For those employed by the pharmaceutical industry that feel they must defend their company/industry to their friends, neighbors and relatives, the news is bad. A recent survey just released by Harris Interactive shows the pharmaceutical industry has lost ground in 2007 versus the prior year. Positive ratings declined another 2 points in 2007 to a low of 26% of American consumers who give drug companies a positive rating.

Who else is ranked with drug companies at the bottom? No one rivals tobacco at only a 10% positive. Airlines tie pharma at 26%, with energy slightly above at 28%. If one looks at the survey from the perspective of negative ratings pharma actually is second to last with 52% having a negative opinion of drug companies.

The fact is that despite the existence of price support programs for many years, too few eligible are enrolled or are aware of them. Most of the ads for the price support program with Montel are placed on news shows, not on prime time or other shows most watched by low income Americans. Second, the real measure of success is how many are enrolled versus those eligible. Until a majority who qualify use the program, high price will be the major issue leading to a poor industry reputation. Therefore drug companies need to evaluate themselves based on the percent of those who need help that are getting help. The mere existence of help and advertising that fact to opinion leaders does not really show a genuine push for success.

Another issue is the perception of sales over safety. Whether the courts or Congress will find real evidence that drug companies did wrong through late disclosure of safety issues is still to be determined. I am sure, however, most consumers believe that drug companies place profits before safety. This belief is partly driven by many recently published mass market books and news stories covering the drug companies. Of course the numerous recent price fixing cases, off label marketing accusations and drug withdrawals provide support for the sales over ethics perception.

The value of good reputation is hard to quantify. Clearly it must help in attracting good employees. I would assume it helps in getting the best research partnerships. It must also help when safety problems emerge with a product. With drug industry reputation so low, credibility is doubted when trying to defend a problem drug. The drug industry must decide what improving their reputation is worth. They could accept the second lowest ranking or decide how to make it better. Clearly their current approach has fallen short and anyone charged with making it better has largely failed, unless the goal was a controlled decline. I know all the good things the drug companies do, and why prices are higher, but you need not convince me. It is the 74% of Americans who do not like you that need the convincing. Will it happen? Maybe it will if a bunch of new wonder drugs get discovered or if prices are drastically reduced. Otherwise, do not look for the second to last reputation spot t o be vacated soon. It is a challenge that must be dealt with by the CEO’s or they risk significant legislative and public backlash.

So what should pharma public relations people take away from this survey? It has to be that all that price support advertising with Montel Williams and other corporate ads extolling the virtues of their R&D is not resonating well enough with Mr. Average American. I have said this before but will say it again. The only way for drug industry corporate ads to work is for the programs advertised to actually be used by a majority of consumers who qualify.

The news that four big pharma companies have agreed to a six month moratorium for new brand DTC is not earth shattering. The four, Pfizer, Schering-Plough, Merck and J&J, had all been recently called to testify before the Dingell/Stupak committee regarding DTC for Lipitor, Vytorin, Zetia and Procrit respectively.

The Congressmen had asked for a two year moratorium on new products to allow for potential safety issues to emerge. The four drug companies agreed to the six month number. Pfizer had previously announced six months, and Bristol Myers said they would wait a year.

I have previously written that I think anything up to year is a fair waiting period for a new class of drug, but no more than one year is a reasonable period to expect a drug company to delay ads. There are unforeseen safety issues that can emerge with a wide scale launch of a new class of drug. A voluntary moratorium should be negotiated for each drug launch where FDA is concerned about safety issues.

So the agreement by the four companies is going to likely spread to all drug companies and may become the PhRMA standard as a minimum. My guess is that eventually a year will be the negotiated voluntary standard given that Dingell/Shupak wanted two years. Is a year a burden to drug companies anxious to launch DTC? Most want to give their detail forces a six month window to establish physician awareness and trial before launching consumer programs. So is the additional six months a problem? That depends on a number of factors such as remaining patent life, novelty of the drug, category penetration, and expected formulary presence. Drugs that expect immediate benefits from DTC will not want to wait.

I want to emphasize that I think a long moratorium is not really needed for additional drugs in existing classes with years of experience. The public safety issues are real in new classes of drugs where clinical studies did not test more than a few thousand people.

The six month moratorium from the four is a concession to Congressional attention. It will not likely satisfy those who want to ensure more restrictions on DTC advertising. That is why I believe that individual new classes of drugs will voluntarily extend that period in negotiations with FDA for approval. The advertising industry will vigorously fight any mandatory moratorium periods but will concede that voluntary negotiations are acceptable. The fear of accepting mandatory waiting periods is that it is a slippery slope that could eventually lead to longer and longer moratorium periods. On first amendment grounds it seems that Congress recognizes it will not succeed in creating mandatory waiting periods.

Ed Silverman in Pharmalot (June 11) comments on the FDA’s report that the biggest reporter of adverse events is now the consumer, not the doctor. In 2007, consumers reported 174,000 events versus only 121,000 from doctors. My take is that part of the reason consumers report more adverse events is familiarity with the side effects partially from DTC awareness. Anyone taking a prescription drug is much more likely to hear about side effects from the ads rather than their doctor. DTC print ads also have a phone number to report side effects, also helping the increased reporting by consumers. Of course no one knows yet whether the increased reporting really adds to public safety, as consumer generated adverse events may not be reliable or drug related.

GoozNews (June 11) also has a take on consumer reported adverse events. Goozner says “what these data clearly show is just how important consumer awareness is in generating those reports.” He wants awareness increased further by adding the adverse event reporting phone number to all packages and all DTC ads, including television. I have been against adding the adverse event reporting number to television ads. Consumers have vivid imaginations and are subject to the power of suggestion. The level of imagined side effects will soar and FDA will gain little knowledge chasing down the increased reporting. At least in print ads, having the phone number is part of an ad where consumers can read the brief summary in detail to understand what may be a side effect.

Mike Huckman in his CNBC blog (June 2) seemed surprised to see a DTC ad running at a movie theater. The ad was for Gardasil, the vaccine for HPV. “Yep, not even in the movie theater can you escape pharmaceutical direct-to-consumer advertising.” The ads are aimed at young female movie goers 19-26, says Merck. Huckman’s consumer poll shows no issue with respondents who were asked if the Gardasil ads in movie theaters were appropriate, with 87% saying it was. The movie Huckman was attending was “Sex and the City,” so I doubt the ad was too racy for that audience.

The Prescription Access Litigation Project blog (June 3) takes a shot at drug companies producing profitable me-too drugs while neglecting diseases such as malaria. “This is the system that has brought us more than 8 prescription drugs for heartburn, and more than 4 for erectile dysfunction, but no new meaningful treatments for diseases that are the true scourges of humanity, like malaria and tuberculosis.” They go on to say that while drug companies do little for poor country epidemic diseases, they use television ads “to convince us all we have restless leg syndrome, insomnia and toenail fungus.” While I agree that this is an issue, I do not see private companies as the problem in not curing diseases in poor countries. Their job is to make money for shareholders, as crass as that sounds. Eradicating malaria and other diseases rampant in third world countries is something that must be solved, but blaming private companies is n ot the answer.

Dr. Jim Sabin, writing in Health Care Organizational Ethics blogspot, May 17, says DTC ads are on balance “more bad than good.” He says drug and device companies should pay a 10-20% surcharge to fund an ad program to counter claims made in those ads. Dr. Sabin says, “Free speech is an important value. But so are public health and not bankrupting Medicare!” I wonder what the Supreme Court would say about that rationale. We should not restrict speech to limit drug demand. Otherwise we could use that logic to prohibit commercial speech that encourages potentially h armful or wasteful behaviors like drinking, buying gas-guzzling Hummers, playing the lottery, etc. That is a very slippery slope.

You think Canada does not care about U.S. DTC ads? In fact a Canadian media company sees lack of DTC ads as a competitive disadvantage. Pharmalot’s Ed Silverman tells us in a June 4 blog that CanWest, owner of magazines, newspapers and television stations, is suing the Canadian government for not allowing DTC. They say they are competing with U.S. publications sold in Canada that have DTC ads and they are losing that revenue source. It is a tricky question for Canada . They have a goal of cost control and do not want their consumers demanding expensive branded medications advertised by drug companies. Of course given media spill into Canada and free use of the Internet, Canadians know about our branded medicines, so pretending they do not by having a ban just seems silly. It is their country, but I wish CanWe st luck in their suit.

Barbara Mintzes, writing a blog on CanWest’s suit for Common Ground (June 2008), says the fact that there is illegal media spill is an enforcement problem rather than a bad policy. She argues against use of DTC in Canada and urges Canadian authorities to enforce regulations that prohibit drug ads. She says U.S. magazines should not be sold and U.S. television DTC ads can be edited and replaced by ads for non-DTC products. She says ads for drugs are dangerous because they use emotional techniques designed to “create a connection and desire for the drug.” I would argue that Canadians are pretty smart folks who can resist the DTC ads where they find no rational value.

In my attempt to dig deep for relevant blogs, I bring you Josh Wildstein who blogs on Internet stocks on Seeking Alpha. His June 1 column was called, Failure to Deliver Meaningful ROI Online for Pharma? In it, Wildstein is skeptical that the online industry will succeed in getting more pharma ad dollars. He says “the ROI being delivered against most online health content is performing poorly, especially for Pharma.” He says most online content is similar and therefore consumers are not seeing unique information on most portals. His solution is that the Internet winners will be those offering innovative products that more deeply engage consumers.

Under the category of shooting oneself in the foot, Novartis CEO Dan Vasella made some unfavorable comments on use of DTC. In the Wall Street Journal’s online column by Jacob Goldstein (June 4), Dr. Vasella said DTC ads may have contributed to recent Congressional ire. He said many DTC ads do not seem to show serious implications for use of drugs, instead showing “people happy and healthy and hugging each other, and it’s the sun and flowers.” Hmm, sounds like Dr. Vasella may be a witness for the next Dingell/Stupak hearing. I think he may have been right a few years ago but DTC ads now are much more sober and serious.
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The 11th annual Prevention Study on consumer attitudes to DTC was just released this week. I am not surprised that after more than 10 years of full media use, DTC consumer attitudes have not changed much from last year. Most consumers still find DTC flawed but useful. 
Drug ads are seen by 78% of consumers as informing them of new treatments. Over half think drug ads are done responsibly at 56%.

About 25% ask their doctor for a specific drug and about 75% get it.
So there was not much new news in the latest study. The Internet is increasing in importance as a source of health information. There is a reported increase in tension between doctor and patient when discussing drug choice. Overall though one could say DTC attitudes do not reflect a need for regulatory change, despite recent Congressional concerns.

After hearing the DTC pro and con arguments for 10 years, it is highly unlikely attitudes will change based on these or any other data. Positions are not really based any longer on data. They have become political surrogates for attitudes on drug pricing, R&D innovation, and safety. Critics will see DTC as raising demand for expensive, me-too brands that are too often risky. Proponents will see DTC as adding to disease information flow and informing consumers about new treatments their insurance company may not be anxious to cover.

I have seen no softening of positions on either side. In fact the political battle lines have become so bitter on drug costs and safety that consumer data is largely irrelevant to decision making. If a Democrat takes the White House and has 60% control of Congress the critics will win the day and will decide DTC should be restricted.
McCain is no fan of drug companies but I doubt he will make DTC a big priority since most in his party are free market fans.

It would be nice to have the real experts make improvements in DTC regulations. Consistency in DTC can be improved as it relates to risk communication. DDMAC and Industry could agree on specific improvements that make it easier for consumers to understand how and when to use drugs and understand the risk/benefit formula. That would be sesible. Unfortunately, as a hot political issue, more likely bluster will rule the day and little in the consumer interest will result. It was clear from the latest hearings that most Congressmen know little about the issue and prefer to make 5 minute speeches rather than actually solving specific problems.

The fact is that DTC is a part of imperfect consumer information flow.
It is flawed. It has problems. No one should think it is objective information but it does at least add subjective information that is countered by competitors, insurance companies, bloggers, doctors, consumer media, and government. American consumers should trust no one source and we do ask them to work hard at making their own judgments.

After more than 10 years of study, DTC issues are the same as in 1997.
It was flawed then and now, but at least most consumers still find it a net positive. How about just accepting its existence and working to make it better?  That would make for duller speeches but would also help real consumers.
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I was intrigued by a comment Novartis CEO Dan Vasella made in an interview with the Wall Street Journal Online Blog June 4. In a discussion on why the drug industry is being hammered lately by Congress, Vasella said one of the reasons was that DTC may set unrealistic consumer expectations for drugs. The Journal reported that Vasella said the drug industry does not “show advertisements where drugs are being portrayed as serious, potentially dangerous interventions. “ He went on to say “it’s all with the people happy and healthy and hugging each other and it’s the sun and the flowers.”

Neither of the recent ads attacked by Congress was for that type of ad. Lipitor was attacked because of the credentials of Jarvik. The ad is rather sober and has no fun elements. Vytorin was attacked because of clinical efficacy versus statins, not because the ad was upbeat. In fact most recent DTC ads have dropped the fun in the sun style. Ads for serious conditions have been predominantly sober and factual. While OTC-like antihistamine ads have featured flapping bees and other sun and flowers type creative, ads for most categories have portrayed drugs as serious, potentially dangerous interventions.

Crestor shows a plaque filled artery as the key element. Lunesta shows a woman resting comfortably. Evista shows ladies listening to a sober pitch on benefits and risks. I guess you can say erectile dysfunction ads still use the fun and sun style with Cialis outdoor tubs and Viagra singers. Most DTC brands, however, that treat depression, diabetes, cholesterol, blood pressure, cancer, and other diseases are subdued and sober. In fact Celebrex is an example of an ad so focused on risks that it dominates the message.

Congressional attacks on the drug industry may point to DTC as a symptom of aggressive marketing. They see marketing by detail representatives, however, as a much more problematic area given the lack of transparency and higher spending versus DTC. They see high prices in the United States as a problem. They see price fixing and safety lapses as problems. Vasella may be absolutely right that DTC is a contributor to Congressional ire, but stopping DTC would do nothing to alleviate the bad image of the drug industry with Congress or both presumptive Presidential nominees.

Drug company critics will not like DTC no matter how the creative is portrayed. Critics feel it leads to inappropriate prescribing whether creative is fun in the sun or single presenters in a studio. Congress feels it raises use of expensive branded drugs that they reimburse. The only DTC acceptable to critics is disease education. While I understand CEO Vasella’s potential concern, I think that drug companies have largely heeded it about 2 years ago, when the DTC code was introduced.

It is certainly all right for a drug CEO to be critical of DTC ads, but in this case his comments may be used to call for restrictive regulations. I doubt that was his intent, but it is news when a drug CEO implies drug ads create over expectations. It will be interesting if Dr. Vasella gets called to testify in future Congressional hearings with Mr. Dingell and Mr. Shupak.

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Welcome to our first issue of Blogspectives. Bi-weekly I will comment on health blogs that discuss pharmaceutical marketing, public policy, and consumer trends and behavior. This is not a blog recap per se, but my editorial spin, comment, rebuttal or agreement with those bloggers.

I scan what I believe are relevant blogs to the DTC Perspectives audience. There are hundreds of health blogs but about 10-20 that specifically cover our industry. I plan to provide Blogspectives twice a month for now and perhaps weekly in the future.

What better way to start a blog on blogs than to report that John Mack of the Pharma Marketing Blog (5/27) wonders whether the little guy blogger can compete with corporate sponsored blogs such as Pharmalot and the Wall Street Journal . He believes that their resources allow them to report more scoops first. While that is true, the independent blogger can comment on news stories and create new perspectives about an event or issue. I do not usually discover news and see myself as adding depth to a news story. I have no doubt the independent health blogger is still needed.

In recapping the House hearings of May 9, Pharmaceutical Executive’s Patri ck Clinton comments the hearings were inconclusive as expected. He believes the real issue is whether DTC causes inappropriate prescribing which he believes has not been answered yet. He also believes the industry claims that DTC educates in a balanced way is “mostly absurd.” I agree with Mr. Clinton. DTC for specific brands is meant to sell product as evidenced by management demanding positive ROI. It is not educational in its mission although PhRMA uses that term in its statements defending DTC. Branded ads may educate but that is not why they fund DTC. It is to sell more product. Nothing wrong with that, except it sounds better to say it is educational. I remember former Pfizer executive Pat Kelly wanting to replace the term DTC with HIFC, (health information for consumers), because of the negative associations with the DTC. It never caught on because it is what it is. DTC is advertising that contains health information.

On the same subject, Merrill Goozner of Gooz News (5/12) references the hearings in asking who stopped the FDA from pulling Procrit ads claiming reduced fatigue from chemotherapy, a non FDA approved claim. He mentions Dan Troy, FDA counsel at the time, and now working for a firm representing J&J, Procrit’s maker. Goozner wrote the the Industry critical book “The $800 Million Pill,” calling into question the drug industry cited cost of R&D. Troy definitely was a champion of limiting FDA power while there but I believe he felt the limits were based on not violating commercial free speech and not because he was in the pocket of the drug industry.

Alison Bass, author of a new book “Side Effects,” the critical story of Paxil and GlaxoSmithKline, covered the House hearing in her 5/11 blog . Her take is that it is unlikely that new regulation will come out of the hearing. Her blog reports mostly on Professor Ruth Day’s negative testimony that side effects are presented in DTC to minimize comprehension. Ms. Bass ends with her bleak assessment “it looks like American consumers are going to continue to be distracted” citing Day’s example of Nasonex and the flapping wings of its bee icon during the side effects reading.

CNBC’s blogger Mike Huckman (5/12) was perplexed by the new bed sheet Evista commercial that promotes reducing the risk of breast cancer as well as the old indication for Osteoporosis. He said “there was something about it that just doesn’t sit right.” He says the commercial was unsettling because of how many women looked like they were on Botox. I admit it is an unusual execution but as I said in my column on May 23 , I liked it for its stopping power and clear message. Mr. Huckman’s blog had a survey and 54% of the 507 respondents said the ad is fine, while 36% said it was kind of weird. Only Lilly will know for sure if the ad works but my guess is it will, weird or not.

Maggie Mahar, in her Healthbeat Blog (5/21 healthbeatblog.org) takes on DTC for medical devices. Ms. Mahar, author of an excellent book on health care policy called “Money Driven Medicine,” feels J&J’s DTC for the Cypher stent can cause significant friction between surgeons and patients. Here, she says, DTC goes beyond pill ads because use of a particular medical device requires specialized knowledge. She also says the reason for DTC may be because the Cypher stent has a higher rate of problems and DTC demand creation can help put pressure on surgeons to use it. I doubt any surgeon will use the stent just because a patient mentions it because it is a more serious decision versus a pill choice. I also doubt a patient would push a surgeon on a brand of medical device, because this is not a simple choice of prescribing a consumer requested anti-histamine or proton pump inhibitor.

In the Wall Street Journal (5/28) blog by Scott Hensley , he reports that a review of media stories on health yields unsatisfactory results. The study, done by HealthNewsReviews.org , shows media stories fail to do a good job discussing cost, evidence of efficacy, alternative treatments, and risks and benefit trade-offs. They analyzed 500 stories and made their subjective assessment. While I did not examine 500 stories, it seems to me that consumers get a lot of coverage on high drug costs and risks of their prescriptions. The reviewers of the stories are doctors, public health experts and a professor of journalism.

On thehealthcareblog.com , Jane Sarasohn-Kahn congratulates Viagra on its 10 th anniversary. She points out that Viagra “reshaped pharmaceutical marketing. The company used direct-to-consumer advertising to great effect.” I do not agree that Viagra reshaped marketing. It received so much free publicity that consumer awareness was achieved without a lot of DTC spending. It did later use DTC to help add new users and probably had positive ROI. Like many observers of DTC, Ms. Sarasohn-Kahn overstates its impact. Viagra was a successful drug before any DTC money was spent. In fact so was Lipitor, also commonly quoted as a drug built by DTC.