Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.

It began suddenly a little over 10 years ago. With impressive fluency, friends, family members and patients started asking me about random medications, the odd syncopations of those invented, polysyllabic pharmaceutical brand names – Viagra, Lipitor — rolling perfectly off their tongues.

The questions they asked about those drugs did not reflect breaking news or the results of scientific studies. Rather, they were a reflection of sound bites, advertisements and the draw of celebrities who endorsed them, all part of carefully conceived marketing schemes.

There’s no question that Americans like their prescription medications. We spend nearly twice as much per person on pharmaceuticals as patients in other developed countries do, and we account for nearly half of all sales worldwide. But in 1997, when the Food and Drug Administration loosened its regulations and the United States became one of only four countries to allow direct-to-consumer advertising (the others are New Zealand, Bangladesh and South Korea), we entered a new era in pharmaceutical consumerism.

Players in the drug industry began aiming their advertisements at patients, and their goal was to define in the minds of patients not only the beneficial effects of the drugs but also the diseases they were designed to treat.

As Vince Parry, a well-known marketing expert, counseled his colleagues, “If you can define a particular condition and its associated symptoms in the minds of physicians and patients, you can also predicate the best treatment for that condition.”

The phenomenon is sometimes referred to as “disease mongering,” redefining what is normal and abnormal in a way that widens potential markets for those who sell treatments. And, as detailed in a recent study in the journal Social Science & Medicine, one marketing strategy has accomplished more in this regard than any other by using what has come to be the very symbol of quality and reliability for doctors and patients everywhere: the checklist. 

Placed on Web sites, on downloadable apps and in pamphlets in doctors’ offices, these checklists of symptoms have become a critical part of every major pharmaceutical marketing campaign. What makes them so attractive is that they make it easy for patients to diagnose their own ailments, to take some control over their own health.

What makes the checklists so powerful is their ability to influence patient preferences.

The makers of Yaz, a birth control pill, for example, used a checklist to help promote the use of their drug as a treatment for premenstrual dysphoric disorder, a controversial diagnosis said to affect up to 10 percent of women. Alongside links to articles on fashion, makeup, hair and celebrity news, Yaz’s Web site offered a “Body Diary” checklist to help patients determine whether they suffer from the disorder.

Taking its cues from the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., which mental health professionals use to diagnose disease, the checklist offered watered-down and potentially more inclusive descriptions. A symptom described in the D.S.M. as “persistent and marked anger or irritability or increased interpersonal conflicts” appeared in the Yaz questionnaire as “Felt angry, or irritable.” “Marked change in appetite, overeating, or specific food cravings” became “Had increased appetite or overate; or had cravings for specific foods.” The printable results that patients could then take to their doctors (the site has since been taken down) were on a form emblazoned with the birth control brand.

“The whole point of tools like this one is to confine people’s experiences into these categories in order to make a diagnosis in line with the branded drug,” said the author of the study, Mary Ebeling, an assistant professor of sociology at Drexel University in Philadelphia who got interested in the use of checklists while doing research at a marketing firm. “I became really intrigued when I saw a group of marketers sitting around a table in Midtown Manhattan and coming up with symptoms.”

Some symptom checklists are clearly branded, so patients and clinicians can easily discern the pharmaceutical interests involved. But many are less obvious or are used as part of advocacy groups’ materials or awareness events. For example, National Depression Screening Day, held annually at college campuses, military sites and community centers across the country, uses a symptom checklist called the Patient Health Questionnaire, or PHQ-9. The nine questions are based on a well-known anxiety screening tool, but its copyright is held by Pfizer, maker of the antidepressant Zoloft.

It’s difficult to ascertain whether efforts aimed directly at consumers ultimately translate into real sales. A recent marketing study found that fewer than 3 percent of patients mentioned a marketed drug by name and less than 1 percent asked for a prescription. However, a separate study comparing patients in Canada, where direct-to-consumer marketing is illegal, with those in the United States found that American patients were more than twice as likely to request advertised medications.

But sales may not be the only measure of success for these campaigns. “The whole point of this marketing and branding is that the name ends up in the minds of the consumers,” Dr. Ebeling said.

While the Obama administration is looking to force pharmaceutical companies to disclose any payments to doctors that might influence their treatment decision, marketing efforts directed at patients are likely to continue to grow. And with those efforts comes a widening, not shrinking, circle of interests that can influence their care.

“There are pharmaceutical marketers, medical device makers, health insurers and whoever is involved in the health industry sitting in the exam room, not just the doctor and patient,” Dr. Ebeling said.

She added, “I find that disturbing, because it’s our health and the quality of our lives that are at stake.”

Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.

Correction: An earlier version of this article incorrectly listed Pakistan as one of four countries that allow direct-to-consumer advertising of pharmaceuticals. The four countries are the United States, New Zealand, South Korea and Bangladesh, not Pakistan.

The government said there was still not enough evidence to recommend routine removal, but allowed free replacement for some women who received the implants under the National Health Service.

This NYTimes article highlights on the latest conflicting messages being sent to women in Europe and abroad about #silicone #breast #implants at the heart of the PIP (Poly Implant Prothese) scandal. How the company, which used industrial grade silicone for use in implants, escaped regulatory scrutiny is a developing story that raises many ‘red flags’. Sadly, recepients of the implants can find little solace in the retrospective investigation. Below are previously posted stories on this subject or at the following link: http://www.gfzambrano.tumblr.com/archive

In August 2010, DePuy announced a worldwide #recall of their ASR and ASR XL Metal on Metal (#MoM) hip joints. At the time, it was estimated the recall applied to nearly 100,000 hip joints. Essentially, the market withdrawal was prompted due to growing evidence that the DePuy hip joints were failing at a higher than expected rate in patients. Nearly a year later, there is growing evidence that increased failure rates may be associated with other available MoM hip joints. Presently, DePuy is the only MoM hip that has been the subject of a formal joint recall and now thousands of related lawsuits by patients. Other hip joints are under growing scrutiny, and potentially subject to lawsuits, for reasons similar to, if not identical, to those the ultimately lead to the DePuy ASR and ASR XL recall. 

Whether additional #recalls, or recall lawsuits will be forthcoming in 2012 remains to be seen given the volume of implants and failure rates. Additional information on the ASR Lawsuits and recalls is available here. General information on Joint Recalls and related products is available here.

Gabriel F. Zambrano, P.A., is the author and sponsor of this blog and commentary. Gabriel F. Zambrano, P.A., is actively investigating cases of failed MoM hip joints, or Joint Recalls, including but not limited to DePuy’s ASR and ASR XL, and those of other manufacturers.

NYTimes reports that:

More than a dozen suits say that the N.F.L. and in some cases helmet manufacturers deliberately concealed information about the neurological effects of repeated hits to the head.

The NYTimes is reporting, that new and popular hip and knee implants are not better than predecessors. So much for marketing and gimmicks claiming the ‘new and improved’,or that modern innovation, advanced these products with patients benefitting. Here is a link to the NYTimes: “New and Popular Hip & Knee Implants are Not Better than Predecessors”.

The author, and sponsor of this blog is Gabriel F. Zambrano. Gabriel F. Zambrano, P.A., has been investigating and representing patients who received recalled Metal on Metal hip joint implants manufactured by DePuy. The DePuy ASR family of products was recalled during August 2010. This recall drew attention to other popular Metal on Metal (MoM) hip joints, the potential that they were failing across manufacturers at a higher rate and the need for additional surveillance and reporting to public health authorities.  Additional information on these products, other recalls and related investigations is available at ASRLawsuits.com and JointRecall.com

French health authorities on Friday recommended that the 30,000 women who received potentially defective silicone breast implants have them removed.

NYTimes reports on silicone breast implants raising concerns in Europe in aftermath of failed manufacturer PIP and growing evidence that it’s implants are leaking or failing. To add to the concern, the silicone used inside their product was not intended for use in breast, but rather in common household products. Sadly, other reports indicate the manufacturer shipped the product worldwide. As a result, the potential implications for women is not limited to Europe, but includes women in South America and elsewhere.

Additional information, and previously reported information on this and related stories is available at BreastImplantRecalls.com  Prior posts appear in the ARCHIVE of this Blog.

Tens of thousands of women in at least a half-dozen countries received the implants that were made with substandard silicone and that have been rupturing at unusually high rates.

NYTimes reports on PIP silicone implants from France and now defunct manufacturer leaving a wake of women worried and concerned about their future. Photo in post above.

“A Senate bill would allow the Food and Drug Administration to force medical implant manufacturers to keep track of their devices’ performance after approval.” from the NYTIMES link above.

Need for information on recalled Metal on Metal Joints or related product recalls discussed in this story? Visit JointRecall.com

An advisory panel stopped short of recommending that the popular pills Yaz and Yasmin warn explicitly of a risk of blood clots.

NYTimes reports 21-5 vote for label change of #DRSP #DROSPIRENONE containing birth control. In narrower, 15-11 vote, panel concludes that benefits of pills outweigh risk.