Government in Your Daily Life


Much of the current controversy in American public life seems to reflect dramatic differences of opinion about the role of government in our society, particularly our public life. The debate is often disturbing, largely for the neglect of historical data on both sides.

If we are asked to name the government agencies that we all interact with in our daily lives, the Internal Revenue Service (IRS) would probably top the list. After all, it’s had to escape the tax man. But what agencies would come next? Those who travel a lot might push for the Federal Aviation Agency (FAA), and investors might list the SEC or the Federal Reserve system. My candidate might not be one you would immediately think of — the FDA. Yes, the Food and Drug Administration.

Why? Well, you may think about drugs first. A few years, ago a Mayo Clinic study[1] documented that almost 70 percent of Americans take at least one prescription drug; more than half take two. Here are more recent, and more granular, data from the CDC website:

  • Percent of persons using at least one prescription drug in the past 30 days: 48.9% (2011-2014)
  • Percent of persons using three or more prescription drugs in the past 30 days: 23.1% (2011-2014)
  • Percent of persons using five or more prescription drugs in the past 30 days: 11.9% (2011-2014).

But you are even more likely to interact with the FDA at the grocery store. Who sets the standards for food labeling? Who’s in charge of health and safety in the food industry? Who investigates outbreaks of food-born illness? Answer: the FDA, for all of the above.

In her new book[2], The Poison Squad, Deborah Blum tells the story of Dr. Harvey Wiley, chief chemist of the US Department of Agriculture, set in the context of America in the late nineteenth and early twentieth century: a rich tapestry of unscrupulous businessmen, reformers, activists, muckrakers, and a few dedicated public servants.

Blum recounts in detail food adulteration with toxic “preservatives” and coloring agents, and adds in the fascinating conflicts over whiskey labeling. The primary theme is Wiley’s lifelong dedication to the scientific study of chemical food additives and to accurate labeling, but the story includes the colorful figures of the times including journalist/writer Upton Sinclair and President Teddy Roosevelt.

The separation of food and drug regulation from the Department of Agriculture and the birth of the FDA represented the culmination of decades of conflict. The price, mortality and morbidity paid in food born illness and toxicity from unregulated “medicines” by countless numbers of our ancestors will never be known.

The Poison Squad will give readers a good story, well told, about the forces that brought about the FDA. In a larger sense, it provides a case study of the question of the role of government in our society, set at a time when America was growing more complex and industry more powerful. The narrative will surely open some readers’ eyes to the positive aspects of regulation.

As Alan Wolfe writes, “The idea that liberalism comes in two forms [“classical” and “modern” or “social” liberalism] assumes that the most fundamental question facing mankind is how much government intervenes into the economy… When instead we discuss human purpose and the meaning of life, Adam Smith and John Maynard Keynes are on the same side. Both of them possessed an expansive sense of what we are put on this earth to accomplish. […] For Smith, mercantilism was the enemy of human liberty. For Keynes, monopolies were. It makes perfect sense for an eighteenth-century thinker to conclude that humanity would flourish under the market. For a twentieth century thinker committed to the same ideal, government was an essential tool to the same end.”



[1] Wenjun Zhong, Hilal Maradit-Kremers, Jennifer L. St. Sauver, Barbara P. Yawn, Jon O. Ebbert, Véronique L. Roger, Debra J. Jacobson, Michaela E. McGree, and others. Age and Sex Patterns of Drug Prescribing in a Defined American Population. Mayo Clinic Proceedings, Vol. 88, Issue 7, p697–707

[2] Penguin Press, 2018. New YorkCuba 2


Bad Blood. A review.

My blog, The Weekly Packet, ( ) of April 30, 2016 ran under the title “The Theranos evidence, waiting for a story.”

In the text, I said, “… looking at the facts is like looking at individual organs at an autopsy, after the diener has washed them, weighed them, and put them in clean pans. What we need now is the pathologist to come in, and with knowledge and experience, he or she will tell the story that puts the facts together into a coherent narrative. At some point, the narrative may well make an instructive case study.”

John Carreyrou’s new book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, tells the story with spellbinding skill and detail. Those of us who had some background, however minimal, in laboratory work knew that Theranos had almost certainly over-promised and under-delivered. None of us knew the details.

Carreyrou’s reporting reveals the astonishing extent of the process in a marvelously “coherent narrative.” He details the scope of the deceptions involved, including misleading deals with Walgreen’s, Safeway and even an attempt to involve the army, the vast sums of money lost, and the lives disrupted.

First, no spoilers. Read the book! Then, after the mesmerizing read comes the hard part: what can we learn from this story?

One obvious lesson relates to corporate culture. A corporate culture that encourages tough questioning across disciplines and insists on facts may sometimes seem harsh. In such an environment, though, mutual respect and civility make the system work. What we see in Bad Blood, though, is the destructive effect of siloing and secrecy. And we see that destructive process emanating from the top levels of management.

There’s another lesson, too. A very old one. Making the error of hubris provokes the outcome of nemesis. David Ronfeldt explained in his excellent essay for the Rand Corporation, “Beware the Hubris-Nemesis Complex: A Concept for Leadership Analysis.”

“In Greek literature, hubris often afflicted rulers and conquerors who, though endowed with great leadership abilities, abused their power and authority and challenged the divine balance of nature to gratify their own vanity and ambition. Thus hubris was no common evil: It led people to presume that they were above ordinary laws…”

He continued on,

“Hubris above all is what attracted Nemesis, who then retaliated to humiliate and destroy the pretender, often through terror and devastation. Thus she [Nemesis] was an agent of destruction. The battle won, she did not turn to constructive tasks of renewal and redemption—that was for others to do. Yet her behavior was never a matter of pure angry revenge. There were high, righteous purposes behind her acts, for she intervened in human affairs primarily to restore equilibrium when it was badly disturbed, usually by figures who attained excessive power and prosperity.”

With Bad Blood, John Carreyrou has written not just a stunning piece of non-fiction reporting, but a cautionary tale for our times.

Aargh! By AARP







I have several medical journals open on my desk with interesting topics that I thought I might mention in “The Weekly Packet.” By and large, the open journals are now properly aged, like pieces of meat at a fine steakhouse.

Nonetheless, they will have to wait. The most comment-worthy item to come along this week was in the AARP weekly flimsy.  Painful truth: my wife and I joined AARP to get the substantial discount offered by our local optometrist’s shop on new glasses. Even more painful truth: I was pulled in by the headlines about “why do drugs cost so much?”

I did not have high hope for a rigorous exegesis in the AARP journal, but the presentation was actually quite balanced. The writers covered the long timelines from drug discovery through clinical trials and the FDA approval process, and even covered phase 4 studies. They also touched on the vast amount that “big pharma” spends on marketing. In all fairness, they at least mentioned that Medicare cannot, by law, negotiate drug prices and touched on the strange role that “pharmacy benefit managers” play in the US system.

What’s my point? An AARP member who actually spent some time carefully reading the article would have a basic vocabulary, would become familiar with some of the players in the market, and would have been introduced to two key facts: pharmaceutical costs are only about 10% of overall health care costs, and big pharma spends as much on marketing as on basic research. Not bad. Although the authors did not point out to their readers that without this industry, their diabetes, high blood pressure, high cholesterol, and cancers could not be treated.

More importantly, what the AARP reader would NOT know, struck me last week when I attended the Clinical Leader Forum in Philadelphia. The pharmaceutical industry, particularly the clinical research organizations that have proliferated in the past couple of decades, exemplifies the new economy.

Let me try to explain. In one lifetime, mine, pharmacology has gone from a collection of empiric facts about medicinally useful herbs like digitalis or compounds, like sulfa, to an integrative science and technology focused on identifying “drug targets” in pathophysiologic processes.

From this point of view, the new drugs that pharma generates are the physical tokens, the representation of knowledge and of enormous amounts of data. The patients are not really paying for the drugs, they’re paying for the data. I think eventually, we will work out something more functional for drug pricing. But take a step back, and look again.

Kids who under-achieve academically will not find jobs in this industry. What I saw during last week’s meeting was a relentlessly driven technological and sociological wedge splitting the workforce into those who could deal with complexity and those who could not.

And I’m sure that other industries are similar.

There is no going back. No matter how much we would like to idealize the post-WWII economy, it’s gone.

Here’s the really scary thing; there’s good evidence most AARP members don’t understand what this kind of industry means for our society.


What you see is what there is…


One of my medical school classmates recently posted a Washington Post article on Doximity, a “social media” site for physicians. The article caught my attention. I think it’s worthy of some comment. The author of the Post article is a brilliant young physician, Dhruv Khullar; his subject was a recent paper in JAMA by Denson, Jensen, Saag, et al. titled “Association Between End-of-Rotation Resident Transition in Care and Mortality Among Hospitalized Patients.” 

The primary finding from this large, retrospective, multicenter observational study was, “end-of-rotation house staff transition in care was associated with significantly higher in-hospital mortality.” The headline for the Post article was “When a new team takes over your care at the hospital, it can be a precarious time.” The change in titles itself is a pretty dangerous transition.

After 14 paragraphs describing the intellectual and emotional uncertainties inherent in teaching-hospital house staff transitions, Khullar finally wrote, “Patients who remain hospitalized during transitions may simply be sicker.” An editorial raising this issue, and the data in the JAMA publication from a restricted analysis that showed markedly lower mortality after attempting to adjust for the degree of illness, at last got some attention in the text.

Here’s my point. There is a critical feature that links all three pieces: the research paper, the editorial, and the Post article; they all acknowledge that the basic premise of the work is flawed, but all three then go on to propose solutions to the  undefined “transition problem” anyway.

Why do I suggest that the analysis is flawed? I’m not a statistician, but after decades of reviewing medical papers, I know enough to realize that this retrospective study was not a statistical problem of tossing fair dice. Patients who are or are not candidates for discharge from hospital on any given day differ in many ways. The study population was not randomized, and as the researchers commented, “the differences observed in patient populations might represent a direct consequence of clinical decisions made because of an upcoming transition rather than confounding. That is, if clinicians try to discharge as many patients as possible prior to transitioning off service, but have more difficulty discharging complex and long-stay patients, the average severity or complexity of patients exposed to transitions in care could be increased.”  [Italics mine]

An ad hoc attempt to adjust for these issues with an alternative approach to analysis demonstrated that the findings were highly dependent on unmeasured factors. As the researchers noted, “The increased 30-day and 90-day mortality risks observed in the main analysis suggest that the delayed discharge of these complicated patients following transition could be detrimental…   The alternative analysis, however, did not demonstrate these findings, [italics mine] which could be related to the noted differences between analyses.”

So, I would like to pose a really interesting question. Why did the authors (and the reviewers and editors) of all three pieces perceive a problem and then propose solutions to it in spite of the facts that the “adjusted” data suggested that the effect of house staff transition was not nearly as great as initially suspected, and that both the authors and the editorialists realized that, “Patients who remain hospitalized during a change in personnel on the inpatient service are likely different than (sic) those who are discharged”?

For the answer, I suggest we ask Nobel Prize winner, Daniel Kahneman. In his book, Thinking, Fast and Slow, Kahneman pointed out, “even compelling causal statistics will not change long-held beliefs…” In the transition-of-care publications authors, reviewers, and editors cling to the long-held belief that doctors can somehow overpower the poor prognosis of old age, frailty, and severe disease by improving the mechanics of healthcare delivery.

In our society, this belief encourages us to think about developing better hand-off forms for interns and residents instead of thinking about how we might really care for patients.

All’s not lost! These observational data do suggest a testable hypothesis. With an upcoming transition in care, rather than pushing early discharge for patients who are basically going to do well, a more productive approach might be to focus effort on recognizing the sicker patients and making appropriate arrangements for them, for example, earlier initiation of specialty consultations, social services for discharge planning, or consideration of hospice or palliative care transfers. In other words, one could randomize two large groups to either usual care (perhaps with the undeniably attractive hand-off forms) or pre-transition intervention starting a week or so before transitions and focused on appropriate discharge planning for sicker patients.

But then again, shouldn’t that be happening now?

P.S. The bird pictured is a blue-footed booby that Katherine photographed in the Galápagos Islands. I included it to make the point that blue-footed boobies do, indeed, have blue feet. This is directly related to the clinical concept that sicker patients do, indeed, do worse.

London in the 1850s


“It was estimated that in 1839, for every person who died of old age or violence in London, eight died of disease caused by poor sanitation practices.”

London began as a Roman town in about 50 AD. By the mid-1800s, the city had become “a Victorian metropolis trying to make do with an Elizabethan public infrastructure.” Thus opens Steven Johnson’s spell-binding non-fiction book, The Ghost Map.

The Ghost Map chronicles the London cholera outbreak of 1854, and central to the story, John Snow and Henry Whitehead’s demonstration that cholera was a water-born epidemic and that the likely source of contamination of the Broad Street pump was a nearby cesspool.

The train of thought establishing the relevance of this 150 year-old story to drug prices today may seem a little erratic at first, but bear with me. As readers of The Weekly Packet know, the evidence supporting pharmaceutical pricing as an important driver of the overall increase in the cost of healthcare in the US is shaky.  On the other hand, the February, 2017 issue of Nature Reviews Drug Discovery has an opinion piece on immune-oncology that shows the huge growth of pharmaceutical research in that discipline. When they come to market, these drugs will not be inexpensive generics, and their prices will reflect the relatively limited numbers of patients for who they are appropriate.

Now, take a look at the facts on the World Health Organization website:

  •  2.4 billion people still do not have basic sanitation facilities such as toilets or latrines.
  • Of these, 946 million still defecate in the open, for example in street gutters, behind bushes or into open bodies of water.
  • The proportion of people practising open defecation globally has fallen almost by half, from 24%to 13%.
  • At least 10% of the world’s population is thought to consume food irrigated by wastewater.
  • Poor sanitation is linked to transmission of diseases such as cholera, diarrhoea, dysentery, hepatitis A, typhoid and polio.
  • Inadequate sanitation is estimated to cause 280 000 diarrhoeal deaths annually and is a major factor in several neglected tropical diseases, including intestinal worms, schistosomiasis, and trachoma. Poor sanitation also contributes to malnutrition.

In addition, WHO says, “The situation of the urban poor poses a growing challenge as they live increasingly in mega cities where sewerage is precarious or non-existent and space for toilets and removal of waste is at a premium. Inequalities in access are compounded when sewage removed from wealthier households is discharged into storm drains, waterways or landfills, polluting poor residential areas.” Sounds like London 150 years ago, doesn’t it?

Here’s how these stories are related. In terms of overall human health, and in environmental quality, the return for dollars spent on sanitation infrastructure is far greater that the return on immuno-oncology. What we are seeing here is that not only has our own US society become divided along economic lines, but our global society has as well.

OK, that’s not exactly “new news.” (I promised that Packet would focus on well-seasoned news.) But here’s a thought. The pharmaceutical industry has a serious problem with its public image. What if, just what if, the industry as a whole agreed to major reductions in direct-to-consumer advertising, focused ads on R&D, and took the lead in supporting improved public health and sanitation infrastructure? What if?

Long-term, it could be a great investment.

(PS: I photographed this mosaic in 2012 at an archaeological site in Greece. It’s not far from the famous ancient latrine often pictured on websites, but much more attractive.)

“Corporate Culture”

Atul Gawande, the Brigham surgeon and author, has a fascinating article titled “The Heroism of Incremental Care” in the January 23rd New Yorker magazine. His subject is the importance of good medical management over time. He writes, “Success, therefore, is not about the episodic, momentary victories … It is about the longer view of incremental steps that produce sustained progress. That … is what making a difference really looks like. In fact, it is what making a difference looks like in a range of endeavors.” He concludes that the corporate culture of healthcare must acknowledge, “The heroism of the incremental.”

The importance of careful process is a critically important subject that I tried to emphasize with house officers in training during my academic medical career. As readers of Nesiritide know, I carried that interest in process over to my work in the pharmaceutical industry as well. So, it may not surprise anyone that over a wee drop of very nice Scotch my neighbor, an upper-level manager in the automobile industry, and I fell into a talk about Volkswagen’s diesel emissions problems. I asked, “What went wrong at VW?” Which is how I ended up reading a fascinating article by Robert Armstrong in the Financial Times of January 13th.

After a review of the public-domain facts, Armstrong came to the conclusion that “something went wrong with VW’s culture such that immoral behavior became acceptable,” and he found this “an uncomfortable conclusion.” He went on, “I will confess I understand little about how corporate cultures work or how to improve them.”

Today, I talked with another friend, a businessman from Chicago, who had heart surgery at the Cleveland Clinic a few days ago. He was delighted to be feeling well and walking in the halls, but what he really wanted to talk about was the Clinic’s corporate culture. He said, “They really DO the patient-first thing here; everyone from the janitor to my heart surgeon does it.”

Corporate culture is about what the members of an organization believe about the enterprise and how they behave in both internal and external interactions. Leadership articulates the vision and values of the corporate culture and implements the practices of that culture.

I’ve been working with a group of college classmates on a project related to President Kennedy that’s driven in part by his 100th birthday this year. As President, he articulated a vision of the national “corporate culture” that asked citizens to participate in the great social enterprise. If we hope to get through the next few years, we must all get involved in defining our vision and values. Have a look at the website, watch the short video, and share your thoughts, please.


I have been working, admittedly on-and-off, on a blog piece dealing with drug prices and “complementary and alternative medicine” (CAM) expenditures. Only something strange happened. The more time I spent with it, the less I liked it.

Initially, it was a reaction to a Consumer Reports article on drug pricing. As I’ve pointed out before, only a small fraction of prescriptions account for about a third of all drug spending in the US. In contrast, people spend billions every year on CAM, in the form of nutraceuticals, herbals supplements, and payments to alternative practitioners. So, it was a good case. Regulate the CAM folks, and use the savings to help pay for expensive drugs. The idea sounds like a campaign speech.

But that’s not a good case. It’s self-serving. At one level, it’s “tax the bad guys that I don’t like and give the money to the good guys who do clinical trials, aka the pharmaceutical industry.” It’s also an exercise in logical behavior that could not be expected from government. Most importantly, it completely overlooks the fact that individuals are involved in all these transactions. People, most of them very ill, find out that a drug that might help with a little relief or a little more time is extremely costly. People, often misled or ill-informed, decide to buy an herbal compound or to see a CAM practitioner. Like those of us who can’t resist a quick pick lottery ticket at the gas station, they are buying a small and short-lived parcel of hope.

As I think back to State Street Junior High, 1956, “health and physical education, third period M-W-F, Mr. Chester Riffle,” meant those were the days I carried my gym bag with shorts, T-shirt, socks, jock and a towel. Health education meant learning that if you don’t dry between your toes after a shower in the locker room, then you will get “athlete’s foot.”

As an aside, medical school is not a place to learn about health. Medical school is where you go to learn to call “athlete’s foot” by its proper name, tinea pedis. Medical school is about disease, not health.

I’m glad that I didn’t subject you to a rant about drug costs and CAM. I appreciate your patience with this alternative. Maybe, just maybe, there’s a need for a book about health. What do you think?

What’s been happening?


I hope that a lot of Americans are willing and able to do what I did last week. I turned off the television and radio news, saved the interesting parts of the newspaper to review this week, and went fishing.

Surprisingly, my actions had no discernible impact on world events. The butterfly effect may be true for weather, but not for my contribution to the overall clamor.

Here’s some of the stuff I saved, in no order other than the random pattern in which I pick the articles up.

Peter Loftus, writing in The Wall Street Journal for Wednesday May 11th, reported that Cigna and CVS Health Corp. (the second-largest PBM in the US) have negotiated outcomes-based pricing for PCSK9 inhibitors, as well as some other costly drugs.

In The New York Times “business day” section of Wednesday, April 27th, Katie Thomas reported that pharmaceutical companies raised list prices for a number of brand-name drugs. You have to read the whole article to learn that overall list prices rose 12%, but actual net prices increased 2.8%, “one of the lowest increases in years.” One expert, commenting on the current pricing issues, said “it’s so complicated, you can’t really unwind it without blowing up the entire health care system.” That was before the outcomes-based pricing negotiations!

Finally, in the next-to-last paragraph, of the 4/27 article, came the real issue. “Specialty drugs…now account for 33% of all drug spending even though they [are used to] treat about 1 to 2% of all patients.”

The New York Times “national” section, Thursday May 12th broke the headline news that more than 1 million people in Texas now have active handgun licenses. The initial application costs $140 and renewal is $70. There is a discount for low-income applicants.

Finally, if you look a little bit deeper into all the fuss about Valeant Pharmaceuticals and the price rises the company has imposed, the two big-issue drugs that reporter Anne Steele mentioned in The Wall Street Journal on May 17th are isoproterenol and nitroprusside. Ms. Steele did not say what percent of the nation’s drug costs are spent on isoproterenol and nitroprusside, but I suspect that handgun license fees in Texas alone might well cover it.

So, here’s an idea. The people who are telling us the news, even the best of them, want to do it in a way that excites us, raises our hackles, and fires us with indignation. Let’s slow down a little. Spend a couple of hours outdoors, with the dog or the kids. And let’s try to put some of these hot-button issues in perspective.

“Just the facts, Ma’am.” More discussion on drug prices

As many readers know, I’m currently working on a new edition of Clinical Management of Heart Failure. This is the third edition in the series, and the first update in about 10 years. I’ve just finished a completely new chapter devoted to the management of heart failure patients with major co-morbid conditions. I haven’t seen anything quite like it, and I thought it would add something of real value to the book.

The conditions that I chose to focus on include Type 2 diabetes (T2DM), chronic obstructive pulmonary disease (COPD), chronic kidney disease (CKD), and cancer. In the course of doing my homework (Yes, Virginia, there is ALWAYS homework!), I’ve documented that the “average” heart failure patient has up to a half-dozen other important medical problems. About half of the heart failure patients have T2DM; one in every four or five has COPD, and about 4 in 10 have Stage III or higher CKD.

In addition, dramatic improvements in cancer management of the past two decades have given rise to a whole new specialty called “cardio-oncology.” Cardio-oncologists are cardiologists with special expertise in managing the various novel forms of heart injury associated with both chemotherapy and radiation treatments for cancer.

Now, what does this have to do with drug costs? Let me suggest that you have a look at an interesting article in the Wall Street Journal that involves a discussion between senior individuals in pharma, insurance, and AARP. Read it carefully! The interesting part is what isn’t there. These leaders all actively press their own agendas, and represent their own perceived constituencies. Not one of them raises the concern that disease is not evenly distributed in the population. The concern about the rising costs of prescription drugs for medically managed chronic applies to fewer than 20% of the population. This subset tends to be older, to have multiple co-morbidities, and to take multiple prescription drugs. (The prevalence of obesity, substance abuse, firearms, and traffic accidents means that a substantial subset of the US population is not “healthy,” but that (approximately) third of the population does not qualify as having a medically managed chronic disease.)

The currently favored buzzwords for dealing with the drug cost “problem” are “transparancy” and “empowerment.”  Let me ask you a serious question. Do you think that your 83 year old Aunt Margaret, who has high blood pressure, diabetes, a chronic cough from 50 years of a pack of Chesterfields a day, and is getting a bit forgetful, is going to carefully analyze her drug costs and discuss the issues with her doctor and her pharmacist? I’m skeptical.

As the WSJ piece makes clear, drug costs for such patients are already vigorously negotiated. “Doing something” about the cost of chronic illness is going to require either limiting care, which most of us find unacceptable, or improving the efficiency of care. Can we do that with improved access to nurse practitioners who can prescribe generic fixed-dose combinations? Sure. But only if we are willing to accept the concepts that the pharmaceutical costs of managing older patients with multiple chronic diseases are the costs of success, not failure. These patients are living longer, with more complicated problems, than ever before. Their drug costs are relatively small.

We can’t let the headlines about an occasional rogue company raising the cost of drugs for relatively rare conditions (e.g., Daraprim for toxoplasmosis) make us lose sight of the real issue here. The large, ethical, research-based pharmaceutical companies have contributed enormously to improvements in quality of life; they have to be able to continue to fund drug research and to generate reasonable profits for their shareholders. Yes, there are some practices in the pharmaceutical industry, particularly direct-to-consumer advertising of specific drugs, that should be curtailed. But let’s not confuse poor judgement with malice, and let’s try to stick to the facts when we think through our health care options.









Lessons from a slow start?

I’ve been saving a folded section of newspaper with Elisabeth Rosenthal’s New York Times article from February 28 on my crowded desk ( New York Times article). In it, she points out that the health care industry spent $14 billion on advertising in 2014.

Only the US and New Zealand allow direct to consumer (DTC) advertising for drugs, and I suspect (admittedly without data) that the problem is much greater in the US. You know that this is a major problem when the AMA recommends a ban on DTC ads.

Interestingly, pharmaceutical companies are not the only players in the field. Hospital advertising has increased 38% from 2011 thru 2014, to $2.3 billion a year.

Now, my industry experience has taught me that the people who decide to spend this kind of money are NOT stupid! Even if we don’t agree with their use of resources, we ought to respectfully ask, “Why are you doing this?” A hint of an answer surfaced in an unreferenced statement by Boston Globe correspondent Katherine Whittemore, who wrote that some 87% of patients who saw a drug advertised and requested a prescription for it actually received the prescription

Additional confirmation for the concept comes from an interview on NPR. “Something like a third of consumers who’ve seen a drug ad have talked to their doctor about it,” Julie Donohue, a professor of public health at the University of Pittsburgh, told NPR. “About two-thirds of those have asked for a prescription. And the majority of people who ask for a prescription have that request honored.”

The answer to “Why advertise?” seems clear. “It works.” Or, at least, it has worked so far.

Now comes the really difficult question, “Is this a wise and constructive use of resources?”

Some serious thinkers believe that the era of blockbuster drugs is coming to an end. Could the dollars that have poured into advertising be re-channeled into more useful and productive activities?

I’ve just come back from the American College of Cardiology meeting in Chicago, and I think the launch of a major new heart failure compound, sacubitril/valsartan branded as Entresto, may hold some clues. Entresto had very positive phase III trial results for the management of chronic heart failure patients with impaired contractile function, and it has an engaging DTC television ad campaign, yet it has been a slow-starter. I did an entirely informal, non-randomized set of talks with colleagues to try to understand why. Two reasons emerged. First, with more and more physicians employed by large organizations, there’s pressure to hold back on “early adoption” of new agents until “the guidelines” clarify their status. Guidelines have become a huge issue. Second, generics dominate the chronic heart failure market, and because the sponsor has pegged the cost of the drug in the $400/month range there are substantial financial constraints on switching to it.

Perhaps, just perhaps, we are seeing something new and important here. Based on the available clinical trial data, I think Entresto is an important advance in heart failure treatment. But “ask your doctor about it” is not working as well as it has in the past. Maybe those advertising dollars would be better spent on another trial or two, and some physician education?