Pharma Marketing

FDA asks 23andme to stop marketing of unapproved test and device

After months of negotiations, FDA finally lost patience and sends a warning letter to Google-backed 23andme, a genome testing company. 23andme was marketing its saliva based genetic test device and the test (Personal Genome Service) itself without an obligatory marketing clearance.

23andMe (Photo credit: brendanlim)


What FDA’s letter means

The letter is very direct and harsh and its tone, reminding Mrs. Anne Wojcicki, the founder of 23andme, that FDA really tried to help:

More than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies

The letter is the final warning. If 23andme fails to cease its marketing activities and provide a plan to align itself to the regulatory demands, FDA will start a regulatory action without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties – FDA warns.
At K-Message, we usually praise innovation, courage and development of new ways of dealing with complicated problems. 23andme could be a hero of our story. But Mrs Anne Wojcicki‘s approach is hard to support.

FDA’s concerns

FDA’s main concern is, as specified in the letter, a potential risk of negative impact of the often alarming test results coming from PGS. False positive or false negative from the PGS may affect actions of the people. Someone who was falsely informed that has high risk of breast cancer (BRCA mutation), can undergo prophylactic surgery, chemoprevention, invasive screenings and last, but not least will suffer tremendous psychological stress.
On the other hand, false negative may lead people from the risk groups to ignore prevention at all. Another dangerous part of 23andme service is informing about personal reaction to the drug. It produces a risk of “self-managing” therapy and lowering adherence to the therapy prescribed by real HCP. Such non-compliance may lead to serious risk of illness, injury and even death, as in the FDAs example of wayfarin, popular anticoagulant or “blood thinner“, which may cause internal bleeding if overdosed.

Problems with 23andme technology

23andme technology is far from being bulletproof. The assumptions it bases on, the links between particular genes and diseases are not really mapped and confirmed in regular clinical trials on big samples. Even Mrs. Wojcicki admits, that her goal is to gather a test sample big enough to  falsify the assumptions on which results are presented to the patients.
But it is not only about state-of-knowledge about human genome as today. Even the software that generates PGS results can mislead patients, as described in this personal story “My deadly disease was just a bug”. It also happened, that 23andme simply mixed the samples and 96 of its users recveived data od someone else, who just had a bad luck to have his/hers saliva on the same testing  plate.
It does not make Mrs. Wojcicki any more apologetic though.

Linda Avey and Anne Wojcicki of 23 and Me
Linda Avey and Anne Wojcicki of 23 and Me (Photo credit: dfarber)

Right to know, but what?

The problem is, Mrs. Wojcicki often diminishes such concerns. She said once, that the main concern of doctors is that her service generates “non-billable, educated questions“. When the Agency first warned 23andme together with other gene testing companies in 2010, Mrs. Wojcicki’s line of defense was freedom to know information about your own body.
FDA has nothing against testing itself and having this knowledge available. The problem is that the knowledge has to be true and not misleading. As Mrs. Elizabeth A. Mansfield, director of personalized medicine in the F.D.A.’s medical device division, said to NYT, the agency agreed that people had a right to their genetic information.
The concern, she said, was that 23andMe was also providing interpretations of what that data meant medically. Some commentators, that come more from a tech than pharma tend to see the conflict between 23andme and FDA as “new vs old” clash.
We believe it is not the case this time. It is rather good ol’ regulatory action against dangerous false claim in healthcare, or even quackery. 23andme does not offer substantial evidence to support the reports provided to their clients. Their often misleading information can lead to health risk, and therefore FDA has to intervene. It has nothing to do with freedom of the information, as the information is too often false and affects really important matter.

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Pharma Marketing

Abbott EPD: the first digital marketing only launch in pharma

Abbott‘s Low Dose HRT brand was launched in the first in the pharmaceutical industry digital marketing only campaign. According to the press release published by PMLive, the campaign for based in Basel, Switzerland, Abbott Established Pharmaceuticals Division (EPD) was the first new-product launch to be delivered solely via a digital channel for the pharma industry. We cannot say whether or not it was really the first digital-only launch in pharma, but we understand that Abbott EPD is satisfied by the results.

Русский: Компания "Эбботт"
Abbott logo (Photo credit: Wikipedia)

Campaign reached to 9,000 doctors who engaged with Abbott’s Low Dose HRT brand via British online professional network This equates to 45% of the NHS population of obstetricians and gynaecologists, and nearly 23% of GPs. Please note that it is not clear whether those were the specializations of the HCPS who received Abbott’s message.
According to Abbott EPG, the brand’s market share has increased and there has been a continuous month-on-month growth in sales in 2013 as a result of the campaign, which included interactive case studies, clinical paper summaries, and an ask the expert section.
The decision to try a digital only product launch via was made following research conducted by Abbott, which found online professional networks can provide a more effective method of engaging with doctors than traditional sales and marketing channels. They enable them to take a more targeted and measurable approach, and to deliver a mix of promotional and educational messages in a way that really benefits doctors’ clinical practice.
More than three million physicians use professional online networks worldwide and statistics from show that 59% of them visit these channels specifically to update their medical knowledge; while 38% do so to get information on new products.
Abbott is already very active in the digital space, and it co-operated with  before. 2013 PM Society Digital Media award for the best HCP website was granted for their Femoston Conti Low Dose Microsite made by
Ajay Mann, Commercial Marketing Manager for Abbott EPD, commented to PMLive:

“The results speak for themselves. The coverage and frequency of the campaign exceed current national call rates by sales reps. What pleases us the most is our increase in market share and continued sales growth. Doctors are coming back to the website, indicating that they find it a valuable resource.”

At K-message we praise courage of Abbott’s digital pioneers. However we doubt some of the claims from the release. In particular, it is hard not to get growth in market share after launch of the product. Even if you sell one dose of the medicine, it will be 100% percent more than nothing. Secondly, we would be very careful with stating a positive impact of sales of any campaign, without a benchmark or a sample. What would happen if Abbott’s launch got traditional detailing instead of digital? Sure the reach of the campaign would be initially smaller and it would reach the target group bit later. After all not every HCP is visited on the regular basis. Nevertheless, we cannot guarantee that those approached by field force would not increase sales more than those who only read a website. We could also imagine, that a combination of digital and traditional would be even more efficient. We just do not know, as it is not clear what would happen with a different set of tools.
To summarize: we believe in the efficiency of digital approach. But we would be far of saying it is the only and the best way to launch a product.

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Pharma Marketing

How Affordable Care Act (Obamacare) changes pharmaceutical marketing in the U.S.?

Will Affordable Care Act (Obamacare) change the pharmaceutical marketing in USA? According to Dorothy Wetzel, founder and Chief Extrovert at Extrovertic there are three ways it will.

English: Barack Obama signing the Patient Prot...
English: Barack Obama signing the Patient Protection and Affordable Care Act at the White House (Photo credit: Wikipedia)

As Ms. Wetzel explains in her “Three ways ACA (Obamacare) changes pharma marketing” post at Pharmaforum, Obamacare enforces on the US market a new reality. The three main points are:

  1. It’s a payer-patient world

  2. Multicultural marketing is mandatory

  3. Value takes center stage

Let’s take a look at the points raised by Dorothy Wetzel.
What does payer patient mean? In the US after ACA HCPs will lose the power to decide which medication should be prescribed. This role will be taken first by payers (insurance companies) who will set strict rules on reimbursement. Secondly, physicians will be obliged to follow their employer’s policy, and most of the HCPs is employed by hospitals or networks of practices. Third, but not less important point is that patients as co-payers will be more careful on what medication is chosen and prescribed.
What it means for pharma marketers in the US is that instead of focusing mostly on HCPs, they will need to coöperate with Market Access teams to gain support of payers. Whenever possible it will be also worth to use DTC marketing, which is still allowed in the US.
Multicultural marketing is something that Big Pharma is familiar with, however up until today global campaign meant “everywhere but US”. Now, also US-based Pharma marketers will need to speak different languages, and Spanish will be the first to learn quickly. Due to social inequality in the United States it is estimated that almost half of newly insured Clients of ACA will come from multicultural communities. For them Pharma has to speak their language, using specific cultural codes. It may also mean that we need more diversity in the field force as well.
The third point raised by Ms Wetzel is value as the center point of the message. This is absolutely clear, taking into account the payer getting more decisive power. Pharma has to prove that the product provides enough benefit to be worth to reimbursed by the payer.
It is worth to note, that this changes, although very impactful for the US market, are actually bringing it closer to the other markets, especially EU, where role of the payer is already very important, and regional campaigns are performed in many languages with different cultural factors in mind.

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Pharma Marketing

GSK selects WPP GO Team for advertising pharma antacid brands

GlaxoSmithKline (Photo credit: Ian Wilson)

WPP’s GO Team is the new agency-of-record for advertising of two GlaxoSmithKline’s (GSK) top antacid brands.
GO – an alliance between Grey and Ogilvy – will provide integrated consumer communications, including TV, print and digital advertising, for GlaxoSmithKline’s antacid brands Tums and Eno.
Previously Grey was agency-of-record for Tums and Ogilvy was agency-of-record for Eno. The new combined account will be led out from New York, leveraging Grey and Ogilvy offices internationally.
GO’s strategic insights into the category played a large part in the selection, according to Anna Humiecka, global marketing director, GI Health, GSK. She also mentioned the team’s “compelling creative ideas and strong resources and talent”.
Available in eight varieties, Tums is the best-selling antacid in the US. Eno’s main markets are Spain, India, Mexico, Asia, Australia, UK, Middle East, Africa, Pakistan, South America, and Hong Kong.
The GO Team is part of WPP Team GSK which operates a portfolio of WPP companies working with GSK.

Pharma Marketing

[Pharma] Marketing with Meaning in Pecha Kucha format

Dose of Digital presents Pecha Kucha on Marketing with Meaning in relation to Pharma Marketing. Enjoy the video and slides below!