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Restasis, the dry eye drug from Allergan will soon see major competition. Shire’s drug Xiidra was recently approved and now widely available. Their unbranded DTC campaign just began with A list star Jennifer Aniston as its spokesperson. This huge market of 16 million sufferers will now have two brands battling it out on the DTC front.

Analysts say Xiidra has potential to be a billion dollar drug. Restasis has sales of around one billion so this should be a category with significant branded DTC presence. Restasis spent over $16 million in 1Q this year and they should be investing heavily to defend against Xiidra in 4Q.

Shire enlisting Jennifer Aniston is a big get. Getting a movie star to promote the dry eye condition must have cost Shire a lot in talent fees. Obviously they think she is worth it. Her ad just went on air under the “myeyelove” title. They have a website myeyelove.com which tells her story of dry eye and has the commercial currently airing. The site has the usual education component with symptoms, causes, prevention and treatment options.

Jennifer Aniston is getting lots of commercial endorsements these days. She is touting skin care brand Aveeno and plugging the comforts of Emirate Airways. I am sure Shire considered whether we at a Jennifer saturation point. My feeling is we can take a couple more campaigns before she gets overused.

The commercial is very well executed with Jennifer telling her story of how dry eye interfered with her life. The 60 second spot uses the Beatle’s song “All You Need Is Love” the classic Lennon-McCartney song recorded in 1967 as background. I do not know if Jennifer will do any branded DTC, and my guess is no. Having her remain non-branded is probably a better use of her celebrity. She can tell a friendly story advising sufferers to consult their eye doctors without needing to deal with fair balance.
I expect a heavy branded component to appear late this year or early next year. Just doing non-branded ads will help Restasis as well, so expect Xiidra to tout its efficacy profile versus Restasis. The Jennifer campaign will help get attention to the launch from both providers and patients. Long term, however, this will be a brand to brand fight and likely a boon to DTC media sellers who love a multi brand battle.

The FDA has done a mixed job overseeing patient side effect education. Consumers have a right to know what the possible side effects are for any medication. They also need to know the real odds of getting them. The FDA has regulated the first well. Patients do get to see and hear the litany of side effects on DTC ads under fair balance requirements. What the FDA has regulated less effectively is educating the public on how often risks and side effects are really likely to occur. Side effect and risk discussion, improperly communicated can scare people away from taking their medication.

Consumers are inundated with side effect information from inserts with their prescriptions, DTC ads, web site chat rooms and online drug sites, and their doctors. Lawyers advertise for clients touting drug side effects. So how is a consumer to know when a prescribed drug might be dangerous? After all everyone has a different risk tolerance. It is also disease dependent in terms of the seriousness of the disease and risk a patient may be willing to accept for a cure or relief of symptoms.

The FDA is exploring requiring less risk disclosure in DTC ads in order for consumers to hear the most important. That is a good first step. What really matters, however, is that consumers make a rational data driven decision on drug use. What are the odds I might die or be permanently injured? A cancer patient may think a 1/100 fatality rate is acceptable while someone considering a statin may find 1/10,000 a risk worth taking.

If you watch DTC ads you do not know how often those serious side effects might occur. Sometimes the package insert has that data, but often that is in medical terms and hard to decipher. The FDA needs to find a reasonable, quantifiable method of telling consumers what might happen. Just lessening the advertised number of risks and side effects is not enough. Our media outlets love to run stories highlighting risks of drugs. They also rarely put these risk in context, thus scaring current and prospective users off. “Deadly drug in your medicine cabinet” is a better headline than “new drug kills one in every 20,000 seriously ill patients.”

So how about a clear system listing the numerical odds of getting the serious side effect? Maybe list only the numerical odds of life threatening side effects to make it easier to communicate. Accurate data exists to provide such odds. Using vague terms like “rare case of fatality” just confuses consumers. My definition of rare might be 1/100 but the real data may show 1/100,000. Therefore, it is time to rework the fair balance in a way that is fair to the public.

DTC spending continues to be very strong in 2016 based on a number of new brand advertisers. I fully expect the 2016 spending to top 2015 by 5% or more. That would put the total at about $5.5 billion. Driving much of the growth in 2016 will be diabetes drugs.

The number of diabetes advertisers used to be relatively small and often confined to print publications. Now many diabetes brands are all over television. There have been several new categories of diabetes drugs launched in the past few years. One is long lasting insulin for both Type 1 and Type 2 patients. Toujeo and Tresiba are the big spenders. There are also new injectables that are non-insulin that control blood sugar. Victoza is the big spender here with Trulicity in the mix. A whole new category of pills that help the kidneys excrete excess sugar burst on the scene in the past few years. Farxiga, Invokana, and Jardiance are all heavy spenders. Another new category of pills help regulate insulin after meals and these recent entrants include Onglyza, Tradjenta, and Januvia.

Why are Diabetes drugs investing so much and launching so many new brands? The market is huge at 29 million people with diabetes. With aging baby boomers swelling the population, this market will receive heavy investment in R&D and marketing. We are also seeing an emphasis on early diagnosis by alerting people with blood sugars over 100 that they have pre-diabetes.The American Diabetes Association says there are 86 million adults with pre-diabetes. While most do not receive treatment they are increasingly made aware of the risks of developing diabetes. That early awareness should help the adoption of advertised drugs as those pre-diabetics evolve to diabetes.

There are many products on the horizon that will be launched that improve blood sugar as companies are looking for new pathways to control blood sugar. A company in Israel is developing an oral insulin which would be a welcome alternative to injections. There are many companies working on devices to test blood sugar non-invasively to replace the finger sticks.

While many DTC critics say drug companies push drugs in categories where treatment may be overused, this is hard to argue in diabetes. The CDC reports that only 57% of diagnosed diabetics have numbers under control (HbA1c under 7). Even small changes in blood sugar have a significant impact reducing complications. The advertising for all these drugs emphasizes control of blood sugar. The challenge for all these drugs is how to say control in advertising that differentiates one brand from another. With so many ads on mass media this is a category that needs continuous innovation in creative development.

Because of the significantly higher incidence among African Americans and Hispanics diabetes DTC has many opportunities for multicultural campaigns. Given the many new types of diabetes treatment pathways there is a need for education on which might be right for patients. That means fertile ground for the use of DTC for years to come. Even the DTC critics should welcome all the awareness created by diabetes DTC advertisers. The estimated annual healthcare cost of diabetes is $245 billion in America. Telling people about blood sugar control serves both societal and drug company objectives in controlling the numerous devastating complications.

In a heart wrenching story by a husband of a lung cancer patient, Opdivo DTC received harsh criticism. The op-ed in the 8/9 New York Times titled Cancer-Drug Ads vs. Cancer-Drug Reality delivers a rebuke to Opdivo for creating false expectations. The author Matt Jablow writes a touching story about his 48 year old non-smoker wife diagnosed with lung cancer who passed away in 2013.

Mr. Jablow recently saw the DTC ad for Opdivo and felt it was misleading in saying it could extend the lives of lung cancer patients. He goes on to say that the drug only helps 20% of patients and only a small added survival benefit measured in months. While I understand Mr. Jablow’s concern I disagree that the commercial is misleading. It says Opdivo gives you a chance to live longer vs. chemotherapy. It says the survival in the clinical study added a few months vs. chemotherapy.

I agree the ad is majestic and bold in showing a headline about a chance of living longer. An ad always features the main benefit and is designed to get you to pay attention. No patient seeing this ad will think their cancer is going to be cured by Opdivo. They will at most ask their oncologist about the potential use for their case. The oncologist will explain benefit and risk and the added survival time will be disclosed.

The idea that a patient will see this ad and have false hope is disingenuous. Any patient or family member of a patient with lung cancer is not going to read too much into the first five seconds of an ad. These patients will investigate the drug advertised and get a lot of information before using it.

We all know Opdivo wants to make patients aware of this new drug because they want to sell more of it. That is what all advertising is designed to do. Mr. Jablow thinks the ad overstates the benefit. The FDA reviewed the ad and did not agree with Mr. Jablow. Mr. Jablow wants Opdivo to withdraw the ad. What about the patients who do benefit from seeing it? While it did not apparently help his wife who was in a clinical trial, it may help someone else's wife.

I do not expect Mr. Jablow to agree with me. No one can fully understand his anguish about losing his wife and his opinion should be respected.  I think his critique is not fair, however, and the commercial is truthful and provides valuable information.

You know the ubiquitous ads soliciting clients who were “injured” by prescription drugs. Lawyers all over the country create a drumbeat of fear over prescription drug side effects. The American Medical Association(AMA) is now concerned that this fear mongering is causing patients to get off or refuse to start needed therapy. Last month the AMA called for warnings in these lawyer ads telling patients not to stop taking their meds without consulting their doctor.

The stats are amazing. About 360,000 lawyer ads were run in 2015 on drugs and devices. Many of these law firms are just bundlers who get leads from the ads and turn the names over to trial firms for a cut. The AMA has called for a ban on drug company DTC which seems odd if they are concerned about the scare tactics used by law firms. Drug ads give the positives and negatives while law firms only give negatives. One would think the AMA would want the positives out there if they fear the effects of fear based lawyer ads.

The most ads were run against Xarelto, with Pradaxa, Invokana, Risperdal and Androgel in the top 10. FDA should conduct a study to determine what affect lawyer ads have on consumer attitudes. While they do not regulate what lawyers say a study could help them determine how consumers react to these risk ads. That might help them determine how drug companies discuss risk.

There is no doubt some patients have legitimate claims against drug companies. Lawyers can play useful roles in protecting patients. These ads go beyond that role as they chase clients and create a climate of fear. That being said, these law firms make money doing this direct response advertising. The fact that 360,000 ads were run show they work. A Congress filled with lawyers is unlikely to hold any hearings take steps to stop these ads.

One would hope ethics would mitigate the egregious nature of these ads. Ethics are clearly not the main concern of those drumming up business by scaring patients off their meds.

I could not leave last week’s column on media inspired patient fear without another example. The excellent New York Times reporter Gina Kolata did a story on patients resisting drug treatment for osteoporosis out of side effect fears. The story in the June 1 New York Times said millions of people were forgoing osteoporosis drugs out of fear from exceedingly rare side effects.

Ms. Kolata highlights the problems doctors are having convincing patients who need drugs to start therapy. Use of these drugs has gone down by 50%. The incidence of broken thighbone side effects is 10-40 patients for every 100,000 and one in 100,000 for broken jawbones. This means millions of sufferers of osteoporosis are needlessly suffering fractures because they fear side effects.

Who is to blame? The media reports are partially to blame because they do not give the minuscule odds of a side effect compared to the effects of non-treatment. Lawyers are to blame fishing for patients who take these drugs and claim side effects. How many commercials do we see from lawyers listing a litany of drugs that may have caused side effects?

The FDA is to blame for requiring these extremely rare side effects be part of the ads. While every patient should know the risks, saying fatality in an ad without context is a disservice to patients. What we need is a reporting of the odds of a serious side effect, not vague terms like rare. Consumers will overstate the odds if they hear the word death in an ad. I doubt too many consumers would avoid a drug with a one in a 100,000 incidence. To consumers, words like rare could mean 1/100 not 1/100,000.

FDA needs to have a much better guidance on quantifying risk. Serious risks require clear quantitative odds of occurrence. Patients deserve it. The media should also be held to a high standard when doing their sensationalist stories on drug risk. As this article reports, scared patients make irrational risk/benefit decisions.