Thursday, February 25, 2010

The Cochrane Collaboration

When people talk about "evidenced based medicine".   They mean Cochrane.

Wednesday, February 24, 2010

Wiki Wiki

From the Wikipedia article on screening mammography.

Critique of screening mammography

The use of mammography as a screening tool for the detection of early breast cancer continues to be debated. Critics point out that a large number of women need to be screened to find cancer. Keen and Keen indicated that repeated mammography starting at age 50 saves about 1.8 lives over 15 years for every 1,000 women screened.[17] This result has to be seen against the negatives of errors in diagnosis, overtreatment, and radiation exposure. Countercritics argue that the benefit is greater. The Cochrane analysis of screening indicates that it is "not clear whether screening does more good than harm". According to their analysis one in 2,000 women will have her life prolonged by 10 years of screening, however, another 10 healthy women will undergo unnecessary breast cancer treatment.[18] Newman points out that screening mammography does not reduce death overall, but causes significant harm by inflicting cancer scare and unnecessary surgical interventions.[19] Finally, a significant recent article points out that a successful screening program should result in an increase in the number of early breast cancers, followed by a decrease in the number of late-stage cancers. However this is not happening with current mammography screening. [20]

Wednesday, February 17, 2010

The Declaration of Helsinki

Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies [3a]. The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties. The Declaration more specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code. A notable change from the Nuremberg Code was a relaxation of the conditions of consent, which was 'absolutely essential' under Nuremberg. Now doctors were asked to obtain consent 'if at all possible' and research was allowed without consent where a proxy consent, such as a legal guardian, was available (Article II.1).

Basic principles

The fundamental principle is respect for the individual (Article 8), their right to self determination and the right to make informed decisions (Articles 20, 21 and 22) regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient (Articles 2, 3 and 10) or volunteer (Articles 16, 18), and while there is always a need for research (Article 6), the subject's welfare must always take precedence over the interests of science and society (Article 5), and ethical considerations must always take precedence over laws and regulations (Article 9).

The right to informed decisions, AKA informed consent, is the ethical cornerstone of every bit of counseling clinicians provide. Tell me, do you think it was proper informed consent to leave out the prospect of the unnecessary diagnosis of breast cancer in the 30 years of screening mammogram counseling?

Tuesday, February 16, 2010

From the head of the CDC to Merck

Merck tapped Julie Gerberding, who was previously Centers for Disease Control director, to run its vaccines unit

Amazing that after overseeing the CDC which effectively controls which vaccines are given to each age group, the CDC which makes recommendations that almost all clinicians view as "evidence-based", the CDC that approved gardasil on her watch.

Now she's going to collect a salary from the corporation which benefited from the CDC recommendations?


The Air We Breathe      

ut oh the AFP changed it to pay per view!  Here's all I can find for free on the web from that article

Almost 160 million persons live in areas of the United States that exceed federal health-based air pollution standards. The two air pollutants that most commonly exceed standards are ozone and particulate matter. Ozone and particulate matter can harm anyone if levels are sufficiently elevated, but health risk from air pollution is greatest among vulnerable populations. Both ozone and particulate matter can cause pulmonary inflammation, decreased lung function, and exacerbation of asthma and chronic obstructive pulmonary disease. Particulate matter is also strongly associated with increased cardiovascular morbidity and mortality. Children, older adults, and other vulnerable persons may be sensitive to lower levels of air pollution. Persons who are aware of local air pollution levels, reported daily by the U.S. Environmental Protection Agency as the Air Quality Index, can take action to reduce exposure. These actions include simple measures to limit exertion and time spent outdoors when air pollution levels are highest, and to reduce the infiltration of outdoor air pollutants into indoor spaces.

So let me get this straight.  We have an identifiable risk factor strongly associated with cardiovascular mortality,  the leading cause of death in this land,  the air we breathe!  More than half of the population breathes air that raises their risk of dying of heart disease?  If there were a pill that somehow filtered the air we breathe,  you bet there'd be ads all over the US for that pill.  

Medicine used to be intimately tied to public health measures like sanitation, nutrition and pollution.  As a matter of fact the largest improvements in longevity and contagious disease control came not from vaccines or antibiotics but from sanitation measures.  But now the best medicine has to offer is "avoid breathing the air outside".  


Improvements in air quality have led to measurable improvements in life expectancy in the United States.

If that's true,  then why isn't getting heart attack causing particulate mater out of the air a priority of the medical establishment?  Here's an issue related to the number 1 cause of death in this country that 160 million people can relate to and the health care system doesn't lead the way partnering with those 160 million people in eliminating this preventable cause of death?

"But it's expensive eliminating pollution!"  

Yeah,  you know what else is expensive?  Heart attacks

Here's the local air pollution monitoring folks : 

Looks like we're a Yellow today,  guess we should all breathe shallow when outside....


Saturday, February 13, 2010

"What's Worse Than?"

What's worse than health care overhaul? No changes

Health care spending hit $2.5 trillion last year, growing faster as a share of the economy than at any time in a half century, yet with results that compare poorly with other advanced countries spending less. Government programs — mainly Medicare and Medicaid — will soon cover more than half the nation's health care tab, a staggering burden for federal and state budgets.

For those with private insurance, the recently announced double-digit premium increases for people purchasing their own coverage with Anthem in California could be a harbinger. Medical costs are rising in a weak economy, causing healthy people to drop coverage and raising costs for those left behind, with no limit in sight.

Now this is supposed to be the fear that pushes us to seek health care reform from DC.  And of course the legislation will "contain costs" right?

Both Democratic bills would begin experiments aimed at providing quality care at lower cost for Medicare recipients, particularly those with chronic conditions such as heart failure and diabetes. Copayments for preventive care would be eliminated. The House bill gradually would close the "doughnut hole" prescription coverage gap, now growing wider and deeper because of inflation.

Experiments at providing quality care at lower costs?  Actually,  they were starting this a couple years ago with Medicare.  Called it a pilot program or some such.  We had to check a box on every fee ticket stating whether we used an electronic prescription deal to prescribe medications.  Medicare was going to give us 1% extra or something like that for using electronic prescribing.  Well at the end of the year they decided they wouldn't.  IF the feds figured out something that was doing more harm than good,  what kind of uproar would there be if they cut reimbursement for that service?  So far Medicare has demonstrated zero ability to incentivize so called quality care.  How much extra would it cost to manage the data gathering and processing to figure out who is following the incentives?  

And what happens if the feds end up incentivizing medical practices that do more harm than good?  Medicare and several insurance companies have been proposing lists of "standards" and "benchmarks" for years for different chronic conditions.  Like if someone has diabetes,  if that patient has a A1C (a blood test monitoring how well blood sugar is controlled) below 9 then the doc's office gets paid more.  If the A1C is over 9,  the doc gets paid less.  The problem is a level of 9 isn't a goal with diabetes.  We want the level around or just under 7.  And a couple years ago we thought we wanted the level as low as possible ,  like closer to 6.  Of course then we learn that pushing sugars that low probably harms those folks who are on insulin by making their sugars dip too low off and on during the day and at night.  Medicare is very poorly equipped to deal with the rapidly changing targets in medicine.  Additionally,  when you pin physician reimbursement on how well a patient takes care of their diabetes you end up mucking up the whole relationship between doctor and patient.  If a patient chooses to not control their diabetes,  because say they can't afford their 100 dollar insulin this month or they were just diagnosed with terminal cancer and it's just not a priority,  well Medicare doesn't have a box to check marked "life is complicated, we're doing the best we can".

And look how barriers to preventive services are touted once again in this article.  Preventive services like screening mammography.  Did you know that the equipment used for screening mammograms has changed?  We're switching over to digital mammograms.  Which cost 3-4 times the cost of the older machines and films.  You can read about them indirectly here:

They harp on whether the extra cost is worth it but they don't address whether these more crisp, detailed images result in better outcomes.  The fact is with screening mammograms we did a great job picking out cancers that are benign.  Over the past 30 years we have been able to find a huge number of cancers,  most of which never needed to be found OR when found early didn't change whether individual was cured.  Now with more detailed images,  are we going to find even more benign cancers that we couldn't see previously?   Are we going to tell even more healthy women never destined to die from breast cancer that we saved their life with screening followed by surgery/radiation/chemo?   Are we just going to run yet another mass experiment and see what happens later?

So what's my point?

Our health care system is a public health menace.  We have been sold services, meds, and tests which offer little benefit and significant harm and we have been made financially destitute picking up the tab.  The poor health delivered by the health care system is applied systematically systemically based on demographics such as gender, race and age.  The medical knowledge base,  made up mostly of clinical trials,  has been built by the organizations marketing the drugs to treat diseases they helped characterize.  The government regulatory institutions are corrupted beyond recognition.  Most the funding for the FDA comes from the pharmaceutical industry through the user fee acts dating back to the 80s and the push for new HIV meds.  

Finding ways to inject 30 million more customers into the system by mandating health insurance and shifting more of the bill to the collective pockets of tax payers is the goal of the proposed health care reform.  People can not afford the price of health care now.  Adding more demand will only drive up costs.  Costs have to go up to pay for all the new equipment and construction that goes into the perpetual expansion of health care.  Hospitals build new parking garages and purchase digital mammogram equipment;  where do you think the money comes from to pay for those projects in the end?  

What's the solution?  

Starve it.  The health care system has continued to expand during the great recession and it is inconceivable for the corporations profiting from this marketing of poor health to budget for anything else.  As people choose to do what's best for themselves and their families,  they will naturally decrease their interactions with the health care system.  People are already overwhelmingly seeking understanding for free online and bypassing the harmful system.  This trend can only continue as costs soar.  

The solution has always been the same all these years.  

Learn about every item the system tries to sell you.  Ask yourself and the employees of the system "what are my risks to begin with,  how much does this med/test/procedure lower those risks, and what are the possible harms of that test/med/procedure".  Treat every interaction with the system like purchasing an item in a pawn shop.  Buyer beware;  our track record is pretty poor overall and almost all of the new fads in treatment and diagnostics end up being abandoned as we learn yet another experiment failed to deliver to goods.  

And understand this is not bad news.  We have a staggering amount of resources available to improve society.  If you pile up all the money wasted on harmful or useless treatments and tests,  we'd have trouble spending it all.  

Can our economy survive the coming collapse of the health care system?  I don't see how.  If a few banks failing causes the gears of the financial system to grind to a halt,  then when 18% GNP goes poof..... 

But one thing I do know.  The health care system like the financial system exists because of the people and not the other way around.  The health care system depends on a progressively enlarging stream of customers.  It has betrayed trust repeatedly and grown incredibly wealthy in the process.   

But we can trust the average person to do what's best for themselves and their family when given the chance.  And information is free.  Sure we're still figuring out how not to drown in all the excessive information now available to us but it's just a matter of time now.  The system has set up a network of incentives which encourage people to bypass the system as much as possible.  

Information is free,  understanding take some work and trial and error.

Understanding is freedom

Thursday, February 11, 2010

It's a record 4 posts in one day

Couldn't resist sharing another article by Dr. Lisa Schwartz

The authors believe relationships between drug companies and journalists might result in more favorable news stories, in a similar fashion to how industry funding of medical research is associated with more favorable research outcomes.


The authors were surprised by the widespread business of pharmaceutical and other healthcare businesses offering cash prizes and travel benefits to journalists. They state, "... we believe journalists accepting these prizes are clearly creating conflicts-of-interest for themselves" and calls for journalists to stop accepting these sponsored awards.

Schwartz says that the practice of medical journalism has evolved to blur the lines between traditional news reporting and producing advertising materials that mimic reporting. News corporations, which depend on advertising, need to be especially vigilant in maintaining a separation between their editorial mission and their advertising sales.

And here's another one from 2002:

Most commonly noted harms were false positive, false negative; few stories mentioned over-diagnosis

So an article from 2002 pointing out the media not mentioning over-diagnosis. And talking about we seem to be much more cautious about taking a pill compared to getting a test.

And another one from 2004 about the public's perception of screening tests:

"Some clinicians will see our results as welcome evidence of the success of public health campaigns for widely recommended cancer screening tests," the researchers write. "OthersÉwill see disturbing evidence that these same campaigns have communicated a misleadingly simple and one-sided message Ð a message that discourages meaningful discussions about the use of these tests in settings when the recommendations are less clear (e.g., screening at younger ages, at advanced age, or for individuals with multiple comorbidities [illnesses]." The public is primed to believe that there is value in having any test that is marketed as being able to find early cancer, suggest the authors. They conclude, "The challenge now is to balance messages and reduce the public's risk for overtesting and overtreatment."

The findings are limited, the researchers caution, because they do not know whether the public's enthusiasm for early detection would change if the potential benefits and harms of screening were fully communicated and understood.

One about over-diagnosing melanoma:

The incidence of melanoma of the skin is rising faster than any other major cancer in the United States. In 2002—the most recent year of data—the incidence was about six times that in 1950, but some dermatologists suspect that this rise may reflect more skin biopsies, not more disease. Welch and colleagues noted that death rates from melanoma have remained stable since 1986; what has increased during that time, they report, is the rate of skin biopsies.

Also in the news today

Noticed this is tomorrow's edition of Science News just now (don't ask me how I have it a day early, science is awesome?)

Just another good review of the information and a little bit of the politics surrounding screening mammograms.

3 posts in 1 day? Raise your hand if you're sick of reading.

Mammograms do catch cancers. But the task force found high rates of false-positive mammograms and treatment for “overdiagnosed” cancer, questioning the benefits of routine mammography for 40-somethings. Your thoughts?

Women need to be clear about their chance of developing breast cancer, how much mammography reduces that chance and what are its associated harms. Imagine 10,000 women age 40. Over the next 10 years, without mammogram screening, about 35 will die of breast cancer. With screening, 30 will die — five fewer. But of 10,000 getting screened, 600 to 2,000 will have at least one false positive leading to a biopsy, and 10 to 50 will be overdiagnosed. They will be told they have cancer, and they will undergo surgery, chemotherapy or radiation, which can only hurt them since their cancer was never destined to cause symptoms or death.

Overdiagnosis is the most important harm of screening. People sometimes find it hard to believe that overdiagnosis is possible. These cancers look the same under the microscope but don’t behave like cancer. Because we can’t tell which cancers constitute an overdiagnosis, everybody who has cancer is treated.

In the news Health Care Reform

Sassi told Sebelius that insurance costs also continue to rise because medical prices are increasing faster than inflation, and people are using more health care. That use increase is driven by an aging population, new treatments and "more intensive diagnostic testing," he wrote.

More reasons to scrutinize the diagnostic tests and new treatments. The insurance companies say that's driving up rates. They also say:

Brian Sassi, the head of WellPoint's consumer business unit, said in his letter to Sebelius that the weak economy is leading individual insurance buyers who don't have access to group plans to drop coverage or buy cheaper plans. That reduces the premium revenue available to cover claims from sicker customers who are keeping their coverage.

So let me get this straight, people drop insurance because insurance is too expensive and insurance companies raise the rates on everyone left to make up for it?

No insurance companies, you go bankrupt. The remaining people aren't made of money and many just needed one more push to drop your plan and 39% will probably do it.

They aren't so stupid that they'd price gouge during a recession?

And all DC can talk about it how they'll force the insurance companies to take people with preexisting conditions and make them compete with each other with the plans they offer.

WellPoint is the largest publicly traded health insurer based on membership and is a dominant player in the individual insurance market in California. Based in Indianapolis, the company runs Blue Cross and Blue Shield plans in 14 states and Unicare plans in several others.

So we're going to break up this giant and have a bunch of smaller corporations compete for people to insure? Will those costs be cheaper? Oh right the plan is to inject 30,000,000 customers by mandating insurance coverage.

And as time has gone by, we have recruited every health person we can to screen and test and diagnose with new chronic conditions treatable only by a newer medication sold by the company that helped characterize the "disease" in the first place.

Who writes this stuff?

Evidence Based Medicine

We like to give lip service to the term evidence based medicine as physicians. It's a hallmark of cutting-edge scientific, modern medicine. Not shooting in the dark with our recommendations, not rigidly following the dogma of the expert's experience, not hoping our theories work out but insisting on PROOF that we're doing more good than harm.

But it goes beyond that.

Evidence based medicine is a way of turning the age old recommendation and paternalistic guidance of the physician into teaching, empowerment. It's rather ironic that as medicine has grown more complicated, we're expecting more and more understanding from our patients. Now patients make decisions after weighing the ups and downs of a medication or test; before patients were compliant with instructions.

And we should praise evidence based medicine; look at what it has saved us from already:

Screening stress treadmill tests which caused more harm from evaluating all the false alarms with heart cath tests (the plastic tube through the groin artery test) than saved lives through early detection

Screening Chest Xrays for catching lung cancer early in smokers (found spots that didn't need to be found AND added radiation which is cancer causing to the smokey mixture in the lung tissue)

Screening CT scans for kidney cancers (found more spots that were never going to spread in the lifetime of the individual than caught and cured genuine deadly cancers)

Screening CT scans for lung cancer (found just as many "cancers" in nonsmokers as smokers, the overwhelming majority never to cause a single symptom)

We learn from our mistakes and abandon harmful practices all the time. But when it comes to screening mammograms, medicine as a culture holds on stubbornly no matter how high the pile of damning evidence grows.

And it's no wonder. To admit that we've done more harm than good with screening mammograms would be admitting that most of the women we labeled as breast cancer survivors were victims of unnecessary treatment. It would also be admitting that the benefits and harms were unclear at the onset of large scale screening in the 80s. Which is an admission that our collective experience with screening mammography has been a large failed experiment.

We live in a society that equates being wrong with failure; we practice medicine with the constant judgment of the "Standard of Care" hovering an inevitable lawsuit away and we devote our lives to curing , relieving suffering and advocating. We have a score card in our head and the evidence tells us that most of the cures, most of the victories were actually harms.

And eventually, admitting screening mammography was a failed experiment without proper consented draws out the conflicts of interest within the wealthy so called advocacy groups such as the American Cancer Society.

Which leads to organizations like DuPont and General Electric (the largest corporation on earth according to Forbes 2009). Companies who have either funded, created and or benefited from the positions and marketing prowess of the ACS.

But more importantly, rejection of screening mammography is a rejection of powerful forces who are hopelessly budgeted to the continuation and expansion of harmful, expensive procedures while minimizing true prevention and treatment.

The health of the largest corporation on earth hinges on screening for breast cancer?

Crazy world.

In other words, I have been wrong and for a decade participated in the promotion of harmful medical practices while gaining financially. I regret my negligence and will strive to prevent the same error from ever happening again as I openly explore what led to my errors.