Junkfood Science: March 2009

March 29, 2009

The silence of evidence

The reality of nationalized electronic medical records is recognized among most medical professionals, who know that the claims of saving money and lives are not supported by the preponderance of credible evidence and that improving health care isn’t about having everyone’s medical records in a federal database for governmental oversight. But the general public has largely been kept in the dark about the controversies surrounding electronic medical records. One reason for this disconnect and why the full story isn't reaching consumers was explained in this week’s Journal of the American Medical Association.

Like the medical literature more often than not demonstrating the failings of electronic medical records, the investigative report in JAMA isn’t being widely reported in mainstream media. You deserve to hear about it. It turns out that electronic medical record vendors have negotiated contract deals that leave them free and clear of liability when their software is inferior and harms patients, and prohibits problems from being revealed to the public.

The JAMA article was authored by professor Ross Koppel, Ph.D., with the Department of Sociology and Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania School of Medicine; and David Kreda, a software engineer with Social Research Corporation, both in Philadelphia. They got right to the point:

Health Care Information Technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability free — “hold harmless” is the term of art — even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions. Vendors avoid liability by relying on the legal doctrine known as “learned intermediaries” and on warranties prohibiting claims against their own products’ fitness. According to this doctrine and legal language, HIT vendors are not responsible for errors their systems introduce in patient treatment, because physicians, nurses, pharmacists, and health care technicians should be able to identify—and correct—any errors generated by software faults.

HIT stakeholders have managed to convince the government that healthcare professionals should know when it’s appropriate to follow the prompts and guidelines in their software. HIT vendors claim that they’ve merely created a software tool and clinicians are in a better position to identify errors resulting in their faulty products, wrote Koppel and Kreda. Given that electronic medical records have become key components of “quality” improvements and following them part of physicians’ pay-for-performance measures, doctors aren’t free to not follow them or use their clinical judgment without repercussions.

Yet the more that HIT software embeds knowledge and performs complex calculations, the more risks there are to patients. For example, at a recent national conference on electronic health records and patient safety, hospital leaders described faulty vendor software that miscalculated intracranial pressures. Nonetheless, had the trauma team not caught the error, the hospital would have been responsible for the resulting harm to the patients involved.

Hospitals and doctor practices, purchasing and implementing the software and making the day-to-day decisions in its use, are at a distinct disadvantage in this deal, they explained. Not only do they not have access to inside information behind the software, but they have no legal recourse when they encounter errors or poorly designed user interfaces.

The substantial disparity between buyers and sellers in knowledge and resources is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures, while compelling users’ nondisclosure of their systems’ problematic, even disastrous, software faults. Even though enforced nonsharing of software problems is an industry norm, it is anathema to improving care, to HIT, and to evidence-based medicine. In addition, clinicians’ and health care facilities’ leverage is weakened by fears that vendors’ finances might be so jeopardized that clients’ HIT departments are left to untangle millions of lines of orphaned software code.

In other words, the contracts mandate that problems cannot be disclosed to the public or even shared among healthcare providers using the same systems. Nor do vendors have to disclose known problems with users.

Implementations of HIT are massively complex and fraught with delays, errors, resistance, work process redesign, frustration, and outright failure. Health care facilities cannot predict the myriad scenarios in which software failures could result in patient harm and liability, and they are not likely to be knowledgeable a priori about frequent vendor updates.

The JAMA article authors describe a number of problems that have been identified in electronic medical record systems. For example,

In many HIT systems, physicians must enter patients’ weights before entering medication orders. For non–weight-based dosages, the physician may estimate weights. However, if the next physician is ordering drugs for which exact weights are critical, the prior estimates could lead to harmful dosing. Adding weight qualifiers (eg, “estimate”) only emerge in hindsight. Another example recounts how an infant’s incorrect weight was entered in the electronic medical record, which then generated dangerous dosing guidelines. Correcting the seemingly simple error required substantial effort and necessitated the vendor’s “unlocking” the electronic medical record.

Other examples of software glitches were confusing kilograms and pounds used to give the doses of medications and erroneously removing warnings about fatal drug allergies. In both cases, said Dr. Koppel, “learned intermediary” clauses held that clinicians were responsible for noticing the mistake before prescribing.

Yet, healthcare providers are being forced to use electronic medical records by the federal government’s latest mandates, under the guise that electronic medical records prevent medication prescribing errors.

To date, governmental agencies and organizations that certify hospitals, Medicare and Medicaid contracts, and third party insurers, offer no protections for healthcare providers. “Professional medical organizations could declare that HIT contracts containing blanket hold harmless/learned intermediary clauses are inconsistent with professional practice,” they wrote. “Vendors would then have further incentive to focus on patient safety concerns in addition to marketing prowess.” But they aren’t.

Marketing interests have taken precedence over patient safety, and HIT vendors with even dangerous products are being held blameless. Even when doctors, nurses, hospitals and clinics follow vendor instructions to the letter, they are left with all of the liability for faulty HIT products.

Professor Koppel and Mr. Kreda said they were unable to identify lawsuits involving harm to patients from faulty vendor HIT because nondisclosure and confidentiality clauses restrict information to the healthcare community, as well as from the public. But neither party has incentives to publicize its role in errors that result in patient harm, so it’s little wonder the public has especially been kept in the dark.

But these contractual provisions jeopardize efforts to protect patient safety in another way, they said. The contract provisions prohibit healthcare organizations from sharing problems and what they’ve learned with other clinicians using the same products. All users should be quickly informed of suspected HIT errors, the authors said, and all users notified of the resolution. “Without open presentation of risks, failure to mitigate even fully verified HIT risks to patient safety remains economically self-serving.”

Shifting liability to the users and inserting contractual language that effectively conceals knowledge of serious faults in their HIT systems from users, they concluded is “both counterproductive and unethical.” While HIT vendors should be held harmless from errors beyond their control, such as poor training and misuse of users, being held responsible for their own errors will bring incentives into balance and speed the repair of faulty products by HIT vendors. Accountability and responsibility is integral to everyone in healthcare.

Last month, Dr. Scot Silverstein, M.D., with the department of Biomedical Informatics at Drexel University Institute for Healthcare Informatics in Philadelphia, wrote in the Wall Street Journal that the UK had spent £12.7 billion [$17.12 billion in U.S. dollars] on national HIT and “still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. HIT (with a few exceptions) is largely a disaster.” Despite all of the assured claims of the benefits of HIT that the public is being told, he said, HIT “is an experimental technology whose benefits are unclear” and expert reviews to date have been less than stellar.

The UK Parliament’s report, released earlier this year, on its National Programme for IT in the NHS since beginning implementation of the program in 2006 was surprising. This is the world’s largest and the best evidence to date of our proposed HIT in actual practice, yet we haven’t heard a peep. You can read it here. It concluded:

Recent progress in deploying the new care records systems has been very disappointing, with just six deployments in total during the first five months of 2008-09. The completion date of 2014-15, four years later than originally planned, was forecast before the termination of Fujitsu's contract and must now be in doubt… The report should include updates on actions to resolve the major technical problems with care records systems that are causing serious operational difficulties for Trusts.

By the end of 2008 the Lorenzo care records software had still not gone live throughout a single Acute Trust. Given the continuing delays and history of missed deadlines, there must be grounds for serious concern as to whether Lorenzo can be deployed in a reasonable timescale and in a form that brings demonstrable benefits to users and patients. ..

The planned approach to deploy elements of the clinical functionality of Lorenzo ahead of the patient administration system is untested, and therefore poses a higher risk than previous deployments under the Programme. The Department and the NHS should undertake a thorough assessment of whether this approach to deployment will work in practice

Of the four original Local Service Providers, two have left the Programme, and just two remain, both carrying large commitments… There are, however, considerable problems with existing deployments of Millennium and serious concerns about the prospects for future deployments of Lorenzo. Before the new arrangements for the South are finalised, the Department should assess whether it would be wise for Trusts in the South to adopt these systems.

The Programme is not providing value for money at present because there have been few successful deployments of the Millennium system and none of Lorenzo in any Acute Trust… Despite our previous recommendation, the estimate of £3.6 billion for the Programme's local costs remains unreliable… the Department should publish a revised, more accurate estimate for local costs and, thereby, for the cost of the Programme as a whole.

The Department hopes that the Programme will deliver benefits in the form of both financial savings and improvements in patient care and safety… There is, however, a lot of work to do within the NHS to realise and measure the benefits

Little clinical functionality has been deployed to date, with the result that the expectations of clinical staff have not been met... The Department has taken action to engage clinicians and other NHS staff but there remains some way to go in securing their support for the Programme…

Patients and doctors have understandable concerns about data security… the Department and the NHS should set out clearly the disciplinary sanctions that will apply in the event that staff breach security procedures, and they should report on their enforcement of them.

The Department does not have a full picture of data security across the NHS as Trusts and Strategic Health Authorities are required to report only the most serious incidents to the Department. The Department's view is that it is not practical for it to collect details of all security breaches but at present it can offer little reassurance about the nature and extent of lower-level breaches that may be taking place…

Confidentiality agreements that the Department made with CSC in respect of two reviews of the delivery arrangements for Lorenzo are unacceptable because they obstruct parliamentary scrutiny of the Department's expenditure. The Department made open-ended confidentiality agreements in respect of these reviews, with the result that information will not be disclosed even after commercial confidentiality has lapsed with the passage of time. We believe this is improper. The Department should desist from entering into agreements of this kind.

American consumers and healthcare professionals might question why the government has rushed to enforce the adoption of nationalized HIT while being silent on the facts that it is an experimental technology with a history of unaccountability and by most available evidence has failed to provide financial or health benefits for people.

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Brought to you by Google

Remember Google Health? That story and the follow-up ones gave us cause to pause before downloading our private medical records for safekeeping with Google. This month, the industry giant made the news for failing to protect the privacy and security of user data stored on Google Docs, and for its latest move to collect, track and store users’ online behaviors. But how many Americans have heard that the government has recently tasked Google to track most government data, as well as the online political-related activities of citizens to profile them?

In the news

The Electronic Privacy Information Center advocacy organization (EPIC) filed a formal complaint this week with the U.S. Federal Trade Commission to investigate Google’s failure to protect the private personal information of users. Just weeks ago, private records with personal information and spreadsheets stored on Google Docs — used by more than 4.4 million consumers — were breached by people without authorization. The glitch, which affected about 0.5% of Google Docs documents, has reportedly been fixed. It led EPIC to question the adequacy of privacy and security safeguards for Google’s “cloud computing services” (where private data is stored on a third-party server and accessed through the internet) and its ability to follow through with its marketing promises.

This story highlighted that no digital database can be completely secure. It followed the FTC’s international conference “Securing Personal Data in the Global Economy” on that subject. But the larger concerns were the lack of accountability.

According to the FTC complaint, Google tells the public: “Rest assured that your documents, spreadsheets and presentations will remain private unless you publish them to the Web or invite collaborators and/or viewers.” Yet, its Terms of Service “disavow any warranty or any liability for harm that might result from Google’s negligence, recklessness, mal intent, or even purposeful disregard of existing legal obligations to protect the privacy and security of user data.”

The bigger news story came earlier this month when Google announced its new behavioral tracking and interest-based targeted marketing program. Google is capturing users’ online activities, IP addresses, browser, time stamp and specific URLs, storing them and using them to create interest profiles of consumers for advertising. How long it plans to keep this data isn’t known. As the Register reported, nearly two years later, Google has yet to say whether it ever actually put in place its promise to anonymize its search logs after nine months.

Remember Doubleclick?

Google’s capabilities were greatly expanded when it acquired DoubleClick, the world’s most powerful online ad firm, last year. You probably remember that DoubleClick has run afoul of the FTC for years for its privacy violations in tracking user behavior through special cookies and creating user profiles. Years ago the company began combining online data, such as IP addresses, with offline tracking data to personally identify people by name and street address, storing it on Abacus Direct, and enable its use for targeted marketing. While DoubleClick has been collecting such data for years, the merge with Google, the industry giant with more than 60 percent of the market, inflates the concerns. The fact that Google already has the poorest record of privacy protections of any online business in the world makes it all the more worrisome. As writer Cade Metz explains :

The concern is that Google is gradually expanding the already vast array of data it stores on each individual web surfer —- data it could be coughed up after a Google hack or the arrival of a subpoena or national security letter. DoubleClick's ad serving technology is collecting surf data across third-party sites. It now appears that Google is combining this with data harvested on AdSense. And if the company ever sees fit, it could easily fold in the data collected on its juggernaut of a search engine.

IT expert, Michael Kassner, also reviewed the technology, security concerns and financial benefits for Google.

But profiling consumers to sell clothes, pharmaceuticals and cars is one thing. Profiling political activities on behalf of the government is something else.

Governmental profiling

Exception Magazine reported that the Administration has a new office called the Director of Citizen Participation and that it emerged from the Administration’s extensive ties with Google:

Google CEO Eric Schmidt is an Obama supporter and informal economic adviser. Katie Stanton, a former business development executive at Google who has helped with Google's election campaign projects as well as Google Finance and Google News, now heads a new, undefined position in the Obama Administration called the "Director of Citizen Participation."

Google claims to have the right to organize all of the world's electronic data for commercial purposes. The Internet giant is now also mapping much of the federal government's data.

Federal agencies are mostly prohibited from using cookies, which track user movements on the web, on their sites. But Obama's administration… use[s] cookies on all those Obama YouTube videos. Google could profit by leveraging this exclusive data to sell targeted ads to political advocacy groups. Critics also fear the Obama administration will be armed with a wealth of data which it can exploit for propaganda purposes. White House YouTube clips have led to this disclaimer: "We may record information about your usage, such as when you use YouTube, the channels, groups and favorites you subscribe to, the contacts you communicate with, the videos you watch and the frequency and size of data transfers, as well as information you display or click on... [and] track which e-mails are opened by recipients."

The National Journal goes on to report that Google’s unprecedented and expanding role in government includes deals with Congress which allow Google to place data-collecting cookies on citizens’ computers “when they view politicians’ video speeches, or even when they merely view the pages where the speeches can be watched.”

This practice overturns former Presidents who had sharply limited data collection on federal websites. This new system also “allows one company to collect huge amounts of data... The idea that the government would be endorsing any corporation having access to citizens’ political concerns... is a concern,” said Jeff Chester, founder of the D.C.-based Center for Digital Democracy.

Google privacy notice on the White House videos is more open-ended, and it's hard to tell exactly how the information is being used. “Google is keeping this cookie information, we know that," said Christopher Soghoian, a computer expert at Harvard's Berkman Center for Internet & Society. “What Google is doing with it is a secret.”

The article then explains that the clue came in March, when that White House YouTube disclaimer appeared. In its investigation, National Journal found that unique cookies, different from those of any other government agencies, were inserted onto their computers when they watched Obama speeches, such as at WhiteHouse.gov and MyBarackObama.com. Other cookies were discovered as being downloaded when browsers visit the Hubs for members of Congress. “The cookie-detecting software also showed that the congressional pages carried additional data files that can be used by tracking and analytical software owned by Google's subsidiary DoubleClick .”

As the article explains, these aren’t session cookies, which get deleted when you leave a site, these persist. According to Jacob J. Lew, former director of the Office of Management and Budget, since he’s not an agency, the President is exempt from the E-Government Act of 2002 and additional regulations issued by the Bush Administration in 2003 which prohibit cookies from being used on federal agency websites “unless, in addition to clear and conspicuous notice, the following conditions are met: a compelling need to gather the data on the site; appropriate and publicly disclosed privacy safeguards for handling of information derived from 'cookies'; and personal approval by the head of the agency.”

Beyond privacy, the article explains how the lines between political campaigning and government function are being crossed:

During the 2008 campaign, the White House collected the e-mail addresses and allied data about the concerns of roughly 13 million supporters and raised more than $500 million online, including tens of millions from donors whose identity the campaign was not required to announce. This data is valuable in part because it will help Obama's re-election campaign quickly raise donations and mobilize volunteers. On March 16, administration officials announced plans to mobilize its supporters, via the Organizing for America site, to help pass Obama's proposed $3.55 trillion budget for 2010.

White House officials declined to be interviewed on the rules governing the separation of campaign and state data. "There are indications that the administration wants to revise some of these laws, particularly with respect to the Internet…

Google is also working with federal officials to map out government data so that Google's most valuable property, the Google search page, can better direct citizens to sought-after government information. Any increased traffic through the Google Web page to federal sites gives the company a greater opportunity to sell advertising to government and commercial customers…

If you haven’t noticed how hard it increasingly is to find independent information when Googling, you haven’t been paying attention. It’s getting easier to understand why Google hits appear more selected on your behalf.

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March 28, 2009

More Reindeer Games

Nearly 3,000 news stories this past week jumped on the bandwagon to report that a new study had found that red meat may be deadly. This is another flagrant illustration that we’d all be a lot healthier if we just stopped reading medical news stories. Not one health journalist reported the study accurately, truthfully or responsibly. As a result, countless people have been needlessly frightened about their food and health and are being led to make health decisions or support policies that have no grounds in sound science.

This was not a clinical study at all. Not a single person was ever examined. It turned out to be another computer data dredge of those AARP member mail-in questionnaires from 14 years ago. It was unable to find a single tenable correlation between meat consumption and premature death — in fact, it not only failed to find an association between meat and higher incidences of cancer or premature deaths, but if you want to split hairs, it found the opposite of many of the claims in the news this week.

Before revealing what didn't make the news, let’s take a quick look at how they did it.

Garbage In

As readers will remember, in 1995-6, the AARP had sent out questionnaires to its members (50-71 years of age) in select parts of country, asking them their height and weight, lifestyle habits, and to estimate how often they had eaten 124 food items over the past year. Only 1.5% of AARP members returned the questionnaires, and they were not representative of adults their age at all. Their self-reported answers were never confirmed, either.

But these mail-in membership questionnaires became the NIH-AARP Diet and Health Study database. It has been used to dredge through and find all sorts of meaningless correlations to frighten people. [The most recent scare was here.]

A total of 617,119 persons returned the AARP member questionnaires. For the study published this week in Archives of Internal Medicine, the authors used questionnaires from 322,263 men and 223,390 women. Based on those food frequency questionnaires, the authors estimated how much red meat the seniors had eaten.

Red meat intake was calculated using the frequency of consumption and portion size information of all types of beef and pork and included bacon, beef, cold cuts, ham, hamburger, hotdogs, liver, pork, sausage, steak, and meats in foods such as pizza, chili, lasagna, and stew.

Taking this already dubious data, they “created three diet types: high-, medium- and low-risk meat diets” and gave a point score of 1 through 3 to people at the different meat consumptions. Using computer modeling, they looked for correlations between their estimated meat consumption scores and deaths over the following ten years, as reported on the Social Security Administration Death Master File. Finally, they estimated odds ratios (also called hazard ratios) of the links that came up. Causes of death were taken from insurance billing codes (International Classification of Diseases, ICD-9 and ICD-10).

Computer games

These types of studies [epidemiological data dredges were explained here] are most rife with misinterpreted statistics, errors and biases, and are most easily manipulated to arrive at whatever conclusions researchers set out to find. They are also the most poorly understood. Not only is it common to mistakenly think that any correlations the computer models dredge up indicate causation, but the public doesn’t realize that, especially for these types of studies, a correlation (“risk”) has to be mighty big to even suggest a true effect. The more data you mine, the more likely you’ll randomly yield hits that are statistically significant, but no better than chance and mean nothing. The bigger the study, the bigger the chances for spurious correlations. Computer modeling errors are often even larger than random chance. So, relative risks for a link between meat and deaths, for example, have to be tenable — beyond what would have come up by random chance and statistical error or as a marker for a confounding factor. Credible scientists don’t accept as tenable any relative risk under 200% to 300%.

But it’s easy to frighten people who don’t understand statistics with inconsequential correlations that sound significant and scary. These are the studies that become the scare of the week.

Computer programs can and do spit out countless nonsensical and contradictory correlations. We only hear about the ones the authors choose to report, though. We never hear about all the others their computer model found that are just as spurious. If we heard the full story, it would be much more obvious how uncredible the entire statistical game is.

For example, we didn’t hear that this study also “found” that among women:

● Being married was associated with more than a 30% increased risk of death.

● Doubling their alcohol consumption was associated with one-third lower risk for premature death.

● College diplomas were associated with a lower risk for premature death.

Yet, no one would seriously suggest that women could lower risks for premature death by hanging up a diploma, getting divorced and hitting the bars! These are clearly markers for factors that might play an actual role. In epidemiological observational studies, foods are most often markers for real factors in health outcomes, although the correlations have never been tenable in the first place. That’s why, every time healthy eating has been put to test in well-designed clinical trials, it’s failed to show a meaningful benefit for the primary prevention of diabetes, heart disease or cancers, or to help people live longer. Meanwhile, all of those clinical research resources could have been spent on finding real cures and treatments, but those aren’t as profitable or as politically useful as “healthy eating and lifestyles.”

What the study found

The authors in this latest AARP data dredge were unable to find even one tenable correlation between any type or amount of meat consumed and the 47,976 deaths in men and 23,276 deaths among the women during the ten years.

This was a null study. It was unable to find any valid link between red meat or processed meats and premature death from any cause.

If you want to have fun splitting hairs among untenable odds ratios, the highest red meat consumption was associated with a greater chance of the men dying from injuries than cancer. Clearly bunkum to think red meat makes men accident prone! Reporting odds ratios rather than actual incidences can also make the risks sound huge and real, like the 22% odds ratio for cancer deaths associated with the highest red meat consumption compared with the lowest consumption among the men. Of course, this odds ratio wasn’t more than random chance to begin with, but no reporter reported that. If the actual incidences had been reported, though, the nonsensical finding would have been instantly apparent. Among the 16,433 cancer deaths among the men over ten years, the difference in actual incidences each year between those with the lowest and highest meat consumption was 1.4% — certainly not a finding that would have generated nearly 3,000 news headlines trying to scare us that red meat is deadly.

Among the women the untenable findings were the opposite being reported. Among the total deaths among the women, the actual annual death rate was 1.19% among women with the lowest red meat intake. This compared to 0.8% among women with the highest red meat intakes. So, the more meat the women purportedly ate, the lower their risks for premature death and of dying from cancers.

Not a single reporter reported that the highest red meat consumption among women was "associated" with the lowest actual rates of premature death from all causes or cancer deaths.

Clearly, no food or health writer understood the study methodology or statistics, or bothered to look beyond the press release. Claims that this study supported the need for everyone to significantly reduce their meat intake were simply not supported in this study.

Nor are such admonitions supported in the body of the soundest evidence to date, as has been covered in-depth previously. We don’t even need to think very hard. Rates of premature deaths from all causes, including cancer and heart disease, have been steadily dropping for more than half a century. Meanwhile, per capita red meat consumption has stayed nearly identical since 1990. It makes all of those unfounded speculations that we’ve heard all week to “explain” why red meat is bad have been the biggest give-away of people who don’t understand science.

If you’re still worried about red meat, though, there’s a simple solution: grill or roast your favorite type of red meat until it’s a rich brown color and enjoy guilt-free. It tastes a lot better, too. :-)

© 2009 Sandy Szwarc

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March 27, 2009

Mr. Greenjeans does science

Imagine if Mr. Greenjeans* decided to write a recommendation that every adult who was over 5 feet tall needed to take one of his green pills every day to be healthy. He then conducted a study in which he totaled the number of adults in the United States who was over 5 feet tall and found that his recommendation would apply to nearly all adults.

● Did Mr. Greenjeans just prove that most everyone “should” be taking his green pills?

● Did he just prove that his green pills are effective in making people healthy?

● Did he just prove that most adults are deficient in green pills?

LOL! Of course not. No one would fall for this fallacy of logic, right? Mr. Greenjeans didn’t do any science, nor a lick of research to test his green pills. Yet, incredibly, this is exactly what every mainstream publication today is reporting.

Either it’s a case of some outstanding marketing to convince people that those little green pills really have life-giving powers, or no health reporter read and understood Mr. Greenjean’s study. You’ve probably seen one of the hundreds of headlining stories today:

Too Much Salt Hurting Majority of AmericansWebMD:

Seven out of 10 U.S. adults get 2.3 times the healthy amount of salt. It's putting us in a world of hurt, says Darwin Labarthe, MD, PhD, director of the CDC's division for heart disease and stroke prevention. "This is a very important message," Labarthe tells WebMD. "There is no room for debate any longer that a high level of salt causes stroke and heart disease, and that lowering salt intake will diminish these very serious health consequences."…

Americans eating too much saltScientific American:

Americans are eating far more salt than is healthy, and those for whom it's especially dangerous are consuming twice as much as they should, federal health officials warned yesterday… “It’s important for people to eat less salt…

Don’t Pass the Salt: Most Americans Get Double What They ShouldBloomberg:

Most Americans should cut their salt consumption in half, to less than a teaspoon a day, according to the first report clarifying dietary guidelines published in 2005...

Most adults should restrict salt but don'tAssociated Press:

Seven out of 10 Americans should restrict their salt consumption, but very few of them do, according to a new government study… "I don't think 'alarming' is too strong" a term for describing the results, said Dr. Darwin Labarthe, director of the CDC's Division for Heart Disease and Stroke Prevention… The new CDC report provides valuable new information in quantifying how many at-risk people are getting too much salt, said Dr. Sonia Angell, of New York City's health department. "We're eating way too much," she said…

Too much salt not good for overall healtheFitnessNow.com:

Many Americans ingest over double the amount of sodium than the suggested daily amount… A new report by the Centers for Disease Control and Prevention (CDC) shows that more than 2 out of 3 adults should not have more than 1,500 mg of sodium per day. CDC, the federal agency for protecting the wellness and safety of American citizens, stated it will unite forces with other authorities in the Health and Human Services department to recommend major food manufacturers and chain restaurants to lower sodium levels in the food supply.

The study being referred to was a report in today’s issue of the CDC’s Morbidity and Mortality Weekly Report by Dr. Labarthe and colleagues at the National Center for Chronic Disease Prevention and Health Promotion at the CDC. It states that the U.S. Department of Health and Human Services recommends that adults should consume no more than 2,300 mg sodium/day and that all middle-age and older-age adults, all blacks and everyone with elevated blood pressure should eat a low-salt diet of less than 1,500 mg/day. Then:

To estimate the proportion of the adult population for whom the lower sodium recommendation is applicable, CDC analyzed data from the National Health and Nutrition Examination Survey (NHANES) for the period 1999-2006. The results indicated that, in 2005-2006, the lower sodium recommendation was applicable to 69.2% of U.S. adults

That's it. No clinical research, not even an epidemiological observation finding a link between salt and health or premature death.

“Recent examples of public health strategies to reduce sodium consumption include a New York City campaign to reduce sodium content in restaurant and processed foods,” the CDC report concluded. Yes, the CDC exemplified a public low-salt campaign — covered in-depth here — led by New York City’s Department of Health and Mental Hygiene.

A campaign found to have no scientific merit.

Not only has the soundest science for nearly half a century— including the government’s own findings on examinations reflecting 99 million Americans; more than 17,000 studies published since 1966; and even a recent Cochrane systematic review of the clinical trial evidence — failed to support salt reductions for offering health benefits for the general public, but Cochrane’s reviewers specifically concluded that such interventions are inappropriate for population prevention programs. They could hurt people, raising risks for heart disease and premature death.

The media, however, is reporting that this CDC study illustrates the need for stronger salt restrictive guidelines. New federal dietary guidelines are coming out next year.

This is called advance marketing.

* This is a fictitious example and in no way meant to reflect negatively on the real Mr. Greenjeans, loved by generations of children.

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March 26, 2009

What’s behind Oz

A writer at the New York Times is finally beginning to get that those health risk assessments that ask about our lifestyle and health history are really fronts to sell drugs. One of the largest and most popular ones — that’s convinced more than 27 million consumers to fill out detailed questionnaires about their health and private lifestyle habits — is RealAge. As Stephanie Clifford writes, “while RealAge promotes better living through nonmedical solutions, the site makes its money by selling better living through drugs.” Pharmaceutical companies pay RealAge for the names of people revealing certain “health risk factors,” she found, for targeted marketing.

As Clifford reports:

Online Age Quiz Is a Window for Drug Makers

… While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing. The test has received widespread publicity because of its affiliation with Dr. Mehmet Oz, a popular author and regular on “The Oprah Winfrey Show.” Dr. Oz — “America’s Doctor,” as he is known on Oprah — is a RealAge spokesman and adviser… Whether they are attracted by Dr. Oz’s appeal or by the ads all over the Internet for the test, people come to the site, then provide an e-mail address to take it. They are asked throughout the test if they would like a free RealAge membership. If people answer yes to any of the prompts, they become RealAge members, and their test results go into a marketing database.

RealAge allows drug companies to send e-mail messages based on those test results. It acts as a clearinghouse for drug companies, including Pfizer, Novartis and GlaxoSmithKline, allowing them to use almost any combination of answers from the test to find people to market to…

The questions on health assessments are designed to identify people with potential health risk factors. Through intense marketing, the public has been led to believe these indices are measures of potential age-related chronic diseases and amenable through healthy diets and lifestyles. In actuality, they aren’t. They are primarily measures of aging, heredity and social class, and virtually all normal adults will have “high” numbers in need of a pill. As the vice president of marketing at RealAge told the newspaper, it can even identify those of low income for specific marketing.

Yet few people who take these online tests realize that by doing so, they’ve “signed up” and become “members.” As Clifford explains:

RealAge’s privacy policy does not specifically address the firm’s relationship with drug companies, but does state, in part, “we will share your personal data with third parties to fulfill the services that you have asked us to provide to you,” and it adds test results to its database only when respondents become RealAge members… “Literally millions of people have unknowingly signed up,” said Peter Lurie, the deputy director of the Health Research Group at Public Citizen, a public interest group in Washington. The company, he said, “can create a group of people, and hit them up and create anxiety even though the person does not have a diagnosis.”

RealAge acts as the middleman between the drug companies and its “members,” she writes. And there’s gold in those questionnaires:

Its access to health information has made RealAge valuable. Founded in 1999, it was acquired by Hearst Magazines in 2007 for an estimated $60 million to $70 million. Though its sales — and the fees it pays Dr. Oz — are not public, it is profitable, and had about $20 million in revenue when Hearst acquired it.

Whether marketed as anti-aging, preventive wellness, or lifestyle medicine, these alternative modalities are the current fad and are as prevalent in mainstream medical arenas and public policies. But they are not sound medicine. “There are no lifestyle changes, surgical procedures, vitamins, antioxidants, hormones or techniques of genetic engineering available today that have been demonstrated to influence the processes of aging,” as the world’s foremost experts on human aging have emphasized. They should be viewed as nothing more than entertainment, they said. Like reading your horoscope.

The unsupportable premises behind lifestyle medicine aren’t just as seen on Oprah. They’ve become core to the growing political movement of a new vision for public health.

Congress — the same people making decisions over our healthcare — has embraced Dr. Oz, too. He was the featured expert witness a few weeks ago at Senate hearings by the Committee on Health, Education, Labor and Pensions called: “Integrative Care: A Pathway to a Healthier Nation.” This hearing coincided with the summit on integrative medicine. Bravewell Collaborative funded and commissioned the private Institute of Medicine to hold this summit to guide a reform of our nation’s healthcare system towards a national agenda of integrative medicine.

The senior member of the Congressional committee, Chair of its Subcommittee on Retirement and Aging, and leading the Senate in Kennedy’s group working in secret to reform the nation’s healthcare system, issued a press release promoting the hearing. Senator Barbara A. Mikulsk said integrative medicine is the key component of healthcare reform and a healthier nation. As she explained during her introduction of Dr. Oz, he founded the Health Corps Foundation to promote health and wellness in children by combating child obesity and school-based programs to teach lifestyle skills and “wellness.”

“Dr. Oz, I am very interested in your views about how integrative health care can play a greater role in care delivery, improve health outcomes, and promote a healthier America, particularly through your work at Health Corps to educate children about wellness and self-empowerment,” she said. “Finally, I am interested in your views of how Congress can work to improve integrative health care policies and perceptions so that integrative health care practices can be more widely adopted.”

Dr. Oz testified that his Health Corps is a “proactive health movement that responds to the obesity crisis through school-based health education and peer mentoring, in addition to community outreach to underserved populations—mostly Hispanic and African American as well as groups with lower than average educational levels.” These health service corps will reinforce the government’s messaging on lifestyle medicine and take it door to door. After defining a health crisis, he went on to repeat the popular obesity myths, saying:

Along with educating students in healthy lifestyle principles, we extend our mission to their families and communities… Our goal is to shift the paradigm towards health and wellness now and for the future of our children.

Obesity in the United States has reached epidemic proportions, with more than 35% of Americans classified as obese and an additional 30% as overweight. Obesity has been a steadily rising trend since the late 1970s. Experts now predict that, without an intervention, the majority of the country will be obese by 2012. Alarmingly, the steepest increase is in children and adolescents. Obesity is directly linked to high blood pressure, type 2 diabetes and atherosclerosis. In turn, these unhealthy conditions are the major cause of heart attacks, strokes and heart failure. We are now seeing cardiovascular disease in teenagers and the average age of first heart attacks has dropped by over 10 years in the overweight patient. Other morbid conditions linked to obesity are certain cancers and arthritis….

Another featured speaker familiar to JFS readers was Dr. Mark Hyman, M.D., who described lifestyle medicine as a new paradigm needed to reform the healthcare system and as “personalized patient-centered care based on how our environment and lifestyle choices act on our genes to create imbalances in our core biologic systems. Those imbalances show up as signs and symptoms we call disease.” He called for the government to establish a new office for health and wellness.

As our country faces growing healthcare needs with an aging population, and medical care becomes increasingly sophisticated, these are the interests that want to decide what medical care we receive, the research that’s funded, and what is taught in medical and nursing schools. It won’t be science.

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Happy Birthday, Dr. Borlaugh

The Father of the Green Revolution, Dr. Norman Borlaugh is credited with saving more than one billion lives from starvation through his life devoted to improving food production. For his work on world hunger, he won the Nobel Peace Prize, the Presidential Medal of Freedom and the Congressional Gold Medal.

Happy 95th Birthday, Dr. Borlaugh.

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March 23, 2009

“Defective premises tend to recur in new settings”

A new experimental program at a nonconventional “lifestyle medicine” center is targeting pregnant women who are Black and Hispanic minority, poor and fat. These women are being enrolled into a free health program which tells them it will benefit them and their unborn babies and make their babies healthier.

No mention is made in the patient literature that, by the soundest clinical evidence to date, compared to the standard of care, the program’s alternative interventions have been shown to lead to poorer chances of survival for babies, higher rates of spontaneous preterm births, and to put babies at greater risk for serious physical and neurological health problems and learning disabilities. There is no indication that these underprivileged minority women are giving their informed consent or are aware they are participants in human experiments that could endanger their unborn babies.

Why has no one cared to notice? The answer to that question is even more disquieting….

In the news

A press release was issued earlier this month by Northwestern University, which the media published with embellishment and without question. The articles publicized a new program at the Northwestern Comprehensive Center on Obesity in Chicago that was said to help babies “beat obesity odds” by keeping expectant mothers’ pregnancy weight gain in check.

Dr. Alan Peaceman, M.D., co-director of the program, told the media that “obesity in pregnancy may be contributing to the epidemic of childhood obesity and diabetes that we are seeing today.” An appropriate weight gain for some women who are overweight is no weight gain at all, he said.

As Reuters reported:

It is based on new research suggesting that excessive weight gain in pregnancy hurts both the mother and her fetus, raising the risk of complications during pregnancy and putting the child at risk for obesity and diabetes later in life… "We've known for a long time that children of overweight mothers are more likely to be overweight themselves," said Dr. Robert Kushner, who directs the Northwestern Comprehensive Center on Obesity. But he said researchers had assumed that was simply because the mother passed along her bad eating and lifestyle habits to her child after birth. Now, animal studies suggest … “The whole idea is, as that child comes out of the birth canal, you've already imprinted that child's vulnerability to be overweight," Kushner said. "It's like being born with handcuffs on. In this environment, how do they have a fighting chance?" said Kushner, referring to the growing obesity epidemic…

This may sell among the public, many of whom have come to believe the myth that type 2 diabetes, like obesity, is caused by overeating or eating too much sugar or junk, but medical professionals know otherwise. Research has documented for years that not only are obesity and type 2 diabetes primarily hereditary, if there even is a link between nutrition in utero and genetic changes that contribute to later diabetes or insulin resistance in a baby, it’s more likely that children born to mothers who’ve had restricted diets, eaten too little, or endured famine (intentional, such as dieting, or imposed, such as the Dutch famine during World War II) during pregnancy may be more likely to develop type 2 diabetes, perhaps especially those with a hereditary tendency to being larger. And low birthweight babies whose mother’s may have not eaten enough during their pregnancies, are more likely to develop impaired glucose regulation and diabetes later in life, independent of obesity or any risk factor (as shown in a recent China study). In other words, based on the clinical research to date, restricting a mother’s diet so that she gains little or no weight during pregnancy could likely have the opposite effect this story suggests, and put babies’ health at greater risk.

The news went on to say that experimenting on pregnant women has been considered unethical because it imposes risks to the most innocent of all — a growing baby. Dr. Kushner was quoted saying that “pregnant women have often been considered hands off because of fear of harming the developing baby [but] it’s time to be more aggressive with fat pregnant women.”

The program has “a special emphasis on treating low-income minority women,” said the nurse coordinator, but several women in the program have also had gastric bypass surgery and fear gaining too much weight. They want to “maintain a normal weight gain in pregnancy, which is no more than 15 pounds because these women are obese,” she said. A young pregnant woman profiled in the news story said she hopes the program will help give her ammunition to resist the pressure she’s getting to gain weight… from her obstetrician.

As the media reported, the program hopes someday to gather data to see if it helped give babies “a better shot at having a healthy weight.” In other words, as the news failed to explain, this program is not part of a study — a randomized, controlled clinical trial, which would be the only “fair test” of the effectiveness of such a medical intervention. This is not research designed to credibly advance scientific knowledge. Also not reported to women and their referring physicians is that this experiment has not released a clinical trial protocol or been registered at clinicaltrials.gov.


The public didn’t hear that this experimental program is through the Center for Lifestyle Medicine, which offers a variety of services for weight loss and “healthy lifestyles” — including dietary and behavioral counseling for weight loss, bariatric surgery, and disease management.* Lifestyle medicine, reviewed here, is the latest popular alternative modality. It is not conventional medicine. It advocates that most chronic diseases of aging are our own fault and caused by the wrong diets and lifestyles, and can be prevented with “healthy lifestyles,” weight loss and special diets. Even as clinical trial evidence is steadily failing to support these beliefs behind lifestyle medicine, this modality is increasingly finding its way into mainstream medicine, academia and public health policies. Lifestyle medicine has become such big business and so widely and heavily promoted, that the fact that most of it isn’t sound, evidence-based mainstream medical care isn’t widely realized among lay people.

JFS readers will remember Dr. Kushner from 2007, when obesity interests rallied to re-interpret the findings from senior research scientists at the CDC National Center for Health Statistics, who had conducted years of investigations into claims that hundreds of thousands of people were dying every year from overweight and obesity. Using data from actual physical examinations on a nationally-representative cross section of the population and U.S. vital statistics, the CDC scientists found that most fat people actually had lower risks of premature death than “normal” weight people — those with BMIs of 30 to 35, for example, were associated with a 23 percent lower risk of premature death.

At that time, Dr. Kushner was the Director of the Wellness Institute at Northwestern Memorial Hospital. He had authored the American Medical Association’s Assessment and Management of Obesity, funded by $50 million from Robert Wood Johnson Foundation. A prolific author, he also wrote Fitness Unleashed: A Dog and Owner’s Guide to Losing Weight and Gaining Health Together and the Personality Type Diet book series. His personality diet suggests that obesity is due to emotional issues with foods, sedentary behaviors, and eating bad foods and at the wrong times of day. It offers a personality test and a weight loss diet for your personality, focused on plant-based, soy, low-fat, high-fiber, “super foods.” There has yet to be a published study showing any long-term effectiveness for weight loss or improved health outcomes of a personality diet. Last fall, on October 21, 2008, the Obesity Society, the largest lobbying organization of obesity stakeholders, announced it had made Dr. Kushner its new president.

Northwestern’s Comprehensive Center on Obesity, located in its new Center for Lifestyle Medicine, opened last November. It was founded, according to the director, to address the global epidemic of obesity by focusing research on fat pregnant women, minorities and children; developing public policies and lobbying for obesity prevention programs; and educating medical students and professionals on the causes and treatment of obesity. It tells consumers that it can help them:

● manage your weight;

● determine if bariatric surgery would be a good option and then, if so, guide you through the surgery, follow-up care, and adjustment period;

● evaluate your risk factors for major life-threatening chronic diseases such as heart disease, diabetes, stroke; and

● counsel you using specific test results and recommend ways to change your behavior that suits your needs and personality

Healthy for 2

The Center for Lifestyle Medicine’s program for minority, poor fat pregnant women is called: Healthy for You, Healthy for 2. The online patient literature tells the women that their obstetrician referred them to the program because they met the criteria by being fat, gained “too much weight” in a previous pregnancy or had gestational diabetes, or had bariatric surgery. Clearly equating weight with health, it says a fat mother passes along the tendency of being fat to her unborn baby, so that by keeping her weight gain in check, her baby may be healthier, too. The women are told that the program has unique interventions that will benefit them and help their baby be healthier, and visits will extend after their baby is born to help them reach their goals (presumably for weight loss).

Participants in this experimental program won’t find that there is no evidence that mothers who try to restrict their pregnancy weight gain to 0-15 pounds can do so safely and that it will help their babies be healthier or prevent the hereditary tendency for obesity in their children. Nor does it appear that these minority, disadvantaged mothers are even being made aware that the evidence, for more than half a century, suggests that such restrictions could increase risks for their babies.

The idea of lowering the weight recommendations for expectant mothers to address the obesity epidemic has been floated by RWJF-funded entities for several years. RWJF-supported anti-obesity initiatives have been promoting weight loss before and between pregnancies, and it commissioned the Institute of Medicine to propose changing the clinical guidelines to recommend more restrictive weight gain during pregnancy. This 22-month initiative has been previously reviewed, along with the reasons why the weight guidelines are as they are today.

Knowing about this research is important for women who want a healthy baby. There is no clinical evidence to support that pregnancy weight gain is to blame for the obesity epidemic or childhood obesity. Studies following women through their pregnancies and their children for years thereafter, found that mothers gaining “too much” weight during pregnancy had little correlation to children’s later weight status.

In contrast, low pre-pregnancy weight or low weight gain during pregnancy is well-recognized as a strong predictor for both preterm deliveries and a doubled risk of retarded fetal growth. Low weight gain by mothers during pregnancy, including women trying to watch their figures, is one of the factors shown to play a role in babies of low birthweight, which is associated with a range of health problems for newborn babies.

A mother’s caloric and fat intake, more so than even recommendations for specific micronutrients, has been shown to play a critical role in ensuring optimal fetal growth and development — something all babies deserve regardless of their mother’s size. Cholesterol, for instance, is essential for the developing embryo, just as dietary fats are critical for growing babies and children. It is common sense that babies not growing normally during pregnancy are at risk, but the risks for intrauterine growth retarded babies just for surviving infancy are staggering. IUGR is responsible for about half of normal-formed stillbirths and babies weighing less than 5 1/2 pounds at birth have mortality rates 5 to 30 times higher than average birth weights. Babies under 3 1/3 pounds have mortality rates 70 to 100 times greater. Babies suffering from undernutrition during pregnancy are also at increased risk for neurological, respiratory, intestinal and circulatory problems during the neonatal period.

The evidence suggesting life-long ramifications for children who suffer IUGR far exceeds any potential harms associated with being a fat child. Low birth weight babies are also associated with earlier and higher prevalence of hypertension, coronary heart disease, adult onset diabetes, chronic respiratory disease, autoimmune thyroid disease and some forms of cancer later in life.

This notion of restricting pregnancy weight gain has been tried before… and proved detrimental for babies. In the 1950s, it became standard practice for public health officials in the United States to recommend restricting weight gain during pregnancy to less than 20 pounds, out of fears that gaining more could risk toxemia and birth complications. But medical professionals recognized that this advice was ill-founded and endangering babies. Among mothers following their weight gain restrictions, their babies had poorer chances for survival and more health problems. The facts finally led to a reversal in the 1970s and the clinical guidelines we have today. The research has continued to show these recommendations help to ensure a safe pregnancy, optimal fetal growth and healthy babies.

JFS recently examined the fact that fat pregnant women are more likely to carry babies to term. They have lower risks for spontaneously delivering premature babies. Obstetricians with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal–Fetal Medicine Units Network (MFMU), a network of fourteen university medical centers that have been involved in clinical research on mothers and babies for more than two decades, have documented that the body of evidence clearly shows that not only is being fat protective, but thinner women and inadequate weight gain during pregnancy are also independent risk factors for premature births. Authors from the Division of Reproductive Health at the Centers for Disease Control and Prevention noted that at least a dozen studies published prior to 2000 had documented this well-established fact.

These experts recognized more than a decade ago that preterm deliveries are also responsible for about eight out of ten perinatal deaths in the United States.

Fat women have far fewer premature babies, with the risks of having a preemie decreasing with increasing maternal weights. More stunning, researchers who had hoped to show that women losing weight before getting pregnant could reduce rates of preterm births, instead found the opposite. Examining all the women who had delivered at one major medical center between 1996 and 2004, for instance, revealed that the more weight the women lost between pregnancies, the greater their risks for subsequently having a preterm baby. A single BMI unit drop (about 6 pounds for a woman of average height) doubled her risks of having a spontaneous preterm delivery. Losing more than 5 kg/m2 BMI was associated with nearly triple the risk of having a preemie (28% to 80%).

The Healthy for 2 experimental program targets minority, poor, fat women.

Recommendations that women gain little or no weight during pregnancy to have healthier babies are clearly not supported by sound evidence. Such recommendations are a public health message that might help sell weight loss and “healthy lifestyle” programs, but could have devastating effects for millions of innocent babies and their families.

The soul-searching part

Look again at the website of the Healthy for 2 program. Do you see any patient information for the women referred to this program that explains any of the potential risks to their babies?

No, they are told only how this program will benefit them and their unborn babies. The women referred to this clinical program are told where to go, with no indication that they have a choice. There is not even an indication that this is an experimental program — it’s listed under “Clinical Care” on their website, and not even linked to the center’s research. Nowhere is it explained that the “unique interventions” of this program mean they are not traditional medical practice and that they depart from standards of clinical practice.

Do you feel that the underprivileged minority fat women being targeted in this program are being given information to enable them to freely give their informed consent to an experimental intervention?

The core principles that guide medical professionals around the world in the ethical practice of medicine and human experimentation were born of the 1946 Nuremberg doctor’s trial in Germany. It's become part of every clinical trial protocol and consent process. Essential is the ability of each person to be in the position to freely give their voluntary, informed consent to participate in experimental interventions. That means no “element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion,” according to the Nuremberg Code. This is why especially vulnerable populations in dependent positions receive special consideration. It also dictates that any human experimentation must weight the risks against the expected benefits for the patients.

FDA guidelines on the elements of an informed consent further states that study participants must be given a full explanation of any reasonably foreseeable risks and a full disclosure of appropriate alternative treatments that might help them, so that they can make a reasoned decision for themselves. The Declaration of Helsinki, adopted worldwide in 1964, adds additional safeguards, calling upon all research on human subjects to conform to accepted scientific principles and be based on adequately performed laboratory and animal experimentation and a thorough knowledge of the scientific literature.

It isn’t known if this experimental program has undergone review by an Institutional Review Board (IRB) to ensure that the rights and welfare of human subjects have been protected. IRBs also review study participant recruitment literature and news releases to make sure that they don’t promise free healthcare or imply a certainty of favorable outcomes or benefits beyond that outlined in the consent document.

In the week since this story first appeared, a multitude of media stories have reinforced the unsubstantiated, and potentially harmful, public health message that gaining weight during pregnancy could lead to obese children and that restricting weight gain might prevent obesity. Medical and public health professionals have been silent.

Every day brings us closer to the frightening parallels by Dr. Edmund D. Pellegrino, M.D., Professor Emeritus of Medicine and Medical Ethics and Adjunct Professor of Philosophy and Director of the Center for Bioethics at Georgetown University, in his sobering assessment of medical ethics today. In describing what he saw happening in medicine, he cautioned that medicine was increasingly being used for purposes other than the good of the sick, and failing to be stewards of sound medical knowledge. “Clearly, the major lesson of the Nuremberg Trials has not been learned,” he wrote. The oppression and violation of human rights has repeatedly felt justified for what's considered to be moral and right reasons.

At its deepest soul, the practice of medicine is founded on the moral commitment to heal and protect patients, especially the most vulnerable. Medical ethics calls upon us to not engage in human experimentation without the voluntary, informed consent of the patient; to ensure that the research conforms to accepted scientific principles and a thorough knowledge of the science; and to particularly safeguard the rights and welfare of vulnerable populations such as pregnant women, babies and children, institutionalized people, the handicapped or economically-socially disadvantaged.

Moral lessons are quickly forgotten. Medical ethics is more fragile than we think. Moral reasoning based on defective premises tends to recur in new settings.Dr. Edmund D. Pellegrino, M.D., “The Nazi Doctors and Nuremberg: Some moral lessons revisited,” 1997.

© 2009 Sandy Szwarc

* JFS has covered the research on the lack of efficacy or effectiveness of these interventions at length. Newer readers, you’ll find a Google search tool to the right, to read about studies you may have missed.

Thanks Anita!

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