[Serkevan]

I'm all for making pharma companies liable for the vaccine damages.

But if we start with that, I also want unvaccinated people to be liable for their spreading the disease. You were not vaccinated, spreaded the disease to a family member in a breakthrough infection and they died? Manslaughter. Sounds like a fair deal.

[reh321]

I'm all for making pharma companies liable for the vaccine damages.

But if we start with that, I also want unvaccinated people to be liable for their spreading the disease. You were not vaccinated, spreaded the disease to a family member in a breakthrough infection and they died? Manslaughter. Sounds like a fair deal.

A Michigan-based big box store has replaced their ‘unvaccinated people please wear masks’ at eye-level on their entrance doors with ‘everyone please wear a mask’ sign. When we went shopping on Monday, about half the people - including store employees - were not wearing masks. Last week I noticed a number of unmasked families, including small children who could not possibly be vaccinated, so I would guess that no one in the family was vaccinated. I just keep my distance from them, and am glad that I am vaccinated.

[aslyfox]

FYI

Covid-19 vaccine booster shots to be offered to Americans beginning September 20, health officials say

US health officials and medical experts announced in a joint statement on Wednesday that booster doses of Covid-19 vaccine will be offered this fall, subject to authorization from the US Food and Drug Administration and sign off from the US Centers for Disease Control and Prevention.

"We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual's second dose," US health officials, including CDC Director Dr. Rochelle Walensky and FDA Acting Commissioner Dr. Janet Woodcock, said in the statement . . .

Covid-19 vaccine booster shots to be offered to Americans beginning September 20, health officials say

[Wheatfield]

FYI
Covid-19 vaccine booster shots to be offered to Americans beginning September 20, health officials say[/url]

For those of us in Canada who got mixed doses of vaccine (example: Astra Zeneca as a first dose, Pfizer as second), booster shots will be made available for those planning to travel to locations where mixed doses aren't recognized.
My wife and I are in that group. I'm planning on getting a booster in the next couple of weeks.

[MarkJerling]

Tell me about it
Were you getting a lot of green stuff ?

Yes, went on for ages. I'm still not 100% clear and it's been weeks.

[barondla]

From what I can tell, 100 percent of migrants are tested at some point during their journey. Is the Biden administration 'not even testing' migrants released in the U.S.? I don't find the Washington Examiner a very trustworthy source.

As far as "emergency approval" for the vaccines, they are expected to have full approval in September. I don't really think that it will change anybody's mind at this point. People believe what they believe and the FDA's approval will be taken as a sign that they are under Big Pharma's control by those who don't wish to get the vaccine. Full FDA approval of Pfizer's COVID vaccine is coming soon. What that means | Fortune

Many Americans don't believe the FDA about any drugs. It isn't just political. Turn on the TV and there is commercial after commercial suing drug companies for drug side effects. The FDA approved every one of those drugs and can't be sued. Why would anyone trust them?

Thanks,
barondla

[Rondec]

Many Americans don't believe the FDA about any drugs. It isn't just political. Turn on the TV and there is commercial after commercial suing drug companies for drug side effects. The FDA approved every one of those drugs and can't be sued. Why would anyone trust them?

Thanks,
barondla

I guess. I have a little less trust of the law firms who are trying to make money by suing. The problem is that if you take all of the medications with side effects off the market you wouldn't have much left. Cholesterol medications are cheap medications (much cheaper than a coronary artery bypass) and are some of the best things we have at preventing coronary artery disease. They also have the possibility of causing liver inflammation and muscle break down. But maybe they should be taken off the market to prevent the possibility of damage to a few people.

(My perception is that if a medication has relatively small number of side effects and benefits people it will be allowed to be sold, but where that risk benefit ratio is at is beyond me).

---

Last edited by Rondec; 08-19-2021 at 02:15 AM.

[swanlefitte]

Turn on the TV and there is commercial after commercial suing drug companies for drug side effects.

I can't think of one. Hernia mesh and abestos are the 2 I hear constantly. What drugs?

[barondla]

I can't think of one. Hernia mesh and abestos are the 2 I hear constantly. What drugs?

Singular, Belviq, Zantac, Xeljanz, etc. All still in litigation.

Thanks,,
barondla

[Wheatfield]

Many Americans don't believe the FDA about any drugs. It isn't just political. Turn on the TV and there is commercial after commercial suing drug companies for drug side effects. The FDA approved every one of those drugs and can't be sued. Why would anyone trust them?

Thanks,
barondla

Yeah, but you guys are notorious for suing for practically no reason.
Lawsuits are as American as baseball and apple pie..

[MarkJerling]

Singular, Belviq, Zantac, Xeljanz, etc. All still in litigation.

Thanks,,
barondla

In all cases, the FDA has acted responsibly.
For Singulair, see: FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast | FDA
For Belviq, see: FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market | FDA
For Zantac, see: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market | FDA
For Xeljanz, see: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) | FDA

With the large numbers of doses given, we now have more data about the various Covid-19 vaccines than many other medicines and vaccines.

[barondla]

In all cases, the FDA has acted responsibly.
For Singulair, see: FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast | FDA
For Belviq, see: FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market | FDA
For Zantac, see: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market | FDA
For Xeljanz, see: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) | FDA

With the large numbers of doses given, we now have more data about the various Covid-19 vaccines than many other medicines and vaccines.

This is bigger than Covid. People see lots of FDA approved drugs recalled. It is easy to see why many don't trust the FDA. Many feel they should have caught most of these problems before approval. Everyone isn't a doctor or scientist and aren't going to research all these drugs. But, they will see the TV commercials.

The CDC, and other world health organizations have similar problems. Their recommendations have been all over the map. People have a difficult time placing a lot of confidence in them. The science may be great - the presentation has been very sloppy.

Thanks,
barondla

[reh321]

Many Americans don't believe the FDA about any drugs. It isn't just political. Turn on the TV and there is commercial after commercial suing drug companies for drug side effects. The FDA approved every one of those drugs and can't be sued. Why would anyone trust them?

Thanks,
barondla

Being sued means nothing; losing repeatedly is what matters. When she was in 7th and 8th grades, our older daughter had a friend whose father received government benefits because emphysema prevented him from working. Later, he died on the operating table, and the insurance company offered the family a $500,000 payment. My view was that they should take the money and run before the insurance company changed their minds, but some lawyer convinced the family that he could get a payment of several million dollars for them. After a trial, they received nothing. Several law firms advertise during our thirty minute local news broadcast every night. The FDA is much more believable than lawyers are.

[Wheatfield]

This is bigger than Covid. People see lots of FDA approved drugs recalled. It is easy to see why many don't trust the FDA. Many feel they should have caught most of these problems before approval. Everyone isn't a doctor or scientist and aren't going to research all these drugs. But, they will see the TV commercials.

The CDC, and other world health organizations have similar problems. Their recommendations have been all over the map. People have a difficult time placing a lot of confidence in them. The science may be great - the presentation has been very sloppy.

Thanks,
barondla

The real problem is people are extremely poor at risk assessment. There is always a risk no matter what we are doing.
People see a one in a million risk with a covid vaccine and forget that the alternative is a one in 50 risk of dying.

[Rondec]

Singular, Belviq, Zantac, Xeljanz, etc. All still in litigation.

Thanks,,
barondla

These are all different types of issues. The ranitidine issue had to do with NDMA contamination. It isn't clear to me if this is a manufacture issue (several other medications were withdrawn for contamination with NDMA in 2020) or a metablizing issue. The medication was completely taken off the market when the issue was identified.

Singulair is a medication that is relatively safe. It actually isn't used frequently (probably more so, now that it is generic), but is often added to antihistamines/inhaled corticosteroids for difficult to treat asthma. Personally, I am glad that it is still on the market -- I think the point of the warnings was not to use the medication for mild cases and that doctors warn patients about possible side effects, as these resolve rapidly with discontinuation.

The Belviq situation was a difficult one. A five year trial showed slight increase risk of cancers (7.7 percent in Belviq group versus 7.1 percent in placebo group). This is the sort of thing that requires large trials for extended periods of time to identify and it is not surprising that it took time to ferret it out. Once the data was in, the FDA acted quickly and pulled the medication.

I actually think the FDA does a pretty good job of approving medications and doing post hoc analysis and adding warning labels to medications as issues come up. Medications with serious side effects should still be allowed on the market, if they are there for life threatening diseases. On the other hand, they shouldn't be used for mild, self-limited diseases.

If the FDA falls down, it is in monitoring off shore generic makers. They currently do inspections every five years and a lot can happen in that time. This is probably not frequently enough to identify issues with generics, but it is the level of funding that they get.

---------- Post added 08-19-21 at 05:57 AM ----------

This is bigger than Covid. People see lots of FDA approved drugs recalled. It is easy to see why many don't trust the FDA. Many feel they should have caught most of these problems before approval. Everyone isn't a doctor or scientist and aren't going to research all these drugs. But, they will see the TV commercials.

The CDC, and other world health organizations have similar problems. Their recommendations have been all over the map. People have a difficult time placing a lot of confidence in them. The science may be great - the presentation has been very sloppy.

Thanks,
barondla

COVID has been a really tough situation. Recommendations now versus a year and a half ago have changed due to studies showing what things have worked and what haven't. Early on, the CDC didn't recommend wearing masks unless you felt sick and then you were really supposed to be in isolation. This was because they didn't think there was much asymptomatic spread and there was a shortage of personal protective equipment for health care workers. Later, it turned out that probably at least 50 percent of the spread of COVID is done by presymptomatic and asymptomatic individuals and there was no longer a mask shortage and they changed their recommendations.

I think the CDC is ready to recommend that people get COVID vaccine boosters at 8 months. The WHO thinks that they aren't needed yet and it will decrease world supply of vaccine. The issue is that we are seeing more breakthrough infections with COVID, but for the most part they are relatively mild disease, not requiring hospitalization. Whether this truly warrants a booster or if we should wait a little longer probably depends on your perspective.

As far as medications, it takes a lot of post-hoc analysis and monitoring to identify some of the issues in them. It would be nice, I suppose, to have trials lasting ten years that involved a million patients. The reality is that no one could afford such a trial and it would take too long to get medications to the people who need them. What ends up happening is a few thousand people are in the Phase 3 trial for 2 to 3 years. This is enough to identify most major, common side effects, but there are still plenty of things that can crop up down the line.