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Why Non-Scientists Should Not Direct Scientific Efforts: Senator Harkin’s Misguided Beliefs Exposed

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I’ve been blogging a lot recently about the problems caused by health policy makers who don’t appear to understand medicine or science. I’ve also been lamenting the relative lack of physician input at the highest level of health reform. But today I’d like to present a prime example of the perfect storm in health policy: when willfulness, ignorance, and magical thinking combine to push an agenda despite billions of tax payer research dollars proving the futility of such efforts.

In this video, Senator Tom Harkin describes the impetus behind the creation of the National Center for Complementary and Alternative Medicine (NCCAM). Harkin suggests that he single-handedly introduced legislation in 1992 that created the Office of Alternative Medicine at the National Institutes of Health (NIH). This office paved the way for an entire new branch of research at NIH devoted to exploring the potential validity of non-science based medical practices such as homeopathy, acupuncture, traditional Chinese medicine, energy healing, meditation and more. He introduced the legislation because a friend of his experienced a substantial health improvement after trying one of these non-science based therapies. Essentially, an entire branch of the NIH was founded on an anecdote.

What’s worse is that after a decade of careful analysis of these alternative therapies, science has shown that not a single one of them appears to be efficacious beyond placebo. One would think that Senator Harkin would be embarrassed by the colossal waste of tax payer resources spent on this pet project of his. But no, instead he chastises the scientists who did the research, saying that they had failed to do their job of “validating” the therapeutic modalities. Wow. I guess he was never interested in finding out the truth about what works and what doesn’t – because when objective analysis reveals that these modalities don’t work, then the science must be flawed.

Now don’t get me wrong – healthy eating, regular exercise, emotional and psychological support are critical factors in good healthcare, and I fully believe that America needs to become a “wellness culture” in order to prevent chronic diseases and improve quality of life. I also believe that Americans are often over-treated and over-medicated when lifestyle interventions might be their best treatment option. However, in encouraging behavior modifications, we don’t need to foist placebo therapies on them under the banner of science. The problem with “integrative medicine” is that it takes some good medical principles and infuses them with scientifically debunked and outdated systems of thought (debunked repeatedly by NCCAM, the very scientific body that Harkin hoped would validate them.)

What we really need to do is stop splitting the practice of medicine into “integrative” vs “non-integrative” and simply follow scientifically vetted best practices. Patients need a comprehensive approach to their health, a medical home with a good primary care physician coordinating their care, reliable health information to support their decision-making, a strategy to eat well and exercise regularly, and mental health services as needed.

Senator Harkins’ plan to continue flogging the alternative medicine “dead horse” is not helpful – it’s not good science, and it’s not a good way to spend our tax dollars. I can only hope that one of the positive effects of Comparative Clinical Effectiveness Research will be to put an end to the promotion of the ineffective therapies that Harkin fervently hoped would be validated. I also hope that the new Federal Coordinating Council will not support funding to pet projects that are founded upon anecdotes, pseudoscience, and wishful thinking. Now more than ever we need good science underpinning our healthcare spending, and we need informed scientists advising our government on priorities for America’s health.

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Addendum:

More outrage from the medical blogosphere over Harkin’s views:

1. Dr. David Gorski:  Senator Tom Harkin: “Disappointed” that NCCAM hasn’t “validated” more CAM

2. Dr. Peter Lipson: Harkin’s War On Science

The AMA And Congress: How To Cross The Cultural Divide

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The AMA’s communications department kindly sent me a copy of a letter that they (and 9 other professional society CEOs or Presidents) recently sent to Barack Obama and 12 members of congress. I’ve been blogging about the fact that healthcare providers in general, and physicians in particular, do not seem to have much of a voice in healthcare policy. In fact, from what I can tell, Dr. Nancy Nielsen is carrying the torch almost exclusively. I don’t mean to belittle anyone’s efforts, it’s just that I’ve noticed that she is often the only physician at the highest level policy meetings.

So it was with great interest that I read the group letter to Obama et al., wondering what collective message our physician leaders were trying to get across. The writing was academic – using terminology familiar to those heavily steeped in medicine – and emphasized the creation of a patient-centered culture supported by evidence based medicine.

However, the letter raised an interesting question in my mind: Will members of congress read and understand it? I believe that the most effective letters to congress are likely to share three qualities: 1) they must be emotionally provocative 2) they must be written at about the 6th grade reading level 3) they must be brief.

Why Letters Must Appeal To Emotion (“Cultural Competency”)

Dr. Nielsen said at a recent Medicare Policy Summit that speaking with Senators can be “pure theatre.” That has been my observation as well. Decades of experience speaking in large committee meetings have taught them that amusing sound bites or emotional outbursts get attention. In fact, it may be the best way to get things done in congress. For example, did you know that the reason why kidney care is the only disease-based eligibility under Medicare is that Shep Glazer testified before congress during one of his dialysis sessions?

Washington , D.C. , Nov. 4, 1971 – In the most dramatic plea ever made on behalf of kidney patients, Shep Glazer, Vice-President of NAPH, testified before the House Ways and Means Committee while attached to a fully functioning artificial kidney machine.

Minutes before, in the corridor outside the hearing room, Shep told reporters from the AP, UPI, and the Washington Post, “Gentlemen, I am going to tell the Committee that if dialysis can be performed on the floor of Congress, it can be performed anywhere.” As his wife, Charlotte , connected him to the machine, he continued, “Kidney patients don’t have to be confined to hospitals, where expenses are $25,000 a year and more per patient. It’s much cheaper in a satellite unit or at home. I want to show the Committee what dialysis is really like. I want them to remember us.”

My point is that in congress, as opposed to medical meetings, emotion is king. Physicians have a hard time speaking from the gut, since we’re trained to speak from data – because we know that the gut can be misleading. However, my plea to physician groups is this: let’s collect our data, understand the science behind our point of view, and then present our advice in a way that is persuasive to congress. That means we’d probably benefit from a few theatre classes (can we get CME credit for them?) I’m not suggesting that we become undignified in any way – I’m just saying that personal stories, case studies, and appeals to emotion are the currency on the Hill. If we want attention, we’ll need to find a way to make our points in their own language.

For example, I was listening in to a recent Senate hearing on healthcare finance, when a Republican senator began his introductory remarks about “out of control spending” with this:

I must tell you that I have major concerns about our current approach to spending. We’ve already sunk billions of dollars into all kinds of bailouts and programs without any clear benefits. But every time I bring up the excessive spending issue, you’d think I was a skunk at a picnic…

An amusing analogy, and one that resonated with his peers. This Senator understood the culture to which he was speaking. In other words, he had a “culturally competent” message.

Why Letters Should Be Written At About The 6th Grade Reading Level (Health Literacy)

Dr. Richard Carmona told me that one of the first things he learned as Surgeon General was that the American people understand health information at a 6th grade reading level. Thus, there is no point in making a 100+ page medical report on the health hazards of smoking the corner stone of a public smoking cessation campaign.

Health information must be written in a clear, and actionable manner – but it must also be delivered in such a way that it resonates with diverse communities. Letters to congress are no different – many of our congressmen and women do not have advanced medical or science degrees. We must be sensitive to that and write to them in a way that makes it easy for them to understand what we’re hoping to accomplish.

Why Letters Must Be Very Brief

Much has been made of the fact that many people who signed the recent 1000+ page stimulus bill hadn’t actually reviewed it. In fact, it is estimated that 306 members of Congress voted for a bill they had not read.

Of the 535 members of the United States House and Senate,  246 House members and 60 members of the august Senate voted for the $787 billion  stimulus bill without having read a single one of the bill’s 1,071 pages or having any idea of where all of this money borrowed from our grandchildren is going to be spent.

So if our members of Congress don’t read the stimulus bill, will they take the time to read long letters from professional societies? I think you know the answer.

Conclusion

The AMA should be applauded for their lobbying efforts on the part of physicians in Washington. However, my personal view is that letters to congress may be more effective if they are written in a concise, jargon-free, compelling way that respects the “culture” of congress. We physicians hear a lot about “health literacy” and “cultural competency” – and must remember to apply those principles to letter-writing campaigns.

Will any letter influence congressional decision-making? It’s hard to measure the “ROI” of group letters to congress – and certainly they’re only one part of a larger strategy. However, it behooves us physicians to find ways to reach across the cultural divide to speak to congress about the issues that trouble us all: the fate of patients. Letters may be helpful, but an increased presence in Washington, along with some heartfelt reasoning, may be our best shot. Perhaps the Broadway actors affected by the economic recession could help us out?

Attention Health Policy Makers: How To Win Docs And Influence Patients

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carnegie_smallPretty much everyone agrees that we need to improve the quality of healthcare delivered to patients. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.

Some 340 thousand physicians have access to a fully peer-reviewed, regularly updated decision-support tool (called “UpToDate“) online and on their PDAs. This virtual treatment guide has 3900 contributing authors and editors, and 120 million page views per year. The goal of the tool is to make specific recommendations for patient care based on the best available evidence. The content is monetized 100% through subscriptions – meaning there is no industry influence in the guidelines adopted. Science is carefully analyzed by the very top leaders in their respective fields, and care consensuses are reached – and updated as frequently as new evidence requires it.

Not only has this tool developed “cult status” among physicians – but some confess to being addicted to it, unwilling to practice medicine without it at their side for reference purposes. The brand is universally recognized for its quality and clinical excellence and is subscribed to by 88% of academic medical centers.

In addition, a recent study published in the International Journal of Medical Informatics found that there was a “dose response” relationship between use of the decision support tool and quality indicators, meaning that the more pages of the database that were accessed by physicians at participating hospitals, the better the patient outcomes (lower complication rates and better safety compliance), and shorter the lengths of stay.

So, we already have an online, evidence-based treatment support guide that many physicians know and respect. If improved quality measures are our goal, why not incentivize hospitals and providers to use UpToDate more regularly? A public-private partnership like this (where the government subsidizes subscriptions for hospitals, channels comparative clinical effectiveness research findings to UpToDate staff, and perhaps offers Medicare bonuses to hospitals and providers for UpToDate page views) could single handedly ensure that all clinicians are operating out of the same playbook (one that was created by a team of unbiased scientists in reviewing all available research). I believe that this might be the easiest, most palatable way to target the problem of inconsistent practice styles on a national level. And as Senator Baucus has noted – the potential savings associated with having all providers on the same practice “page” is on the order of $757 billion. And that’s real money.

I highly recommend a bottom up approach, not top down. That’s how you win docs and influence patients.

Another Example Of Good Medicine That Does Not Follow “Protocol”

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As far as I can tell, there are very few physicians currently involved in the innermost circles of healthcare reform. This is concerning to me, not because I’m one of those “paternalistic doctors” who “drive up in their Porsches threatening to pull out of Medicare” but because I think that many policy makers don’t really understand the incredible complexity associated with doing the right thing for patients. Here is an excerpt from the WhiteCoat’s Call Room blog that perfectly illustrates why practicing good medicine often requires a break from protocol:

It isn’t just the patients who think I’m a bad doctor.

Based on the information from all the pinheads at Medicare’s “HospitalCompare” web site, I’m downright dangerous.

For those who don’t know about Hospital Compare, it is a site where the general public can compare the “quality indicators” for hospitals on measures deemed important by the AHRQ.

I failed to meet a couple of indicators recently, so I received notices from our hospital administration that I am now considered out of compliance with the HospitalCompare guidelines and am bringing down our numbers on the HospitalCompare.gov web site.

In other words, Medicare thinks I’m a bad doctor.

Let me tell you about the patients I screwed up on.

The first patient was a gentleman in his 70’s who started having chest pain at home. He got sweaty, passed out, and hit his head on the concrete floor in his house, causing a nice goose egg on the back of his noggin. When he arrived in the emergency department, he was still having chest pain, so we hooked him up to an EKG and … lo and behold … he was having a myocardial infarction.

According to the quality indicators at “HospitalCompare”, if a patient with a heart attack is going to receive thrombolytics (”clot busters”), the thrombolytics must be given within 30 minutes of the patient’s arrival at the hospital. If a health care provider takes longer than 30 minutes to administer thrombolytics to someone with a heart attack, the government considers that provider to be practicing bad medicine.

Now I’m faced with a choice:
A. Do I give clot busters to someone who sustained a significant head injury (and may be bleeding internally) so that I can look like a “good doctor” to Medicare and HospitalCompare.hhs.gov? If there is bleeding inside his brain, clot buster medications will make the bleeding worse and could kill him.
-OR-
B. Do I perform a CT scan on the patient to make sure that there is no bleeding inside his brain before I give the clot-buster medications? If I do the CT scan, there is no way that we’ll get the results and be able to give the patient thrombolytics within the 30 minute window.

If I choose “A,” the hospital stays in the upper echelon of facilities that meet HospitalCompare.hhs.gov’s guidelines. Doesn’t matter if the patient dies – according to Medicare, “We’re Number ONE!”

If I choose “B” I’m doing what is right for the patient, but our hospital will look bad and HospitalCompare.hhs.gov will plaster it all over the internet that our hospital doesn’t follow Medicare’s rigid and sometimes life-threatening guidelines.
I chose “B.”

According to HospitalCompare.hhs.gov, my decision made me a bad doctor…

Comparative Clinical Effectiveness Research: How Will It Impact Healthcare?

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When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.

What Is Comparative Clinical Effectiveness Research?

The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:

“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”

Any mention of “comparative cost effectiveness” or value-based language is notably absent.

How Does It Work?

The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).

The budget for the CCER will be divvied up as follows:

400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ

Here is a quote from the ARRA bill, discussing the mechanics of CCER:

“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”

A Game-Changer For Pharma, Medical Technology, and Biotech

There is no doubt that CCER stands to radically change how industry does business. I anticipate that industry will develop their own internal CCER teams, and begin the process of comparing their new product (to others currently available) as early as phase 3 clinical trials. By and large, that’s probably a good thing – though there are potential unintended consequences that deserve mention.

While it’s appropriate for drug, device, and equipment manufacturers to consider whether or not their new product actually contributes something new/better to our current cadre of treatment options, there will be clear winners and losers in this game. And when companies lose, we lose companies. That’s generally not good for the economy. Manufacturers without diversified product lines are more likely to go out of business – and it will become more difficult for new players to enter the marketplace.

Although comparative clinical effectiveness research is distinct from comparative cost effectiveness research – it is likely that payers will use CCER to build their formularies. This means that even though the government (at this point in time) is not mandating coverage decisions based on CCER, health insurers are going to be using the information liberally to justify coverage preferences and even potential denials of coverage.

There’s also the question of stifling innovation. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.

As Dr. Rich argues in his excellent blog: healthcare rationing is inevitable – but it’s more ethical to do it overtly than covertly. I would also like to suggest that insofar as physicians can be enlisted to translate CCER for patients (rather than being handed down inflexible rules from on high) and help them make the best decision for them – that would be even better. The inflexibility of national decisions about healthcare rationing does make me nervous.

What’s Good For The Geese Isn’t Necessarily Good For The Goose

First of all, most key healthcare stakeholders would like to be able to compare efficacy of one treatment option over another. Informed decision-making is hard to do when head-to-head studies are simply not available for most treatment options.

However, population-based conclusions do not always provide a clear “best choice” for individual patients. Individual genetic differences, allergy profiles, complicated drug regimens, unique constellations of diseases, socioeconomic factors, and psychological issues all influence clinical decision-making.

Dr. Nancy Nielsen recently voiced concern about CCER at the Medicare Policy Summit. She said that the AMA’s position is that CCER is for information purposes, not for coverage decisions. CCER’s goal is to help patients make informed choices, not limit their choices. I’m afraid the horse may have already left the barn on that one – but I agree with Dr. Nielsen’s sentiment. It would be wonderful if CCER could remain in its supportive role for shared physician-patient informed decision-making. My fervent wish is that in doing the right thing by the geese, we don’t kill off the occasional goose. Physicians need the flexibility to make exceptions when necessary for their patients.

Republican Unrest

A certain degree of hysteria related to CCER has recently wafted up through the hallowed halls of government. Are republicans overreacting to the bill? Maybe – though the bill doesn’t include any provisions for using CCER to mandate coverage decisions or ration care, it seems that Pete Stark has made it clear that he’d like the FCC to “direct medicine” which does kind of send a shiver down my physician spine, and provides some insight into what some democrats are hoping to accomplish with CCER – laying the foundation for future government involvement in the diagnosis and treatment of patients.

Also one particular congressional report is proving helpful in “reading the tea leaves” regarding the democrats’ plan for CCER. In describing the comparative effectiveness provision, the report states that items, procedures, and interventions “that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”

While congressional reports are not binding, they do give an indication of intent.

The bottom line is that though CCER is not supposed to be used for “cost effectiveness” decisions – there’s no policy in place to protect that from happening.

Conclusion

Information about the comparative clinical effectiveness of treatment options is critical for the practice of evidence based medicine. Such information supports informed decision-making, and could be the single most important strategy for reducing the use of wasteful or ineffective therapies in healthcare.

On the other hand, CCER will certainly have some negative consequences, both anticipated and unanticipated. When “cost effectiveness” conclusions are drawn from clinical effectiveness data, rationing ensues, patient choices are limited, people lose their jobs, and some companies go out of business. As a recent article in the New England Journal of Medicine points out, “saying no isn’t nice.” I greet this 1.1 billion dollar initiative with muted enthusiasm.

Post Script

In my research for this blog post I came across some interesting quotes. I thought I’d add them here for your consideration:

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And before you tell me we need such bills in order to be more scientific, take a minute and ask yourself just how scientific you think the government will be when it applies cost-cutting measures to medicine.  The congress is certainly a hot-bed of evidence-based legislation, isn’t it?

– Edwin Leap, M.D.

When things go wrong, which of course they will, we reach for 2 tools to try to fix them: rules, and incentives. We see this at work in our response to the current financial crisis – but the truth is that neither rules nor incentives are enough to do the job.

When we turn increasingly to rules and incentives, they may make things better in the short run but they create a downward spiral that makes them worse in the long run. Moral skill is chipped away by an over reliance on rules that deprive us of the opportunity to improvise and learn from our improvisations, and moral will is undermined by an incessant appeal to incentives that destroy our desire to do the right thing.

Without intending it, by appealing to rules and incentives we are engaging in a war on wisdom.

Don’t get me wrong, we need rules. Most Jazz musicians need some notes on the page, and we need more rules for the bankers, God knows. But too many rules prevent jazz musicians from improvising and as a result, they lose their gifts – or worse, they stop playing altogether.

We need incentives – people have to make a living. But over-reliance on incentives demoralizes professional activity. It causes people who engage in that activity to lose morale, and it causes the activity itself to lose morality.

– Barry Schwartz, Ph.D. from his lecture at TED

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