An ounce of prevention is worth of pound of cure

So the FDA has acted (the ounce). Yes they work slowly but personally I prefer they do that and not rush drugs through the approval process. (Something about deadly

But I digress. Because of that evil man who jacked up the price of a drug because he could and didn't care about the patients, the FDA has moved to see if they can expedite reviews of certain generic drugs (the pound).

"The agency plans to expedite reviews of applications for generic drugs where only one treatment is currently sold."

I like this idea. A lot. Since a generic is essentially the same (but not quite exactly) of existing patented medications, the approval process is much easier than for brand new drugs (or so I believe). The problem is the agency has a backlog of generic medication applications. So now they will see if they can speed some up.

The more generics available, the better. This makes me happy. 

Here come the biosimilars

The FDA has just approved the first biosimilar for the US. These are drugs which are similar but not identical to the original patented drug. Amgen defines them as:

"Unlike generic medicines where the active ingredients are identical, biosimilars are similar to but not identical copies of the originator biologic. They are similar, but not the same. Biologics made by different manufacturers differ from the original product and from each other."

The first FDA approved biosimilar is Zarzio, which is a biosimilar for Neupogen - the lovely injection many of us got after each chemo infusion to help ward off infections. But not to be confused with Neulasta. This first drug could add up to $6 billion over the next ten years.

"Zarzio’s introduction — primarily as a competitor to the Amgen blockbuster Neupogen — marks a milestone, and could add up to savings of $6 billion over the next 10 years, according to drug benefit manager Express Scripts. But that’s just the start — Express Scripts estimates that if 11 other biosimilars pass muster with the FDA, they would shave $250 billion off spending on comparable existing biotech drugs over that same period."

So as big pharma comes up with these fancy new drugs at sky high prices, upwards of $100,000 per patient per year, which overwhelm the insurance companies, the new biosimilars can cut the market prices by 40-50%, which is not as much as the 70-80% savings with a generic.

I realize that biosimilars and generics are not for everyone but a little competition is good for the industry. Insurance companies can use the availability of a biosimilar to negotiate lower pricing for the original drug and shift many patients to the biosimilar to help with substantial savings.

I welcome these changes as a significant step to help contain medical costs.

Generic drug prices going up

Brand name prescription drug prices are sky rocketing. The silver lining for all of us patients is that generic drugs would become available at a much lower price. But now those prices are going up as well.

In the US, the government does not negotiate drug prices or mandate generic drug prices - which have been priced based on the cost of key ingredients - the smart way to do pricing instead of basing it on how much it is worth for the patients life (which is another blog post).

But now, a Senate panel is looking at generic prices and how much they have gone up in the past year. Hmmm..... I smell a rat.

Let me start by saying that I am a huge fan of generic drugs and most of my affordable prescriptions are generics. But my brand name prescriptions cost me anywhere from $35-$105/month. Ouch. And that's mail order prices. Which means I have to keep my chemo brain/fibro fog focus on refilling prescriptions before I run out.

I also am not a fan of too much government regulation. I do prefer when market forces run prices. While I am jealous of drug pricing overseas, I find it unfortunate that certain industries make their huge profits on the backs of American patients.

Now back to that rat that I smell.I suspect that something more is afoot than just market forces on the generic prices. Maybe some collusion somewhere. I don't know what that rat is but I am suspicious. Call me a concerned patient for now but I will keep digging around on this one.

An even playing field please.

I admit to being a little confused here. Why aren't manufacturers of generic drugs held to the same standards of the patent manufacturers and vice versa? This is a tad confusing.

There are lawsuits out there about side effects from generic drugs which are being heard in the Supreme Court.

Basically a generic is the same as the original medication. Federal law requires generic drug makers to provide identical ingredients, warnings, and labels as brand-name products.

If generics make up 80% of the drugs sold in the US, they should have the same accountability standards as the original manufacturer. And any side effects are therefore more likely to occur to the generic manufacturers.

"Drug companies have long asserted various doctrines of pre-emption, saying they are protected from most product-liability claims if they have met federal safety approval standards."

[This is a load of crap in my opinion. No one is above the law.]

"They argue that federal regulatory judgments trump state consumer safety laws, which are often tougher than Washington's standards.

But the high court had given a big victory to patients and consumer rights groups in 2009 when it ruled in favor of plaintiff who sued Wyeth -- now owned by Pfizer -- after losing an arm to gangrene from a common, brand-name anti-nausea prescription medication. She had won a $7 million judgment from a Vermont jury for her claims."

[About time.]

"Then last year, the Supreme Court ruled 5-4 that generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge."

[Seriously?]

Its time to even the playing field here.

Good news for patients

There occasionally actually is good news for patients. This time its financial. Many brand name drugs will have their patents expire in 2011 and 2012. In the Boston Globe today was an article "Drug Prices Will Fall Sharply As Patents Expire" (A poor title that I read first as 'patients expire'.)

The article mostly talks about Lipitor, Protonix, Plavix and other medications I don't take the but the point is there. All these expensive drugs that came out in the early 1990s or so, now will lose their patent protection and generics will take over.

I get my Femara by mail order - simply because I can't afford it at the local pharmacy. It cost me over $100 for a copy for a single month (OUCH!) so I switched to my insurance mail order and it cost me $70 for a three month supply. Then my last refill was $10 for a three month because it was for the generic. I found the retail price of Femara on line as: $386.28 - 30 day, $763.53 - 60 day, and $1,141.89 - 90 day. Basically that's more than $10 per pill... And if you get it in the retail packaging it has a nice little designer bottle to go with its designer beige/yellow colored pills. I prefer the white mail order prescription bottle myself filled with generic tablets.

My husband takes Concerta for his ADD and he recently switched to a generic as well. The cost savings haven't been as significant but I am happy to see any cost reduction.

The article does point out that: "When a drug loses patent protection, often only one generic version is on sale for the first six months, so the price falls a bit initially. Then, several other generic makers jump in, driving prices down dramatically. So in six months, maybe costs will be better.

It then adds: "The flood of generics will continue for the next decade or so, as about 120 brand-name prescription drugs lose market exclusivity, according to Medco Health Solutions Inc., a prescription benefit manager."

I would have thought the pharmaceutical manufacturers would be worried but I guess not.
"“A blockbuster drug that goes off patent will lose 90 percent of its revenue within 24 months. I’ve seen it happen in 12 months,’’ says Ben Weintraub, a research director at Wolters Kluwer Pharma Solutions.

Twenty drug approvals in the United States this year, and others in the next few years, will help replace the revenue."

I realize that most generics have the same effects for most people but are not equal. Sometimes a generic doesn't work as well for some people and they need to go back on the brand name. But still many people will see savings.

So we should enjoy our lowered costs while we can, before our doctors switch us to new medications that are 'better' and protected under patents.

Generics and prescriptions

Living here in Massachusetts, there is a state law which mandates the use of prescriptions unless the doctor specifies 'no substitutions'. (I could be wrong, this could be a federal law but since I have no brain I'll just say state law.) All of my prescriptions, of which there are many - they cover the top of my bedside table, are generics except one - Femara which was released just a few years ago.

A recent study says that generics are just as effective as the brand name drugs. But we need to remember a generic is not an identical drug but (as the fancy word implies) are biosimilars - meaning they are close but not quite. Now there is a movement to shorten the 12 years in which drugs are protected from generics in the US. Basically biotech companies say they need the 12 years to recoup their development costs. Now this my be true as many drugs that are developed never make it through the testing process so they do have lots of overhead. I can understand this point.

I can also understand the issue that lengthy drug development allows for time for clinical trials and FDA approval. It is my understanding that the FDA is working on speeding up their approval process but this is not without issue as drugs are released and then recalled - Vioxx for example. If you cut the clinical trials time and speed up the approvals, are more potentially dangerous drugs made available to all? Generic versions make them more affordable - which is important in an era of skyrocketing medical costs.

Perhaps its not the drug companies or the FDA that are the cause of the problems? But perhaps it is the system through which drugs are developed? I am not an expert here but clearly we have some kind of problem. Biotech companies go through lengthy development processes and need to cover their overhead. Can the system somehow be changed to make it less expensive while allowing for safe drugs to be developed? You will note I am avoiding the topic of biotech company profits at this point as they clearly need to take a hit.

Anyway, I called my doctor yesterday to (whine and) discuss my pain issues. The call I got back was one that I really did not want. 'It can take up to two weeks for your hip to get back to normal. The procedure irritated the nerves that go into your hip and the need that long to reduce inflammation.' I don't recall this being mentioned in the pre-procedure information. Grr...

I have found if I take a pain pill and a Tylenol every six hours, the pain is manageable provided I don't do things like stand or walk for more than ten minutes at a time. (I cook dinner in ten minute increments and then take a break.) Sometimes lying in bed gets painful too. I was also told I could add a Motrin to the mix which I will add in this morning. (I just googled it and found out Motrin is a fancy name for ibuprofen.) If I take two pain pills, I am in a coma and can't function. For example, Extreme Makeover: Home edition was difficult to follow and I got the four episodes I watched in a row, all mixed up in my brain.

Today I have to go to work where I will mention I am on medication and I am sure my coworkers will use that knowledge to have a few laughs. Nothing like a bunch of supportive co-workers. Actually they are all very nice and care about me but have a biting sense of humor that is always flying around the office. But in a caring way. Now I am late so I must get moving.