Cigarette Packs Get a Makeover

In June 2009, the House passed a tobacco bill that allows the Food and Drug Administration (FDA) to regulate tobacco products through their content, their packaging and their advertisements  (Wilson).  One of the changes in the bill was to have color graphic warnings about the dangers of smoking cigarettes that take up 50% of each cigarette package by 2012 (Wilson).   Yesterday, the FDA unveiled some of the possible warning labels, as shown below (Harris).

Photo taken from The New York Times, Harris

Currently, there are 36 proposed warning labels, some of which are a little graphic, such as a man laying in a coffin and a mother blowing smoke on her baby, but the FDA hired a company to conduct research on which labels would be most effective and want to narrow it down to 9 (Harris).  The company will use survey research to reach 18,000 smokers and find out which labels would most likely encourage a smoker to quit and which labels would most likely discourage teenagers from beginning to smoke (Harris).

The U.S. decision to change cigarette warning labels from the classic “Surgeon General’s Warning” came from 39 other countries that print large graphics of the effects of smoking on their packages, such as in Europe, where they use pictures of “blackened teeth and decaying mouths” (Harris). 

Of these new cigarette labels, secretary of health and human services, Kathleen Sebelius, said, “Today marks an important milestone in protecting our children and the health of the American public” (Harris).  In 2009, Obama said the tobacco bill will “protect our kids and improve our public health” (Wilson).  These anti-smoking efforts appear to want to improve the health of the “20.6 percent of the nation’s adults, or 46.6 million people, and about 19.5 percent of high school students, or 3.4 million teenagers” (Harris) that smoke cigarettes, which they do, but the real reason for encouraging people to stop smoking lies within half of one sentence in this article: “About 440,000 people die every year from smoking-related health problems, and the cost to treat such problems exceeds $96 billion a year (Harris).”  Yes, we are trying to cut down on healthcare spending. 

I personally think that these labels won’t tell anyone anything they don’t already know about smoking cigarettes, but some researchers feel that the graphics will speak more to teenagers than the fine print does.  I think that these new labels could be effective in shaming people into not buying cigarettes anymore, but that’s not exactly good public relations on behalf of the government.  I think that these labels will only annoy and anger smokers, but if they do prevent teenagers from starting then that will be quite an accomplishment.  So what do you think, will these new extreme warning graphics prevent teenagers from picking up their first pack?

Ophthalmologists Face Drug Dilemma

According to an article in The New York Times by Andrew Pollack, the pharmaceutical company Genentech is secretly offering rebates to eye doctors who prescribe their drug Lucentis (Pollack, Genentech Offers Secret Rebates to Promote Eye Drug).

Lucentis is an FDA approved drug to treat macular degeneration and is used in the form of an injection in the eye.  Injections cost about $2,000 each and can be given as often as once a month (Pollack).

Genentech has another drug called Avastin that is only approved by the FDA to treat cancer, but studies have shown that it is as effective as Lucentis when used to treat macular degeneration.  Avastin only costs about $20 to $50 per injection so many doctors are using the drug off-label to treat macular degeneration (Pollack).  Pollack states that the use of Avastin instead of Lucentis saves Medicare hundreds of millions of dollars each year.

Next spring, there will be a clinical trial comparing the efficacy of Lucentis and Avastin in treating macular degeneration, and if results say the drugs are equivalent, more doctors will switch to Avastin, causing Genentech to lose money.  Some are speculating that Genentech launched this rebate program to slow down that switch (Pollack).

Although the rebates offered by Genentech for Lucentis are technically legal, there is an ethical dilemma surrounding the issue.  Should doctors prescribe the more expensive drug to receive rebates, or should they prescribe the cheaper drug off-label?  Earlier blog posts of mine discussed the ethical implications of administering drugs off-label in exchange for kickbacks, but in this case, prescribing Avastin may help the financial standings of the government and patients, so is it okay? 

While I am weary of the use of drugs off-label, I personally think that ethically, if the doctor is prescribing the drug for the correct reasons and not just for monetary gain, it is less of an issue.  In terms of public relations, as this story hits the public, both the doctors and the pharmaceutical companies have valid reasons for prescribing/promoting the use of each drug, so I don’t see this turning into a crisis for Genentech or any of the various doctors who are using the drugs.  Rebates and kickbacks on drugs are so common that I don’t think the average consumer cares as long as they are getting the correct treatment. 

Losing Faith in Healthcare Industry

According to an article in The New York Times by Gardiner Harris and Duff Wilson, pharmaceutical company GlaxoSmithKline will pay $750 million in law suits for selling 20 tainted or ineffective drugs (Harris & Wilson, Glaxo to Pay $750 Million for Sale of Bad Products).

“Among the drugs affected were Paxil, an antidepressant; Bactroban, an ointment; Avandia, a troubled diabetes drug; Coreg, a heart drug; and Tagamet, an acid reflux drug” (Harris & Wilson). For example, through manufacturing, the active ingredient of Paxil CR was separated and never packaged; causing consumers to only receive the “barrier chemical,” and an ineffective drug.

Harris & Wilson added that there haven’t been any reports of patients suffering health consequences from consuming any of the drugs, but that links would be “difficult to trace.”

GlaxoSmithKline and other pharmaceutical companies have paid billions of dollars in lawsuits because of illegal marketing, but this is the “first successful case ever to assert that a drug maker knowingly sold contaminated products” (Harris & Wilson).

This whistle-blower case was filed by Cheryl D. Eckard, who was the quality manager for GlaxoSmithKline. In 2002, they received a warning letter from the Food and Drug Administration (FDA) regarding their manufacturing facility in Puerto Rico, and they sent Eckard and a team of 100 quality experts to fix the cited problems.  While at the facility, Eckard found that the FDA missed some problems and that the quality control was very poor (Harris & Wilson).

Some of the problems she found were: “…the water system was contaminated; the air system allowed for cross-contamination between products; the warehouse was so overcrowded that rented vans were used for storage; the plant could not ensure the sterility of intravenous drugs for cancer; and pills of differing strengths were sometimes mixed in the same bottles” (Harris & Wilson). Eckard stated that she urged top executives to fix the additional problems, but instead, she was fired.

Regarding this case, Carmen M. Ortiz, the United States attorney for Massachusetts said, “The harm is really in the public’s confidence in the health care industry. When you go to a pharmacy and you buy a drug, you expect that drug is what it purports to be and you don’t expect it to have any micro-organisms or not be sterile or not have the power or have too much power” (Harris & Wilson).

It would be very interesting to conduct a content analysis of GlaxoSmithKline’s responses to this lawsuit through its website and major newspapers and track its attempt to restore relationships with its stockholders, since American shares have already fell 0.35 percent this past Tuesday (Harris & Wilson).  They already released a statement on their website Tuesday regretting their actions, but I think it’s going to take a lot more than that to restore stakeholders’ faith in the industry, let alone GlaxoSmithKline. It would also be interesting to do a content analysis on responses from Johnson & Johnson and McNeil regarding their many recalls in 2010 and compare tactics since in both cases, the companies knowingly sold contaminated drugs in result of internal error.  Hopefully GlaxoSmithKline will do a better job than J&J has. 

Life After 100 Years Still Golden

Snapshot from The New York Times

Advancements in healthcare are allowing people to live longer than ever, with many reaching 100 years of age or more.  Some question the quality of life at this age, but a set of interviews conducted by The New York Times shows that you can have a very meaningful and enjoyable life in old age if you take care of yourself.

The New York Times published a multimedia feature called “Secrets of the Centenarians,” produced by Karen Barrow, Jon Huang, Soo-Jeong Kang, and Andrew Kueneman.  To create this feature, they conducted qualitative field research and collected qualitative data, which, put simply, is “…observations not easily reduced to numbers” (Babbie, pg. 315).  They conducted qualitative interviews with eight people aged 99 and older.  According to Babbie, a qualitative interview is “…an interaction between an interviewer and a respondent in which the interviewer has a general plan of inquiry including the topics to be covered, but not a set of questions that must be asked with particular words and in a particular order” (pg. 340).

Babbie also adds that, “a qualitative interview is essentially a conversation in which the interviewer establishes a general direction for the conversation and pursues specific topics raised by the respondent. Ideally, the respondent does most of the talking” (pg. 340).

That is exactly what happened in the interviews with the subjects of “Secrets of the Centenarians.”  They were asked open-ended, probing questions, such as what their favorite memory is, what they do to keep busy, what their hobbies are, and what they think the secret to life is, among other things.  These questions allowed each of the subjects to tell a story and let the listeners really get to know them.  I think that a qualitative research approach to this subject is much more effective than quantitative because it allowed the interviewers to get a full and complete spectrum view of these Centenarians’ lives.  The stories and memories shared made these subjects more relatable and personified the aging process, rather than being reduced to a number that filled out a survey.

Although this qualitative research wasn’t done with scientific hypotheses and research questions in mind, it does show us that the technology not only allows us to live longer, but also allows us to have more years to enjoy the things we love.  Some of the subjects still drive, exercise, go out dancing, work and go out to dinner multiple nights a week.  I think that this information could be helpful to scientists who are studying the aging process and also to the doctors who are constantly making health discoveries to prolong and improve the quality of life.

One of the subjects, Phil Damsky, who is 100 years old, leaves us with some good advice: “I thought I was going to live forever, but there’s no such thing. But enjoy every minute that you’re living. I think that’s some good advice” (Barrow). 

Meridia Withdrawn from Market

Andrew Pollack outlines the withdrawal of the weight loss drug Meridia from the market because of the risk of heart attack and stroke in an article from The New York Times (Abbott Labs Withdraws Meridia From the Market). 

The Food and Drug Administration came to the decision to encourage Abbott Laboratories to recall Meridia because of the results of a clinical trial requested by regulators in Europe called the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (FDA). 

SCOUT followed the guidelines of a classical experiment with all three components, as listed by Babbie: independent and dependent variables, pretesting and posttesting and experimental and control groups (Babbie 247).  The independent variable in SCOUT was the administration of the drug, Meridia, and there were two dependent variables; one was weight and the other was cardiovascular health, which were measured by pretests.  Weight was simply determined by weighing the population, and cardiovascular health was determined by the history of cardiovascular disease, the existence of extra weight in the waist, history of type 2 diabetes mellitus and what was called  “cardiovascular risk factors,” such as hypertension, dyslipidemia, smoking, and diabetic nephropathy (FDA).

SCOUT had a randomized sample of about 10,000 men and women aged 55 or older from Europe, Latin America and Australia.  There was a control group and an experimental group; the control group received placebos and the experimental group received Meridia.  The study was also double-blind, meaning that “neither the subjects nor the experimenters [knew] which [was] the experimental group and which [was] the control group" (Babbie, 250).  The study began in January of 2003 and ended in March 2009 (FDA). 

The posttest again measured weight and cardiovascular health after the 5-year period of SCOUT (FDA).  “SCOUT demonstrated there was a 16% increase in the risk of a composite or combined set of serious events—non-fatal heart attack (myocardial infarction), non-fatal stroke, resuscitation after cardiac arrest, and cardiovascular death—in the Meridia group compared to the placebo group” (FDA).  Through the posttesting they also discovered that the loss of body weight of the people taking Meridia compared to those taking the placebo was only 2.5%, which isn’t very significant for a weight loss drug (FDA). 

Abbott contends that the results from SCOUT aren’t applicable because the majority of subjects had cardiovascular disease and Meridia is not meant for such people.  However, Abbott did voluntarily withdraw the drug from the market because its harms outweigh its benefits (Pollack).

I think that the clinical trial, SCOUT, was effective because it was set up according to the guidelines of a classic experiment, according to Babbie, and was conducted fairly through the use of randomization of subjects and making it a double-blind experiment.  While Abbott argues that Meridia shouldn’t be pulled off the market based on this one clinical trial because the majority of subjects had cardiovascular disease, I think that SCOUT was smart to use subjects with cardiovascular disease because Meridia is mostly prescribed to patients who are obese, and those that are obese are more likely to have cardiovascular disease.  This experiment fairly tested Meridia on a sample of people who closely resemble the population of people who were or would have been prescribed the drug.  Abbott agreeing to withdraw Meridia voluntarily was a good public relations move because it shows that they care more about the safety of their customers than their bottom line.

Share Care, Boost Sales?

According to an article written by Stuart Elliott in the New York Times, a study by comScore Inc., a company that studies online consumer behavior and digital marketing, revealed that out of the 212.6 million web users in the United States over a one-month period, 45.4 percent (96.6 million) searched for health information on the Internet.  The study also revealed that the top two health information web sites were Everydayhealth.com and WebMD (Elliott, Web Site to Offer Health Advice, Some of It From Marketers).

Starting today, another web site they may be able to add to that list is Sharecare.com, an interactive health information web site that allows people to post health related questions, which will be answered by experts such as the American Cancer Society, the American Heart Association, the American Red Cross, AARP and Dr. Oz (Elliott). 

However, Sharecare will also allow “knowledge partners,” such as Colgate-Palmolive, Ortho-McNeil-Janssen Pharmaceuticals, Pfizer, Unilever, UnitedHealthcare and Walgreens to answer questions and become official sponsors in exchange for paying Sharecare around $1 to $7 million (Elliott).

If that doesn’t cause you to be concerned, perhaps that fact that Dove will answer questions about the importance of good skin care and Pfizer will answer questions related to fibromyalgia and how to stop smoking, when two of its leading pharmaceuticals are Lyrica and Chantix, will change your mind (Elliott).

According to Sharecare, all answers supplied by the knowledge partners will be clearly labeled with both their names and logos (Elliott) to avoid confusion of consumers about which answers came from who, so that takes care of the transparency issue and more presence online through the use of social media does help foster an organization’s relationships with its publics, but I’m wondering if any of those Public Relations departments are worried that this behavior may be deceptive.

I am very curious to see what these knowledge partners’ ROI will be from participating on Sharecare; could there be a direct correlation between the number of questions they answer and their sales?  It would also be interesting to conduct an experiment of Sharecare users to see if consumers can in fact tell the difference between questions answered by the experts and the knowledge partners.  While the companies’ names and logos will appear on the screen, it may look very similar to online advertisements that show up in the banners and sidebars of many web sites.

What do you think?  Is a company’s participation in Sharecare deceptive to consumers?

Pom Not-So-Wonderful

The Federal Trade Commission (FTC) is charging Pom Wonderful for making unsupported claims in their advertisements, according to an article from The New York Times by Edward Wyatt (Regulators Call Health Claims in Pom Juice Ads Deceptive). 

Their advertisements assert that drinking the Pom Wonderful juice helps to reduce the risk of heart disease, prostate cancer and erectile dysfunction, but the FTC asks them to halt medical claims in their advertisements until they are supported by the Food and Drug Administration (FDA) because Pom Wonderful research, although they claim to have spent $34 million on it, is not conclusive and in some cases didn’t produce notable support statistically (Wyatt).

“… [The] results ignored the fact, the commission contended, that as early as May 2007 the company knew that a large study financed by the company showed no significant difference in arterial plaque buildup after 18 months between patients who drank Pom and those who drank a placebo” (Wyatt).

Ad from Fitness magazine, taken from nytimes.com

Pom wonderful retaliated by filing a lawsuit against the FTC arguing that it is their first amendment right to share their research findings with the public and issued a press release, which is posted on their website, “POM to FTC: ‘Stop Persecuting Pomegranates!’”

“Because POM products may in fact offer the promise of better health, we believe it is important to share the research results as they become available.  This is especially true since our products do not carry the risks associated with pharmaceutical drugs…. We do not make claims that our products act as drugs.  What we do, rather, is communicate, through advertising, the promising science relating to pomegranates.  Consumers and their health providers have a right to know about this research and its results” (POM).

So, who is right, Pom Wonderful or the FTC?  While it is Pom’s first amendment right to publish factual information about a food, is it the FDA’s responsibility to approve the efficacy of a food if there are claims being made regarding health? 

Time will tell, as the hearing is scheduled for May 2011; however, I hope that Pom Wonderful has more money stowed away in their research fund because it would be wise for them to conduct social research of their publics to find out if consumers will be less likely to trust them and their products now.  The research would help Pom to prepare for a possible drop in sales by gathering information to design a new campaign.  For example, did people buy the juice just because they like it, or because of the health claims communicated in its advertising?  I’m not sure, but at around $6 per 16 oz bottle, I’m guessing there’s more to it than just taste.

Of course, Pom Wonderful could just submit their findings to the FDA.  After all, if they “stand behind the vast body of scientific research documenting the healthy properties of Wonderful variety pomegranates,” what do they have to lose?

Health Insurance Companies Prepare for New Rules with Research

Starting today, the first changes of the health care bill go into effect.  According to an article in the New York Times, health insurance companies are working to get ahead by training employees to build better relationships with customers and researching and improving on technology to build better relationships with doctors and hospitals (Insurers Scramble to Comply With New Rules, by Reed Abelson).

“Under the new law, insurers that offer child-only policies must start covering all children, even the seriously ill, beginning on Thursday. Insurers must also begin offering free preventive services, and for the first time, their premiums must start passing muster with federal and state regulators by the end of the year” (Abelson).

According to Abelson, Blue Shield of California trained its employees about the impact the bill will have on them and on how to speak with customers by providing them with information to ensure they are helpful and answer customer inquiries correctly.  In addition, Blue Shield is reprogramming computer systems and establishing costs of new policies. 

All of these actions will improve relationships with customers, but the bigger problem will be improving upon the cost and quality of care by working with doctors and hospitals, which Blue Shield is planning to address by researching new ways to pay doctors and hospitals and upgrading its technology systems (Abelson).

“The challenge for the industry as a whole will be to demonstrate an ability to oversee patient care and work closely with hospitals and doctors to find ways to improve the quality of care while trying to contain costs. To that end, insurers are making big investments in technology systems and new areas of expertise” (Abelson).

Although over the years insurance companies and the U.S. health care system in general have had a bad reputation, it seems that companies like Blue Shield are trying to improve upon their relationships with customers, doctors and hospitals, which is the basis of public relations.  They’re using research and experimentation to determine the best changes they can make to comply with the new bill and improve quality of care.  It may take awhile to get things right and some companies may stumble along the way, but they’re headed in the right direction.

Medical Journals Lack Transparency

An article by Duff Wilson in The New York Times discussed a study released this past Monday from Columbia University, which revealed that 25/32 consultants of medical device companies in 2007 did not disclose their payment within their articles published the following year in medical journals Medical Industry Ties Often Undisclosed in Journals, by Duff Wilson.

(Image taken from Wilson)

This was a cross-sectional study, which is, according to Babbie, “…observations or a sample, or cross section, of a populations or phenomenon that are made at one point in time” (Babbie pg. 110) of orthopedic device companies and the financial disclosures of their consultants within medical journal articles (Wilson).  They studied a total of 32 medical doctors and doctoral researchers who published one or more journal articles in 2008 and were paid a minimum of $1 million in 2007, and found that the majority of doctors did not divulge their financial connections with the companies (Wilson).

Medical device companies examined in this study were: Zimmer, DePuy Orthopaedics, Stryker, Biomet and Smith & Nephew (Wilson).

“… $114 million went to 41 doctors, the study said, of whom 32 wrote or were co-authors on orthopedic journal articles the next year…. It said 51 of them, or 54 percent, did not mention the financial relationship with a company. It showed that 25 of the 32 authors did not disclose some or all of the time” (Wilson).

Similar to my last post, I find this behavior to be highly unethical for all 3 parties.  It is unethical for the medical device companies to pay consultants and doctors such outrageous amounts to review their devices, it is unethical for the doctors to accept that money and allow it to alter their views while writing the articles, but not disclose their financial relations with the company to the readers, and it is unethical for the journals to not be more aware of this issue and require that all writers disclose their financial relationships with companies, if any.  The research and reports are simply unethical because money clouds judgement.  One of the profesors from Columbia who wrote this study shares a similar view:

“Professor Rothman called for stricter disclosure policies, including precise amounts of consulting payments. He said journal readers needed the information to consider the potential for bias” (Wilson).

I think that it would be interesting to conduct a longitudinal study, which is, according to Babbie, “A study design involving data collected at different points in time,” (Babbie, pg. 110) on this topic to see if this is a new development or if it has been going on for years.  If it has been going on, it would also be interesting to see how it has changed over time, especially in the amounts of money given to consultants and the level of transparency.

Off-label administering of Botox for Migraines

My name is Caitlin Mooney and I am 22 years old.  I am currently a graduate student at Quinnipiac University in Hamden, CT in the Public Relations program.  This blog is part of my Public Relations Research course and I will be discussing issues within healthcare and public relations research each week.


This week, I will be discussing off-label administering of Botox for a variety of medical conditions.  According to an article in the NY Times written by Natasha Singer, so far, the Food and Drug Administration has approved the use of Botox to alleviate uncontrolled blinking, muscle spasms and stiffness, excessive sweating and, most famously, wrinkles.  However, the maker of Botox, Allergan, has been promoting the use of Botox for uses unapproved by the F.D.A. such as pain, muscle spasticity, cerebral palsy in children and most recently, migraines. While it is legal for doctors to prescribe drugs for medical conditions unapproved by the F.D.A. as they see fit, it is illegal for drug companies to promote the off-label uses.


"Court filings have described an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as a headache treatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors; and paid kickbacks to doctors to induce them to prescribe Botox" (Natasha Singer, After Fine, Botox Awaits Approval for Migraine - NY Times).


I find this to be highly unethical practice because according to the principal deputy commissioner of the F.D.A., these drug companies, such as Allergan, are promoting these off-label uses without proof or evidence that the drug is in fact safe to use for the medical condition they are promoting.  This puts patients at high risk for serious side effects.  I think that the drug companies and the doctors that are administering the drugs and accepting kickbacks are being negligent.  This is a public relations problem because if there is a large number of serious side effects from prescription of drugs for off-label uses, a serious crisis could occur for the drug companies and the medical practices where the doctors are administering these drugs.  This shows that the drug companies do not care about the well being of their customers, but are only interested in money, which severely tarnishes a reputation.


Throughout the article by Natasha Singer, it also mentions that Allergan has spent "hundreds of millions of dollars in medical research and development of new uses for Botox;" however, according to Earl Babbie in The Basics of Social Research, it is impossible for research to be totally objective because the researchers are human.  Therefore, if the drug company is conducting the research, obviously they will find and report evidence that supports the usage of their drug, not the opposite.  The drug company values sales and money, and it is hard to put that aside while conducting research, especially when "...Wall Street analysts have estimated that sales of the drug for migraines could reach $1 billion or more annually worldwide by 2016" (Natasha Singer, After Fine, Botox Awaits Approval for Migraine - NY Times).  "...researchers should not let their own values interfere with the quality and honesty of their research..." (Earl Babbie, The Basics of Social Research 5th ed. pg. 89).  In my eyes, this makes the research being done by Allergan to be unethical, and I would say that the off-label uses of the drug are unsafe.  Only when the F.D.A. conducts research and comes to a conclusion would I say that it's okay to prescribe the drug for off-label uses, because they are an objective party in this research.