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WaPo Frets over Drug Safety Risks While Ignoring Vaccine Risks

Disconnect-old-phoneNOTE: From Washington Post - imagine that? Drugs are approved and then found to have risks? Say it ain't so! But vaccines? Oh don't be a silly ninnny!  Vaccines are virgin fairy pee and miniature unicorn farts from the moment they are dreamed up by pharma to "cure" the next deadly scourge.   This disconnect between "drugs" and vaccines is laughable. And cry-able. One is open to lawsuits, the other is protected by the government. And that (legal road less traveled) has made all the difference.

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New safety risks detected in one-third of FDA-approved drugs

Almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval, according to a study published Tuesday.

The researchers said the study, which appeared in JAMA, shows the need for ongoing monitoring of new treatments years after they hit the market.

“We seem to have decided as a society that we want drugs reviewed faster,” said lead author Joseph Ross, an associate professor of medicine and public health at Yale University. That makes it critically important “that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively,” he said.

To win FDA approval, medications must be shown to be safe and effective. But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients.

“No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals,” said Ross.

The researchers reviewed 222 products approved between 2001 and 2010 and followed them through February of this year. With 32 percent of the medications, they found, the FDA took some kind of action to deal with safety issues that emerged after approval.

Three of the drugs were withdrawn from the market. The FDA also required 61 new black-box warnings — the agency's most serious safety alert, included in the drug's packaging — and issued 59 safety communications to inform doctors and consumers about newly identified concerns. Some products had more than one boxed warning added or safety communication issued over the time of the study.

The median time for an FDA action was 4.2 years after approval, according to the study.

Eric Topol, founder and director of Scripps Translational Science Institute, who was not involved in the research, said he wasn't surprised about the safety risks, but added, “the fact that it is one out of three of FDA-approved drugs is troubling.”

Part of the problem, he said, is that clinical trials often cherry-pick patients likely to produce the best results. “We don't get a real-world representation,” he said.

He suggested that the agency consider granting new drugs conditional approval, then collect safety data from every patient to see, early on, whether a problem emerges. “Why not have a standard where we put every new drug under watch, and see if we could catch a problem before the drug is widely advertised?” he said.

Comments

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Laura Hayes

David Burd...thanks for the shout out :)

Michael, super ideas regarding who the test subjects should be! Maybe one of our creative AoA readers can create a meme for your ideas!

michael

Drugs and vaccines need to be tested on those who prescribe them. If the government mandates a vaccine, it needs to tested on those who regulate, administer, evaluate or anyone involved in the supply chain. If it is a vaccine targeting pregnant women, fetuses, infants or children under age 6, it needs to tested on those closest to the production of the vaccine and not as controls.

Bob Moffit

@ kws

I forgot to post the site I recommended for reading on FDA approval of Gardasil ......

http://jwatch.us/VaccineRecords

kws

OK Bob, I read it. Immediately below is one of the tragic excerpts, there were many others.

"Information has been received from a physician’s assistant concerning a 12-year-old female with no reported medical history who on approximately 15-Sep-2007 was vaccinated with Gardasil . . . On 06-OCT-2007 the patient died in her sleep. No further information was provided. VAERS ID: 297528-1 (D)"

Gardasil is just more poison from Merck, just like the MMR which crippled my son when he was 2 years old. It sucks and it shattered our lives. We'll never get another chance.

To my statement on faster drug approval, AIDS activists rallied in the late 80's to gain access to experimental drugs faster. I believe this was warranted. I also support access to stem cell therapies in some situations. It doesn't excuse shoddy clinical work by Merck on Gardasil or the MMR. That's corruption and bad science. For example, longer trials are clearly indicated for MMR since the onset of autism can take time and is difficult to diagnose at an early age. The efficacy of Gardasil against cancer itself needs to be proven, apparently they studied precancerous lesions. Aluminum adjuvants need to be tested against placebo for both. In my opinion, both vaccines deserve a black box warning.

For drugs with incomplete data. Well, many good folks with AIDS did this and did it by choice. Some benefited, some didn't, but at least they had a chance. Other folks take Viagra and we really don't have generational data on it. Until a drug is out there for many, many years, we really don't know the full gamut of side effects. Gardasil is different...we do know the risk to benefit ratio is grossly inverted and should not mandate that crap anywhere. Japan and Canada have apparently figured this out. Merck pushes it through our system by bribing politicians, the press, and doctors. That's corruption.

Mandatory usage of ANYTHING is against my beliefs, and the Nuremburg code. Sorry my response is so long but that was a long, frightening, and revealing article. thanks

david m burd

All, darn it! -- Here's the actual 10 minute Gary Null flu vaccine testimony before the NY State legislators; the previous youtube by Gary Null was sent by accident. Pass them both on!

https://www.youtube.com/watch?v=y3XlJB7J5-o

david m burd

All, and a special shout-out to Laura Hayes (just in case this has escaped her),

This 10 minute youtube is the most riveting public-testimony indictment of vaccine carnage I've ever seen; Gary Null focuses several times on vaccines causing autism and other neurological damages, also the complete lack of ALL vaccine trials lacking true placebos - and also being very short term.

https://www.youtube.com/watch?v=Ch5OuzB9L48

Pass it on!

david m burd

Laura Hayes for one has many times revealed the facts:

1) That ALL vaccine "safety" tests/trials (for at least the last 30 years) were done short term for maybe 3/4 weeks - and

2) NONE of these tests/trials have used a true saline solution as a so-called placebo but instead use another toxic vaccine (or similar) containing all its toxic excipients, changing only the also-toxic "disease antigens."

Others that have revealed this incredibly dishonest vaccine test/trial FRAUD include Dr. Gary Null testifying before the NY State Assembly Health Committee in 2009 fighting the new mandatory H1N1 flu vaccine for health care workers (admitted by the CDC to have 25 micrograms of ethlymercury). Null's testimony was riveting and taped for public release, and this time the flu vaccine mandate was reversed. I'll try to put this UTube tape on a subsequent comment.

Bob Moffit

@kws

"Faster drugs...fine.
Drugs with incomplete safety data....okay.
Mandatory drugs with incomplete safety data...no thanks.

If you have the time .. shouldn't take more than 30 minutes .. I recommend reading this site .. Judicial Watch .. an organization that has been very pro-active regarding the dangers of the Gardasil vaccine .. which outlines 24 (brief) pages of "discovery" they received through filing Freedom of Information requests .. including VAERS reports and the shoddy, flawed process .. by which Merck received "fast track" approval for Gardasil.

As bad as "fast track" FDA approval for drugs are .. at least MERCK had to pay approx. 1 BILLION because of Vioxx .. it is even worse when the FDA "fast tracks" MERCK's Gardasil vaccine .. because .. WE THE PEOPLE HAVE TO PAY FOR THE DAMAGES CAUSED.

Margaret J. Jaeger

Just a comment on this last repost...how can theybflag 77 out of 22 drugs? Are the numbers backwards...or I'm just not understanding. Also such a surprise of this article came from the Washington Post...or was that referring to the first paragraph only..? I don't read the Post so don't know for certain but think this is among a rare printing of a negative about vaccine approvals and injuries. But, it wasn't concluded with any reasons Why the drug companies were allowed by CDC, FDA, etc. to use these faulty products.....

Laura Hayes

"But many pivotal clinical trials used for approval involve fewer than 1,000 patients with follow-up of six months or less, according to the study. Safety problems often crop up years later after therapies have been used by much larger numbers of patients."

I can top that. Read the section of my WAPF presentation which covers the "testing" of Merck's Recombivax Hepatitis B vaccine for newborns. It is about 2/3 of the way in.

http://www.ageofautism.com/2016/12/vaccines-what-is-there-to-be-pro-about-laura-hayes-to-weston-a-price-foundation-conference.html#comments

kws

Faster drugs...fine.
Drugs with incomplete safety data....okay.
Mandatory drugs with incomplete safety data...no thanks.

Mark Wax

I know Dr. Topol from my association with Cleveland Clinic. If you will recall the events leading up to the damage done by Vioxx, allow me to remind people of the following. Dr. Topol stood up and did his duty. He exposed the dangers of Vioxx use along with Dr. Nissen. The politics at Board level led to Dr. Topol being forced out at Cleveland Clinic. P. S. The Chairman of Merck, maker of Vioxx, had plenty to do with it. The community lost an outstanding cardiologist and Dr. Topol proved to be hero. He stood by his oath. You must be willing to do the right thing at any cost. He is living proof.

Bob Moffit

(With apologies .. this was submitted in yesterday's AoA .. but .. I think it is better suited for today's)

If it were not for having "double standards" .. the NY Daily News and NY Post EDITORS .. (indeed, most major media outlets) .. would have NO standards at all.

Consider the following ... not only a small item .. but .. also published in small print .. buried on page 19 in today's NY Post .. as compared to the routine editorials and full page attention BOTH papers routinely have given to ANY measles outbreak .. seizing ANY opportunity to demonize RFK, Dr Wakefield .. while spewing how "safe and effective" the EDITORS of BOTH papers believe them to be:

"Almost one-third of new drugs approved by US regulators over a decade ended up years later with warnings about unexpected, sometimes life-threatening side effects or complications, a Yale University analysis has found. The researchers flagged 71 of 22 prescription drugs as having safety issues such as increased risks of serious skin reactions, liver damage, cancer and even death"

Remember .. the very SAME EDITORS that all but buried the YALE research that found almost one-third of ALL new drugs approved by regulators .. end up having "safety issues" including increased risks for live damage, cancer and even death .. are the very SAME EDITORS that viciously OPPOSE ANY suggestion that our President seek a Commission to study the "safety and efficiency" of vaccines?

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