Alphabet, formerly known as Google, has decided to enter the health insurance business according to a CNBC report. The entry of big data companies into health insurance could have significant impact on costs. The Alphabet health subsidiary is called Verily. Why might big data companies affect costs of care?

They have tremendous capabilities to know their user base’s behavioral tendencies. That could lead to better analysis on how to improve communicating targeted health information. This capability is both on a group level and increasingly on an individual basis. Verily could have an enormous opportunity to effect change in terms of health behavior. Knowing us as they do, one can envision an automated outreach to help prevent and treat illness before it escalates into expensive hospital care.

Verily will likely try to work with existing insurers, both public and private, to use their data smarts to lower payer costs. This could be through better identification of populations to message needed health information or to provide individual outreach to individuals identified as high risk or non-compliant on treatment.

If it sounds like big brother watching over you, it is. We may eventually see Verily or another data giant like Amazon become your health advisor and remind you to take a diagnostic test, track your vital signs, analyze your DNA, find the best doctor, make your appointments, store your medical data, and potentially use algorithms to diagnose and offer treatment plans. One can envision an avatar of a doctor replacing the real doctor one day.

Verily is likely trying to make insurance cheaper and more widely available. Clearly, they have a huge financial incentive to enter the market where premiums have become too high for many Americans. I love to hear when innovative private companies are entering the health care sector. I bet they will do a better job at innovation than HHS or some other government department. Whether they merely support the existing insurance industry with consulting or expect to replace it entirely remains unclear.

Drug companies should expect these data innovators to be adept at negotiating prices based on patient outcomes. Verily and others will eventually be able to advise providers, payers, and patients which branded drugs to use. They may also be the ones to sell drugs to patients. No one expected Amazon to dominate the retail world 10 years ago. I would not bet against Verily, Amazon, or a new tech company to reinvent the whole health care delivery system. The world of 2028 will be significantly different in how we interact with payers and providers. Of course, if we get single payer government run healthcare then all bets are off as to innovation. Let’s hope the innovative tech giants get their chance first.

While branded DTC Ads dominate the spending, there are some drug makers investing heavily in disease education. Most do it because when they have a drug for the disease coming out shortly or are in the introductory physician awareness phase for a newly approved drug. They usually have the only drug available for the condition or are the dominant drug in a category.
Disease awareness ads help on many fronts. First, they create patient conversations during the sell in phase between patient and doctor. By not mentioning the brand, the drug maker will not embarrass the doctor if they have not yet heard about it or tried it with patients. Second, drug makers can give insurers some pressure to put the drug soon to be approved or just approved on formulary. Finally, disease education ads can be more flexible creatively as there is no fair balance.

One of the most interesting new ads is on the lesser known effects of Parkinson’s disease. We all know about the tremors from Parkinson’s. I was unaware that one of the effects of Parkinson’s is experiencing delusions. Acadia has launched a compelling disease education campaign on the delusions and hallucinations experienced by sufferers. They call it “Secret Visitors” which was created with their agency STRIKEFORCE. We see those “visitors” in the spot through the eyes of a man who hallucinates and are told over 50% of disease sufferers experience such hallucinations or delusions. The first part of the 60 second ad is shot in a low light as the man is seeing things that are not there.

The final part of the spot is then seen in normal daylight as the voice over discusses treatment options and the man sees his grandchild outside coming for a visit. “Secret Visitors” is a very engaging spot that highlights the effectiveness of disease education ads. Devoting a full 60 seconds to telling a compelling story is what makes a disease education spot a good DTC choice. Acadia has the only approved drug to treat Parkinson’s delusions called Nuplazid, which was approved in the United States in April 2016.

It is not uncommon for drug makers to hold off on DTC until the physician community has been detailed and opinion leaders get some prescribing experience. Allowing the 18 months from approval to the disease education spot, as in this case, is not atypical for a first in class specialty drug. I do not know if a branded spot will follow as that may depend on whether a competitor will enter and when. Nuplazid is a premium priced drug costing about $3000 a month at retail. While not at the very top of the cost curve, $3000 a month is at the higher end of Rx drugs. Of course most patients are insured or get patient assistance so their cost is much less.

Nuplazid may be a blockbuster for Acadia, with some analysts projecting a billion dollar potential. At that sales level, we can expect DTC advertising to continue beyond the well crafted introductory disease education campaign. DTC television used to be for big high incidence disease categories only, but the recent trend is for small market premium priced drugs to do DTC television. Acadia continues the trend and is off to a good start with this campaign.

Amazon, JP Morgan, and Warren Buffett’s Berkshire Hathaway have announced a joint venture to improve healthcare coverage for their three companies. There are a lot of unknowns as to what this means for the broader healthcare sector. Is this just the start of Amazon disrupting how insurance is provided? Or, is it more limited to squeezing company costs for their combined employee base of 1.2 million?

Perhaps this is the start of a massive transformation where employees are provided their own network of providers employed by the new venture. It is unlikely that Amazon will stop just with the three companies serving their own employees. Bezos, Buffett and Dimon are the A-list of CEOs and most likely think they can disrupt how insurance and delivery of medical services are done. While America is great at offering speedy service for any test or procedure needed, there is high cost of those services. Consumers are seeing rising deductibles, premiums and co-pays and we have an unsustainable trajectory. Companies do not want to accept the rapid growth of their healthcare costs and are looking for ways to get more for their money.

I am looking forward to seeing how these three leading companies find ways to provide services at lower cost. Some players may have to pay a price for that as many smaller provider companies may fall victim to being squeezed out of business by the new giant disrupter. Will we see Amazon Cancer Centers across the United States? Will our routine lab tests be available with Amazon Prime? Will Amazon be negotiating prices and supplying our drugs? Amazon should not be underrated for its ability to create value services that we love. Few of us love our current health insurance companies. Most of us like Amazon.

Changing a $1.4 trillion system is not going to happen quickly. There are so many complexities across the Byzantine American fee for service model. The lobbyists for insurance companies, drug makers, physician and hospital networks are very powerful and will defend their turfs aggressively. Lots of companies are making money in our inefficient system and anyone benefiting will fight to survive. Patients are the ones desperately in need of a break in cost. Amazon has the clout to challenge the status quo but even they will see how difficult major change will be.

I thought I woke up in a dystopian 1984 world when I saw an article on the low number of warning and untitled letters issued to drug companies in 2017. Written in the NY Daily News on 12/11/17 the article bemoaned the fact that only three letters were issued in 2017 compared to eleven in 2016. Somehow the lack of violations bothered the authors and DTC critics he quoted.

Drug companies complying with FDA regulations in this dystopian world is now somehow a bad thing. Something must be amiss because we all know drug companies are trying to hoodwink consumers with rampant false claims. Where are all the letters? Noted drug company critic, and former FDA Commissioner Dr. David Kessler is quoted in the piece as saying that the lack of letters “certainly raises questions.” Yes, comrade drug maker your clean record is very suspicious. We are very concerned you did not commit any crimes.

The article points out that there are only 60 FDA staff to review 75,000 promotional pieces. Therefore, the implication is that many deceptive pieces must be slipping through the cracks of an understaffed agency. That might be a legitimate concern but please provide any evidence that violative ads are airing undetected. FDA has the resources to watch all the television ads. In fact, maybe it would take about 120 minutes of one staffer’s time to review every ad on air. Oh, the workload required to watch those ads must be so stressful that no Federal agency can be expected to accomplish this task.

Can FDA miss something out of the 75,000 pieces submitted? Yes, there may be some sales aids or long pieces missed but not in anything seen in mass media. I think the author and Dr. Kessler can sleep at night knowing that wildly false and misleading claims are not being made in DTC Ads. I do not see FDA complaining that false claims are a major concern.

Critics of DTC will not be satisfied until our legislators ban it, or make DTC more difficult to do. Making it harder to do is certainly a policy goal of many on Capitol Hill. In fact, if the Dems retake Congress in 2018 we can expect the usual anti-DTC bills to make it to a vote. Ending tax deductibility of DTC, putting a moratorium on ads for new drugs for three years, and forcing drug makers to disclose prices in ads, are all recent proposals.

The same media outlets that rail against drug companies in their news coverage are also the leading purveyors of drug ads. That must be an interesting conflict between the business and editorial side. They should be careful what they wish for because if DTC is legislated away who will sponsor network and cable news? Think about that Wolf Blitzer!

Good is good and the three letters issued are a sign that drug companies know how to comply with DTC regulations. Drug companies complying does not fit the critics narrative therefore it must be a sign of bad enforcement. Only George Orwell could envision such a scenario.

In the latest attempt to kill DTC, Senator Claire McCaskill (D-MO) tried to amend the Trump tax bill with an elimination of the tax deductibility of DTC as a business expense. It was defeated. This is the umpteenth time this tactic has been tried by Congress hostile to the drug industry.

I have lots of friends and relatives who are Democrats. I respect their right to think the drug industry charges too much and tries to create demand for drugs for diseases they advertise. Trying to limit the right to advertise lawful products, especially heavily regulated DTC advertising, is a huge mistake and creates a slippery slope. May I remind my Democrat friends that there are many categories of advertising that interest groups do not like.

Do we ban beer ads because drunk drivers cause accidents? Do we restrict ads for Mercedes because many people cannot afford them and feel bad? What about those violent video game ads? How about ads for violent movies? Somehow legislators have singled out drug ads for special treatment. Let’s deal with the common assertions about drug advertising.

Drug ads raise prices because critics point out that consumers eventually pay for those expensive ads. Sounds like a rationale argument but facts prove otherwise. Drug ads represent 1-2% of drug sales. We spent less than $100 million on Lipitor ads when sales were over $5 billion. No one ever mentioned advertising as a basis for pricing. Price is set based on a number of factors unrelated to advertising. What is competition charging? Are we first to market? How will pricing affect insurance coverage? How much patent life remains? What did we spend on development? How many markets worldwide are we in? The bottom line is we as an industry spend $5 billion on a revenue base over $400 billion. That is hardly an expenditure that would drive price up.

Drug ads create demand for products which are not needed. This is the second assertion usually made. Drug makers create disease awareness for ailments that are not a real problem say critics. Social anxiety, low testosterone, restless leg syndrome, are just some of the examples raised by critics. Critics also say advertised drugs are often no better than their generic alternatives. These are fair criticisms as there are people who turn to prescription drugs too quickly. I admit that. The issue is between doctor and patient to decide whether no drug, a generic drug, or the latest premium price drug will work best. Trying to ban commercial speech to prevent a patient learning about a drug is a bad solution to concerns about over use.

Like it or not, we are a country that believes in free markets and selling what we make. Having the right to advertise provides an incentive to develop new products. Some of these are bad products that we waste money buying, but that is the price we pay to have a free market. We would all save money driving a Chevy, wearing Walmart clothes, and buying generic groceries. That decision is left to consumers and not by government forbidding advertising for products they feel we should not buy. I know what the critics say. Drugs are different than other consumer categories. Life saving meds should not be marketed like perfume.

The critics forget that we need a drug industry that is anxious to do research and can get rich risking lots of money. Yes, we may not need all the me-too drugs being sold or advertised. Those drugs provide cash needed to take risks on new technologies. The next pandemic will one day be upon us and we better have a strong drug industry ready to find life saving drugs.

Time to have a little fun with the unknown. Predictions are nice for stimulating discussion so here goes.

1. The DTC spending will increase modestly in 2018 by around 5%. Some of that increase is media cost inflation. So, I am expecting a strong year but not a boom in spending.
2. FDA will not take any action in 2018 to make DTC harder or easier to execute. It is possible we could see a guidance on reducing risk presentation, but I doubt it.
3. The media mix will change slightly to include more digital and point of care, but television and print will still be dominant. FDA will do nothing to make social media easier to execute and will not change word search requirements on indication and needed fair balance.
4. Drug company reputation will still be an issue due to pricing concerns. DTC will be attacked regularly for causing demand for high price drugs and for creating higher prices. I am not predicting any Congressional action on price controls or reimportation but the mid-term elections in 2018 might alter the balance of control to Democrats and then something could happen in 2019.
5. Virtual medicine is going to become the next big thing. That means cheaper opportunities to interact with a doctor online for lower cost and get drugs prescribed. Married with online tools to track vitals and other useful diagnostic tools will accelerate the shift.
6. Genomics companies will continue to grow in offering tests to determine our likelihood of getting diseases. Consumers will be more informed and be more active partners in deciding with doctors what tests are needed and what treatments are best.
7. Consumer cost burden will continue to rise as insurers and employers continue to expect higher deductibles and co-pays. That means more of us are really self-insured in a normal year and we pay the full bill. That means consumers will be questioning any service, test, or drug where they are paying most of the bill.
8. Media targeting will be a higher priority as technology improves to micro target potential users. As DTC for higher cost drugs targeting smaller segments in cancer and other targeted diseases increases, the need to better target potential customers increases.

There you have it. 2018 will be a relatively quiet year as nothing should happen to dramatically alter how we use DTC. Just my opinion and many of you will have a different take on these and others not mentioned. Have a great holiday as this is my last column in 2017.

A week ago, my wife Debra broke her hip in a fall. The experience has given me a better appreciation of our health care system. While not perfect, I am impressed with the speed and quality of the care American style. That is, the for profit hospital was interested in her satisfaction as a customer. They were interested in making her happy, so they can be known as a customer centric facility. In today’s social media world customer ratings matter. They touted their ratings on billboards placed in their lobby from several sources such as Healthgrades and US News and World Report. They were aware that she may go to customer rating sites after her discharge and did whatever they could to ensure good feedback.

I frankly expected the typical poor hospital experience based on past interactions with emergency rooms and being admitted for surgery. The last time I was hospitalized was about 20 years ago. That experience was characterized by a diffident nursing staff, a cramped double room with a moaning roommate, and of course lousy food. Move ahead 20 years and everyone at this hospital was interested in ensuring a positive experience.

My underlying point in this is that those who advocate the federalization of healthcare may not like the result. I have had few positive experiences with government agencies. It is not that they are staffed by bad people, it is that they do not make customer service a priority. They do not have to. We have one choice for paying our taxes, getting our passport, getting through airports, and that is Uncle Sam. Sometimes he can be slow, unfriendly, rigid, and lacking in empathy.

In the case of my wife’s emergency surgery I had choices and could accept or reject the hospital and surgeon. Admittedly, once my immobile and in agony wife was brought in, we were kind of a captive audience. Still they knew she could request a move to another hospital and went the extra mile to ensure she stayed. My personal physician did not have privileges there so it was a serious consideration to move.

What I noticed most was the staff always asking if she was satisfied. This was from the ER nurses to the aides taking her meal orders. She felt like a valued customer rather than a burdensome patient. While she was anxious to get home she felt comfortable staying there. The lesson I learned was the enormous opportunities that still exist in healthcare to delight the patient. The hospital staff explained that all the rooms in the new wing were now singles because they knew patients valued their privacy. The visitors have free valet parking. Nice touches.

I know Bernie Sanders thinks government would do a better job running the healthcare system. Somehow I doubt single rooms and valet parking would be part of their plan. I also doubt customer satisfaction would be anywhere as a top priority. Yes, I am confident care would be adequate under a government run system. For my wife the stress of breaking her hip and going through emergency surgery was enough, and adequate care was not what we wanted. We wanted customer centric care and the for profit model provided it.

I thought about how much more we can do to unleash free market customer centric care. We can lower costs and improve care just by letting for profit companies compete. Profit and free choice are powerful motivators for innovation. We should encourage more of it rather than hope government is the solution. Just think the post office versus FedEx as the analogy. I know which I would choose.

The widely reported story that Amazon is considering entering the prescription drug market has made current drug sellers nervous. Could Amazon revolutionize drug sales? Or, would they just be another mail order supplier in a crowded market? The answer is unclear.

Amazon certainly has the strength to cut deals with drug companies, insurers and major employers to supply drugs. If a major insurance company wanted to work through Amazon to try to cut costs it is likely they could shave some expense. I do not, however, understand yet how Amazon would be able to fundamentally change drug delivery or pricing.

Drug companies have established a complex supply chain with numerous levels of prices across different customer categories. Drug companies have no problem quickly supplying patients through drug stores, mail order houses, or in store pharmacies at supermarkets/big box chains. While certainly a convenient place to shop its many product categories, are there advantages for customers buying their drugs there?

I have increasingly bought more things on Amazon because I get free delivery through Prime. Their service is reliable. It is nice to be able to buy directly from them or their listed sellers. That being said, Amazon is still just a giant online market. Patients already have a vast array of options filling their prescriptions and I never heard anyone complaining how hard it is to fill a prescription. Unless Amazon can significantly lower consumer price, or save insurers lots of money, then the game changing aspect of their market entry is unclear.

I love Amazon and was lucky enough to hold on to my 200 shares bought at $35 many years ago. As big a fan as I am of their company, to change how drugs are sold is not easy. Maybe all Amazon wants to do is be another online option and grab a share of the huge market. Certainly, they have an enormous customer base who would be happy to add drugs on with other purchases.

Of course, Amazon is an innovator and maybe they will be able to add consumer value to drug purchases. Perhaps they will be able to launch retention and compliance programs using their customer research base. Alternatively, they may be able to innovate in disease and drug education. Their major asset is consumer trust and that should never be underestimated. Amazon has a team evaluating entering the market and my guess is they will enter, even if just as an ordinary supplier at the start. Long term I suspect they are thinking of ways to shake up the supply chain to offer substantial discounts to their customers.

My question to the DTC community is why can’t we come together with FDA and make DTC advertising more understandable.

I am not talking just about risks but also benefits and indications. We are all letting the approved label dictate how we say what we say. That label information is generally not consumer friendly. Consumers see advertising, not as a whole sales pitch, but merely the start of a buying process. DTC, because of regulations, seems to be treated as requiring an entire pitch where virtually everything must be discussed. Look at cancer advertising for example on non small cell lung cancer. I’ll use Keytruda as an example which is required to say it is indicated if PD-L1 is positive and there are tumors with no abnormal EGFR or ALK gene. Huh? Merck has to say it but does any consumer know what any of that means? I doubt it.

What we have are technically oriented government regulatory bureaucrats in a non-technical DTC world. They should spend their time making sure everything said is true but also understandable. Instead of forcing Merck to discuss abstract qualifications on who might benefit, consumers would be better served knowing more about clinical results. Wouldn’t it be better to say Keytruda only benefits a segment of lung cancer patients and only your doctor can say if you might benefit? After all, patients do not self diagnose PD-L1 or their gene abnormalities.

FDA can make the 60 or 90 second ads much more consumer friendly and increase comprehension if they acted more like common sense regulators. They know many ads are data crammed and difficult to follow but it is their view that the label is like the Ten Commandments. Thou shall not deviate. So we get required language that is just wasting valuable air time that might be redirected towards giving consumers information they need and more importantly understand. I know Merck would probably like to do that. I also think OPDP would like it that way because I know the people there are trying to do right. Do we really think Congress intended consumer confusion in the 1970s when they wrote the regs never contemplating DTC?

Has OPDP pushed back on the Congressional committee regulating drug promotion that we need new promotional regulations? We can recognize that consumers just want mass media advertising to inform them that something might help them. They do not need the whole story rather just enough information to ask their doctor or search the Internet. Using the excuse that the regulations require all this complexity is abdicating the role FDA should have. We want drug DTC claim ads to be accurate and disclose serious risks. Surely, there is a better way. It will take FDA, Congress and drug makers to collaborate to determine how to improve. This is simple really and FDA should lead that effort.

Does anyone feel that we have done the proper job educating consumers when arcane medical terms are dominating DTC? Regulators tick off required boxes on their label checklist for DTC knowing full well consumers are often left clueless. My suggestion is OPDP have hearings on how to completely over haul DTC communication for today’s media environment, instead of using the excuse that they are captive to regulations written almost 50 years ago.