Hold Big Pharma #RxAccountable for Dangerous Drugs

December 5, 2019

ANH is launching a campaign and a legal initiative to get dangerous drugs off the market. You can help! Action Alert!

Thousands of Americans die every year from taking prescription drugs, and millions more are hospitalized. This isn’t an aberration; it is a feature of a crony medical system in which the agency that is supposed to evaluate and approve drugs is beholden to the pharmaceutical industry. ANH is launching a campaign to remove cronyism from the drug approval process and require transparency on drug labels when a drug is newly approved. We’re also launching a legal initiative to help get dangerous drugs off the market. Go to our Legal Center to see how you can get involved.

The fundamental problem is the FDA approval process itself. The data suggest that drug safety has suffered since the passage of the Prescription Drug User Fee Act of 1992 (PDUFA). This law called for drug companies to pay user fees to the FDA to fund drug approval. (This is one of the lynchpins of the crony medical system because it makes the FDA financially beholden to the industry it is meant to regulate.

What has PDUFA done for safety? A JAMA study found that nearly a third of drugs approved by the FDA between 2001 and 2010 had a post-market safety event. Drugs approved after the enactment of PDUFA were more likely to receive a black box warning or be withdrawn.

The standards for drug approval also leave much to be desired. As of 2014, 37 percent of approved drugs were backed only by a single study; 68 percent compared new drugs only to placebo, meaning that the drug was better than nothing but not necessarily better than a drug already on the market. Pre-clinical trials for drugs suffer from many shortcomings: they’re too small to give a proper estimate of adverse events, some last only a few months when some side effects occur only after several years, and many trials select healthy participants to show a drug works, which doesn’t reflect the drug’s use in the real word.

Nor does the FDA do a proper job of monitoring the drugs it approves. For this task, the most important tool in the FDA’s toolbox is their adverse event reporting system (the FAERS database). This database relies on patients, doctors, and drug manufacturers (who are required by law to submit adverse events they receive to the FDA) to send information about dangerous drugs to the agency’s database. The FDA then determines, on a product by product basis, how seriously to monitor adverse event reports.

There are several obvious problems with this approach, as experts have pointed out. Underreporting is the biggest one; it’s estimated that between 1 and 10 percent of adverse events are reported to the FDA every year. Adverse event reports also are not standardized—different names for the same drugs and the use of different clinical terminology can make the FAERS system difficult to search. There are also delays. FAERS is updated only once every quarter, prolonging the time that Americans are exposed to dangerous drugs.

The Government Accountability Office (GAO) also found serious problems with the FDA’s post-market safety monitoring of drugs. In a 2015 report, the GAO concluded:

FDA lacks reliable, readily accessible data on tracked safety issues and post-market studies needed to meet certain post-market safety reporting responsibilities and to conduct systematic oversight…[These problems] have restricted the agency’s ability to perform systematic oversight of post-market drug safety.

The FDA is required to routinely monitor and analyze FAERS and publish quarterly reports on new safety information and potential risks they uncover, but this process is slow and does not meaningfully keep patients in the loop. Consider Uloric, a gout medication approved in 2009 that is currently facing a number of lawsuits after studies have shown the drug can cause serious heart problems. The FDA first noticed an issue in 2011, when the agency’s post-market surveillance analysis added an additional side effect to the drug’s label. It wasn’t until 2019, however, that the FDA added a black box warning to Uloric for increased risk of death; that is, ten years after the drug is approved, the FDA warns us of serious, life-threatening risks with the drug. Something is seriously wrong here.

In light of the myriad problems with drug review and post-market safety surveillance, ANH-USA is supporting three key reforms to help Americans avoid dangerous drugs:

  • More transparency in post-market surveillance. In its quarterly reports on drug safety surveillance, the FDA routinely states that it is “reviewing the need for further regulatory action.” How many of these drugs, like Uloric, will eventually get a black box warning, or additional side effects added? When the FDA is reviewing an approved drug for additional safety concerns, this information should be meaningfully communicated to the public so patients can make their own decisions, in collaboration with their doctors, about whether to continue taking the drug. Additionally, doctors should be required to alert patients when the FDA is reviewing an approved drug for additional safety concerns early in the review process.
  • Mandatory labeling identifying newly approved drugs. Given the safety issues with many new pharmaceutical products, drugs should carry labeling that identifies the product as a new drug that has undetermined side effects. Doctors prescribing these drugs should also be required to inform patients that the drugs are recently approved and may have side effects beyond those currently identified in the drug’s insert. This will empower consumers to start a conversation with their health care providers about the potential benefit of taking a drug that has been on the market longer with a more established safety profile. This is already done in the United Kingdom and was even recommended by the Institute of Medicine in 2007, but the FDA did not adopt the labeling measure.
  • Third party drug testing. Because of the user fee system, it is clear that the FDA is compromised in its ability to assess the safety and efficacy of drugs. Currently, drug companies submit their own studies for FDA approval and can hide studies that show danger. A third-party review system would eliminate this obfuscation and make drug approval more transparent. Universities or other qualified parties could contract with the government to anonymously review drugs and devices. Drug companies would pay up-front for the cost of reviewing and approving drugs without knowing which entity would be doing the work. This change will eliminate cronyism in the drug approval process.
  • Allow free speech about supplements. Another linchpin of our crony medical system is that the FDA protects drug monopolies by throttling natural products. Because synthetic drugs can be patent-protected, drug companies can afford the astronomical costs of FDA approval; only FDA-approved drugs can claim to treat or prevent disease. Supplements, as natural compounds, generally cannot be patented (or can only receive weaker patents compared to drugs), thus cannot go through FDA approval. So even though there is strong scientific evidence backing the use of supplements to help prevent or treat a host of illnesses (like vitamin D and the flu), the FDA makes sure the public cannot know of these benefits, leading many people to buy dangerous drugs. Allowing natural products to communicate the scientifically-proven benefits they can confer will help break the drug monopoly on healthcare.

While we fight to improve the system for how drugs are approved, labeled, and monitored, we’re also launching a new legal initiative to get dangerous drugs off the market. Visit our Legal Center to learn about ways you can help this cause. This page offers information on lawsuits that are in progress on dangerous drugs and the injuries they cause. If you or someone you know has taken any of these drugs, you may be able to help us get these products off the market.

Surveys have found that 55 percent of Americans regularly take prescription drugs; those who do take an average of four prescription drugs. It is our families, friends, and loved ones taking these medications, and the preceding data should alarm all of us. The FDA is approving dangerous drugs and then not monitoring them properly, and we’re paying the price. According to one report, each year more than 2 million people suffer an adverse event from a drug and 100,000 people die. This is completely unacceptable.

Action Alert! Write to Congress and the FDA, urging them to support key reforms to the drug approval system and post-market safety surveillance. Please send your message immediately.

40 responses to “Hold Big Pharma #RxAccountable for Dangerous Drugs”

  1. jean publiee says:

    i agree

  2. david champeau says:

    please do the same for vaccines for which Big Pharma is not accountable AT ALL.

    10s of 1000s of children are injured or dead and more happening every day

    • Deborah says:

      I agree healthcare is over subscribing pharmaceuticals but we need to also stop the excessive amount of vaccinations administered to infants and children etc. These vaccines are extremely toxic and harmful causing major health problems that are life threatening.

    • I agree with you 100%! There should be NO “FORCED” VACCINATIONS! A very good group is NVIC (National Vaccine Information Center), that helps parents and others to fight the dictatorial local governments who are in league with the selfish, dangerous, big pharma companies who are behind “forced” vaccinations! I’m a retired nurse (RN), and both nurses and doctors all were brainwashed, while in training, to believe the lies that vaccines are all safe! Another problem is that there are multiple horrible side effects of antibiotics like CIpro, etc. (fluoro-quinolones). Don’t let anyone you care about ever be given FQ (fluoro-quinolone) antibiotics! I’m editing my own website to add this information. My free website is called Can’t Breathe? Suspect Vocal Cord Dysfunction.

    • Liberty G says:

      Thanks so much, David, for bringing this up. Unfortunately, most people are brainwashed to think that vaccines are the magic cure for everything. They don’t hear – certainly not from mainstream media or medical honchos, about the risks and limits of vaccines. (Note: I’m not “anti-vaccine” – just against mandates & false info.

    • CMK says:

      Totally agree!!!
      My 30yr old autistic son had every possible side effect except death after receiving routine MMR & DTAVP AS BABY!
      He has been medically complex his entire life~
      Disabled for LIFE! His kidneys failed five yrs ago…on peritoneal dialysis for first five yrs; now on hemodialysis bc of
      Serious almost fatal complications this spring.Hes been waiting five years for a kidney transplant; we are told it could be another year.
      This IS NO LIFE FOR A YOUNG MAN!!!
      In 1986, US CONGRESS MANDATED SAFETY&EFFICACY STUDIES THAT HAVE NEVER BEEN DONE!
      In 1986, US CONGRESS SET UP A SECRET VACCINE INJURY COURT…THEYVE PD OUT $$$BILLIONS IN VAX INJURY CASES.
      IM TOLD OUR CASE IS TOO OLD!🤢🤮🤬
      This is how BIG PHARMA HIDES THEIR CRIMES!
      #believeMOMS!…WE ARE RAISING AN INJURED ARMY OF AUTISTIC CHILDREN INTO ADULTHOOD!
      PLEASE HELP US PUT AN END TO UNTESTED VACCINES CONTAINING HEAVY METALS THAT CROSS
      THE BRAIN BARRIER!
      ThankYOU in ADVANCE!
      CMK
      (For fear of reprisal…pls DO NOT PUBLISH MY EMAIL ADDRESS…THANK YOU)

  3. Neil E Wilson Jr says:

    stop poisoning us!!!!

  4. Patricia Chambers says:

    Sometimes I believe the FDA is paid off to approve drugs. Mainly because way too many have serious side effects. Yet they’re on the market in record time.

  5. Randy Thomas says:

    Quit ripping people off with high drug prices..

  6. Barb Van Dusen says:

    The FDA approves drugs that are dangerous. Oversight is necessary. Prescription drug third party drug testing is compromised.

  7. Jan Weisel says:

    Please implement these important reforms so people know what side effects they can experience and are able to make informed choices about the drugs they take.

  8. a says:

    Support key reforms to the drug approval system and post-market safety surveillance!

  9. Thomas Nelson says:

    More transparency in post-market surveillance. In its quarterly reports on drug safety surveillance, the FDA routinely states that it is “reviewing the need for further regulatory action.” How many of these drugs, like Uloric, will eventually get a black box warning, or additional side effects added? When the FDA is reviewing an approved drug for additional safety concerns, this information should be meaningfully communicated to the public so patients can make their own decisions, in collaboration with their doctors, about whether to continue taking the drug. Additionally, doctors should be required to alert patients when the FDA is reviewing an approved drug for additional safety concerns early in the review process.
    Mandatory labeling identifying newly approved drugs. Given the safety issues with many new pharmaceutical products, drugs should carry labeling that identifies the product as a new drug that has undetermined side effects. Doctors prescribing these drugs should also be required to inform patients that the drugs are recently approved and may have side effects beyond those currently identified in the drug’s insert. This will empower consumers to start a conversation with their health care providers about the potential benefit of taking a drug that has been on the market longer with a more established safety profile. This is already done in the United Kingdom and was even recommended by the Institute of Medicine in 2007, but the FDA did not adopt the labeling measure.
    Third party drug testing. Because of the user fee system, it is clear that the FDA is compromised in its ability to assess the safety and efficacy of drugs. Currently, drug companies submit their own studies for FDA approval and can hide studies that show danger. A third-party review system would eliminate this obfuscation and make drug approval more transparent. Universities or other qualified parties could contract with the government to anonymously review drugs and devices. Drug companies would pay up-front for the cost of reviewing and approving drugs without knowing which entity would be doing the work. This change will eliminate cronyism in the drug approval process.

  10. John Dellasala says:

    Please support key reforms to the drug approval system and post-market safety surveillance.

  11. cindy says:

    Stop charging the normal people so you can line the pockets of politicians

  12. Linda Lane says:

    Again, we cannot believe a company will not cheat us or really provide drugs that do not destroy lives for big profits until the drug is banned after enough lives are murdered by the drugs. There is no such thing as “corporate responsible” behavior. They all must be closely regulated and inspected, our lives depend on it. Clip the lines to the “golden parachutes” and let them fall into jail.

  13. susan michetti says:

    The toxic industrial water fluoridation being added to our water is a drug whose studies have been reviewed by THE NATIONAL ACADEMY OF SCIENCE and found to be harmful to infants, to teenage boys (bone sarcoma), young girls (pre-pubescent breasts), elderly women (hip breakage from inferior bone tensile strength from fluoride vs silicon, boron). These tests use pharmaceutical grade fluoride but the water being poisoned in our wells uses industrial fluoride contaminated with heavy metals and other toxins that are simply watered down to pass the safety tests. I find this a serious form of dishonesty. the FDA has the power to speak up to disclaim the use of industrial contaminated fluoride products with heavy metals that remain unprecedented in adding poisonous heavy metals to our drinking water under the claim of it being a needed drug for the teeth of poor children whose parents feed their children mostly sugar. If the FDA carried at all about toxicity from drugs, it would speak up about this claimed false drug without pharmaceutical grade being insisted on being added to our water by certain dentists who never obtained an MD degree for internal medicine and are practicing medicine without the proper credentials. Yet the FDA has allowed this to continue for decades. Shame on the FDA.

    • You are so right! In fact, we are lucky to live in a semi-rural area, where we drink our own “well” water, that was tested first, years ago, to be safe (without pesticides, etc.). I bring my well water with me, in re-usable bottles, wherever I go by car, so that I don’t have to drink fluoridated, chlorinated water, at restaurants, or anywhere else! For those who don’t have their own wells, they can buy bottled commercial spring or well water at health food stores, supermarkets, gas stations, etc. But never drink distilled water, which leaches (pulls) minerals out of bones, contributing to osteoporosis. Natural spring or well water is the best, safest water. There are (I think) some water filters that can remove fluoride from drinking water, but they might be expensive.

  14. Lillian says:

    Stop production of opioids, enough have died already.

  15. Sherry says:

    so what are people supposed to do if they have had back surgery and are in chronic pain??? –

    • Josette says:

      Look into Nerve block (works great for knee pain).

    • I agree with you, Sherry! When I had an infected tooth pulled, I literally HAD to take opioids, to prevent the intolerable excrutiating pain from the infected tooth extraction (pulling). Luckily, I only had to take those pain pills for a few days, since I’m not an addictive person. However, for those who might become addicted, they need to be MONITORED, by caring health people, to help them wean off the pain killers, when they don’t need the drugs any more.

      I also want to warn folks about the horrible side effects of FQ’s (Fluoro-Quinolone antibiotics) such as Cipro, etc.

      There are safer antibiotics, so I urge folks not to take Cipro etc. if they want to come back to a normal life after their infection(s).

  16. Lee says:

    This system is broken. The FDA is the wolf watching the hen house. The very people and government organizations who approved drugs get posh jobs in the drug companies they are supposed to provide oversight. Talk about a conflict of interest. Drugs are toxic chemicals that harm the human body. They use the FDA to protect them from their competition and that is natural health products. Big Pharma drugs are one of the leading causes of death in this country. The FDA and Big Pharma are nothing but a criminal cabal operating under the color of law. They even buy off congressmen to pass laws to protect them from us. Just follow the money. We the people have lost our freedom of speech when it comes to our health and what we can say. We the people need to have freedom to select any form of alternative health care but what happens. Big brother stops or bans anything in the natural healthcare that gets safe results or discredits the docs who promote solutions that work. The FDA protects its poisonous big pharma clients from natural solutions that work. You have got it all wrong. Big Pharma Drugs are the problem. None of them are safe. Give me a break. You put poisonous chemicals in the body and expect good things to happen. We the people need to have a choice between poisonous drugs or natural solutions without the power of governments stopping what mother nature has given us for thousands of years. I almost forgot. Take a look at the phony, fake science studies, bought and paid for by big pharma to justify putting their products on the market. What you are doing is not going to solve the real problem. The public needs to be educated about the truth. Big Pharma solutions are nothing but lies.

    • Josette says:

      I totally agree.with you. What can we do ?

    • Liberty G says:

      Lee, I agree with what you have said except saying that “You have got it all wrong” , seemingly to Alliance for Natural Health? We do have a broken and corrupt system, and the greatest need with this, as with some other issues, is to stop the Feds from preempting our choices about health – and protection from environmental scourges.

  17. Liz S says:

    Equally important is the inadequate methodology used to approve vaccines. As “biologicals” vaccines are not held to the same standards as pharmaceutical drugs. They are approved without placebo testing, with very short observation periods, without testing for mutagenicity, carcinogenicity or impairment of fertility, and they are recommended by the CDC for populations in which their use was never tested (such as in pregnancy, even though they were never tested on pregnant women) Also, they are not tested in combination with other vaccines, which is how they are almost always given today because the CDC’s vaccine schedule crams so many into children’s first years of life. The corruption in the vaccine industry is outrageous, and our children are suffering many unintended consequences as a result of greed in the pharmaceutical industry.

  18. helen murphy says:

    LEAVE PERCOCETTES OUT OF THIS, I TAKE ONE A DAY FOR YEARS AND I CAN FUNCTION,
    SO
    HANDS OFF THIS ONE,

  19. helen murphy says:

    leave percottes opt of this they help me a lot, one a day.

  20. B Powers says:

    Big Pharmaceuticals control the FDA, the FDA has actually been bought out and doesn’t uphold its standard to test enough, thus for decades it has knowingly allowed harmful new products be sold to the public. Can it ever be trusted? Not with the lower standards to which is has become accustomed. It is a farce, it has sold the public down the river while padding it’s pockets. So, yes, it must be held to a much higher standard of testing all new drugs before giving the pharmaceuticals the go-ahead to produce and sell. I’ve got dibs on that not happening in my lifetime, though.

  21. Gail says:

    I agree with you Lee. I want natural treatments that support and help the body heal itself. Big Pharma’s chemical poisons destroy ones health. They DRUG the brain. It’s a medical mafia. It’s about money, making and keeping people ill, and death. That’s why true healing substances are not covered by insurance.

  22. Rossen Vassilev Jr says:

    Big Pharma is killing people along with the insurance companies.

  23. David V says:

    It is supposed to be ‘Health Care’ not Death Care!

  24. Dorlis Grote says:

    I agree 100%. I also wander about opiod use. Suddenly now that they are exposed, there are several drugs available for opiod treatment.

  25. Susanne says:

    Please explain how the antibiotic Cipro is still on the market? The side effects to that drug are horrible. ( look up Cipro toxicity on the internet and the Facebook page, of all the people sharing their stories of what it has done to their lives) It has a black box warning and I was prescribed this drug for a sinus infection.
    The horrible side effects of this drug are not worth risking, when there are other antibiotic options out there.
    It should be immediately pulled off the market.

  26. Susanne says:

    More about Cipro…taken from the following law firm

    The FDA has received more than 50,000 reports of adverse events and 2,600 reports of deaths associated with Levaquin, Cipro, Avelox, and Factive, through June 30, 2015. According to FDA estimates only about ten percent of all adverse events are actually reported to the FDA, as these are voluntary reports.May 8, 2019

    TorHoerman Law › bad_drug_lawsuit
    Fluoroquinolone Lawsuit | Lawyers For Fluoroquinolone Antibiotics …

  27. Thomas Mueller says:

    We need to encourage the greater use of herbal and other natural remedies as opposed to so many synthetic chemicals which are big money for Big Pharma.

  28. A concerned American says:

    I looked up the “Side effects” of a particular drug that was being prescribed for me, and was shocked to find that leukemia can be one of the so-called “Side effects!” I refused the drug and the doctor quite literally screamed at me. I was then told by an insider in the field, that the insurance co’s “encourage” the docs to prescribe this drug because it costs them less than other drugs that require more followup.
    Then I was prescribed another drug, looked up the “Side effects”: Lo and behold, liver tumors. Refused the drug, corresponded with someone who had actually used it and lo and behold again ,he had liver tumors that were said to be “benign” so we are supposed to be so grateful that we end up without liver cancer, “only” with tumors.
    ****Then they say that the naturopaths are the quacks.*****
    Aren’t shadow projections just stunningly accurate? I find it amazing, every time.
    It is time for class action lawsuits left and right. Thank you ANH for what you are doing!
    People need to read up about side effects and talk to their doctor before taking Any mainstream medication. Buyer beware, the doctors are brainwashed and spoonfed information based on “Studies” that are tweaked and faked. True, they do see the cross sectors reacting or not, based on their clinical experience which says something. But they also may not see or hear from those who do react and may not know if someone is more sensitive than someone else. Careful there.

  29. James Johnson says:

    SEEMS LIKE A REALLY GOOD PLAN TO MAKE THE POPULATION WEAK, SICK, DEPENDENT, AND MIND CONTROLLED IN MANY WAYS, ESP WITH CHEMICALS AND PHARMACEUTICALS, AND COULD ALSO REDUCE THE NUMBER OF FOLKS ON THE PLANET.. WHAT A CLEVER SCHEME. AND MAKE A LOT OF MONEY DOING IT. BRILLIANT! AND HEARTLESS AND EVIL.

  30. terry antonacci says:

    fda not looking out for our safety!
    nrrd natural alternatives!

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