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March 28, 2016 0

As a result of the sudden Zika virus outbreak, both big pharma companies and non-profits alike are diving head first into vaccine research in hopes of halting this life-threatening virus. First to the table was Sanofi Pasteur, announcing that they “would lead the way against Zika”. Following their successful launch of the dengue fever vaccine, Sanofi is confident they can tackle Zika as the two viruses are similar in nature. Apart from Sanofi’s progress, the WHO has announced that fifteen other groups, both government agencies and big pharma are also working on a vaccine formulation.

To read more about progress on the Zika vaccine, click here.

 

Lily Stauffer


March 25, 2016 0
Drug companies defend DTC by arguing it creates disease awareness and information on treatment options. Critics of DTC say it pushes high price drugs and creates undue pressure on physicians to prescribe branded drugs when alternative treatments are just as good. An article in the March 23 issues of US News and World Report written by Dr. Kevin Campbell is representative of the anti-DTC position.
The reality is DTC may do what both supporters and critics say. There is no doubt DTC raises disease awareness. There is also legitimate concern that we may take drugs more often than needed. Drug companies benefit from disease awareness by eventually selling more drugs. While drug companies advertise to sell more of what they make, that does not mean consumers are not also being helped.
Bob Ehrlich
“DTC is ..an important part of the patient’s information set.”
-Bob Ehrlich
In fact, DTC lets patients know what new treatments are out there for consideration. That is all DTC can and should do. Drug companies are not objective sources of information. What they say should be vetted by regulators, physicians, payers and consumer advocates. We cannot assume that anyone else involved is objective. Payers want to spend as little as possible whether they are private or public. Physicians have their biases as to which drugs to use and many are slow adopters of new treatments. No one cares about your health as much as you do.
Therefore DTC is just one part, but an important part of the patient’s information set. Unfortunately, there are competing motives in deciding which drug to choose. Patients want the best treatments regardless of what it costs payers. Payers want cost efficiency and are willing to settle for les than perfect treatments. For example, what is the extra few months of life worth to you versus what it is to a payer? That dilemma exists in many end stage cancer treatment decisions. Ads for Provenge and Opdivo for prostate and lung cancer are offering just such hard treatment choices.
Hep C drugs costing $80,000 are another hard choice. The cure is expensive and payers are assessing the benefit of treatment versus other options. Patients want the cure but payers may be reluctant to spend the $80,000 on you. DTC, alerting people of their options, serves a catalytic purpose.  Payers might want to delay covering the new drug to take their time studying its economic value, while patients want to get better now. DTC forces the discussion of coverage sooner.
DTC critics like to say drug selection is a complicated decision best left to the physician. That argument is nice in an ideal world where cost is not a factor. We all know that payers want to pay less and sometimes that means delaying, denying, or refusing coverage. Those payers make doctors go through hoops to argue for reimbursement and being busy folks they can get discouraged. Without pressure on payers, patients lose.
Of course drug companies do DTC to increase sales, not to be Mother Theresa offering selfless advice. They want to increase demand. While it sounds better to say they want to increase disease awareness, they advertise to increase sales. So what is wrong with that? Drug decisions for all constituencies are cost/benefit based. Patients, through DTC are given reasons to ask about the advertised drug. Physicians and payers can accept or reject those reasons. It is messy and sometimes inconvenient for physicians to deal with patient requests. That is the new reality of the information age. Going backwards to restrict patient information is not wise or viable.

Bob Ehrlich


March 18, 2016 0

For many years  media pundits have predicted the end of broadcast/cable television as both a dominant medium and as a successful seller of ad space. As a DTC information provider we at DTC Perspectives are media agnostic. We believe in DTC but do not choose one advertising medium to favor. That neutrality has us question the media pundits that say television is a dinosaur waiting to be hit by an extinction event. Every year at the DTC National I ask new media presenters why drug marketers still spend so much on mass media if digital/mobile is replacing it. They usually say drug companies are slow adopters and their agencies steer them to television because it is easier to buy.

Bob Ehrlich
“Television use… has never been stronger…”
-Bob Ehrlich

I usually push back to say drug marketers and their agency associates are smart folks and would not use a medium that does not work. After all, their career success is based on drug sales response to their media selections. They use television because it generates a strong ROI and  can have a fast market share impact. It also puts pressure on insurers to cover reimbursement and motivates doctors to learn about a drug faster.

Despite the dire predictions, television use for DTC advertisers has never been stronger. The latest Nielsen data show television got 68% of the spending in 2015. Nielsen does not measure point of care and understates Internet spending. If we add those numbers  which trade sources say are about $500 million for point of care and around $250 million for Internet, then we have about $6 billion in total spending with television still comprising 59%.

Why has television remained dominant when other industries have spent much more in digital? There are several reasons for the wide use of television for DTC advertisers. Most important is the age of the majority of prescription drug users. The largest drug categories are dominated by older users. They do use the Internet a lot but still watch more television than younger folks. Second, drug ads can be executed well in the 60 second television ad unit and still meet regulatory requirements. In other words television allows for motivating messages. Third, DTC is serious information and that is why the drug makers dominate network, and cable news shows.

I should mention that print spending is still quite healthy. FDA still requires a print brief summary source be mentioned in the television ad. While print titles are declining those that remain are seeing over $1.5 billion in revenue from DTC advertisers.

The health of television does not mean drug marketers are ignoring digital and point of care. New techniques are growing in each area. Point of Care has exploded, and digital is finding a way to introduce drug and disease awareness despite FDA limitations.

I am sure many media pundits in 1997 would be surprised to see television so strong in 2016. Time shifting through DVR devices, Netflix, on-demand options, as well as competition from game apps were predicted to drastically reduce broadcast television use. While teens and millennials may be watching less, and shifting to watching their television on demand, the drug using  baby boomers and their parents still watch a lot of broadcast and cable. Of course eventually the pundits may be correct and television as we know it will be extinct, but it looks like a decades away event.

Bob Ehrlich


March 18, 2016 0

This year’s DTC Perspectives Top 25 Marketers of the Year list includes ad campaigns both old and new. In addition to the long-advertised household names such as Viagra from Pfizer and Crestor from AstraZeneca, brand managers for some up-and-coming drugs made the cut as well. Such campaigns include Jardiance from Eli Lilly, Belsomra from Merck, and Entyvio from Takeda. Jennifer Kovack, Director of Publishing and Awards at DTC was quoted saying, “the mix of young and old drug campaigns is relatively new to the awards, partly because of the way the industry is changing and adopting more patient-centric marketing methods”.

To read the full article from Fierce PharmaMarketing, click here.

For the complete Top 25 Marketers list, click here.

Lily Stauffer


March 18, 2016 0

Despite pressure from all angles for stricter limits on prescription drug ads, the industry continues to expend billions on their campaigns. Sky-high spending has been continuously increasing over the past few years; surpassing the $5 billion mark this year. It is estimated that one quarter of this $5.2B came from five campaigns: Humira, Lyrica, Eliquis, Cialis, and Xeljanz. According to DTC Perspectives CEO and Chairman Bob Ehrlich, “there’s no doubt that [direct-to-consumer advertising] is now seen as almost a must-do for a drug that wants to be big”.

To read more about the controversy over pharmaceutical advertising, click here.

Lily Stauffer


March 11, 2016 0
Last week I wrote about the recovery in DTC spending in 2015. That should have been a happy event and one we all should have celebrated. Yet, another anti-DTC bill emerged in the Senate, sponsored by Al Franken and three other Democrats. This bill calls for ending the tax deductibility of advertising.
The bill will probably go nowhere based on constitutional free speech issues. Putting barriers on commercial speech uniquely for drug companies will fail. What industry will be next? Politicians do not like a lot of industries and why not limit those tax deductions as well? We know they dislike health insurance companies, gun companies, video game makers, tobacco producers, liquor companies among others.

Bob Ehrlich
“Let’s err on the side of more not less information.”
-Bob Ehrlich

What drug company executives have realized is that DTC is only one of many things critics hate about them. They know that if they stopped doing DTC to appease Al Franken, then he would still demand European prices, shorter patents, less detailing and sampling, and less tolerance for side effects. Therefore, drug makers have gone all in on DTC. They recognize that offering to give up their right to advertise a lawful product serves no purpose.

What politicians seem to think is that a public denied information is better served. They want an ignorant public because then they can influence providers and payers to avoid higher priced drugs. I have absolutely no problem with government and insurers offering effectiveness and price/value data to the public. An advertised drug may in fact not be better than a generic or non-drug alternative. Insurance companies, drug critics, government, and consumer watchdog groups are all free run counter advertising to drug ads with information on drug effectiveness, cost, and safety.

Instead politicians like Franken make the mistake of thinking the consumer is too ignorant to understand drug selection. It is a scary thought that FDA vetted advertising claims are considered dangerous and must be stopped. The rationale that $5 billion of advertising is too much in an industry that has $374 billion in sales is shaky logic. There is no impact on drug prices resulting from advertising. Advertising creates competition and consumer and doctor awareness of competing brands keeps price competition alive. Banning advertising means established brands face no DTC challenges from newcomers. Advertising certainly speeds up adoption as providers are pressured to learn about newly advertised drugs.

The drug industry cites numerous studies about advertising causing more diagnosis of disease earlier. That is a very positive benefit. Drug companies should not be afraid to also say they advertise to sell more drugs. That ability to advertise gives drug companies incentive to speed up drug development knowing they can tell the world through mass communication what they have discovered.

I know Sanders, Clinton and Franken would prefer some all knowing government agency overseeing drug development, testing, selection, and pricing. In that world of central planning, we as consumers, would have no say in drug selection. Advertising is just one source of consumer information and is of course designed to create brand requests. That is why the FDA reviews the ads for accuracy and why there are hundreds of health web sites to offer reviews of those drugs. Let’s err on the side of more not less information.

While consumers may complain about drug ads most learn about new drugs from advertising and I doubt they want to go back to the pre-1997 era. FDA is planning its first comprehensive consumer attitude survey since 2002 and I welcome that study. That could be fielded in late 2016, or 2017 as FDA moves at a government agency pace.

At the DTC National this April we will be discussing what the drug industry should do to respond to the latest threats and how marketers can influence public policy. Drug makers need to carefully balance the public concern while maintaining their right to advertise.

Bob Ehrlich


March 4, 2016 0

DTC spending continued its strong comeback in 2015, following a strong 2014. Spending was $5.17 billion in 2015 according to Nielsen, the best performance since 2007 when $5.33 billion was spent. Fueled by many new product launches, DTC advertisers spent heavily in 2015. Some of the biggest newer spenders were Xifaxan, Toujeo, Belsomra, Breo Ellipta, Harvoni, Trulicity, Jardiance, Namzaric, and Brilinta.

Bob Ehrlich
“DTC spending tops $5 billion in 2015…”
-Bob Ehrlich

The new spenders are across a wide array of categories including irritable bowel, diabetes, insomnia, COPD, Hep C, Alzheimer's, and blood thinners. Returning to the $5 billion level is a strong recovery from $3.47 billion in 2012. In 2013, the DTC recovery began with $3.8 billion followed by $4.53 billion in 2014 and $5.17 billion in 2015.

The recovery has been fueled by both new products and a realization by drug companies that DTC is essential to drug success. DTC has largely been used for large incidence categories like cholesterol, depression, and diabetes. What has been a new trend is use for more limited incidence diseases like advanced stage cancer, Hep C, binge eating, sleep disruption for the blind, and advanced heart failure.

Many drugs with high annual price tags have started to use DTC heavily. Provenge, Harvoni, and Opdivo are a few of the drugs, costing up to $100,000 a year, to begin using DTC in the past few years. DTC is now seen as a way to raise awareness of premium price drugs which are harder to get on formularies. Ads create demand and put pressure on insurers to cover those premium priced drugs.

DTC spending should continue to grow in 2016 but likely will slow its growth rate. It is entirely possible we will see the 2006 record of $5.4 billion eclipsed. This is welcome news to media companies who have counted on DTC as a key revenue contributor. With higher spending comes more criticism from the army of drug company bashers. Despite the constant criticism, drug companies are eager to advertise because DTC works in creating consumer awareness and eventual higher sales.

In 2012, some industry observers and a few pharma executives were saying DTC was dying. That pronouncement was obviously premature given spending increases in 2013, 2014, and 2015. We who work in DTC have to continue to defend the use of consumer advertising. Critics will try to take away the right to advertise and our industry must provide the positives of advertising to politicians, the media, regulators, and consumers. Clearly drug companies have shown the desire to allocate more resources to DTC and should continue to do so in 2016 and beyond.

Bob Ehrlich


March 1, 2016 0

New technology in the form vitamin-sized capsules, known as edible electronics, may be the future of colorectal cancer screening. Currently in development, such capsules can be swallowed and used to capture images inside the digestive tract. One design known as PillCam, from Medtronic, uses two mini-cameras that are capable of capturing 35 frames per second. What distinguishes PillCam is its ability to harvest images of the small intestine; a particularly difficult spot to reach with the traditional scope. Innovative as they are, edible electronics are not yet a perfect formulation. During a procedure, doctors can spot polyps and usually remove them on the spot. With a PillCam, photos can be captured, but nothing can be removed. Despite this, the FDA has approved Medtronic’s device for screening certain types of colon cancer in those not suited for anesthesia. Looking forward, researchers strive to turn these capsules into full functioning robots, which are capable of both capturing images and performing tasks.

For more information about edible electronics, click here.

Lily Stauffer


March 1, 2016 0

With a sweeping 89-4 Senate vote, Dr. Robert M. Califf was confirmed as FDA Commissioner on Wednesday, February 24th. A cardiologist by training, Dr. Califf spent years supervising clinical trials within the pharmaceutical industry. In his interview, Califf stressed the importance of using electronic medical databases as early-warning systems to identify safety lapses of drugs and devices. Further, he is adamant on the subject of identification numbers on medical devices; explaining that such numbers will allow the FDA to distinguish between minor device glitches, and those that are a major safety threat. Lastly, Califf expressed his discontent on the topic of opioid painkillers, and believes regulation needs to made priority.

To read more from WSJ about Dr. Califf, click here.

Lily Stauffer


February 26, 2016 0

There are several candidates talking about the high costs of drugs. The Republican front-runner, Donald Trump, has said in his town halls that we could save $300 billion a year by negotiating pricing through competitive bidding. Bernie says drug companies make outrageous profits and through a single payer system, he would dramatically lower costs. Hillary says there will be a monthly cap on what Americans will pay for drugs, and she will institute Medicare price controls, and end tax deductions for DTC.

Bob Ehrlich
“Expect drug marketing to disappear…”
-Bob Ehrlich

Mr. Trump has greatly exaggerated the potential savings. Medicare spent about $85 billion on prescription drugs through its Part D program in 2015. Total spending for drugs in the United States was $374 billion in 2014. Assuming price negotiation through Medicare can match Canadian prices, Medicare could save about 30% or $25-26 billion. Assuming private insurers would use these new Medicare prices to help negotiate harder, maybe they can squeeze another 10% out of drug makers. That would add another $28-30 billion.

Let’s say the public and private sector savings add to $53-56 billion annually. And for sake of argument let’s assume both Bernie and Hillary plans get the same. What happens to the drug industry losing $53-56 billion in revenue? About 85-90% of the lost revenue would be profit. That means about $45 billion. Total drug industry profits are in the $100 billion range.

What would happen to an industry that loses 45% of its annual profit? Massive layoffs in all areas of operations, relocation of jobs that remain to China and India, slashing of research budgets, and a focus on less risky drugs would occur. Bernie may think drug companies make outrageous profits but he has no experience how businesses work since he never had a regular private sector job. High risk industries need large incentives to take risks. Many drug companies fail in their research efforts and lose billions doing so.

Assuming Mr. Trump or Hillary succeed in price controls, they will turn the drug industry into a quasi government contractor. New drugs will be those that government agrees to subsidize. That means many smaller disease categories will be ignored as government will focus on the diseases that impact broad populations.

Expect drug marketing to disappear under a government dominated system. Medicare under its price negotiation authority would discourage, if not outright ban drug advertising. After all they do not want Americans to use expensive drugs. All of us in DTC will need to find other work.

There may be private innovators who still develop breakthrough drugs. It will be harder under reduced pricing and I suspect fewer small drug companies will get venture capital. Government will have an increased role in basic research and drug companies will be secondary. Nationalizing R&D sounds great to socialists, but how many new drugs came out of the Soviet Union?

An electorate hostile to drug companies may actually buy into the narrative that price controls work. Our total health expenditures are about $3 trillion in the United States. It would be shame to gut the vital drug industry for a $50 billion saving. Next time we see an Ebola outbreak, a Zika like virus, a new flu, or a drug resistant bacteria, we will want a vibrant drug industry to give us cures. While politically popular to rail against drug companies, the American people need to understand the unintended consequences from a punitive approach to drug profitability.

Bob Ehrlich