Sometimes those sites blur the reality of who is behind them. FDA has cited Novartis in a letter dated 4/21 for using a site that goes too far in promoting drug use. The sites cmlalliance and GISTalliance were cited by DDMAC for improper promotion of the cancer drug Gleevec. The core issue is that the drug’s generic name was mentioned for unapproved uses and there was no fair balance. It appears Novartis was creating what they thought was a non-branded third party site and did not feel they were promoting the drug directly.

FDA considers control as a key determinant on whether the site is considered a company site. Here DDMAC said the sites were owned by Novartis and therefore were considered promotion directly by the company. The same standard would apply to single sponsored editorial pieces on a disease. If the drug company is the sole support financially for a disease education site or publication FDA would consider the company bound by the rules for advertising for all content. Therefore all editorial content is the responsibility of the company even if it claims a different company wrote it and all they did was run an ad. 

In this case even though the brand Gleevec was not mentioned FDA concluded the sites promoted the drug for unapproved uses. They said the sites were similar perceptually the to the branded site, had the Novartis logo, had a link to the Gleevec site, and referenced the Gleevec drug name in citation of clinical studies. The combination of these factors made FDA conclude it is a promotional site bound by all the rules of a branded site.

Drug marketers have frequently run into these issues on publicity campaigns when celebrities, paid by the company, promote a drug in the media without full risk and side effect balance. To the FDA, the key is who really controls the information and the spokesperson. If it is the drug company then they must act as if the information is an advertisement. While that may make some of these public relations campaigns clumsy to execute it is still required. Marketers also have these problems with paid medical experts who appear in the media.

The Gleevec case is a common one and while a grey area to marketers it is becoming more black and white to the FDA. You control it, you own it should be the standard all drug marketers consider when deciding whether information on a third party site or publication is their responsibility. The more vigilant FDA will be watching for tie-in sites with close financial ties with the drug company. The sites from Novartis have been temporarily taken down and FDA is asking Novartis for a plan for corrective messages to the audience exposed to the sites.

Is this proposed rule anything new? My interpretation is there is no major change to what FDA required in the guidance previously. The proposed rule requires four things in discussing side effects and risks. Information must be in language readily understandable by consumers. Audio must be understandable in volume, articulation and pacing. The text used to mention side effects and risks must be presented against a contrasting background for sufficient duration and in a size that allows for easy reading. Finally there can be no distracting audio or visuals during side effect or risk discussion.

These same standards have been used up to now in DDMAC assessing broadcast ads. The real issue is whether DDMAC will be stricter in what is acceptable. They could interpret any of the four requirements to make it harder to do broadcast ads. Any ad on television now could be found in violation depending on what is meant by each of the four requirements. My guess is that DDMAC is not saying the requirements will be tougher. They seem to prefer a rule to replace the existing guidance.

We will have the DDMAC representatives at the DTC National next week so I am sure they will clarify if they are intending to use different standards in the future. This new proposed rule could be much ado about nothing or big news depending on how DDMAC acts. DDMAC, if they want, can make it more difficult to do broadcast ads under this rule because you can drive a truck through the possible interpretations.

Given that wide latitude in interpretation by reviewers, pre-clearance would seem to be the only prudent course drug companies can use to ensure ads do not violate the rule. The FDA will be under enormous political pressure to show how tough they can be in monitoring DTC ads. Therefore, it is probable more problems will be found in the proposed ads during the pre-clearance process. I would also expect more warning letters once this rule is adopted as Waxman and company will be watching.

It is bad, however, that Democrats suspend the laws of economics in providing all these goodies. Private insurance companies cannot take on all the high risk patients with pre-existing conditions, costing tens of thousands of dollars annually and still stay in business. That is they cannot survive, unless they can raise premiums on all the rest of us. They will, if allowed, and that means costs keep rising for most of us. The penalties for not getting insured are so low that healthy younger people will not sign up until they get sick, and that premium revenue is being counted on by insurance companies to subsidize pre-existing conditions.

Since 15 million of the newly insured are going into the dysfunctional Medicaid system we will see a provider supply problem emerge. Providers get low reimbursements for Medicaid patients and many refuse to treat them. Coverage therefore does not necessarily mean access to providers. With 32 million added patients, who will treat them all?

What we have here is a nice plan without a clear ability to execute. When the flood of new patients appears in a few years we will see long delays in treatment and a likely decline in quality. When people do get treated we will see a dramatic rise in costs of diagnostic testing and hospitalizations. More coverage means more use of already expensive services.

Our Congress thinks they can just mandate everything and all will be right. That is plain wrong and wishful thinking. Has our government run anything well lately? Our Medicare system is a Ponzi scheme. Our Medicaid system has put states in great fiscal distress. What gives anyone confidence a huge new government bureaucracy can create insurance exchanges that lower cost, or suddenly eliminate massive Medicare fraud?

Although I agree with the goals of this new plan I am highly cynical that it will work within the CBO cost estimates. I would bet the ranch that the estimated $940 billion will be close to $2000 billion once all costs are in.  On the other hand, I am not for repeal as many Republicans now advocate without having a clear alternative that deals with access, pre-existing conditions, and cost containment. Let’s take the political bluster out and all gear our efforts towards universal coverage that works. That means essentially ending fee for service medicine. We cannot control costs and let providers and patients order whatever tests and surgeries they want. Somehow we do need to end our obsession with testing for everything right away. We need to accept that sometimes less is more in medicine. Watchful waiting is not a bad practice in many cases. That means we will need rationing in order to live within an acceptable cost range. Outcome based rewards will be critical to give providers the right incentives.

How will drug companies do under this plan? If we increasingly go to evidence based medicine I suspect drug companies will have much less direct influence over doctors.  That means less marketing and less me-too drugs. Only drugs that are truly differentiated will be reimbursed by the various highly regulated insurance companies and government run programs. DTC will be discouraged by creating new hurdles in risk disclosure. It is clear the Obama plan is emulating many European plans and that does not bode well for aggressive brand marketing. This evolution may take a few years but marketing as we know it will change. I expect more focus on disease prevention marketing and that means more educational marketing. Drug marketers will still have a role but less through the hard sell and more through co-op marketing with advocacy and government groups.

The net is the Obama plan does move us forward by at least in doing something different than status quo. I do buy the moral argument that America should want to cover its citizens and that the wealthier among us can pay a bit more to make it happen. I just do not trust my government to do it well. I resent excessive government mandates and regulations. I think the free market would have done it better and at lower cost. We did not have a true health free market before so we will never know if that option could have worked well. I accept the reality that we now need to make the government plan work. It is possible Republicans will take back Congress and win the Presidency in 2012. That is the only way the new plan will be altered or repealed as I doubt the Supreme Court will declare it unconstitutional. Obama’s plan is not what I would have done, but now that we have it as law, let’s unite and move on.

Much to my surprise I saw, in his 3/15 column in Ad Age, that Bob Garfield strongly supports DTC advertising. Not that Bob likes drug company marketing much, letting us know in the first paragraph that “pharma marketing is a cesspool.” I wondered how is he was going to attack DTC in later paragraphs. He explained his cesspool comment on pharma by saying that clinical data is suppressed, physicians are bribed with samples, thought leaders are paid to attach their names to clinical articles they did not write, and medical journals are co-opted with drug company ad revenue.

Expecting him to give the big hammer on DTC, Bob shocked me by saying he could not add DTC to the bill of indictment. Instead he said “Tens of millions of people have received successful treatment for disorders large and small that would have gone unattended had not they made aware of the pharmaceutical possibilities.” It is nice to see someone so expected to hammer DTC actually support it. The drug industry has been making the same claim of this positive effect for years. DTC, for all its supposed faults, does exactly what Bob said it does. Critics may not like branded drugs pushed directly to consumers but it is clear that it brings people in the doctor’s door. If it is an erectile dysfunction ad that brought them in then so what, if that leads to a new diagnosis of heart disease or high blood pressure that caused the problem.

For all its faults DTC is just information, carefully vetted by the FDA. Bob Garfield is no fan of the drug industry and by seeing the good in DTC one hopes other critics can see the positives. For a Congress using every trick in the book to not be transparent on passing health reform, it is highly hypocritical for those same folks to criticize the most open and transparent form of drug marketing. Thanks Bob for finding some value in that “cesspool” of marketing. I am sure he will not win many friends at PhRMA, but at least he likes our small part in the drug marketing mix.

The issue as with all drugs is benefit/risk ratio. Avandia may cause a heart attack just as aspirin may cause a stroke or intestinal bleeding. The issue is how many heart attacks we should accept versus the serious risks from poorly controlled diabetes.

The harsh reality of drugs is that they have side effects and risks. There are no completely safe drugs. There may be real issues with Avandia’s benefit/risk ratio and I am not downplaying the issues raised by critics. The feeding frenzy from lawyers and drug critics seeking a new scapegoat for drug company evil is what bothers me. Since Avandia was a DTC drug we can also expect new calls for bans based on claims that consumers were led to take ”dangerous” Avandia by DTC ads.

I have been a critic of how risk is regulated by FDA. People need to know the real odds of a serious side effect, not vague terms describing every potential risk. If a diabetes sufferer well-controlled on Avandia is given the odds of them suffering a heart attack, they can make the decision with their doctor. My guess is that the real odds of increased risk are quite small. The media will report figures like a 50% increased risk of heart attack which sounds horrible to consumers. In reality that may mean 1.5 in a thousand get a heart attack versus 1 in a thousand not on the drug.

I sympathize with Glaxo’s plight because I was on the Rezulin team in the late 1990’s when we faced the same issue. Rezulin, in the same class of drug as Avandia, was associated with fatality. As I recall the level of fatality was one in thousands, but since alternative drugs existed, it was pulled. The lawyers had a feeding frenzy and a good drug was no longer available for the many patients it helped.

To the person getting a rare side effect the consequences are devastating. We cannot, however, have life saving drugs if we will not accept that some people may actually die taking those life saving drugs. The question is always how many die versus how many saved? Much of the latest criticism of Avandia has been hyped to the point that it will scare diabetics from treating their disease. If Avandia has a negative risk benefit profile it should be withdrawn but not because of lawyers and knee-jerk critics but because of hard facts. I now see commercials from lawyers seeking “harmed” Avandia patients. Glaxo may face billions in potential liabilities as lawsuits grow exponentially. These lawsuits raise the cost of our medicines as eventually all of us pay for liability settlements in higher prices.

We can also expect new Congressional hearings on drug safety so our legislators can get face time bashing executives on what they knew and when did they know it. The Avandia commercials will be shown as examples of demand creation for a dangerous drug. Waxman will call for a moratorium on drug ads. Sidney Wolfe will cry cover up of key clinical information. No critic will be dealing with facts just hyperbole du jour. That is a sad reality in the world of drug makers.

The good news is every major new product launch has used DTC. The medium that remains number one is network television. Television is continuing a slow decline but still is 61% of the media mix, down from 63% in 2008. I expect Television to continue its strong presence in major launches for the foreseeable future. Internet grew 128% and its share of media is now 7% up from a small base of 3%. This is the first year we have seen quantum growth in use of the Internet which drug companies had been slower to adopt from than other industries.

Magazines had a tough year down 9% from 2008 and its share of media mix declined to 28% from 32%. On the other hand newspaper spending rose 93% and grew from 2% to 4% share of media.

The next few years’ spending will largely depend on whether the FDA tries to make DTC harder to execute. The FDA is clearly under pressure to be tough on advertisers, as the increase in warning letters indicates. FDA could require more risk disclosure and more visual and audio balance in portraying such risk. Any increase in risk disclosure will require more space/time and that may make DTC ads less attractive. My guess is that such additional requirements will not happen near term and any FDA action will be in more and faster warnings for lack of fair balance and risk disclosure.

The latest spending is great news for all of us who rely on DTC for our livelihoods. DTC is not going away, despite vigorous efforts from some in Congress to end it. That $5 billion provides a lot of good information to consumers, and is carefully vetted for accuracy by FDA. My new call for 2010 is up 3% from a previous call of no gain. New brands are the lifeblood of DTC and I expect pipelines to be robust long term which means double digit spending rises will likely occur in a few years.

One of the benefits of a home office is I can watch television so I watched the six hour summit. I thought it was promising in that there is a wide area of agreement on goals albeit a cavernous gap in how to do it.

The basic gap seems be in several areas. Republicans feel the cost curve is not sent downward with either House or Senate bill. They also want more private sector free market solutions and less Federal mandates. A key area missing, say Republicans is tort reform and fraud reduction. Republicans would agree that we need more affordable insurance rates, more protection for pre-existing conditions, and more focus on prevention. Republicans want a step by step approach rather than a comprehensive system wide bill desired by Democrats.

The Democrats think they address these provisions at least partially. They say costs will come down because they establish a medical panel to evaluate what works, provide preventive care without co-pays, and are working on incentives for states to reduce lawsuits.

I think that if the Democrats included full tort reform and less mandates they can come to an agreement this year. The Republicans would need to agree to Federal standards on coverage mandates for insurance companies, although maybe they can be scaled down so costs can be less for consumers. What is striking is that the CBO says rates will rise more than 10% because the government mandates coverage levels higher than we get now.

The level of political theater was evident on both sides. I would say at least 50% of the comments were substantive and could lead to a bridge between the parties. I was disappointed that Reid, Pelosi and McCain and several Republican house members were highly political rather than cooperative. Leadership seems to be a problem on both sides as many junior members had better comments than senior members who seem so set in the blame game.

Obama was very good. He did not give his normal 10 minute answers and let members talk. He listened and minimized blame. He appeared to be genuinely trying to see what the common agreement was between the sides and tried to encourage positive discussion. On the other hand, it seemed that he was fairly set in his views that the Democratic plans do achieve the goals Republicans wanted since it has many of their ideas in it. If he wants a bi-partisan bill passed he will need to give a lot more. It seems up to Republicans to agree that the current bills have many of their ideas rather than have Democrats conclude that for them.

One of the best arguments came from Tom Coburn, a Republican who is a physician, said we must go much more aggressively after the estimated 15% fraud in Medicare. He suggested we use undercover patients who can reports fraud and Democratic Senator Chuck Schumer said that can be added. Coburn also admitted that he and his fellow doctors practice defensive medicine that is also raising costs greatly. We need, Coburn said, tort reform to allow doctors to prescribe only tests patients need and not for legal protection.

It is clear from the day long talks that Obama will need to mediate much more as the Congressional leaders are much more set to blame each other than compromise. What Obama needs to do is to give enough to Republicans that their moderates are satisfied. If he tries to pass this bill through reconciliation it will be a major political blunder. I believe the current bill is not the needed solution to our problems. No one convinced me that cost will be controlled under the current bills. All that will be achieved is more coverage at a huge cost to taxpayers. I think Republicans are correct that cost must be the primary focus. Obama says the bill is deficit positive but that is because we are all paying more taxes and premiums to fund it.

DTC, as it is largely done today, is about treating the disease once it is diagnosed. Very few DTC ads are designed to encourage prevention. Once could argue that cholesterol drugs do promote prevention of heart attacks among people with high cholesterol. Or that diabetes pills promote control which prevents serious complications later in life.

The majority of ads, however, target existing disease sufferers for treatment. Under pressure from DTC critics drug companies have increased campaigns to encourage early diagnoses and testing. Clearly though, spending is about 90% in the brand awareness building among current sufferers.

The future of health care cost control will depend on keeping us from getting chronic illness. Some of this will be the result of early diagnosis. Much will be targeted to keep us from getting disease. The problem we face as advertisers is convincing America that they must slim down, exercise, and eat better. If it was easy to succeed through simple public service ads, we would not be getting fatter and more sedentary.

Michelle Obama is doing a good thing urging American parents and their kids to exercise and eat right. The issue is how to change behavior which clearly has been trending in the wrong direction. Drug, OTC, diet, exercise and food companies have an enormous opportunity to develop products and services to address prevention. They are fighting an enormous counter marketing machine for tasty, cheap products that create obesity. Marketing disease prevention will take all the creative talent we can muster.

I expect that marketing disease prevention is a huge future industry once we recognize that we do not have the budget to effectively treat a nation of obese diabetes and heart disease sufferers. Ten people in good shape might be able support the one costly sedentary sufferer of diabetes and heart disease. The reality is that we may have one in shape person for every obese person. That math will not support generous treatment. Sounds like our social security dilemma where the numbers just do not add up for affordability long term.

Once we get healthcare reform we can expect prevention to be a huge part of its metrics for success. We need to incentivize good behavior and penalize bad behavior. We can no longer allow people with bad health habits to get a full government subsidy to maintain bad habits. Medicare and Medicaid do just that. One day I suspect cost pressures will force government to shift co-pays to those who fail to maintain healthy habits. The fast-food, couch potato, smoker crowd may resent that but that is the way it has to be. Prevention will be encouraged and good habits rewarded with lower premiums and co-pays. Otherwise we will all go broke treating preventable disease.

FDA has indeed speeded up its process to issue warning letters. The new head of FDA Dr. Margaret Hamburg has pledged to step up enforcement. Most of the letters are for inadequate fair balance. Obviously, there is always a desire from drug companies and advertising agencies to stress the positive. No one wants ad space dedicated to stressing negative points. The law, however, requires balance and some drug ads were non-compliant.

No one can argue against a vigilant FDA. The public needs it and drug companies are better off if violators get caught. The more warnings issued the more likely Congress will realize that the FDA is vetting drug ads, thoroughly and quickly warning offenders to end their campaigns. Companies who fully comply expect FDA not to let their competitors get away with unfair balance.

What FDA needs to do is continue to issue guidances and educate drug companies with examples of acceptable and unacceptable treatments of fair balance. As long as FDA is consistent and clear in what is violative the drug companies will have no problem complying. It is clear that most new drugs are using DTC in their launch campaigns. Therefore the guidances on what is acceptable treatment of risk are critical to brand teams developing DTC. No drug company wants a warning letter and its possible consequences and I believe they do want to comply. In the past there have been inconsistent decisions as to what is a violation. I hope the FDA reviewers are huddling with each other to ensure standards for one category are the same as others.

So go to it FDA, and if warnings increase in 2010 from 41 to 81 so be it. All the industry can ask is for clear standards, fast pre-clearance and sensible negotiation over disagreements on what is fair balance. That requires continued quantitative studies as to what consumers take away from drug ads so we all know what is fair disclosure. It is not in the public interest to overwhelm consumers with information as studies have shown less can be more in terms of risks and warnings. Drug companies have a right to sell their products through DTC and it is in everyone’s interest to have a well staffed FDA overseeing it.

Obviously, this category thrives on DTC advertising because demand creation is critical for an elective treatment not covered by insurance. Our aging population seems to demand perfection. Look at the shows from the Real Housewives series as examples of a society driven to look good. Most of the women profiled are proud to talk about their numerous enhancements. Men are also increasingly using Botox and getting facelifts and hair transplants.

What is interesting is that there is a huge potential international market long term as developing countries will increasingly be able to have enough discretionary income to support enhancements. Currently 60% of cosmetic enhancements come from the United States. That means long term opportunity in the emerging middle class markets. I am sure Real Housewives of Beijing will want to emulate Orange County in breast size and smooth skin.

Another potential boom category for DTC is preventive testing. Early diagnoses and treatment will grow as government puts more effort into cost effective treatments at early stages of disease. This means genetic testing companies will see a boom in sales as they get better at identifying subsets of the population that will benefit most from Rx and medical device treatments.

I still see a healthy DTC market for traditional pills for existing categories. Our society is still getting fatter and more prone to diabetes, high blood pressure, heart disease, impotence and other diseases. Major drug companies will see price pressure from government and other payers. Therefore market expansion will be crucial to success and DTC is great at creating awareness. More users, even at lower prices, will keep drug company profits strong and society will be healthier.

So whether in traditional DTC categories or new or expanding ones, it is highly likely DTC advertising will grow significantly over this decade. It is also likely other countries will be more liberal in allowing health ads from drug companies, although in the disease prevention and treatment area, not in branded ads.