J&J Recalls Grape-flavored Children's Tylenol: Another Missed Opportunity for Social Media

[Great minds think alike! Be sure to read Update at end of this post.]

Here's another case where CHEAP social media -- ie, YouTube -- could have been used by a pharmaceutical company to support patients using its products, but was not.

Johnson & Johnson DID use social media -- Twitter -- to inform followers of its decision to recall of U.S., Infants’ TYLENOL® Oral Suspension, 1 oz. Grape. According to a letter sent to J&J employees' Denice Torres, who’s the President of McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, said:

"We’re recalling the product at the retail level after receiving a small number of complaints from consumers who reported difficulty using the product’s SimpleMeasure™ dosing system. SimpleMeasure™ includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the dosing syringe. No adverse events associated with this issue have been reported to date and the risk of a serious adverse medical event is remote."

The letter was posted on the JNJBTW Blog (see here), to which the Twitter post mentioned above linked. J&J will offer people a refund, which is good. But are they abandoning the new dosing system, which is also a good idea? Perhaps it needs a new design, but even so, it should include instructions for use -- and not just written instructions, which many people won't understand. Video would be better.

So, I immediately thought: "Why didn't J&J post a video on YouTube that showed people how to use the dosing syringe?"

Such a video would be almost as easy and cheap for J&J to create as the post to JNJBTW. And it would be more likely to be seen by consumers because YouTube is the second -- maybe now the first -- most used search engine on the Internet! The video could also be embedded within the product web site. [Or even at the end of blog posts such as this one!]

I did a quick search of the product web site and found no information on how to use the SimpleMeasure™ dosing system and no video.

Last week I attended the ePharma Summit, which included a popular presentation titled "I wish I'd Done That! Social Media." Presenters would review competitors' social media campaigns that they liked.

What we really need is a session on "The Social Media We Should Have Done, But Didn't!." I think I will gather my contenders for this session and post them here!

Meanwhile, I hope this gives J&J an idea.

UpDate:
I just learned learned via a Twitter post from @JNJComm at 10:05 AM that there is a YouTube video on How To Use Infants' TYLENOL® SimpleMeasure™: Watch a video about how to use Infants’ TYLENOL Simple Measure > http://www.youtube.com/tylenol

Funny or Die Spoof: "Paula's Victoza Injected Sneaky Snacks!"

"All of my desserts are injected with Victoza to lower my blood sugar and keep me immortal," says "Paula Deen" in the spoof YouTube "Paula Deen's Diabetes Ad" posted by Funny or Die (see video here).

Next: Saturday Night Live!

Is Pharma Part of Problem or Solution to Current State of US Economy?

When Americans were asked "Thinking about the role each of the following sectors played in the current state of the American economy, do you think each of the following sectors is a part of the problem, a part of the solution, or are you unsure?," only 15% said the pharmaceutical industry was part of the solution, according to the 2012 Harris Poll Annual RQ survey. 50% said the industry was part of the problem (see chart below):

According to Harris, that puts the drug industry on the cusp of being a "malefactor" - an industry that Americans blames for economic woes. You can find the complete Harris report here.

Meanwhile, PhRMA, the industry's trade association in the U.S., continues to churn out press releases that warns Americans that if the government passes such-and-such law or over-regulates such-and-such activity of the pharmaceutical industry, it will result in the loss of thousands, nay millions!, of American jobs.

For example, in a response to the President's Fiscal Year 2013 Budget, PhRMA stated "America's biopharmaceutical industry is a key driver of economic growth; the President's proposed budget would weaken our ability to innovate and create jobs. This is not an investment in America's future and these proposals should not be considered" (see "PhRMA Statement on the President's Fiscal Year 2013 Budget").

Of course, the drug industry can be both part of the solution and part of the problem. It depends on whose problem/solution you are talking about.

It's part of the solution for white collar workers who work in the U.S. pharma industry, have Rx medical coverage, and can afford prescription drug co-pays. Blue-collar workers and retired folk who depend more on government "safety nets," however, may see  high drug prices and the drug industry's antipathy toward Medicare rebates as part of the problem. The latter are not among the typical U.S. pharma work force since the drug industry is shipping more and more blue-collar manufacturing jobs overseas to countries like China.

Not only does this NOT support jobs in the U.S., it also endangers our drug supply.

In a story about counterfeit Avastin in the U.S., the link between overseas drug manufacturing and counterfeit or tainted drugs in the U.S. was suggested: "Most Americans don't question the integrity of the drugs they rely on. They view drug counterfeiting, if they are aware of it at all, as a problem for developing countries. But the latest incident, which follows the appearance of other fake drugs in the U.S.—including counterfeits of the weight-loss treatment Alli and the influenza treatment Tamiflu—suggests it is a growing risk, especially as more medicines and drug ingredients sold in the U.S. are made overseas [my emphasis; see "Roche warns of fake cancer drug in US"). For more on this, see "Unsafe Drugs: Is It Counterfeiters or the Supply Chain That's the Problem?"

Is Pharma Part of the Problem or Solution to America's Economic Woes?
	Solution
	Problem
	Both, as you say
	Unsure

Former FDA Führer von Eschenbach Favors Approving Drugs for General Use Without Proof of Efficacy!

Andrew von Eschenbach, famous for resigning as FDA commissioner and leaving the agency leaderless on the very day that Obama was inaugurated (see Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"), is now employed as chairman of conservative think tank Manhattan Institute's Project FDA initiative.

If von Eschenbach has his way, FDA will be out of the business of approving new drugs based on efficacy, but will merely rubberstamp any drug that won't kill humans outright! In essence, the entire U.S. population will become non-volunteer experimental subjects. A drug's efficacy will be proven (or not) in the marketplace.

Instead of the FDA asking pharma companies to complete "laborious clinical trials proving efficacy," says von Eschenbach in a WSJ Op-Ed piece (see here), "after proof of concept and safety testing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish efficacy through post-market studies."

This is free market economics gone wild!

Currently, "post-market studies" are a undertaken to test the SAFETY of drugs as they are used in the real world. Such studies are not required of all drugs. What von Eschenbach proposes is to use post-market studies to test if drugs work as advertised, not if they are safe.

The problem is that post-market studies are NOT scientific because there are no controls to determine a baseline against which to measure efficacy. It's easy to find safety problems because that does not require controls.

I am amazed that von Eschenbach headed up the FDA and before that the National Cancer Institute! The fact that he is advocating tossing the scientific method aside takes my breath away considering that he is now well-positioned in the conservative political arena and no doubt has hopes that a future Romney or Gingrich administration will appoint him FDA commissioner or worse, Secretary of the Department of Health and Human Services!

Pharma Social Media Silent About Drug Shortage: Boehringer, Novartis, #FAIL!

The pharmaceutical industry is not interested in using social media to inform or support patients using their products. It's only interested in using social media to push out positive news about their companies and products. This is evident by the industry's deafening silence regarding the shortage of cancer drugs such as methotrexate, a drug used to treat children's leukemia among other maladies.

Letters from the American Society of Clinical Oncology, American Cancer Society of Pediatric Hematology/Oncology and Children's Oncology Group, a nationwide network of researchers, were sent to top executives at four U.S. makers of the drug pleading for help. Two of these companies -- Ben Venue Laboratories and Sandoz -- are owned by major non-U.S. Rx pharma companies (Boehringer Ingelhein and Novartis, respectively). The letters state in part:

"As you know, since December we have seen a significant decline in the country’s production of preservative-free Methotrexate (MTX). This drug is critical to the treatment of children with ALL. Approximately 3,500 children and teenagers are diagnosed with ALL each year, with cure rates approaching 90%. Without this drug, patients are at dramatically heightened risk of dying."

As reported in the Chicago Tribune (see here), "the FDA says the main reason for the shortages is manufacturing deficiencies leading to production shutdowns. Shortages also are resulting from companies halting production of drugs with low profit margins, companies consolidating in the generic drug industry and supplies of some ingredients shrinking."

"Established in 1938, Ben Venue Laboratories is the manufacturing arm of Bedford Laboratories, a Boehringer Ingelheim company," says the company's web site. "Bedford Laboratories is one of the largest generic injectable pharmaceutical companies in the United States, offering a broad range of multisource injectables across multiple therapeutic classes."

In November, 2011, Ben Venue Laboratories (Boehringer Ingelheim), for example, shut down its manufacturing and distribution operations at its site in Bedford, Ohio due to significant manufacturing and quality concerns (see here).

Meanwhile, the Twitter accounts of Boehringer and Novartis roll merrily along posting positive tweets about their commitment to cancer patients, while completely ignoring the cancer drug shortage issue. Here are some recent tweets:

• @BoehringerUS: "@WHO estimates that 84 million people will die of cancer between 2005 and 2015 without intervention. #WorldCancerDay"
• @Boehringer: "@martin_dudziak Very true. We are also committed and believe in continued research & clin trials as a major key factor in fighting cancer!"
• @MylanNews: "Mylan Committed to Expanding Access to High Quality, Affordable #HIV/AIDS Treatment. Company Honors #WorldAIDSDay"
• @Novartis: "Novartis continues to research ways to control tumor growth in advanced #breastcancer"

The Rx drug industry is betting its future on developing complex biologics to treat major diseases such as cancer. If the current crisis is any indication about how successful they will be in (1) manufacturing biologics and (2) using social media to inform the public about the products and support patients who depend on these products, then, IMHO, I  doubt they will be successful.

P.S. Meanwhile, Boehringer is developing a Facebook "game," Syrum, which is designed to "educate" the public on how the drug industry develops drugs (see "Pharma & Fun, Not Oxymoronic? Here Comes Gamification!"). I suggest the company's PR people can better spend time and resources using Facebook to support their patients. Currently, BI's Facebook page does not mention the drug shortage problem nor anything else that can be considered helpful to patients who take their drugs!

Greece & US Top List of Big Drug Spenders - A Shared Sign of Debt Risk?

"Greece’s continuing high level of spending on medicines is a striking example of the broader problems facing the country as it battles under international pressure to cut public expenditure and rein in the nation’s debt," say the authors of a Financial Times article (see "Athens struggles to rein in medical excess").

If drug expenditure per capita and as a per cent of GDP is a measure of a country's financial instability, then the U.S. is in the same league as troubled Greece (see chart on left).

Interestingly, a Merck executive blamed rampant consumerism!

"There were no controls on spending in the past, the whole system favoured consumption," says the director for Merck, the US pharmaceutical group, in Greece. "It was not only supplier-led, but demand-led by doctors and patients."

The same could be said of the U.S., the gold standard among health systems that "favor" consumption. But if that Merck pharma executive were to say the same about the U.S. system, he probably would be sent off to an "emerging" market such as Russia.

P.S. Actually, we are not comparing apples to apples here. Greece is a one-payer healthcare system, whereas in the U.S. there are several payers -- including consumers. So, in terms of state debt, healthcare expenditures are a bigger factor in Greece than in the U.S. However, in the U.S. personal debt caused by healthcare expenditures can keep the economy sluggish and have an impact on the ability of the U.S. to pay its debts and fund the future.

FDA Mobile Regulatory Fear Mongering by PhRMA

In a blog post provocatively titled "An App for That, But For How Much Longer?" (here), PhRMA's Kate Connors agreed with a Washington Times op-ed piece that suggested the FDA will soon require apps such as medication prescription renewal reminders and blood glucose level tracking functions to be regulated as medical devices. You can read the op-ed in this threaded archive: "How safe is that app? Should pharma apps be registered as medical devices?".

The op-ed author, Joel White, executive director of the Health IT Now Coalition, "suggests that this effort would lead to increased costs as well as constraints on user access to these apps, which 'may cause developers to move on to other, less burdensome endeavors.' In the end, this could hinder the way that patients can actively improve their own care," said Conners.

Before I get to destroying the case made by Connors and White, I should point out how these two people are related. White is the president of JC White Consulting, a registered lobbying firm (see here) retained by the Health IT Now Coalition and PhRMA, among others (see here). In her blog post, Connors said "A few days ago, I missed an op-ed in the Washington Times that I just came across today – and I’m glad I did." Joel, you should have DM'd Kate! Whatever! It's nice that White gets paid to write this "independent" op-ed piece that PhRMA can cite as if it were independent! Guys! Wake up! It's the era of transparency! Unfortunately, you can fool some -- maybe even most -- of the people all of the time and that is what keeps PhRMA in business.

Anyway, back to "FDA Mobile Regulatory Fear Mongering." I say "fear mongering" because it can't be true that White and Connors failed to read FDA's July guidance in which it stated that the agency does NOT consider the following types of apps to be mobile medical apps for purposes of the guidance:

"Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to a healthy lifestyle and wellness."

PhRMA/White do not quote FDA because to do so -- as I just did -- would kill the argument that FDA mobile guideline/regulations will stymie pharma from developing apps and will "hinder the way that patients can actively improve their own care." You should also read "No, the FDA is not assaulting mobile technology, Washington Times editorial misguided" published by iMedicalApps.

Meanwhile, there are medical apps being created by pharma that SHOULD be regulated by the FDA, IMHO. These are "calculator" apps designed to be used by physicians during diagnoses. One such app had to be "recalled" because of a bug that generated incorrect results. Unfortunately, thousands of physicians may not have heard of the "recall," which merely removed the app from app stores, not from the phones of physicians who downloaded the app. These physicians may still be using the buggy app. See "The Problem with Unregulated 'Calculator' Apps for Physicians: Buggy Software!"

P.S. Connors pointed out that PhRMA has its own medication reminder app for patients: "In fact, we at PhRMA have helped support the Script Your Future campaign, which itself includes medication reminders as a tool."

Just for fun, I signed up to receive reminders. I was, however, somewhat put off by the long legal disclaimer, which said, in part:

"You acknowledge and agree that we provide the reminder service and access to the reminder service as an "as is" and an "as available" basis, that your use of the reminder service is at your own risk, and that we make no representations, warranties or covenants whatsoever with respect thereto. For greater certainty, we do not guarantee that the reminder service will be available, run error-free or uninterrupted, that we will correct all errors or deficiencies related thereto or that all messages sent by you will arrive at their intended destination on time."

ROTFL! In essence, PhRMA says it makes no promises that this app will be useful. How is this supposed to help me improve my care if PhRMA does not even care to fix errors or deficiencies? Not a very consumer-friendly attitude, I must say! BTW, I am sure the FDA did NOT require PhRMA to write that.