Partnerships with CROs Wrap-up

Day 2 of the Partnerships meeting in Orlando is over and while there is a day 3 tomorrow, I go home in the morning.  I was lucky enough to be on two panels discussing clinical trials in emerging markets.  Here are my highlights.

Day 1 - The morning was all pre-conference workshops so the mass of conference attendees were not evident yet.  My panel of 4 experts on the emerging regions - Mark Lanfear, Julie Margules, Nagaraja Srivatsan and me - gave a 4 hour workshop in the morning with maybe 45 people in attendance, many of whom stayed for the whole 4 hour period.  We divided up the world by regions and shared some of our experiences.  Good discussion ensued.  The session was blogged by Keith Russell, link here.  Lunch was a meeting of the Partnerships Emerging Markets Advisory Board.

In the afternoon there were some additional sessions of contracts, RFPs, and phase 1 study design concerns, followed by the keynote speaker Ethan Zohn and a reception in the exhibit hall, lots of networking.

Day 2 - The keynote speakers were Dr Jack Dean, chairman of Partnerships and then Sen. Tom Daschle who gave an excellent talk about the policy points of Health Care Reform.  He summarizes the debate in language refreshingly devoid of political heat )although I may not be unbiased as I supported the need for health care and insurance reform and thought the resulting law does not go far as it should).  He said the key points of the debate were/are: 1. the role of government; 2. the complexity of a $2.5 trillion problem; and 3. the size and nature of the pie - how big will it be, and how big will be the slice that goes to each party? Daschle then described the solution - or at least as defined by the new law - as threefold:  insurance reform, payment reform and access reform.  Of the three, the insurance component has the most detail in the new law, phasing in a series of reforms in two year increments until 2018.  Many of the most needed elements come in this year: no exclusions for pre-existing conditions in children, no recisions, no lifetime or annual limits, a small business tax credit, and rebates for seniors caught in the Rx drug gap in Medicare.  Payment and delivery reforms have less detail, but they are intended to shift the reward from volume to value, incentivize wellness, end fee for service, encourage electronic medical records (1 out of every $5 spent in health care goes to administration, paper records), encourage the use of best practices and evidence based medicine.

In the afternoon I attended a talk by Michael Marcarelli of the FDA.  He was refreshingly engaging and disarming about the business of compliance monitoring and reminded us all about the sponsor's responsibility to provide oversight for and service providers, including providing training for investigators and CROs.  He made an odd anachronistic comment when answering a question near the end when he noted with apparent surprise that so many site monitors these days do not have medical degrees, and 'sometimes they (sponsors) even send Gal Friday to monitor'.  I don't know where he has been all this time, but the industry realized literally decades ago that CRAs/monitors need not be medically qualified and even then most monitors in this country were nurses, never doctors.  And the 'Gal Friday' comment was plain offensive.

Finally it was our turn again and this time my two colleagues - Larry Fiori and Graciela Racaro - and I shared a relatively brief 45 minutes sharing what are the different considerations when doing studies in the global space, particularly the newer countries.  This session was blogged by Foreign Exchange Translations, here.

Questions

A former GCP student sent me this question today:  "Can you tell me if it is OK for a principal investigator to have his signature Xeroxed onto the ICF for the subject to sign?  This doesn’t seem appropriate to me, but I am having trouble finding anything that says otherwise.  Also, can they sign the ICF in advance of the subject signature, or should it always be after the subject consents to be in the study."

Every class term starts with my passionate admonishment that GCP is more than just knowing the rules, in fact knowing the rules is only a small part of the task.  To understand the rules, we have to think through why those rules exist.  Reading this students' question gave me an unsettling feeling that I am not being very effective at getting this point across.

Whether there is or is not a regulation about pre-signing informed consent forms, whether in ink or by photocopying, stamping, or smoke signals, is entirely beside the point.  The point is not the signature at all.   The point is what the signature represents.  (*Extra credit: is the investigator's signature even required under US regulations?)  My students have all been taught that the signature represents that the investigator's obligations to the patient with respect to the nature of the study, risks and discomforts, alternative treatments, right to withdraw and all the other elements of consent have been met.  Therefore, of course it is unacceptable to pre-sign the form, Xerox a signature onto the form or whatever else this investigator has thought up.



*Answer: No, only the patient's (21CFR 50.27(a)). Under ICH guidelines the consent should be signed by the patient and by the person who conducted the informed consent discussion (ICH E6 4.8.8).

New Year, New Challenges

The new year has hit the ground running hard and many colleagues are just trying to hang on. The good news is that though we are still in the midst of some hard times, we are starting to see an upturn in movement of money, new clinical programs under development, and jobs. Enrollment is up in the UC Santa Cruz certificate programs where I have taught for the last 10 years and in honer of the winter term just getting underway, I posted a picture from my most recent trip to India of a woman walking her children to the school bus in Bangalore.

The conference season is in full swing. I just came back from the Indian Society for Clinical Research's excellent 3rd annual national conference at the Hotel Leela Kempinski in Bangalore. Attended by 500 participants from all over India and beyond, the conference featured many of the most influential people in the Indian clinical research field as well as many young CRAs and project managers, and it was a fantastic opportunity to listen and learn from the people who know the region best.

This week I will be attending and presenting at Outsourcing in Clinical Trials West Coast in San Francisco, on the topic of Offshoring to Emerging Countries: Navigating Uncertain Waters. I gave a similar talk last week as an advance for the Partnerships in Clinical Trials event to be held in Orlando in April. I'm told a podcast of last week's talk is forthcoming and I will make it available to anyone who contacts me for it. This week I am also presenting in a webinar entitled Biotech and the Global Marketplace for the US Commercial Service. My task is to discuss clinical trials in emerging markets and opportunities for US biotech companies to enter into co-development projects with sister companies in these regions.

My partner and I were recently featured in a blog post over at goBalto.com about the Indian clinical trial market- see it here.

I receive regular updates from Audrey Erbes, who is a faculty colleague of mine at UC Santa Cruz extension and teaches in the biosciences certificate program. I took her 2 day course on business development and highly recommend it. Here is her excellent blog where she freely shares huge amounts of information from her network including job postings with students and colleagues alike. Highly worth subscribing to in your reader.

2010 represents my 30th year in the clinical research field. Next year I will have to rename my blog to '3 Decades, Full Stop'.

Pfizer, Drug Pricing, Conflict of Interest

The photo was taken last December in New Dehli.

Lately this blog has been beating up on Pfizer, here and here. They are big, they can take it. Here is some more. Fierce Pharma today links to a Telegraph report covering Pfizer CEO Jeffrey Kindler's rehabilitation tour, first last week in the UK and now in the US. This year Pfizer has not once but twice made huge court settlements: one for the Trovan case discussed previously, and the other for $2.3 Bn to settle the ongoing investigation of its off-label marketing practices, the largest settlement of its kind, in the same month that Lilly settled its Zyprexa woes for $1.4 Bn. Like those television preachers who, after getting caught with their hands in the till - or worse, quickly come back on stage with a tearful repentance speech and then start lecturing everybody on how they should behave, now we have the spectacle of one of the largest drug companies telling us all that we should follow the rules - or else.

And it is the 'or else' that matters here. We don't need to spend much time adjusting our expectations of Pfizer or its kind. Kindler makes clear in his remarks the real motivation behind all this soul-searching: change or face increased regulation. Kindler is not the only one worried about this. Merck's chief exec was on the stump about this very same issue last spring. At least he is on to something that would actually improve big pharma's image as well as improving people lives, and that is pricing. Drugs cost too much in this country, even after factoring in the high development costs and low ROI. Nearly every other major government and quite a few minor ones control drug prices, but not the US. People on fixed incomes have to decide whether they are going to buy their medicines or pay the heating bill. That should not be. Apparently Congress thinks so too, but do they think so enough to do something about it?

The Pharmalot blog seems to have relevant content a lot of the time. Today they link to a new report out from Seton Hall University on managing conflict of interest in clinical trials. Some of the report's suggestions seem unwieldy, such as not allowing payment for screening activities - who will bear those costs if not the sponsor? And what incentive will investigators have to find patients for trials, a task that has become increasingly difficult in this country? If you go to this link, be sure to note the comments section at the bottom.

And if you've made it this far, how about a little shameless self-promotion? I will be presenting at this meeting Partnerships in Clinical Trials in Orlando, April 2010. Hope to see you there!

Fall Term Catchup

The picture is of the Capitola, California beach on a beautiful fall day last week, the last warm day before temperatures dropped. The fall term is nearly over (yay) and my inbox is stuffed with items I've been marking to blog but somehow never found the time. So here is a whole bunch of them in one go.

First up: a nice piece on direct-to-consumer advertising from Slate. My students know I love to take off on big pharma's fatal attraction for DTC advertising and how it can be directly linked to the problems of Merck's Vioxx. While the Slate writer makes a nice, facile point with his analogy of running shoe ads, there is still a fine line between educating and developing the marketplace versus creating one out of whole cloth.

This piece from MicroArray blog points out an issue that I see within the scope of Anhvita, and that is the propensity of trained monitoring staff within India to 'job jump'. This is creating a work force with great breadth but insufficient depth, and is also contributing to a loss of continuity for sponsors which could directly and adversely effect safety reporting, among other things. We need to create a cultural shift that encourages professional staff to develop all their skills, instead of leaping to the next attractive salary and perks package.

Here is an update to an item I posted a while back about the Pfizer-Trovan-Nigeria case. In case you thought justice was imminent after the US 2nd Circuit Court of Appeals' decision last summer to let the case finally be heard in the US courts and Pfizer's subsequent $75M settlement - think again. Pfizer did indeed fund the settlement, all but $30M of which is going to line lawyers' and Nigerian government officials' pockets, but they also appealed the decision to the Supreme Court. The Supremes have asked the Obama Justice department to render its legal opinion, so we may see a ruling this term. Meanwhile, Pfizer is continuing its one-company crusade to lose the hearts and minds of the prescription-buying public - who is not inclined to cut the pharma industry a break in the best of times - by requiring victims in the case to submit DNA in order to receive compensation. It's all here. One of the salient facts of the case is that there were no medical records left behind from the two week study conducted at Kano in 1996, so it isn't immediately clear exactly what the DNA samples are supposed to be compared to. If the whole thing is not a ploy to avoid paying out compensation to the victims, then Pfizer certainly seems comfortable with giving that very impression.

And speaking of fall days, this one is over. More next time.

Farewell, Joey

This blog has at times attempted to be quite high-minded and instructive, other times more introspective. Today it is going to become sentimental in an adolescent way because today I am going to mourn the loss of my cat, Joey, pictured here about 7 years ago.

This picture does not really do him justice. His fur was a beautiful, soft, shiny silver that caught the light like water. He had long legs and a small head like a cheetah, and though he was at least 14 years old, he looked as beautiful the last time I saw him as he does in this picture, and indeed the first day.

Joey was not really meant to be mine. The first time I saw him he was running down the street at top speed with his ears laid back, with two neighborhood dogs hot on his heels. The dogs didn't catch him, they almost never do, and the cat disappeared into a hedge. I saw him again a couple of days later; he was on our front porch peering in our window and meowing at the top of his lungs. After a day or two of this I was a goner. I wanted to put food out for him but I knew that would be delaying the inevitable, and I told Rob as much. We already had two cats that I had before we were married. It was early enough in our marriage that Rob probably had a hard time saying no to me. He has since got past that.

With what seemed to be Rob's blessing I brought the cat inside. He had a cut over his eye and his paw pads were bloody from his high speed chases on the asphalt. We cleaned him up, fed him, and took him to the vet to make sure he didn't introduce any new feline diseases to the population. He slept for two days straight.

At first things seemed to go well. He looked like another silver cat I used to have named Chloe, so Rob named him Joey. Joey was about a year old when we took him in and very playful. Rob used to entertain both himself and Joey for hours poking his finger out from under the sofa blanket or seat cushions. The cat was endlessly fascinated with this game, which we called blanket thing.

Joey was fearless, often tempting fate in a way most cats are too cautious to try. We had an older cat named Ben who had developed some curmudgeonly tendencies by this time, and didn't cotton much to the younger cat crowd, preferring to sit in meatloaf position on the sofa with his eyes half-closed. Joey used to take a bead on a dozing Ben from across the room, run across at top speed and do a drive-by pounce on Ben, making at least 3 passes each time. The first pass he would get away with the sneak attack, but by the second Ben was ready and he would deliver a perfectly timed blow to Joey's head just as he came into striking range that would send the younger cat reeling. Just to make sure it was not a fluke, Joey would make one more run at Ben, get sent packing, and call it a day.

Joey was also the most friendly and curious cat toward dogs I've ever known. He always wanted to engage them, surprising since he first came to me because he was running away from dogs. Once he greeted a friend's dog who had come visiting. A skirmish ensued and the next thing I knew we were picking silver fur out of the dog's teeth.

Joey was an easy cat to live with in many ways - clean, low maintenance, no vet bills - except one important one: he developed a habit of marking the belongings of people he liked, and since he liked almost everyone, there was a lot of marking. No one was spared, although I seemed to get tagged the least, and nothing we did seemed to discourage him, despite seeking advice from every source we could find, knowledgeable and otherwise. Over time Rob developed a deep loathing of Joey which he attributed to the marking problem, but the visceral, almost pre-verbal nature of his animosity for this very small animal seemed to me disproportionate to the crime. Many, many times I offered to find another home for Joey but Rob wouldn't take me up on it, insisting for some reason to put up with it. It became one of our rare points of contention, the kind of issue that can be a pressure valve in a marriage: you bicker about these little things to let off steam from daily life.

As Rob's animosity increased, Joey found himself restricted to smaller and smaller sections of the house. Recently he spent most of his time in my office curled up on my desk chair. Whenever I worked at my desk he jumped onto my lap and settled there, purring and gently working his paws. I was the only one who showed Joey any affection at all, yet as though he remembered all those games of blanket thing, Joey never stopped trying to get Rob to pet him or play with him, which of course did not happen.

Earlier this week we noticed that no one had seen Joey for at least a day. We looked everywhere, in all the closets and under all the beds. Joey was nowhere to be found. The only thing we could think of was that the door was left open when Rob was bringing stuff in from the car and Joey got out while I was at work. An indoor cat with a curious nature, an open door had always presented a flight opportunity and we were usually careful. But on that day, not careful enough. Since then I've looked around the neighborhood for him, waiting for the dogs to chase him down the street, but he is gone. It looks like Rob got his wish.

I am sad that it ended this way. It hurts to think of him out there alone, frightened and hungry, his beautiful soft fur matted and dirty. I hope someone has taken him in as I did all those years ago and that he is sitting on her lap right now, purring softly and working his paws.

Home

A blogger called Jung At Heart that I follow with some regularity did a post on home this week that got me thinking abut what defines home. (No I don't knit, but a couple of my blogger friends do.) I am still on summer break from teaching and need to start thinking about my curriculum for the fall classes. But since I have nothing relevant to post on clinical research ethics or the like, I will muse for a bit on the idea of home.


In our house, my husband and I have tried to establish a no-shoes policy. We have a large basket near the front door for shoes. The policy hasn't seemed to take hold for a variety of reasons: my feet are usually cold, so I keep them covered; Rob takes his shoes off and deposits them under the living room table - within clear view of the shoe basket - approximately 4 seconds before he hikes his feet up on the sofa. Our kids mostly leave theirs on because we rarely enforce the no-shoe rule.

Near the end of last term, I had a little gathering at my house for some of my students, most of whom come from India. Each of them left their shoes on my front porch as they stepped inside, just as they would do in their own homes.





A couple of months ago I was in Bangalore working with my business partner. I stayed in a lovely apartment that she provided. When I arrived and she went into this apartment with me, we kept our shoes on. As I settled in by myself after she left, I put my shoes by the door, like most Indian households do. When in Rome, and so on. A few hours later when my partner came back to collect me for dinner, she walked in and without the slightest pause, ditched her shoes by the door where mine were. I interpreted this to mean that this space was now, at least for the next few days, home to me, and she treated it as my home instead of an unoccupied space.

My Jungian blogging friend posted the following questions as a springboard to understand the definition of home. Let's see what we can learn, shall we?



Where is home for you?

These days my definition of home has expanded beyond a physical space and a building, and I find I feel much more at home within myself as I get older. Having said that, home is very much the space I share with my husband.




What is the difference between home and house for you?

When I was a child my parents loved to go house-hunting and to look at model homes. I hated this. I couldn't see the point of looking at a house that no one lived in. The difference between a house and a home was whether or not someone lived there, and more to the point, whether or not I lived there. Not only was I not interested, it scared me to look at houses. I was always afraid we would move into one of them, and none of them was home.


Are you at home now?

Indeed yes.



Have you always felt at home?




I have often felt not at home even in my own home, usually having to do with who else I might have been sharing my home with. Recently we converted one of our bedrooms into a music room - fresh paint on the walls, brought in all the various instruments from various parts of the house, set up the electronic keyboard that I use for a piano (which I bought specifically because it has a true piano-like action to the keyboard). This opened up a room that I had previously not stepped into for several years, and gave me access to a little bit more of my house.



What makes a place a home for you?

I think it must have less to do with the physical space itself and more to do with my state of mind, and who lives in it with me. I lived entirely alone for maybe 16 years of my adult life, usually in smallish apartments, places I generally felt at home. Having my stuff in the home helps - my pictures, books, animals - but I don't necessarily have to make all the choices about how the house looks. For instance, for the music room above, Rob chose the color on his own pretty much sight unseen by me. The same thing when we had the exterior painted last year; he chose the color, which was a different tone than we had before. While I actually preferred the older color, I didn't prefer it enough to make myself part of the decision making process.

How has where you lived impacted you?

I lived for the first 20 months in an orphanage. I lived with other relatives for about 18 months when I was 5-6. In my childhood through college I lived in 10 different houses; as an adult or well over three quarters of my life, only another 5. I would say that where I have lived as a child has impacted most substantially my choices of where and how I live as an adult.

Do you think you can go home again?

No. I think you move on from each home and there is only forward movement, never backward.



How did you find your home?

We went house-hunting - which I still hate - on a Sunday afternoon. When we walked into the house we now own, which was I think the second one we saw that day, Rob said this is the one. We made the offer the next day and had it accepted by the end of that week. It has three 60 foot tall liquid amber trees in the front yard, hardwood floors, and lots of windows. I dislike dark rooms. We are hip-deep in fallen leaves every November and December. The house is small, only 1500 square feet. But we have great weather. My friend Mary says that's why we pay prices this high for houses this small.

What is your ideal home?

A little less cluttered than my homes tend to me, especially living with cave-bear Rob.