For many people, it’s important to know about a medication before taking it. That’s reasonable. But it doesn’t mean spending hours on the computer reading about side effects and personal experiences. The trust factor (between patient and doctor) comes in here. Just as a doctor must trust a patient to take medications as prescribed, a patient must let their doctor treat them.

The patient reports changes in condition after a change in medication. Asking questions gleaned through a bit of research can be beneficial.

So a trusting but gently questioning attitude, during psychiatric appointments, is probably best. The idea is to be somewhat skeptical, but to work with the doctor, and ultimately apply their suggestion(s). Psychiatrists have tirelessly cultivated their skill in medical school and beyond.

Some people find, after several months, that they would prefer to work with someone else. That’s fine, so long as its not to get a certain drug prescribed that won’t be therapeutic.

And yet there still might be a case to be made against pharmaceutical corporations. Their wealth and power could influence the dispensing of dangerous or useless drugs. They have an enormous power to lobby congress. Why should we trust them?

Here’s why…

The largest of the six entities of the Food and Drug Administration (FDA) presides over drug approval, substances fit for human consumption. But the corporation testing the drug must pay for its evaluation. Approved drugs can end up costing approximately 3,000,000,000 dollars over about a decade. There are also chemicals that make it however far, and show negative results. Even if hundreds of millions, or more, has been spent on esting that drug, it is now done for. Depictions below illustrate this course.

But the FDA spells out the comprehensive approvement process and related material on their website. Here’s the drug approval process in pictures, from development, to inspection of production facility:

This is the condensed version:

  1. Development, animal testing
  2. Investigational New Drug (IND) application
  3. Phase I
  4. Phase II
  5. Phase III
  6. Review meeting
  7. New Drug Application (NDA)
  8. Application reviwed
  9. Application reviewed (again)
  10. Drug labeling
  11. Facility inspection

https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm

  1. An entity that develops drugs finds positive results in animal testing
  2. Development, animal testing
  3. The entity submits an Investigational New Drug application (IND)
    1. must meet certain criteria, including abiding by the Federal Food, Drug, and Cosmetic ActImage result for IND application
    2. Once secured, this allows trials on human beings to begin
    3. Three IND types exist
      1. A physician submits the form and carries out the procedures, perhaps for an existing drug to gain an official indication
      2. An emergency situation in which time doesn’t allow for the standard process
      3. A somewhat nebulous situation, seemingly the same as #2, in which time doesn’t permit the normal process
    4. There are two IND categories
      1. Commercial
      2. Research
    5. Information must be included on
      1. Pharmacology and toxicology (how it works, and how dangerous it is)
      2. Information on the ability of a company to consistently supply the substance
      3. A method for determining if the drug is dangerous as early as possible
      4. How qualified the professionals who are to carry out trials are
      5. Obtaining consent of subjects tested upon in trials
      6. Affirming review of trials by an independent institutional review board (IRB)
      7. A promise to adhere to IND regulations and boundaries
  4. After 30 days, if the FDA has not deemed the chemical as unreasonably risky or put it on “clinical hold”, clinical trials may begin
  5. The FDA may at any point in the study also stop a clinical trial at any time
  6. Clinical trials begin to determine efficacy and safety
    1. Must have good clinical practices
    2. Must have human subject protection
    3. Studies are subject to on-site examinations by the bioresearch monitoring programRelated image
  7. Image result for medication clinical trials statisticsAfter significant safety and efficacy has been demonstrated in clinical trials, a New Drug Application (NDA) is submitted
    1. The NDA is the formal proposal that the Food and Drug Administration (FDA) allow the medication to be sold to consumers
    2. The NDA includes
      1. Information on how the benefits of the drug outweigh the risks, and that it is both safe and effective for an indication
      2. Information ascertaining that the package label/insert informs consumers sufficiently about the drug
      3. That the production and control of production adequately maintain “identity, strength, quality, and purity” of the chemical
  8. After being reviewed twice, by two independent groups of experts, the information of safety and efficacy is verified
  9. The substance then must be labeled properly
    1. How to safely use the substance
    2. Accurate information regarding what the substance can treat, and side effects it can cause
    3. In absence of sufficient data and testing, there must not be any implications of what it can treat
    4. More so, there must be no false information whatsoever on the substance
    5. All information must otherwise be supported by actual, statistically rigorous testing
  10. The facility and production of the substance must undergo rigorous testing by the governmentImage result for FDA drug approval facility inspection
    1. Known as Quality Control
    2. First, a Pre-Approval Investigation (PAI)
      1. knowing that the given substance is being created, and that data submitted by the corporation is correct
  11. The rest involves constant testing by the FDA
    1. Post-Approval Investigation
      1. Monitors changes after initial approval
    2. Surveillance inspections monitors for continuous..
      1. Safety
      2. Identity
      3. Strength
      4. Quality
      5. Purity
    3. The entirety of post-marketed substances is very rigorous
    4. Here we have the Pharmaceutical Quality Control Guide by the FDA

It can take 9.5- 15 years for the one in about 5,000-10,000 chemicals to make it to the market, through testing and approval. Longitudinal studies, which evaluate subjects over a long period, must affirm efficacy; this type of test can go on for decades. Cross-sectional studies, also used, gather data from all participants at a certain time. Here we see the costs for phase three trials

Image result for medication clinical trials statistics

The illustration below shows the time-span to be 9.5-11.5 years, the cost being 600,000,000 through phase III trials

It seems that sometimes the process can take a decade and a half just to reach the final study.

This graph suggests that things can get pretty complicated. Some drugs can have the sequence accelerated, for instance. A modern example might be a cannabinoid mixture, the approval being a treatment-resistant anti-epileptic (antiseizure) drug.

The process ensures that not many approved drugs had to be removed. Corporate medication development has an amazing record. Medications have been pulled from the market otherwise, but only a select few have caused absolute an major issues. Regarding the relatively clean record, here are the major exceptions

Sources: Ben Komor, Dr. John Bezirganian, Dr. Bernard Member, https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development, https://www.ignitedata.co.uk/enroling-the-right-patients-onto-your-study-faster-is-what-its-all-about/clinical-cost-drivers/, https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development, https://www.slideshare.net/WilliamJacksonPharmD/ind-application-wj-10aug14-final, https://www.fda.gov/drugs/resourcesforyou/consumers/ucm295473.htm, https://www.ipqpubs.com/2017/10/23/fdas-office-of-pharmaceutical-quality-continues-to-advance-reviewinspection-integration/