Being Stuck Between a Rock and a Hard Place...Drug Studies

By GabbyPA Latest Reply 2014-09-06 10:51:36 -0500
Started 2014-09-02 08:20:18 -0500

We all hear it. The new drug on the market with all the side effect warnings. They are more scary than what the drug supposedly treats sometimes. Those warnings can be based on multiple incidents in a trial, or just one. So that can be very unclear just how serious the side effects are based on you, not the person who suffered those effects. Its a very complex thing to balance the benefits of a future medicine with the risks of each individual taking it.

"On August 11, the drug division of the FDA held a public hearing to discuss this issue [of cardiac events], and the diaTribe and Close Concerns teams presented on behalf of patients.

The day featured public presentations and discussion from a range of experts, including the ADA’s Dr. Robert Ratner, who spoke most compellingly on behalf of patients, in our view (he was a very respected long-time researcher before taking the reigns at the ADA running the science side). Some talks, including ours as well as Dr. Ratner’s, centered on ways the FDA should balance innovation with the need to gather long-term safety data on new drugs. diaTribe editor-in-chief Kelly Close presented on the challenges of revealing early results from CVOTs [cardiovascular outcomes trials], as well as the consequences of the CVOT requirement on innovation (e.g., multi-year delays on Novo Nordisk’s insulin degludec and potentially transformational combo insulin/GLP-1 Xultophy, fewer funds going into the field, etc.)."

Read the full article (and all the sub articles) here:

I know I personally want to know if a drug may kill me so I can weigh the benefits versus the risks. The additional study of cardio events in a study may slow things down, but is it worth it? That is a hard question. The hearing held had many prominent people saying that drugs should not be held up for the extensive (and more expensive) cardio event trials. And I do get their point. What it could do to save lives could be monumental. It could also be devastating.

What do you think?
Would you rather have a potentially life saving drug on the market earlier?
Or would you rather know as much about the risks of the medicine before it comes to the market?

24 replies

karen7t2 2014-09-05 16:58:08 -0500 Report

Something I fail to understand is who do they use to test these drugs on to make sure they are safe? How do they know the risks without people taking them for sure?
I fully understand your fears, Gabby. No one wants bad or life threatening side effects, that's for sure. I am presently taking a medication that is very controversial about whether or not it causes breast cancer or not. My Dr. says it's just a 3% chance and a friend who has taken it says it was what caused her breast cancer. I stopped it on my own for awhle, but have since then, restarted it. There is no breast cancer in my family, only heart and diabetes, but there s always a first.
I know this is answering your question with a question but, it's something I've always wondered about.

GabbyPA 2014-09-05 18:31:58 -0500 Report

I totally understand that testing will never cover every possible scenario. That world of combinations is too huge to even think of that. I do want it tested and I have done a drug trial myself. The study was suspended when a member of the test died of liver disease. How do you prove it was the drug that caused it, or if it was something else in her genes. It was a horrible loss, but how do you make it clear?
So I ask for the possibilities and then I can make my own assessment just like you are doing.

karen7t2 2014-09-06 10:51:36 -0500 Report

I really think we are all guinea pigs for any drug, tested or not. I have heard of reports of drugs after being on the market for 20 yrs etc that are suddenly recognized to cause damage to some organ or other. And also, immunizations shots that are given from birth are not thought to cause autism, which went undiagnosed for many years back in the day.
Like you said "make your own assessments" Russian roulette.

GabbyPA 2014-09-04 07:40:26 -0500 Report

Wow, I didn't think this would be so one sided. I am surprised. I think the only reason I would try an unproven drug would be if I were actually in the throngs of death. Then if it kills me, I was already there. Like you all, I don't really want to add to my problems.

dsiderio 2014-09-03 20:02:49 -0500 Report

I understand the feeling of wanting to get to something that can help as quickly as possible, but I'd rather wait for all the trial results to be compiled. I do not want to risk causing myself more medical problems than I already have. I'd rather wait out all the trials and get as much information as I can before I take a new drug.

Chopstix 2014-09-03 13:33:57 -0500 Report

I would rather treat drugs like I do cars and electronics: Don't jump on the band wagon until all the bugs and kinks have been worked out. Look at all the law suits being advertised on TV now for a pill for men that is/or may cause skin cancer and the product men use to color their grey hair. Excuse me! I'm more worried about what's going on inside me than on the outside. Guess I've never been that vain…

brazosbelle 2014-09-03 11:14:57 -0500 Report

The legal profession couldn't proceed with all the class-action lawsuits unless there were a lot of people harmed by these prescription medications. I am thankful that at 65, the only thing (besides insulin) that I need is the nutrition that I put into my body. Cholesterol issue was resolved, blood sugar management is getting better all the time and energy level is up, up, up! (4 miles walking today)
Call me crazy, but there has got to be a connection with our food supply/additives, etc. and all the health conditions of today…

Type1Lou 2014-09-03 10:02:40 -0500 Report

I think we can credit the legal profession for all of these dire warnings about what might/could happen. (If we thought all would happen to us, we wouldn't take most of the medications/treatments.) But, I would rather know about the side effects and make my own decisions as a result of that knowledge and my medical options. Also, adequate testing and trials need to be done prior to the drug being marketed, IMHO…remember the thalidomide babies?

GabbyPA 2014-09-03 12:03:15 -0500 Report

I don't remember thalidomide babies...what was that?

Type1Lou 2014-09-03 14:18:41 -0500 Report

Here's what wikipedia says about thalidomide: "Primarily prescribed as a sedative or hypnotic, thalidomide also claimed to cure “anxiety, insomnia, gastritis, and tension".[3] Afterwards it was used against nausea and to alleviate morning sickness in pregnant women. Thalidomide became an over the counter drug in Germany on October 1, 1957. Shortly after the drug was sold, in Germany, between 5,000 and 7,000 infants were born with phocomelia (malformation of the limbs)." It was truly a tragedy.

GabbyPA 2014-09-03 17:22:11 -0500 Report

Wow...I had not heard that. There are so many things that even years of study will not reveal. It's creepy.

available jones
available jones 2014-09-03 00:44:55 -0500 Report

ihad a terrible episode with heart meds,my bp droped so low my kidneys stopped working only took 2 pills 1 each day. after I was released from the hosp. I had a talk with a different doctor which wa my regular doctor.i was advised if possible to take meds 5 too 10yrs old.they would more likely to have most problems worked promises there would be no no-one in meds today.research,ask questions ck meds out anyway you may even be surprised how helpful friends can one seems to talk about this subject,unless asked-sometimes the answers are good,sometimes I wished I had not have asked

GabbyPA 2014-09-03 06:09:33 -0500 Report

Do you mean 5-10 years already on the market?
Like buying a new car model. Never buy the first year. Take some time to work out the kinks

jayabee52 2014-09-02 19:10:16 -0500 Report

Howdy Gabby

Thanks for the notice.

I believe the CVOT requirement should stay as is. I have had cardiovascular events (ministrokes) and if a medicine has a tendency to cause CEs I'd like to know about it before it is released to the general public as a prescription. To shorten the process would only make us into big Pharma's guinea pigs more than we already are. I see this as a move by big Pharma to get the product out to be prescribed quicker and get the dollars rolling back to them quicker.

my 2 cents.


GabbyPA 2014-09-03 06:12:30 -0500 Report

Actually, what surprised me about the article was that a diabetic advocacy group is who is putting up the challenge. If you read the article, it is a little confusing. I had to read through it a couple of times to figure out whose side I wanted to be on. The group said they represent the patients, but I felt kind of funny about what they wanted.

jayabee52 2014-09-04 10:36:01 -0500 Report

Well those "diabetes advocacy groups" can be affected by big Pharma to advocate for the outcome big Pharma wants. Perhaps that's why you felt what they wanted seemed "off" to you. The changes they wanted did not seem to me to really benefit consumers of the medications.

GabbyPA 2014-09-04 10:54:17 -0500 Report

I trust diaTribe though. Maybe I should look a little deeper. They say much of what they do is based on the surveys we take. That may be true, but maybe I am in a minority among those they survey.

TLTanner 2014-09-02 13:20:05 -0500 Report

I haven't read the article yet, but to answer your last two questions…

Personally, I'd rather know all the risks and benefits before and when it hits the market. I want to weigh all the pros and cons myself, discuss it with my doctor and see if it is the right medication for me. Like you said, I want to know if it's going to kill me BEFORE I take it.

Thank you for such a thought provoking post! Now, on to read the article.

jim hammock
jim hammock 2014-09-02 12:25:15 -0500 Report

My Doctor has his own goals for me,which is more than recommend for my age.I do try to reach his goals,but quality of life is becoming an issue.

debcox 2014-09-02 11:51:18 -0500 Report

I want to know what the risks are before I decide if the medication is for me. My doctor wanted to put me on cholesterol meds because insulin will often increase cholesterol. We get health journals monthly here at home and they say not to use cholesterol meds so I discussed this with my doctor and we ended up disagreeing. The thing is that it is my body and I do get to choose what goes in it so I told her that while my cholesterol was under 200, I would not discuss taking the medication. My cholesterol was at 182 at the time but now after watching my diet and exercising, I'm expecting it to be lower when it is tested at the end of this month.

Sly Kitty
Sly Kitty 2014-09-02 11:30:48 -0500 Report

To me it is very simple, all testing and trials should be done previous to putting it on the market. I get that there are people that are anxious for something that will give them some relief, but putting drugs out before knowing the outcome of the majority is dangerous. This is just my opinion because you asked.