A Catholic Hospital Refuses To Give Patients Vital Information

What little I have read about clinical trials (my field is entirely pre-clinical) indicates that there are extremely strict requirements about informed consent for volunteers.

I specifically remember that patients can never be denied neccesary treatment for the sake of the experiment (results can get muddled when you have several treatments at once) and that patients need to be informed of their treatment options and known effects and side-effects. My impression is that requirements for information become more strict, not more lax, in the case of clinical trials.

Given this I wonder how a hospital could get the green light for clinical trials when they are announcing that they will give less than full information to their patients, particularly when the consequences could be so dire. That the Catholic heirarchy could be so callous and cruel is hardly a surprise anymoe (I mean, what’s several million African lives between friends?) but I would like to know why Australian authorities aren’t taking action.

Outrageous! There isn’t much more to say.

From what I gather, the odious behavior consists solely of not telling people that they can use birth control. But they are not hiding the fact that this drug presents a risk in regards to birth defects, correct?
If I am correct, this stupid behavior in and of itself isn’t in any way preventing the use of birth control by patients. They simply aren’t advertising the different kinds of birth control available. Irritating and silly, yes, but hardly as evil as telling Catholics in 3rd world nations that condom use to prevent the spread of HIV is to be discouraged.

And the next time, when a promising new drug’s clinical studies pass over this hospital because of actions like this stunt, I’m sure that Martin Laverty will be the first in line to cry religious persecution.

Is any adult in the developed world unaware of their birth control options?

Apparently in the US, a lot of sex-ed is abstinence only “education”. It’s the reason for the very high teen pregnancy rate, which is demonstrably higher in more religious states

I don’t think there are many people who don’t about condoms, but beyond that it becomes more problematic. Many know about the pill, but that’s as far it goes for a significant amount of people.

I will never understand why doctors and other medical professionals are willing to risk their livelihood over religious based policy set by the hospital. When something bad happens the policy makers won’t have their back. It’s easier to overcome a loss of a doctor due to a loss of a license than for a doctor to overcome the loss of a license to practice (or a lawsuit for that matter).

I work in clinical trials in the US. If the study drug has the potential to cause birth defects, the protocol would require the female participants to be on birth control to be eligible to participate in the study. It’s not enough to just inform the patient of the potential to cause birth defects.

I don’t know the regulations in Australia but in the US, this hospital wouldn’t be allowed to participate in the trial. The pharma company sponsoring the trial wouldn’t risk the potential lawsuits before their drug ever made it to market.

First schools, and now hospitals are becoming more and more like churches.

So I used to work for Celgene, the company that produces lenalidomide (Revlimid). At least in America, the rules for prescribing or being prescribed Revlimid are incredibly strict. Every doctor that wants to prescribe it and every pharmacy that wants to dispense it must by approved by Celgene. For patients, men must promise to always use a condom, no matter how old they are or if they’ve had a vasectomy. Women (before or near menopause) must use at least 2 forms of birth control, where NFP does not even qualify as one. And she must still take regular pregnancy tests. If a test comes up positive, the pharmacy must stop dispensing the drug. Even the patients in clinical trials had to follow these rules. http://www.revlimid.com/hcp/hcp-revassist-pre.aspx

The massive birth defects caused by thalidomide (which is what lenalidomide is derived from) is one of the reasons the FDA has the regulatory power it does today. http://en.wikipedia.org/wiki/Food_and_Drug_Administration_%28United_States%29#Expansion_of_premarket_approval_process:_1959-1985

I don’t know if a different company is marketing lenalidomide in Australia, but I highly highly doubt Celgene would allow this to happen.

Ah…good ole’ Catholics…caring for the unborn but telling people that are alive “you’re fucked” as always -_-

And for Laverty to say the hospital is built on ethics…that’s a nice breach of ethics right there the liar!

It’s a “Catholic” hospital, in name only, and the “ethicists” who take their sick cues from Rome, will decry birth control. The Catholic church, among others, affiliates themselves with hospitals, even if the parishioners make no direct contribution.

Off topic, but continuing my rant about religious influence in Australia. On the Australian government website FAQ for school chaplaincy. A secular alternative is only possible when all other avenues to get a chaplain have failed.

What do I need to know about Secular Pastoral Care Workers?
Around 2700 schools were granted funding under the program in 2007. These schools were able to submit applications for funding without having yet identified a chaplain. They would then have an appropriate period to locate and employ a chaplain who met their school’s needs. Due to shortages of suitable candidates available, many of these schools have reported difficulties in employing a chaplain. For this reason, the Government made the decision to allow the funding already approved for these schools to be used for alternative support workers, if they could not find a chaplain by July 2008. These alternative providers may include counsellors, youth workers or other secular support staff.

The offer only applied to those schools that had exhausted all reasonable avenues to find a suitable chaplain. It does not affect any other school that has successfully identified a chaplain that meets the school community’s needs.

Based on my memories of the NSW system in the 90’s, Australian public schools have a pretty good sex education curriculum. If you’ve been through school then you know: where babies come from, what all the reproductive organs do, most of the common forms of STD’s (symptoms, risks and your duty to see a doctor if you think you are infected) some very basic psychology of sex, most of the available contraceptives (condom, vasectomy, diaphram+gel, pill, morning-after pill, implant, IUD and dental dams) along with the fact that all of them have a small failure rate and there are some methods which plain do not work. (withdrawal, douching)

Having said that, there are any number of ways that people can fall through the cracks. Not everyone finishes their education, meaning they only learn what is in the earlier, less detailed lessons. Religious/charter schools are rife and not always obliged to stick to the same rules as everyone else.

The biggest problem I see is that even though most Aussies know to use birth control and know that they are not 100% reliable, not everyone will make the connection that they need to use multiple contraceptives. That means an increased, and unacceptable, risk that someone will bear a deformed baby.

The second biggest issue is that this hospital is corrupting the trial data. They’re doing something different then all the other participants and adding an extra variable. This is bad science. In real terms they are telling people to make a choice between their medication and sex and you just know that there will be a few who would choose to stop taking their medication.

Seriously though, telling people to not have sex never works. This is a well know fact. So it should be a requirement of the trial itself that participants have no moral or religious objections to contraception.