Drug Clinical Trials, Comparative Effectiveness, and much more

In 2013, I ran a 2 column series on how pharmaceutical products are tested and evaluated before going on the market (see link below). In light of the current discussions about drug prices, here are some things you might be interested in knowing plus an illuminating article from The Washington Post about the drug Pradaxa:

1)            Clinical trials:

  1. Trials are conducted with a limited number of people for a limited about of time. The people who participate in the trials often don’t have other health conditions. Consequently-
  2. When a drug comes on the market people with additional medical problems can face problems with other medications they are on and/ or with other health conditions.

 2)      Comparative Effectiveness:

  1. Drugs are only tested for safety and effectiveness. They are usually not compared against other comparable drugs on the market.  For example, one anti-depressant drug is not compared with others for effectiveness. Consequently-
  2. Products for the same condition are tested against other produces on the market to see if is more effective than existing products. This also applies to medical devices.

 3)      Costs:

  1. A drug’s cost is not a factor in the approval process.  The company sets its price  and the FDA sets the price it will allow. If there are price negotiations they between the pharmaceutical and insurance companies and some other groups, such as  the Veterans Administration and Medicaid. When Medicare Part D became law it was specifically prohibited from negotiating prices with pharmaceutical companies. Medicare is the nation’s largest and fastest growing health system.
  2. The Congressman who took leadership on the law left Congress to head PhRMA (Pharmaceutical Research and Manufacturers Association) the professional and lobbying arm of the Pharmaceutical industry.

4)   Patents:

  1.  A pharmaceutical product has a patent on a drug for 20 years.  When the patent expires the drug often becomes a generic product that can be made by the company or other companies that manufacture generic drugs and/ or it can become an over the counter drug.  However-
  2. A company can change the patent enough to become a “new” drug and the patent can be extended. This process can be repeated endlessly and has been with some drugs for chronic diseases.
  3. There are also “exclusively” provisions which can impact patents.  For FDA information on drugs and exclusivity, see the FDA requirement link below.
  4. 5)       Research and Development Costs:

1)      These costs are tax deductible.

Here is the link to the 2013 blog: http://oconnorreport.com/2013/06/special-report-worth-the-cost-and-benefit-drugs-and-devices-who-decides/

For an example of the FDA evaluation process of one drug in particular, see The Washington Post article on Praxada.  It  is worth reading to the end.


If these issues are of concern to you, write a letter to your Senator and Representative voicing your concerns.  A well-written letter is especially valued. It is best to send to the local office.

Kathleen O’Connor (c) October 15, 2015

About Kathleen

Kathleen O’Connor: 30+ year health care consumer advocate, non-profit executive and author. For more information about Kathleen, please see "About" on the main content bar above.
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