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September 29, 2017 Bob Ehrlich0

With the failure to come up with an alternative to Obamacare, Congress has left drug companies in a more precarious position. The goal was to make health care more free market oriented and less government controlled. That would have created more competition among health care providers and insurance companies. Patients would have more choice and more responsibility to use their health care dollars more wisely.

Bob Ehrlich
“DTC will likely weather the political storm.”
-Bob Ehrlich

Proponents of Obamacare say more free markets would mean less guarantees of coverage. The Congressional Budget Office has said the Republican plans would have led to many millions losing coverage. I do not want to take sides here. I will say that we do need a compromise that gets votes from both sides to have a long term plan that can endure changes in party control. Obamacare is helping many patients with pre-existing conditions, while hurting many others who are paying higher premiums with super high deductibles. This cannot go on as we are all paying too much for coverage. Our plans are increasingly becoming useful only for major illnesses, not covering routine expenses.

How do drug companies fare in this failure to repeal Obamacare? I am afraid they will now be a target for both parties as a driver of increased premiums and higher deductibles. Congress will have to deal with these issues and will look to drug companies to cut costs. Single payer will not pass, but we can expect to see more government involvement in pricing. Bernie wants reimportation from Canada which he says will save consumers $7 billion a year. He and many others want Medicare to have negotiating power with drug companies. Others in Congress want to end DTC or use tax policy to make it a non deductible expense.

California wants to legislate a notice period for drug price increases and mandate insurers tell them what percent of premiums are the result of drug costs. Other states will also try to add measures to embarrass drug makers with marketing disclosures.

Most patients will support measures against drug makers. We all want lower costs. Few patients understand the industry arguments that innovation justifies higher prices. While most Congressmen understand the need for a profitable drug industry, many think that profit is excessive and will be willing to cut that level of profits. Bernie thinks he knows how much is a fair profit and is perfectly willing to risk innovation for Canadian level prices.

DTC will likely weather the political storm because of commercial free speech provisions. The question is will drug companies voluntarily stop DTC if Congress demands it as a price to prevent reimportation or Medicare price negotiations. Drug makers will do what they need to to keep free market pricing. Unfortunately that means DTC is vulnerable to horse trading.

Drug companies like using DTC and its expanding use is proof they get a good ROI. Remember, however, that DTC spending is only about 1% of US Rx sales and might drive about 2% of sales. It is true that some brands are driven heavily by DTC but most establish 90% of their sales through physician promotion. So, can the drug makers stop DTC and still be successful? Most brands can and will adapt to a no DTC world.

My conclusion is the advertising lobby will prevent any punitive provisions affecting DTC. After all, the same media companies who bash drug companies regularly in their news coverage depend on DTC ads for a large portion of revenue. What is clear is the risk of those DTC restrictions are higher than ever before and we in the drug advertising world must stay involved in defending DTC as a positive force for educating consumers.



September 22, 2017 Amrita Bhowmick0

For years, many luxury goods retailers, concerned about exclusivity and control, either sniffed at or completely ignored the internet as a marketplace.

Now, a recent McKinsey & Company Marketing & Sales report tells us “Nearly half of luxury goods buying decisions are already influenced by what consumers hear or see online.” The same report predicts that by 2018, “global digital sales for women’s luxury fashion are expected to grow from a current 3 percent of the total market to 17 percent, for a total market size of $12 billion.”

Conventional wisdom also underestimated the internet’s power as a source for health information, but a Pew Research Center study shows “80% of internet users have looked online for information about any of 15 health topics such as a specific disease or treatment.” The same study finds “34% of internet users, or 25% of adults, have read someone else’s commentary or experience about health or medical issues on an online news group, website, or blog.”

Likewise, conventional wisdom held that patients would never use social media for health information. However, Health Union research found that 26% of the patients used Facebook once a day or more for health information and more than half (52%) use it at least monthly.

Hubs for medical innovation

While the emergence of social media tools and online health communities as hubs for medical innovation might seem far-fetched, their importance in a digital environment can’t be overstated. We now live in a world where communication is multi-directional, information is more accessible, and experience-sharing is simple and fast.

But what can online health communities contribute to health research?

DTC Perspectives | DTC in FocusNot surprisingly, descriptions of a patient’s experience are most valuable when they come directly from the patient. Posing questions to an online community or monitoring conversations aids in the observation of trends in habits, desires, symptoms, and other information otherwise unavailable or difficult to obtain. Trends can be analyzed and online communities can provide feedback regarding product attributes that patients and caregivers find most important. Observational studies can inform researchers about real patient experiences and patient-driven research can serve as a starting point for future trials or as verification of previous results.

Online communities also offer valuable input for clinical trial design and feasibility. While the current belief is that patients are generally not involved, we’ve found that patients are very interested in contributing to the study design process. Patient advocates can add value to study development by identifying challenges and helping to create patient communications.

The rise of patient-driven research

We are witnessing a growing trend of patient-driven data from wearable technology from companies like FitBit, Garmin, and Apple as well as from direct-to-consumer health testing such as 23andMe or recently FDA-approved tests that can detect a predisposition for late-onset Alzheimer’s or Parkinson’s disease.

At the same time, we see an increase in patient-driven research. Although it is a less-controlled form of study, there is potential for it to complement controlled, scientific studies. And while there is a possibility for inaccurate data, there is significant potential for fast, large-scale, and low-cost data collection.

As an example, consider a recent online community’s participant-led study of the effects of lithium on patients with amyotrophic lateral sclerosis (ALS). The study had no control arm and required patients in the community to self-report their experience and ALS symptom progression while taking lithium.

The results from the community indicated there was no connection between lithium and symptom progression. Researchers then completed a scientific study, analyzed the patient data, and compared the experimental group to a control arm utilizing existing electronic patient records. Researchers concluded that the results of the patient-driven study held validity. These results also confirmed the findings of a previously conducted clinical trial investigating the same hypothesis  —  that lithium did not affect ALS progression.

Though these types of trials can have academic merit, they are not a suitable replacement for FDA-approved clinical trials. However, they show promise as a means of validating previous study results, or generating interest in a particular treatment method.

What motivates patients to participate?

Health Union’s latest survey data from nearly 20,000 individuals representing 12 different chronic conditions finds the majority of respondents (64%) are interested in participating in clinical research. We find the same trend among condition-specific communities such as migraine (74%), rheumatoid arthritis (64%), and inflammatory bowel disease (57%).

Community members are motivated by a desire to improve the quality of medical care for themselves and others, and to help researchers understand what it’s like to live with the condition. Other insights we’ve uncovered influencing motivation are also personal and compelling:

  • “As a young person who was diagnosed with something that can make you feel helpless, research and taking charge by devoting my career to making a positive impact has pulled me through.” — Stephanie B., MultipleSclerosis.net
  • “Being able to say they actually wanted my opinion…can make a person feel validated and important.” — Katie G., Migraine.com
  • “I think the patients [researchers] are looking to recruit would be more apt to be part of a clinical trial that has patients and researchers working together.” – Cathy C., MultipleSclerosis.net

Tapping into the desire to participate in clinical research, online health communities can broaden the scope for recruitment of research participants beyond traditional methods and often accelerate the speed of enrollment.

The incredible potential of online communities in health research

Online health communities can change the efficiency, feasibility, and speed of health research while engaging a larger population than ever before. Trials have the possibility to be designed for maximum retention and recruited with more efficiency.

The possibilities within this realm are vast and, if treated with appropriate caution, can have a tremendous impact on patient care along with the quality of health research and innovation.



September 1, 2017 Bob Ehrlich0

The FDA is starting the process of possibly reducing the required number of risks presented in television ads. They have opened a docket to solicit public input on 8 questions they raised. I expect this process to be lengthy as speed has never been a guiding principle of the FDA’s Office of Prescription Drug Promotion (OPDP). They are taking their usual approach of being extremely cautious in making changes to their risk disclosure guidance.

Bob Ehrlich
“OPDP already has enough data.. to issue a revised guidance…”
-Bob Ehrlich

This is not the only area of a slow pace in recognizing the changes in consumer communication. They have, for years now, failed to recognize the role of DTC in social media and delayed any useful guidance that recognizes how consumers actually use the Internet. Thus, it is still prohibited to actually use a drug name and indication without the fair balance, as if consumers do not know how to click through to get more information.

Their own recently published research showed that less risk presentation is better for consumer comprehension and retention. For them that finding is the start of a rigorous research process to see if their hypothesis that “less is more” in risk presentation should be implemented in terms of changing their guidance.

Some conclusions are obvious and action is sometimes better than continued study. While I know OPDP is deliberate in making any changes to guidances, we have had broadcast ads for 20 years already. That is slow even by government standards. It is painfully apparent that DTC ads are presenting way too many risks and that litany approach is ridiculed by satirists and critics. Consumers complain about the many risks presented and have been for years. What does FDA do about it? They seem to want more and more studies so they can come out with a “perfect” guidance. This attitude is hurting consumers. A whole generation will have watched DTC ads with too much confusing risk information before FDA finally acts. OPDP already has enough data and should have the people with the judgement skills to be able to issue a revised guidance today.

Studying how risks are presented in DTC ads made sense in 1997 in the introductory DTC broadcast period. For them to just begin to study reducing the number of risk disclosures after 20 years is both puzzling and concerning. OPDP frequently says as a reason for slow progress on studies is that they have constrained human and budgetary resources. Yet they have managed to conduct several studies on things that many in the drug industry find tangential and not actionable. They should have focused more on this area as comprehensible risk presentation is critical information for consumers. They must develop a better strategic focus on what are their priorities for DTC research. If you look at their research web page, you see a lot of projects that seem to be all over the map that may satisfy the curiosity of their researchers but has no actionable benefit to consumers.

I am sure they will get a mountain of feedback from their docket request and they will meticulously wade through that to use as a basis for new studies. I personally know some of the researchers at OPDP and they are top notch professionals. Maybe they are as frustrated as I am. They must be caught in the bureaucratic ways of government, however, to be taking so long to resolve the risk disclosure issue. Maybe it is time for OPDP to move things along or get new leadership. No one in the private sector would still have a job after taking 20 years to resolve such a fundamental issue. Sadly, OPDP is allowed to operate in a different universe of accountability.