Do unto Patients what you would do unto You

That right there should be the guiding principle for policy makers !

One early April morning, my dad who resides in Kerala woke me up, quite distressed about not being able to source his anti-diabetic drug (Metformin combination) in Kodungaloor, Trichur & Cochin. He requested me to purchase it in Mumbai & courier it across. His blood sugar which was steady for long had started fluctuating again since his diabetologist started him on two new drugs/ brands instead of the combination brand he had been taking for 3 odd years. The fluctuating levels made him feel faint several times in a day even when he was eating well & taking the new drugs prescribed a fortnight ago.

That got me thinking. While the pharma industry was reeling under the Govt diktat of ban on 343 drug combinations, getting ready for a protracted legal battle after getting stays on the ban, both the Ministry of Health (MoH) & pharma really never thought about what the patients & doctors would have to go through. Without so much as a warning to both of them, drugs were banned leaving patients in the lurch and doctors having to bring blood glucose again under control which we all know really takes time. Endocrinologists have gone on record detailing the challenges being faced by them with this sudden-ness of ban. What if the MoH had cautioned doctors beforehand , atleast six months in advance, the doctors would have got time to inform the patients and start the titration process with them. That would have been so comfortable for the patients, don’t you think ?

Both pharma industry and the govt (MoH) have an acute challenge with being patient centric in their thinking & actions. The MoH did ban the drugs keeping patients safety at the core, but forgot about the same while planning their implementation. Patients will suffer interim challenges, in this case a possible hypoglycemic episode, so does the end justifies the means ? This looks so formulaic in light of the recent decisions of surgical nature, implementation hitches et al. But even the govt must know such surgical strikes cannot be carried out when its patient’s health is at stake.

Those in the know can argue most of the drug combinations that were banned belong to the respiratory, pain and antibiotic categories. But if any of the drugs were being used for a chronic condition such as persistent cough linked to asthma, or even acute conditions like migraine headaches, we know the relief is strictly associated with brand prescribed by the doctor & taken for a long time.

This also brings me to the last point - Did the brand heads/ marketing heads & BU heads pause and think how they would communicate about the possible ban & resultant unavailability to the patients via the doctor? Did they brain storm regarding how to address patients concerns in the interim period ? The answer is probably a big fat No. There would have been discussions galore & hours of man-hours spent on how to get a stay on the ban, Plan B to manage top line & bottom line if the inevitable happens, even what story to tell the doctors; but no thought spared for the patients who are left high & dry!

So the broad action point here for the industry in my opinion is : Let us move patient centricity out of the board room talk into the strategic framework for the company, not just the brands. This will ensure more pushback from the industry on patients behalf when strikes of this sort is orchestrated by the MoH. Action point for govt : Let’s educate the policy makers so they understand & include the patient impact when they frame policies. Above all lets educate the people so they are empowered to understand the situation & act in tandem with doctors instructions.

We owe this to our country ! And we as patients deserve this !

Two women leaders; Two diverse response to crisis !

Three stories in the recent past have caught my attention, all featuring female protagonists. 
The first being Theranos CEO Elizabeth Holmes, second - Mylan’s CEO, Heather Bresch and 
the third - Yahoo’s CEO, Marrisa Mayer.

Let me take the first two in this post since they are linked to Biopharma segment, hence closer 
home. Let me give you a background of both these companies & women leaders so you get to
understand their perspectives & decisions taken by them in light of the recent storms; which 
they continue to face till date. Elizabeth Holmes, a Stanford dropout founded the company Theranos in 2003. The promise of Theranos was a revolutionary technology that allowed 240 
blood tests to be conducted (cholesterol to cancer) with few drops of blood taken from a finger 
prick akin to routine blood monitoring of blood glucose done by patients with diabetes; a shotgun
approach to blood tests which rely on venous blood (blood drawn from the vein which can be painful for some people and cumbersome for many). Theranos was valued at $9 Bn dollar 
company when the controversy started in last quarter of 2015.  

Heather Bresch joined Mylan in 2002; in the capacity of a clerk at their factory. She rose to 
become the CEO of Mylan in 2014 and was named by Fortune magazine as one of the '50 most
powerful women in business' in 2014. Mylan acquired the rights to Epipen, the quick dose of 
Epinephrine used by people to stop allergic reactions in 2007. Epipen is the life saving constant companion of parents with children who have nut allergies or those who are allergic to bug 
bites. In 2007, the cost of Epipen was about $94 for two. Nine years later, it's above $600. 

Unsurprisingly, this inducted Mylan into the public rogue's gallery of "greedy" drug makers

(in the company of Valeant & Turing Pharma) who jacked up prices and more important, kept

life-saving treatments out of the hands of patients who need it. Profits over people, as slogan

goes.

With that background, lets get to where they are now !

Theranos has been banned from operating in the blood testing market for atleast two years & 

facing federal criminal investigation into whether it misled investors about its technology and 

company operations, Heather Bresch is facing intolerable amount of heat from the US Congress 

with both Republicans & Democrats baying for her blood.

Being a Pharma Nerd, I was/am  following both these stories avidly. I was keen to understand their response to the crisis since there were valuable lessons to be learnt here....

Lifeguards know a little secret that saves lives. When a current is dragging you to the sea, stop 
fighting it and start swimming parallel to the beach. The current will shift soon enough and you 
will reach the beach without drowning yourself. 

Mylan’s Heather Bresch handled the outrage towards her company’s pricing of Epipen in a 
similar manner. Rather than swim against the criticism, she started swimming along, hoping 
to change the narrative. As anyone who has sold a drug knows, there are many added cost a
and layersthat touch the product, wholesalers, distributors, pharmacy- benefit companies, 
retail pharmacies, etc. Bresch said the $608 price tag brings in $274 to Mylan. Rest goes to 
the middlemen.  She went on to say, instead of raising prices, she wishes she could lower prices, 
without risking the profits required to keep the Epipen in the market. “No one is more frustrated 
than me, Everyone should be frustrated" 

By turning the discussion towards the law makers, this may  seem risky, but in a political season 

when no one trusts politicians, it helped to reshape the narrative. Days later after raising its 
copay coupon system to cover $300 of people's out of pocket cost for Epipen, she went on to 
reveal plans for launch of generic version of Epipen at half the cost. Apart from the obvious
benefit of ensuring a larger market share for Mylan when the market opens up to more 
generic players, this move also crecreated a price barrier for these said generic players.

Shifting the attention to the second protagonist, Elizabeth Holmes, the self made billionaire 
who founded Theranos in 2003. Theranos wowed investors, journalists and even groups like
the Cleveland Clinic and Walgreens with what you might call an “iMedicine” vision of blood 
testing. Basically, the idea was this. A few drops of blood from a fingertip are collected into a
“nanotainer” collection tube and analyzed on the company’s proprietary machine, named
after famed inventor Thomas Edison. How exactly the Edison devices work is unknown. But
the claim was that many, possibly dozens of tests could be run on those few drops of blood.

Trouble started when Wall Street Journal did an exposé which alleged Theranos might actually 
be performing the majority of its tests using traditional machines, the kind already in use in 
labs across the country, instead of its own much touted Edison devices. And then the FDA 
called the nanotainer an “uncleared medical device.” In contrast to Heather Bresch’s approach 
to swim along and change the narrative, Holmes went out all guns blazing. The day the article
broke, Theranos issued a point by point rebuttal of WSJ allegations on its website. And later 
that evening, Holmes sat down for an interview on Mad Money. "First, they think you’re crazy,” 
she told Jim Cramer with her characteristic gravitas, “then they fight you, and then all of a 
sudden you change the world.” By promptly hitting the media circuit immediately afterwards,
Holmes showed he world she was “not backing down, not shying away.” She also issued a
statement accepting full responsibility for the issues at Theranos labs and undertaking 
comprehensive remedial actions. Theranos is now additionally facing federal investigations over
misleading investors and regulators about its technology and company operations. 

Recently, when Holmes was invited to deliver a 90 min talk at the American Association for 
Clinical Chemistry (AACC), instead of using the session to present scientific data in defence of 
her company’s proprietary blood- testing technology as it was expected to, she audaciously 
used her appearance tounveil a completely new machine, the MiniLab, which she said could 
enable small samples of blood to be analysed remotely using cloud computing. She continues 
her fight to keep the company afloat.

If Theranos indeed has the ground breaking technology they claim to possess, they will be able 
to tide this crisis over and Elizabeth’s spirited defence is a brilliant response but if her guts tells
her to do this knowing that its wrong, then it is entirely different story because peoples lives 
are on the line !

Two diverse response to crisis ; will both prove to be right in their own space ? Were they the 
most appropriate responses ?  Only time will tell. Meanwhile I will be closely following both 
these stories and updating it here. Watch this space : )

Source : WSJ, The Entrepreneur, The Scientific American

Diabetes Management Goes Digital !

Do you know the Worldwide estimate of Diabetes population is pegged at 400 million !! That's 5.4% of world population right there. If there is one disease segment that needs immediate digital intervention like never before, Diabetes is the one ! How amazing it would be if Diabetes can be managed without the daily jabs for monitoring glucose levels every day & injecting insulin for those dependent on Insulin for managing their glucose levels !

Eliminating these daily jabs is the holy grail of Diabetes management !! Thankfully many 
innovators across the globe have seen this need- gap & trained their guns to come up with revolutionary solutions in form of apps and devices to help people with Diabetes manage their challenge better & improve their Quality of Life !

Read on to know more ..

First up  ...

Pocket-sized gadget wonder called Dario !

A pocket sized gadget called Dario can be connected easily to a smart phone which makes recording and monitoring the blood sugar levels a breeze. What’s more , the smart phone can also give hypo alerts to near and dear ones with GPS location in case of an emergency. Talk about a pint sized warrior for diabetes management and you get Dario ! This innovation from Labstyle Innovations has received US FDA approval in Dec 2015

Food scanners

How cool would it be if by scanning your food, an app can tell how much carbohydrates, proteins, 
fats, calories and the glycemic load you have in your food along with many other features. Tellspec, 
a Canadian company has come up with a food scanner that just does that !

Digital Contact Lenses

Google has patented a digital contact lens through which we can get more information from the digital world plus it can measure blood glucose levels from tears as an added benefit. In 
partnership with Novartis, Google plans to develop these smart contact lenses that can track 
diabetes and fix farsightedness as well.

 

Bionic pancreas

Developed by the Engineers from Boston University, the Bionic Pancreas is a medical device that combines insulin delivery with glucose monitoring. The device can measure blood glucose levels constantly and decide upon the insulin delivery itself. No more daily jabs !!!!  I am sure patients with Insulin dependent diabetes would like a break from daily jabs : )

Wireless monitors

This is the holy grail of daily blood glucose testing and monitoring we are talking about ! Released by Abbott, Free Style Libre system uses a small sensor which automatically and continuously stores blood glucose readings day and night. Discreet glucose readings with a painless one second scan even through clothing. So goodbye to lancets and daily pricks to monitor blood glucose levels. 

R

Apart from above, there is some talk about Digital tattoos that can measure glucose levels by using electric current to attract glucose to the surface of the skin.

So we have seen a host of technology aided solutions which helps manage diabetes in a comfortableway. These are not available in India; but it wont be long before versions of the same reach Indian shores or we develop it with indigenous brains , customizing it to suit the needs of Indian patients. Along with the new drugs which include inhaled insulin and islet cell transplantation, my belief is the best is yet to come !!!!

Source : Marcia Radosevich, Berci Mesko, WSJ, Medical Futurist, US FDA site, PR newswire

One step forward... Two step backwards !!

Perfectly sums up the prevailing scenario in pharma industry !!!

We have an eager beaver government initiating several well meaning (?) measures only to be met by a scrappy belligerent industry spoiling for a fight, mostly in an individual capacity ! 

However weak the front we put up, it has forced the MoH from fully implementing some 

measures for the time being thereby blunting the impact. Take the ban on irrational combinations. 

It has lead to unprecedented chaos leading to the stockists and retailers attempting to dictate the 

market and more importantly, succeeding at it ! NPPA price cuts; Kokate committee calls for a 
big ban, Govt calls for doctors to prescribe only generic drugs.. One move announced by the GOI

& the industry stocks take a mighty tumble. So who is the loser ? 

Highly fragmented, much to the benefit of the ruling government, domestic pharmaceutical industry

has never had it so bad. If there was a time to present a united front,  it is now. 
But who will convey this precious piece of wisdom to the industry stalwarts who govern the bodies

like OPPI, IDMA, IPA et al ? Guess we, the concerned conscientious ringside view observers & affected parties should  do that ! The time to act is now .. 

I hope to do my part with this blog discussing the moves made by Industry and govt & its implications ;  A humble beginning no doubt .. tell me what’s your move champ ?