"Duck, Duck, Doom" - When Big Pharma Decides Who Among Us Is Worthy Of Saving

"When a pharmaceutical company decides who among us is worthy, and who among us is not, we are no longer living in an ethical, moral society.  We are playing duck, duck, doom.  I pray no one dies."

These are the heart-felt words of Joanna, a 50-year-old Californian woman who faces death within a few short weeks if the drug that she takes to keep her alive is not released from FDA-sanctioned recall, and/or offered to patients by the drugmaker through a "special use" program (at the patients' risk).

The troubles began early last month when Japanese drug-maker Takeda Pharmaceutical pulled Natpara, which was
approved four years ago to treat hypoparathyroidism - a rare endocrine disorder that can lead to heart failure and death.

Takeda recalled the product after learning rubber particles may clog needles in multi-dose cartridges that deliver the solution. However, Takeda did not indicate why the rubber particles were suddenly appearing or how long the problem may last.

Meanwhile, as Statnews.com reports, the FDA upped the ante earlier this month by giving the recall a Class 1
designation, which is reserved for products that may cause serious injury or death

This requires patients to return all products, although the regulator has offered no information about the extent of the problem, confusing patients and physicians.

The move by Takeda and the FDA has left about 2,700 patients without alternatives - the possibility of a painful death awaits absent the recombinant human protein that has no alternative.

For an adult facing excruciating pain and death within weeks, one might have thought that it would be their decision whether to take the risk of using the recalled drug - but between the FDA's 'rules' and the drugmaker's plans, that opportunity is not available to the suffering patients (some of which have a few weeks supply stored).

Notably, the supply interruption comes even as Takeda was reportedly looking to sell the drug as a way to improve its balance sheet after its $58 billion buyout of Shire last year. The deal was opposed by many investors because of the debt Takeda had to take on to make the buy.

But now there is hope, as Statnews.com reports, a group of lawmakers including Bernie Sanders, are pushing the FDA to resolve the shortages of the life-saving medicine immediately, noting that the European Medicines Agency has not taken any such recall action.

“Patients across the country have already been hospitalized due to an inability to get Natpara, and we fear that as more patients run out of Natpara, the number of avoidable hospitalizations — or worse — may increase,” the letter says.

As the letter notes, to appease anxious patients, the company created a temporary “special use” program in which anyone facing a life-threatening situation could use cartridges to administer single doses. But only a tiny fraction of patients - as few as 1% - are qualifying for the program... Joanna is among those who did not, despite the most egregious circumstances:

"Last February I went off Natpara, under doctor's orders, to check my PTH levels with the miraculous hope that perhaps I was making my own.  Two days later, while at the lab, tetany came on fast and furious and within minutes I could not move, talk or process.  911, Ambulance, ER visit...you know the rest.  This is me off Natpara, so without hesitation, and without my own PTH, I went back on Natpara while still in the ER.  Life Saving.

Two months ago, I passed out while watching the sunset with my husband.  He is a surgeon and could not find my pulse for 5 seconds.  I was out twice for a total of 15 minutes.  I have no memory of this episode.  I am currently undergoing cardiac testing, and we all think this episode was calcium related."

Joanna continues:

"Despite these episodes, and the risk my doctor, an Endocrine Specialist, feels I am under if I stop Natpara, Takeda denied his SUP request."

So just how 'sick' does Takeda think its potential 'special use' patients should be to be deemed worthy of receiving the life-saving (but FDA-recalled) medicine?

Between the questionable ethics and potential disturbingly profit-driven actions of the drug-maker and the over-arching nanny-state control of the FDA, it is little wonder that those on the margin, those who need more than others, are losing faith in the American way.

As Joanna concludes in her letter,

"I feel the defeat, depression and hopelessness that many of you have also felt with a rejected request for our life saving medicine.  I feel that this recall has been handled irresponsibly, unethically, and inhumanely.  I am needing a timeline, communication, some humanity, and accountability."

So the next time you hear about big pharma's soaring prices or globally disassociative pricing mechanisms (i.e. charge what we can, where we can, as there's a sucker - insurer - born everyday, somewhere), consider for a moment the other levers that are pulled by drugmakers to restrict supply and potentially drive up demand, and the integrated risk that an over-bearing government bureaucracy builds on controlling how we as adults get to decide our own healthcare needs.

While Facebook CEO Zuckerberg discusses the end of freedom speech, it appears that in the 'Land of the Free', the freedom to make a well-informed, risk-reward-balanced decision about one's healthcare should be a given - after all - according to all 12 of the Democratic candidates on stage this week, healthcare is a right (a right that apparently is only accessible on their terms).

But one thing is for sure...while Bernie Sanders backing this pressure on Takeda is indeed admirable and may well save the lives of Joanna and many others, more centrally-planned medicare-for-all decision-making is not the solution (taking more decisions out of the hands of patients, instead of giving them back control of their own bodies).

Joanna summed it up perfectly:

"When a pharmaceutical company decides who among us is worthy, and who among us is not, we are no longer living in an ethical, moral society.  We are playing duck, duck, doom.  I pray no one dies."

"duck, duck, doom" indeed!

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More details on the Natpara can be found here.