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.

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Health

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?

Signs of a health issue along I-75

Good afternoon, everyone.

The Weekly Packet will be getting back to regular sailing now that Nesiritide. The Rise and Fall of Scios has passed the final proofing and is on the way to the printer. Please look for the title as above on Amazon, or alternatively search by author: Roger M Mills, MD.

I have also been scrambling to get to a final draft of Clinical Management of Heart Failure, 3rd edition. The co-authors (Jim Young and Javed Butler) and I opted for starting the third edition with a clean slate. As a consequence, I have just made the long drive from our camp in Michigan’s Upper Peninsula to spend a day with Jim at the Cleveland Clinic. Which leads to what’s really on my mind.

On June 7th, JAMA ran an opinion piece titled “Lifespan Weighted Down by Diet” by David S. Ludwig, MD, PhD from the New Balance Foundation Obesity Prevention Center at Boston Children’s Hospital and Harvard Medical School. In response to the recent widely publicized observations of decreasing life expectancy among US counties in the Southeast and Midwest, Ludwig raises the hypothesis that technologic advances may no longer be sufficient to compensate for the adverse health effects of obesity.

He goes on to state, “Direct medical costs associated with obesity among noninstitutionalized adults have been estimated to have reached $190 billion annually in 2005, an amount that does not include losses from lower worker productivity.”

What does this have to do with driving the 495 (Mapquest) miles from Hulbert Lake to the Cleveland Clinic? Everything! With the exception of the very sparsely populated areas in northern Michigan, the trip is a visual festival of high-caloric density food. The woods and fields of the rural Midwest are blotted out by billboards for McDonald’s, Wendy’s, Kentucky Fried and scores of local places like Cops and Donuts (Clare, MI). And the drive thru lanes and parking lots for these places are packed. This observation prompted the following chain of thought.

First, I have read, learned, and written a lot about drug costs and their relationship to overall health care costs. Second, JAMA now publishes an expert from Harvard who tells us that the medical cost of obesity passed $190 billion a year a decade ago! Third, new data suggest that dietary composition may have an impact above and beyond caloric balance alone. Fourth, the fast-food industry is not about production and consumption of “high-quality proteins, fruits and vegetables, legumes, nuts, and other whole foods,” as a basic diet.

Where does this leave me? I cannot avoid the growing suspicion that some large players in the food industry are making profits by making us unhealthy, and driving the overall cost of health care up in the process. This seems at least an order of magnitude more villainous than making profits for discovering and developing new drugs to make us healthier.

One of the core values of writing the Packet was to use data to gain perspective on problems. Over the summer months, I’ll look for more data and a clearer perspective on these and other epidemiologic questions.

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.

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?

Craftsman

Last night, as my wife and I watched the early minutes of the Republican debate, she commented on how strange it was that Dr. Ben Carson, a physician, could hold such an unscientific view as belief in creationism.

I responded, “A great sculptor does not have to be a geologist, nor does a talented woodcarver have to have studied forestry.”

She felt this was a bit obscure, and requested a further explanation. That explanation took me far beyond Ben Carson.

My point was that a medical doctor, physician or surgeon, is a craftsman, not a scientist. You can certainly turn the proposition around if you like. Finding a great geologist who is also a talented sculptor is also unlikely. Either way works.

The actual “doing” of medicine does not involve scientific methods, but rather the skillful use of tools. For the surgeon, the tools are the familiar instruments of the operating room. For non-surgeons, the vast majority of our proven effective tools are drugs. As time goes by, we medical doctors become fond of our tools, the drugs we use frequently. We get to know them, to feel comfortable with them, and to have a sense of how we can use them most creatively.

How strange, it  seems to me, that we seem to have developed a love-hate relationship with the pharmaceutical industry that provides us these tools. Isn’t it appropriate for the tool-makers to want to share best practices and new information with us? Don’t we want the tool-makers to make improvements so that we have new and better tools to use? And isn’t it reasonable for the tool-makers to want to make a living by charging for the products they make?

The problem is the patient. Unlike the sculptor’s stone or the woodcarver’s log, the patient has a deep sentient and personal involvement in the outcome of the doctor’s craft. In many cases, the patient and/or his agents are also involved in paying for the tools. Now the issue of “value” enters the discussion. Are the tools worth the cost? How do we know? And why advertise the tools to the patients?

In this week’s New England Journal of Medicine, two PhDs from Harvard and Chicago have written an editorial piece titled, “Pharmaceutical policy reform – balancing affordability with incentives for innovation.” They suggest that “our laissez-faire system may not be achieving the balance [between] affordability and incentives for innovation that Americans want.” That’s a difficult point to argue.

In the last few years, the toolmakers have put powerful, effective new tools at our disposal. A “system,” such as it is, that could manage the distribution of sulfa drugs, small molecule anti-hypertensives, and first-generation antibiotics has been overwhelmed by biotechnological synthetics, by monoclonal antibodies, and by novel anti-neoplastic agents. A woodcarver who can handle a good set of chisels, may be somewhat challenged by a 3-D printer.

As I see it, the critical issue for all of us as we struggle toward a new way of making, distributing, and consuming medicine is to maintain our respect for the other participants in the process. The craftsman has to care for his tools and has to have profound respect for his materials. The toolmaker has to feel proud of his role in a creative, life-sustaining activity. And all of us must earn the patient’s trust.

The “drug cost crisis.”

During my relatively brief tenure on the faculty of the University of Kentucky College of Medicine, I enjoyed the privilege of participating in UK’s first “Certificate in Medical Management” program. The business school faculty ran the course, with some additional input from other faculty. Although I might stumble on some specifics, the major themes of what we learned have stayed with me. I think that explains my fascination with the “drug cost” headlines that are appearing with alarming frequency.

This is a topic that can arouse even the most factually unarmed to foaming fury, so I’ll proceed very carefully. Peter Bernstein, in his wonderful book Against the Gods, documents that various forms of the insurance business have been around since at least 1800 BC. Without getting too technical, today’s insurance practices have benefitted from steady advances in both math, basically statistics, and data handling, so-called “big data.” However, there are some fundamental and intuitive facts that no one can dispute.

First, illness is not equally distributed in the general population. Some individuals have substantially greater health burdens than others. In fact, the National Institute for Health Care Management Foundation analysis of data from the 2012 Medical Expenditure Panel Survey shows that the less expensive 80% of the civilian non-institutionalized US population accounted for 18% of the cumulative total health care spending that year, while the more expensive 20% of the population accounted for the remaining 82% of spending. The “80/20 rule” has some validity!

Second, with the exception of a few dramatic diseases like Ebola, in developed societies the burden of illness is both chronic and costly.

Third, other things being equal, if the goal of insurance is to cover the health care costs (or automobile losses, or shipwreck costs) of a population, a larger the pool of insured individuals will result in a lower cost to each individual.

Given these three basics, the conclusion seems straightforward that the least expensive approach to health insurance is to require that everyone in a large pool, say the US population, have a basic policy.  Does this mean the end of the private health insurance business? It hasn’t in Europe, where private insurance often adds coverage beyond the basics. It’s the kind of approach that says, “At least, everyone should be able to ride a bus or a train. If you want a fancy car instead, that’s up to you.”

Now, just for fun, let’s move on to drugs. I would like to call your attention to a piece by Peter Sullivan posted on a site called “The Hill.” The Center for Medicare Services, or CMS, has collected some interesting data. The spreadsheet is available on line and worth a careful look. The take-home message is that just 40 drugs out of the 3,761 in the Medicare prescription drug program make up a full 33 percent of the total $121.5 billion in yearly costs. That’s even more lopsided than the 80/20 rule. What’s more interesting is that if we focus on the set of indications for those drugs, we will narrow the field even more to hepatitis-C, oncology, and severe forms of mental illness.

Well, cost cutters, one approach would be to deny progress. These expensive drugs are used to treat illness that has not been treated previously. Instead of having patients die from liver failure and metastatic cancers, we are adding to the population of individuals with expensive chronic diseases. Of course the total cost of drugs will go up! One alternative would be not to use these new agents, and let the diseases run their course. Aside from the moral issues, that’s NOT what insurance is about. It’s about spreading the cost across the largest possible pool.

In addition, as we have learned from the EU, national health systems have a lot of leverage in negotiating drug costs.

To summarize what the data really show about the US drug cost “crisis” is that:

  1. The real drivers of health care cost increases are hospital costs and personnel costs.
  2. A large majority of the population accounts for only a small portion of health care costs.
  3. Expansion of the subset of patients with complex chronic disease that can only be managed with expensive new drugs accounts for most of the increase in drug costs.

Are these problems that can be entirely attributed to the pharmaceutical industry? I think not. Rightly or wrongly, the industry has tried to figure out what price the fragmented market will bear. In the rest of our society, that’s a generally accepted practice. On the other hand, we can’t escape the fact that multiple competing interests have repeatedly defeated attempts to develop a more rational health care system.

The drug price hullabaloo…

 

The Weekly Packet for Friday, December 11, 2015

This post comes a couple of days early. Dermatologic cancers are part of the price one eventually pays for a career in the cardiac catheterization laboratory, along with skiing, tennis, and fly-fishing. I have my third new lesion of the past 2 years, a real beauty (imagine growing a rhino horn just in front of your right ear). I’m having Mohs surgery on Friday. It’s all under local, and not a big deal, but can take quite a long time.

Campus issues at my alma mater, Amherst College in Amherst, MA, made the New York Times last week. My class of 1964, now 55 years post-graduation, has an active email list-serve (yes, kids, the old guys can adapt!) and the commentary has been spirited. Give me a bit more time on this one, though.

From time to time, “A-ha” moments come along where observations from several different settings suddenly click into place and make sense. Something along that line happened this morning while I was walking with Posie. For the past fortnight, the media have been filled with discussion about drug pricing and the rather significant bump in US healthcare costs this year. The “A-ha” went as follows.

In the disciplines of scientific and clinical research, we repeatedly tell ourselves that association is not causation. This is not true in journalism, where the process can easily be extended further to “juxtaposition implies association, and association implies causation.”

The journalists who do not do their homework would like to lead you along a path that is marked by logical, but false assumptions. A dramatic increase in the price for an off-patent drug for toxoplasmosis (Daraprim, Turing Pharmaceuticals) may be socially unjustifiable, but the incidence of toxo is not high enough for its treatment cost to impact the US healthcare budget. (See: http://www.nytimes.com/2015/09/21/business/a-huge-overnight-increase-in-a-drugs-price-raises-protests.html?_r=0 )

Here are a few facts to discuss with friends, family, and co-workers.  First, the three key drivers of US healthcare costs in decreasing order are: hospital care, physician and clinical services, and other professional services. Prescription drugs are very near the bottom of the list, just ahead of durable medical equipment. See: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf for the data.

What percentage of our health care spending goes for pharmaceuticals? The various figures range from a low of 9.7% to a high of 11.9%. The 11.9% figure comes from a reputable source, the OECD, so let’s use it, and round it off to 12%. If spending on pharmaceuticals increased a breath-taking 20%, the increase in total health care spending would be less than 2.5%. Actually, as a percentage of overall per-capital health spending, the US expenditures on pharmaceuticals are rather middle of the road. See: https://data.oecd.org/healthres/pharmaceutical-spending.htm#indicator-chart

This may be because “generics now account for 28 percent of pharmaceutical spending and 84 percent of drugs dispensed in the U.S., which is high by OECD standards.” http://www.pbs.org/newshour/updates/americans-spend-much-pharmaceuticals/. Absent the introduction of the very costly anti-hepatitis C drugs, the bill for branded drugs would probably have grown very little.

Now, to wrap up, let’s ask why the industry is getting such bad press when most of the facts don’t support it? Here, I am going to venture into opinion. I think the time has come to have some serious discussions with senior management about marketing. Here’s a direct quote from Ron Shinkman, http://www.fiercehealthfinance.com/story/big-pharmas-greed-continues-drive-healthcare-spending-and-prices/2015-02-16  “But the marketing of those [prescription] drugs has become at times questionable. John Oliver’s take on his HBO show last week was spot-on, poking fun at the young, sexy (and undereducated) pharma sales reps, the free meals and “thought-leader” designations for doctors, and the anthropomorphized bladders and other visual insanity in television commercials (Oliver was also kind enough to cite our sister site, FiercePharma). As a matter of fact, drug companies now spend more on marketing than product development. He didn’t even get into some of their even more troubling practices, such as lobbying Congress to bar Medicare from negotiating on pharmaceutical prices in bulk or buying them overseas, where the predominance of single-payer healthcare systems has forced drug companies to price their products at much lower prices.”

My take? When the ethical pharmaceutical companies ventured into “direct-to-consumer” marketing, they gave up far more than they gained. The widespread public respect for science-based companies that developed new medicines to manage or cure serious diseases was bound to crumble with “ask your doctor about (insert out drug)” followed by a list of contra-indications and adverse effects in the verbal equivalent of small print.

If those of us who work (or worked) on the scientific side of the pharmaceutical industry want to feel proud of what we do (or did), we have to realize that the industry itself has made some decisions that have not worked out well.