Archive for the ‘Ethics’ Category



Very big news for Vertex75% of hepatitis C patients never treated before achieved a viral cure after receiving a 12-week course of the company’s experimental drug telaprevir plus the current standard of care, according to results from a phase III studymore

Genzyme’s Pompe remedy approved by FDA; meanwhile, more detail on their consent decree.

More on alleged Wyeth tactics to promote Rapamune off-label. If true, yuck! Gold-in Rule at work.

Connecticut passes new pharma ethics code.

Part 2 of my interview over at MessagingLab blog (by Karl Schmieder): Pharma, Social Media, and the FDA.


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Social Media in Pharma stuff today: An “Ultimate Guide to Facebook“, from our friends over at Pixels and Pills. And, reporting adverse events on social media. More? Sure – comparing how pharma companies are using social media currently (from @healthcarengage). Even more? OK, you asked for it – Social Media and Celebrities in pharma (from John Mack’s blog)


Examples of Lightning Photography. Stunningly beautiful.


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Big approval news for Gilead Sciences Gilead Sciences Inc., the world’s largest maker of HIV treatments, won U.S. approval of an inhaled antibiotic for lung infections in cystic fibrosis patients. The Food and Drug Administration cleared sales of the medicine, given the brand name Cayston, the company said today in a statement. Outside advisers to the FDA backed the product’s safety and effectiveness in a 15-2 vote on Dec. 10more

What is the future of “personalized medicine”? Probably, it’ll look a lot like this (encouraging story from NY Times). Plus, in a cooperative effort, Eli Lilly, Merck and Pfizer have formed an independent, not-for-profit company Asian Cancer Research Group (ACRG) to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asiamore

Of course, in this industry, there is often a mix of good news and bad – and “bad” usually means bad behavior by people who love dollars above sense: lack of openness at AZ?; secret tapes and GSK (plus, a “fixer” who spiked research?); research fraud by rogue doc; kickbacks and J&J; risk of depression assessment and Eli Lilly (are you alive? then you’re at risk!!!). Reminds me of some prior posts on the Gold-in Rule

Novartis looking to expand even more at East Hanover campus. Including themed food venues!


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I’m feeling much safer now. FDA finally comes out against “ear candling“! Next up, perhaps – a prohibition of USB-to-nasal-passage uploads??


Delightful (and BIG) pictures from Vancouver Olympics. Love the colors in the very first one. From Boston.com’s very nice The Big Picture section.


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What should be the foundation of a pharma company’s business ethics – the Golden Rule or the Gold-in Rule? That’s the subject of my guest post on the healthcare blog KevinMD. And, lest any think I have unbalanced views, here’s a counter-balancing thought (for the record).

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Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.


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The big news this week is the scandal surrounding Eliot Spitzer, Democratic Governor of New York who has been caught in a pattern of gross hypocrisy.

Spitzer is hardly the first politician to be caught in a situation of moral compromise. But he is in a very awkward position – his entire public career was built on being the ethics enforcer. The prosecutor. The one going after the transgressions of the rich and powerful. Eliot Spitzer was all about fighting corruption. But, more than that, Spitzer managed to gain a reputation for ruthlessness, pettiness, selfish ambition and arrogance. Some of his moves as Attorney General – and as Governor – were highly questionable. And so, when someone like that is caught in hypocrisy, there is little chance of recovery. If the charges prove true, he’s done.

No person holding public office is flawless – in fact, everyone of us is rife with embarrassing flaws, weaknesses, and inconsistencies. Even good men and women stumble morally. But if Spitzer has been involved in prostitution, he is more than flawed – he’s a fraud.

(Fraud (n): a person who makes deceitful pretenses, practices trickery, betrays trust)

And there is a lesson here for the pharmaceutical industry, and any of us involved with it. Companies and people make mistakes. Errors occur, drugs sometimes show previously-unknown side effects, processes fail, flaws exist in all that we do. We can expect some level of understanding and forgiveness when we (as companies or individuals) have our flaws exposed – and we seek to rectify them. But when we can legitimately be accused of being a fraud, not merely flawed, then a whole new level of accountability is introduced.

It’s getting much harder to hide, folks. Digital cameras, electronic files, blogs…fraud is very difficult to conceal nowadays. Scrutiny and exposure can occur in nanoseconds. Pretty scary if you have something to hide!

I’ll never be any better than flawed. But I hope and pray that I won’t be a fraud.

[note: Eliot Spitzer has just resigned from office. Which was the only right and honorable thing to do. He sounded the right notes about taking responsibility, but he certainly took the legally “safe” road by not really admitting to anything specific except “private failings.”]

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The article starts out this way:

    I look at the pharmaceutical industry from a public-relations perspective and I see this: A business that has lost its heart and its soul.

Kevin is an editor and blogger over at O’Dwyer, a P.R. news firm. He goes on to describe the downward spiral of the reputation of “Big Pharma,” and the many events that have led up to this current state. Lots of factors have contributed to the battering of the reputation of the pharmaceutical industry, and many of them are self-inflicted wounds.

Spin control won’t restore heart and soul. At the risk of seeming overly simplistic or moralistic, let me suggest three very concrete perspectives that, if embraced and practiced, will make any company sturdy and respectable:

    1. There will be many choices to make between maximized short-term profits, and doing what you know is right. Err on the side of choosing the latter.
    2. Assume that everything you say and do will be exposed someday (this used to be called the fear of God. Now it seems to be the fear of blogs!)
    3. Admit when you’ve screwed up.

Nothing brilliant or original here. Just good old-fashioned honesty and the Golden Rule, applied to business. But that’s where you get reputational capital – not from fawning Wall Street analysts, or spinmeistering P.R. professionals. As long as companies (& individuals) choose short-term gain varnished over with cover-up du jour, the public floggings will continue.

Hat tip on P.R. article: PharmaGossip blog

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It Stinks Around Here

As I drove down our street this morning, to drop my son off at school, my nostrils were assaulted by the evidence that one of God’s creatures was compelled – by imminent threat or by rapidly-revolving Goodyears – to let loose a malodorous expression of its displeasure.

skunk.jpgEven now, as I sit in my home office typing, the air quality has one overriding, pungent aspect to it…

It stinks around here.

No matter how many other pleasant scents, sounds, and scenes are outside, all are temporarily obscured by an overpowering odor that none can ignore.

Which brings me to this industry in which I work, and for which I have affection and concern.

It stinks around here.

The many contributions of the pharmaceutical industry to our overall health and well-being would be difficult to enumerate. Life-changing medicines have fundamentally altered the way we live; and for many, have given or restored life itself. But when it comes to many of the commercialization strategies, I’m afraid that the industry has shot itself in the foot.

The sales rep arms race. Spending-for-influence among doctors. Biased study results. Questionable DTC practices. Patenting incremental changes. The list could go on and on, but here’s the question: Why?

Here’s the answer: Commercialization strategies focus on maximum volume at maximum profit.

Now there’s a careful line we must tread here. All business focuses – legitimately – on growing volume and profit. That’s business; and if you don’t like it, go off in the woods and join a commune somewhere. But what should be the goal of a pharmaceutical company?

Let me propose a simple series of 5 statements:

    The right medicine,
    for the right people,
    at/for the right time,
    used in the right way,
    for the right reasons.

Who can argue with this overarching goal? What would you propose as an alternative – the wrong medicine, for the wrong people, for the wrong reasons?

Actually, yes – when your commercial strategy is to grow at any cost, that is exactly what will happen.

How would this simple set of 5 statements change the way we do business?

Here’s an example. Erectile dysfunction is a real medical condition. Pfizer, with Viagra, brought it to public awareness. Competitors followed on. But now the market must be grown – somehow. So all of a sudden, the conversation is changed to erection quality, and statistics are generated to try to expand the notion of prevalency, and ads morph away from medical emphases to recreational themes.

Now, put all that next to the touchstone of the 5 statements, and it becomes clear why something stinks around here. We’ve sacrificed right use for volume. A company’s commercial strategy exposes its true values. And everyone can see what the emperor is wearing for an outfit.

Off-label promotion is a violation of the entire set of statements. Neurontin was originally approved for epilepsy. However, the folks at Parke-Davis (later acquired by Pfizer) promoted it for a whole range of other uses, such that about 90% of the prescription volume was for non-epilepsy cases. Doctors are, of course, free to prescribe off-label, but companies operate under black-and-white rules about promotion, and Pfizer eventually paid huge fines for the stench of this kind of marketing.

Much of the commercialization stink has arisen because of a drive to get new prescriptions. But if we look carefully at the idea of patients getting the right medicines at/for the right time, that should drive companies to put far more effort into patient compliance/adherence. For many patients, taking their medicines for the right amount of time – sometimes, the rest of their lives – is the critical piece, and huge numbers simply do not follow through and continue their prescriptions. Better strategies to address this major health concern (and incidentally, huge potential source of profit for drug companies) would go a long way toward creating more good-will and encouraging responsible use of pharmaceutical products.

We could go on and on but you can fill in the blanks yourself with many other examples. Many good people and good companies operate under the cloud of stench produced by this self-inflicted spray of misguided commercial strategy. It’s a shame that it stinks around here. But let’s not point fingers elsewhere to find the cause.

Here is the challenge I present: Will any company take these 5 statements, post them in their boardrooms and front lobbies, and actually conduct business by them? What a breath of fresh air that would be – for employees, healthcare professionals, and patients alike!

It’s pretty simple, really – if you love the gold more than the Golden Rule, you’ll stink. No P.R. strategy or cover-up will save you. You’ll invite government regulation like flies attracted to…well, dead skunks. Come to think of it, I’ve got to go close the window now…

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gold-sm.jpgGolden Rule #1treat others the way you’d wish to be treated

Golden Rule #2do what’s necessary to maximize my gold

Business ethics can seem complicated. Frankly, I think most of it boils to down to a pretty straightforward choice:

Do I do what’s right? Or do I do what is expedient to try to ensure maximum (income/profitability/bonus/stock price/etc.)?

What is right? That’s a debate that can draw in threads from theology, philosophy, psychology, and other disciplines, but let’s not over-complicate it. How would you want to be treated in a similar circumstance?

You’re working on the clinical research side of a pharmaceutical company, and a promising drug candidate starts to show some anomalous results. Some potentially dangerous side effects. Not a whole lot, mind you, and just a bit of tweaking and data-scrubbing could get it below the threshold of statistical significance. The company has been investing millions into this product, and the pipeline is a bit thin. Do you report it? Do you “work the numbers”? Do you ignore and cover over the warning signs? How does all this impact your job?

Wrong questions. How about this – would I give this drug to my child?

You’re promoting a diabetes product out in the field. Let’s say it’s Avandia. You get a direct question from a physician about cardiovascular side effects. Maybe he’s leaning toward transitioning some patients to Actos, or trying out Januvia. Your quota numbers, and your potential quarterly bonus, dance before your eyes. Do you answer the question directly and forthrightly, or do you shuffle and shift?

And here’s the baseline question – if you were not employed by GSK, and you had your choice of medicines…what would you want to have prescribed for you?

Which Golden Rule do you follow? Here are two simple tests: do you like what you see when you look yourself in the mirror? And how do you sleep at night?

One company that seems to embody this principle-centered approach to business is Johnson and Johnson. However imperfectly it is followed by any given individuals in the company, J&J’s one-page Credo is a marvelous example of how to flesh out the Golden Rule – Golden Rule #1, that is – in a business philosophy:

Our Credo

We believe our first responsibility is to the doctors, nurses and patients,
to mothers and fathers and all others who use our products and services.
In meeting their needs everything we do must be of high quality.
We must constantly strive to reduce our costs
in order to maintain reasonable prices.
Customers’ orders must be serviced promptly and accurately.
Our suppliers and distributors must have an opportunity
to make a fair profit.

We are responsible to our employees,
the men and women who work with us throughout the world.
Everyone must be considered as an individual.
We must respect their dignity and recognize their merit.
They must have a sense of security in their jobs.
Compensation must be fair and adequate,
and working conditions clean, orderly and safe.
We must be mindful of ways to help our employees fulfill
their family responsibilities.
Employees must feel free to make suggestions and complaints.
There must be equal opportunity for employment, development
and advancement for those qualified.
We must provide competent management,
and their actions must be just and ethical.

We are responsible to the communities in which we live and work
and to the world community as well.
We must be good citizens – support good works and charities
and bear our fair share of taxes.
We must encourage civic improvements and better health and education.
We must maintain in good order
the property we are privileged to use,
protecting the environment and natural resources.

Our final responsibility is to our stockholders.
Business must make a sound profit.
We must experiment with new ideas.
Research must be carried on, innovative programs developed
and mistakes paid for.
New equipment must be purchased, new facilities provided
and new products launched.
Reserves must be created to provide for adverse times.
When we operate according to these principles,
the stockholders should realize a fair return.

Sure, J&J companies and employees fail to live up to this standard of excellence and fair play every day. But that doesn’t mean that the standard is wrong. Only that, at any given time, individuals choose themselves above others.

What is the root cause of the parade of scandals we see in Pharma (and, for that matter, in plenty of other industries)? Most of the time, we need look no further than Golden Rule #2.

We moan and groan about Sarbanes-Oxley, OIG, regulatory meddling, whistleblowing, and all the other thorny features of rules and disclosures that address wrongdoing. But who is to blame? All those who lead their companies, their teams, and themselves by Golden Rule #2.

I’d love to see some pharma CEO take a stand squarely on Golden Rule #1 and drive it throughout the entire organization, come whatever may. The short-term disruption would pale compared to the long-term benefit.

A peaceful conscience and an intact reputation – priceless.

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20070713110344.jpgSo now we find out the details on how the Big Hormone Scare of 2002 was seriously overblown. Some voices were raised, at that time, about the flawed methodology used to draw those early conclusions from the Women’s Health Initiative, but they were effectively drowned out by the panicky stampede of newspaper ink jumping on the story of how something everybody thought was good for women – the use of hormones later in life – was suddenly bad.

We’re seeing a repeat of this process with the bash-Avandia bandwagon in the present day. It may indeed turn out that there are serious problems with Avandia – but then again, there are still open questions. None of that seems to give pause to the rush to judgment – particularly if it gives a chance to gain headlines, and bash Big Pharma.

Personally, I thought that the hammering of Tysabri a few years back, and its temporary withdrawal from the market, was a major mistake. But it was great fear-mongering and sold papers, so the knee-jerk crowd carried the day.

All this is to say that we need to cultivate some skepticism about this process. Taking slices of data and turning them into major crises may be great for journalists, but it’s not good for medicine. There are plenty of skeptics who have their guns perpetually aimed at this industry – people who figure that Michael Moore must ride a white horse, and that the only evil agenda is to be found within corporate boardrooms – but that is naive. We need to reject Kool-Aid drinking in either direction, and press for solid presentation of facts and honest analysis of data. Everyone – CEOs, doctors, bloggers, journalists, film-makers, regulators, authors, politicians – has an agenda. Maybe the most difficult discipline of all is keeping a cool head and waiting for the truth to sift out.

[Speaking of being skeptical, take a read of this article from a pro-pharma blog, DrugWonks. The premise is that sampling is good, because it gives access to newer medicines, and it quotes from a “study” purporting to show that there are longer life spans in states where there is better access to newer medicines. Here is the article referenced. I’m having a very difficult time swallowing the idea that this study has truly addressed all the relevant variables, and managed to pinpoint with such precision that better access to more-recently approved medications explains the life-span differential between states. Something about this whole premise does not pass the smell test.]

(Image credit)

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