Wednesday, July 05, 2017

Is FDA Too Slow to Approve New Drugs?

Back in March, 2017, President Trump "called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency’s current process as 'slow and burdensome'”(here).

According to Dr. Michael Carome, Director, Public Citizen’s Health Research Group, president Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications and medical devices are safe and effective (here).

In an analysis published in The BMJ last week, Thomas Marciniak, a retired team leader within FDA's Division of Cardiovascular and Renal Products, and Victor Serebruany, a professor at Johns Hopkins University, attempt to debunk some of these claims, reports RAPS (here).

"This crude depiction ignores industry's contribution to the clock after clinical trials are completed but before the FDA receives the formal application," they write. "It may be possible to accelerate drug approvals in other ways, such as changing processes earlier in the development programme, before the end of the pivotal trials," they write, while cautioning that lowering FDA's standards to speed reviews "may prove costly for patients and healthcare budgets."

Of course, the real issue is how long it takes drug companies to come up with the evidence in order to submit an NDA (New Drug Application) to the FDA. Pharma has won the battle to get FDA turnaround times down to the bare minimum. It now has to turn to allowing drugs to be approved with less evidence. That's really what this is all about. FDA is just a convenient scapegoat, IMHO.

There is one solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients.

Tuesday, June 27, 2017

The Forgotten eHealth Code of Ethics

Recently, I was sorry to see that the eHealth Code of Ethics, which I helped create back in 2000, was not included in the list of references to an article about trust and credibility of web-based health information. According to the Code, individuals need to be able to judge for themselves the quality of the health information they find on the Internet. Sites should disclose what sources the site or content provider has used, with references or links to those sources.

Any research or effort designed to improve the quality of health information on the Internet must build upon the work already done by the creators of the international eHealth Code of Ethics, which is as relevant today as it was back in 2000.



Click on "Read more >>" for the transcript of this podcast and for links to the code and other related information.

Monday, June 12, 2017

Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its DTC Advertising Principles & Code on Interactions with Healthcare Professionals. Why Not?


In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance the PhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.

Despite the thundering unanimity of the PhRMA Board, several current board members are NOT signatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!

Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guidelines. In addition, Alkermes, which sells Zohydro, a powerful opioid (see here), is not a signatory to PhRMA's Code on Interactions with Healthcare Professionals

Alkermes also markets Vivitrol - an expensive drug approved by the FDA for treatment of opioid addiction (click "Read more >>" for background). The photo above shows a "reminder ad" for this drug on a NYC subway train. Technically, this ad does not violate DTC Principle 13, which prohibits such ads that do not disclose the drug's indication or side effects. That's because Principle 13 ONLY applies to TV ads!

Meanwhile, Alkermes specifically bypasses physicians and focuses on "a deft lobbying strategy that has targeted lawmakers and law enforcement officials."

Monday, June 05, 2017

Funny, Witty, Snarky Pharmaguy Memes About Pharma

The original, pre-internet definition of a meme is, “an element of a culture on system of behavior that may be considered to be passed from one individual to another by non-genetic means, especially imitation”.

Today, the “element of culture” is often an image or photo that has spread through social media or texting and which has been modified to include overlaid text. At least, that is how my son defines meme.

Over the years I have created numerous memes that I hope will be copied and passed on from one pharmaceutical marketer to another. This PowerPoint presentation includes many of my favorite memes and some insights on why I created them. Most of these memes have to be viewed in context of the news and events that inspired them. So for each one, I provide links back to the original social media post in which they appeared. Hopefully that will provide the necessary context.

Enjoy and feel free to spread them through your social media channels!


Friday, June 02, 2017

Defining "Patient Centricity"

Patient Centricity used to be a buzzword in that it was often mentioned but seldom practiced by pharma companies.

A lot of progress has been made in the past years to achieve patient centricity, but not all drug companies have had much success. Unfortunately, that has had a negative impact on the industry’s reputation.

Timothy White, Head of Global Customer Interaction Management at Lundbeck, once said people on the commercial side of the pharma business have an “unhealthy obsession with ‘buzzwords’.”

Worse than that, noted White, marketers cannot articulate the usefulness of the buzzwords they use.

Two years ago I compiled a list of “Buzzwords” used by pharmaceutical marketers. Patient Centricity was one of them (read "Pharma Buzzwords Heard During a Conference").

In a recent podcast (listen here) I pointed out how patient centricity has paid off in a big way for the drug industry when it comes to marshaling patients in support of speeding the approval with the FDA, which, by law, must include the patient perspective in the drug approval process.

But pharma still struggles to achieve patient centricity. Rich Myer, author of World of DTC Marketing Blog, reported recently that according to IMS a majority of pharma companies have attempted patient-centric initiatives but only a third have reported any success. Only 4% reported a high degree of success and nearly 60% of pharma professionals said there is no consistent definition of patient centricity in their organization (read "Why Does #Pharma Have Problems With Achieving Patient Centricity Success?").

To be successful at patient centricity, the drug industry must first define what they mean by the term. Astrazeneca has taken the first step to doing that.

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