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Category: Drug Companies

Why Consumers aren’t Buying “High Cost-of-Developing Drugs” Argument

The Economist recently published an article on the government of India denying Novartis the patent for its cancer drug, Glivec (in the U.S. marketed as Gleevec).

In reading the reader comments, it is obvious that a sense of fairness violation was perceived by readers who felt that the government was correct in denying Novartis this patent, given that the readers perceived the company should have “made back its R&D losses” in developing this drug and beyond.
Image by Chris Holder
Pharma companies cite R&D development costs as well as the pitiful yield in its success rate in developing novel drugs as the reason why drugs cost so much. Thus patent is given as a way for companies to recover overall losses in this risk-intensive business as well as remain sustainable over the long term.

Yet companies are also known to go for patent extension strategies that do not represent truly novel contribution to market, by creating slightly different forms – or formulations of the drug – and then gaining patent on that slightly different form. Then companies use their sales and marketing arms to then keep patients on the “newer” (in patients’ mind, “better”?) version of the drug instead of the cheaper generic.

Those who argue for patent protection speaks about the risk and astronomical costs in bringing a drug to market. This is true, especially during human clinical trials, which consumers are rarely given the full picture of just how much “each patient” in a clinical trial actually costs the company to run the complete trial, especially when there is tremendous overhead in setting up these trials across different clinical settings within the country.

But consumers also perceive the unfairness of the pricing and when it comes to healthcare and medicine, emotions run high and it is common to conclude that pharma companies are greedy and being unfair given that they should have had already recuperated on their fixed costs and now they are using strategies to boost their bottom-line when they aren’t really investing in that drug (but they have to keep investing in their pipelines of drugs, many of which will fail, rendering huge losses to the companies).

Drug companies try, and its advocacy arm (PhRMA in the u.s.) tries, but the approach and message don’t seem effective. These messages are often very abstract and statistics-driven, which do not lend well to personalization. Statistics aren’t stories the average consumer can relate to.

Dream and Nightmare of Web-Scale Pharmacovigilance

I’m not going to tap into fear-mongering of why Microsoft is involved in the study that pulls adverse event (side effect) data from the internet, but I’m wondering what’s taken people so long to figure out the vast pool of patient experiences available online. Oh wait, those of us involved in industry know about this, only we don’t want to know about it.

There is at least one valid reason: you need to have a full picture of what is involved behind a side effect, to say with some level of confidence that your reported side effect experience came from the drug you said you took, not the other drugs you’re conveniently not saying you’re taking (especially the not-so-legal kind), or that you have a drinking habit (alcohol has major interactions with every drug under the sun), or that you’re taking 20 supplements you got from the nutritional store, and some prescription med you got off the internet by some shady doctor who asked you a few questions before writing you the Rx…

But reality check. Web-scale pharmacovigilance is here, and needs to be here, and should be leveraged conscientiously and systematically.

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Some years ago I gave a talk at a DTC conference in New Jersey about the patients’ voice when it comes to safety information. I am not in the business of web-based pharmacovigilance, nor did I set out to collect this information, but patients started sharing their personal experiences with an antidepressant on my mental health website. Yes, there are paroxetine/Paxil-related reports, but for the most part patients talk about bupropion/Wellbutrin, and over the span of many years there are hundreds of patient reports that are consistent in terms of their side effect experience.

This all started with one reader asking a question about a particular side effect of bupropion, and whether there were any published studies about a particular side effect. I’m sure there are scores of data from the manufacturer, but like much of drug data, these are kept “proprietary” with the ever-present “data on file” label on clinical slide presentations that the manufacturer supplies to a well-selected public (doctors).

Industry shouldn’t fear it or revile it: pharmacovigilance is critical for gathering drug information over time as part of safety monitoring, and the FDA sucks at making this an easy task for anyone with the desire to report adverse events with bureaucracy.

Read NYT’s take on web-scale adverse event reporting and drug safety monitoring.

Pharma Companies that Can’t Handle Comments Should Get Off Facebook, Good Riddance!

Jonathan at Dose of Digital talks about pharma’s fear of Facebook pages centering around 2 issues that pharma thinks require 24/7 monitoring: Adverse Events and negative publicity.

I hear the same excuse on why pharma companies are so scared to look at patient comments on blogs: adverse events.

I’m sorry, but adverse events are happening whether pharma companies are monitoring or not, and this is different from monitoring whether someone’s posting something “bad” about your company (newsflash: not everyone’s going to like you, better to expect it and have rules to address it than bury your head in the sand).


Adverse events are crucial for patient adherence and avoiding Facebook comments for fear of posts on AE is a missed opportunity for pharma to engage with patients in an issue that they all care about.

Patients expect drugs to work — rarely will patients want to get on a pharma page to thank the company for making a product that works. You may have a cancer patient who will do this if the company has gone above and beyond the call of duty to help the patient gain access to the drug that the patient otherwise cannot afford. But for the most part, patients have a “love-hate” relationship with pharma companies that is more “hate” than “love”, and I can’t blame patients for feeling this way.

What patients gripe about, and fear, and dread, are the adverse events.

Adverse events chip away a patient’s hope of getting better.

Adverse events erode a patient’s quality of life.

Adverse events make patients wonder, “would I rather stay ill, or deal with this horrible side effect?”

Then they look at companies avoiding discussion about something that is so key to their treatment experience, they naturally assume “profits before patients”. Never mind the realities of bureaucracy in adverse event reporting, I know it’s a bitch… the FDA knows it too.

That’s how pharma companies come across in their being so scared about Facebook.

Funny… I rarely recall pharma companies coming across scared when some of their sales and marketing teams find creative ways to fly under the radar to promote off-label. Somehow these companies are fine with breaking the law to “expand” usage of their drugs, but now they’re claiming they can’t deal with lack of guidance where Facebook pages are concerned.

Better companies pull their pages off Facebook if they are hard-headed about not allowing comments. Leave those who are more enlightened to get those patients’ eyeballs and possibly gain some goodwill.

Companies who want to control the message and behave hypocritically are doing the right thing by leaving Facebook: they aren’t adding value on the social network anyway.

Stop Pretending You Don’t Know, Pharma Companies!

I remembered years ago I was speaking to a Forest employee who told me how proud she was to be working at Forest because of how ethical the company and the CEO was.

That same employee was critical of me for talking to the WSJ about some of the less ethical practices that pharma companies have been using medical science liaisons – especially when all other quotes were positive – mine was the only one dealing with the abuse and misuse of the role. She felt that I should have used the media opportunity to “talk up” the profession.

I said that “talking up” the profession was what I’d done for all those years that I was running the MSL Institute. It’s time to “talk honestly” about what ails the profession so change can actually proceed.

I find what has happened with Forest Labs part of a lot of denial that some companies’ employees and executives experience when they see one thing but are told what they should be seeing.

If they oust the CEO, it will send a message to other CEOs at other pharma companies: “you’d better start hiring people underneath you who are capable of producing profit within the law, or you’ll pay for your bad hiring decisions.”

While it would be more poetically just to oust those who directly violated – firing the CEO is also part of the solution. The CEO’s job is to ensure that the people s/he has hired know how to create that ethical culture, not just talk a good talk but walking a different way when the feds aren’t watching.

After a while investors, who are always interested in protecting their investments, will catch on with the reality that golden parachutes are no longer a good deal.

Or is this too vicious of a cycle to ever catch up with the investors and the Street’s pocketbooks?

Pharma and Social Media: It’s Not About Controlling the Conversation, but Finding the Right Venues for Engagement

Now that Facebook Pages is to Marketing what LinkedIn Profiles is to Job Seeking – pharma companies are in pickle: Facebook is going to open up comments no matter what.

This means pharma companies can no longer restrict people from commenting on their Facebook pages.

Er…. DUH! Why is this big news? People get on Facebook to socialize – and not just to socialize – but to socialize in a mildly (or very) uninhibited manner. Facebook is MySpace done artfully and profitably, where we aren’t subjected to blinking starry page backgrounds or annoying music on auto-loop.

But remember why Facebook was created, and why Facebook has taken off with businesses – it is because when people are less inhibited, they are more suggestive, and more likely to click on links that businesses want them to click to buy stuff!

If businesses want stuffy and formal – there’s already a Facebook for that – it’s called LinkedIn.

I realize that it makes good sense for pharma to get its brands and company names out there. The problem is that when the public engages pharma, if they don’t ask about products, what would they want to engage pharma about?

[Assuming they aren’t interested in engaging pharma companies to ask, “why are you charging such high prices for drugs I need to save my life?”]

It’s akin to expecting a customer who drives a Toyota Corolla here in the U.S. not to engage the company Toyota to ask about the Corolla he drives. Unless that customer happens to work in an area that involves some business process, thereby predisposing the customer to want to ask about how Toyota “the company” works, customers often equate the company with the brands they use.

I understand that pharma industry supporters, including myself, would love if pharma can once again establish credibility with consumers by focusing on their support of disease state research and advancement.

Only another party’s already settled in that domain: they’re called physicians.

Physicians are typically seen as providers of support to patients in disease areas, from the consumer perspective. Let’s say I experience the symptoms of clinical depression – I’d naturally think, “I need to seek info from the doctors (once I learn more about this on the web)”.

I am not thinking, “I wonder what information GSK or Pfizer is providing in treating depression.” I’m not even thinking, “I wonder how Forest Laboratories or AstraZeneca are supporting R&D in depression relapse.”

But I may think in drug names, like, “I wonder if I should ask my doctor about Abilify, or Zoloft.”

[note: this would be an off-label use of Abilify, since Abilify is not approved for first-line use in treating depression, only as an adjunct to a first-line treatment if that treatment isn’t working as well as it should; it’s like a “boost”. But I use Abilify because I’ve been seeing so many ads on TV for it, and I honestly haven’t seen that Zoloft bouncy little ball in ages on TV.]

Thus there is first a cognitive hurdle that will not be easily passed. It is that diploma on the wall that garners the physician ‘credibility’, just as it is the commercial/business status that garners the pharma industry ‘lack of credibility’ when it comes to its participation as providers of information on the disease state, no matter how objective pharma tries to be.

In fact, even a recent survey of U.S. physicians had shown that they don’t want to pay for their own CMEs, yet they also won’t trust the CME content that is supported by pharma thereby making CME affordable (“free”) for them!

Logistically, the speed of Facebook and Twitter is exactly why Pharma should must hesitate.

People don’t go on FB/TW expecting a support-ticket time-frame (“slow”) response. They are on these platforms for just in time/immediate responses (“fast” “NOW!”). Otherwise, why bother? There are already online forums or patient info phone numbers for support-ticket speed “communication”.

It is not just about the platform, but the patient expectation that comes with the platform.

If you had ever engaged in a hashtag-driven Twitter chat, then you’d know how it’s next to impossible to follow every single conversation that comes at you in firehose fashion. Imagine then if there’s one or two patient complaints or problems amid the 20 other divergent discussions.

That’s what trying to retain “form” around a topical discussion may look like when Facebook comments are opened up for pharma.

[Lest any of us had forgotten – remember the “Motrin Mom” event, where a twitter indignation went viral and before the end of the weekend, the U.S. VP of Marketing at McNeil had to take that YouTube ad down? Try controlling THAT hashtag outbreak; I was there and saw how quickly it amplified.]

I’m 100% for increasing dialog between industry and consumers/public. Yet I think we can’t equate social media platforms the same, just as we can’t equate popular venues the same for medical education.

There are some social media platforms that are akin to a quiet, business like conference room.

Then there are social media platforms where people go for happy hour and unwind and engage in more personal conversations than business.

Then there are social media platforms where people go in expecting a brawl and in fact that’s why they showed up in the first place.

Pharma needs to identify these types of platforms and, rather than forcing or imposing artificial constraints by making everyone show up to a bar in a business suit.

The question Pharma needs to ask is, “is the purpose we intend to serve by showing up here feasibly achievable by the expectations of the crowd who will also show up?”

Would You Cancel a Surgery if Your Surgeon is Getting a Kick-Back?

The specific question is about getting kickbacks as a surgeon using a medical device, and was originally asked on Quora. The explanation to the question (posted by the asker) said,

“The department of justice has investigated conflicts of interest, and the Pittsburgh Post Gazette has published on the topic. To quote from the gazette:

Payments to other Pittsburgh area physicians include:
• The Orthopaedic Group of Pittsburgh received $75,000 to $100,000 this year from Smith & Nephew, and two of its doctors, Ari Pressman and Allan Tissenbaum, received individual fees. Smith & Nephew reported paying the same range of fees to Carnegie Mellon University, and to Carnegie Mellon professor Dr. Jeffrey O. Hollinger, a bone tissue regeneration expert.

• Biomet has a relationship with the University of Pittsburgh Medical Center’s Department of Orthopaedic Surgery, through Dr. Freddie H. Fu and Dr. Christopher Harner, paying $75,000 to $100,000.

• DePuy’s largest payment went to Dr. Lawrence Crossett, a UPMC surgeon who has received $250,000 to $275,000. On Dec. 6, he’s scheduled to perform two knee replacement surgeries, which will be broadcast over the Internet by DePuy and viewed by doctors.

• Zimmer, the largest of the joint manufacturers, paid out the most to Pittsburgh doctors, $1.16 million through Oct. 31.”

Regrettably, this is a relatively small fraction of the total physicians, giving the impression that most physicians have these conflicts of interest. Fortunately, the department of justice’s investigation has helped curtail these conflicts of interest. Having said that, if you discovered the night before your procedure that your surgeon has such a conflict, would you proceed with your surgical procedure or would you cancel it? Assume that the procedure is elective, not emergent.

I think there are various caveats to the question being asked, and perhaps, a different way of asking the question that can help the patient make better decisions about whether to stay with the surgeon or find another doctor:

Questions that came to my mind were:

  • Does the surgeon opt to cut when there is no clear benefit to surgery or when another therapy would give as good of a result?
  • Does the surgeon opt for one device over another device and is this decision based on a kickback or is it based on clinical data that suggests a benefit for the patient’s profile?
  • Is the surgeon an inventor or co-inventor of the device?*

Conflict of interest comes to light when surgeon has mostly a financial incentive to choose one device or another or to recommend surgery over nonsurgical alternative if there is no clear clinical benefit or if the recommendation introduces new side effects to the patient.

The last point that I marked with * warrants discussion because this is not so “clear cut” a conflict of interest as the first 2 bullets. In devices the physician may be an inventor or coinventor and then licenses the technology or device to a company.

Even though the physician may have a conflict of interest – by receiving royalty payments for example – the physician is also the best expert on the technology that s/he has invented, so the choice to go for one’s own device may have less to do with a kickback and more to do with the physician’s belief in the invention’s efficacy/benefit.

Here’s a link to an article a while back (and how I got the “mostly royalties” impression) from WSJ when device companies had to post what they’d paid to orthos – although the asker rightly pointed that that the medical device company engineers are probably the majority of inventors to the technology rather than the MDs themselves.

Yet there’s also the argument made by Andy Lemke on Quora (in the comments section) that a doctor who serves as consultants to several companies must know his/her stuff since s/he is so sought after by device companies, so it’s not necessarily going to hurt that physician’s integrity in the eyes of the patient.

Why I Chose NOT to be a Doctor

I was once a premed.

I chose not to become a doctor because I wasn’t truly interested in the profession, it was something I felt I “had” to do or “should” do because I happened to major in biology. And being a first generation Asian-American there was also pressure from being a “Tiger Cub”: we have limited career options: doctor, lawyer, engineer. I suck in math and was good in biology. Guess which option I had?

In my undergrad classes I was among other premeds; many of them went in for the Money, the Prestige, for their Parents. But they will all talk about how much they love helping people/patients on their applications.

I did consider taking the MCAT and even paid for one of those “prep courses”, in case I changed my mind. But I knew my grades weren’t good enough, I didn’t have “connections”, and I wasn’t going to throw good money after a bad risk, especially when that money was already borrowed money via student loans. I went to grad school instead.

Then I started working in the healthcare industry, first working for the pharma industry. Maybe the nature of my work in pharma predisposed me to witness the doctor-industry relationship in a way that brought out some of the unsavory traits of the medical profession.

I saw some of these doctors up close – their lives (and lack thereof), their values (and lack thereof), their character (and lack thereof), bedside manners (and lack thereof).

We are constantly reading about how “evil” the Pharmaceutical Industry is and how they corrupt doctors and so forth – that gets a lot of coverage in the presses. Well, I’ve seen it from the other side: there are doctors who have become savvier businessmen than they are savvy clinicians and they are perfectly capable of manipulating drug companies to fulfill their personal interests. I’ve had doctors asking me for favors that I knew had nothing to do with improving patient care. I’m not embarrassed to admit that my first year of working in industry had almost completely destroyed the trust I used to have in doctors.

I saw the state of Managed Care and the “healthcare business” that has made doctors more busy with administrative work than taking care of patients. A HMO doctor once explained to me that he goes through each day making sure he breaks even by seeing 50 patients. He knows how much $ he gets paid per patient from the HMO. So he has to see a certain # of patients to stay in business. Depending on the patient’s condition, say the patient has a cold, he’d spend a few seconds with the person, and knowing that the patient would expect “something” for the visit, the doctor would write a prescription for an antibiotic just to get that patient out of the office, so he could see the next patient.

The medical profession was not something I’d ever wanted for myself if I did not have a deep-rooted passion and conviction about going into the profession. In fact, the medical profession is one that I would not encourage my child to go into, unless again, he expresses a serious conviction about becoming a physician. I actually have to be careful about my own prejudices – that I do not vehemently discourage my child from considering this profession. That would be as bad as the Tiger Mothers who force their children into the medical profession.

I know this puts me in the “outlier” group of Asian mothers. But then again I’ve always been an outlier.

FDA Has to Slow Down to Keep Up with Drug Companies

Steve Woodruff is hopping mad with the apparent gross inefficiency and indecision of the “guidance process” for pharma company promotional practices when it comes to social media, and I can’t blame him!

But I’m on the FDA’s side this time.

Let me say up front that I never liked how the FDA remains vague and slow in the past, it sucked when I was a pharma employee trying to figure out just what the FDA “wants”, but the FDA had long acted like a tripped out lover who has something in mind but we’re supposed to guess or better yet – read his mind.

But today I am much more forgiving of the FDA than I am of pharma company management.

I was looking at a recent run down of 2010′s lawsuits settled by drug companies and to say that I’m disappointed with industry’s continual hypocrisy is a gross understatement.

It’s one thing when you can say that you’re working toward implementation of compliance practices. It’s another when you take one step forward and 3 steps back as an industry in something as “common sense” as “don’t mislead the public” (in every which way that can be done via old media/new media).

For so many years whether as employee or consultant, I have heard company management say “Patients are our #1 concern! People are our greatest asset! We want to do the right thing!” in public forums and company meetings. Then I look at the actions that are motivated by incentives and hidden rules at companies.

I’m not surprised why the government keeps ramping up its prosecution arm. I get that pharma changes are slow, but this looks almost as if pharma wants to test how slow it can change.

I’m not surprised the FDA has to “slow down to keep up”.

I have read some of the recent untitled warning letters sent to pharmacos, and the violative actions from pharmacos. HAVE YOU READ THESE? Look at the list growing from year to year. And how the SAME CITATIONS KEEP COMING UP, AGAIN AND AGAIN.

If I had to cull through the sheer amount of garbage that pharmacos continue to churn out as sales aid, my resources would come up short as well.

It’s like, pharma companies can’t learn!

It makes me want to say, “come on pharmaco people, you guys come armed with MBAs and doctorate degrees, you have teams of lawyers…. SERIOUSLY? THIS TYPE OF VIOLATION – STILL?”

Or more accurately, maybe they just don’t want to learn.

Maybe it’s still a game to see how much money you can make when you push the envelope and offset the profits with FDA imposed penalties and fines.

Even when you slapped with a huge lawsuit costing you hundreds of millions of dollars, well you can act like this is the stock market and say if you earned more revenue than lose it as a liability of “market fluctuation or market conditions” you’ll still come out on top.

Meanwhile, patients lose, healthcare loses, and pharma employees who actually want to do the right thing when earning their keep lose.

Big Pharma Shilling and WebMD.com MayoClinic.com Smack-Down

New York Times Online is likening WebMD’s “information” as “using the meretricious voice of a pharmaceutical rep”.

I don’t know… I never found WebMD’s interface “apparently attractive” but I suppose some people like all the flashy stuff. I mean, I find the ads on NakedMedicine.com mildly annoying, but these only go toward keeping the site alive and paying for the internet connection. If I had to start paying staff writers and “physician experts”, I can see how I may need to squeeze ads onto every available white space on a website.

The few times when I did look at WebMD there are so many different ads for so many different things (often unrelated to the topic on the page) that it’s no wonder WebMD brings in over $500M revenues a year. The only time I recall seeing an ad-free page on WebMD is on their “CME” topics… and I do wonder who is paying for those (and for how much!) to keep those pages ad-free. Someone’s paying for these.

But I personally like MayoClinic.com if only for the ease of getting at the information I was looking for without having to block a gazillion ads.

I think Ms. Heffernan is seeing more of the truth in the relationships between the members of the American Medical Association and the drug industry through what she sees on WebMD.com . Maybe in the doctors’ offices we get to see a sprinkling of drug “detail pieces” and miss the piles that are thrown away or hidden (I’ve always wondered why drug companies don’t just stop leaving these behind because they’re the biggest waste of trees). The real goodies are often hidden away – in the form of shadowy monetary compensation that the feds have caught up on.

After all, when you get a world famous oncologist bragging about how many thousands of dollars he can get drug companies to pay him “per patient” in a clinical study, what’s a drug company to do?

Johnson&Johnson: Don’t Just Cite Your Credo, APPLY IT.

When I used to consult in the pharma world, I notice that J&J employers love their company credo. It makes a deep impression on them. They believe truly that they’re joining a company that takes pride in their history and reputation. There’s this feeling of “pedigree” for being part of the Johnson & Johnson family.

But times have changed and I suppose companies too, and the people who run these companies have forgotten that credos don’t do much good as engraved paper weights and for recital purposes only. Credos are supposed to be applied.

http://www.nytimes.com/2011/01/16/business/16johnson-and-johnson.html

http://deniscollins.tumblr.com/post/2780912540/can-johnson-johnson-get-its-act-together

http://managementhelp.org/blogs/business-ethics/2011/01/16/jj-dig-deeper/

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