Archive for the ‘risk’ Category

We are constantly bombarded with alarming announcements about heart attack risks.  Many hundreds of billions of dollars are spent annually in multiple ways  trying to avoid dying from a heart attack.

It is a bit shocking to actually see what the 10 year heart attack mortality risk looks like.  I don’t know what your reaction will be but my was, “Huh, wow, that’s not such a big deal.  Maybe I should just relax, live as healthily as possible and ignore all the medical screaming and shouting.

I have used the data table found on page 128 in the very readable, and useful book Know Your Chances by Woloshin, Schwartz and Welch.

About the illustration-

There are 100 women icons. The darker icons represent the number of 65 yr old nonsmoking women who will die of heart attack before they become 75 yrs old. (2.5 women in this group will die of heart attack in the next 10 yrs.)

Now let’s do the same sort of chart for a 100 women who smoke.  In this case, the data claims that 4.5 of these 65 yr old smokers will die of heart attack before the age of 75.

By the way, if you want to create a graphic of this nature, you can find the tool to do so at  http://understandinguncertainty.org/visualfraction

We are constantly bombarded with alarming announcements about heart attack risks.  Many hundreds of billions of dollars are spent annually in multiple ways  trying to avoid dying from a heart attack.

It is a bit shocking to actually see what the 10 year heart attack mortality risk looks like.  I don’t know what your reaction will be but my was, “Huh, wow, that’s not such a big deal.  Maybe I should just relax, live as healthily as possible and ignore all the medical screaming and shouting.

I have used the data table found on page 128 in the very readable, and useful book Know Your Chances by Woloshin, Schwartz and Welch.

About the illustration-

There are 100 men icons. The darker icons represent the number of 65 yr old nonsmoking men who will die of heart attack before they become 75 yrs old. (5.2  of this group will die of heart attack in the next 10 yrs.)

 

Now let’s do the same sort of chart for a 100 men who smoke.  In this case, the data claims that 7.4 of these 65 yr old smokers will die of heart attack before the age of 75.

Here is a link to a pdf which has downloadable risk charts:  Health Risks by Age, Sex and Smoking Status

In a complex system like a hospital where there are multiple players and a staggering variety of technologies all mixed up together, it is frequently the simple things that lead to big problems. Tubes are used for many purposes and tend to all look alike.

The excerpt below are from an article about medical tubing and injuries, it is from the New York Times written by Gardiner Harris

…Their deaths were among hundreds of deaths or serious injuries that researchers have traced to tube mix-ups. But no one knows the real toll, because this kind of mistake, like medication errors in general, is rarely reported. A 2006 survey of hospitals found that 16 percent had experienced a feeding tube mix-up.Experts and standards groups have advocated since 1996 that tubes for different functions be made incompatible — just as different nozzles at gas stations prevent drivers from using the wrong fuel.

But action has been delayed by resistance from the medical-device industry and an approval process at the Food and Drug Administration that can discourage safety-related changes.

Hospitals, tube manufacturers, regulators and standards groups all point fingers at one another to explain the delay.

Hospitalized patients often have an array of clear plastic tubing sticking out of their bodies to deliver or extract medicine, nutrition, fluids, gases or blood to veins, arteries, stomachs, skin, lungs or bladders.

Much of the tubing is interchangeable, and with nurses connecting and disconnecting dozens each day, mix-ups happen — sometimes with deadly consequences…

much more via US Inaction Lets Look-Alike Tubes Kill Patients

Here is a second link on this topic which explores a possible solution to the tube problem based on a strategy developed at Toyota Motors:

from the Postscript blog:  ….make medical tubing error-proof

The question is how can a physician perform 500 unnecessary stent operations in a hospital and nobody notices?

btw, in the excerpt the term “rainmaker” is used, a “rainmaker” in this case is a physician who earns huge profits for his organization.

The tale is told by Bob Wachter M.D. on his blog Wachter’s World

excerpts below are from from Wachter’s World

A couple of months ago, a Baltimore reporter called to get my take on a scandal at St. Joseph’s Hospital in Towson, an upscale suburb. A rainmaker cardiologist there, Dr. Mark Midei, had been accused of placing more than 500 stents in patients who didn’t need them, justifying the procedures by purposely misreading cath films. In several of the cases, Midei allegedly read a 90 percent coronary stenosis when the actual blockage was trivial – more like 10 percent.

Disgusting, I thought… if the reports are true, they should lock this guy in jail and throw away the key. After all, the victims now have permanent foreign bodies in their vascular beds, and both the stent and the accompanying blood thinners confer a substantial lifetime risk of morbidity and mortality. As I felt my own blood beginning to boil, the reporter asked a question that threw me back on my heels.

“Why didn’t peer review catch this?” he asked.Cypher stent

Hospital peer review is getting better, partly driven by more aggressive accreditation standards for medical staff privileging. In my role as chief of the medical service atUCSF Medical Center, I’m now expected to monitor a series of signals looking for problem doctors: low procedural volumes, unusual numbers of complications, and frequent patient complaints, unexpected deaths, and malpractice suits. When a flashing red light goes off, my next step is to commission a focused review of the physician’s practice. The process remains far from perfect, but it is an improvement over the traditional system, in which docs tapped a couple of their golfing buddies to vouch for their competence.

But cases like Dr. Midei’s don’t trip any alarms. Most of his patients were probably quite content – many had chest pain and a stent undoubtedly seemed like an appropriately aggressive, high-tech cure. “He put two stents in almost immediately,”said one grateful patient. “I felt relief.”…

…The problem is this: as long as the cardiologist reading the cath is the one who pulls the trigger on the intervention, we have a potential Fox/Henhouse problem…

…cardiologists don’t perform caths on desert islands – they are assisted by cath techs and nurses. In my experience, these folks become as adept at reading cath films as any physician. If the allegations against Midei are true, it strains credibility to think that no one in the lab knew that inconsequential lesions were being read as tight stenoses and treated with stents…

…While it is possible that no St. Joe’s leader knew precisely what was happening, I’m guessing that some did but chose to look the other way: the pressure to steer clear of the golden-egg-laying goose must have been intense. Perhaps the fact that the hospital’s CEO and two other senior executives resigned after the case broke provides a clue as to who knew what when….

much much more at Can Peer Review Catch Rogue Doctors?

I encourage you to click the link, read the whole story and the comments. In addition, you can find more pertinent comments associated with this story at The Health Care Blog

Some medical procedures are to be recommended and unavoidable when the health risks of not undergoing an operation or therapy are serious. Here is an article that goes into the details of surgical risks in an open manner.

the passages below are from Laura Landro of the Wall Street Journal:


…More than 30 million operations are performed in the U.S. annually to remove deadly cancers, repair diseased organs and replace worn-out joints. Yet going under the knife can be risky, leading to serious infections, blood clots, heart attacks and pneumonia. Those risks increase with age and for patients who are obese, smoke, abuse alcohol or have medical conditions such as diabetes and hypertension.

The nonprofit Institute for Healthcare Improvement, which works with hospitals to improve the quality of care, estimates that 2.5 million to 3.5 million surgical patients each year experience unintended harm resulting from or contributed to by surgical care. While some complications are unavoidable, surgical teams often make mistakes, such as leaving a surgical sponge in a patient, or fail to take steps known to prevent complications, such as delivering antibiotics to a patient within one hour before beginning surgery, which can dramatically cut infection rates.

Complications are also costly. The Centers for Disease Control and Prevention estimates that there are more than 290,000 surgical-site infections each year, and the cost to treat them ranges from about $12,000 to nearly $35,000 per patient—or as much as $10 billion annually…

much more at Calculating the Risks of Surgery

here is a link to the Euroscore patients’ calculator which will allow you to imput personal information and calculate your risks if you were to undergo cardiac surgery:

http://euroscore.org/patienteuroscore2logistic.html

New analyses are showing that Avandia, the diabetes drug, has been implicated in a large number of heart attacks, strokes and deaths. It is still on the market years after serious questions were raised. In mid-July the FDA will have a meeting to decide whether to let it remain available.

If Avandia were spinach, peanut butter or meat, the FDA would have been recalled it years ago. But being a drug it is subject to a much more lax recall standard.

here are some story excerpts from NPR

..The study looks at what happened when nearly 230,000 Medicare recipients took either Avandia or a related drug, Actos. Dr. David Graham of the FDA, the study’s lead author, says the results were alarming.

“If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death,” Graham says, “compared to if you had treated 60 patients with Actos.”

That’s a substantial difference. Graham says it means nearly 50,000 elderly Americans have died or had heart attacks, strokes or heart failure due to Avandia since the drug came on the market in 1999. Add in those under the age of 65, the number is probably 100,000, Graham says…

..Avandia still brings in more than $1 billion a year for Glaxo in worldwide sales, about a half in the United States…

..Graham, the FDA’s most vocal inside critic, says the way the agency has handled Avandia shows it has failed to learn the lessons of the painkiller Vioxx, whose maker pulled it from the market in 2004 after studies indicated it raised the risk of heart attacks.

What Vioxx and Avandia represent, Graham says, “is a failure of FDA decision-making -– a failure to place patient safety first, ahead of corporate profits.”…

much more at Diabetes Drug Poses Safety Test for FDA

here is a link to the New York Times Story

for those of you who like the technical details here is a link to the Graham Avandia study in JAMA

This series by Forbes is well worth a look to get a quick rerun of spectacular medical disasters that have occurred  since the turn of the century.

In Pictures: Medical Flops Of The Decade

 

Medical Flops Of The Decade from Forbes

Drug and medical device companies have slowly chipped away at diseases like cancer and heart disease with treatments that can extend lives and help patients feel better. But medical progress is a bumpy road, and Murphy’s Law applies. The number of new medicines introduced each year, for instance, has been constant for decades, despite vast increases in research spending. Many medicines and devices that initially seem promising turn out to be dangerous to use, or far less effective than hoped. Here’s a look at some hyped products that never made it to the market, proved to be commercial flops or were recalled due to safety problems.

much more via In Pictures: Medical Flops Of The Decade – Medical Flops Of The Decade – Forbes.com.

here is the link to the accompanying article via Forbes.com

 

This links to a long article on the history of leaded gasoline in America published in 2000. It may seem off topic but I deem it relevant because it incorporates many of the elements that are damaging health care now: industry sponsored scientific research, patent protections which skew choices, political pressure, support by the major health institutions/associations and cooperation by mass media. As usual, the objectors were ignored or ridiculed.

Well, the good news is that after 50 years leaded gasoline was outlawed in the US. It is still being used around the world though.

As a bonus, you will learn about the uses of ethanol back in the early 1900’s.

The article is a good read and will provide you with a crash course on how science and technology are perverted for commercial purposes.

this is from The Nation Magazine
written by Jamie Lincoln Kitman

…Lead was outlawed as an automotive gasoline additive in this country in 1986–more than sixty years after its introduction–to enable the use of emissions-reducing catalytic converters in cars (which are contaminated and rendered useless by lead) and to address the myriad health and safety concerns that have shadowed the toxic additive from its first, tentative appearance on US roads in the twenties, through a period of international ubiquity only recently ending. Since the virtual disappearance of leaded gas in the United States (it’s still sold for use in propeller airplanes), the mean blood-lead level of the American population has declined more than 75 percent. A 1985 EPA study estimated that as many as 5,000 Americans died annually from lead-related heart disease prior to the country’s lead phaseout. According to a 1988 report to Congress on childhood lead poisoning in America by the government’s Agency for Toxic Substances and Disease Registry, one can estimate that the blood-lead levels of up to 2 million children were reduced every year to below toxic levels between 1970 and 1987 as leaded gasoline use was reduced. From that report and elsewhere, one can conservatively estimate that a total of about 68 million young children had toxic exposures to lead from gasoline from 1927 to 1987.

How did lead get into gasoline in the first place? And why is leaded gas still being sold in the Third World, Eastern Europe and elsewhere? Recently uncovered documents from the archives of the aforementioned industrial behemoths and the US government, a new skein of academic research and a careful reading of that long-ago period’s historical record, as well as dozens of interviews conducted by The Nation, tell the true story of leaded gasoline, a sad and sordid commercial venture that would tiptoe its way quietly into the black hole of history if the captains of industry were to have their way. But the story must be recounted now. The leaded gas adventurers have profitably polluted the world on a grand scale and, in the process, have provided a model for the asbestos, tobacco, pesticide and nuclear power industries, and other twentieth-century corporate bad actors, for evading clear evidence that their products are harmful by hiding behind the mantle of scientific uncertainty.

This is not just a textbook example of unnecessary environmental degradation, however. Nor is this history important solely as a cautionary retort to those who would doubt the need for aggressive regulation of industry, when commercial interests ask us to sanction genetically modified food on the basis of their own scientific assurances, just as the merchants of lead once did. The leaded gasoline story must also be read as a call to action, for the lead menace lives….

much much more at The Nation

here is a 1924 article in Time Magazine 

In the search for causes of autism, there is some support for the idea that infertility treatments are perhaps  one of the causes.  In this article printed in Time, several recent studies on the subject are discussed.  

These studies are not conclusive but they do suggest that further investigation is needed.  The researcher that headed up the Harvard study, Kristen Lyall states that in women over 35, that the incidence of autism is increased from 2% to 4% and less in younger women.  

To me, an autism increase from 2% to 4% is huge.

from Studies Link Infertility Treatments to Autism – TIME

 …A study presented Wednesday at the International Meeting for Autism Research in Philadelphia provides some of strongest evidence to date that Landes might be onto something. The study, conducted by a team at the Harvard School of Public Health, found that autism was nearly twice as common among the children of women who were treated with the ovulation-inducing drug Clomid and other similar drugs than women who did not suffer from infertility, and the link persisted even after researchers accounted for the women’s age.

Moreover, the association between fertility drugs and autism appeared to strengthen with exposure: the longer women reported being treated for infertility, the higher the chances their child had an autism spectrum disorder (ASD).

A second paper presented at the conference by an Israeli team found an association between autism risk and in vitro fertilization, which also involves the use of drugs that stimulate ovulation. Taken together, the studies add to a growing body of evidence that a history of infertility and treatment for infertility could play a role in causing autism. However, the papers raise more questions than they answer…

via Studies Link Infertility Treatments to Autism – TIME.

Here is a short article that discusses the topic of absolute risks focusing on the now withdrawn drug, Vioxx.  

My own highly speculative opinion is that Merck withdrew Vioxx rather than heavily publicize the absolute risk numbers because it understood that if  the public became aware of the importance of absolute risk and benefit statistics it would ultimately hurt profits more.

Why? Well, because stated in terms of absolute benefit, very few drugs are worth the cost and the bother.

Please read this carefully as even in professional circles the concepts of absolute vs relative risk and benefit statistics not understood well.

from Cardiobrief:

Posted on May 7, 2010 by Larry Husten

There’s a fascinating discussion about Vioxx echoing around the blogosphere. (William Heisel has a nice summary here.) A few weeks ago Catherine DeAngelis, the editor of JAMA, spoke at the recent meeting of the Association of Health Care Journalists and said:

I believe Vioxx should not have been taken off the market. At least a million people, if told the truth about its side effects, would accept it because their lives could be lived with a lot less pain. There are a lot of people now whose lives are miserable because they have to live with arthritic pain.

At the same meeting, the editor of Reuters Health, Ivan Oransky, was critical of the way the Vioxx issue was reported by many journalists: “There was a doubling of heart attack risk, but the doubling was from a 1% risk to a 2% risk. If you lay that all out to readers, they can make much better decisions.”

I think DeAngelis and Oransky make valid points, but I think they miss a much more important point.

DeAngelis of course is right: there are probably a million people who even now would be willing to make the calculated risk and take Vioxx. The problem is that not only were those 1 million people never told about the risk, there were another 19 million people taking the drug as a first line analgesic who were extremely unlikely to derive any unique benefit from the drug and who never should have been started on the drug in the first place. In a carefully selected patient population the risk to benefit equation yields very different results than in an indiscriminate population 20 times the size.

Let’s assume Oransky’s and DeAngelis’s numbers are true. (It’s the general concept, not the actual numbers, that are important here.) If a million patients took Vioxx then the number of heart attacks doubled from 10,000 to 20,000. That seems like a lot, but if all these people were deriving significant pain relief from Vioxx, after having failed previous agents, then perhaps the excess risk could be deemed worthwhile.

But if 20 million people were taking Vioxx then the number of heart attacks jumps from 200,000 to 400,000, although only 1 million people are likely to derive any benefit from the drug. Suddenly the small increase in absolute risk is pretty frightening…

find the rest via Vioxx, Avandia, Vytorin: absolute risk versus relative risk « CardioBrief.

here is a link to William Heisel’s most recent post on this subject