. The most compelling is that there is no convincing evidence that men who are treated when their cancers are detected at PSA levels below 4 have better outcomes than men who are treated when their PSA is higher than 4. In fact, there is no proof that PSA screening even saves lives.

Again, this brings us to the disconnect between EBM and the real world. You can bet that this study will increase the number of prostate biopsies, despite the absence of PSA mortality evidence. In light of this study, it probably would be easier to err on the side of the biopsy than to risk relying on EBM in court.

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Hiccups

Medpundit wrote about hiccups today. It reminded me about one of my patients who had protracted hiccups for 5 years - you could only imagine how frustrating this was. He was a 70-yo male who started having hiccups after surgery. Multiple medications were not successful: PPIs, H2 blockers, Thorazine, Reglan, Compazine, Neurontin and Dilantin were given without success. Endless GI and neurology consults were not revealing. There were some small studies using Baclofen for the control of hiccups - and this resulted in mild improvement. However, there continued to be breakthrough episodes. I also read some case reports using Amitriptyline to treat intractible hiccups. Currently, with a regimen of Amitriptyline 100mg at night and Baclofen 10mg 3x/day, it seems like they under adequate control so that the patient can resume a normal life.

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Medicare drug discount cards - still not enough

AMNews compared two Medicare discount cards with Drugstore.com and a Canadian mail-order pharmacy. As you can see, the discounts still aren't enough. There is also pretty wide variability between the two Medicare cards:

Medication / Card 1 / Card 2 / Drugstore.com / Canada

Celebrex $105.64 / $162.87 / $76.99 / $38.69
Lipitor $60.85 / $66.82 / $62.99 / $49.85
Nexium $109.39 / $262.87 / $120.99 / $64.73
Norvasc $39.32 / $44.75 / $42.99 / $39.43
Plavix $106.27 / $106.27 / $114.99 / $67.70
Prevacid $113.51 / $132.31 / $120.99 / $56.54
Protonix $89.52 / $112.26 / $98.89 / $56.54
Zocor $111.74 / $111.75 / $123.99 / $63.98

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Earlier treatment for osteopenia

From the Archives of Internal Medicine, comes a study that suggests that the majority (82 percent) of osteoporotic and hip fractures occured in women with T-scores greater than 2.5 (i.e. at osteopenic, not osteoporotic levels). This suggests that treatment at an earlier stage (i.e. with T-scores between 1 and 2.5) may be considered.

Remember that the USPSTF recommends that women aged 65 and older be screened routinely for osteoporosis and that routine screening begin at age 60 for women at increased risk for osteoporotic fractures.

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Toxic neckties?

This story caught my eye - guess I'll think about dry-cleaning my ties from now on:

A small study of neckties worn by doctors at a Queens hospital found almost half the 42 ties tested harbored microorganisms that can cause illness.

Of the 42 physician neckties sampled, 20 contained one or more microorganisms known to cause disease, including 12 that carried Staphylococcus aureus, five a gram negative bacteria, one that carried aspergillus and two ties that carried multiple pathogens.

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Restless legs syndrome

A recent study concluded that "about one in 10 people suffer weekly from [restless legs] syndrome that causes leg discomfort and leads to sleeplessness, and few are properly diagnosed by their physicians." I've certainly diagnosed my fair share of this, but only after having a high enough index of suspicion. More information can be found on this patient information page.

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Support for the VA healthcare system

The VA hospital has always been special to me. My very first clinical rotation as a medical student was inpatient wards at the Jamaica Plain VA Hospital in Boston. Today, I still do occasional shifts in the VA emergency room, and see first hand the work and effort that is put in every day caring for our veterans, despite serious shortages in money and personnel. Today's Boston Globe published a story about this, and talks about the many achievements of the Boston VA Healthcare system, despite operating in today's difficult medical environment.

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E-patients and the new paradigm

Good stuff from the UK today - first the Lancet editorial on OTC statins and now this article form the BMJ.

Entitled The first generation of e-patients, the article comes up with these observations about the world of the e-patient:

. . . many clinicians have underestimated the benefits and overestimated the risks of online health resources for patients . . . Many e-patients say that the medical information and guidance they can find online is more complete and useful than what they receive from their clinicians.

. . . medical online support groups have become an important healthcare resource. These groups now provide emotional support, guidance, health information, and medical referrals for nearly all medical conditions—around the world, 24 hours a day and seven days a week, for free.

. . . When clinicians respond negatively to e-patients' requests to discuss materials they have found online and act as if they feel that their authority is being challenged by such requests, it may damage or disrupt the doctor patient relationship.

As many of you may (or may not) know, I spend a lot of time with online patient education, through my work at Med Help International as well as Google Answers. The American health care system is not conducive to patient empowerment nor education. Not when there is increasing pressure to see more patients every 15 minutes. Not when the focus is in avoiding lawsuits. Not when there is persistant pressure to watch what medications and tests you're ordering. Physicians get compensated by how many patients they see and how much revenue they generate - physicians who are not "productive" get fired. The patient does not come first in our system.

The e-patient is a natural evolution, and will be more prevalent as the internet-savvy generation ages. Instead of chastising patients for "self-diagnosing over the internet", we should encourage their wishes to be self-empowered and work with them to properly interpret the information. The e-patient is turning to the internet, because it is there where they come first.

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More on OTC statins

Graham from Gross Anatomy, agreed with previous assertions that the motive for OTC statins is all about the money. I continue to have mixed feelings about it, but still believe there are too many driving forces (i.e. drug company profits, insurance savings) to prevent it from happening in the US.

In the May 22nd issue of The Lancet, the editorial slams the recent UK OTC decision, and comes to the same conclusion:

In the absence of evidence of the overall mortality benefits of OTC simvastatin, it is difficult to avoid concluding that the motive behind the Government's decision is saving money. Statins are currently prescribed to about 1·8 million people in the UK, costing the NHS £700 million a year. With the NHS bill for statins predicted to be more than £2 billion a year by 2010, transferring costs to patients might seem timely. But privatising the prevention of heart disease will increase inequalities, with many unable to afford the likely £10-15 per month longterm. For the manufacturer, of course, the motive is clear. With simvastatin now off patent, creation of a new market (perhaps 8 million more people in the UK) will please shareholders.

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Evidence-based medicine up for trial . . . and loses

I came across this case from JAMA in January, 2004. Here are the basics:

1) A third-year resident, Dr. Merenstein, saw an educated 53-yo man for the first time at his resident clinic. A PSA level had never been done before.
2) A documented discussion about the risks and benefits of screening was done, and the patient was enouraged to consider the information. He was never seen by Dr. Merenstein again.
3) The patient was later seen by an older doctor who, disregarding current clinical guidelines, ordered a PSA without discussing the risks and benefits.
4) The PSA came back high and the patient was diagnosed with incurable advanced prostate cancer.
5) Dr. Merenstein and the residency program were later sued, with Dr. Merenstein being "exonerated" and the residency found liable for $1 million.

The physician's actions are supported by the USPSTF and the ACP's guidelines for prostate cancer screening.

Unfortunately, the concept of evidence-based guidelines did not stand up well in court:

. . . A major part of the plaintiff's case was that I did not practice the standard of care in the Commonwealth of Virginia. Four physicians testified that when they see male patients older than 50 years, they have no discussion with the patient about prostate cancer screening: they simply do the test . . .

. . . It is often claimed that malpractice is a mechanism for holding physicians accountable and improving the quality of care. This case illustrates quite the opposite: punishing the translation of evidence into practice, impeding improvements to care, and ensconcing practices that hurt patients. In our legal system, the physicians who are slow to change are the winners . . .

. . . During closing arguments the plaintiff's lawyer put evidence-based medicine on trial. He threw EBM around like a dirty word and named the residency and me as believers in EBM, and our experts as the founders of EBM. He defined EBM as a cost-saving method and stated his belief that the few lives saved were not worth the money. He urged the jury to return a verdict to teach residencies not to send any more residents on the street believing in EBM . . .

Think about that last statement for a moment. Do physicians tell lawyers how they should be trained? I find it disturbing that lawyers feel they are entitled to dictate how physicians are trained.

Dr. Merenstein sums up the moral of the story perfectly:

During that year before the trial, my patients became possible plaintiffs to me and I no longer discussed the risks and benefits of prostate cancer screening. I ordered more laboratory and radiological tests and simply referred more. My patients and I were the losers.

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Low-carb diets

The Annals of Internal Medicine reported a study comparing a low-carbohydrate, ketogenic diet program (i.e. Atkin's) with those of a low-fat, low-cholesterol, reduced-calorie diet.

The study concluded the following:
Compared with a low-fat diet, a low-carbohydrate diet program had better participant retention and greater weight loss. During active weight loss, serum triglyceride levels decreased more and high-density lipoprotein cholesterol level increased more with the low-carbohydrate diet than with the low-fat diet.

Here are comments from the accompanying editorial:
We can encourage overweight patients to experiment with various methods for weight control, including reduced-carbohydrate diets, as long as they emphasize healthy sources of fat and protein and incorporate regular physical activity.

So over 24-weeks, it seems that the low-carb diet is efficacious. Clearly, more studies examining the longer-term effects would be the next step to further legitimize the low-carb trend.

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Too nice a guy . . .

I've been recently beta-testing Google's upcoming (and free I might add) Gmail service and used my allotted invites to give my fiance and brother Gmail addresses. Little did I know what else I could have received for the invites, or how high the bids on eBay went for them.

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Fast food antibiotics

Packaging antibiotics in "paks" is nothing new and is only gaining popularity. Patients love it, and it's easy for physicians to write "***-pak, use as directed". Azithromycin has the popular 5-day formulation (Z-pak) and a 3-day formulation (Tri-pak).

Levaquin now has the 5-day Leva-pak (750mg x 5 days) - which has the potential for wide-spread (ab)use. This is especially troubling given the emerging Streptococcal resistance to quinolones, but that's another story.

I am now informed that a single-dose Azithromycin for respiratory infections is in the works. There are some studies that show equivalent efficacy, and I have no doubt that it's an inevitable trend in our instant-gratification, fast-food culture. As broader spectrum antibiotics become easier to take (why take 10 days of Amoxicillin, when you can take 1 dose of Azithromycin?), there can be no doubt that we're taking a step back in the fight against bacterial resistance.

"I'll have a Z-pak to go" - can we be far off?

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Now we have the mobile lawyer

From EMedConcepts, a physician took this picture of a "mobile lawyer van" parked outside the emergency room. When security chased the van away, it moved across the street where it stayed for the rest of the day. Unbelievable.

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Sodas and cancer risk

Just noticed this headline as I was drinking my diet soda. I'll have to see the actual study myself to come to any conclusion, but here are the salient points from Reuters:

A team at Tata Memorial Hospital in India found a strong correlation between the rise in per capita consumption of carbonated soft drinks in the past 50 years and a documented increase in rates of esophageal cancer in the United States.

The number of esophageal cancer cases clearly followed the rise in intake of carbonated soft drinks, the researchers found.

That could be coincidence, but they also found research that showed a possible biological basis for the effect. Carbonated soft drinks cause the stomach to distend, which in turn causes the gastric reflux associated with esophageal cancer.

The researchers found similar trends worldwide. Countries with per capita annual consumption of more than 20 gallons of fizzy soft drinks also had rising rates of esophageal cancer.

Clearly more study is needed, but now I'll think twice before I buy my daily diet soda for lunch.

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Warts and duct tape

Just saw a patient with warts on her hands and remembered there was a small study that was released comparing duct tape and cryotherapy. I quickly Googled it and here's the data:

In the study, researchers randomly assigned 51 patients, aged 3 and 22, to receive either a maximum of six cryotherapy treatments or two months of "duct tape therapy."

Duct tape therapy consisted of a nurse covering the wart with a piece of duct tape roughly the same size as the wart. Patients kept the tape on for six straight days.

Researchers found that 85 percent of those in the duct tape group, compared to 60 percent of those in the cryotherapy group "had complete resolution of their warts."

I ended up freezing them anyways, but then recommended duct tape to use at home. We'll see how it turns out in a few weeks. The abstract is found here.

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Comeback for laparoscopic colectomy

A laparoscopic approach to colon cancer was initially explored in the early 1990's, but then abandoned due to questions regarding the efficacy for achieving appropriate resection. A recent study from the NEJM, did a controlled trial which concluded similar rates of cancer recurrance between open and laparoscopic resection.

Here is an excerpt from the accompanying editorial:
Approximately 250,000 colonic resections are performed each year in the United States. Currently, the average general-surgery resident finishing a training program in the United States has performed fewer than one laparoscopic colon operation during training. Either our educational programs and teaching methods must be modified to take on the challenges to come, or an increased number of laparoscopic experts must be trained to perform colectomies. We suspect that both will happen. Although the frequency of open colon resection is unlikely to diminish to the degree that open cholecystectomy has, the number of laparoscopic colon resections will increase dramatically over the next decade. Many proponents suggest that 70 percent of small- and large-bowel operations can be performed with the use of minimally invasive techniques. The world of colorectal surgery will have to adapt.

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More on OTC Cholesterol Drugs

Associated Press:
Some of the world's biggest drug companies are working behind the scenes to convince regulators to let older cholesterol-lowering drugs be sold without a prescription in low doses, as Britain has just done.

While doctors say the drugs are safe, less than one-half of Americans who could benefit take them, mostly those at highest risk of heart disease, other complications and death, experts say. Most of the 18 million at moderate risk, defined as having a 10 percent to 20 percent risk of such problems over the next decade, are not on medication.

"What we're proposing with over the counter is, let's treat that 10 to 20 percent (group)," said Jerry B. Hansen, vice president of marketing for Johnson & Johnson-Merck Consumer Pharmaceuticals Company, a joint venture seeking FDA approval for a low-dose, nonprescription version of Merck's Mevacor, the first statin drug.

The added publicity also could drive more people at high risk to their doctors.

Hemant Shah, an independent pharmaceutical analyst with HKS & Co. in Warren, N.J., expects it would significantly expand statin use by people at mild to moderate risk without stealing sales from newer cholesterol drugs such as Lipitor, Zocor and AstraZeneca' Crestor, because they are much more powerful and will be used by higher-risk patients.

But Dr. Sidney Smith, past president of the American Heart Association, worries that some patients won't see a doctor regularly and address all their risk factors, including high blood pressure, smoking, diabetes, diet, exercise level and weight.

I still think it's inevitable that OTC status is coming. As DB stated in his blog, it's all about the money. Savings for insurance companies, continuing profit for the drug companies. With some reservations, I agree that OTC status will be beneficial to the public, encouraging those who should be on these medications to do so.

There will be many who believe that these medications would be a "quick fix" for lifestyle modification (i.e. those who pop a pill after a steak). Instead of wondering if it's going to happen, we should start focusing on educating the public on the changes that potential OTC cholesterol medications will have on their lives.

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Loopy fish

Loopy fish, who designed this website, has commented on his design of the Kevin, M.D. blog template as well as the usability of the recently improved Blogger. Check out his very interesting blog of eclectic interests.

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Osteoporosis and homocysteine

Today's NEJM released studies from the Netherlands and from the Framingham Study concluding that elevated homocysteine levels being a predictive risk factor for osteoporosis.

Here are comments from the accompanying editorial:
Whether it is a culprit or a bystander, homocysteine can now be added to the growing list of risk factors for fractures. Its use might increase the predictive power of an assessment based not just on bone mineral density, but on multiple risk factors. Such an assessment is sorely needed to provide realistic individualized estimates of the risk of fracture that can guide physicians and patients in planning prevention and treatment.

Homocysteine can be lowered by vitamin supplements such as folic acid, cobalamin (vitamin B12) and pyridoxine (vitamin B6). Discussion about whether these supplements should be added to the current spectrum of osteoporosis treatment would be the next step to consider.

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Zocor OTC in the United Kingdom

The UK is the first country to allow statins to be sold over-the-counter. It's inevitable that statins will be OTC in the United States when the US patent for Zocor expires in 2006. With the success of OTC Claritin and Prilosec, pushing medications to OTC status will allow drug companies to continue reaping profits after patent expiration.

Risks of elevated liver enzymes, muscle aches, as well as people self-diagnosing themselves with hypercholesterolemia needs to be weighed against the benefits of statins: namely the lowered risk of heart attack and stroke for people at risk.

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Echinacea doesn't work for colds

There has been conflicting data regarding the efficacy of Echinacea for the common cold. Another study came out suggesting it doesn't work:

After exposing 48 healthy adults to a virus that causes the common cold, U.S. investigators found that people who took Echinacea were no less likely to develop colds than people who took an inactive placebo pill.

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Here's a novel idea to "treat" viral infections

AMNews:
Cold kits stifle pleas for antibiotics

Minnesota physicians may have found a way to satisfy patients who hate to take no for an answer where antibiotics are concerned, researchers announced Feb. 29 at the International Conference on Emerging Infectious Diseases.

Patients with upper respiratory illnesses or acute bronchitis were provided boxes filled with over-the-counter pain relievers, decongestants, cough syrup and lozenges, powdered chicken soup and a teabag when their physicians believed an antibiotic would be of no help.

Researchers who examined whether the kits were effective found that patients who visited clinics where the kits were distributed were significantly less likely to fill a prescription for antibiotics within three days of their visit.

"In addition to the study data, we have had a lot of anecdotal feedback from physicians that it was a great idea to have something to give patients when you know they don't need antibiotics," said Pamala Gahr, MPH, a Minnesota Health Dept. epidemiologist and a researcher on the study.

Physicians in six health plans distributed approximately 31,000 kits during the 2000-2001 winter season. The kits were part of the Minnesota Antibiotic Resistance Collaborative's public education campaign, "Get Smart: Know When Antibiotics Work," which was mounted in conjunction with the Centers for Disease Control and Prevention.

This is a nice idea to stem to tide of unnecessary antibiotic use. I think with the rising co-pays (ranging between $15-25 in my area), patients are going to start expecting more from physician visits. This is one way to enhance the value of the visit.

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Physicians provide more than $5 billion in uncompensated care

The ACP released a paper today focusing on uncompensated care for the uninsured. This paper coincides with Cover the Uninsured Week taking place from May 10-16:
In 2001, for instance, the American health care system provided close to $99 billion in care to uninsured patients, $35 billion of which was uncompensated.

Hospitals provided $24 billion of that care while physicians volunteered about $5.1 billion in uncompensated care, including donated time.

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D-Dimer in pulmonary embolus diagnosis

I recently saw a case of a young lady for shortness of breath. No other medical issues, only medication was oral contraceptives. No family history of blood clots. Chest X-ray clear, no desaturations on room air. My pre-test probability for pulmonary embolus was quite low, however she was concerned and asked to be "checked for a blood clot". With such a low index of suspicion, I did not think it warranted a CT-PA or a V/Q scan (which would have required an ER visit since it was after-hours), and was wondering what the current data was on the efficacy of a simple D-Dimer test.

Conveniently, a recent Annals of Interal Medicine article did a systematic review on this, suggesting that: "For excluding PE or DVT, a negative result on quantitative rapid [D-dimer] ELISA is as diagnostically useful as a normal lung scan or negative duplex ultrasonography finding."

So, she was sent to our local hospital, received a negative D-Dimer test in 15 minutes, with both of us being reassured of a very low likelihood of a clot.

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Herbal viagra frauds

Reuters:
"Herbal" Viagra and other so-called natural alternatives for treating impotence advertised on the Internet and in men's magazines are often contaminated with real drugs and could kill those who take them, researchers said on Monday.

"These are being marketed as being safe and natural products," said Dr. Neil Fleshner of Princess Margaret Hospital in Toronto, Canada. "It is plausible that deaths have occurred or could occur."

Like we needed studies to tell us this? Bottom line - stick to FDA-approved medications: Viagra, Levitra, and Cialis. Every other non-prescription option does not have consensus data supporting its safety or efficacy.

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A case for defensive medicine

AMNews:
A family sued their infant's pediatrician, an emergency department physician and an on-call pediatrician at the hospital for not ordering a CT scan. To the doctors, the 11-month-old boy appeared normal and in no need of the test.

But after the infant had more serious injuries resulting from an incident at his babysitter's home a couple of weeks later, the parents faulted the physicians for not ordering the CT scan they believe would have shown the boy was being abused.

The babysitter originally brought the baby, Jack, to his pediatrician's office around noon on Nov. 18, 1998. The infant's mother met the two there. The babysitter told the doctor that the infant hit his head on the floor.

The pediatrician didn't see any signs of injury -- no bleeding, no bruises. The boy appeared alert and neurologically normal. The infant didn't have a history that would lead the physician to suspect child abuse. The pediatrician sent the infant home with his mother, Robyn Sprague. He told her to keep an eye on the boy and call if there were any concerns.

When her husband John came home from work, he agreed with Robyn that the boy wasn't his usual energetic self. They phoned the pediatrician who saw Jack earlier in the day; he told them to take the infant to the emergency department.

The Spragues said they believed they were going to the hospital to get the CT scan because their pediatrician wanted it and because their infant was not behaving the way he normally did.

But, the three physicians told jurors there was no reason to order the scan because the infant showed no signs of trauma that would call for the test. According to the physicians' attorney, Jack's pediatrician said he would call ahead to let the emergency department know that the family would be arriving and that the infant may need a CT scan so the machine would be ready in the event it was needed. Jack's pediatrician could not order the CT scan; that would have to be done after the infant was seen by doctors in the ED, according to the physicians' attorney, A. Gwynn Bowie Jr.

The emergency physician examined Jack and then called the on-call pediatrician to examine the boy. Similar to the boy's pediatrician, neither of the doctors in the ED saw outward signs of injury, and neurologically the boy seemed healthy, Bowie said.

The emergency physician described the infant as playful, bright and engaging, and the pediatrician described him as alert and active, according to the physicians' attorney. An ED nurse also described Jack as playful and active.

The CT order that the emergency physician wrote after the infant arrived at the ED was canceled. The boy was discharged, and his parents were advised to follow up with their private pediatri