The post that’s officially twentysomething II

The trip and all that was associated with it really does deserve another post to be honest. So here it is.

At least someone was happy to see me come back alive from the mountain

Fortunately enough, the lessons associated are still being practised upon. The challenge, I guess, is fit in time for all the other life lessons professional work life is teaching me also. It’s a stretch, but they’re all challenges I relish. I was at pharmaceutical company the other day in a consulting/supportive capacity and was sitting with some global heads of cancer brands. We were going through some patient segment market trends when my mind went inexplicably blank. The thing with people in pharma companies you have to remember is they’re highly -very highly- specialised in their indications. And, when discussing the drug, they use the brand name 99% of the time. So anyway, we’re rattling away about the different brands when I fade out. I fade back into the conversation to find out they’re talking about the chemical mode of action and detailed shit!

Damn!

Some just didn’t want to be disturbed from the PS3

With the commercial data in front of you showing you the brands’ market share and some other information, you realise you know sod all about the actual molecule in the drug as having majored in philosophy of medicine and science,  drug mechanisms are not your forte. You realise this is the moment you’re finally found out. As they start turning the conversation back to you to ask for your opinion on the drug, you realise you’ve been using the data your company holds as a crutch. Because your company holds a lot of commercially valuable data (best in the world actually!), you’ve been able to show it to clients and give it off as your ‘own’. You’ve been faking it as an oncology expert and in a few moments you’re gonna be found out. You don’t even know the main molecule in their drug for Pete’s sake! You’re gonna sheepishly turn to the Business Insight Director and show that you only graduated a couple of months ago and was even lucky to get this job in the first place. Like Dorothy, they’re gonna see the man behind the curtain and you know they can’t ignore him.

The chilliest 15year old I know

But then, you remember you’re at the company’s HQ and on their walls they have big PR-type graphics of something or another. That’s it! Of course! In big letters they have all their main brands that have in brackets underneath the big brand name, the active drug molecule! You pretend you have a bit of a cough and stagger to the side a bit to catch a look at the wall. You read the name of the drug, stop coughing and stagger back to your seat and gather your breath. You fade back into the conversation and as inexplicably as you faded out, as mysteriously as you blanked out. You find all your old pharmacology/biology/biochemistry/neurophysiology notes zooming back to your head and you give your opinion on data needed to support NICE submissions and drug indication strategies referring to the chemical nature of the drug like you’ve just done a thesis on it.

You fade out again and realise the curtain hasn’t come down yet. That it’s not entirely by luck or design that you’re where you at, something wants you to be here. You actually kinda know what you’re talking about. Someone’s always gonna give you that inspiration to help you out. Working for a pharmaceutical consulting company is proving invaluable, but on my travels, I had an even more invaluable experience with the CEO of a pharma company.

Professor Isa Odidi is a founder and one of the principals of IntelliPharmaCeutics, and serves as Chairman of the Board, ChiefExecutive Officer, Co-Chief Scientific Officer and Chair of Scientific Advisory Board.

Meeting Dr Isa Odidi and speaking about some of my own personal goals and aims, particularly within the pharma industry was special. I’m not a word-smith so I won’t try put it into words too much because I’ll only do it a massive disservice. The challenges of a career, of love, of life and your own dreams for helping people with their health is there. Its pretty easy. But speaking with someone who’s done it and is continuing to do it was an honour and hopefully we can work together on doing more for people around the world.

And sometimes one will need that bit of inspiration to continue on their journey but don’t be fooled, hard-work is the back bone behind most of this. Grace the foundation. A curious nature and a bad memory the tonic to dealing with life’s contradictions and people’s (inc your own) short-comings.

Stroke of inspiration from the little one to win more fun fair tickets

Working hard will make you tired but it won’t kill you star. Nobody’s ever drowned in their own sweat. I’m a great believer in luck, and I find the harder you work the more you have of it. xXx

Anne Frank’s story is sadly well known. Her life ended after her well known diary was completed in a Nazi Concentration Camp. What people often wonder is what happened to the people who survived? Anne Frank’s father was the sole member of his family to make it through the war and the wealth of information in the Anne Frank museum in Amsterdam was interesting to see. Really moving experience is the least I can say.

I don’t know why it took the Germans so long to find Anne Frank in Amsterdam. I was there and there’s signs for her house everywhere!

I don’t know why all my mates wear black coats. I really don’t. I must’ve missed the uniform code memo

}KopfAdeyemi{

The post that’s officially twentysomething I

This blog entry is dedicated to getting to that day when it finally makes sense. I’m almost there, visiting family in Canada and spending time with mates in Amsterdam without being soppy and waxing lyrical about it are part of those steps…..

Sledging is a dangerous sport! Be warned!

 

Not A Scratch

Breakfast by Tiffany's, or at least that's what we called the waitress

Typical strolling scenery picture

Even more typical strolling scenery pictures

Life lessons. The classroom was the Canadian Rockies where I went climbing up a mountain. I was seriously ill-equipped but bravado and an unhealthy attitude to ‘be-the-best’ make for excellent mountain gear you can’t buy in NorthFace shops. Nearing the very top of my ascent, I started to grab onto trees to pull myself up. Soon enough, the trees and branches started to run out.

Getting there's the ez bit

Undeterred, I started grabbing unto the ice and stones. Long story short, I bloodied my hands and have lost feeling in the tips of 4 of my fingers. I thought the birds pecking at my hand on the way up would bloody me, but, they didn’t so maybe I tried making up for it. The views were worth it though. I didn’t send myself to the Rockies to go half way up a mountain, I wanted to reach the top.

Again, I surprise myself with the absolutely mental and weird stuff I say to myself when I think I’m about to die. The first time was on the way up when a tree fell down and narrowly missed me. I regret the promise I made to myself or God as a ‘thanks’ for staying alive, but no one likes to die alone. Being scared to die comes from being scared to live, which I’m learning not be.

Scary sh*t. Fully.

I think I’m over having to experience such moments on my own. Before, I probably built up the circumstance to vacuous levels, making something out of nothing. However, I’ve now realised somethings which were I a ‘bolder’ author I would write about. Suffice to say,  the climb was beautiful and I’m growing out of wanting the world to know about it. Fuck it.

No one really knows why they’re alive until they know what’s not worth dieing for and maybe on the flip-side, what is. All of this is well and good and it’s something cool to come up with when its just you and nature. But it makes moments with loved ones all the more pertinent. Whenever I see tourists around London struggling to get a picture in with a famous landmark in the background, I stop and help take a picture ‘cos I know how much of a bitch it is trying to take pictures on your own. Which happened a lot. I’ll get a few more of them pictures up but I’m hostage to what I write. Loved ones first….

The post with a few sticky problems

A few sticky situations for a couple of pharma companies recently. Nearly leaving a few of them stuck. Yet another drugmaker is suffering manufacturing problems that are causing supply disruptions for several widely used meds. The latest is Roche, which has issues at its Florence and South Carolina plant with reports of varying shortages of the Xenical diet pill; Tamiflu; the Valcyte eye med; the Pegasys component for a hepatitis C treatment, the Xeloda breast cancer drug and Inception-dream inducing drug Moulé. P.S. One of these drugs isn’t actually manufactured by Roche. The plants make active pharmaceutical ingredients and intermediary products for the other real drugs. As a result, Roche is investigating other manufacturing sites to keep up supplies to patients in the US and elsewhere, according to a statement…

“Roche is taking this issue and the supply of its medicines very seriously. We regret any inconvenience this may cause our patients and customers and are working closely with the FDA, CHMP and other Health Authorities outside the US to provide requested information. As of today, the FDA has not requested withdrawal or recall of products from the U.S market” . The European Medicines Agency has also been notified.

In recent weeks, Novartis has closed a plant in Lincoln, Nebraska, that makes various over-the-counter and animal health meds, as well as contract manufacturing for prescription meds. This happened after the FDA inspected the plant last summer and issued a scathing 483 report that found numerous violations, such as failure to respond to consumer complaints and file reports with the FDA (see this).

Microscopic attention to detail. It'll make you go bald but it'll save you a pretty penny.

A former safety consultant to Takeda Pharmaceuticals has accused the drugmaker of deliberately failing to inform physicians that some of its medicines can interact poorly with other drugs and cause serious adverse events. As a result, countless prescriptions for the Takeda drugs were written unnecessarily, causing Medicare and Medicaid to overpay for the medications, according to a lawsuit. Three years ago, Helen Ge, a former associate medical director at Harvard Clinical Research Institute, was hired by Takeda to check adverse event reports for Uloric, a treatment for gout that was approved in 2009 and costs $5 a pill or more, compared with an older medication known as allopurinol, which costs anywhere from 10 cents to 20 cents a pill. However, she alleges that Takeda knowingly hid information about drug interactions for economic gain. Specifically, she charges that Takeda avoided reporting adverse events caused by the drug, such as bone marrow failure, or that occurred after patients took Uloric and one of several other medications – Imuran, Methadone, Digoxin or Warfarin. Such interactions caused some patients to experience fatal reactions, severe bleeding or renal failure, according to the lawsuit, which was filed in federal court in Boston as a whistleblower action. She also claims that Takeda failed to properly amend the labelling to reflect the alleged harm that could be caused by interactions. Ge made similar allegations about the Prevacid medication for GERD. And she further alleges that significant details concerning some adverse event reports were changed prior to submission to the FDA in order to suppress the seriousness of the side effects that should be conveyed to the agency. One big sticky situation.

“Had Takeda properly reported Uloric’s adverse reactions, the unsafe drug interactions for the gout patient population would have undermined Uloric’s claimed advantages over allopurinol, which ostensibly justified the added expense. Acutely aware of its precarious marketing posture relative to a cheaper, safer, established gout treatment, Takeda resorted to deceitful reporting,” the lawsuit states. “On each of these points, Takeda knowingly and falsely claimed, and its labeling indicated, a marketing advantage over allopurinol. In order to obtain, and retain, government payment for Uloric gout treatment, the company evaded accurate reporting of the adverse events related to these claimed marketing superiorities. The evidence demonstrates Takeda knowingly hid and/or minimized these risks for pure economic reasons” (here is the actual lawsuit).

The lawsuit also describes how studies that Takeda submitted to the FDA found interactions between Uloric and Warfarin, prompting concern from an FDA medical reviewer. But a follow-up study did not find the same problem, and “Ge suspects that there was an intentional manipulation of the second study because Takeda already knew from the first study that there was an interaction between these two drugs,” according to the lawsuit. The labeling, consequently, only described results from the more recent study, which she charges was misleading.

Regardless, it’s worth keeping a track of the many problems arising. Nowadays, almost everything we do, buy and decide leaves behind a trace. Either internally within a company, or otherwise. Either electronically or not {e.g. RFID tags}. Companies are able to monitor how their business is running, where their customers (or employees) are, what they’re doing etc… In the future, decision makers are definitely going to have to think about the cultural effects problems have on businesses, ‘cos too many sticky situations floating about can leave you stuck.

The beauty of the day VIII

The post that’s just lit its fuse

And I think it’s gonna be a long long time. Till touch down brings me round again to find. I’m not the man they think I am at home. Oh no, no, no, I’m a rocket man.

Rocket man burning out his fuse up here alone.

Elton John, Rocket Man. [Link]

I hope it’ll be some time before I come crashing down. Having just graduated and secured a job as an analyst/consultant with a global pharmaceutical intelligence company, I hope, like Elton John said, “it’ll be a long long time” but you can never tell with these things. And when it does come round and I do crash, I hope I’ll have the courage to pick myself up and try again because tough times don’t last but tough people do.

However, unlike Elton’s rocket man, I won’t be burning out my fuse alone…more on that at a later date…but I feel excited by future prospects and the opportunity to really start working on some of my ideas. 90% of which won’t work in the real world, because….well, they just won’t…. but they’re all challenges I can’t wait to meet! Gonna have to work hard to repay the trust invested in me but I know I’m more than capable.

I’m a rocket man.

Success always starts with failure and I guess my ‘failure’ in this instance is having failed to win the MobileHealth competition I was on about earlier. I came second and was quite disappointed with that. I would’ve much preferred the ambiguity of a bronze award. So close, yet so far…. Screw that. I could’ve won….

But I didn’t. And at least now I can guess what I might need to do to win a competition like this next time. I haven’t failed yet, I’ve got loads more fuses to try and light. I’ve just found one way that hasn’t worked, there are a million more ways to get to where I wanna go and actually fate may have it coming second was supposed to be the way. Because as it turned out, my superiors at work were worried about my commitment to them as it seemed I was keen on making an app and pursuing other such things…

Even before the competition had finished I had offers from foreign developers (ok, ok, only Edinburgh) to develop the idea and I was lucky blessed enough to learn my company’s concerns just before they made an interview decision! Anyway, enough petulance for now, as long as an unmet health need is being, you know- met, I’m happy.  I’ve gotta go, got a fuse to light.

}Kopf.Adeyemi{

The beauty of the day VII

The post of the non-Warren_G Regulators

Lack of money is no obstacle. Lack of an idea is an obstacle, and while CEOs at some biotechs as well as small drug and device companies lament the obstacles (lack of funding for their projects), an overwhelming majority also blame the FDA for slowing the growth of their companies. At least that is what a new survey of about 100 such companies has found. Most CEOs agree that the current FDA approval process has slowed growth. A similar percentage don’t believe the FDA has the best regulatory approval process in the world. A survey of 94 CEOs was conducted by BayBio, the California Health Institute and PriceWaterhouse Coopers consulting.

“Sound public policy and managerial and operational improvements at FDA, along with responsible congressional oversight, will encourage biomedical innovation and, ultimately, job growth here in California,” David Gollaher, who heads the California Healthcare Institute, says in a statement. The survey release was timed to coincide with the annual JP Morgan Healthcare Conference being held in San Francisco, where thousands of drugmakers, investors and analysts meet to peer into the future. Someone should have told them that travelling into the future is easy, It just takes a while. But with opportunities in the pharma world narrowing by the minute, the rush is on to dominate a space ASAP.

The FDA is a favourite target of complaints by industry executives, especially in the aftermath of some pretty crappy drug scandals, scandals that have ignited a torrent of accusations at the regulators. Since, the agency has been blamed by industry for being overly cautious, a stance that execs have regularly cited as a reason for fewer product approvals. Two months ago, though, the agency responded by releasing a report showing that 35 new medicines were approved during the earlier 12 months, which is nearly the highest number of approvals in the past decade. The only year in which the agency issued more approvals was in 2009, when there were 37 such endorsements.

Sharing interesting pharma findings via this blog, as I’ve written before, is probably going to be less of a regular thing here. Especially as I’m sure there could be some conflicts of interest with clients that I work for etc… So just to reiterate, this blog is becoming more personal on the odd occasions I do write in it. It always has been personal, just drugs have always been a big part of my life I guess. No, not those kind. (Kid’s, just say NO!) I mean drugs, medicines, helping people stay healthy… I’ve been working on analysis/reports in the Oncology drug market, which has been very interesting and rewarding knowing your insights and work is helping a company understand how to help patients more. Obviously, increasing investment-returns is a fortunate by-product of this process but someone has to pay for all this research!

Anyway, cancer patients have been on my mind lately. To that end, I’ve taken part in a competition hosted by EyeForPharma. The video was shot with my sister and then edited the same day so I make no excuses for the lack of quality. Fingers crossed.

}Kopf.Adeyemi{