The Continuing Saga of Drug Shortages

Another day, another drug shortage:

Shortage of critical TB, lung infection drug worries patient, doctor

Note that drug in question, ethambutol, is sold by Valeant Canada. Valeant is also the manufacturer of Delatestryl, one of only two brands of IM Testosterone available in Canada, and one that has been subject to several shortages, including two last year. The reason for shortage is “Delay caused by the manufacturing site transfer” — a change in location of where it is made in Canada. Efficient as always, Valeant!

Last week, DAILY VICE released an interesting (and alarming) video featuring Dr. Jacalyn Duffin, a doctor who has been raising red flags on prescription drug shortages in Canada since 2010. Dr. Duffin runs CanadaDrugShortage.com, a website dedicated to tracking the problem in Canada. From the website’s home page:

1. Why does Canada not start making the missing generic drugs for itself and others?
2. Why is the pharmaceutical industry divided into two warring factions–brand-name (called research) and generic?
3. Why doesn’t Canada show some international leadership in measuring the impact and extent of this problem and in finding solutions?
4. Why does Canada not have an Essential Medicines list as recommended by WHO and our own federal Standing Committee on Health?

In the video, Dr. Duffin notes that the growing problem of drug shortages was known to both patients and physicians as early as 2010 but that there has been very little governmental policy development since that time. She goes on to say that 75% of doctors hypothesized Big Pharma manipulation as the root of the problem by 2011.

When asked about the drug shortage I was facing in 2011-2012, my doctor told me that drug shortages were “orchestrated to drive up pricing.” Case in point: Due to a Pfizer shortage at the end of 2008, I switched from Pfizer Depo to Delatestryl. In 2010, the price of Delatestryl doubled in Canada, from $60 CAD to just over $120 for a 10ml vial of 200mg/ml. (Compare to two vials of 10ml Pfizer Testosterone Cypionate 100mg/ml, currently available for just over $70.) During the 2011-2012 shortage, the cost of Pfizer increased to between $80-90 for the same amount of the drug. Pricing went down again after the shortage. (See: Transition Expenses)

Watch the video now: VICE Meets Dr. Jackie Duffin

vicevid

(I submitted my story to Dr. Duffin’s website in 2012, which is addressed at 9:15 when hormone replacement drug shortages facing trans people are discussed. There’s another story from 2014 of a Delatestryl shortage on Dr. Duffin’s website here.)

“The causes are behind a curtain that no one wants to lift… In a country like ours, with all our resources, and all our creativity, and that we have this problem and that we’re putting up with it, I want to find out why.” — Dr. Duffin


If you have followed my blog for a while, you’ll remember that I’ve written about testosterone shortages in the past:

Canada’s Testosterone Shortages
Jan 15, 2012
When I was considering testosterone therapy and weighing my options, one thing I felt sure of was that because testosterone is a common medication for men — not a “transsexual drug” — I wouldn’t be subjected to shortages. This was naive. In the 3 years and 9 months of being on testosterone, I’ve experienced not one testosterone shortage, but four. Testosterone shortages seem to be quite common here in Canada.

Testosterone Shortage Update: Sandoz Suspending Production
Feb 20, 2012
We can now safely assume that Sandoz testosterone will remain unavailable for some time: Sandoz Canada announced Sunday it was temporarily suspending production at its Boucherville, Que., facility.

Testosterone Shortage Update: ETAs, Alternatives and Causes
Feb 28, 2012
An update on the current intramuscular (IM) testosterone shortage affecting both Valeant and Pfizer brands.

Since that time, I’ve continued to track news stories about how the Canadian government is addressing—or not addressing!—the problem of drug shortages:

Aglukkaq calls out Sandoz on drug shortage
Mar 13, 2012
A stern letter written by Health Minister Leona Aglukkaq to Sandoz Canada about its “lack of transparency” isn’t good enough, according to the NDP, which will propose a motion in Parliament Wednesday that aims to prevent another worrying drug shortage.

NDP drug shortage motion gets government’s support
Mar 14, 2012
The House of Commons unanimously supported a motion from the NDP on Wednesday that would require drug companies to report any planned production disruptions to Health Canada. Conservative MPs, including Prime Minister Stephen Harper, sided with the NDP and the Liberals when the non-binding motion was put to a vote Wednesday.

Plan needed to fight drug shortages, journals argue
Aug 20, 2012
Ottawa needs to take the lead in formulating a national plan to manage Canada’s prescription drug supply and deal with ongoing unpredictable medication shortages, argues an editorial jointly published Monday in two medical journals. As with most countries worldwide, Canada has been experiencing shortages of many critical medications, among them chemotherapy drugs, antibiotics, anesthetics and pain killers.

Voluntary drug-shortage reporting adopted despite concerns
Health Canada bureaucrats worried of ‘bad company behaviour’ by drug makers
Dec 27, 2012
The federal health minister opted to let drug makers voluntarily alert doctors and pharmacists of medication shortages despite concerns from her own department that the approach could put Canada’s drug supply at risk, documents show.

Drug shortages worsening as Health Canada starts study to address it
Health Canada starting 6-week consultation on how to avoid pharmaceutical shortages
May 26, 2014
The president of the Canadian Medical Association says the problem of drug shortages is becoming more and more common. Dr. Louis Hugo Francescutti says doctors are raising the problem with him every time he travels across the country as president of the CMA. And they all want to know why the problem is getting worse.

Drug makers to be required to post info on shortages
Doctors have criticized voluntary system of posting information
Feb 10, 2015
The Canadian government has announced it will make it mandatory for pharmaceutical companies to post public notices when drugs are not available. Currently, posting notices to a website about drug shortages is voluntary. For months, doctors and patients have complained the approach is not working, and people are not able to get the medication they need.

And here’s an interesting article about one of the causes of drug shortages in the U.S.:

‘Fake pharmacies’ tied to drug shortages in United States
Mar 21, 2012
U.S. lawmakers are investigating three pharmacies in Maryland and North Carolina accused of passing critical drugs in short supply directly to wholesalers, who are likely to profit from the scarcity of life-saving medicines, rather than to the patients that need them. The probe in October sought to discover why certain companies were peddling cancer drugs at more than a hundred times their normal cost [emphasis added], while hospitals and patients were scrambling to receive any. The findings illuminate gaps in the patchwork of state legislation that governs this sometimes shady network of pharmaceutical distribution known as the “grey market.”

Because money is surely at the root of drug shortages, I’ve also tracked articles that discuss the booming Testosterone industry. This one in particular caught my attention, from the New York Times:

A Push to Sell Testosterone Gels Troubles Doctors
Oct 15, 2013

Aging, insecurity and the $2 billion testosterone industry

Aging, insecurity and the $2 billion testosterone industry

Sales of prescription testosterone gels that are absorbed through the skin generated over $2 billion in American sales last year, a number that is expected to more than double by 2017. Abbott Laboratories — which owned AbbVie until Jan. 1 — spent $80 million advertising its version, AndroGel, last year.

“The market for testosterone gels evolved because there is an appetite among men and because there is advertising,” said Dr. Joel Finkelstein, an associate professor at Harvard Medical School who is studying male hormone changes with aging. “The problem is that no one has proved that it works and we don’t know the risks.”

Nevertheless, many insurers cover the cost of the high-priced hormone treatments, requiring only a small co-payment from patients. AndroGel and another popular testosterone gel, Axiron, by Eli Lilly & Company, sell for more than $500 a month retail, and about $400 with pharmacy coupons.

Such advertising also leads patients to seek out more expensive treatments, rather than cheaper ones that are often equally effective. [emphasis added] Drugs that are advertised are almost always the ones that are costly.

The puzzling FDA approval of Aveed last June also got me thinking: at almost $900/injection, Aveed certainly represents a more profitable form of IM Testosterone compared to the standard T. cypionate and T. enanthate formulations, which ring in at about $8-14/injection. Does the introduction of Aveed put us on a path to limited access to Testosterone for those without insurance or the means to pay? Even worse, is it the first step of the phasing out of affordable Testosterone in the U.S.? (Aveed is the U.S. brand name for the long-acting testosterone formulation known in other parts of the world as Nebido. Nowhere else does it cost as much as it does in the U.S.)

Now, concurrent to this boom in Testosterone profits, I’m also seeing troubling signs of limited access to the cheaper IM Testosterone in the form of anecdotal reports from trans men, including:

  • Intermittent shortages around the U.S., including the popular Strohecker’s Pharmacy which in the past has been a rock star of reliability in providing T.
  • Some pharmacies and(/or?) insurance companies in the U.S. have been putting 28 or 30 day blocks on re-orders of IM Testosterone.
  • Inability to locate vials of T larger than 1ml in the U.S. Some brands of 10ml vials have been on backorder in the States for over 6 months.
  • Some insurance companies in the U.S. no longer covering 10ml vials, only 1ml vials.
  • Bayer Spain has suspended production of Nebido: “The Ministry of Health has forced it to lower its price by 35%… and now considers that it is no longer ‘profitable’.” A petition on this issue started by a trans man in Spain has acquired almost 65,000 signatures. A German company warned that price revisions made by the Spanish Ministry of Health “could jeopardize the situation of Nebido in Europe because the price of medicines in some markets becomes a reference price for other countries.” (Note: While Aveed and Nebido are the same drug, licensed by the same company, Nebido has been drastically less expensive in the EU compared to the cost of Aveed in the U.S.: less than $200 USD vs. almost $900 USD for a single Aveed injection.)
  • While not verified, I’ve heard from trans men in Texas who were recently told that injections must now be performed at a doctor’s office or approved clinic.

The result of these limitations to access is inconvenience. But I don’t mean that lightly: the inability to acquire medications like Testosterone for all men, trans and cis gender, has serious health repercussions. And while I’ve focused my blogging on the drug shortage that has affected me, Testosterone, please note that people from around the world have died as a result of shortages of drugs ranging from cancer to HIV medications. Drug shortages have reached global epidemic proportions.

What’s a Trans Guy to Do?

Have no fear, Big Pharma’s got your back, brother! With persistent IM T. shortages, the convenient option, according to drug manufacturers, is to switch to one of the more expensive preparations, like AndroGel, Nasonex or Aveed. They’ve planned well for this, haven’t they? I hope you have insurance!

Meanwhile, there’s no end in sight for the intermittent Testosterone shortages in North America. Valeant had two shortages of Delatestryl in Canada last year, and several U.S. brands continue to be unavailable. (Mexico has also faced testosterone shortages, including a 6 month back order on Sustanon in 2011.)

Resources:

Have you been affected by a Testosterone shortage? Please share your story in the comments below!


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