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Archive for December, 2008

A while back, I linked to a story in which an opinion was offered that, after the new (updated) PhRMA code goes into effect in January ’09, about the only marketing tool a rep will have left is samples.

The link to this story is right here, and I suggest you read it for background. I forwarded it privately to a number of folks in my “inner circle.” There were some interesting reactions, including one very long written one, which I’ve gotten permission to reprint below (that’s why you want to scan the original article first – the context is important).

These are thoughts from Joe Elliott, Director of Marketing – Urology, Watson Pharmaceuticals:

Our company recently conducted some marketing training and review of what the updated PhRMA guidelines mean for acceptable marketing and promotional tactics Although there are a lot of rules, there’s still room for interpretation, and you will see variable application based on each pharma company’s interpretation of risk. In fact, most of the guidelines have to do with perception (and any lawyer can find a compliance problem if he/she wants to perceive one!) For example, if I held a meeting with MD’s at a Ritz Carlton (“resort” perception) with a sleeping or meeting room rate of $100 per person, that would NOT be acceptable compared to, say, a Marriott, even though I was paying >$250 per person.

However, some things, such as the giveaways mentioned in the article, will certainly disappear. It’s pretty amazing that states like Massachusetts and others want “gifts” to the MD of >$50 value reported. As one person in academia put it to me, the legislators certainly don’t think too highly of the MD’s in their own state if their ethics can be corrupted for $50!!

We’ll probably also see increased use of CME; bearing in mind, however, that the rules for involvement of the pharma company with the CME provider are now so draconian, that perhaps the opposite will happen. If you can’t provide input into the therapeutic content, or even suggest known MD experts, then how do you know that content relative to your product will be discussed or presented?  The concern about “programming” the content may or may not be legitimate, but in general historically these programs have been quite valuable to all involved, and honestly conducted. Rules on this have been in place for some time anyway.

As far as reps go, if their view of the world is that they must have samples to engage the MD, but do not actually do so, there probably is no need to employ those kinds of reps. Some reps may not realize it, but they still have promotional information, literature, and study data that they can deliver.  While it is clearly more difficult in general medicine and mass market therapies (e.g., hypertension) to have a dialogue with the physician, in fact the main responsibility of the rep is to exchange information of value to the MD in terms of optimizing patient treatment (see quote on p. 8 about the BEST way to see doctors). Doctors still see reps, especially specialty reps, because they are able to perform this function (see the quote in the article by Dr. Clark).

The best reps know the disease state, not just their drug, as well as the MD, and can therefore provide information about the most appropriate clinical situation that will fit their drug. If it doesn’t fit, the best reps acknowledge this, and are even willing to make alternative, competitive, suggestions. THAT behavior, focused on serving the interests of the patient, and the physician’s practice, is the basis of any credibility that the rep has, and why the MD will continue to see them. I can personally give you 5-6 stories of doctors calling reps into their offices to personally thank the rep for literally saving a patient’s life, through either the information they delivered, or the resources of the company that they provided access to.

The one area where reps will really have a difficult time under the 2009 guidelines is prohibition of meals outside the office or hospital. Typically a dinner (where the rules on what can be spent and what can be said- in-label info only- are already in place for every company), with a therapeutic discussion, are valuable and fuller interchanges, since there is no time pressure once out of the office, and no patients are waiting. However, now this can only be done with speakers present, which actually drives up the cost of these programs. I would not want to be a new pharma rep now, as it is much more difficult to build a personal relationship, which is the hallmark of all repetitive selling. A professional relationship based on established credibility and trust is not a bad thing, and is no more inappropriate in pharmaceuticals than in any other type of product.

As far as samples go, I don’t think you’ll see them disappear anytime soon, unlike the other giveaways. They’re simply too valuable to the patient and the doctors. Dr. Cutrona (see quote in the article) is inaccurate about safety issues, as any new prescribing information, including black box warnings, MUST be communicated by company representatives to the prescriber, whether they are treating children or not. Perhaps she doesn’t want to acknowledge that it is her responsibility to prescribe with knowledge of the full PI, and if she doesn’t know it, that’s exactly what the reps are for!!

If it was up to the drug companies though, and they felt every other company would behave similarly, they would eliminate samples tomorrow, simply based on the expense. The article makes a big point about how samples are used to generate prescriptions for brand drugs, which they surely are. But the physician has the option to prescribe whatever drug, including the generic version of the sample if it exists, that he wants. Few ever give drug companies credit for providing these samples for the right reason, which is to make sure the patient can tolerate the drug before a prescription is generated.

And while we’re talking about brands, and whether they have any incremental benefit vs. other older drugs, that also is the MD’s decision, and is the basis of FDA approval for the newer brand. It’s unfortunate that neither the provider community nor patients fully recognize that even incremental changes in drugs within the same class can be beneficial. If that was not the case, everyone would be on Mevacor, instead of Lipitor. One drug choice per drug class is not the right answer clinically for all patients. People simply respond and react differently. If it really is not any better, both provider and payer, as well as pharmacist, can implement decisions to force use of the older generic. In fact mandatory substitution by pharmacists already exists in most states.

I also don’t see too much credit being give to pharma for the free drugs (in the 10’s of millions of dollars per major company) being given away for indigent patients, or for the reimbursement support, co-pay assistance programs (which cannot legally be attached to any individual drug), rare disease programs, CME events, and medical society support (without which NO medical society would be solvent), etc.

Frankly, where the industry should spend more money is on compliance and persistence programs. MD’s assume that patients are taking the drugs as prescribed, but there is much documentation that 20-30% of the prescribed drug is never taken, for a variety of reasons. This leads to therapeutic failures that are often misunderstood or misinterpreted, as physicians do not always catch this. If patients increase this behavior for the economic reasons suggested on the last page of the article, not only drug profits would be affected, but so would patient outcomes!

(as with Chris in the original article, these thoughts are Joe’s and do not necessarily reflect those of his employer)

What are your thoughts? Feel free to give your two cents in the Comments!

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General news:

Approvals: Genzyme’s stem cell transplant drug Mozobil; Abbott‘s triglyceride drug TriLipix; Eisai‘s Lusedra for anesthesia.

Novartis‘ experimental MS drug (oral) looking really good compared to competition.

Wyeth and ghostwritten articles. This is going to be ugly – Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors, a U.S. senator said. Documents from lawsuits suggest the drugmaker hired DesignWrite Inc. of Princeton, New Jersey, to draft manuscripts related to the Wyeth products and breast cancer risks, according to letters released today from Senator Charles Grassley of Iowa to the companies. Wyeth makes the hormone replacement drugs Prempro and Premarin…more

Roche CEO to other pharma/biotech companies: Let’s get gloomy.

More trouble for Elan/Biogen’s Tysabri – Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized…more When you look at the numbers, however, it’s still a pretty small incidence. My question – if it weren’t an exotic brain infection, would this get so much press attention??

Would you like some Ritalin with that syllabus? – “We should welcome new methods of improving our brain function,” they write. “In a world in which human workspans and lifespans are increasing, cognitive enhancement tools – including the pharmacological – will be increasingly useful for improved quality of life and extended work productivity, as well as to stave off normal and pathological age-related cognitive declines. Safe and effective cognitive enhancers will benefit both the individual and society.” more

Newer antipsychotics: much ado about nothing? – The common distinction between first- and second-generation antipsychotics has no scientific basis and should be dropped, according to a paper in The Lancet. A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotics are more effective than older drugs for symptoms of schizophrenia, MedPage Today writes…more

Choose your friends wisely-and happily – Researchers looked at the social networks of more than 4,700 people whose happiness, along with other factors, had been tracked for 20 years. Those surrounded by cheery souls were more likely to have sunny dispositions, even if they didn’t known them…more

KV Pharma CEO: walked out or booted out? – This is one for the gossips. Marc Hermelin, the KV Pharmaceuticals ceo, is leaving under what could be politely called disputed circumstances. The drugmaker says he was fired, but Hermelin issued his own statement that he informed the board earlier this week that he is simply retiring, according to reports…more

J&J loses another Duragesic patch verdict, to the tune of $16.5M

Malaria vaccine one step closer – Two papers published in The New England Journal of Medicine are reporting the success of a pair of new vaccines tested in children in Africa. And experts say the results may open the door to sweeping trials of the vaccines in seven African nations by early 2009 and a completed formulation ready for approval by 2011. “We are,” Christian Loucq, director of the PATH Malaria Vaccine Initiative, tells Time, “one step closer to the day when malaria will join diseases like smallpox and polio.”  more

ImClone to cut field sales force by almost half, following acquisition by Eli Lilly.

Two blows to Avandia, one to Actos. Increased death risk: Avandia. Increased fracture risk among women: Both.

Using nicotine as a cure? Nope.

A summary of “where we’re at” with MS drugs, from PharmExec.com.

Fewer sales reps? Docs are OK with that. And here’s a 33-company list of where the jobs ain’t (recent layoffs). Ouch.

PhRMA’s beefed up drug advertising guidelines. As the pirate says, “these are more like guidelines…”

AstraZeneca‘s Symbicort cleared by FDA panel for asthma.

Top 50 Health 2.0 blogs.

Last week was ASH (American Society of Hematology) week, so we’ll feature a number of news items about blood diseases and treatments…

Encouraging blood platelet boost seen with Glaxo’s oral drug Promacta – Patients treated with GlaxoSmithKline PLC’s Promacta rather than a placebo were eight times more likely to have sustained increases in platelet counts, according to pivotal trial results announced by the company on Saturday…more

Zevalin – effective. You’ll have to flounder through all the technical terms to grasp the details!

Encouraging CLL treatment results with Celgene’s Revlimid in older patients.

Treanda may get to first-line treatment – Cephalon Inc’s Treanda was as effective in treating non-Hodgkin’s lymphoma as the standard chemotherapy regimen with far less toxicity, according to interim analysis of a late-stage study that could pave the way for the drug’s use as an initial treatment for the disease…more

Allos experimental drug for lymphoma shows strong results – Allos Therapeutics Inc said on Saturday a small, but potentially pivotal, trial of its experimental drug pralatrexate found it helped curb cancer in 27 percent of patients with an aggressive type of lymphoma…more

Efficacy of long-term treatment with Novartis’ Glivec/Gleevecawesome. And good stuff with Tasigna in CML patients also. Staying with Novartis, results reported for its oral iron-reducing drug Exjade.

Rituxan + chemo for leukemia: yep. – A combination of Genentech Inc’s cancer drug Rituxan and chemotherapy reduces by 41 percent the risk of death or cancer progression, compared with chemotherapy alone, for patients with a common form of leukemia, the company said on Saturday…more

The coming clot-busters.

On the breast cancer front:

Zometa: tumor shrinker – the osteoporosis drug zoledronic acid (Zometa) appears to shrink breast tumors in patients who undergo chemotherapy. The drug is already approved to treat breast cancer that has spread to the bone and, earlier this year, was reported to lower the risk of breast cancer recurrence in pre-menopausal women with early estrogen- or progesterone-positive tumors…more

Tykerb + Femara = survival benefit.

Hormone replacement pills: not good news – Taking the hormones for five years doubles the risk for breast cancer, according to a new analysis of the Women’s Health Initiative, a large federal study, revealing the most dramatic evidence yet of the dangers of the popular pills..more

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After Hours

Happy skies, part 1, part 2.

Really bad timing.

Templar University.

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You have a day job, which is developing and deploying the most effective training possible. That means finding good vendor/partners – but who has time to know that entire provider landscape?

That’s my “day job” (and I’m STILL finding great new suppliers, month after month!). I thought it might be helpful to provide you with a grid of all the areas of training where I have built up a partner network, so that as needs come up, you can better know where I can help.

Here’s the file, suitable for posting in your cubicle and/or passing along to your colleagues.

This list is not meant to be exhaustive, because I go out and find suppliers for my clients when they toss me needs outside of these categories! Which is one way that I keep expanding the network of great providers for the next time that need comes up.

The one area where I’m not likely to be able to help much is commodity-level, off-the-shelf programs (training on MS Office applications, for instance), or general, non-pharma specific themes such as generic leadership programs provided by big training companies. Impactiviti specializes in pharma-specific partners who provide focused programs (sometimes off-the-shelf, but usually custom or partially customized). So, if you need Fleet training or How-to-use-Excel, we’re not your resource. Pretty much anything else, give us a call and we’ll try to help!

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This is not the most wonderful time in the overall economy, or in pharma, so a lot of folks are looking for jobs – including former employees of both client and vendor/provider companies. We field calls regularly from folks in the Impactiviti network (and I really don’t mind!) looking for help with new opportunities, or available resources.

A few things to help out, including something new (see point 4)!opportunityweb

1. One of the reasons we launched the Impactiviti Job Board was to try to provide a one-stop place for sales training professionals to see what’s out there (we also have some vendor positions advertised there). But there are other resources you might want to look into:

2. Blogging colleague Jason Alba has a site called Jibber Jobber to help manage your job search, and to provide resources. Here’s a helpful recent post with 10 Resources for Job Seekers Right Now.

3. Social networking sites are a great way to build up your network. I’m a big fan of social media and I think that creating your own “Opportunity Network” is the best job security you can have. Here’s a recent CNN article with helpful do’s and don’t’s.

4. I’ve spoken about LinkedIn before, and even created a group “Impact” just for pharma/biotech/device professionals (no vendors or recruiters) to facilitate networking. You who are training professionals (on the client side) can join here.

Starting today, I’ve just launched a new group (ProActiv) for those on the other side – this group is specifically FOR vendors, contractors, freelancers, consultants, recruiters, and potential employees of vendor/provider companies. The purpose is to create a place where companies and professionals can more easily find each other when looking for resources and work. If you are someone looking for work on the provider side, or looking to hire contractors or employees, you can join that group here.

As always, I’m open to suggestions about better ways to strengthen our community and provide resources and networking opportunities. Give me your feedback and let’s see how we can continue to build an “Opportunity Network” that helps us all!

(Image credit)

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More job cuts coming up at Sanofi U.S. – Chris Viehbacher, the new CEO of Sanofi-Aventis, isn’t a man to let the grass grow under his feet. Just two days in his new job, and Sanofi is cutting its U.S. sales force, Dow Jones Newswires reports…more (Update: the number is 10%)

Generic heart medicines: just as good as brand-name stuff? – Generic heart drugs work just as well as the brand-name treatments they mimic at a fraction of the cost, according to a new analysis that challenges why some people still have doubts about generics’ benefits after almost 25 years…more But, take a look at this fresh data on adding a CCB to standard treatment.

Novartis’ new malaria treatment looking good at the FDA – Swiss drugmaker Novartis AG’s widely-used malaria drug, Coartem, appears safe and effective in the treatment of malaria, a U.S. advisory panel overwhelmingly said on Wednesday…more

Was DTC advertising a mistake? – U.S.-style direct advertising to consumers has been a big mistake for the global drug industry, undermining the reputation of the sector in the eyes of patients, according to a top executive at Roche…more

The drug cost/benefit calculus in Britain – For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer…more

J&J to pay a billion for Mentor – Expansion is the theme here. The health care giant is snapping up Mentor, which sells silicone-filled breast implants (see the site) as it moves into the market for cosmetic and reconstructive medicines, even as the lousy economy raises questions about consumer willingness to pay for such things (J&J statement)…more

Will Pfizer turn it around? Some think yes. And, here’s some post-mortem learning from the torcetrabip (failed) trials.

Interesting and promising early results treating sickle cell pathology in the lab (using virus-aided gene therapy).

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If you’re looking to improve the “on-boarding” and “up-skilling” (don’t you love terms like that??) of your new sales trainers, Impactiviti can help! We’ve worked with one of our partners to come up with a multi-phase program – customizable to your needs, but with a lot of already-developed core content.

This Train-the-Trainer program runs from new trainer on-boarding, to advanced trainer training and pre-management.

  • Delivered in phases, in-house
  • Customizable
  • Performance consulting and effectiveness assessment
  • On-line and blended versions

Contact us here at Impactiviti (stevew at impactiviti dot com) to discuss!

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