FDA's Advisory Committee Voting Double Standard

FDA's Advisory Committee Voting Double Standard

I learned today that the FDA allowed physicians with ties to Bayer to participate and vote in an advisory committee weighing whether or not the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk (read the WSJ story here: "FDA Advisory Committee Members Had Ties to Bayer").

At least one of the physicians (Paula Hillard, Stanford Univ; see her financial disclosure info here) was a Yasmin advocate. According to a Bayer document released during litigation, Hillard "enable[d] us [Bayer] to now have another huge ... Yasmin advocate here in Nor Cal -- she will be well utilized!"

Hillard, the advocate, was allowed to vote on the issue.

In the same story, it was noted that drug-safety crusader Sidney Wolfe -- who was appointed to a four-year term on the FDA's Drug Safety and Risk Management Committee (see "Wolf(e) at DTC Piggy's Door Huffing and Puffing") -- was NOT allowed to vote "because he had publicly criticized the drugs' safety in newsletters published by his Public Citizen Health Research Group."

So, an "advocate" of a drug is allowed to vote whereas a "critic" of a drug is not allowed to vote. This is an astonishing double standard, IMHO.

This little excerpt from the WSJ article is also interesting:

The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to "ensure ... transparency." However, committee members must disclose potential conflicts only to the FDA, which doesn't generally make the information public.

Jill Hartzler Warner, an FDA official who oversees advisory committees, said the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When picking committees, the FDA weighs "whether a meeting would affect the financial interest" of a panelist. The agency also does "look at whether past relationships would give the appearance of being a conflict," she said.

I was not aware that the FDA is "prohibited" from supplying information contained in financial disclosures, but it may be a moot point in a year or so when the physician sunshine act is in full effect and all payments to physicians are made public. We'll just have to wait for that and do our own research. Still, with FDA's double standard regarding voting privileges, it won't much matter how much transparency there is in who serves on these committees!

P.S. For more on how the FDA determines whether or not a physician's financial conflicts disqualifies him or her from serving on FDA advisory committees, see "FDA Advisor Rule Loophole?" where you'll find a complex chart depicting FDA's "Algorithm for Considering Advisory Committee Member Participation."

P.P. S. For some more background on Wolfe vs FDA regarding Wolfe's participation in this committee, read "FDA Pulls Wolfe Off Panel Over ‘Intellectual’ Conflict" (Pharmalot).

Thera Max YouTube Video "Social Media Strategy" Makes Americans Look Like Fools!

Thera Max YouTube Video "Social Media Strategy" Makes Americans Look Like Fools!

"A reporter in Times Square gathered over 200 random people and allowed them to try Thera Max™ Cold and Flu right on the spot. The results provided would give a non-biased, random and unscripted evaluation of the product and the results it provided. The overall consensus was, 'It really works.'"

According to the press release (read it here) this was the result of "A Social Media Strategy in Times Square [that] Boasts Great Results for TheraMax Cold and Flu."

What's the social media component? Videos from the TheraMax "No Cold Here -- Times Square, NYC" promotion have been uploaded to the Thera Max Facebook and YouTube pages.

Luckily, this social media "strategy" hasn't garnered very many views on YouTube (see video here). There have been only 148 views so far and half of them were by me!

I say "luckily" for a couple of reasons:

1. The claims of efficacy made in the video for this "homeopathic remedy of ingredients pre-approved by the FDA" are shameful. "Awesome", "no nasal congestion here." etc. No wonder Rx drug marketers have social media envy! 


2. The "random people" trip all over themselves trying to promote the product as if they were auditioning for a TV ad spot! Wait! They ARE auditioning! "On February 1, 2012, one Grand Prize Winner will be selected at random to receive a TheraMax customized iPad2," says the press release!

I don't have the stomach to see what's happening on the Facebook page!

The following montage of frames from the video demonstrate the depths to which some people will stoop for a chance to star on YouTube and win a lousy iPad2!

Lilly Sales Reps Learn Marketing Lessons From Disney's Animal Keepers

Lilly Sales Reps Learn Marketing Lessons From Disney's Animal Keepers

Lilly sales representatives are learning about customer service by observing Disney Animal Kingdom workers as they "[greet] families at the gate and [answer] questions around the attractions," according to an article in today's Wall Street Journal (read "Drug Sales Reps Soften Pitches").

"Lilly's most recent national sales meeting, held at Disney's business training institute in Florida in February, was devoted to customer service, not product training," said the WSJ.

"Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits" are, said David Ricks, president of Lilly's global business unit.

I'm not sure it was necessary for Lilly to bring its sales reps to a Disney resort in order to learn about the "new service model," which I have been writing about for the last few years in collaboration with Kantar Health (a client). You can read the latest installment, "Stakeholder Effectiveness: Maximizing the Value of Your Interactions with Multiple Stakeholders" (here - use discount code '101701stake'), which ranks the top 15 pharmaceutical companies on how well their sales reps provide services desired by physicians. Also, you can read the first article in the series, "Reinventing the Sales Model: Moving from Sales to Service" (pdf).

Each year Kantar Health asks physicians in the U.S. and Europe if they have started to notice a move toward a “service model” experience, where other services are emphasized beyond sales reps detailing physicians, such as patient education and information and internet-based services. They quantify this using what is called a TRI*M™ index. The lower the TRI*M, the better service provided and the higher the ranking. The 2009 through 2011 U.S. Primary Care Physician rankings are shown in the following chart (click on it for an enlarged view).

Lilly improved its rank somewhat in the last two but is still not among the "Top Tier" companies such as Pfizer, Merck, and GSK. Hopefully, Disney's animal trainers will help improve Lilly's TRI*M index in 2012.

Some Interesting Numbers Regarding US Sales Reps & Budget

As reported in the WSJ (op cit), "the industry has slashed 33,000 sales jobs in the U.S. from its peak five years ago, when 105,000 representatives flooded the zone. Most recently, AstraZeneca PLC said it would cut its U.S. sales staff by 24%, or 1,150 jobs. The industry spent $14.5 billion on marketing in the U.S. in 2010, down about 15% from five years ago, according to Cegedim Strategic Data."

Predicting the Future of the Drug Industry: 2012 and Beyond

Predicting the Future of the Drug Industry: 2012 and Beyond

It's time to revisit a survey I ran a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold in the next 5 to 8 years (ie, 2012 to 2019).




You can take the survey here. But before you do that, let's review the first-round of results (ie, responses collected from 2 December 2009 through 8 January 2010). Events since then may have made some of the following scenarios more or less likely. You tell me.

The scenarios -- with my updated comments included in brackets [] -- that are included in the survey are as follows (see the chart afterward for the first-round results):

1. New follow-on biologics legislation in the U.S. will increase competition from generic equivalents and eventually decrease brand profits. [I think the legislation is still bogged down and when finalized may not have much impact within the time frame specified.]
2. Broadcast (ie, TV) Direct-to-Consumer (DTC) drug promotion will be banned or sharply curtailed by law in the U.S. [This may have been a big issue back in the day, but it doesn't seem to be center stage right now.]
3. The European Union will finally allow Direct-to-Consumer (DTC) advertising to its citizens. [The European Commission, the executive arm of the EU, recently ruled that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. For the details, see, "In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice"]
4. Internet-based drug promotion (including search engine marketing) will overtake TV-based DTC in the U.S. in terms of dollars spent. [There's still time for this to happen. I'm guessing that right now only about 5% (maybe 10% if you include search advertising) of pharma's DTC advertising budget is spent on Internet advertising whereas TV accounts for over 50% of the budget. See "Double Dip in DTC Spending Plus 33% Drop in Internet Display Ad Spending!"]
5. Due to decreasing effectiveness of traditional physician detailing and rise of non-personal detailing, the role of traditional sales representative will become obsolete. [I'm surprised that over 50% of respondents think this is likely to happen before 2020 (see chart below). Perhaps a sign is the recent closing of Pharmaceutical Representative Magazine (see here). Also read this article: "Consequences of eDetailing Technology".]
6. New healthcare reform legislation will dramatically increase the sales of drugs in the U.S.
7. Extensive outcomes data available to payers and comparative effectiveness research will force the industry much further down the path of pay-for-performance (ie, adopt a more flexible approach to pricing). [For background in this, read the article "A Case for Supporting Comparative Effectiveness Research".]
8. Patients will become even more influential and empowered in making healthcare decisions as they are forced to pay a larger share of costs and/or have access to health information from a variety of sources. [For more background on this, read the article "The Empowered Patient: What It Means for Pharma Marketers".]
9. Despite lack of innovative new drugs and/or generic competition, sales of brand drugs worldwide will show a sharp increase due to increased demand in emerging markets (eg, China). [See the following articles: "Getting Market Research Right in Emerging Markets", "Getting Market Research Right in the Middle East", and "Getting Market Research Right in India & China".]
10. More efficient targeting of drugs and marketing to specific patient populations will greatly increase effectiveness and decrease side effects of drugs. [See, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales". At least one targeted therapy (I can't recall which), however, recently failed and that may cast a shadow on progress in this area.]
11. Social media marketing will become a significant part (>10%) of the pharmaceutical marketing mix. [Hmmm... A lot of people seem to believe this is likely (see chart), but FDA's delay in issuing guidance may have dampened the outlook for pharma use of social media.]
12. The next BIG opportunity for targeted marketing to patients and physicians is mobile apps on "smart phones." [To prepare for this, I recommend you read the article "Everything You Need to Know About Mobile Platforms". Take the survey and you will get a discount code that allows you to get this at no charge.]
13. Pharmaceutical and biotech companies will continue to increase their outsourcing of clinical trials and related drug development. Outsourcing will account for more than 50% of R&D spending by 2019.

The following chart summarizes first-round (prior to January 2010) survey results. Please take the survey now and help me get a more current view of what may be dow the road.