On Generic Drugs and Health Care Savings

Watch for Misdirection

Ella is about to become a senior in high school, and it is hard for me to believe because it seems like just yesterday I was cutting the umbilical chord and holding her for the first time.  In looking back at her life so far, she has been through a great deal and come out of it well.

When Ella was three years old, she began exhibiting strange behaviors and for several days we had no clue as to their meaning.  She was having difficulty with her toilet training, and we guessed that the stress was manifesting itself in what we shortly learned were partial-complex seizures.  The expressions varied in the first few days, so when we attempted to describe them to the primary care physician, he was prone to agree with our assessment but asked us to come back in if the behaviors continued.

With increasing frequency, Ella’s hands would tap on her knees and she would start making strange vocalizations like she was trying to get words out while the muscles in her face and jaws weren’t synchronized with her vocal chords.  Her expression was vacant.  She would look directly at the person next to her and had a strange smile resembling Jack Nicholson’s “Joker” character in Batman more than a smile.  The episodes lasted no longer than 10 to 15 seconds each, but their frequency grew steadily from one per hour on the first day they appeared to a separation of 20 minutes by the third day.

Her mother took her to the doctor for them to observe the episodes, and they sat with a nurse practitioner for nearly 30 minutes, waiting for the NP to be able to observe to see whether she could identify what was going on.  Poor Ella had no clue as to why we were concerned, because she had no awareness during her seizures and no memory of the events coming out of them.  She only knew that all of a sudden, her parents were very concerned about her.  During the observation period with the NP, she didn’t exhibit the behavior.  The NP gave Elaine instructions to carefully time and observe the episodes and to talk to Ella while she was experiencing them, to say a word and ask Ella to repeat it when she came out.

On the way out of the clinic, Ella had an episode and the NP recognized the symptoms.  Ella had developed epilepsy with partial-complex seizures.  I was completely surprised when her mother called me, because my only experience with epilepsy had been to observe a coworker who fell to tonic-clonic seizures.  Tonic-clonic seizures are the type most often referred to as “grand mal” seizures.  Ella didn’t fall and writhe uncontrollably, and she wasn’t in danger of biting her tongue. She recovered completely from each seizure, so it didn’t fit in with my limited experience of what epilepsy is like.



After a week in the epilepsy ward at United Hospital (a long week of few answers), the neurologists settled on a combination of Tegretol and Lamictal to control the seizures.  We had some counseling and training on dose administration and how to handle situations in which she might miss a dose.  We were given instructions on how to administer Valium suppositories should the anti-seizure drugs suddenly lose their effectiveness.  The neurologist carefully explained that we were always to insist on the brand name version of the drug when refilling at the pharmacies and not to let the insurance company try to steer us towards generics.

The explanation that he gave us was that the controls used in manufacturing anti-seizure medications were far too variable to be safe.  According to the instructions, there could be a 25% variation in the level of the control agent in the generic version. This is important for two reasons:

  1. The body has a narrow band of tolerance for the active ingredient in Lamotrigine.  If the level of active ingredient in the blood is below the band, it is ineffective.  If the level is above a certain threshold, it can have dangerous side effects, including a neurological rash.  This became a serious issue when Ella started menstruating.
  2. Lamictal is very expensive.  If I had not had prescription drug coverage during this period, we would have been looking at a bill of $550 per month at the dosages prescribed.  In 1995 when this all began, my insurance company allowed Lamictal in its formulary so that we only had a $25 copay for each refill.

When Ella was twelve, the prescriptions became increasingly hard for the neurologist to calculate because she began to menstruate, and the variability in her own blood affected the levels of Lamictal.  In one day she went from no seizures to over forty, and then after three days back to none.  She was once again admitted to United Hospital for evaluation.  At this time, the neurologist had better tools to diagnose and find the locus of the seizures and was able to map out a section of her temporal lobe for rescission.

No, the section of her brain that was responsible for seizures is no longer there, and one would expect that she no longer needs the meds.  What we learned, though, is that Lamictal creates a dependency.  If she ever stops taking it, she will go into seizures and Lamictal will never again be effective at preventing them.  She will be taking anti-seizure meds for the rest of her life.

Over the years, we have had many battles with the various insurance companies over the formulary.  The copay had risen to $75 by 2007, and then after switching to a new employer and a new health plan, I discovered the “Doughnut Hole.”  This is the gap between per-person maximum prescription payments at $1,000 to where coverage again picks up at $2,500.  The idea is that in order to cut down on the over-medication problem, consumers are supposed to question their doctors for necessity each time a scrip is written.  We are to become educated consumers and help control costs as health care costs eat the economy.

I agree in some respects. We are all aware of the tendency of many doctors to just give their patients something, especially antibiotics for flu.  The doctors know better, but they write anyway just to get their patients to think they are “doing something.”  It’s a practice that is leading to some dangerous germs, as they are evolving rapidly to resist our best antibiotics.

But that isn’t the issue with Lamictal.  It’s a proven medication, and it has the desired effect of reducing the incidence of seizures, and it has no evolutionary consequences because it fights an effect rather than a germ.  It’s not a “cure” for a syndrome, it is an effect mitigator.

For three months in 2007, I had to use my credit card in order to pay for Ella’s prescriptions.  I am still paying down that balance as well as I can.  The insurance company kept on telling me that generic Lamotrigine is an approved substitute for Lamictal, but the doctors continued to say, “No, it must be Lamictal.”

This year, we ran into the same problem again, but when Ella’s mother went back to the neurologist, they finally relented and said to try the generic to see what happened.  The refill is now $10 per month and, to our great surprise, the effects of using the generic have been the same as they were using the brand name version.  Blood tests have borne this out and the expected variability has not been an issue.

I am torn between relief that we have an affordable option, and anger at the neurologist for being so insistent for so many years.  I am suspicious that he was so insistent because he has been relying on Glaxo-Smith-Kline’s information, but I hesitate to make that accusation because he is a professional.  It does seem to me, however, that we faced an incredible economic problem because of such insistence and the warnings of dire consequences if we failed to heed his advice.

Enter the Dragon

Robert Bate is by all accounts a charming, personable and informative gentleman who engages in issues related to science and culture.  He’s not a trained scientist but has been effective behind the scenes at framing science for the masses, especially regarding DDT and malaria in Africa.  When I use the term “framing,” I am using it more in the meaning of “falsely accusing” than in the Matthew Nisbet sense of making science more appealing to religious people by telling atheists to sit down and shut up.

Chris Mooney and Sheril Kirshenbaum’s book Unscientific America devotes a chapter to pointing out that the connection between atheism and science should be de-emphasized, because said connection is a roadblock for many people in accepting science.  I think that this is a mistake and is based on a false premise.  People are interested in science, but they are confused by the many misdirections and are not sure whose science to trust.  Carbon industries fund scientific “journals” to publish what look to be genuine peer-reviewed literature, which throws doubt into to the established connections between carbon dioxide levels and its effects on the climate.

Climate change deniers refer to themselves as “skeptics,” which grants them an air of legitimacy. They are actually fed misleading data and pass it along as if it disproves the science of the leftist environmentalists who hate capitalism. If not disproving the real science of Anthrogenic Global Warming, it is enough to cast doubt and forestall meaningful action until all the facts are in and the “sound science” is followed.

You may have heard of “sound science.”  It is a propagandistic trick, to make it seem as though there are two competing sides to issues in science and the differences are based more on opinion among scientists than they are on hypothesis testing.  Robert Bate has been effective at moving the phrase “sound science” into a doubt-casting phrase to be used by conservative think tanks.

He is also responsible for the public perception that a DDT ban was not only not warranted because its evil effects have not been sufficiently proven, but that millions have died of malaria in Africa thanks to a worldwide ban on DDT.  It’s not true, any of it, but it sounds true enough that people buy into it and Rachel Carson has become a villainess (Millard Fillmore’s Bathtub) for publishing her work Silent Spring and pushing for a ban on DDT.

Bate is apparently bored with the issue of malaria and DDT now.  He is planning to move into the field of generic drugs and create a new frame that in the new health care policy to be hammered out, we can’t allow the government to force us to accept inferior quality generics to replace the brand name drugs developed and marketed and sold by American pharmaceutical companies.

In a new article at Stories That Matter (Public Education Center), “Bate and Switch:  How a Free-market magician manipulated two decades of environmental science,” Adam Sarvana explains how Bate is going to assist the pharmaceutical companies in maintaining their market share against the manufacturers of generics:

The switch in terminology from “generic” drugs to “counterfeit” drugs is typical, neatly suggesting that the problem is not affordability but quality. For his part, Bate says his interest in the issue came from an experience in Africa. “I spoke to doctors in field (Zimbabwe, [South Africa], India) who were coming across fake drugs,” he wrote in an e-mail response to questions following our meeting. “Realized it was important topic, and main focus was on fake Viagra, rather than fake anti-malarial drugs, which kill 100,000s.” The corollary to this newfound interest is his prediction that the Obama administration will import more generic drugs as part of health care reform, which he says would be misguided. “If they were true copies of the well-produced drugs,” he told me, “then you’re just dealing with an economic argument: Should you support the brand originator, those who developed the drugs in the first place? I would argue probably yes, but that’s an economic argument” – hardly the terrain on which he’s preferred to engage in the past. So, instead: “The assumption they make that all these drugs are equal is going to have to be fought, because it’s not true. That’s where I think I’m going to have my biggest battles over the next year, is on how good are generic drugs.”

Bate will be creating a “He said/She said” narrative on the issue.  In my experience, the issue of generic drug prescription has produced doubt on the claim that generic drugs are not safe in most circumstances and shouldn’t be used.

The problem is that in order to be able to fully understand the issue and to be able to read the literature and understand the facts, I would probably need to be a trained pharmacologist.  I can read and understand some levels of professional journals and keep PLoS in my bookmarks.  Largely, though, the methodologies and terminologies are intended for at least post-graduate level reading, and I rely on abstracts and summaries for the conclusions of peer-reviewed papers.  I simply don’t have the training to be able to read the papers with confidence that I understand the effects being described.

Those of us most affected by the debate between generics and trade names, that is health care consumers, are going to have to place a great deal of trust on the issue in experts.  The problem is that it is getting harder and harder to know who the experts are, and who they represent.  Are the reports based on true, unbiased science, or are they commissioned and executed according to the needs of vested interest?

In 1993 the Superconducting Supercollider funding for a Hole in Texas was halted because Congress pulled the funding.  As physicists decried the halt, a new and emerging libertarian meme that industry and not government should be funding science was voiced in the call “If there is so much profit to be made from such huge and expensive projects, then industry should fund it.”

Conservatives like to cite the “Invisible Hand” of economics as described by Adam Smith in the Wealth of Nations (Wikipedia cite):

Many other cases, led by an invisible hand to promote an end which was no part of his intention. Nor is it always the worse for the society that it was not part of it. By pursuing his own interest he frequently promotes that of the society more effectually than when he really intends to promote it. I have never known much good done by those who affected to trade for the public good. It is an affectation, indeed, not very common among merchants, and very few words need be employed in dissuading them from it.

The idea is that government should get out of the way and let industry take care of us. Their profit is in our long-term good. I am not sure of that, given the number of (anecdotal) counterexamples. Here’s what to watch for in the coming debate over the efficacy of generics in cutting health care costs: Who will be funding the “studies”?  This is where financial disclosure becomes important.  If studies funded by pharmaceutical companies suddenly make their way into the press to indicate that generics, or counterfeits are “dangerous,” then that becomes a factor in deciding whether or not the studies are “sound science.” In the tennis match that has characterized public perception of “He said/She said” science regarding evolution, global warming and DDT, the goal has been achieved. People don’t know what to think about the issues and throw up our hands while the battle over related public policy is waged.

Here is one more interesting aspect. In Bate’s new push, a government entity will become the “friendly.” The FDA will be the arbiter of safety and efficacy. In his prior drives, government entities were the “enemy,” and most notably the EPA.

Final note to Chris and Sheril: PZ Myers is not the enemy in the problem of an Unscientific America. Robert Bate is.

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6 Responses to “On Generic Drugs and Health Care Savings”

  1. July 14th, 2009 at 11:43 am

    qetzal says:

    “In Bate’s new push, a government entity will become the ‘friendly.’ The FDA will be the arbiter of safety and efficacy.”

    That’s odd, since FDA is already the arbiter of safety and efficacy for all US drugs, branded and generic. They are the ones who set that ‘25% variation’ rule that your neurologist was concerned about. FDA is also quite aware of claims that drugs with narrow therapeutic ranges might require tighter standards. Yet even in those cases, FDA doesn’t typically require tighter limits (see Section VI.F at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf).

    FDA clearly disagrees with Bate’s claim that many current generics are not “true copies of the well-produced drugs.” I don’t understand why Bate would think FDA is “friendly” to his position.

  2. July 14th, 2009 at 1:56 pm

    Mike Haubrich says:

    The factual accuracy of what he says isn’t the issue (and never has been.) It’s the doubt that he will creat by using “counterfeit” in place of “generic.” He will have them say that the trade names have made it through the FDA and are the only ones to be trusted, even though the generics will also have been approved. He won’t say they haven’t been disapproved, but will imply it.

  3. July 14th, 2009 at 2:30 pm

    Jason Thibeault says:

    Bate’s argument smacks of the same “anti-establishment” thinking that informs the antivax folks about how evil the Big Pharma folks are. Only in this case, directed at the FDA. Now, where did we hear anti-FDA sentiment last expressed? By shills for Zicam…

    Without some kind of proof that the FDA is intentionally acting more lax with respect to the guidelines of the generic drugs, I’d say it’s more likely the generics are cheaper mostly because they didn’t have to spend on the R&D and advertising that the original did. Making pills, by my understanding, is cheap and safe and efficient and accurate, regardless of who’s doing it, and I’d have to see extraordinary evidence to prove that the tolerances are not met as often with generics. Granted, generics may well HAVE a higher incidence of missing tolerance guidelines, but if they’re FDA-approved to begin with, that’ll get smacked down in a hurry, wouldn’t it?

  4. July 14th, 2009 at 2:49 pm

    qetzal says:

    I tracked down the “Bate and Switch” story. (Your link is 404’d. I found it at http://www.storiesthatmatter.org/index.php?option=com_content&task=view&id=161&Itemid=1.)

    I’m not sure Bate is arguing against generics in general. He seems to mainly arguing against importation of non-FDA-approved generics (and perhaps against drug re-importation in general). For example:

    “Bate himself is agnostic: While he fears Obama will ‘open the market up to drugs approved somewhere but not by the FDA, I don’t know how realistic that concern will be.’”

    I agree we shouldn’t open the US market to drugs that haven’t passed FDA scrutiny. I also agree it’s highly unlikely that Obama or anyone else would attempt such a thing. That Bate professes such concerns does seem to suggest unstated motives, but I’m not convinced he’s trying to denigrate generic drugs in general.

    If that is his goal, he should probably avoid statements like this:

    “Therefore it doesn’t surprise me when I hear some generic drugs aren’t up to standard. They’ll pass the basic tests, but are they bioequivalent? Will they release in the body at the right time at the right proportions? That’s a test you can only do in vivo, and [generic drug makers] may not be required to do those tests.”

    Because the simple fact is that FDA-approved generics are required to do those tests, and they are bioequivalent. Perhaps you’re right that Bate doesn’t care about the accuracy of what he says, merely that he creates a cloud of doubt around generics. But if he’s really such a magician at all this, I’d expect him to raise concerns that are less easily dismissed.

  5. July 14th, 2009 at 6:31 pm

    Mike Haubrich says:

    I’ll update the link as soon as I get the chance. I am pretty sure that he is actually more intersted in the “Cloud of doubt.” I don’t have the right training to be able to discern the truth on it, which is mostly the point of the piece. (Try it now.)

  6. July 14th, 2009 at 8:41 pm

    Mike Haubrich says:

    That has a lot to do with it, yes. But he knows better. He uses whatever fits his clients’ needs.

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