safety concerns

For decades we were staunch defenders of the FDA. We thought the agency did an amazing job protecting consumers from bogus products. We applauded the organization for making sure Americans’ medications were safe and effective.

We were especially enthusiastic about generic drugs. We were convinced that the FDA helped patients save tons of money with generic products that provided absolutely identical formulations as the brand name medicine. It seemed like the perfect system.

Over the last 15 years we have begun to question our old assumptions. A new report by investigative journalist Charles Seife provides data to support our concerns.

Although the Food and Drug Administration “is the oldest comprehensive consumer protection agency in the U.S. federal government” according to the agency website, we wonder if it has abandoned its mission.

In the early years of the 20th century, patent medicine salesmen peddled snake oil with unknown and often dangerous ingredients. The Pure Food and Drug Act of 1906 was intended to protect people from contaminated or dangerous drugs.

The FDA now focuses a lot of resources on approving drugs as quickly as possible, but it doesn’t make its decision process nearly as transparent as many would like.

What Is the FDA Hiding?

An expose in the journal JAMA Internal Medicine (online, Feb. 9, 2015) found that when the FDA discovers research misconduct in clinical trials, it does not let the public know the details.

The author, Charles Seife, explained in a Slate essay:

“When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted” (Slate, Feb. 8, 2015).

Seife concludes that: “the FDA has shown a pattern of burying the details of misconduct.” Faked reports, forged data and falsified clinical trial results are often hidden from the public eye.

A spokeswoman for the FDA responded to Seife’s charges. She told us that when the FDA provides details on scientific fraud, the agency has to avoid exposing confidential commercial data. She added that the allegation that FDA buries this information is not true.

Nonetheless, the FDA’s documents are frequently redacted. Even when they are available, information on the drug, the study site or the pharmaceutical company involved may be blacked out, making it difficult to trace which drug was involved.

We’ve encountered these FDA policies ourselves in our quest to find out which generic drugs are truly bioequivalent. The agency requires all generic drug makers to show that their product is absorbed into the blood stream at the same rate and to the same extent as the original brand name medicine. But the FDA doesn’t share these data with doctors, pharmacists or patients.

The agency’s mantra seems to be, trust us; we know what we are doing. But the Budeprion XL 300 debacle makes us wonder if that is true. This generic form of the long-acting antidepressant bupropion (Wellbutrin XL 300) was introduced late in 2006. By February 2007 we were getting the first reports from people who found that the generic did not control their depression well, although it did have side effects. Eventually we heard from hundreds of people having difficulties with this generic drug.

At first, the FDA assured us that these folks were having a psychosomatic reaction to a change in the look of the pill. But finally the agency commissioned its own test of bioequivalence. The product failed, and the company was asked to withdraw its drug on Oct. 3, 2012 because it was “not therapeutically equivalent.”

How many other generic drugs might not live up to expectations? Right now, we can’t tell because bioequivalence data are considered trade secrets.

Physicians, pharmacists and patients deserve to see key generic drug data so they can verify that such drugs are indeed as good as the FDA maintains they are. That is the only way the public can regain trust in the FDA and its generic drug approval process.

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  1. nancy
    Reply

    Excellent comments. I urge everyone to contact the FDA, President, etc. and urge reform. Some will think that this is useless, but history has shown otherwise. Also, if everyone knows of an action site (not where I’d have to start a petition like MoveOn, but something simplier) I would love to know. MoveOn is excellent, but my time is extremely, extremely limited.

  2. Mary
    Reply

    I am so grateful that I am not taking ANY drug.

    I do use various supplements to improve my life.

  3. RICHARD
    lakelamd, fl
    Reply

    My son formerly worked for the FDA that check meds for proper contents and use. When they discontinued the practice he thought it was rather a dumb thing to do and he probably thinks so today.

  4. Helen M
    Modesto, CA
    Reply

    Unfortunately the FDA is not a totally tax payer supported organization; rather it collects fees from drug companies and that money far outweighs the money a negligent government supplies. It is as always: follow the money. Additionally personnel go back and forth between the FDA and the drug companies. I personally know someone who started as a scientist for the FDA and after trying to reform the organization from within, quit in total frustration from the corruption. We need a whistleblower with impeccable credentials to wake Congress up. We also need more outside scientists to participate in the approval process. I too was happy when many of my meds went generic; the cost savings to someone on a fixed income was considerable. Alas, I find the generics just don’t work as well as the branded medications. Yet, between my income and my insurance company, I am stuck.

  5. joe
    EDELSTEIN IL
    Reply

    Just had a problem with generic bupropion 300 when local pharmacy switched manufactures , so complained to pharmacy and filled out FDA form. Received a phone call from caller asking lots of questions I had answered on form, assumed it was FDA. Finally was told would be sent a mailer for pill bottle and pills for testing, what a surprise when the mailer was addressed to the Manufacture of the meds Parr Pharmacy not the FDA, what a farce, like let the fox guard the hen house.

  6. RocketScientist
    Los Angeles
    Reply

    Medical devices is another area where the FDA has let manufacturers run the show. Proof of safety is often a missing step in the approval process. The FDA has a long history of leaving the public and medical professionals to prove a device is unsafe – eg. scopes, CT scanners, x-ray, sonograms. Years go by while manufacturers claim there is “no peer-reviewed research” to prove the device unsafe. Who would fund such research? Certainly not the FDA or the manufacturer.

  7. Danielle
    Seattle
    Reply

    I no longer respect or trust the FDA. I always thought it held the consumers’ best interest as its priority. Now I’m not sure what is driving their negligence. Two weeks ago I switched to the new generic of Celebrex, I have severe arthritis that the medication helps control. I can at least function. Two days after going on the newly released generic celexicob, increased pain kept me off my feet. After four days, I was in tears and felt pain in places I didn’t even know I hurt when I was on Celebrex. On the fifth day, I returned the generic to the drug store, expecting them to charge me for a new Rx of Celebrex. Without a question, they gave me the full Rx of Celebrex at no cost, didn’t even have me pay for the celexicob I’d taken. This made me think I wasn’t the only one who had returned this medication. I was right: my chiropractor told me dozens of her patients have complained about how ineffective celexicob is.
    How can the FDA let ineffective products like these come on the market? I have lost all respect for them.
    Oh, and Celebrex is only SEVEN dollars more than celexicob (on Medicare’s scale).

  8. Dee
    Reply

    FDA is in desperate need of a complete top to bottom overhaul, beginning with their widespread practice of employing former drug company executives & allowing drug company executives to be on their advisory panels (and then ignoring other members of the panels who warn against approval of the drug in question). A more obvious conflict of interest could not exist. These conflicts of interest extend to GMO (aka frankenfoods) and lead containing cosmetics. How sad, pathetic & dangerous that an agency created to protect consumers is instead protecting the companies that are in most need of oversight. Are you listening, Congress? Or does an adverse event have to occur in one of your families before you act?

    • Pat C.
      IL.
      Reply

      I am blown away to read your letter about the people occupying seats in the FDA!
      No wonder these actions, claims and downright terrible results keep happening to
      patients. They’re getting squashed, ignored, shoved ‘under the rug’ so to speak, so
      this can all continue. How and where do people need to start to demand changes of
      a department who is in no way going to change, serve or protect us patients and those
      that will follow us.
      This is pure ‘corruption’ people!

  9. beachbouy
    Reply

    The FDA needs to be dismantled and something more effective in protecting consumers created in it’s place. It is painfully clear that the FDA is one of the most corrupt agencies associated with the U.S. government. The taxpayer is funding an agency that protects big pharma, not the people it was intended to protect.

  10. Christopher Wunsch
    United States
    Reply

    This is utterly ridiculous! How can anyone be expected to entrust his/her life to a doctor who isn’t privy to the clinical data, he needs in order to justify a medication to prescribe to the person who has essentially placed their life into his/her hands. And the FACT that the FDA knowingly buries this vital information…is nothing short of Tyranny!

  11. Lee
    Charlotte, NC
    Reply

    Too often federal regulatory agencies become embedded with the industries and companies they regulate. It’s always a balancing act, but there must be line in the sand to ensure the health and safety of the public. Transparency is the best way to define that line, not rules regarding graft, kickbacks, etc.; rules just present myriad opportunities for circumvention.
    I worked in the commercial nuclear power industry for 40+ years. I suggest that the FDA (and all other agencies) go to school on the Nuclear Regulatory Commission (NRC, the AEC when I started) regarding transparency. Check the nrc.gov website to find hundreds of thousands of word-searchable documents, and millions more older documents available on micro-fiche. Very few documents have been withheld, and I can’t recall seeing any available documents with black-outs, due to the requirements of 10CFR2.390 (e.g. personal privacy, national security, etc.). The NRC’s not perfect, but I expect that it is the most transparent federal agency regarding it’s regulations, processes and regulatory enforcement actions.
    Transparency is the way.

  12. Rondo
    Jacksonville, FL
    Reply

    I’ve had this problem with generic Xanax I’ve been purchasing from Sam’s club. The quality is not nearly as good as the generic from CVS or Walgreens. The reason? Its manufacturer is Qualitest. They’ve had numerous complaints regarding this and other generics for quite some time and have in the past come under FDA scrutiny for lack of bio equivalency in other drugs as well. Did you know that a generic is allowed to have a 20% difference in active ingredients and still be considered to be bio equivalent? Makes me wonder who’s testing Qualitest, if anyone at all. Also heard that up to 80% of the precursor ingredients that our drug manufacturers are using to make medications that are dispensed in the US are from China. The same China that woefully lacks quality control on most everything it makes and ships abroad. Any wonder, eh?

    • Michelle
      New Jersey
      Reply

      I also had a problem with a Qualitest generic. It was apparent that the medicine was not the same as the brand. The brand was easy to swallow; the Qualitest was hard and would not go down. After a few weeks I began to have insomnia. There were breakthrough symptoms which are taken seriously in my condition. And I was using this along with the brand to reduce cost.

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