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Court Orders Merck to Produce Entire Database of Gardasil Adverse Events.
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2023 Apr 11, 5:49am 317 views 3 comments
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1
KgK one
2023 Apr 11, 12:12pm
Merck has done well, even without creating covid vaccine. Vulture lawyers are hovering it.
Pharmas have very robust safety AE adverse event systems. They record all AE from doctors, phone calls, facebook ,twitter... and provide report to fda within 15 days.
Even employees are asked to report anything they hear,or see so they can follow up an investigate.
Typical pharma spends about 1 to 2 billion to comeup with a new product and about 10 years of testing, bulk of it Clinical trial to see safety and efficacy. blackbox phamplet covers all side effects, its up to user to evaluate and make decision if its worth it. This is risk based approach.
Typical NDA new drug application can be thousands of pages.
Point is more regulation means More tests , time for drug to be in market/ save people and more it will cost.
Be careful what u wish.
Since fda already has most of this info, giving detailed version should not be an issue.
Pharmas have very robust safety AE adverse event systems. They record all AE from doctors, phone calls, facebook ,twitter... and provide report to fda within 15 days.
Even employees are asked to report anything they hear,or see so they can follow up an investigate.
Typical pharma spends about 1 to 2 billion to comeup with a new product and about 10 years of testing, bulk of it Clinical trial to see safety and efficacy. blackbox phamplet covers all side effects, its up to user to evaluate and make decision if its worth it. This is risk based approach.
Typical NDA new drug application can be thousands of pages.
Point is more regulation means More tests , time for drug to be in market/ save people and more it will cost.
Be careful what u wish.
Since fda already has most of this info, giving detailed version should not be an issue.
2
Al_Sharpton_for_President
2023 Apr 11, 3:32pm
Al_Sharpton_for_President
2023 Apr 11, 3:32pm
KgK one says
Companies should not release products that have significant adverse events for indications that are not life threatening, like sexually transmitted HPV. A condom can prevent transmission. In cases of convenience, a higher bar of safety needs to exist.
Merck (the Vioxx company) has done well, even without creating covid vaccine.
Companies should not release products that have significant adverse events for indications that are not life threatening, like sexually transmitted HPV. A condom can prevent transmission. In cases of convenience, a higher bar of safety needs to exist.
3
KgK one
2023 Apr 12, 7:17am
All drugs have side effects. Significant AE is relative term. They have tons of statistical studies with .01 critical value , highest of any industry. People die from food poisoning , and power tools etc we don't ban them.
You know we can't even make cars with 100 parts correctly, so many defects and recalls. Human body has millions of parts all interacting with each other. Each drug is a miracle going from 40 yr lifespan to 80 years in last 100 years. There are cures and relief for so many diseases.
They catch most of the side effects during 10 yr clinical trial. And monitor after to see if any major side effect appear, also it gets listed and fda get notified in 15 days.
What I don't agree is sometimes government mandates these drugs and that is not needed.
E.g. forced covid vaccine
It should be personal choice. Each person should evaluate pro n cons n pick if drug works for them.
Hpv can be prevented by condom so can all others stds. But if you get hpv, you can also die from cancer and may not be able to reproduce j lifetime. It should be available in High risk areas .
You know we can't even make cars with 100 parts correctly, so many defects and recalls. Human body has millions of parts all interacting with each other. Each drug is a miracle going from 40 yr lifespan to 80 years in last 100 years. There are cures and relief for so many diseases.
They catch most of the side effects during 10 yr clinical trial. And monitor after to see if any major side effect appear, also it gets listed and fda get notified in 15 days.
What I don't agree is sometimes government mandates these drugs and that is not needed.
E.g. forced covid vaccine
It should be personal choice. Each person should evaluate pro n cons n pick if drug works for them.
Hpv can be prevented by condom so can all others stds. But if you get hpv, you can also die from cancer and may not be able to reproduce j lifetime. It should be available in High risk areas .
Western District of North Carolina, issued an order on March 20, 2023 in which he stated, “[p]laintiffs’ and their experts should have the same opportunity as Merck to review and analyze the entirety of the data.”
The data Judge Conrad refers to in his order consists of all information from Merck’s Adverse Event Reporting and Review System (MARRS), which is the company’s internal version of the federal government’s Vaccine Adverse Event Reporting System (VAERS). The government created VAERS as a vaccine surveillance program to help track “unusual or unexpected” adverse events following vaccination. While the data in VAERS is publicly available, Merck has fought to withhold its complete MARRS database from Gardasil plaintiffs’ attorneys.
That sequestering of key adverse event data will end with Judge Conrad’s order. Attorneys for plaintiffs suffering post-Gardasil injection autoimmune conditions like postural orthostatic tachycardia syndrome (POTS) and premature ovarian failure (POF) will now have access to all of Merck’s reports pertaining to HPV vaccine adverse events as submitted by doctors, patients, publications, and from its clinical trials of Gardasil.
“This order is another step in the process toward transparency, which is something we will always fight for when it comes to consumer safety,” says Wisner Baum senior partner Bijan Esfandiari, who is on the plaintiff’s leadership in the Gardasil HPV vaccine MDL.
Senior partner Michael Baum, who works alongside Esfandiari stated, “Gaining access to the entire Gardasil adverse event database enables expert scientists who have been demanding this information for years to finally research the patterns of complex autoimmune conditions, not just the sequestered view Merck had been imposing.”
Wisner Baum serves as one of the co-leads in the consolidated Gardasil litigation representing the majority of Gardasil-injured women and men who allege Merck knowingly and fraudulently concealed the HPV vaccine’s risks. Some of the most common side effects alleged in Gardasil lawsuits include:
• Auto-immune disorders
• Chronic fatigue syndrome
• Chronic regional pain syndrome (CRPS)
• Dysautonomia
• Fibromyalgia
• Movement disorders
• Postural orthostatic tachycardia syndrome (POTS)
• Premature ovarian failure (POF)
In 2022, the Judicial Panel on Multidistrict Litigation (MDL) consolidated all federally filed Gardasil cases before Judge Conrad in North Carolina, where more than 75 claims have been consolidated. Another 80 cases that have already gone through the mandatory Vaccine Injury Compensation Program (VICP) are expected to be filed in the MDL in 2023. At least 200 additional cases are currently pending in the VICP, and another 150 are under review. Most of these cases will likely end up in the federal Gardasil MDL. The Gardasil MDL is captioned In Re: Gardasil Products Liability Litigation MDL No. 3036. It is also known as 3:22-md-03036-RJC.
As of 2023, the VICP program has paid roughly $70 million in compensation to girls and boys injured by the Gardasil vaccine. Until recently, the U.S. Food and Drug Administration (FDA) had received more adverse reaction reports related to Gardasil than any other vaccine in history.
https://www.wicz.com/story/48681181/court-orders-merck-to-produce-entire-database-of-gardasil-adverse-events