About the people's distrust of "medicines" these days...

[Bonobo]

I just read this headline here on DU in the Health Forum:

GSK antidepressant Paxil to blame for baby's heart defects, US jury rules

I have 4 points about this:

1. Does anyone here think that it is even POSSIBLE to test for every single possible adverse effect? How does one go about testing to see if a drug will have an adverse effect on every potential health problem, drug interaction, etc?

2. The pharmaceutical company's financial incentive is clear. Furthermore, the cost of any potential class-action lawsuits is also very easy to quantify. IOW, they already factor in potential damages that may result and can weigh that against their potential profits in order to make a business decision.

3. It seems to me that the time that it takes the FDA to approve medicines to go to market has shortened in the last couple of decades. There are now more recalls of drugs after the fact. I will have to check that, but I am fairly sure of this.

4. Media scares like Avian Flu, SARS, etc. have been on the increase at the same time that scare tactics like color-coded warning levels, etc. have been increasingly used against the population of this country in order to manipulate our buying and voting habits.

So, adding up all of those things. Is it really any wonder that people are feeling distrustful, suspicious?

[wtmusic]

1. The cost of potential litigation is very difficult to quantify

for the very reason you mention: it's not possible to test for every single adverse effect and what its severity will be.

The FDA is getting it from both sides these days - when news like this shows up they haven't tested enough; when a new drug shows up that could potentially save lives, clinical trials take too long.

Overall distrust and suspicion is healthy. Drug companies like Glaxo can't be allowed to suppress new findings to increase their bottom line.

http://www.nytimes.com/1992/05/06/health/new-study-backs-ulcer-cure-theory.html

[Warpy]

2. These are actually great points

1. There is no way to test for all adverse effects. Most drugs come with a pregnancy and/or breastfeeding warning because they don't test drugs in pregnant women due to liability issues. In fact, few drugs are adequately tested in women, at all. There is no way to know what all a drug's side effects will be until the drug is in general use for several years. Most new drugs have greater benefits than risks. A few are stunning failures.

2. Yes, they do budget for lawsuits, it's one of the things that make patented drugs expensive, although the largest expense is simply recouping the cost of large scale human testing of that drug and others that didn't make it to market. Most companies either budget for lawsuits or pay insurance companies. The tough part to swallow is how a few companies have withheld adverse testing data from the FDA, example Vioxx, and this has destroyed trust more than knowing they budget for suits.

3. When the AIDS crisis hit in the 80s, there was a great deal of pressure to fast track drugs that were needed so desperately. The FDA relaxed the rules somewhat for that class of drugs, and large scale testing in hospitals generally wasn't the double blind testing that would have killed half the participants. I don't know that the rules were relaxed for other blockbuster drugs. Some new uses for old drugs, like inhaled instead of injected pentamidine, went from university to hospital.

4. People are sick of scare tactics and now tend to dig in their heels and resist them. This is probably your most salient point. People get sick to death of hearing that little boy cry "wolf" and get numb to all sorts of warnings, some of which might represent real warnings. I think this is one of the factors at work in the current resistance to the H1N1 vaccine, a resistance that will undoubtedly cost a few lives.

This is a crisis partially due to uncontrollable events but partial blame also has to fall on an industry, itself, that lacked adequate self policing. Other blame can be laid directly upon the media and their constant alarmist drumbeat. Fear sells, but soon that's no longer going to be the case. People are getting sick of it.

[ellenfl]

5. ah, so,

2. Yes, they do budget for lawsuits, it's one of the things that make patented drugs expensive,

the more expensive the drug the more likely the pharmaceutical company will have a big payout in a lawsuit! sounds like a good measure to me. :eyes:

ellen fl

[Warpy]

6. Your conclusion is not supported by evidence.

Sorry.

[ellenfl]

23. maybe, but i think it makes sense. eom

[onlyadream]

3. A local 8yo boy died last week after having the seasonal flu

shot. Apparently, he had an adverse reaction to the shot.
http://www.news12.com/articleDetail.jsp?articleId=237036&position=4&news_type=news

People from the hospital have stated that it was an adverse reaction to the shot (I read this on msg forums), however, the media is playing that down (for obvious reasons). The fact is, he would be alive today if he did not have the vaccine. Would the flu have killed him? Very unlikely (but possible).

As for testing for possible side affects; yes, that would be smart - maybe the boy's life would have been spared. But, they want to make money and testing will slow the process down (and cost money).

[donco6]

4. How much testing is needed for seasonal flu shots?

It's been offered for many many years to ... hundreds of thousands? Millions? of people?

[onlyadream]

10. They are egg based

so, at the very least, they should make sure the recipient doesn't have an allergy to eggs. Granted, that most people find this out earlier than age 8, however some kids refuse to touch eggs (and thus they don't know).

[SOS]

7. Big Pharma lost much of it's public trust since 1981

One approach: Try to use only older drugs which have stood the test of time.

I would take Percocet for pain, Valium for occasional anxiety or amoxicillin for a bacterial infection.
I wouldn't take Ambien, Celebrex or Nexium if you paid me.

[Arkansas Granny]

8. Add to that all of the advertising for prescriptions drugs (ask your doctor about . . . .)

and the list of side effects and warnings that they are obligated to list, it makes it appear that many of the drugs can be more harmful than the conditions they are trying to correct.

[Bonobo]

9. That is also a good point.

How could anyone be confident about anything with those mixed messages!?

"Here's a drug to help you feel happy, but it might make you depressed or even kill yourself."

"Here's a drug to help your asthma, but it may make your breathing worse or even kill you."

Etc. etc.

[onlyadream]

11. It's all a big business

and that's what happens.
They'll advertise a drug to help with depression but yet you can become unstable and kill yourself. When you hear that, you really have to wonder what the heck is going on.

[TZ]

15. Its nothing different than what comes in your pamplet with the meds

or what your doctor would tell you before surgery of any sort. Oy. People have no common sense.
The fact is the older drugs have THE SAME GODDAMN RISKS as the newer ones!

[Sgent]

12. This possibility is mentioned in the Prescribing Information

From the Paxil prescribing info:

Usage in Pregnancy: Teratogenic Effects: Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. The findings from these studies are summarized below:

GSK warned of this side effect, why is the jury holding them responsible? I could see holding the doctor responsible (assuming no informed consent risk/reward discussion), but why GSK?

[Bonobo]

13. Link please.

[Sgent]

18. Link

http://us.gsk.com/products/assets/us_paxil.pdf

Search for pregnancy, it starts on page 14.

[Bonobo]

20. "Starts" on page 14? Wow, how could anyone miss THAT?

I think there's a problem if you have to read through 14 unreadable pages before you can even get to that.

Does that strike you as an appropriate warning?

Consider the plusses vs. the minuses here.

PLUS= anti-depressant
MINUS= deformed baby.

Sort of out of whack, no?

[Sgent]

21. All prescribing information is like that

The pregnancy side effects are found in the same approximate place in every one I've seen. Physicians should know where to look, patients not so much.

As for being depressed, if the mother suffered from major depression, then it might be worth taking the chance depending on suicide and self harm potential. There are other antidepressents without this side effect, but apparently either the physician didn't know / look up the side effects, the physician didn't discuss this with mom, or mom and the physician decided to continue treatment despite the risks.

In the first two options, the physician should be held liable, but I don't see how GSK is responsible.

One final note, prior to the publication of the studies mentioned in the prescribing info, paxil was either Class B or C (not sure which), meaning that there were either no studies showing adverse effects, or there were studies showing adverse effects in animals but not humans to date.

[Bonobo]

22. Yeah, I know.

My wife was given a varicella vaccination shot (chicken pox) and then we found out later she was pregnant.

We had to read through all studies available and contact Merck. It was still pretty scary and unclear. Not enough studies done, it amounted to.

Everything is fine, but it sure was a scary time.

Individual decisions vis a vis the flu shots may not always be in line with govt's desires. Different motives at work.

[Celebration]

19. I wonder, too

Unless the warning came too late, but they had evidence prior to the warning. Has it always been there? If they had the evidence, but failed to put it into the insert in a timely fashion, that could be the problem.

I sure want people to have a wide variety of drugs to choose from, but we have to know the evidence, pro and con.

[OffWithTheirHeads]

14. The real problem is that we have been lied to, cheated and robbed

by almost every institution we used to have faith in. Questionable business practices have been with us throughout history but the Bush turned EVERYTHING into the wild, wild West. You really are on your own in the wilderness now days.

Now, no-one has ANY credibility. We have been scammed by everyone from the president on down. The FDA, the EPA, Fema, the SEC, the FCC, the banks, big Pharma, ALL insurance companies, the news media, the oil companies, the utility co.s, hell, even the ad in your paper telling you that they will install a new furnace in your home for $1,500.00 is a scam.

The faith that we the people used to have in our social institutions to more or less do the right thing and play by the rules has been so eroded that we can't trust in anything anymore. The social fabric that used to hold us together as a nation has been shredded to the point that it is not only hard, it's dangerous to believe anything anyone tells us.

Ronnie Ray-gun said "Trust but verify." I say don't trust until you can verify.

That said, I still have faith in the public library system but the powers that be are trying to de-fund those as fast as they can.

We are being Shock Doctrined folks.

[TZ]

16. And yet, no one reports on the thousands of people

like me that take their scripts (and some powerful ones like interferon-that has a list of potential side effects a mile long) with no problems EVER and have their lives saved because of them.
How is it we all scream about the MSM when it comes to most stories, but anytime a story about a bad problem with medicines pops up and is distored and fear mongered as usual its EVUL PHARMACEUTICALS NOT the true story..the media blowing things out of proportion.
As for the scare mongering story about the influenza vaccine...Its long been known that on a rare occasion people can have serious side effects from them. ON ANY INFORMATION SHEET that you get when you get the vaccine IT TELLS YOU THIS.
Once again, I'm astounded by the lack of critical thinking skills on this site. But hey..if screaming EVUL PHARMA SHILL works for you have at it!:sarcasm:

[The Straight Story]

17. They don't report them because working is the expected behavior

"As for the scare mongering story about the influenza vaccine..Its long been known that on a rare occasion people can have serious side effects from them"

Which is why so many are against mandatory vaccines. I don't mind getting them myself, they don't scare me personally.

But I still believe "Her Body, Her Choice" is not just for abortion.

It is a medical procedure and carries risk, and the one taking on that risk should have a choice.