More about generic drug shortages

Teva Pharmaceutical Industries agreed in May of this year to purchase Cephalon for $6.8 billion. Cephalon is best known for its blockbuster drug Provigil - FDA approved for treatment of narcolepsy but commonly used for treatment of Alzheimer's, and for (in theory) boosting the brain power of university professors and students.

Now why would Teva, a manufacturer of generic drugs, want to purchase Cephalon, a manufacturer of brand name pharmaceuticals?

Provigil had about $1.1 billion in annual sales, which are at risk once patent protection goes away next year. However, Cephalon spent about $4 million this year advertising Nuvigil, the next generation of Provigil, promoted for shift workers to alleviate their symptoms of fatigue at 4 o'clock in the morning. It is, of course patent protected.

So what Teva, a manufacturer of generic drugs, stand to gain from the purchase of this particular pharmaceutical company? $1.1 billion dollars per year in sales is nothing to sneeze at.

Then ask yourself why Teva stopped making doxorubicin, an inexpensive generic cancer drug which has been unavailable since early this year. Or why the company stopped making leucovorin, a form of folic acid essential for cancer chemotherapy with 5-FU. Leucovorin is also an inexpensive generic. There is a much more expensive brand name leucovorin called Fusilev which has been in plentiful supply all year.

It is curious that we have a plentiful supply of brand name patent protected drugs, and yet many generic inexpensive drugs are on back-order, some of them on indefinite back-order.

Do you wonder about drug shortages?

The cancer literature is full of articles about shortages of the older (and less expensive) cancer drugs. Outrage even hit the pages of the venerable New York Times in early August, in the form of an editorial by Ezekiel J. Emanuel, MD - an oncologist and professor of medical ethics starting at the University of Pennsylvania in September 2011.

Emanual writes: "Only about 10 percent of the shortages can be attributed to a lack of raw materials and essential ingredients to manufacture the drugs. Most shortages appear instead to be the consequence of corporate decisions to cease production, or interruptions in production caused by money or quality problems, which manufacturers do not appear to be in a rush to fix...You don’t have to be a cynical capitalist to see that the long-term solution is to make the production of generic cancer drugs more profitable. Most of Europe, where brand-name drugs are cheaper than in the United States, while generics are slightly more expensive, has no shortage of these cancer drugs. "

But it's not only cancer drugs that are in short supply.

Simple things like magnesium sulfate (used to lower the blood pressure in eclampsia of pregnancy), Vitamin C in the intravenous form (currently available only at 4 times the price of a year ago), and amino acid solutions (used in cancer patients who are unable to maintain protein intake) are also difficult, if not impossible, to find.

We have switched to Magnesium chloride instead of Magnesium sulfate, because the latter is on "indefinite backorder". And now our suppliers tell us that Magnesium chloride is also becoming more difficult to find.

Emanual notes in his editorial that the newer chemotherapeutic pharmaceutical drugs are in plentiful supply. They don't work very well - they only prolong life by a short time, unlike some of the older drugs which were actually curative. But they are available - for a very expensive price. And insurance covers them.

What is wrong with this picture?

Is it possible that the profit margin in low enough on the generics, and the older drugs, and the chemicals that pharmaceutical companies simply decide not to manufacture them any more?

Is it possible that the Federal Drug Administration has such close ties with the pharmaceutical industry that it is inspecting the manufacturers of generic drugs more diligently than manufacturers of newer drugs still under patent protection?

Is it possible that the pharmaceutical companies have purchased a controlling interest in any of the manufacturers of generic drugs, to get them out of the market? I do note that Hospira appears to belong to Sanofi-Aventis. I have not been able to track down similar information about any of the other companies.

I don't know that we will ever get answers to these questions. But I do find it very curious that for months now we have been able to obtain the pharmaceutical version of leucovorin (used in cancer chemotherapy) but the generic version (at 1/10 th the price) has been unavailable since the fall of 2010.

Something is definitely wrong here. The big question is whether the wrongness is simple incompetence or actually deliberate...

Pre-existing condition and no isurance available?

There are options finally.

For information about coverage in individual states, go to https://www.pcip.gov/StatePlans.html.

In Arizona, the following obtains:

Pre-Existing Condition Insurance Plan: Arizona

Eligible residents of Arizona can apply for coverage through the Pre-Existing Condition Insurance Plan program run by the U.S. Department of Health and Human Services.

To qualify for coverage:
• You must be a citizen or national of the United States or lawfully present in the United States.
• You must have been uninsured for at least the last six months before you apply.
• You must have a pre-existing condition or have been denied coverage because of your health condition.

PCIP covers a broad range of health benefits, including primary and specialty care, hospital care, and prescription drugs. All covered benefits are available for you, even if it’s to treat a preexisting condition.

Please note rates have changed as of July 1, 2011. The monthly premiums for the State of Arizona are:

Age Standard Option Extended Option HSA Option
0 to 18 $104 $141 $109
19 to 34 $157 $211 $163
35 to 44 $188 $253 $195
45 to 54 $240 $324 $250
55+ $334 $450 $347

In addition to your monthly premium, you will pay other costs.

In 2011, you will pay a $1,000 to $3,000 deductible, which varies by your plan option, for covered medical benefits (except for preventive services) before the plan starts to pay. A plan option may have a separate drug deductible. After you pay the deductible, you will pay a $25 copayment for doctor visits, $4 to $40 for most prescription drugs, and 20% of the costs of any other covered benefits you get. Your out-of-pocket costs cannot be more than $5,950 per year. These costs may be higher, if you go outside the plan’s network.