Close to one-third of drugs approved by the FDA are found to have safety problems, according to a research report from The Journal of the American Medical Association.

JAMA’s report stated that these safety issues, known as “postmarket safety events,” are “common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

The study sought to identify the “frequency of postmarket safety events” of FDA-approved drugs. It revealed that 222 “novel therapeutics” were approved by the FDA between 2001 and 2010. Out of those 222 FDA-approved products, there were 123 safety issues later found in 71, or 32 per cent, of the approved drugs. Actions taken for the 71 drugs included withdrawal of the substance, new safety announcements highlighting discovered risks, and issuing “black box” warnings.


These safety problems “were more frequent among biologics, therapeutics indicated for the treatment of psychiatric disease, those receiving accelerated approval, and those with near–regulatory deadline approval,” according to the report.

Products that completed speedy reviews were not necessarily as likely to see safety complications down the road. However, drugs that were approved by the FDA near the review deadline were more likely to reveal future problems.

“The authors interpreted this as suggesting that if drugs have strong pre-market safety data and can sail through their reviews, it may be a good indicator of their overall safety. Whereas, when drugs get hung up in their reviews, possibly because regulators are trying to parse weak or questionable pre-market safety data, it may be a red flag that there are post-market safety problems to come,” noted Ars Technica.

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Another problem highlighted in the study was drugs approved by the FDA via “accelerated” reviews also ending up with safety issues.

The public would likely and see tremendous benefit, and a decline in detrimental complications, with more thorough and consistent follow-up reviews of approved drugs. Legislators have continuously pressed the FDA to speed up their drug approval process while paying far less attention to the long-term safety of these drugs once available to the public.

In investigative journalist Ben Swann’s 2016 Truth In Media episode examining the relationship between the FDA and the pharmaceutical industry, Swann spoke with Emory University Professor Doug Bremner about the issues with the FDA’s follow-up on approved drugs. Bremner told Swann that Congress limited the budget of the FDA in past years, “but they’ve also demanded that they increase the speed of which they approve drugs.

So the number of people working on new drug approval has been increasing at the expense of those who are supposed to be watching the drugs coming onto the market.”

The 21st Century Cures Act, passed by former President Barack Obama in December 2016, aimed in part to further speed up the drug approval process. The Act allows the FDA to include “real world” evidence to approve drugs, “the kind provided by patients using the medication in a real-world setting as opposed to carefully designed and controlled trials,” according to a report published by the Dallas Morning News.

This could potentially lead drug companies to move away from opting for long-established clinical trials. Dr. Giuseppe Giaccone, the associate director for clinical research at Georgetown University, told the paper that this is “pretty bad for the FDA and very bad for patients, but it’s good for drug companies” and that it allows drug companies “more freedom to do whatever they like.”

New Hampshire-based writer Annabelle Bamforth is focused on breaking the left/right paradigm through new media and local politics. Annabelle is the editor-in-chief of Emmy-winning journalist Ben Swann's Truth In Media Project and a producer for Mr. Swann's Truth In Media episodes.
  • Steven Toal

    its more than 30%

    • JGC

      Citations, please.

  • Deplorable Nate

    Its all about the profits for the Pharmaceutical Industrial Complex. People do not matter for these money junkies as their mindset is this Profits come first, and people don’t matter.

    • IceTrey

      Wouldn’t having people sick from the vaccinated diseases be more profitable for them?

      • mark

        do the maths? A life time of meds vs days of fever – even hypothetically – big difference?

      • Heather James

        No. Vaccinated kids are far more likely to have chronic issues, requiring daily medication, for many years, even for life. Most diseases for which we vaccinate only make pharma money if there are (rare) complications. Vitamin C, oatmeal baths, Vitamin A, and other normal supports for measles, chicken pox, pertussis, etc, make no money for pharma

        • JGC

          “Vaccinated kids are far more likely to have chronic issues, requiring daily medication, for many years, even for life.”

          Citations needed.

          ” Vitamin C, oatmeal baths, Vitamin A, and other normal supports for measles, chicken pox, pertussis, etc, make no money for pharma”

          Vitamin C, oatmeal baths, Vitamin A, and other normal supports for measles, chicken pox, pertussis, etc. also do absolutely nothing to reduce the incidence of these infectious diseases, to alter the course of an infected person’s disease, to reduce the number of hospitalizations and deaths that occur due these diseases, etc.

    • Mick Price

      Why would it be profitable to market unsafe drugs without the FDA? Without them the only assurance that the drug was safe would be the Pharma companies word, and they could be sued for getting it wrong. Now however they can say “Hey the government said it was OK, why shouldn’t we have sold it?”. It’s not that it makes it impossible to show the company was negligent but it makes it a lot harder.

      Ditch the FDA and let the free market work it out with lawyers. It’s actually LESS expensive.

  • IceTrey

    One study is not science.

    • mark

      selective deletion is corrupting science

      • IceTrey

        It’s the internet there are a billion other places to post it.

        • DonRice

          You seem to be missing the point. It was deleted in spite of being peer reviewed. That alone is cause for concern and articles like this should be spread far and wide.

          • IceTrey

            A lot of peer reviewed stuff turns out to be wrong.

          • Robert Zemojtel

            Sooo you’re supporting big pharmacy with an anonymous mask for a face… that’s a little oxymoronic…. How many studies can you list that you trust that were supported and conducted by the FDA or CDC… Knowing that they do intentionally poison us?

      • Jason Keep

        The study was pulled because it was found to be inaccurate. The results were based on mother’s reports as well. Studies are not science. It’s one study. I’m sure there are plenty of articles that do get pulled because they contradict popular opinion. This is not one of them though. This is why it’s important to do your research don’t blindly trust everything.

        • Dan Quixoté

          Can you provide a link to a source detailing its alleged inaccuracies, or enumerate them yourself? Or are you just making that up?

    • Heather James

      It’s not “one study”. Similar surveys have been done in Europe and New Zealand. With similar results.

      It’s very interesting that the inquiry over why the study was pulled was referred to the funding dept. Sounds like one of their funding sources was displeased with the journal publishing the info

      • Dan Quixoté

        You might want to post links to those studies you mention to bolster your case.

      • Robert Zemojtel

        I would like those links too so I can show my family that I do understand what I’m talking about and am not just some kook

  • Ilse Botes

    Why is proper and full information not available to all? Why is some research suppressed and other findings trumpeted as gospel? Makes you think and this is what feeds the doubts and mistrust. You cannot present a reasonable argument if your language is peppered with emotional terminology or you resort to name-calling.

  • mdak06

    “Incidentally, this isn’t the first time this study has been pulled from the Internet: the same thing happened last year, under similar circumstances — i.e., furious backlash on methodology and sampling — but, notably, not for the results.”

    If the methodology and the sampling is flawed, then that would suggest that the results are not reliable.

  • adam

    you don’t even need science or fact to disprove government backed studies. if it sounds like they are lying that’s good enough for me

    • JGC

      Because gut instinct trumps actual evidence any day, right?

  • Donald Bezzina

    One study is not the be all and end all of this saga but shall we go back to the Polio cases that left disabled kids in a wheelchair for life- just to mention one disease that has almost been eradicated but for sheer ignorance.

    • Dan Quixoté

      About that polio business some folks like to parrot. It wasn’t that common as portrayed in the media, and was already in steep decline prior to Salk et al; “…before Salk developed his vaccine, polio had been constantly regressing; the 39 cases out of every 100,000 inhabitants registered in 1942 had gradually diminished from year to year until they were reduced to only 15 cases in 1952… according to M. Beddow Baylay, the English surgeon and medical historian.” Slaughter of the Innocent, Hans Reusch, Civitas Publishers, Switzerland, and Swain, New York, 1983.

      “Many published stories and reports have stated, implied and otherwise led professional people and the public to believe that the sharp reduction of cases (and of deaths) from poliomyelitis in 1955 as compared to 1954 is attributable to the Salk vaccine… That it is a misconception follows from these considerations. The number of children inoculated has been too small to account for the decrease. The sharp decrease was apparent before the inoculations began or could take effect and was of the same order as the decrease following the immediate post-inoculation period.” Dr. Herbert Ratner, Child and Family, vol. 20, no. 1, 1987

      In fact, the polio vaccines CAUSED more cases than they prevented. Both Ratzner and SALK himself confirm this: ““So far it is hardly possible to gain insight into the extent of the immunization catastrophe of 1955 in the United States. It may be considered certain that the officially ascertained 200 cases (of polio) which were caused directly or indirectly by the (polio) vaccination constitute minimum figures… It can hardly be estimated how many of the 1359 (polio) cases among vaccinated persons must be regarded as failures of the vaccine and how many of them were infected by the vaccine. A careful study of the epidemiologic course of polio in the United States yields indications of grave significance. In numerous states of the U.S.A., typical early epidemics developed with the immunizations in the spring of 1955… The vaccination incidents of the year 1955 cannot be exclusively traced back to the failure of one manufacturing firm.” Dr. Herbert Ratner, Child and Family, 1980, vol. 19, no. 4, “Story of the Salk Vaccine (Part 2).”

      “Suffice it to say that most of the large (polio) epidemics that have occurred in this country since the introduction of the Salk vaccine have followed the wide-scale use of the vaccine and have been characterized by an uncommon early seasonal onset. To name a few, there is the Massachusetts epidemic of 1955; the Chicago epidemic of 1956; and the Des Moines epidemic of 1959.” Dr. Herbert Ratner, Child and Family, 1980 vol. 19, no. 4.

      “The live (Sabin) poliovirus vaccine has been the predominant cause of domestically arising cases of paralytic poliomyelitis in the United States since 1972. To avoid the occurrence of such cases, it would be necessary to discontinue the routine use of live poliovirus vaccine.” Jonas Salk, Science, March 4, 1977, p. 845.

      Or never mind. Just repeat what the box with the moving pictures on it told you to say.

      • Donald Bezzina

        There should not even be one case of Polio in 2017. We spend billions on space research but still have diseases like that…..

        • Dan Quixoté

          Clearly caring people want diseases gone. “Polio” is weird and fishy – after each new polio vaccine license is granted by FDA, simultaneously the CDC had changed the definition of polio’s aggregation of symptoms, with the apparent intent of demonstrating a step function decrease in “polio” to bolster the vaccine. But then the kids who still have the same class of symptoms get assigned a different diagnosis. Since a 1956 directive to doctors from the AMA, any chronic paralysis is now to be diagnosed as (acute flaccid paralysis), MS, MD, Bell’s Palsy, cerebral palsy, ALS (Lou Gehrig’s Disease), Guillian-Barre, etc. And you may have noticed those diagnoses are skyrocketing.

          Because I’m not omniscient, I can’t be sure of what’s going on with the whole polio fiasco, but Dr. Ralph Scobey and Dr. Mortind Biskind testified in front of the U.S. Congress in 1951 that the paralysis around the country known as polio was being caused by industrial poisons and that a virus theory was purposely fabricated by the chemical industry and the government to deflect litigation away from both parties.

          Many years ago, I personally thought the whole vaccine thing was a good idea, hacking the immune system. Bummer that it hasn’t been working out all that great. The good news I try to spread is that all these are preventable and curable by other, better means. I personally got cured of something nasty, “incurable”, and fatal by natural means, only the second natural cure case I’d ever heard of. Many years of looking into these things further, I find out people have been curing themselves of everything under the sun, and they’ve been very generous in sharing with the rest of us seekers. Anyway – from the immunology literature and human experience in circles, including my family’s, the best prevention for these communicable diseases is a highly detoxed, highly nourished body, having a deliberate equilibrium between external and internal microbes. It’s been years since I’ve gotten sick since changing all this, and we visit sick people as often as possible with no fear of catching it. It’s a good life I wish everyone could take advantage of.

  • Samuel

    It’s still online, on the funders own website:
    So it looks like there isn’t a coverup. I expect one of the authors submitted it to Open Access Text without realising that the original journal and the funders held copyright, and it has been removed for copyright reasons only. This is very common with scientific papers on any subject, it’s just routine.
    Very interesting study, I’d encourage people to click this link and read it.

    • Posting a study on the internet is not the same as having it published in a peer-reviewed journal. It’s good that it’s available to read, but it is very unfortunate that this study was accepted and then “un-accepted”…twice!

      • Samuel

        It is published in a peer-reviewed journal – the Journal of Translational Science. It has never been “un-accepted”. The published paper was then shared on an independent website, then later removed from that independent website again, probably purely for copyright reasons. Just download the paper at the link I shared and you’ll see it is a fully genuine scientific paper, not some random person’s opinion on the internet.

        • Please locate and send me a link to this study on the Journal of Translational Science website. You won’t find it. That’s because they pulled it, and have not explained why. The paper is on a website, yes, but in science it is important that a study be published in a peer-reviewed journal. I totally agree that this IS a genuine study…in fact I know the main author…however this is the CRUX of the issue here, since this study had been peer-reviewed and accepted by two different journals but then inexplicably pulled.

          If you find this study interesting, then you should learn more about the science of vaccine safety concerns and how it has consistently been silenced.

          1. Google “Simpsonwood mercury verstraeten”

          2. https://www.safeminds.org/blog/2015/10/19/safeminds-review-of-vaccine-safety-and-autism-like-outcomes-in-a-non-human-primate-model-identifies-distortion-in-public-reporting-and-argues-need-for-full-disclosure-of-research-documents/

          3. Stream the documentary VAXXED from its website.

          • FallsAngel

            The black helicopters will come for you soon, Dave.

          • JGC

            If you’re interested in the real story of the Verstraeten study reported at the Simpsonwood conference, rather than anti-vax myths that some kind of cover-up by the CDC took place, I recommend you visit

          • Ding ding ding ding!

            One of the Absolute Truths of The Pseudo-Skeptics is that anytime you mention the 1999 Verstraeten debacle, and the ensuing Simpsonwood conference where they decided that the numerous significant findings were to be “embargoed”, the pseudo-skeptic will invariably cite this article. And only this article. Don’t you all have any other articles to refute claims about this study? 🙁

            Let me break some news to you…Emily Willingham is not the sharpest tool in the shed, I’ve debated with her in online comments numerous times and she clearly does not have a strong understanding of any of these issues.

            What I would suggest is that you read information from alternative viewpoints, I’ll include some links below to get you started. See if you can get a firm understanding of (1) the initial study design and findings; and (2) the changes made to the study, at least 5 changes over a 4 year span, and how these changes resulted in a study with only one significant finding of an association between mercury exposure and tics (does that concern you?).

            Now after you have this new understanding, perhaps you can explain why the following quote, from one of the authors of the original 1999 abstract, actually shows us how the study design was changed in a scientifically inappropriate way to make significant findings go away (hint: the original study included “unexposed” children and a high exposure group, both of which were removed with no explanation provided…seriously…how would one justify these changes when exposure to mercury is what you are studying?):

            “Now with autism, if we limit it to children with exposure at either one
            month or three months of age… there is a relative risk that is no
            different than one… .”

            I pointed this out to Willingham as a top comment (initial comment, not replying to anyone else) on her article. Then we had a long and entertaining debate which she ran away from once the errors in her article were exposed. I went through the comments of this article carefully, twice, and I no longer see our interaction…it has been removed. See this is how concerns about vaccine safety are silenced.

            Here is a good overview of what is wrong with Willingham’s op/ed:


            Other links:

            Overview from Safeminds

            Put Children First Summary


            http://thinktwice.com/CDC_quashed_study.pdf (Original 1999 study abstract!)
            http://www.putchildrenfirst.org/media/2.20.pdf (Verstraeten’s letter to CDC/authors: “Disprove an unpleasant theory”)
            http://www.putchildrenfirst.org/media/2.7.pdf (letter Verstraeten to David/Destefano “it won’t go away”)
            http://www.putchildrenfirst.org/media/2.9.pdf (Transcript of meeting)
            http://www.putchildrenfirst.org/media/5.13.pdf (Verstraeten’s excuses in 2005)
            http://www.putchildrenfirst.org/media/2.3.pdf (Merck and Smithkline letters: “we can be thimerosal-free today”)
            http://www.putchildrenfirst.org/media/2.18.pdf (Robert F Kennedy’s letter responding to refusal to immediately remove mercury)

          • JGC

            Let me break it to you, David. Whether or not Emily Willingham is the sharpest tool in the shed is irrelevant. Arguments stand or fall on their own merit, not as a function of who is advancing them.

            Here are the facts:

            Verstraeten designed a two phase study to evaluate the safety of vaccines incorporating thimerosal as a preservative.

            The first phase was completed and an abstract was presented at a conference held at Simpsonwood on June 7th and 8th, 2000, offering preliminary results.

            The preliminary data suggested an increased relative risk for tics and speech delays associated with thimerosal. It also reported a increased relative risk of developing a neurological developmental disorder in the group receiving the highest exposure to thimerosal at one month when compared to the group which were not exposed of 1.8 , with a 95% confidence interval that almost includes 1 (1.1 to 2.8).

            All presentations and supporting documents were placed under a news embargo until June 21st, 2000 when they were published by the Advisory Committee on Immunization Practices (that’s a whopping 13 days).

            Verstraeten then completed the second phase of the planned two phase study, which involved analyzing records from a third health care provider as well as confirming reported diagnoses by review of medical histories. The results of the first phase of the study could not be not reproduced or confirmed in the second phase, indicating that they had represented a false positive.

            Vertraeten published a report of the completed study in 2003 (PMID: 14595043).
            Note that Verstraeten’s study is only one of multiple studies which have found no evidence of a causal association between vaccines incorporating thimerosal and neurodevelopmental disorders. In fact, the only reason it is so frequently invoked is because, unlike all other studies, it yielded a false positive after the completion of its screening phase.

          • You should take my initial suggestion and learn more about what really happened here before you further document your ignorance.

            First, like Willingham you assume that a two-phase approach existed from the outset. That is false. Verstreaten did have a multi-phase approach, however once Phase I produced significant results they immediately deviated from their initial study design and began modifying the initial study iteratively, but acting like it was somehow “Phase II”.

            In any event, what was presented at Simpsonwood was NOT even the original results from Verstraeten’s initial poster presentation (THAT was where this was first presented, btw).

            The data and information presented at Simpsonwood was NOT released to the public, it was reported as “lost”. It was only later through FOIA requests that the transcripts of the Simpsonwood meeting were obtained.

            There was no second “Phase II” like you suggest, instead the CDC researchers manipulated the data on at least 4 different occasions until they came to a consensus that they could finally publish their mostly negative 2003 study.

            We see that you cannot get even the most basic facts correct.

            In addition to the links I have sent, I highly suggest you read the following (warning: long) direct rebuttal to Willingham’s op/ed:


            The formatting is annoying and it weirdly refers to the author in the 3rd person, but the information is accurate and is consistent with other accounts of this saga.

          • JGC

            It isn’t an assumption: the Verstraeten study was planned from the outset to be a two phase study: screening and confirmation.

            The data presented in the abstract presented at Simpsonwood was the original data and was released to the public by the ACIP on June 21st, 2000.

            Nothing in the transcript of the conference supports claims of a cover up or data manipulation.

            You’re entitled to your own opinion, but not to your own facts.

            BTW you’ve yet to address that the Verstraeten study is only one of multiple studies that have failed to find any evidence of increased risk of ASD associated with thimerosal containing vaccines.

            Have they all, even those conducted by researchers and public health agencies in other nations, had their results manipulated by the FDA?

          • Show me evidence that the initial plan was for the Verstraeten study to be two phases AS EXECUTED. The data presented at Simpsonwood was not the original data, it resulted from the first massaging of data by the researchers. The original data was claimed by the authors to be “lost”, the original study can never be replicated. The transcripts of the Simpsonwood meeting were never released to the public, they were obtained by a FOIA request.

            As for your other studies, I’ve probably given you this numerous times by now and I’m sure you haven’t bothered to read any of it, but for the reader who may be interested in what’s wrong with those other studies you mention:



            For the issue with thimerosal the Verstraeten study was pivotal as it was the primary research used by the IOM to declare that there was no link between vaccines and autism, to suggest that research into such a link stop, and to prevent thousands of parents of vaccine-injured children compensation from our government after trying to do the right thing.

          • JGC

            1) From “Thimerosal, the Centers for Disease Control and Prevention, and GlaxoSmithKline”, Thomas Verstraeten, Pediatrics 2004;113;932

            “Because I was responsible for nearly all aspects of this study, including study design, data gathering, data analysis, and writing of the article, I wish to give my opinion on these claims. These are my personal opinions and do not represent the opinion of the CDC or GSK.

            Did the CDC water down the original results? It did not. This misconception comes from an erroneous perception of this screening study and other epidemiological studies. The perception is that an epidemiological study can have only 1 of 2 outcomes: either an association is found (or confirmed), or an association is refuted. Very often, however, there is a third interpretation: an association can neither be found nor refuted. Let’s call the first 2 outcomes “positive” and “negative” and the third outcome “neutral.”

            The CDC screening study of thimerosal-containing vaccines was
            perceived at first as a positive study that found an association between thimerosal and some neurodevelopmental outcomes. This was the perception both independent scientists and antivaccine lobbyists had at the conclusion of the first phase of the study. It was foreseen from the very start that any positive outcome would lead to a second phase. Whereas the original plan was to conduct the second phase as a case-control study, we soon realized this would be too time consuming. The validity of the firstphase results needed urgent validation in view of the large potential public health impact.

            RE: “the original study can never be replicated”, sure it can, just not necessarily with the same subject pool. If the apparent increased risk that Verstraeten found to be a false positive study instead represents a real association it should be found in any subject pool.

            The transcripts weren’t, agreed. Hardly surprising, as it isn’t standard practice for transcripts of conference discussions to be published. All reports and other documents were published by the ACIP about two weeks following the conference as is standard practice.

            it’s not that I haven’t read them, but that I’ve read them all before, (the “14 studies meme” in particular is a PRATT that turns up over and over again: see https://sciencebasedmedicine.org/welcome-back-my-friends-to-the-show-that-never-ends-part-ii-generation-rescue-attacks-14-studies/ for a dissection of the merit (or rather tack thereof) of the claims made regarding them.)
            And no” the Verstraeten study is not ‘pivotal’ to a finding that thimerosal at exposure levels achievable by routine childhood vaccination was not seen to be associated with neurodevelopmental disorders such as autism: it’s just one of the many, many ‘bricks in the wall’.

          • AutismDadd

            WARNING : FDA Approved!

          • Proponent

            David Foster: “The paper is on a website, yes, but in science it is important that a study be published in a peer-reviewed journal.”



            PNAS | “Administration of thimerosal-containing vaccines to infant rhesus macaques does not result in autism-like behavior or neuropathology”


            Safemind’s backpedaling article in response.

            And/or certainly NOT..

            An exercise in obfuscation conducted by frauds looking to exploit the pain and suffering of parents and children and presented on celluloid or otherwise.


          • How ironic you should choose another example of good science getting covered up. Also ironic you characterize the Safemind’s response as “backpedaling”, when that is exactly what the authors of the study did.

            In case anyone wants to know what really happened to THIS study, here is Safemind’s response so you can judge for yourself (Mr Proponent hasn’t actually read it):



            Comprehensive response:


  • EllyW

    I appreciate your writing about this study, but there’s a serious error in your article. “Mawson and his team of researchers included nine charts and a full 71 references in their comparison of the long-term health prospects between vaccinated children attending public schools and their unvaccinated, homeschooled peers…” Please note that ALL of the children in this study were homeschooled children; the study compared vaccinated homeschool children with unvaccinated homeschool children. Please correct this error.

  • edzo

    What is it’s the home schooling that’s making kids healthier?

  • Matthew Marcus

    Silly medical industry professionals.. you’d think they’d be intelligent enough to know that you don’t just “delete” anything from the internet…


  • Robert Zemojtel

    I believe I have a copy of the study…

  • Mike Stevens

    “JAMA Admits 30% of Drugs Approved by FDA-Approved Are Seriously Dangerous”

    Annabelle, I see you are an “Editor in Chief”. Does that position require any knowledge or experience, or possible an ability to understand articles before commenting about them?

    Please can you point me to the bit where JAMA says that 30% of these drugs are “seriously dangerous”.
    I trust you can do that, because if you can’t you are guilty of blatant misreporting and misrepresentation, and should be fearing for your editorial job (or you would be in any reputable media outlet. I guess in the freethoughtproject you can get away with dishonesty though…)

    • JGC

      Of the 72 drugs that were found to have safety issues during post marketing surveillance 32 were pulled from the market between 2001 and 2010.

      The headline, to be accurate, should at the least be revised to read “JAMA Admits 14.4% of Drugs Approved by FDA-Approved Are Seriously Dangerous”

      • Mike Stevens

        Wasn’t it only 3 that were pulled?

        • JGC

          Ah–I see my error. I totaled up a list of drugs pulled from the market between 2001 and 2010, but mistakenly included drugs pulled from the market in other nations by agencies other than the FDA such as Germany.

          • Mike Stevens

            So if one assumes a “seriously dangerous” drug would have its licence pulled, then it was 3 out of 222 drugs that resulted in serious adverse effects.
            Not good, even so, but 1.5% is somewhat less than “30%”.

          • JGC

            The problem of course is that in many cases it is often impossible to detect serious adverse consequences which occur either with low frequency or in specific subsets of all persons for which the drug would be indicated during clinical trials.
            It’s only once the drug has been approved that post-marketing surveillance when observations from a subject pool much larger than can be recruited during clinical trials makes it possible to detect these adverse events.

  • Mark Hopkins

    All I want to know is how in hell the researchers,scientist, and doctors thought that an Opiate pain relief substance would not be addictive.