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Comment by phkahler | Hacker News Reader

>> People who had irrational fears of vaccines claimed harms from the Lyme vaccine that probably were not caused by the vaccine.

No, people who actually got the vaccine claimed they got arthritis from it. Weather those claims are true or not remains unverified. Of course the clinical trials showed no such side effects, but I doubt they were even looking for that (if I'm really cynical, do you even trust them not to hide that?). So when mass-marketed, alleged issues showed up and they pulled it. This is not different from other drugs that were pulled - and turned out to have actual problems. The fact that vaccine makers are legally protected and they still pulled it says a lot here.

That said, TFA says the anti-vaxers are ready to attack any new lyme vaccine that may come along, and that's unfortunate.

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So if the trial was not corrupt then it must have been incompetent? The FDA and CDC investigated and did not find reason to believe that the vaccine caused arthritis, but the unnamed people who reported the arthritis are more believable than all those public servants?

Come on.

>> So if the trial was not corrupt then it must have been incompetent?

In a sense yes. Clinical trials are not great at finding things like that. Phase 1 is all about determining toxicity - in other words, how much of a substance can people tolerate. Later phases are for determining dosage and effectiveness - how well does it treat a condition, or in this case how well does it immunize a person against infection. If side effects are not reported during the trials or are of low frequency, they may not get noticed at all. In fact, the FDA is starting to look at all-cause mortality for some drugs. For example, does taking something to lower cholesterol actually increase life expectancy (vs does it lower cholesterol which theoretically increases life expectancy). Do you really think they've been looking at all age-related effects (arthritis is one) of taking a vaccine?

I'm not saying the claims against it here are real, but that it is unfair to lump those people into the general category of anti-vaxxers. Especially since they were supposedly vaccinated.

Also, companies don't generally pull something from the market unless there is a serious reason to do so. Vioxx is thought to have killed 500k people before it was pulled from the market: http://www.theweek.co.uk/us/46535/when-half-million-american...

Be sure to read the after report on the vaccine, linked in a cousin comment:

https://news.ycombinator.com/item?id=9613520

Especially the stuff about the VAERS database, which tracks/looks for patterns in reported side effects over time...

> ... but the unnamed people who reported the arthritis are more believable than all those public servants?

And you can be sure that millions are going to die, not because they are stupid, but because the authorities are reluctant to crack down on the minority among their number that are corrupt.

IF one or two politicians are found to break the law, but get away on a technicality, the people will simply assume that all politicians are crooks. If a couple of scientists sell their integrity to corporate interests and the whole of the scientific community does not respond publicly and in full force, at least ruining the careers of the crooked scientist and suing the corporation for the undermining of the scientific method, people will simply assume that Science(TM) is just another racket to keep them down.

What you are seeing is a crisis of legitimacy. I agree that it is a very unfortunate event, but blaming the messenger is not going to fix it.

> I doubt they were even looking for that (if I'm really cynical, do you even trust them not to hide that?).

The drug companies do not do the data for their clinical trials - a third party supervised by the FDA does. The penalty for hiding data is pretty high.

Why should I expect the FDA to be more reliable than the drug companies?

Well, that's a trust the government debate, but I worked at one of the third-parties and they did a pretty damn fine job of it. Their reputation was pretty important to them.

I was astounded by the cost in a study. Thousands of samples overnighted to the lab with multiple tests run on each. The bill for that alone is staggering.

You shouldn't trust any of them to begin with, but rather grade them on their accomplishments (e.g. eradication of polio). Similarly, you should also have approximately zero trust in anecdotes about unnamed people when making medical decisions.

Or so I heard from some person who I believe to be reliable. Way more reliable than the others.

The trouble with grading people or groups on their accomplishments is that it's only useful if you're evaluating net accomplishments. If, for instance, whoever is responsible for preventing lots of deaths from polio also caused more deaths for other reasons (obviously I'm not suggesting this is the case; it's only an example), I might still be hesitant to trust them.

I wouldn't suggest otherwise, but there's a lot of publicly available research for interested parties to examine - http://jid.oxfordjournals.org/content/201/11/1607.full

So in your hierarchy of trust the drug companies are the least trustworthy, the FDA is slightly more trustworthy and random unnamed people are the most trustworthy?

I haven't decided on a hierarchy. I asked why I should expect the FDA to be more reliable than the drug companies.

because they aren't for profit? their only reason for existing at all is to keep harmful things from being approved for sale.

I'm by no means saying the FDA is perfect or infallible, far from it. Just that it's super easy to rank them above the drug companies in reliability as to a drugs safety and efficacy.

I don't see why profit incentive is obviously a worse way to get reliability than the incentives of politicians and FDA employees.

Does every thread have to devolve into a debate about the merits of libertarianism?

Curios on the subject. How would a vaccine cause arthritis? I assume they are injecting you with a protein so the body produces antibodies. Could the antibodies/immune response cause arthritis?

Lyme disease can cause a type of arthritis and it was hypothesized that the vaccine might result in a similar autoimmune response in certain genetically-disposed individuals. There are many more details about Lymerix and what happened here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/

[EDIT: Just to be clear though, there was no evidence in the numbers that the vaccine in fact caused arthritis.]

> Could the antibodies/immune response cause arthritis?

A lot of peoples arthritis is auto-immune.

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