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?