11 - 12 September 2017 | Boston, MA

Thursday, August 17, 2017

PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies

As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is "harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health."

"FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exponential pace," Kelly Goldberg, PhRMA vice president and senior counsel for biopharmaceutical regulation, and Ryan Kaat, senior director of law, wrote in comments published 11 August on an FDA notice.

"PhRMA has long sought to ease FDA's rules on advertising and promotion particularly as FDA last November held a meeting to consider the off-label promotion of drugs with some regulations," noted RAPS. Some FDA officials at that meeting, however, questioned industry's arguments and motives for loosening regulations on off-label promotions (read “Ex-FDA Commish Califf Says #Pharma Needs a Code of Ethics to Prevent ‘Misleading’ Off-Label Marketing”).

But now, PhRMA is taking FDA to task for proposing new studies "seemingly without fully appreciating its own previous research" and some proposed studies "are often unnecessary in light of existing data."

PhRMA also takes exception to FDA research on "obscure topics," such as "Spousal Influence on Consumer Understanding of and Response to Direct-to-Consumer Prescription Drug Advertisements" (read “Does Your Spouse Influence Your DTC Viewing Experience?”) to "Animation in Direct-to-Consumer Advertising." (read “FDA Will Apply the ‘Uncanny Valley’ Hypothesis to Test the "Eeriness" of Animated Characters in Drug Ads”). See my SlideShare presentation ("Gallery of FDA Studies of DTC Advertising") embedded at the end of this post.

But PhRMA may be "shooting itself in the foot" by criticizing FDA.

Tuesday, August 08, 2017

"Fake Advertising": Allergan Should Be Red in the Face for Using "Before & After" Images in Rhofade & Kybella Ads


Allergan is again resorting to side-by-side "before and after” images in a drug ad to prove that Rhofade - its new drug for the treatment of redness of the face, aka rosacea - works. This is the same technique the company used  to promote Kybella for double chin syndrome.

In the Kybella case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image. That ad, however, claimed they were “unretouched photos” (read "Kybella Double Chin TV Ad: Are the BEFORE & AFTER Photos REALLY Unretouched as Claimed?").

Despite some anonymous commentator to my Kybella blog post claiming he/she “worked on this campaign and I saw first hand that not one photo in the treatment area was retouched,” I don’t buy it.

But I will point out that the photos in this ad for Rhofade are definitely not retouched versions of the same photo. The ad, however, says “Illustration only.” Which means this is not a real case study of a real person’s response to the drug.

Perhaps that commentator to my Kybella post learned from my blog to be more careful about using fake before-and-after imagery.

Whatever! Allergan is again practicing misleading and/or false advertising, IMHO!

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."

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