Lab Soft News

Seeking a Shorter, More Efficient Path to New Drug Development

A recent article in the New York Times discussed new ways being considered to decrease the cost and time required for new drug development (see: Seeking a Shorter Path to New Drugs). Read the whole article if you have the time. Embedded in it was the passage below that caught my attention:

[What's] smaller than a breadbox, can cost $800 million or more, and takes more than eight years to research and develop? [A new medicine and] that’s just for traditional drugs made by using old-fashioned chemical molecules. Developing new biopharmaceuticals — those high-tech wonder drugs fashioned from living cells — can cost $1.2 billion, according to the center....Now big-picture thinkers, within the industry and outside it, are re-examining every stage of drug development ...in an effort to foster faster innovation....The Massachusetts Institute of Technology...started a pharmaceutical innovation program this year to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals....One short-term goal [of the program] is to identify, and rectify, the root causes of bottlenecks in the existing system....If [progress] is to happen, some drug companies that have been fierce rivals will have to play nicer....One idea is for drug makers to share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy. Although many companies have committed to publishing the results of clinical trials, whether or not they succeed, drug makers don’t typically publish information about projects that fail at an earlier stage. A result is that companies waste many millions going down experimental paths that their competitors have already found to be dead ends....In the absence of a public database on failed drug compounds, a small group from the Sloan School of Management at M.I.T. and the Harvard Business School has created Pharmer’s Market, an online prediction market that uses crowd-sourcing to forecast the likelihood of a drug’s success. Introduced last month, the market has invited biomedical researchers and other drug industry experts to place anonymous bets, using virtual money, on the likelihood that certain breast cancer drugs, currently in clinical trials, will succeed or fail.

The notion and rationale for encouraging pharmaceutical companies to reveal information about compounds that they have tried and shelved is self-evident and requires little further discussion. However, the idea of using crowd-sourcing to forecast the likelihood for the success of a candidate drug in clinical trials may be unknown to some readers. Here's a definition from the Wikipedia of crowd-sourcing which is a key component of prediction markets:

Crowdsourcing is a neologism for the act of taking tasks traditionally performed by an employee or contractor, and outsourcing them to a group (crowd) of people or community in the form of an open call. For example, the public may be invited to develop a new technology, carry out a design task (also known as community-based design and distributed participatory design), refine or carry out the steps of an algorithm (see Human-based computation), or help capture, systematize or analyze large amounts of data (see also citizen science).The term has become popular with businesses, authors, and journalists as shorthand for the trend of leveraging the mass collaboration enabled by Web 2.0 technologies to achieve business goals.

Crowd-sourcing seems to work even in the apparent absence of respondents who have expertise in the topic under discussion. It seems to me, however, that an opinion about a candidate drug in clinical trials can be based on informed opinions from a broad segment of pharmaceutical researchers such as the history of similar compounds or adverse reactions to them. At any rate, this approach is certainly worth a try.

Confusion Caused by Conflating "False Positive" and "Overdiagnosis" in Breast Cancer

I have previously discussed some of the issues regarding the recent controversy about mammography screening for women in their 40's (see: Science-Driven Medicine Bumps Up Against Perception of Risk with Mammography; President of the ACP Defends Evidence-Based-Medicine and USPSTF). Gina Kolata, a highly regarded health reporter for the New York Times, has written one of the best articles to date about how the panel of experts developing the mammography guidelines arrived at their conclusions (see: Behind Cancer Guidelines, Quest for Data). Having said this, I also should also state that a portion of her article was very confusing, conflating false positive test results with overdiagnosis. Below is an excerpt from it. The Dr. Heidi D. Nelson referred to in this excerpt led a team of researchers in Oregon whose work was the basis for new guidelines on breast cancer screening.

Dr. Nelson’s group drew upon a National Cancer Institute database of eight million mammograms in the United States telling what sort of mammogram — digital or film — the women got, when they got it, and whether they had follow-up tests. Analyzing those data, she concluded that women in their 40s have about a 10 percent chance of a false positive and a 1 percent chance of having a biopsy each time they have a mammogram. While those risks are small, they gain more significance when weighed against the relatively small risk of cancer for women in their 40s — a risk of 1.5 per of 1,000 women. The serious harm, panel members said, is overdiagnosis, finding cancers that are better off not being found. In 2002, when the group last reviewed breast cancer screening studies, the idea of overdiagnosis was not well formed. It has been hard for many people, even scientists, to believe that some cancers start then stop or even regress. But researchers all over the world have been finding overdiagnosis in studies of all sorts of cancers. Dr. Barnett Kramer of the National Institutes of Health, who was not part of the panel, described overdiagnosis as “pure harm” because it means that women are treated with measures like chemotherapy, radiation and surgery for tumors that do not need treating.

A false positive test is one that it erroneously confirms that a patient has a particular disease (i.e., breast cancer). It's a misdiagnosis plain and simple, a misinterpretation. In the case of a breast biopsy report, it's commonly the result of an error on the part of the pathologist interpreting the biopsy. Overdiagnosis, in my opinion, is very different. The various stages of the development of breast cancer constitute a spectrum of disease from a lesion that shows the earliest signs of malignancy to one in which the cells are highly atypical under the microscope and represent an aggressive lesion. One type of overdiagnosis can occur if and when a pathologist tilts in his or her judgment toward a slightly more malignant interpretation on this continuum. This may not be an error on the part of him or her but may rest within the range of correct diagnoses. The pathology report may simply reflect a difference in judgment. The diagnostic criteria may be broad or the experts may not totally agree about them.

However, there is yet another form of overdiagnosis based on the biologic nature of the cancer. Into this category falls those lesions referred to above as "better off not being found." In such cases, for example, all pathologists diagnosing such the lesion might agree that it shows similar morphological criteria of malignancy. However, the lesion may not possess the genes programming it to invade and metastasize in vivo. A competent pathologist would be unable to make this determination because the lesion's morphology would not reveal its true nature. In fact, such a determination might impossible given today's state of knowledge. Lesions of this type should not be biopsied at all because they could lead to the "pure harm" referred to above. Unfortunately and at this time. we don't have a means to determine a priori which breast masses not to biopsy because any diagnosis would constitute overdiagnosis and any treatment would be overtreatment.

President of the ACP Defends Evidence-Based-Medicine and USPSTF

In a previous blog note about the recent flap relating to mammography recommendations for women in their 40"s (see: Science-Driven Medicine Bumps Up Against Perception of Risk with Mammography), I made the following statement:

So the question for health and lab professionals is whether this is a general vote in favor of early screening and against EBM and comparative effectiveness as tools and analytic methods for the future. I think that the answer to this question is probably no because of some of the unique aspects of mammography in particular and women's breast health in particular. Breast screening in so ingrained in our culture through long-standing practice that it will be nearly impossible to alter in any substantial fashion. However, any health panel recommendations in the future may need to take the individual wishes and perceptions of healthcare consumers into consideration. For me, this is the major lesson that has now been learned.

The pressure is now on regarding evidence-based medicine and expert task force recommendations, forcing Dr. Joseph W. Stubbs, MD, President, American College of Physicians, to rise to the occasion, defend EBM, and scold the authors of the "ill-founded attacks" (see: Statement on the politicization of evidence-based clinical research). Below is an excerpt from his statement:

The American College of Physicians (ACP)... believes that it is essential that research on the effectiveness and comparative effectiveness of different medical treatments not be influenced by political considerations. The U.S. Preventive Services Task Force (USPSTF) recommendations on mammography...have regrettably been used by some critics of the health reform bills being considered by Congress to make baseless charges that the bills would lead to rationing of care. Other critics have made unfair and unsubstantiated attacks on the expertise, motivations, and independence of the scientists and clinician experts on the USPSTF. ACP believes that it is essential that clinicians and patients be able to make their own decisions on diagnosis and treatment informed by the best available scientific evidence on the effectiveness of different treatments and diagnostic interventions....As is often the case with evidence-based reviews, the USPTF's recommendations will not always be consistent with the guidelines established by other experts in the field, by professional medical societies, and by patient advocacy groups. Such differences of opinion, expressed in a constructive and transparent manner so that patients and their clinicians can make their own best judgment, are important and welcome. It is not constructive to make ill-founded attacks on the integrity, credibility, motivations, and expertise of the clinicians and scientists on the USPSTF. Some critics have erroneously charged that the USPSTF's recommendations were motivated by a desire to control costs.....[I]n situations where there is likely to be some effectiveness of the service, the Task Force searches for evidence of the costs and cost-effectiveness of implementation, presenting this information separately from its recommendation and the recommendations are not modified to accommodate concerns about insurance coverage of preventive services, medicolegal liability, or legislation, but users of the recommendations may need to do so.

Here's what I think that Dr. Stubbs is saying in plain language. "Holy Toledo! There is some very serious stuff going down here. First of all, evidence-based-medicine is taking a beating in the press. Secondly, our esteemed journal and the USPSTF (how is this acronym actually pronounced?) is being accused of taking cost-effectiveness into consideration in its scientific deliberations. Thirdly, we are also accused of being in league with the insurance industry by paying attention to the cost of care. These canards are unworthy of comment but I am going to issue a statement anyway. If we made any mistake at all, it was ignoring the wishes of the female healthcare consumers of the country. But since when do prestigious medical task forces need to anticipate and factor the wishes of consumers into their recommendations?" I think that the answer is starting now.

It's Time for the FDA to Prohibit Direct-to-Consumer Advertising by Pharmaceutical Companies

I have generally been suspicious about direct-to-consumer (DTC) advertising by pharmaceutical companies on TV and in glossy magazines. This type of advertising provides the drug companies with an opportunity to manipulate the viewing public with brief, slick messages. I expressed my reservations in a previous blog note (see: Effectiveness of "Direct-to-Consumer" Drug Advertisements). A recent article emphasizes how these ads may not boost sales and also that the taxpayers may actually be funding them. Below is an excerpt from it (see: Drug ads ineffective for boosting sales, could cost taxpayers: UBC-Harvard study):

US Taxpayers may be on the hook for the high cost of drug advertising that does little to boost sales, according to a new study led by a University of British Columbia health policy researcher. The study...examined the US sales patterns of clopidogrel, a top-selling drug also known by the trade name Plavix used to prevent blood clots after heart attack or stroke. The drug was selected to study the impact of advertising on sales because it was sold for more than three years before the launch of its first direct-to-consumer advertising (DTCA) campaign in 2001. "While clopidogrel use has been increasing for some time, we found advertising it to consumers didn't make use rise any faster," says [one of the authors of the study] The researchers found a significant jump in the drug's price that coincided with the launch of its DTCA campaign. This higher price added US $207 million to the pharmacy bill for Medicaid, a publicly funded health program in the US for individuals and families with low incomes...."The key issue is whether advertising to consumers, which has risen 330 per cent in the last 10 years in the US, contributes to the significant cost increases in publicly funded health insurance programs such as Medicaid," says [another author of the study].

This news comes at the same time that the FDA is holding hearings about whether pharmaceutical companies should be allowed to use social media such as Twitter to promote their products (see: FDA Begins to Shape Rules for Online Drug, Device Ads). My reaction to this latter issue was instantly negative, given the fact that Tweets are limited to 140 characters. In such a setting, the contraindications to the use of a drug cannot be adequately covered. Moreover and at least in my mind, there is the distinct possibility that the less ethical pharmaceutical companies could pay individuals to post glowing reports about their products on social media as a form of viral marketing. There is no way that the FDA could police such underhanded activities on Twitter with a current daily volume of about 25 million message.

Let's put an end to all DTC advertising by pharmaceutical companies on TV and magazines. These companies should, of course, be allowed to communicate with physicians via the web and printed materials. As I noted above, the web, but not web-based social media like Twitter, is the most appropriate communication channel for healthcare consumers who want to acquire detailed information about drugs. In essence, they would be looking over the shoulders of the doctors. Web advertisements and reports by these companies, of course, can easily be scrutinized by the FDA. Consumers browsing the web can also get ready access to medical journal articles about the effectiveness of drugs and also adverse reactions, achieving a balance not available on TV or consumer magazines.

Science-Driven Medicine Bumps Up Against Perception of Risk with Mammography

The recent recommendation of a panel of experts that routine mammography is no longer necessary for women in their 40's was greeted by widespread skepticism and will probably be ignored by most physicians and patients. My personal interpretation of these events is that most women viewed early detection of breast cancer as trumping the "problems" associated with false positive reports. For those with health insurance, the cost of care for many does not play a large part in this decision process. The New York Times published a short but excellent analytical piece about this issue with a look at the future (see: Medical Science and Practice in Conflict). Below is an excerpt from the it:

This week, the science of medicine bumped up against the foundations of American medical consumerism: that more is better, that saving a life is worth any sacrifice, that health care is a birthright....The backers of science-driven medicine, with its dual focus on risks and benefits, have cheered the elevation of data in the setting of standards. But many patients — and organizations of doctors and disease specialists — find themselves unready to accept the counterintuitive notion that more testing can be bad for your health....For decades, the medical establishment, the government and the news media have preached the mantra of early detection, spending untold millions of dollars to spread the word. Now, the hypothesis that screening is vital to health and longevity is being turned on its head, with researchers asserting that mammograms and Pap smears can cause more harm than good for women of certain ages....The challenge of persuading patients and doctors to accept such standards requires a transformational shift in thinking, particularly when the disease involved is as prevalent, as deadly, and as potentially curable as cancer. How do you convince them that it is in their best interest to play the odds when they have been conditioned for so long to not gamble on health? After all, for the one in 1,904 women in their 40s whose life would be saved by early detection of breast cancer, taking the risk would in retrospect seem a bad choice.

I was fascinated by the author's use of the term "science-driven medicine" -- I will take it to be largely synonymous with evidence-based medicine (EBM) with some overlap with comparative effectiveness. I have an image of a panel of experts poring over research articles, weighing the data, and concluding that the earlier screening was not cost-effective. Organizations with the most financial skin in the game such as the American Cancer Society and the American College of Radiology were the first out of the gate, decrying the evidence and the conclusions of the panel. The women of America as the consumers of the service then weighed in aggressively in favor of the earlier screening -- whatever evidence was present to support the conclusion was left in the dust.

So the question for health and lab professionals is whether this is a general vote in favor of early screening and against EBM and comparative effectiveness as tools and analytic methods for the future. I think that the answer to this question is probably no because of some of the unique aspects of mammography in particular and women's breast health in particular. Breast screening in so ingrained in our culture through long-standing practice that it will be nearly impossible to alter in any substantial fashion. However, any health panel recommendations in the future may need to take the individual wishes and perception of healthcare consumers into consideration. For me, this is the major lesson that has now been learned.

A Quick Look at Cardiovascular Information and Imaging Systems (CVIS)

I must have been sleeping at the switch. Outside of my lab/LIS world, a new category of integrated clinical information systems has arisen -- the CVIS or cardiovascular imaging and information system. McKesson provides a CVIS web site promoting the McKesson product. Listed below and copied from the "comparing solutions" tab of this web site is a summary of the functionality of their system:

• Reporting: (1) Real-time reporting; (2) Remote report creation and signing; and (3) Automated rules-based report distribution
• A single, coordinated image display, to view all medical images
• Single sign-on for clinicians to access multiple systems
• Patient-centric workflow
• Robust digital archiving (efficient access to historical images and data, including echocardiograms, and ECGs and hemodynamic waveforms)
• Web access for clinicians and referring physicians

Readers of this blog will undoubtedly be familiar with the major "ancillary" information systems: LISs, RISs, and pharmacy information systems. In addition, we now have the PACS variants in both radiology and pathology. They are used for archiving the digital images acquired in both departments. The CVIS is a very interesting variant on this theme of specialty-oriented systems because, it combines workflow, reporting, and digital archiving similar to LISs, RISs, and PACSs. Note the reference above to a "single sign-on for clinicians to access multiple systems." Cardiologists, the major users of CVISs, obviously need access to the hospital EMR to integrate various streams of clinical data such as current medications and nursing progress notes.

I have suggested in previous notes that hospital EMRs are not adequately designed to hold the text and image files generated in diagnostic departments such as the clinical labs, pathology, radiology, and cardiology. Here are two quotes from a previous note discussing the superiority of "ancillary department automation" over EMRs and the goals of EMR vendors (see: EMR Failures and a Recipe for Their Avoidance in the Future):

• ....Mr. HIStalk's proposed solution [for managing hospital information systems]: stick with ancillary department task automation. I will take his definition of ancillary information systems to primarily involve LISs, RISs, PACs, and pharmacy information systems. Unfortunately, few CIOs and CMIOs have in-depth knowledge about the lab, radiology, or pharmacy systems. They are managed by the knowledge and process domain experts in the specific hospital departments, frequently with hosting by the central IT departments.

• For their part, EMR vendors continue to pursue their short-term strategy of selling inadequate and poorly designed systems that that are difficult to install, don't scale up, or perform inadequately. CIOs and CMIOs keep buying inadequate EMRs, despite the long  history of failure of these systems, because they are paid to deploy "modern" systems and there are few if any in the market that respond to their wish lists. You have two sets of players that are pursuing a flawed business model in concert.

So what is the take-home lesson from all of this. Pretty simple, really. The "departmental diagnostic systems" continue to evolve, frequently integrating images with reporting information. Moreover, they also manage patient and physician mission-critical workflow for the various specialties. This is in contrast to hospital EMRs that more frequently serve as data repositories relating to clinical care. The LISs, RISs, radiology/pathology PACS, and now CVISs are thus on a different development trajectory than EMRs. I am not exactly sure of the future relationship of the EMRs to these ancillary systems but the "integration" challenges will be formidable.

Reader Suggests Substitutes for the Term "Soft Copy Read" in Digital Pathology

In a blog note posted yesterday, I suggested that the term soft copy read could be used by pathologists to describe the process whereby a scanned image of a tissue lesion is reviewed using a terminal rather than a microscope (see: Digital Pathology, Pathologists, and the "Soft Copy Read"). I am not completely satisfied with this phrase, borrowed from the radiologists, but think that its use, or a similar phrase, could be useful in the digital pathology dialogue. In response, Lance submitted the following comment:

Perhaps a more applicable term would center around the [term]: 'digital diagnosis' or 'z-view diagnosis'. Note, in both terms, inclusion of the term 'diagnosis' implies that the final decision/diagnosis rendered was made using the preceding word's methodology. For the two (off the cuff) terms - 'digital diagnosis' would imply/mean that the diagnosis was made using a digital display, and the latter incorporates the fact that the digital scanner incorporates a z-plane. Granted, with the latter term, a 'z-plane' is technically a component of glass slides as well, though we often don't think of it in such terms. Moreover, this renders an interesting question regarding terminology and nomenclature. One factor not fleshed out in this post is the permanent inclusion of a term (such as 'glass diagnosis' or 'glass review') that details/parallels the 'hard copy', e.g. glass in the world of pathology. Perhaps the term 'tissue diagnosis' remains correct, but it greatly generalizes things and may become akin to saying a clinical diagnosis was made...a term that, in actuality, fails to convey any methodology used, but rather is a generalized 'waste basket' term.

First of all, I agree with Lance that the inclusion of the term diagnosis in the phrase could be misleading. Frequently, there is no lesion present so no diagnosis can be rendered. The use of the term z-view is also misleading because most paraffin sections, but not necessarily cytopathology smears, will be scanned only in one plane. The terms glass view or glass review suggested by Todd above have much to recommend them. I will also suggest the phrase glass read that is quite similar to soft copy read and has a clarity and directness that appeals to me. Given that tissue sections mounted on glass will not disappear in the foreseeable future, any term including the word glass should have a long life.

So, to recap the discussion, we are considering at several terms to describe the review of a scanned image on a terminal screen by a pathologists. The current candidates are the following:

• Soft copy read
• Soft copy review
• Glass read
• Glass review
• Glass view

Among these, I personally favor glass read or glass view because they are short, descriptive, and to the point. What do you think?

Digital Pathology, Pathologists, and the "Soft Copy Read"

A reader of Lab Soft News has suggested that it would be useful if pathologists were to adopt the phrase soft copy read as part of the ongoing discussion about digital pathology. The term is in common usage among radiologists. Digital pathology, of course, refers to the process by which the images obtained from fixed stained paraffin sections of tissue are converted to digital format, interpreted by pathologists, and then stored. Soft copy read refers specifically to the rendering of a diagnosis from an image displayed on a monitor without the creation of a hardcopy image as an intermediate step. Radiologists, of course, have a history prior to the development of digital radiology of "reading" a hardcopy film copy of the image.

The use of this phrase may be useful because the term digital pathology is often used to describe the entire digital pathology process. I can see the value of teasing out individual steps and assigning them specific names. I personally was initially confused by the use of term soft copy read because pathologists have never made use of a hard copy like radiologists. In other words, this intermediate step has never really existed for pathologists other than in the occasional post-diagnostic step of integrating one or more images of a lesion in the printed report sent to the test-ordering clinician. 

Having said this and not being sure that the use of the term soft copy read will gain currency among pathologists and digital pathology experts, I do understand the value of its use. In my subsequent notes on this topic, I will try to make it a practice to use this term and we will see if it has staying power.

Some Key Questions in Cytopathology That Require Immediate Answers

I recently shared the podium for a lecture with Dr. Liron Pantanowitz. This took place at the annual conference of the American Society of Cytopathology (ASC) in Denver. The two of us discussed innovation and the relevance of information technology (IT) for the field of cytopathology. At the end of his lecture, he presented to the audience the following key questions that are confronting the field and require immediate answers:

• Are conventional Pap smears still considered acceptable standard of care?
• Is autoverification (no human review) of imaged abnormal Pap tests feasible?
• Will future re-screening require morphology review or molecular tests?
• Will automated screening be applied to non-GYN specimens and FNA biopsies?
• Once [cytopathology] images are [stored] in...computer system[s], [can or] will [their interpretation] be outsourced?
• Are new technologies being incorporated into [our training and] educational programs?
• Can we do it? i.e. keep cytologists in the center of [the] clinical decision-making [process]?
• Can this technology help provide affordable cytology services in unscreened populations without an effective cytology infra-structure? If not, what is the best way to develop this infrastructure?
  
• Will disruptive technology (i.e. new technology that transforms markets) “replace” cytotechnologists &/or pathologists?

I have concluded on the basis of my participation in this conference and other observations that cytopathology professionals have been energized by the availability of vaccines such as Gardasil against human papilloma virus. These vaccines have the potential to eventually eliminate most cervical carcinoma. Much of the energy and professional attention of this group over many decades has been devoted to screening Pap smears for cervical disease. Logically, questions are now being raised within the group about the future of the specialty if and when carcinoma of the cervix is largely eliminated.

From my perspective, it is an urgent matter for pathology groups such as the ASC develop answers to questions such as the ones developed by Dr. Pantanowitz. In fact, I am confident that the ASC leadership is already in the process of addressing many of them. However and for me, these answers are required so quickly that what I regard as the standard approach used by professional societies is no longer adequate. I would recommend instead some variant of the following process:

• Set a deadline of, say, six months to a year hence for the delivery of answers to these and related questions from newly empaneled task forces drawn from the members of the society.
• Although the members of the society should comprise the bulk of the membership of these task forces, they may need to be supplemented by technical and medical advisers from outside of the society when necessary and appropriate.
• It may also be necessary to engage outside consultants to help manage and advise these task forces in order to deliver reports in the aggressive time-frame described above.
• Additional financial resources may be required to support these task forces and quickly arrive at the necessary answers. It may thus be necessary to turn to vendors in the cytopathology field to help fund these initiatives with grant support. These vendors, of course, would not be able to influence the deliberations of the task forces but would obviously derive great benefit from their deliberations.
• Finally, I believe that it is insufficient to merely provide an informed academic discourse about these questions in reports or white papers. In addition, it will be necessary to develop a set of actionable items such that the talent and expertise of cytopathology professionals can be utilized  in diagnosing and treating disease in the face of the new types of "disruptive technology" and social forces that will be confronting them.

Will Posting Calorie Counts in Fast Food Restaurants Help Curb Obesity?

I am a person who thrives on acquiring new information and believe that information can be used to modify one's behavior. In short, I am an informavore (see: Are We Turning into Informavores?). I suspect that many others share this same quality but many in the U.S. population do not. A recent op-ed piece in the New York Times explored the benefits of posting calorie counts in fast food restaurants. Listed below is what I perceive to be the key passage in the article:

Based on the scientific literature, we know that people who seek out and use calorie information are likely to be different from other eaters in many ways, including their motivation to cut calories. Sure, it’s possible that some people who looked at the information were persuaded to consume fewer calories, but it is equally plausible that those who were intending to order lower-calorie meals were more likely to seek out the calorie information. By helping consumers make more informed decisions, calorie posting may be desirable even if it fails to reduce calorie intake. But effective policies to deal with obesity will need to involve much more than posting calories. People eat too much because calorie-dense foods are convenient and cheap, with large portion sizes priced to encourage overeating.

Note the passage above that references "people who seek out and use calorie information." I suspect that they are in the minority in our population. On the other hand, my guess is that the legislators who propose the calorie-posting rules, and the scientists and nutritionists and scientists who advise them, tend to be among those who seek information and are influenced by it. They are also anxious to address the obesity epidemic that we are facing in this country. I personally read calorie counts on labels and would certainly scan them, and be influenced by them, in a fast food restaurant. How many people know that a teaspoon of mustard contains 5% of your daily value for sodium?

However, and as noted above, fast-food-addicts gravitate to these restaurants because of convenience, price, and because the food tastes good to them. These foods taste good because they are loaded with fat, salt, and sugar, all of which have additive qualities (see: Federal Tax on Soda Pop Proposed: Can This Be Justified?). I seriously doubt that posting calorie information in fast-food restaurants goes to the root of the problem that the rules are intended to correct. Our legislative energies should be directed to policies that work rather than those that appeal to information-lovers.