The Cautionary Tale of Fenofibrate

Today's Managing Health Care Costs Indicator is $700 million 

Source. Click image to enlarge 

The Archives of Internal Medicine has an illuminating narrative today about how Abbott Pharmaceuticals managed to maintain effective brand name pricing for this questionably-effective lipid medication for over TEN YEARS after its patent expiry.   The authors had an earlier paper showing the striking different use of fenofibrate in Canada compared to the US  - which I linked to in 2011. The annual cost to health care consumers and purchasers: $700 million!

Abbott’s plan, called “a novel and especially clever approach” in the accompanying editorial:

1) Sue potential generic manufacturers for patent infringement. This netted Abbott 30 additional months without generic competition
2) During this 30 month window, Abbott filed for a new formulation – with a slightly different number of milligrams per pill. The drugmaker did no new studies to show clinical efficacy –but rather simply showing that the new formulation was equivalent to the older formulation
3) Before the generic came out – Abbott moved 97% of all patients off the drug that would be substitutable, and to the “new” drug for which a generic had not yet been approved.  

Although the new drug was equivalent to the old one, generics could not be substituted.

4) When a generic was just about to come out for the second formulation – voila – Abbott introduced a third formulation – again showing only equivalency to the old formulation, and again preventing generic substitution.   The company only convinced 96% of patients to switch to the new, equivalent, nonsubstitutable brand name medication this time.

During this time, large studies failed to show survival or cardiac benefit to treatment with fenofibrate, which nonetheless was aggressively marketed.  Rates of use of this medication continued to rise!

The authors suggest a number of solutions to this problem – which could have been addressed by better regulatory efforts, a mandate to allow substitution for equivalent drugs, or prescribing physician unwillingness to go along with this decade-long charade.  

H/T to Marilyn Mann for pointing out this article.

The Perils of Low Cost Medicine

Today’s Managing Health Care Costs Indicator is  128,000

I’ve often posted about “accretive innovation,” new medical technologies that cost a lot, and offer only a small portion of patients what is often only a tiny benefit.  I've talked less about the consequences of when prices are too low - which means we'll not obtain the potential societal benefits of a new drug. 

First, an example of accretive innovation.

In 2001, Xigris (human activated protein C, Lilly) was approved for use in severe sepsis based on a small study.   The drug was heavily marketed by Lilly – including hiring a PR firm and secretly funding an ethics task force which came up with guidelines that promoted Xigris use.  Subsequent studies showed that the drug was associated with a higher risk of brain bleeding and did not improve survival rates. The drug was withdrawn from the market last fall.  The result of all of this marketing is that a wildly expensive drug ($8000 per dose) gained high market acceptance; sales were $200 million per year. 

I’m reminded of the Xigris story by the New York Times last week, which reported that tranxemic acid, a dirt-cheap generic medication, could save up to 128,000 lives a year, 4000 of them in the US.

From the Times report:

For months, a simple generic drug has been saving lives on America’s battlefields by slowing the bleeding of even gravely wounded soldiers.

Even better, it is cheap. But its very inexpensiveness has slowed its entry into American emergency rooms, where it might save the lives of bleeding victims of car crashes, shootings and stabbings — up to 4,000 Americans a year, according to a recent study.

Because there is so little profit in it, the companies that make it do not champion it.   

This isn’t the first time we’re seeing the ugly side to drugs costing too little.  We have serious shortages of generic oncology medications and generic attention deficit disorder medications right now.  We need effective drug company marketing to bring pharmaceutical innovations to physicians – but disseminating knowledge about drugs is difficult if there is no one with a profit motive to do so.    

I was aghast at the FDA approval of brand name colchicine,  a drug that cost pennies, was well-accepted for gout and other indications, and which skyrocketed in price to over $5.    I felt rage when the Wall Street Journal reported that a pharmaceutical would charge $1500 for a previously-generic $20 progesterone injection to prevent premature deliveries.  But perhaps my anger is at least partially misdirected. 

It’s obvious that we can’t afford ridiculously high prices for drugs.  It's a bit less obvious but no less true that we need high enough prices for effective drugs that their makers will manufacture them and market them for appropriate use.