You had me at “drug companies do not want to see enacted...”.

Now, I think everyone supports the idea of safer drugs and ensuring the publication of information on testing.

However, if this goes beyond mere publication to impose a whole new range of costly and unnecessary tests, then it could result in an increase in research costs. The result in such instances is that cost could be pass on to consumers.

Also there is a need that in seeking quick action one must not make hasty decisions ungrounded in facts. Thus if a drug is discovered to cause a certain side-effect on a small portion of people, action should be clearer instructions to physicians to prevent prescription to these people rather than wholesale withdrawal which may affect people who benefit from the drug without side effects.

Finally, in case one is of the opinion that the current drug approval mechanism has lowered it standard, such opinion is false. An examination of records for the past few decades show that the ratio of approval to rejection is similar and that the number of drug recalls have not climbed in recent years.

This isn’t about more testing, this is about making the tests being done available to the public. Please read up on what we’re advocating before criticizing it.

I can get behind full disclosure. Wasn’t that supposed to be one of the functions of the FDA, though, to provide a regulatory and standards body to defend against this kind of game?

And how about so called “natural” or alternative meds? Are policy-makers going to suddenly get a clue and start requiring these to disclose their studies as well?

Oh, wait, silly me, that would mean they would have to *have* valid studies to start with.

No, I have no confidence in the abilities of the people in Washington to actually protect their constituancy. Even if they enact this they’ll water it down so bad the bill will have no teeth.

Through my job, I do a lot of work with a particular contextually-relevant drug company. I have visited its facilities, met several employees, and perused a wide range of sensitive internal documents. All of this has given me a drastically different impression of this company from the one I initially had, and from the one I would still have if I could only read about it in the paper, rather than see its inner workings firsthand. Everything I have seen about this company indicates that it is chock-full of people whose genuine primary concern is saving lives. While it’s certainly possible that there are some powerful individuals concerned only with profits, at the possible expense of public health, I just haven’t seen any indication of that, and it certainly isn’t part of the culture of the place. I also work with the vaccine division, which might be a contributing factor to my estimation of the place.

Those folks have an impossible row to hoe. It’s impossible to make a 100% safe vaccine, or a 100% safe anything, really. Yet most people won’t weigh the risks of taking a vaccine against the risks of catching whatever illness is being vaccinated against, and thus won’t get vaccinated if there is any appearance of risk associated with the drug. If people don’t get vaccinated, then we will see a resurgence of the numerous diseases that we have all but eliminated through vaccination, which would have disastrous effects on public health in the long run. For an illustration of this, one can look at the areas of the UK where concerns about adverse reactions to vaccines have led to a drop-off in vaccination rates, and which are now seeing a sharp increase in things like childhood pertussis deaths.

Imagine the conundrum of the hypothetical altruistic drug company: if they inform the public of the risks inherent in their drugs, even if those risks are tiny and far outweighed by the potential benefits of the drugs, then they run the chance of people not taking the drugs, which could have disastrous effects. These effects could be direct (an increase in disease deaths due to a decrease in vaccination) or indirect (a decrease in the company’s ability fund the development of new life-saving drugs). These are very tricky considerations, and that’s without even getting into the related issue of lawsuits, which can cost a company millions of dollars regardless of any merit.

I’m not trying to shield drug companies from criticism, but I am trying to suggest that the issues involved may not be nearly as black and white as they seem. In any case, it’s not surprising to me that drug companies object to the FACT Act. They may just be evil SOBs, but they may also be concerned that if the lay-person gets ahold of their clinical trial results, it could result in a misinterpretation of the data that would ultimately have negative consequences for everyone. Perhaps the best solution would be full disclosure of clinical data, with an accompanying push to educate people so that they could make informed decisions about prescription drug use, but that solution is not without its problems.

I don’t want to defend drug companies either, but the issue is complicated, as Ulfrekr points out.  Another problem, covered in the New Yorker last month -I can’t find the whole article online, here’s a synopsis:
http://newyorker.com/printable/?talk/050124ta_talk_surowiecki

is that juries are more likely to award damages against companies that tested their products and found problems than against companies that didn’t bother to test at all.  Not an encouraging atmosphere for public safety.

Double-dipping to clarify that the drug company I’m referring to, as far as I know, doesn’t release any drug unless they’re pretty damn sure that the risk is very tiny, probably even statistically insignificant. Also, in my experience a lot of the most alarmist claims concerning safety rest on a confusion between plausible risk and actual risk, which are actually different things.