FDA required post-market trials are also different ethically than comparative-effectiveness research, Faden points out. For the latter, the medical establishment truly does not know what intervention works best and for whom, as opposed to testing something that they suspect might be causing harm against an alternative.
Pulling a therapy from the market without testing is also undesirable, Faden points out, because "sometimes the worries are unfounded," or the intervention proves perfectly safe for a particular set of patients.
The FDA, which requested the IOM begin its analysis in 2010, said in response to the report that it is "currently engaged in developing a systematic process for assessing and communicating new information about a drug after it is marketed," according to a prepared statement from the Center for Drug Evaluation and Research released this spring. The statement (to which FDA representatives referred comment requests) does not make specific reference to whether the agency will take into account the IOM's recommendations.
The FDA also has ethical obligations to use the data from these post-market trials that it requires, Faden and her colleagues argue. She acknowledges that the agency already faces huge resource challenges and that overseeing additional ethical controls could be a strain. But she projects that if it could reduce the chances of future trials ending like the one for Avandia did, it would ultimately be an efficient long-term investment.
The bottom line on which both the FDA and the IOM agree is that there needs to be better, more transparent tracking of drug safety throughout a product's development, release and use. Just because a treatment gains FDA approval does not mean that it is ultimately safe or even safer than older options. "There's no line in the sand that magically happens," Faden says. "We keep learning about drugs over their lifetime."
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Add CommentHelsinki declaration dates to the 70s, written informed consent is mandatory, and both the hospital Ethical Review Committees and the Health Regulatory Authorities have facilities and personnel devoted to the quality assurance and the control of the fulfillment of rules of every clinical trial (CT). I was aware of an informed consent text in the 80s for a CT that spoke about "this drug has been linked to side effects, specially in women, including death..." My feeling is that the overall tone of the article doesn't reflect actual facts, and documents, including package inserts and informed consent handouts are there to be read. Just take some time, and ask about the things you don't clearly understand if you've offered participating in a Clinical trial, your doctor has a legal obligation to fully inform you, and will do it with great pleasure, and remember, you can withdraw at any time from a clinical trial you accepted to participate in without having any obligation to give an explanation, although for sure, they'll ask you for the reason why, but if you don't want to answer, you can shut and go away, nobody bad will result for you, at least coming from the people making the clinical trial, your disease may be a different thing, as outcomes rarely are 100% positive, but Niels Bohr said, "It's extremely difficult making predictions, specially about the future". Yeah, in some cases post-marketing trails do overlap with the commercial promotion of new drugs, seeding campaigns and stuff like this, so it's good checking in the governments' databases for CTs if you're offered a real one, every decent trial has an official trial number, and the sponsor must be known, or just a doctor is being paid for prescribing the drug in a payment for case way, it won't be the first time this has happened. Pharmaco-surveillance, or data gathering about side effects not known before the drug was put for sale, as the number of patients in phases I, II and III sometimes misses rare side effects, is not exactly a clinical trial, and probably the only issues would be around the confidentiality of data, and the protection of the patient's privacy. Drug makers must report for legal reasons any serious side effect of they drugs they are aware of, so it's supposed that health regulatory authorities have the same info about safety of a drug as its producer, the costs of non-compliance of this rule would be so enormous in the case of a legal suit, that nobody can even think in making hiding drug safety data an actual choice.
Reply | Report Abuse | Link to thisRe: "...documents, including package inserts and informed consent handouts are there to be read." Expecting an increasingly non-science-literate population to read the materials mentioned constitutes being in complicit denial about what is entailed in communicating risk to trial participants. I conduct research with human subjects, and have created a plain language statement, including relevant potential risks, which we read through aloud with our participants, pausing to ask questions to make sure they have understood. This process is costly in terms of the paid time for my interviewers, and annoys some of the participants, but generates a much higher likelihood of TRULY informed consent.
Reply | Report Abuse | Link to thisThose inserts all read the same. Almost word for word.
Reply | Report Abuse | Link to thisAnd it is very hard to tell what is ACTUALLY likely to happen for this drug or that drug - the best way is still to monitor yourself when taking a new drug, and letting your doc know if there are any issues.
Another thing they REALLY need to update - you enter these trials at your own risk. If they cause you to have a heart attack requiring multiple bypass surgery - the trail folk are not going to pay for it. And chances are your insurance will also refuse to pay for it because it was the result of a drug trial you voluntarily entered rather than a natural-for-you medical condition.
And the medical/insurance industry is still not wild about doing that kind of thing without money up front.
You can easily have full disclosure and word it in such a way (and in such find print) that few if any of your participants will read it and understand it if they DO read it.
Both of you are right, but handouts and package inserts don't come out of the blue, the doctor must always be there, and has a legal obligation to duly answer any question the patient may have. The actual practice may differ in some cases, but is the doctor and the HRA's responsibility to guarantee a fair flow of info to the person screened as a candidate for entering as volunteer in a CT, if some people, icluding doctors, behave unproperly, it's their responsitibity, and it's the Sponsor, HRAs and ERBs task looking for violations of rules that put in danger the patient's autonomy or safety, as in other fields, neither the Commands that Moshe's announced, nor the Codes, nor Commow Law made mankind perfect; if rules were needed, it was because abuses existed that harmed third parties, or innocent bywatchers, even when it was said that sin entered the world because of the law, as before the law, there was sin, but it was not imputed. I have no direct contact with patients on Clinical Trials since I left a Pharmaceutical Company in 1988, so I don't know the situation of actual info provided to patients as of today. Salut +
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