Perpetual Exclusivity

Biologics CostA year and a half ago, during the great “health care reform” debate, I was startled by a little-discussed provision in the proposed legislation that was going to grant an extended period of exclusivity (i.e. protection from generic competition) to biotech firms. According to what I was reading in the press, the aim of these new laws was twofold: 1. ensure that the companies continue to innovate by ensuring that they are able to recoup their considerable research & development costs, and 2. protect consumers from the “inherent” unsafety of generic biologics.

I decided to do my own research in order to gain a more thorough understanding of what was really going on. I read the actual text of different versions of the proposed legislation. I looked at studies on the safety of brand-name versus generic drugs. I found and figured out how to interpret the financial reports of the major biotech companies. I queried donors/donations to certain members of Congress, and so on. Granted, this wasn’t my field of expertise (I have my BA in Architecture from Columbia and MA in Architecture from Harvard), but it was what I considered to be a pretty thorough review of numerous primary sources of information. The results can be read here: The Battle Over Biologics.

And while anything remotely related to this topic was causing heated political discussion (if it could even be called that) at the time, I was still shocked by the quantity and the content of many of the comments that I received here on this blog, in response to my post. I was accused of advocating for an increase in the number of drug-related deaths.  I was called a communist, a socialist, and everything in between. I was told I had no clue of business requirements and new product development (I guess I should have included all of my “credentials”, including the fact that I have more than 10 years experience working in new product development for high tech companies in Silicon Valley). I “had no clue” what I was talking about. I didn’t know this…I didn’t know that…and the attacks went on and on.

What I did know was that I had just done countless hours of research, this was my blog, and I was not going to engage with or respond to these particular individuals. I never did publish any of these comments.

There is one more thing that I actually did know: that there are ways of easily determining where certain comments come from.

An [unnamed] law firm in Washington, D.C., located on K Street (lobbyist, anyone?), which specializes in the protection of intellectual property and patents. The throw-away personal email address didn’t include a full name, but it did include enough information to determine exactly which one of the members of this law firm actually wrote the comment (nothing nefarious…just a quick review of said company’s website was all it took). Do I really need to say that this individual’s main clients were the same bio-tech firms that gained to profit so much from the proposed legislation?

Dear [unnamed] lawyer, I don’t think you were playing fair. You didn’t identify your real role in this debate, you just pretended to be a casual reader of Rheumatoid Arthritis Guy. Your firm probably receives huge amounts of money to lobby for your side, and have access to all types of press and media. Please allow those of us–who suffer directly from your decisions–to have our own little place, here on this blog, to discuss the issues amongst ourselves.

But it gets even better. Another individual, who said that I had blood on my hands because I was advocating for generic biologics, was actually the Director of Quality Control for a major [unnamed] biotech company. A few more clicks on the web (once again, nothing nefarious) reveal that this company had recently been accused by government agencies of producing its (brand name, mind you) drugs in production facilities in China…production facilities that lacked standard inspections and basic levels of quality control. Oh, and the worst part? All of the above was discovered only after the deaths of numerous patients. The reason for their deaths? Consumption of the tainted drugs that were produced and sold by this company. A few more clicks, and I was able to download a scanned copy of the company’s response to the government investigation…it even including the signature of the above-mentioned director of quality control.

Dear [unnamed] director of quality control, I’ll keep it simple: pot calling the kettle black!

So why, months (almost years) later, am I once again writing about this topic, and finally sharing what happened when I last wrote about biologics legislation? The biotech companies won. They got their 12 year exclusivity period. (Some had even hoped for as many as 14 years.) It’s because if they once again get their way, they are going to get something even “better”: a perpetual period of exclusivity.

Take a look at the following snippet that appeared in today’s Wall Street Journal Health Blog:

Biologics Brouhaha: A bipartisan group of senators is asking the FDA to interpret a provision of the health-care overhaul law in a way that would favor brand-name drug makers over companies hoping to make close copies of existing biologic drugs, the WSJ reports. The provision in question grants makers of biologics 12 years of market exclusivity; the letter, signed by Sens. Orrin Hatch, Kay Hagan and others, says the 12-year-clock should be reset if the original maker alters the drug to make it safer or more effective.

Their cover is blown. It’s not about recouping investment costs. It’s not about protecting consumer safety.

It’s about altering the drug before time runs out, and resetting the clock. Alter. Reset. Alter. Reset. It’s about preventing generic alternatives from ever coming to market. It’s about guaranteeing that the prices of these medicines continue to rise.

It’s about greed.

A lot of people who take biologics tell me that they would never use a generic alternative, even if it were less expensive. I respect their decision. I do not take biologics for my rheumatoid arthritis, but if I ever do, I would like to be able to make my own decision. I would like to be able to choose between a brand name option and a generic option.

Call me a socialist, call me an idealist, call me an advocate of death…it doesn’t really matter. What does matter is improving the the health of all of us who live with chronic and debilitating diseases. What does matter is ensuring that these drugs become more accessible and more affordable not just now, but also in the future.

It’s saddens me to see that we continue to head down the wrong path.

Stay tuned…for the next adventure of Rheumatoid Arthritis Guy!

Updated:

Jeff Levin-Scherz from Managing Healthcare Costs:

“These Senators are asking the FDA to make a decision that would be very good indeed for the biopharmas – but would increase the future cost of health care. This kind of decision would likely also diminish innovation, as firms tasked their scientists to protect expiring patents, rather than to develop novel treatments.”

9 Comments
9 comments
  1. Kelly says:

    Hey Rheumatoid Arthritis Guy,

    Don’t let the comments get you down. I do take a biologic and would be leery about changing to a generic BUT having the option would open up the medications to more and more people. I have phenomenal insurance coverage and pay a small amount for my Humira but I know of others who spend hundreds of dollars a month on a fixed disability income. I do support health care reform b/c I realize that not everyone is as fortunate as I am to have the medical insurance that I do. In some ways, I feel guilty that I can afford biologics and others I know can’t. I feel that reform can help those people who are suffering unfortunately, I know others don’t agree with me and I won’t judge. I only represent myself….as you are representing your beliefs. I appreciate the information.

  2. Robin says:

    Reading this makes me want to scream and cry at the same time. I wish these people working at the biotech companies had to either find an employer who is willing to hire you and take a $20,000 insurance hit or live in constant pain.

    I would love to see the generic drug companies start a collection for lobbying our government in order to let generic biological drugs be made.

  3. Yvonne says:

    I too take a biologic and am fortunate to have great insurance which covers it as it has made a world of a difference in my RA. However, I too think that the government should allow generic biological drugs to be made, for many of the reasons listed above. As with other diseases, sometimes a generic is fine, at other times it is not…depending on the progression or severity of the disease. The option should be available.

    As to the “alter.reset.alter.reset.” This should NOT be allowed to happen! The exclusivity clause should only apply to the drug, in the exact form/ingredients it was when the exclusivity clause began to run. Period!!! To twist the law otherwise is shameful! Yes, it is commmendable if they want to make the drug safer, or more effective….but it is by definition not the same drug at that point….the proponents of any interpretation otherwise know better…they just want to get away with it for their own reasons as you suggest! And this is coming from an attorney….what a pity that this is occuring, and prohibiting people from acquiring medicines that are effective, cost efficient and in the long term make a difference not only to their quality of life, but quantity of life….and would probably save millions of dollars to boot!

  4. Susan says:

    I just saw that Rituxan was approved for generic copy by the FDA this past week. I am one who would consider taking a generic form of this medication and am waiting for them to be copied. The whole redo option is the same as Ambien and Ambien CR, although the first is out in generic form the second (better) version is still protected. I willingly take the generic and have found no difference other than cost. Thank you for all that you do…….How was lunch?

  5. Rod says:

    Situation is so dramatic. And this is the result of the extreme liberalism that we’re living on this days. Now, in order to get those drugs that all the rheumatologists say that will make a difference in your prognosis, you have to get yourself subject to the decisions on the insurances companies,the pharma lobbys and their goverment allies.

    Basically, think this as you will have to work just for feeling better. Not to live. This is so unfair..almost make me cry makes me loosing the hope on the human being.

    For humanity’s sake, I hope that law about reseting the clock never gets approved.

    Really inspiring post RA dude. IDK if your lack of biologic treatment is because the place of the world you’re living in, hope I’m wrong. Nobody with this horrible disease should not be treated because economical or political reasons.

    Have a nice day :)

  6. Laurie says:

    Good morning, RAGuy…as usual another thought provoking blog.

    I thank God that there are folks like you who do research RA related things that we might not have known about otherwise.

    Having been on 6 biologics and knowing that they “failed” me, I would hate to see the alter/repeat cycle that benefits only the drug companies..would be interested to know how many of their employees/reasearchers have RA.

    As for the generic/proprietary debate, as a nurse I have seen good and bad generics. With a biologic I would probably chosen the brand name…however on Tuesday the OB unit where I work announced that as of 1//31 the unit will be closing and over 35 nurses are losing our jobs. There are 3 OB jobs at our other branch that we could transfer to. So, due to the generous severence package they are offering I have insurance until the end of February, when I get to COBRA it at a higher cost. I guess in March I’d wish Enbrel was generic. In the meantime I am trying to get 3 month refills on all my meds so I will at least have those.

    Keep up the good work!

  7. Lizz says:

    This is such a great post!!! Though it makes me wanna scream at these ppl. I am not blessed with good insurance…I get $50 a month for Rx’s….That is soooooo not even close to covering anything. I have tried most of the med.s that I can afford and none seem to work very well. I am in a clinical trial for the sub-dermal form of a medicine allready aproved in an iv infusion. It seems to have finally started working but the study is allmost over and I don’t know what I will do then.
    I know some ppl wouldn’t chose the generic option even if it was available but as someone who doesn’t have a choice, I don’t understand why I don’t get to feel better because the biotech companies want to make a buck. If anything, once the med. is approved, it should just be the standard to offer a generic so that people like myself can have some relief!!!
    This has acctually been on my mind for a while but I feel like this post was able to let me vent it…Thank You Soooooooooo Much Rheumatoid Arthritis Guy!!!!!!!!!

  8. deb aka murphthesurf says:

    You have opened a very big can of worms. Worms meaning the pharma companies, politicians accepting donations from said companies, and lobbyist prowling Washington streets for influence. It just sickens me to see what continues to unfold here in the US. Just sickens me and not just figuratively…physically as well. And throw into the mix that the FDA only voluntarily tracks adverse medication reactions and we are one big can of worms. Great article!

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