What’s New is the World of (Legal) Drugs?

The Big Pharma Shuffle—Yet Again

Over the years, large pharmaceutical companies (Big Pharma) have purchased (in friendly or unfriendly takeovers) smaller pharmaceutical companies (Less Big Pharma) that had popular and profitable drugs on the market. Pfizer (Big, Big Pharma) has been very good at this. Since Pfizer’s Viagra will no longer be patent protected after 2020, Big Pfizer needed a new superstar drug. Viagra has been one of the most profitable drugs ever. Teva Pharmaceuticals will produce a generic version of Viagra starting in 2017 (just thought you’d want to know that).

Enter Xtandi (enzalutamide), Medivation’s successful and very expensive late stage prostate cancer hormone treatment. Pfizer was willing to pay $14 Billion for the company and Medivation was willing to take it. The transaction is in process. When approved, Pfizer will simply write a check with a lot of zeros on it. Earlier this year Pfizer received FDA approval for an advanced breast cancer drug called Ibrance. With the merger Pfizer will immediately become a major player in oncology. Pfizer explains it all in a very comprehensive Press Release.

In the Big Pharma world, big companies get bigger and smaller companies disappear. Fewer companies own more drugs and have more control over drug costs. This is good for corporate profits but might not be so good for us consumers in the long run. Just sayin.’

Drug Price Increases

Massive drug price increases have been in the news recently—Epi-Pen and Albuterol and Embrel and Humira are well-known brands that come to mind. Many other drug prices have risen steadily but often by smaller percentages several times a year and they don’t attract as much attention.

Generic drug makers are just as likely to hike prices as the brand names. It’s just that the generic drugs often start out at much lower prices and the increases are not always as obvious. People complain, they contact Congress, they flood social media, threaten to boycott the drug (which hurts the patient), and the result of all this is: nothing changes. 

Drug Companies (AKA Big Pharma) do just fine. Having a monopoly on a necessary or life-saving drug makes for a good business plan for any pharmaceutical company.

Truth in Reporting

I have at least two connections to this article that may keep me from being totally unbiased. First of all, I used Xtandi for several months when my previous medication (abiraterone/Zytiga) became less effective. My short experience with Xtandi was unsuccessful. In just a couple of months my PSA skyrocketed and I moved on to chemotherapy. So, no matter how expensive it was it didn’t work for me. Bummer. And second, I have a close relative who works for Pfizer.

Big Pharma, expensive drugs, corporate mergers, and the customers will pay the price. Nothing changes under the sun. Except that everything under the sun becomes more expensive.

axman

My 2016 Prostate Cancer Predictions

...and a few musings.
After 13 years of "Adventures in Prostate Cancer," I believe I have earned the right to make a few predictions--sometimes tongue-in-cheek. And even if I don't have the right, here goes.

Q-1. Will there be a cure or partial cure for prostate cancer or any other cancer in 2016?
A-1. Very unlikely. Very complicated. And it probably has nothing to do with the astronomical profits from cancer treatment medications.

Q-2. Will new and more effective prostate cancer meds be approved by the FDA in 2016?
A-2. Yes and No! The FDA will probably approve a drug or two (the YES part). And NO, the new drugs will not likely be more effective than the current selection. This leaves room for even more drugs in 2017.
But it's a good bet they will be more expensive in 2016 (unless you can buy them in almost any other country).

Q-3. Am I really as jaded and skeptical as I sound in these first two predictions?
A-3. Again, Yes and No! Yes, it seems that in many ways cancer treatment is just another big business. Costs, treatments, and medications are prohibitively expensive and out of reach for many cancer patients who do not possess the needed resources. Big numbers trump (not that trump) individuals. No, my personal experience has included excellent medical care from doctors and nurses I consider friends. I believe they are looking out for my best interests (in spite of the fact that I am a "problem" patient). I have never had to go without the best treatments currently available.

In my head, I'm still a cup-half-full kind of guy. I believe that the increasingly serious side effects I am experiencing can be managed. I've undergone procedures I never knew existed--and there are more to go.

I'll post a step by step explanation of all my newest adventures in the new year.

axman

Generic Drug Prices Run AMOK!

And you probably thought you could still afford those ‘cheap’ generic drugs…

You may have noticed recent increases in generic drug prices. More than 85% of all prescriptions are for generic drugs. What is a generic drug? According to the FDA, generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, quality, performance characteristics and intended use. And they have always been much cheaper than brand name drugs.

Truthfully, I had not paid much attention to this, although I saw some of the reports. But when it hit close to home… I have used a generic prescription ointment to treat my eczema. In October 2014 the retail cost of my prescription was about $47, and with my copay I paid much less. In January 2015 when I went to refill the prescription, I was told the retail price was now $500! That’s a 1,000% increase.

So I was off to Google to find out what’s going on. No problem—there were hundreds of articles, surveys, editorials and even an inquiry by The House Committee on Oversight & Government Reform, (created in 1816). You know we’re in good hands when you hear, “We’re from the government and we’re here to help you.”

Reports in The New York Times and an article in Slate Magazine titled Drug Bust, laid out some of the sad facts. It seems that in the past couple of years, many generic drugs have increased in price by 1,000%, 5,000%, or even 8,000%! 

Why, pray tell, is this happening? It seems there are several reasons, sort of. There have been shortages of some generic drugs and that always pushes prices up. With generic drugs the research and development costs have long since been recovered. I’m thinking that greed, a good thing according to Gordon Gekko, may also be a factor. But that’s just a cynical guess on my part.

Many common and necessary drugs are included in the long list of large price jumps. In addition to the 1,000% increase in my clobetasol, other increases include:

Digoxin, used since 1785, for heart failure and irregular heartbeat, has increased in price by 884%.

Albuterol Sulfate, used to treat asthma, has increased in price by more than 4,000%.

Pravastatin Sodium, used to control high cholesterol, has increased in price by more than 500%.

Doxycycline Hyclate, an antibiotic, has increased in price by more than 8,000%! There are many, many more examples.

What are the implications for consumers (like all of us)?

1 Individuals without drug coverage will be (and are) paying higher and higher prices for these formerly ‘cheap’ drugs. Some people will be priced out of even getting their prescriptions—not a good situation.

2 While the copays may still be small (mine, for example, is $8 for tier one meds) the insurance companies must now pay for the huge increase in generic drug costs. For those of us who have insurance and drug coverage, our copays and premiums are bound to go up and there will likely be higher insurance costs for all consumers.

3 There are no indications that the trend of rising generic drug prices will end soon.

Bottom Line

Your guess is as good as mine and I haven’t heard of any plan to resolve the situation. This is a serious situation that could have a major health impact on all of us.

axman

What’s in a name?

Drugs 101—pay attention, there will be a test later
 

There are many Prostate Cancer medications in current use (and approved by the FDA). New ones are approved as older ones become less effective and disappear. Part of the formula has to do with money. No drug manufacturer wants to produce and market a drug that won’t make a profit for them. After the patent runs out—usually 17 years from the date it went into effect‑‑the drug becomes generic and can be manufactured by just about anybody and will almost certainly be less expensive.

If you’re taking a prostate cancer drug you probably know its name (at least one of them). But did you know that every drug has three or more names? The name you know is probably the brand name. It also has a generic name, and a chemical name or formula, mostly impossible to understand. Sometimes the chemical name is abbreviated during the Clinical Trials stage, something like FUN-4U.For example, I take Zytiga, the brand name of a drug manufactured by Johnson & Johnson (aka Janssen). The generic name of the drug is abiraterone acetate, assigned by the FDA when it was approved, and the chemical formula is 3β-Acetoxy-17-(3-pyridyl)-androsta-5,16-diene. When a drug finally becomes available in generic form it may have yet more names. Confused yet?

You can find the names and history of your drug or drugs at the NIH prostate cancer drug site. You might discover that there is a much less expensive generic version of your brand name prescription drug. That is good. Generic drugs are required by the FDA to be exactly the same as the original brand name drug. Another personal example of this—I take prednisone along with my Zytiga. The prednisone, a generic drug, costs pennies a month. The Zytiga, a brand name drug, costs many thousands a month (before my Medicare Part D kicks in and reduces it to just many thousands a year).

Some men who need these very expensive drugs are not rich or do not have a health insurance plan that helps enough. This is also true of drugs for other cancers and many other medical conditions for both men and women. Sadly, life-saving treatment for some still depends on their ability to pay.

Oh, there is no test, you passed by just reading this far so you can relax.

axman