Fact Box and Risk

The New York Times (2/26) ran a story on a Dartmouth Study that concludes a fact box on risk/benefit is good for consumers. A fact box was mocked up with clear risk and benefit information in numerical terms versus placebo. The study concluded that consumers found it easier to pick effective drugs using a fact box.

I was interviewed for the story by the writer Natasha Singer. I will reiterate what I said. A consumer deserves clarity in all advertising on both risks and benefits of taking a drug. While impractical in television ads to show fact boxes, in print it is very useful. If a drug mentions a serious side effect then please tell consumers the odds of the risk. For drugs that mention fatality it is particularly critical to spell out the odds. Most consumers, I bet, will overestimate the odds of dying if they hear it mentioned on an ad. This is not good if it steers them away from taking a good drug. I worked on this issue about ten years ago when we were doing ads for a diabetes drug. Consumers thought the statement “rare chance of fatality” was about 1 in a 100. Most drugs that mention it likely have odds of less than 1 in 20,000. Rare is a term that should be reserved for steaks or Rembrandts and not used to define fatality from using an Rx drug.

Drug companies and FDA should also include all relevant information in a fact box. That means having some inclusion of post marketing data, even if that is less perfect than controlled clinical studies. That would take a lot of work from the objective medical community but it is worth it. It might take a special advisory board to continually review and update all risk/benefit studies. Certainly those boards exist and could be expanded for evaluation of risks.

The Dartmouth Study will be presented shortly to FDA as part of the risk communication work they are doing. I support anything that gives consumers clear and numerical information on how a drug may help or hurt them. Whether we work in the drug industry or not, we are all patients and so are our families.

Recently stories in Time and Business Week speculated on the end of DTC as we know it. Business Week, in a January 24 story on the Pfizer takeover of Wyeth, said “Congress is widely expected to restrict direct-to-consumer advertising by drug companies this year.” Time titled their February 4 story, “Are Direct-to-Consumer Drug Ads Doomed?” The Time story concluded that DTC is not doomed, but the threats of mandated moratoria are real.

The fact that popular media is reporting on the possibility of an end to DTC likely makes the practitioners of the medium nervous. Given that Congress is busy saving us from financial ruin; it is unlikely that DTC restriction is a high priority. We first need an HHS head and then numerous studies and hearings how to restructure our unsustainable health care system. The role of pharmaceuticals is a small but important part of that restructuring. Pharmaceutical cost is the big issue and marketing is a sub issue of that discussion. My point is that DTC will be addressed in the future as part of the larger issues.

Given that even the most critical Congressmen are not talking about a ban, DTC practitioners should be somewhat relaxed about the future. The worst case will be a moratorium on DTC for new drugs and pre-clearance of all ads. Drug companies, their ad agencies and media suppliers do not want either of those mandated. They are afraid that any permission needed from the government to advertise sets a dangerous precedent for additional restrictions.

The reality is that we already have a moratorium of about one year anyway as drug companies delay ads to give their detail reps time to sell and sample physicians. We also have the vast majority of drug companies using voluntary pre-clearance of ads. As I see it, we may be talking about extending the moratorium period by another year for the riskiest drugs. We may also see mandatory pre-clearance as part of drug approval conditions.

Neither of the above would end DTC or cause major declines in media spending. I conclude, therefore, that DTC will be here for a long time because the public likes knowing what treatment options are available. Critics have valid concerns about raising utilization of expensive and sometimes risky medications. That is balanced by our free flow of information in a market oriented society. Americans are used to checks and balances in information flow. They know DTC ads are attempts to sell to them and are rightfully skeptical of claims. They are also aware that their physician is under pressure from insurance companies to avoid prescribing expensive drugs. DTC is just one point of view consumers use to evaluate their treatment options. They do not want that taken away from them.

I would not expect any Congressional action in 2009 on DTC. The FDA will be busy assessing the state of DTC through additional studies but their process is slow. Any change in DTC regulation before 2010 would surprise me. No, DTC is not doomed. Good news for a company called DTC Perspectives.

I always will think of Yaz as a baseball player with the impossible to spell last name. I date myself because Carl Yastrzemski was a star in the 60’s and 70’s. This Yaz is the contraceptive made by Bayer.   Unfortunately for the Bayer Yaz, news this week was not positive. As a condition of a settlement of a deceptive claims action by 27 states, Bayer began running a $20 million corrective advertising campaign.

The settlement with the states and FDA should help convince DTC critics that drug companies do not get away with over stating benefits. FDA has been called complicit and lax in allowing drug companies to keep deceptive ads on too long and with no real penalties. Corrective advertising is a serious penalty. The drug company must publicly admit it made mistakes in past ads and spend some serious cash correcting the past errors.

For drug marketers seeing another DTC drug get slapped with corrective ads, the effect can be chilling. In these times, no drug CEO wants to see their company reputation damaged. Drug companies have a public image aligned with big oil and tobacco so any further dilution in not welcome. The lesson for all DTC marketers is that the risks of aggressive claims are high. Pre-clearance is always wise.

Many drug marketers start copy development too late in the launch process forcing risky decisions whether to air an ad.  The late start for many companies may lead to avoiding voluntary FDA pre-clearance or running a mediocre ad. I think avoiding FDA review is highly dangerous since they almost always will find something wrong with an ad. I also think too many ads suffer from “average syndrome” and ads that are in the pack will not be too effective. Kevin Clancy, a legendary marketing writer, cites research that ads that test in the top tier are twice as effective as average ads. Having the time to develop a top tier ad should be the goal of all marketers. In my consulting assignments I have found the copy development was started too late forcing limited concept options and rushed testing.

The Yaz story received wide coverage in the popular press. The DTC Industry obviously is not helped by bad publicity this corrective campaign received. On the positive side, it shows regulation does work. The public and Congress should be somewhat reassured that the state and federal regulatory authorities are monitoring DTC ads. Although we will not avoid additional hearings and regulation on drug marketing, the critics can no longer say penalties are a slap on the wrist.

We live in a new world of marketing career paths. I have noticed a lot more people networking with me recently who have or expect to lose their jobs. I am always happy to help anyone who needs advice. Our terrible economy is creating massive dislocation in the drug industry and has spread to all other marketing driven companies. For those of you generation X’ers, please heed this bit of advice. No company can be trusted to take care of your career. Every company can be bought out, merge, go bankrupt, reorganize, downsize and outsource in a corporate nanosecond.

Therefore, your hard earned company career equity can become worthless pretty quickly. The good, loyal soldier approach is fast becoming extinct. I worked at Warner-Lambert in the 1980’s when a young marketing professional expected to stay in one place for a long time. The company had the same expectation. Of course we had turnover, and people did jump to other companies for a promotion or money. The difference was that if you wanted a long career the company gladly provided it. That was of course until Pfizer bought us in 2000. All bets were off. Our senior management flew the coup with their fortunes and all the loyal soldiers found out their years of service meant little to the new management. Today, no marketer should expect to be rewarded with a steady one company career. Today’s marketers should think of themselves as hired guns. Do your best, take the rewards, but do not expect that effort will lead to a career. Loyalty will not be rewarded with any long term guarantees. So, the smart young marketers should do the maximum to expose their talents to the broader marketing world.

I guarantee the good soldier who never leaves their company headquarters, to build an external reputation, will one day face a difficult and lonely job search. Get out there and get yourself a full list of peer contacts. Take every opportunity to get known. How can you do that? Write articles for trade magazines. We actually have a hard time getting good articles for our magazine. What better way to be known than to have been published in your industry trade magazine. We also always welcome conference speaking submissions from within drug companies. I guarantee that speaking is the best way to mass network. It may take some effort to write and deliver a speech and to get it through your corporate legal and public relations departments. It is worth it. Your company gets a reputation extolling its marketing prowess and you get a reputation as an expert.Attend as many conferences as your supervisor will allow. There must be a dozen good ones available each year. Be sociable, and meet your fellow marketers. Too many marketers run up to their rooms at every break to write memos, call the office and consequently miss the best networking time. The product manager that is just too busy to bother to attend industry events is making a huge mistake. All of us will likely get fired one day. In the DTC world, it is relatively easy to know most of your peers. We are a small industry and it is not hard to get known. Your company does not care much whether you are known. After all, they already know you and are not thinking of what happens to you if the company gets acquired or you get fired. You need to take control of your own publicity.